APPROVED BY CLIA, COLA, JCAHOACCEPTED BY THE COLLEGE OF AMERICAN PATHOLOGISTS

2015P R O G R A MG U I D E

2015 Program Guide Cover - 14831PTS.indd 3 12/18/14 2:18 PM

1

GENERAL TABLE OF CONTENTS 2015 Schedule…......................…………………………………………………………….…………….....................................................................................3 General Instructions……………………………………………………………………………….............................................................................................4-7 Online Reporting Instructions………………………………………………………………………………...............................................................................7-8 Reporting Form Instructions......................................................................................................................................................................9 Chemistry............................................................................................................................................................................................10-20 Specialty Programs…………………………………………………………………………..…………………………………………………………..………………………………19-20 Clinical Microscopy & Urinalysis.........................................................................................................................................................20-21 Coagulation.........................................................................................................................................................................................21-24 General Hematology Instructions............................................................................................................................................................24 Hematology.........................................................................................................................................................................................24-31 Immunohematology General Instructions...............................................................................................................................................31 Immunohematology...........................................................................................................................................................................31-33 Immunology........................................................................................................................................................................................34-37 Microbiology.......................................................................................................................................................................................38-45 Mycology……………………………………………………………………………………………………………………..………………………………………………….………………..47 Embryology, Andrology & Fetal Fibronectin.......................................................................................................................................48-50 Grading Procedures............................................................................................................................................................................51-52 Analyte Index......................................................................................................................................................................................52-66 General Attestation Form........................................................................................................................................................................67 Proficiency Testing Action Form...............................................................................................................................................................68 Corrective Action Checklist.................................................................................................................................................................68-69 Evaluating Proficiency Testing Results................................................................................................................................................70-71 GUIDE TO SPECIFIC PROGRAMS Acid-Fast Smears......................................................................................................................................................................................38 Activated Clotting Time.......................................................................................................................................................................21-22 Adulterated Urine....................................................................................................................................................................................10 Advanced Hematology with Manual Differentials……………………………………………………………………………………………………………………………..25 Affirm Microbial Screen...........................................................................................................................................................................38 Alcohol.....................................................................................................................................................................................................10 Ammonia, Serum.....................................................................................................................................................................................10 Antinuclear Antibody...............................................................................................................................................................................34 Antisperm Antibodies..............................................................................................................................................................................47 Antistreptolysin-O....................................................................................................................................................................................34 Bacteriology........................................................................................................................................................................................38-39 Bacteriology Complete……………………………………………………………………………………………………………………………………………………………….…40-41 Bilirubin, Supplemental……………………………………......................................................................................................................................10 Blood Gases........................................................................................................................................................................................10-11 Blood Cell Identification (Hematology programs)...............................................................................................................................24-25 Blood Culture, Bacteriology Complete.....................................................................................................................................................40 Campylobacter Screen, Bacteriology Complete……………………………………………………………………………………………………………………………….…41 Cardiac Markers, 2-vial.............................................................................................................................................................................11 Cardiac Markers, 5-vial………....................................................................................................................................................................11 C. Difficile Toxin Antigen Detection.........................................................................................................................................................41 Centrifugal Hematology......................................................................................................................................................................26-27 Chemistry and Microscopy, Body Fluids..................................................................................................................................................20 Chemistry, Basic.......................................................................................................................................................................................12 Chemistry, Comprehensive......................................................................................................................................................................13 Chemistry i-STAT......................................................................................................................................................................................13 Chemistry, i-STAT, Waived.......................................................................................................................................................................13 Chemistry, Special....................................................................................................................................................................................14 Chemistry, Urine......................................................................................................................................................................................14 Chemistry, Waived..............................................................................................................................................................................14-15 Chlamydia/GC/Strep Group B Antigen Screen.........................................................................................................................................41 Cholesterol Certification………………………………………………………………………………………………………………………………………………………………….…19 Clinical Microscopy..................................................................................................................................................................................20 CoaguChek PT XS/XS Plus, Basic..............…………......................................................................................................................................22 Coaguchek PT XS/XS Plus, Comprehensive..............................................................................................................................................22

2

GUIDE TO SPECIFIC PROGRAMS - continued Coagulation, Plasma................................................................................................................................................................................23 C-Reactive Protein...................................................................................................................................................................................34 Cryptococcal Antigen…………………………………………………………………………………………………………………………………………………………………………46 Cryptosporidium/Giardia Immunoassay..................................................................................................................................................42 D-Dimer, Chemistry..................................................................................................................................................................................15 Direct Antiglobulin Testing.......................................................................................................................................................................32 D (Rh) Typing Only By Slide or Tube Method...........................................................................................................................................33 Drug Monitoring, Therapeutic.................................................................................................................................................................15 Drug Screening, Urine..............................................................................................................................................................................15 EGFR/Creatinine…………………………………………………………………………………………………………………………………………………………………………..19-20 Embryo Grading.......................................................................................................................................................................................47 Erythrocyte Sedimentation Rate..............................................................................................................................................................25 Erythrocyte Sedimentation Rate-Rapid....................................................................................................................................................26 External Quality Assessment – WB Glucose……………………………………………………………………………………………………………………………………….19 Fertility Endocrinology.............................................................................................................................................................................16 Fetal Fibronectin (fFN).............................................................................................................................................................................47 Fetal Membrane Rupture Test.................................................................................................................................................................47 Fetal RBC’s………………………………………………………………………………………………………………………………………………………….……………………………..33 Fructosamine...........................................................................................................................................................................................16 GC Culture..........................................................................................................................................................................................38-39 Glucose, Whole Blood……………………………...............................................................................................................................................16 Glycohemoglobin.....................................................................................................................................................................................17 Gram Stain................................................................................................................................................................................................42 Gram Stain, Bacteriology Complete.........................................................................................................................................................40 Helicobacter Pylori Antibody...................................................................................................................................................................34 Hematology w/Diff A 3-part.....................................................................................................................................................................27 Hematology w/Diff B 5-part.....................................................................................................................................................................28 Hematology w/Diff C 5-part.....................................................................................................................................................................28 Hematology w/Diff D 3-part.....................................................................................................................................................................28 Hematology w/Diff E 5-part.....................................................................................................................................................................29 Hematology w/Diff G 5-part.....................................................................................................................................................................29 Hemoglobin & Hematocrit, Waived.........................................................................................................................................................29 Hemoglobin and Hematocrit, 5-vial.........................................................................................................................................................30 Hemoglobin A1C, Afinion.........................................................................................................................................................................17 Hepatitis Markers...............................................................................................................................................................................34-35 HIV Antibodies, Oral Fluid........................................................................................................................................................................35 HIV Antibodies, Waived...........................................................................................................................................................................35 HIV Markers.............................................................................................................................................................................................35 hsCRP.......................................................................................................................................................................................................17 Immunochemistry....................................................................................................................................................................................17 Immunohematology, Basic.......................................................................................................................................................................31 Immunohematology, Comprehensive................................................................................................................................................31-32 Immunohematology, Comprehensive Plus…………………………………………………………………………………………………………………………..…………….32 Immunohematology, Educational……………………………………………………………………………………………………………………………………..……………….32 Immunoproteins......................................................................................................................................................................................36 India Ink Preparation………………………………………………………………………………………………………………………………………………………..……………….46 Iron Binding Capacity…………………………………………………………………………………………………………………………………………………………..……….18-19 IVF Embryo Culture Media.......................................................................................................................................................................48 KOH Prparation……………………………………………………………………………………………………………………………………………………………….…………………46 Lead, Blood, Waived.................................................................................................................................................................................17 Lipids........................................................................................................................................................................................................18 Lyme Disease............................................................................................................................................................................................36 Microalbumin/Creatinine, Urine..............................................................................................................................................................18 Mononucleosis, Infectious, Waived.........................................................................................................................................................36 Mononucleosis, Infectious, 5-vial.............................................................................................................................................................36 Mycoplasma Antibody……………………………………………………………………………………………………………………………………………………………………....42

3

GUIDE TO SPECIFIC PROGRAMS - continued Occult Blood, Fecal...................................................................................................................................................................................20 Occult Blood, Gastric................................................................................................................................................................................20 Oximetry, Blood.......................................................................................................................................................................................18 Parasitology..............................................................................................................................................................................................43 Pregnancy, Serum or Urine (HCG) ...........................................................................................................................................................18 Reticulocyte Count...................................................................................................................................................................................30 Rheumatoid Factor...................................................................................................................................................................................36 Rotavirus……………………………………………………………………………………………………………………………………………………………………………………………44 Routine Hematology with Manual Differentials…………………………………………………………………………………………………………………………………30 Rubella.....................................................................................................................................................................................................36 Shiga Toxin…………………………………………………………………………………………………………………………………………………………………….………………….44 Sickle Cell Screen......................................................................................................................................................................................30 Sperm Count............................................................................................................................................................................................48 Sperm Morphology..................................................................................................................................................................................48 Sperm Motility.........................................................................................................................................................................................48 Sperm Viability.........................................................................................................................................................................................49 Strep Group A Antigen Screen.................................................................................................................................................................43 Strep Group A Antigen Screen, Waived...................................................................................................................................................43 Strep Group A Antigen Screen, Bacteriology Complete...........................................................................................................................40 Syphilis Serology.................................................................................................................................................................................36-37 Throat Culture.....................................................................................................................................................................................38-39 Throat/Urine Culture..........................................................................................................................................................................38-39 ToRCH Test...............................................................................................................................................................................................37 Tumor Markers........................................................................................................................................................................................19 Urease, Rapid Test (CLO)……………………………………………………………………………………………………………………………………………………………..…….45 Urinalysis..................................................................................................................................................................................................21 Urine Colony Count..................................................................................................................................................................................44 Urine Culture.......................................................................................................................................................................................38-39 Viral Antigen Screen.................................................................................................................................................................................45 Viral Antigen Screen, Waived……………………………………………………………………………………………………………………………………………………….……45 Whole Blood Prothrombin Time.........................................................................................................................................................23-24 2015 Ship Schedule Chemistry Shipping Dates Last Day for Replacement

Specimens Cut-off Date for Results Submission

Evaluations Returned

Q1 2015 January 20 January 26 February 2 February 27 Q2 2015 April 14 April 20 April 27 May 22 Q3 2015 September 1 September 8* September 15* October 9 Non-Chemistry Shipping Dates Last Day for Replacement

Specimens Cut-off Date for Results Submission

Evaluations Returned

Q1 2015 February 24 March 2 March 9 April 3 Q2 2015 May 19 May 26* June 2* June 26 Q3 2015 October 20 October 26 November 2 November 27 Andrology, Embryology

Shipping Dates Last Day for Replacement Specimens

Cut-off Date for Results Submission

Evaluations Returned

S1 2015 March 31 April 6 April 13 May 8 S2 2015 November 3 November 9 November 16 December 11

4

GENERAL INSTRUCTIONS PRECAUTIONS All units of human blood or blood products used in preparing specimens, except those used in the Hepatitis and HIV Markers program, have tested negative for HBsAg, HCV antibody and HIV antibody at the donor level.

When handling specimens from AAB-PTS, follow all precautions and recommendations from CDC and FDA, as well as the Occupational Safety and Health Administration (OSHA) Final Rule on Occupational Exposure to Bloodborne Pathogens published December 6, 1991 (Federal Register Volume 56, Number 235, pages 64175-64182). These recommendations and rules include but are not limited to the following: 1. The specimens should be handled only while wearing impermeable gloves. 2. Gloves should be replaced if torn or contaminated. 3. Specimens should be opened wearing a face shield or other appropriate eye, nose and mouth protection. 4. Do not pipet by mouth. 5. No eating, drinking or smoking is allowed in the laboratory. 6. Before leaving testing area, wash hands after removing gloves. 7. Specimens should be disposed of as biohazardous waste.

RECEIPT OF THE KIT 1. Samples are shipped via Federal Express. 2. E-mail notification of the FedEx tracking number is sent the day of each shipment to those participants that have

registered for email services. 3. Open immediately upon arrival. Check for damaged or missing specimens. 4. Call 800-234-5315 if replacements are required. Replacements will be sent only until the Monday following the

shipment date. Hours are Monday thru Friday 8 a.m. - 5 p.m. Central Time. 5. Most samples require refrigerated storage and some frozen storage. Please open the kit and read storage

instructions. Store samples as directed until they are analyzed. 6. Participants are responsible for notifying AAB when the testing kit has not been received within 3 days of the

shipment date. 7. Alternate shipping dates cannot be provided.

TESTING REGULATIONS The Clinical Laboratory Improvement Amendments of 1988 (CLIA ‘88) requires PT specimens to be analyzed as if they were patient specimens. To be in compliance you must not delay testing PT specimens unless your patient testing is also being delayed. Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Failure to return PT results or have them postmarked by the cut-off date displayed in the 2015 schedule on page 3 is unsatisfactory performance and results in a score of 0 for the testing event.

Per CMS requirement, under no circumstances should you ever send any proficiency testing sample to another laboratory for testing. This emphatically includes samples that you would normally send out for confirmation or follow up identification. This is to be followed REGARDLESS of your laboratory policy on such follow up testing. CMS will immediately revoke the license of any laboratory found to be referring proficiency testing samples, even if they are following their laboratory procedures for confirmation. Equally, CMS requires that you not perform testing on any sample that you suspect may be a proficiency testing sample received from another laboratory. You also must report laboratories you suspect of such activity. Severe penalties will apply to laboratories that perform proficiency testing for other laboratories or sites as well.

REPORTING RESULTS 1. See the sample reporting form on page 9 for more specific instructions on executing the forms. 2. To submit results via the internet, please see the instructions for online reporting on pages 7-8 or go to the website,

www.aab-pts.org, for instructions.

5

GENERAL INSTRUCTIONS - continued REPORTING RESULTS, continued 3. The attestation statement on the front or reverse of the Centers for Medicare and Medicaid Services (CMS)- scored analytes forms must be signed for each analyte by the analyst performing the procedure. In addition to the analysts’ signatures, the director or the director’s designee must sign only once for each reporting form. The designee for moderate complexity testing is the technical consultant while the technical supervisor is the designee for high complexity testing. There is no attestation statement for non-CMS scored modules (1 & 2 vial programs). If your state or other regulating agency requires attestations for these programs, please use a copy of the general attestation form found on page 68. CAP Participants, please note. The College of American Pathologists requires a signed attestation for all analytes. Please utilize the general attestation form found on page 68, or create an attestation form for all analytes through your on-line reporting form. 4. Retain photocopies of your results and submit the red printed originals in the envelope provided. For online results,

be sure to click the SUBMIT button. Be sure to print the final results page which includes your confirmation number. No corrections can be made for any results without a confirmation number.

5. Telefaxes and photocopies are not acceptable. Originals are required for optical scanning. 6. Results must be postmarked by the cut-off date displayed in the 2015 schedule and on each reporting form. 7. Late results will not be processed and will be scored as zero. 8. AAB is not responsible for results lost or delayed in the mail. Please consider taking advantage of our online

reporting. If online reporting is not an option for you, consider the use of either an overnight service or a 2-day service that can provide confirmation of delivery.

CODING YOUR METHODS Each shipment includes Instruction sheets. Do not return the instruction sheets with your reports as they are for your use.

Method Data sheets are included with each shipment, which include your specific reported Method Codes from the last reporting event. These Method Data sheets are only carried for one quadrimester and then are deleted. Since this data will determine how your currently reported results will be evaluated, please verify the entries in this list. If an entry is correct, do not recode it. If entries are missing or incorrect, please amend this list by coding/recoding method data directly on your results form(s). One exception is the Method Codes for WHOLE BLOOD GLUCOSE. These must be entered each time.

When coding your methods, ensure that you use current method codes. Refer only to those codes listed in red and white reporting form, the General Instructions pages or the Method Code Addendum for the current event. Only method codes (not method descriptions) can be used to code participants’ methods on the reporting forms.

If no acceptable method description can be found in the method list, leave the method code blank. Paperclip a package insert and/or method description to the report and we will code your method. If submitting results online, enter comment and fax insert and/or method description to 713-781-5008. Please write your AAB account number on the insert to allow us to match the new method with your results. If you do not report, or if you are late in reporting your results for an event, your method codes will be deleted from our database. You must recode all methods, reagents and instruments the following event or your results will be graded as “Method Code Not Reported”.

Coding a method other than the one actually being used usually jeopardizes a participant’s grading, even when results are transformed to mimic those of the method coded. We strongly recommend that participants report their results without transforming them to look like results from a method other than the one actually being used. Reporting untransformed results is not in violation of CLIA ‘88. CLIA ‘88 mandates that sample processing (not result processing) conform to that routinely applied to patient specimens.

SECONDARY METHODS / INSTRUMENTATION PT samples must be treated the same as patient testing. Testing proficiency samples by more than one test method or instrument during an event is not permitted by CMS, unless patients are also subjected to such testing. Starting in 2015, AAB offers special events for secondary instruments. You can run and report the samples on your primary and secondary analyzers as you choose. We will analyze the data and provide you with group statistics for each analyzer and

6

GENERAL INSTRUCTIONS - continued a correlation analysis for your primary and secondary analyzers. These program events ship after the scheduled PT event for the analyzers. CMS SCORING INSTRUCTIONS All scores for CLIA regulated analytes are automatically sent to CMS and State Agencies. Results are also sent to COLA and the CAP for participants that supply a COLA or LAP number. Scores will appear on the CMS cumulative score sheet only for those analytes that are regulated. The lists below indicate the priority assigned for reporting CLIA equivalent analyte groups to report to CMS. If you would prefer that different analyte from a group be preferentially sent to CMS, please let us know in writing as to your preference and we will be happy to accommodate your needs. If you are unable to participate for a proficiency testing event you must notify us in writing in advance of the event close. A CLIA requirement for excused non-participation is that patient testing not be performed during the timeframe of the event. Therefore your statement of intent not to participate must include an attestation that patient testing is not being performed at the time of the event, the reason for not participating in a proficiency testing and event when or if patient testing is expected to resume. If the non-testing is permanent or has no anticipated resumption, then you will receive a code of Dc indicating to CMS or your CLIA deemed authority that you are no longer performing this test. If you anticipate resumption of testing, and if you meet the CLIA requirement of participation in the two prior events, you will receive a code of ER or excused reporting. Please be aware, that a code of ER is subject to review by CMS or your CLIA deemed authority. We are required to abide by their decision and will remove the ER and convert your report to NR with a score of 0 if they feel your reason for non-participation is inadequate.” Bacterial Antigen Screen Glucose Microbiology Strep A Antigen Screen Serum Glucose Bacteriology Chlamydia Antigen Screen Blood Gases Throat/Urine GC Antigen Antigen Screen i-STAT, Serum Urine Strep B Antigen Screen Whole Blood Glucose Throat C. dificile A GC Culture C. dificile B Chloride/Potassium/Sodium Basic Chemistry Hematology Parasitology Blood Gases Hematology w/Diff A,B,C,D,E&G Cryptosporidium i-STAT Chemistry i-STAT Hgb & Hct Giardia Coagulation Parasitology Prothrombin Time hCG / Pregnancy Gardnerella WB Prothrombin Time hCG/b-hCG (quantitative) Coaguchek XS Plus, Protime, Serum pregnancy PO2 / PCO2 / pH Comprehensive (qual. Basic Chem) Blood Gases Prothrombin Time, Hemochron Serum pregnancy (qualitative) i-STAT Chemistry Urine pregnancy (qualitative) Syphilis Serology FTA-ABS HIV MHA-TP/TP-PA Anti-HIV-1 Confirmation VDRL/USR Anti-HIV-1 Screen EIA, RPR, RST, Trust HIV-1 p24 Antigen Viral Antigen Screen Oral Fluid HIV Screen Influenza A Oral Fluid HIV Western Blot Influenza B Respiratory Syncytial Virus (RSV) Rota Virus

7

GENERAL INSTRUCTIONS - continued Please follow all directions in filling out your reporting form completely. Once a report is graded, CMS does not allow for corrections due to participant’s clerical and/or omission errors.

CMS requires that laboratories failing to participate in testing events to be given unsatisfactory performance and results in a score of 0 for that testing event. CLIA Law states in PART 493--LABORATORY REQUIREMENTS, Subpart H- 493.823(b) the following: Sec. 493.823 Standard; Bacteriology (b) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- 1. Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; 2. The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and 3. The laboratory participated in the previous two proficiency testing events.

CORRECTIVE ACTION If the evaluation of your results indicates that corrective action is necessary, the Corrective Action Forms on page 70 may be copied and completed for your internal records. Do not submit these forms to AAB as it is for your internal use only. Remember that ungraded samples require review. You must determine that you have met the CMS requirement to demonstrate the accuracy of your method. If your review indicates you may have an accuracy problem, you must complete a corrective action just as if you were flagged for a miss.

ADDRESS CHANGES Address changes must be received in writing by either fax, email, or mail on institutional letterhead. Notice must be

received 14 days prior to the next shipment date for the address to be updated. Participants will be responsible for shipping charges to resend a shipment due to a late address change.

CANCELLATION POLICY A cancellation notice, on institutional letterhead, must be received by fax, email or mail 21 days prior to the shipping date in order to receive a credit or refund on a future shipment. Late enrollments received within the 21 days prior to the shipment waive the cancellation policy and no credit will be issued. The registration fee is nonrefundable.

ONLINE REPORTING INSTRUCTIONS Go to www.aab-pts.org. Log on using your account number (do not type any leading zeros) and password. Your initial password is printed on all of the red reporting forms; change this password after you log in. Please refer to the reporting forms you received with your specimens for result codes, method codes and special instructions. For questions pertaining to methods, testing procedures, or specimen problems ask for technical support. You are required to sign and keep the Attestation Statement for your records (see reporting forms). For your convenience, we have included the Attestation Statement on your online reporting form(s). You can print and sign these forms for your records. If you have any questions pertaining to the submission of results via the internet please call. The preferred method of reporting is via online submission, however if you prefer to mail your results, remember that the envelope must be postmarked by the cut-off date located on your reporting form. You will assume full responsibility for lost or delayed results that are sent by mail. Do not submit both mailed and online results.

IMPORTANT! After logging in please check the e-mail addresses we have on file by clicking “Update Account”.

8

ONLINE REPORTING INSTRUCTIONS -continued

1. Go to the Login page (http://www.aab-pts.org)

a. Enter your AAB Account Number & Password and click “go”. Disregard leading zeros. b. If this is your first time logging on you will find your initial password at the top of your reporting form otherwise

use your established password. 2. For qualitative results do not enter anything in the result fields other than the numeric codes listed on the forms.

Characters such as “+ -, pos neg, P or N” will not be recognized and results will not be processed. 3. Most methods codes do not have to be entered if we have your codes on file from the previous reporting period. If

you did not submit results for the previous shipment then you will have to reenter your method codes. Please see the “Method Data Sheet” for the codes we have on file for your lab.

4. Please enter the less than (<) and greater than (>) signs when appropriate in the online result field along with your lowest or highest reportable range.

5. Decimal points are designated for each analyte. The online reporting forms have fixed decimal place holders. For both online and paper reporting forms, be sure to enter proper decimal point designations. Boxes to the right of a decimal point should not be left blank.

6. After you complete each form, click the “Submit” button and print a copy for your records. The form you print should indicate a status of “Submitted” and include your confirmation number. Results are not accepted without a valid confirmation number. If you need to make changes to your form after clicking “Submit” simply click “Unlock this form” and resubmit before the deadline.

7. The on-line cut-off date and time is strictly enforced and once the deadline has passed you will no longer be able to enter results. Be certain to click submit and print a copy of your form.

We highly recommend you do not wait until the last day for on-line reporting to begin entering your results. Results reported on-line are downloaded at 10:00 pm Central time on the posted date, therefore If you happen to still be logged on after the cut-off time, results will not be evaluated.

9

MANUAL REPORTING INSTRUCTIONS

These forms are designed to be read by a scanner which translates hand print into characters a computer can use thus reducing human intervention. Please exercise care in filling out these forms. To ensure that your results are translated correctly please follow the rules listed below. 1. Please adhere to the decimal points that appear on the form. Do not add decimal positions that do not appear on

the form. This is also true if you report on-line using the web-based forms. The scanner will ignore any decimal points not already on the form. Example: If you enter a value such as “9.0” in a field that requires whole numbers, your result will be recorded as “90”. It is also very important to zero fill all positions to the right of the decimal points where applicable.

2. Use a ball point pen with black or blue ink. 3. Place entries wholly within the red result boxes. Do not create or draw your own boxes as the red ink is a special ink

that drops out. 4. Do not write comments on the reporting form. 5. Do not draw lines across the page. If you do not perform a procedure, simply leave it blank. 6. Do not use highlighters. 7. Do not staple. 8. Do not punch holes. 9. Use white out to make corrections. Do not try to redraw the red boxes. 10. Do not tape or stick anything to the form. 11. Do not include your machine print-outs unless you are communicating a problem running the tests. 12. Submit the completed original red reporting form. Faxes or copies cannot be read by the scanner. Only use

photocopies to record any non-numeric information such as (<) (>) and/or comments, as appropriate. 13. When calling, please have the AAB account number available so as to expedite

10

CHEMISTRY ADULTERATED URINE TEST Two simulated urine specimens per testing event, 10 mL For use with adulterant detection methods testing the following analytes:

Creatinine pH Interpretation of specimen Nitrate Specific Gravity

ALCOHOL Five liquid serum specimens per testing event, 2.0 mL The specimens are for the analysis of Acetone and Ethanol. They contain 1.0 g/L of sodium azide as preservative. Code reagent from the list on the reporting form. Code instrument from the list found in the General Instructions or Addendum, which is included with each testing event.

AMMONIA, SERUM Two liquid serum specimens per testing event, 2.0 mL The specimens are for the analysis of ammonia. Code reagent from the list on the reporting form. Code instrument from the list found in the General Instructions or Addendum, which is included with each testing event.

BILIRUBIN, SUPPLEMENTAL, 2-VIAL Two liquid specimens per testing event, 1.0 mL

BILIRUBIN, SUPPLEMENTAL, 5-VIAL Five liquid specimens per testing event, 1.0 mL Specimens are ready to use: 1. Do not open the vial until immediately before you are ready to test. Invert gently 5-10 seconds prior to sampling 2. Dispense the amount needed for testing and immediately re-stopper the vial and return it to the refrigerator. Keep

vials tightly capped and protected from direct light until testing is completed. 3. Minimize the samples exposure to air.

The specimens should be processed as fresh patient serum. Code reagents from the lists on the reporting form. Code instrument from the list found in the General Instructions or Addendum, which is included with each testing event.

BLOOD GASES Five aqueous specimens per testing event, 3.0 mL For the following analytes:

Chloride pH Glucose pO2 Ionized Calcium Potassium pCO2 Sodium Hematocrit

Duplicate specimens are sent in each shipment. Participants must process these specimens in the following manner: 1. Before using, the specimens must be brought to room temperature (20-28ºC). If the material has been stored at

temperatures above or below this range, remove ampules from the box and allow 1 hour for the material to equilibrate to room temperature. The gas-liquid equilibrium in each sealed ampule is dependent upon temperature. The most precise measurements will be obtained when storage temperature is controlled at 25ºC. The parameter most sensitive to temperature is pO2; it changes inversely with temperature approximately one percent per degree.

2. To complete the equilibration of gas and liquid phases, shake the ampules vigorously for at least fifteen seconds immediately prior to use. Hold the ampules at the tip and the bottom (with forefinger and thumb) to minimize temperature changes in the specimens.

3. Protect fingers with gauze, tissue or gloves and carefully snap off the neck of the ampule. 4. Introduce sample from the ampule within one minute after opening, using the procedure below which is appropriate

to the transfer method required: a. Direct Aspiration: each specimen may be sampled directly from the ampule.

11

CHEMISTRY continued BLOOD GASES, continued

b. Syringe Transfer: after opening an ampule, immediately insert a 20 gauge, 1 inch needle fitted to a clean, gas-tight syringe. Aspirate the specimen slowly from the bottom of the ampule without entrapping any air bubbles. Expel one or two drops through the needle, detach the needle from the syringe and immediately inject the sample directly into the instrument port.

Please test samples as patients unless specifically directed otherwise by AAB or your instrument manufacturer’s directions. Roche/AVL Omni users please note: Per manufacturer’s instructions you must run the samples in “patient mode” and not in “aqueous mode”. Chloride, Glucose, Potassium and Sodium-Do not report results from vials labeled Basic Chemistry here. If also enrolled in the Basic Chemistry module, select only one set of Chloride, Glucose, Potassium and Sodium results to be sent to CMS. Select the results from the Blood Gases module, only if you do not routinely test electrolytes on your main chemistry instrument.

Hematocrit - If you do not perform Hematocrit by another method, please let us know, otherwise Hematocrit results will not be reported to CMS.

Code your method/instrument using the list on the reporting form instructions.

CARDIAC MARKERS, 2-VIAL Two liquid samples per testing event, 1.5 mL, for the following analytes

BNP pro-BNP D-dimer Troponin I Myoglobin Troponin T

Test samples immediately upon receipt. If testing cannot be performed within 24 hours of receipt, store samples refrigerated at 2° to 8° C. Allow samples to sit at RT (20-28° C) for 15-20 minutes before testing.

Code reagents from the lists on the reporting form. Code instrument from the list found in the General Instructions or Addendum, which is included with each testing event.

CARDIAC MARKERS, 5-vial Five liquid samples per testing event, 1.5 mL, for the following analytes:

BNP pro-BNP CK2 (CK-MB), Qual. Myoglobin CK2 (CK-MB), U/L, Troponin I ng/mL or % of Total Troponin T D-dimer

1. Test samples immediately upon receipt. If testing cannot be performed within 24 hours of receipt, store samples refrigerated at 2° to 8° C. 2. Allow to sit at room temperature (20-28° C) for 15-20 minutes before testing. Code reagents from the lists on the reporting form and code the instrument from the list found in the General Instructions or the Addendum, which is included with each testing event.

D-Dimer - Qualitative or Semi-Quantitative methods must be reported as 010 for Negative and 011 for Positive. For Semi-Quantitative methods report any values above the normal range of your assay as Positive. Incompatible with Agen SimpliRed.

CK2 (CK-MB)-The reagent codes reported for CK2 (CK-MB) Isoenzymes reflect the units U/L, ng/mL or % of Total in which results are reported. However, participants must report their results directly, without conversion to other units. For example, participants using electrophoretic methods must report their results only in % of total enzyme, and participants using activity-based or mass-based methods must report their results only in U/L or ng/mL, respectively.

Troponin-Please test as soon as possible after receipt of specimens. CAP participants must enroll in the Cardiac Markers 5 vial program for BNP, proBNP, Troponin I and Troponin T

12

CHEMISTRY continued CHEMISTRY, BASIC Five liquid serum specimens per testing event, 5.0 mL, for the following analytes: Alanine Aminotransferase (ALT or SGPT) Aspartate Aminotransferase (AST or SGOT) Albumin Phosphorus Alkaline Phosphatase Potassium Bicarbonate Pregnancy (hcg), Serum Bilirubin, Total Sodium Calcium Total Protein Chloride Triglycerides Cholesterol, Total Urea Nitrogen Creatinine Uric Acid Glucose

Code the method and instrument from the list found in the General Instructions or the Addendum, which is included with each testing event.

Calcium-Results must be rounded to one decimal place and reported in mg/dL. To convert to mg/dL, multiply mmol/L by 4 and mEq/L by 2. If reporting ionized calcium concentrations, code your reagent as 0061 (all ionized calcium methods) for proper grading.

Creatinine-Vitros DT-60 participants using the 2-slide (ammonia-based) method should not report results based on diluted specimens if the diluted result is less than 7.5 mg/dL.

These samples are not compatible with the Nova CRT enzymatic method.

Electrolytes-Diluted or indirect ISE methods are those in which the sample is introduced to the electrode along with the diluent. In undiluted or direct ISE methods, the sample is passed directly to the electrode without being diluted. Undiluted methods tend to give higher readings, especially for sodium and chloride. Because of this, correction factors may be employed to make undiluted methods agree with diluted ISE and flame photometer methods. Use reagent codes labeled “diluted ISE” or “dil ISE” if you use a diluted method. Use reagent codes labeled “und ISE” for ISE methods with no diluent and use reagent codes labeled “und ISE/flame eq.” for undiluted ISE methods with a flame photometer correction factor.

Glucose-Do not report glucose values on the Basic Chemistry form using visual strip tests or instruments (usually hand-held) that generate whole blood glucose values. Whole blood glucose values are not equivalent to serum glucose values. Many whole blood instruments, such as the Abbott Vision and the Roche Reflotron do give serum glucose results and should be reported on the Basic Chemistry form. True whole blood glucose results can only be reported on specimens in the Whole Blood Glucose program.

Pregnancy (hCG), Serum-Basic and Comprehensive Chemistry vials can only be used to report serum pregnancy results. Results obtained using Basic and Comprehensive Chemistry vials must be reported on the Basic or Comprehensive Chemistry reporting form. If you are also enrolled in the Pregnancy module, you must report the results obtained from the Pregnancy vials on the Pregnancy reporting form. On the Pregnancy module, you may report either urine or serum results. You must select one set of results from among the serum pregnancy, urine pregnancy or quantitative hCG for CMS/COLA scoring. All other results will be graded, but the scores will not be reported to CMS/COLA as per CMS guidelines.

13

CHEMISTRY continued CHEMISTRY, COMPREHENSIVE Five liquid serum specimens per testing event, 5.0 mL, for the following analytes: Amylase Lactate Dehydrogenase Alpha-Fetoprotein (AFP) (LD or LDH) Cortisol Lipase Creatine Kinase Magnesium (CK or CPK) Thyroid Stimulating Glutamyltransferase Hormone (TSH) (GGT) Gamma Thyroxine, Free (FT4) hCG (beta or intact) Thyroxine, Total (TT4) Iron Triiodothyronine, Total (T3) Lactic Acid T Uptake

Code the method and instrument from the list found in the General Instructions or the Addendum, which is included with each testing event.

Lactic Acid-Report results in mmol/L.

Lipase-Report results in U/L.

Magnesium-Report this analyte’s results on the proper line (according to the units used - mg/dL or mEq/L).

Thyroxine, Free (FT4)-Report results in ng/dL. To convert pmol/L to ng/dL by multiplying by 0.0777.

Triiodothyronine, Total (T3)-Report results only in ng/mL. Divide ng/dL results by 100 to convert to ng/mL.

T-Uptake-Participants using the Abbott AxSYM, IMx or TDx; Roche fluorescence polarization method or the Roche Elecsys should report results on the TUp Units/TBI line. The FT4 and T-uptake analytes are not compatible with the J & J Vitros/Eci instrument.

CHEMISTRY, i-STAT Five liquid specimens per testing event, 2.5 mL, for the following analytes:

Bicarbonate (CO2) pH Calcium, Ionized pCO2 Chloride pO2 Creatinine Potassium Glucose Sodium Hematocrit Urea Nitrogen (BUN) Hemoglobin Lactate

For CMS purposes, you must choose between i-STAT Chemistry and routine Chemistry for reporting analytes. In addition, for CMS purposes, you must choose between i-STAT Hemoglobin / Hematocrit and any routine Hematology Program. We cannot report duplicate analytes between i-STAT and/or routine Chemistry / Hematology Program(s)

CHEMISTRY, i-STAT, WAIVED Two liquid specimens per testing event, 2.5 mL, for waived cartridges

Bicarbonate (CO2) Hemoglobin Calcium, Ionized Lactate Chloride Potassium Creatinine Sodium Glucose Urea Nitrogen (BUN) Hematocrit

If using both waived and non-waived cartridges, you must purchase the 5-vial non-waived program. Do not report non-waived cartridges with the waived program.

14

CHEMISTRY continued CHEMISTRY, SPECIAL Two liquid serum specimens per testing event, 3.0 mL, for the following analytes:

Ferritin Prostate Specific Antigen Folate (PSA), Total Homocysteine T3, Free Pre-Albumin Testosterone Prolactin Vitamin B12

Code reagents from the Instrument Master List on the back of the reporting form. Code instruments from the list found in the Addendum, which comes with the specimens. Testosterone-Report results only in ng/dL. Multiply ng/mL results by 100 to convert to ng/dL.

CHEMISTRY, URINE Two liquid synthetic urine specimens per testing event, 10.0 mL, for the following analytes:

Amylase Phosphorus Calcium Potassium Chloride Sodium Creatinine Total Protein Glucose Urea Nitrogen Magnesium Uric Acid Osmolality

Only results from vials labeled “Chemistry, Urine” may be reported on the Chemistry, Urine form. Do not report results from the “Basic & Comprehensive Chemistry” vials on this form. Code reagents (which include method principles) from the list on the reporting form and instruments from the lists found in the Instrument Code list, which comes with the specimens.

For qualitative or semi-quantitative results, please enroll in the Urine Microalbumin/Creatinine or the Urinalysis programs. This program uses its own vials. Be sure not to use the Urinalysis or Urine Microalbumin/Creatinine vials for Urine Chemistry testing.

Calcium - Results must be rounded to one decimal place and reported in mg/dL. To convert to mg/dL, multiply mmol/L by 4 and mEq/L by 2.

Creatinine - Vitros DT-60 participants using the 2-slide (ammonia-based) method should not report results based on diluted specimens if the diluted result is less than 7.5 mg/dL.

Electrolytes - Diluted or indirect ISE methods are those in which the sample is introduced to the electrode along with the diluent. In undiluted or direct ISE methods, the sample is passed directly to the electrode without being diluted. Undiluted methods tend to give higher readings, especially for sodium and chloride. Because of this, correction factors may be employed to make undiluted methods agree with diluted ISE and flame photometer methods. Use reagent codes labeled "diluted ISE" or "dil ISE" if you use a diluted method. Use reagent codes labeled "und ISE" for ISE methods with no diluent and use reagent codes labeled "und ISE/flame eq." for undiluted ISE methods with a flame photometer correction factor.

CHEMISTRY, WAIVED Two liquid serum specimens per testing event, 5.0 mL, for the following analytes NOTE: This is for waived instruments only. Cholestech users do not need to enroll in separate lipids analytes program: Alanine Aminotransferase (ALT/SGPT) Aspartate Aminotransferase (AST/SGOT) Albumin HDL Cholesterol Alkaline Phosphatase Phosphorus Bicarbonate (CO2) Potassium Bilirubin, Total Pregnancy, Qual. (urine) Calcium Protein, Total Chloride Sodium

15

CHEMISTRY continued CHEMISTRY, WAIVED, continued Cholesterol, Total Triglycerides Creatinine Urea Nitrogen (BUN) Glucose Uric Acid

Code reagents from the list on the reporting form and instruments from the Instrument Code list, which comes with the specimens. This program is compatible with the Abaxis Piccolo and the Cholestech. For users of the Cholestech LDX, to insure uniformity of results and per manufacturer’s directions, you must be sure to change the sample type on the instruments Configuration Menu to “Serum”. You must do so even if you routinely only run whole blood samples. Please do not forget to reset the instrument to “Whole Blood” once you are finished with proficiency testing. Glucose - Do not report glucose values on the Chemistry, Waived form using visual strip tests or instruments (usually hand-held) that generate whole blood glucose values. Whole blood glucose values are not equivalent to serum glucose values. Many whole blood instruments, such as the Abbott Vision and the Roche Reflotron do give serum glucose results and should be reported on the Chemistry, Waived form. True whole blood glucose results can only be reported on specimens in the Whole Blood Glucose program.

D-DIMER Two liquid specimens per testing event, 1.0mL, for the analysis of D-Dimer Note: Use Cardiac Markers Vials 1 and 2. Specimens should be processed as a fresh patient sample. Test samples immediately on receipt. If testing cannot be performed within 24 hours of receipt, store samples at 2 to 8 degrees C. If samples are frozen, thaw samples completely at room temperature. Occasionally mix by gentle inversion. Do not heat sample to thaw. Code your method using the list on the D-Dimer reporting form. Qualitative or semi-quantitative results must be reported as 011 positive/ 010 negative. Report any value above the normal range for your assay as positive. Incompatible with Agen SimpliRed.

DRUG MONITORING, THERAPEUTIC Five liquid serum specimens per testing event, 5.0 mL, for the following analytes:

Acetaminophen Phenytoin Carbamazepine Salicylates Digoxin Theophylline Gentamicin Tobramycin Lithium Valproic Acid N-Acetyl (NAPA) Vancomycin Phenobarbital

Salicylates-Report results in the appropriate line for your reporting units (mg/L or mg/dL). To convert mg/dL to μg/mL, multiply by 10. Note that mg/L and μg/mL are equivalent.

Code reagents from the Method List on the reporting form. Code instrument from the Instrument Master List found in the General Instructions or Addendum, which is included with each testing event.

DRUG SCREENING, URINE Two vials of synthetic, liquid urine per testing event, 10 mL, for the following analytes: Drugs of Abuse Minimum Target Category Concentrations Alcohol (Ethanol) 0.050% or 50 mg/dL Acetaminophen 0.4 μg/mL Amphetamines (dl-Amphetamine, d-Methamphetamine) 1000 ng/mL Barbiturates (Secobarbital) 300 ng/mL Benzodiazepines (Diazepam) 300 ng/mL Buprenorphine 20 ng/mL Cannabinoids (11-nor-delta-9-THC-carboxylic acid) 100 ng/mL Cocaine Metabolite (Benzoylecgonine) 300 ng/mL Cotinine 200 ng/mL

16

CHEMISTRY continued DRUG SCREENING, URINE, continued LSD 0.5 ng/mL MDMA (Ecstasy) 500 ng/mL Methadone (Dolophine) 300 ng/mL Methadone Metabolite 100 ng/mL Methaqualone (Qualudes) 300 ng/mL Methamphetamine 1000 ng/mL Opiates (Morphine) 2000 ng/mL Oxycodone 100 ng/mL Phencyclidine (PCP) 25 ng/mL Propoxyphene (Darvon) 300 ng/mL Tricyclic Antidepressants (Amitriptyline) 1000 ng/mL

When present, drugs are spiked at greater than the minimum target concentrations listed above. These concentrations are not cut-off values. Code method codes from the list on the reporting form. If your method does not discriminate among Amphetamine, Methamphetamine and/or MDMA, please report Amphetamine results only. Do not report Methamphetamine or MDMA. Similarly for Opiates, please report Opiates only if your method does not discriminate among Methadone, Oxycodone and/or Morphine.

FERTILITY ENDOCRINOLOGY Two liquid serum specimens, 5.0 mL, per testing event for the following analytes:

DHEA-s Follicle-Stimulating Estradiol Hormone (FSH) Estriol (unconjugated) Luteinizing Hormone (LH) Progesterone

Run Estradiol and Estriol testing as soon after receipt as possible. If testing is to be delayed, the Fertility Endocrinology samples must be frozen within 48 hours of receipt. Thaw samples completely at room temperature. Occasionally mix by gentle inversion. Do not heat sample to thaw. Code reagents from the list on the reporting form. Code instrument from the Instrument Master list found in the General Instructions or Addendum, which is included with each testing event.

FRUCTOSAMINE Two liquid serum specimens per testing event, 1.0 mL Code reagents from the list on the reporting form. Code instrument from the list found in the General Instructions or Addendum, which is included with each testing event. Report on the appropriate line of the reporting form, depending on whether your method is calibrated in μmol/L of glycated polylysine (pLys) or in mmol/L of 1-deoxy-1-morpholino-fructose (DMF). Samples are not compatible with the LXN Duet.

GLUCOSE, WHOLE BLOOD Two (Basic) specimens per testing event, 1.0 mL Five (Comp.) specimens per testing event, 1.0 mL This material is a plasma based sample specifically formulated for whole blood instruments, small whole blood based glucometers. Instruments such as the Roche Reflotron and Abbott Vision should enroll in the Basic Chemistry module. Abbott i-Stat instruments should enroll in i-Stat or Basic Chemistry.

The samples uses special additives which mimics whole blood without the interferences found in hemolysate of fixed RBC based products. Allow the vials to stand for 15 minutes at room temperature (15-30 °C). Mix vial gently by rolling between the palms of the hands for 20 seconds. Gently invert 2 -3 times then repeat the rolling for 20 more seconds. Assay the specimens for glucose using the same procedures that you would use for patient fingerstick specimens.

Method codes are included on the reporting form(s) and must be reported each time for results to be peer graded.

17

CHEMISTRY continued GLYCOHEMOGLOBIN, 2 vial Two liquid hemolysate specimens per testing event, 1.0 mL.

GLYCOHEMOGLOBIN, 5 vial Five liquid hemolysate specimens per testing event, 1.0 mL.

Make sure results are reported on the correct line according to method type – HbA1c, HbA1 or GHb.

CAP participants must enroll in the 5 vial program.

INSTRUCTIONS FOR USE 1. Liquid 1.0 mL sample. Remove sample from refrigerator and mix by gentle inversion. Do not shake or mix

mechanically. 2. Refer to instrument or assay instruction manual for analyzing control material. 3. After sampling, replace stopper and return to original package for maximum open vial stability at 2 -8 degrees C.

Specimens are to be processed as if they were whole (un-hemolyzed) blood, even though they will arrive without the cells intact. For Tosoh instruments please follow your instruments procedure for running control material.

Code reagents from the list on the reporting form. Code instrument from the list found in the General Instructions or Addendum, which is included with each testing event with the specimens.

HEMOGLOBIN A1C, AFINION Two liquid hemolysate specimens per testing event, 0.5 mL. Samples are for hemoglobin A1C assay (HgbA1c) with Afinion by Axis Shield.

HIGH SENSITIVITY (hs)-CRP Two liquid specimens per testing event, 1.0 mL, for the analysis of hsCRP. Specimens should be processed as a fresh patient sample. Note: use Cardiac Markers Vials 1 and 2. Samples should be tested immediately on receipt or stored refrigerated until testing is performed. If samples are frozen, thaw samples completely at room temperature. Occasionally mix by gentle inversion. Do not heat sample to thaw. Quantitative results are to be entered on the hsCRP reporting form. Code the method used by entering the appropriate code from the list on the form.

IMMUNOCHEMISTRY Two lyophilized specimens per testing event, 2.0 mL, for the following analytes:

C-Peptide PTH Insulin Vitamin D

Reconstitution instructions: 1. Add 2.0 mLs of deionized or distilled water to each vial with a volumetric pipette. 2. Mix by gently swirling the vials followed by 2 to 3 gentle inversions. 3. Allow to sit for 15 minutes and then gently swirl to ensure complete mixing. 4. Inspect vials to make sure that all the material is dissolved. Full reconstitution should take no longer than 30 minutes 5. PTH must be tested immediately upon reconstitution or kept frozen until ready to test. Insulin is good for 2 days

when kept tightly stoppered at 2-8° C.

Code your reagent using the list on the reporting form. Code instrument from the list found in the General Instructions or Addendum, which is included with each testing event with the specimens.

LEAD, BLOOD, WAIVED Two liquid hemolysate specimens per testing event, 6.0 mL, for blood lead. Code reagent from the Reagent Code list on the form. For use with waived methods only. Not for CMS reporting.

18

CHEMISTRY continued LIPIDS Five liquid serum specimens per testing event, 1.2 mL, for the following analytes:

Apolipoproteins A1 and B Lipoprotein (a) HDL Cholesterol LDL Cholesterol

Code reagents from the list on the reporting form. Code instrument from the list found in the General Instructions or Addendum, which is included with each testing event. For users of the Cholestech LDX, to insure uniformity of results and per manufacturer’s directions, you must be sure to change the sample type on the instruments Configuration Menu to “Serum”. You must do so even if you routinely only run whole blood samples. Please do not forget to reset the instrument to “Whole Blood” once you are finished with proficiency testing.

Lipids module is not compatible with the Abaxis Piccolo.

MICROALBUMIN/CREATININE, URINE Two liquid synthetic urine specimens per testing event, 3.0 mL For testing the following analytes:

Creatinine, Quant Creatinine, Semi-quant Microalbumin, Quant Microalbumin, Semi-quant

This program uses its own vials. DO NOT USE the Urinalysis or Urine Chemistry vials for Urine Microalbumin/Creatinine testing. Code reagents from the lists on the reporting form; Code instrument from the list found in the General Instructions or Addendum, included with each testing event.

OXIMETRY, BLOOD Five lyophilized specimens, 0.5 mL per testing event. Specimens are Carboxyhemoglobin, Methemoglobin, Oxyhemoglobin, and Total Hemoglobin measurements; compatible with all Oximetry instruments. Special attention is required to achieve a homogeneous solution after reconstitution. Reconstitute these specimens as follows: 1. Refrigerate at 2-8oC unopened until ready to analyze. 2. If materials are cold, allow to stand for 15 minutes at RT (15-30°C). 3. Remove metal cap and lift stopper carefully. 4. Add 0.5 mL of reagent grade water and replace stopper. 5. Hold at a 45 degree angle and gently swirl for about 30 seconds. 6. Allow to stand for 5-15 minutes. 7. Repeat steps 6 and 7 until a homogeneous solution is obtained. 8. Vials are ready to use and should be analyzed within one hour. Code your instrument using the Method Codes list on the form.

PREGNANCY, SERUM or URINE (hCG) Five liquid specimens per testing event, 1.0 mL Samples are suitable for both serum and urine pregnancy kits. Only results from vials labeled “Pregnancy” may be reported on the Pregnancy form. Do not report results from the “Basic & Comprehensive Chemistry” vials on this form. Code your method using the list on the Pregnancy reporting form.

IRON BINDING CAPACITY Two lyophilized serum specimens, 2.0 mL for the following analytes:

TIBC (Total Iron Binding Capacity) UIBC (Unsaturated Iron Binding Capacity) Transferrin

Report the measured parameter only. Do not report both if one result is based solely on a calculation using total iron and the second answer. 1. Add 2.0 mL reagent grade deionized water with a volumetric pipet. 2. Invert occasionally until completely dissolved (do not shake or vortex). 3. Let stand for 15 minutes after dissolution.

19

CHEMISTRY continued IRON BINDING CAPACITY, continued 4. Invert again prior to sampling.

Code reagents from the lists on the reporting form; Code instrument from the list found in the General Instructions or Addendum, included with each testing event.

TUMOR MARKERS Two liquid serum vials, 2.0 mL, for the following analytes: Beta-2-microglobulin

CA 15-3 CA 19-9 CA 27-29 CA-125

Carcinoembryonic Antigen (CEA) Prostate-Specific Antigen, (PSA) Free Prostatic acid phosphatase (PAP)

Tumor Markers should be tested immediately upon receipt. If delay in testing is anticipated, keep the samples frozen. Once opened the samples are good for 5 days when kept tightly stoppered at 2-8oC.

Code reagents from the lists on the reporting form; Code instrument from the list found in the General Instructions or Addendum, included with each testing event.

SPECIALTY PROGRAMS EXTERNAL QUALITY ASSESSMENT - WB GLUCOSE Two specimens per testing event These samples are intended for multiple-site assessment of WB Glucose; up to 20 sets of WB Glucose values, in any combination of different operators and/or methods. However each line of results reported must be derived from the same method for all specimens.

The samples uses special additives which mimics whole blood without the interferences found in hemolysate of fixed RBC based products. Allow the vials to stand for 15 minutes at room temperature (15-30 °C). Mix vial gently by rolling between the palms of the hands for 20 seconds. Gently invert 2 -3 times then repeat the rolling for 20 more seconds. Assay the specimens for glucose using the same procedures that you would use for patient fingerstick specimens.

CHOLESTEROL CERTIFICATION Six fresh serum specimens per testing event, 3 mL Certification of clinical laboratories is based on a direct comparison of their measurements of fresh patient samples with measurements obtained with the Abell-Kendall reference method.

Receipt and Storage Upon receipt, examine contents for completeness and for any damage or leakage. There should be one set of 6 samples (3 mL each).

Specimen Analysis • Run specimens in duplicate over three consecutive days--for a total of six analyses per sample--over a period of

no more than 5 days from the date of receipt. • Return unused portion of the samples to the refrigerator for next day testing. • Operate and calibrate the analytical system according to the usual protocol for the test system.

EGFR/CREATININE Three liquid serum samples per testing event, 1 mL Storage and Stability

• Samples must be stored refrigerated at 2-8°C / 46-46°F and unopened samples will remain stable for 10 days at refrigerated temperature.

• Opened samples will remain stable for 7 days when refrigerated at 2-8°C / 36-46°F.

20

SPECIALTY PROGRAMS-continued EGFR/CREATININE, continued Sample Handling

1. Invert the sample gently several times to assure homogeneity of contents – avoid foaming. 2. Pipette the required volume of sample for testing. Re-cap and refrigerate the remaining sample. 3. Allow the aliquot of sample to equilibrate to room temperature (18-30°C / 64-86°F) before analysis. The sample

must be analyzed in the same manner as a patient specimen. Code the reagent and instrument used by entering the appropriate codes from the Master lists provided

CLINICAL MICROSCOPY & URINALYSIS CHEMISTRY AND MICROSCOPY, BODY FLUIDS 1 challenge per testing event, 3.0 mL

Liquid sample for analysis of the following analytes: Albumin LDH Amylase pH Chloride Sodium Cholesterol Total Protein Creatinine Triglycerides Lactic Acid Uric Acid

Photo images of fluid cells, crystals and other structures (Examples of Body Fluid: CSF, synovial fluid and exudates)

CLINICAL MICROSCOPY Six photomicrographs and one digital image per testing event for identification of the following analytes:

Fern Test Sperm Count, Qualitative KOH skin prep Stool Leukocytes Nasal Eosinophils Vaginal Wet Mount Pinworm Prep

Code your answers from the list on the bottom on the reporting form. If a photomicrograph demonstrates features which would be referred to another laboratory for identification, report the code for would refer. Sperm, qualitative photomicrographs are available as online digital images only. The image link (URL) will be found at the top of your online data entry form for Clinical Microscopy. If you cannot access the image online contact AAB Technical Support so other arrangements can be made. To insure that all aspects of Clinical Microscopy are covered, we will occasionally present variations from the normal samples or stains. In such cases adequate information on specimen preparation will be presented on the photo micrograph page. Please use the information from the micrograph page in making your result selection. If you would not perform testing using a given sample or stain, you should simply code your results Would Refer.

OCCULT BLOOD, GASTRIC Two simulated gastric specimens, per testing event, 2.0 mL

Occult blood pH

Refrigerate samples if not tested upon receipt. Allow to reach room temperature before testing.

Code methods from the list on the reporting form.

OCCULT BLOOD, FECAL Two liquid, simulated stool specimens per testing event, 1.5 mL

Refrigerate samples if not tested upon receipt. Allow to reach room temperature before testing.

Code methods from the list on the reporting form.

21

CLINICAL MICROSCOPY & URINALYSIS - continued URINALYSIS One liquid urine specimen per testing event, 10 mL, for the following analytes:

Bilirubin Nitrite Blood (Hemoglobin) pH Creatinine Protein Glucose Specific Gravity Ketones Urobilinogen Leukocyte Esterase

Two graded photomicrographs and one educational challenge per testing event for Sediment Identification.

CMS does not monitor urinalysis scores, except for urine pregnancy testing. The liquid specimen is intended only for Urinalysis procedures. Do not use for urine hCG or urine chemistry determinations.

Code your qualitative and semi-quantitative answers using only the codes listed on each line of the reporting form. Code your methods from the lists on the reporting form. If using a Bayer instrument, code the instrument rather than the dipstick. Use “pH-corrected” Specific Gravity codes only if you routinely correct for the pH of your specimen; otherwise, use the “pH-uncorrected” codes.

The liquid sample may contain crystals, red blood cells and/or white blood cells. These are primarily intended for screening of the presence of microscopics using automated instruments. If you wish, you may report the presence or absence of these microscopics on lines 13, 14 & 15 using a regular microscope. Do not report these as Urine Sediment Identification.

The Urine Sediment Identification consists of three photomicrographs; two graded challenges and one ungraded educational challenge. Choose your answers for the two graded challenges from the General Identification list on the form. The ungraded sample may present a more challenging photomicrograph for educational purposes. Choose your answers from either the General Identification or Detailed Identification lists on the form. If your laboratory does not perform detailed identifications of urine sediments, be sure and choose the best response from the General Identification list.

If you do not perform Urine Sediment Identification, leave all result fields blank. DO NOT report code 015 (would refer) for all 3 fields. If a photomicrograph demonstrates features which would be referred to another laboratory for identification, report code 015 (would refer) for that photo. You will be flagged as incorrect for reporting “would refer” for a normal cell feature. Leave all results blank if you do not perform Sediment Identification.

COAGULATION ACTIVATED CLOTTING TIME Two lyophilized specimens per testing event, diluent provided.

The specimens provided are intended only for activated clotting times, using Actalyke, International Technidyne (ITC), i-STAT or Medtronic instruments. Code the method used by entering the appropriate numeric code from the list on the reporting form and use only the reconstitution instructions on the reporting form which are specific to your method. PROCESS ONE SPECIMEN AT A TIME, including rehydration with the following instructions: a. Allow vials to reach room temperature. Equilibration may take up to 30 minutes. b. Be sure to use only H2O Diluent #1 to rehydrate ACT Specimen #1 and only H2O Diluent #2 to rehydrate ACT Specimen #2. c. Twist and flip up the caps on an ACT SPECIMEN vial and an ACT DILUENT vial with matching numbers (use only vials with white caps!). d. Use a plastic 3cc syringe to transfer 2.00cc of diluent to the specimen. e. DO NOT AGITATE THE SPECIMEN BEFORE 10 MINUTES. Allow at least 10 minutes for rehydration. Perform testing within 1 hour after rehydration.

22

COAGULATION-continued ACTIVATED CLOTTING TIME, continued Perform the ACT in the same manner as you would test a patient specimen (according to the manufacturer's instructions), with the following exceptions:

Hemochron (other than Hemachron Jr.) method: Using the same syringe you used for rehydration, transfer 0.50 cc of ACT CaCl2 to the specimen to start your timer. BE SURE TO USE THE YELLOW CAPPED VIAL WHICH IS NUMBERED THE SAME AS THE SPECIMEN! Before testing, shake the specimen vigorously for 20-30 seconds. The specimen needs to be uniformly dispersed before testing.

Hemochron Jr. method: Insert a cuvette into the analyzer. When the analyzer display reads “ADD SAMPLE…PRESS START”, use the same syringe you used for rehydration to transfer 0.5 cc of ACT CaCl2 to the specimen. Before testing, shake the specimen vigorously for 20-30 seconds. The specimen needs to be uniformly dispersed before testing. You have 5 minutes to complete the CaCl2 addition and to transfer sufficient specimen to fill the center well of the cuvette flush to the top, then press Start.

HemoTec ACT/ACTII methods: DO NOT USE THE INCUBATE SWITCH! Before testing, shake the specimen vigorously for 20-30 seconds. The specimen needs to be uniformly dispersed before testing.

HemoTec LRACT method: Before testing, shake the specimen vigorously for 20-30 seconds. The specimen needs to be uniformly dispersed before testing. Add the sample to each cartridge channel in the same manner as you would test a patient specimen, using the same syringe you used for rehydration. Then add 40 uL (~1 drop) of CaCl2 (Medtronic Catalog #550-11 or equivalent) to each channel.

i-STAT system method: Using the same syringe used for rehydration, transfer 0.5cc of ACT CaCl2 to specimen. Before testing, shake the specimen vigorously for 20-30 seconds. The specimen needs to be uniformly dispersed before testing. Draw sample back into same syringe, minimum of 2.5cc, and dispense necessary volume to fill line of i-STAT cartridge. Close cartridge and immediately insert cartridge into i-STAT analyzer.

As per manufacturer recommendations, use the Proficiency Test path. See Technical Bulletin 17-Mar-11

COAGUCHEK XS/XS PLUS, BASIC Two lyophilized specimens per testing event. COAGUCHEK XS/XS PLUS, COMPREHENSIVE Five lyophilized specimens per testing event

NOTE: These samples are compatible with Roche CoaguChek XS and XS Plus instruments only for testing of INR only on the XS, and Prothrombin Time (PT) / INR on the XS Plus. Participants with instruments which assay either plasma or whole blood such as Bayer/CVDI TAS, HemoTec ACT or Sienco SonoClot, should enroll in the Coagulation module.

Reconstitute according to directions below and test one vial at a time. The reconstituted PT solutions are stable for 30 minutes after the diluent has been added. 1. Allow the samples to come to room temperature for 15-20 minutes before reconstituting. 2. Remove the screw cap and rubber stopper from the bottle, taking care not to remove any of the dried plasma. 3. Cut the tip off of the diluent dropper to dispense diluent into the bottle without touching the dried plasma or spilling

any diluent. 4. Gently squeeze the dropper bulb to dispense the entire contents of the dropper into the bottle and replace the

rubber stopper. 5. Do not discard the dropper as it will be used to dispense materials onto the test strip. 6. Do not shake or invert the bottle. Gently swirl to dissolve the dried plasma. 7. Allow the bottle to sit undisturbed for at least 1 minute, but test materials within 30 minutes. 8. Follow the manufactures instructions for inserting a test strip into your meter. 9. Use the dropper to take up and dispense materials onto the test strip. 10. Repeat reconstitution instruction steps above, for each PT sample material. 11. Enter results on your reporting form and enter the appropriate code from the list on the reporting form.

23

COAGULATION - continued COAGULATION, PLASMA Five lyophilized plasma specimens per testing event, 1.0 mL, for the following analytes:

Activated Partial Thromboplastin Time (APTT) Fibrinogen INR Prothrombin Time (PT) Reconstitute these specimens as follows: 1. Add 1.0 mL reagent grade water with a volumetric pipet. 2. Invert occasionally until completely dissolved (do not shake). 3. Let stand for 15 minutes after dissolution. 4. Invert again prior to sampling. Once reconstituted, the five coagulation specimens should be processed as though they were fresh citrated patient plasma. If a result’s endpoints lack reproducibility, leave the result blank and paper clip a photocopy indicating an indeterminate result. When reporting online, use the comments section to report indeterminate results.

Participants using Roche CoaguChek XS or Roche CoaguChek XS Plus should enroll in the CoaguChek XS/ XS Plus Survey. Participants using the i-STAT instrument should enroll in the Whole Blood Prothrombin Time program. Participants using the Roche CoaguChek, CoaguChek S should note that these instruments are no longer supported and no compatible testing materials are available. Participants using the Hemochron should enroll in the WB Prothrombin Time, Hemachron program.

Code the reagent and instrument used by entering the appropriate codes from the lists provided on the reporting form. All manual coagulation methods must report instrument code 699 (tilt tube) or 700 (wire loop).

Users of Diagnostica Stago instruments, per manufacturer’s instructions, you must use the 0.85 slope correction factor when reporting APTT results. You must use this correction regardless of whether or not you use it for patient results.

Fibrinogen-Report fibrinogen results only in mg/dL.

WHOLE BLOOD PROTHROMBIN TIME Five specimens per testing event These specimens are compatible with the Abbott CoaguSense and i-STAT coagulation systems. The ITC Microcoag and Roche Coaguchek instruments are NOT compatible with these samples. Code the instrument by entering the appropriate code from the list on the reporting form.

Combined Instructions for the i-STAT and CoaguSense Systems

NOTE: Please read all instructions before testing. It is recommended that you process one specimen at a time. Specimens must be used IMMEDIATELY after reconstitution. You will receive 5 vials of lyophilized plasma and 5 vials of calcium chloride diluent.

1. Remove the five plasma specimens and five calcium chloride diluent vials from the refrigerator and warm to room temperature (18-30°C) for a minimum of 45 minutes.

2. Remove the cap and stopper from one vial of lyophilized plasma and the cap from one vial of diluent. 3. Pour the entire contents of the diluent vial into the vial of plasma. Insert the stopper back into the vial of

plasma. 4. Allow the vial to sit at room temperature for 1 minute. While this is occurring, be sure to have your analyzer

turned on and the Prothrombin Time (PT) cartridges or test strips available.

o If you are using the i-STAT analyzer, as per manufacturer recommendation, use the Proficiency Test path. See Technical Bulletin 17-Mar-11.

o If you are using the CoaguSense analyzer perform the following steps: o Remove a PT test strip from its pouch and insert into meter. o Display reads “WARMING UP” for less than a minute. o Meter then displays “APPLY SAMPLE”

5. Mix the contents of the plasma vial by gently swirling for 1 minute and then slowly inverting for 30 seconds. Do not shake the vial vigorously as this will cause bubbling and foaming of the sample. Be sure all lyophilized material has been reconstituted within the vial before continuing with step 6.

24

COAGULATION - continued WHOLE BLOOD PROTHROMBIN TIME, continued

6. If you are using the i-STAT analyzer: Using a transfer pipette, immediately transfer the reconstituted plasma into a PT/INR cartridge. Immediately seal the cartridge and insert it into the analyzer. Record the result.

If you are using the CoaguSense instrument: Using the CoaguSense pipettor or transfer tube, immediately apply 12 μL of sample to the test strip, as meter displays APPLY SAMPLE. Record the result.

7. Repeat steps 2 through 6 for the remaining samples. Code the instrument by entering the appropriate code from the list on the reporting form.

HEMATOLOGY GENERAL HEMATOLOGY INSTRUCTIONS Mixing Instructions All specimens for all programs must reach room temperature (18- 25oC) before being resuspended. To resuspend contents, roll the vials between the palms of the hands for 20 seconds in upright, then inverted positions. Place the vials on a mechanical mixer or gently invert manually for five minutes per instructions. Please review specific program instructions to verify if a mechanical mixer is permitted for your samples.

General Precautions Automated Instrument Issues-Participants may experience “backlit” white counts or “R” codes; without any other indications of specimen degradation. Participants need not be reluctant to report these results.

General Reporting Precautions Participants with 1-part differential instruments use only the first line designated “Lymphocytes” in the differential section of their forms. Participants with 2-part differential instruments must not use the second line designated “MD/MID/Mixed/Mono/Other” in the differential section of their forms; these participants must report one part on the “Lymphocytes” line and the remaining part on the “Granulocytes” line, regardless of more inclusive terms on their instruments (such as “MO+GR”).

Some participants have instruments that report specific granulocyte results (eosinophils and basophils) in addition to the total granulocyte count. These participants should use a 5-part differential appropriate for their specific instrument. Diff B, C, E and G are 5-part differential programs. Diff A and D are 3-part differential programs

BLOOD CELL IDENTIFICATION Five graded photomicrographs and two digital image educational challenges per testing event. Refer to the Blood Cell Photomicrographs result code list on the form and code a single answer for the cell(s) or cellular features(s) indicated by an arrow or circle in each photomicrograph without regard to results obtained from any of the Hematology blood specimens. All photomicrographs are derived from the same blood smear and should be associated only with the CBC data provided at the top of the photomicrographs sheet.

Choose your answers from either the General Identification or Detailed Identification lists at the bottom of the page. Many laboratories do not identify abnormal cell(s) or cellular feature(s). DO NOT attempt to identify structures beyond what you would routinely report from your laboratory. If your laboratory does not perform detailed identifications blood cells or cellular features, be sure and choose the best response from the General Identification list. If your laboratory performs detailed differentials or identifications, then you may use codes from either the General or Detailed Identification lists. Do not report code 610 (would refer) for all 5 fields. If a photomicrograph demonstrates features which would be referred to another laboratory for identification, report code 610 (would refer) for that photo. If you do not perform microscopic analysis of peripheral blood smears, leave all result fields blank and submit request to cancel program.

Do not use abnormalities in the provided clinical data as sole justification for reporting abnormal result codes. The photomicrograph must clearly represent an abnormal condition in order for a response of abnormal to be considered correct. Using an abnormal code for normal cells or cellular features will be flagged as incorrect. When a single cell is indicated for identification, do not use general descriptors such as Poikilocytosis unless asked to describe an overall condition in the instructions. Use either the general abnormal code; e.g, 615 Abnormal RBC, would refer, or a specific

25

HEMATOLOGY - continued BLOOD CELL IDENTIFICATION, continued code such as 641 Target Cell (codocyte) as appropriate. Under no circumstances should you ever send any proficiency testing sample to another laboratory for testing. Per CMS requirement, this emphatically includes samples that you would normally send out for confirmation or follow up identification. This is to be followed REGARDLESS of your laboratory policy on such follow up testing. CMS will immediately revoke the license of any laboratory found to be referring proficiency testing samples, even if they are following their laboratory procedures for confirmation. Equally, CMS requires that you not perform testing on any sample that you suspect may be a proficiency testing sample received from another laboratory. You also must report laboratories you suspect of such activity. Severe penalties will apply to laboratories that perform proficiency testing for other laboratories or sites as well.

Note: the same result codes may be used more than once per event.

Educational Challenge The educational challenges are optional ungraded samples representing more difficult cells or features. No credit or flagging is given. The results will merely be summarized and expert commentary provided to assist the laboratory in the assessment of more complex cell identification. These digital slide samples are only available online as link attachments on the reporting form. Computer requirements for viewing the digital slides using DigitalScope TM are given below in the Advanced Hematology with Manual Differentials.

ADVANCED HEMATOLOGY WITH MANUAL DIFFERENTIALS Digital images for manual, whole slide WBC differentials for High Complexity laboratories: The WBC differentials are combined with reporting of 2 challenges each of WBC and RBC identifications and 1 platelet identification/estimate. 2 - Whole-slide WBC Differential (s) 2 - WBC Morphology 1 - Platelet Morphology/Estimate 2 - RBC Morphology

This program uses DigitalScopeTM, using internet access. Please review computer system requirements for using the DigitalScopeTM. This program is based on electronic slide images found at http://aab -pts.org on the results entry page for Advanced Hematology with Manual Differentials. You will need a computer with access to the internet and Microsoft Internet Explorer 6.0 or later or Fire Fox 2.0 or later with Microsoft Silverlight plug -in installed. Differential You will perform a general review of the slide then you will be guided through a 25 cell differential. Please be sure to enter a result for each differential parameter, even if the results are 0%. Please use the basic differential groupings as taken from CLSI Standard H20-A2. Morphology Click on the respective morphology specimen links to view those cells. Use the result codes below for your identifications.

ERYTHROCYTE SEDIMENTATION RATE Two specimens per testing event Allow the samples to stand at room temperature for 20 minutes prior to use. Gently invert the vial until packed cells have been re-suspended and continue mixing for 30 seconds. Avoid foaming and do not vortex. Follow the manufacturer’s directions for filling the sample tubes.

These specimens are for manual and automated methods. Round all results to whole numbers to fit the reporting format provided. Code the method used by entering the appropriate numeric code from the list on the reporting forms.

Micro-ESR methods use tubes with 1.0 mm internal diameters. Westergren methods use tubes with approximate 30 cm length and 2.5 mm internal diameter. Wintrobe methods use tubes with approximate 10 cm length and 2.5 mm or larger internal diameters. Check the manufacturer’s package insert to verify the type of method to report. If the sample is diluted with saline prior to analysis, choose a diluted method for reporting results. PolyMedco Sedimat method is not compatible with elevated sedimentation rate samples provided in this program.

26

HEMATOLOGY – continued ERYTHROCYTE SEDIMENTATION RATE-RAPID Two specimens per testing event These specimens are for rapid ESR test systems only. Instructions and method codes are included on the reporting form. Compatible with Pro Sed Auto 5, Polymedco SediMat 10 and 15. All other methods should be enrolled in the Erythrocyte Sedimentation Rate program.

CENTRIFUGAL HEMATOLOGY 5 whole blood specimens per testing event for the following analytes:

Granulocytes Leukocytes Hematocrit Lymph & Monos Hemoglobin Platelets

Please test as soon as possible after receipt of the specimens, within 4 calendar days if possible. These specimens are only compatible with the Quantitative Buffy Coat (QBC) series of instruments, except the QBC HemaScan. Participants using older models in this series of instruments (which do not generate hemoglobin results) may report hemoglobin results on these specimens using the methods listed in the hemoglobin method code list on the reporting form. Specimen preparation instructions are included below and on the reporting form. Method Codes are listed on the reporting form. You must report these codes to have your results graded according to the tube and/or instrument used.

GENERAL INSTRUCTIONS TO PARTICIPANTS 1) This module contains centrifugal hematology specimens which are whole blood specimens for QBC Hematology methodologies. These specimens are extremely sensitive to stress such as exposure to temperature extremes, being left at room temperature or unusual agitation. Upon arrival, the specimens should be neither warm nor frozen. Examine specimens for severe hemolysis which may be caused by extreme temperatures or rough handling. Please refrigerate specimens immediately upon receipt in your laboratory and until testing can be performed. For optimum results run specimens as soon as possible after receipt. 2) Mixing: Mix one vial at a time and immediately prepare the QBC tube. Completely resuspend sediment before testing by rolling vial between the palms of the hands for 30-45 seconds. Do not use a mechanical mixer or rotator. 3) Sampling: Gently invert the vial 5-10 times just prior to sampling. Choose the QBC tube type that is used most frequently: QBC E-Z Prep and Standard: Using the QBC pipetter, aspirate the specimen directly from the well mixed vial. QBC CAPILLARY: Insert the capillary tube into the well mixed vial and obtain the specimen by capillary action. QBC AccuTube: Using the QBC pipetter, aspirate the specimen directly from the well mixed vial or obtain the specimen by capillary action until the specimen level is between the two black lines. QBC STAR: Using capillary action fill the QBC STAR tube from the well mixed vial. Rock the tube at least 4 times to mix before capping. 4) IMPORTANT: Selecting the correct assay mode is necessary for the appropriate evaluation of your results. Do NOT use the Proficiency Testing Mode.

27

HEMATOLOGY – continued CENTRIFUGAL HEMATOLOGY, continued All Manual Model Users: Once the tubes have been prepared, select the proper assay mode, venous or capillary, on the reader and complete reading as usual.

AutoRead Series Users: The identification of the QBC tubetype is automatic. Standard venous tube users should analyze QBC tube in the patient mode, "Insert QBC Tube" mode. All other QBC tube types should be analyzed in the control mode. Press the mode key until the control mode message appears in the display. Insert the prepared tube and close the platform door to start the analysis. QBC STAR Users: The identification of the QBC tube type is automatic. Promptly insert the tube into the QBC STAR analyzer. Close the analyzer door and press the start button.

CAUTION: POTENTIAL BIOHAZARDOUS MATERIAL Human blood components were not used in the manufacture of QBC Control. However, this product contains blood components from a non-human source and may transmit infectious disease. Follow the same precautions used for patient samples when handling or disposing of vials.

HEMATOLOGY w/DIFF A, 3-part 5 whole blood specimens per testing event for the following analytes:

Erythrocytes (RBC) Lymphocyte Hematocrit Md/Mid/Mixed/Mono/Other Hemoglobin Neutrophils/Granulocytes Leukocytes (WBC) Platelets

These specimens are compatible with the following instruments: Abbott Cell-Dyn 1200, 1400, 1600, 1700, 2000, 1800 series, Emerald and 2-part diff

Coulter Ac• J series, MD series, S Plus series, ST series, and T series (excluding Ac•T-5 & -8), Onyx and Nova impedance only

DANAM/Infolab all 2-part diff models, DC/Excell, DC18/Excell 16/I-1600 & 1800,

Diatron Abacus

Drew D3 and Evolution

HORIBA ABX all 3-part non-8-900 diff instruments, 9018, 9020, 9120, Argors/Helios series, Micros, Micros Stx/Stel/Stex and Spirit

Medonic CA620/530, M-Series and all 3-part diff instruments

Mindray BC-3200

The specimens must reach room temperature (15 -30°C) before being re-suspended. To re-suspend contents, roll the vials between the palms of the hands for 20 seconds in upright, then inverted positions. Place the vials on a mechanical mixer or gently invert manually for 5 minutes.

This program is intended for instruments with a 3-part differential therefore only total granulocytes are reported. Do not separately report eosinophils and basophils with this program.

Participants with 2-part diff instruments must report one part on the “Lymphocytes” line and the remaining part on the “Granulocytes” line, regardless of more inclusive terms on their instruments (such as “MO+GR”). 2-Part differential instrument users must not use the second line designated “MD/MID/ Mixed/Mono/Other” in the differential section of their forms.

28

HEMATOLOGY – continued HEMATOLOGY w/DIFF B, 5-part Five whole blood specimens per testing event for the following analytes:

Basophils Leukocytes (WBC) Eosinophils Lymphocytes Erythrocytes (RBC) Monocytes Hematocrit Neutrophils Hemoglobin Platelets

These specimens are compatible with the following instruments: Abbott Cell-Dyn 3000, 3200, 3500, 3700, 4000, Sapphire, Ruby DANAM Excell 22 and Excell 2280

The specimens must reach room temperature (15-30°C) before being re-suspended. To re-suspend contents, roll the vials between the palms of the hands for 20 seconds in upright, then inverted positions. Place the vials on a mechanical mixer or gently invert manually for 5 minutes.

HEMATOLOGY w/DIFF C, 5-part Five whole blood specimens per testing event for the following analytes:

Basophils Leukocytes (WBC) Eosinophils Lymphocytes Erythrocytes (RBC) Monocytes Hematocrit Neutrophils Hemoglobin Platelets

These specimens are compatible with the following instruments: Coulter DXH800, Gen-S, HMX, LH500, LH750/755/780, MAXM and STKS (the VCS series)

The specimens must reach room temperature (15-30°C) before being re-suspended. To re-suspend contents, roll the vials between the palms of the hands for 20 seconds in upright, then inverted positions. Place the vials on a mechanical mixer or gently invert manually for 5 minutes.

HEMATOLOGY w/DIFF D, 3-part Five whole blood specimens per testing event for the following analytes:

Erythrocytes (RBC) Lymphocytes Hematocrit Md/Mid/Mixed/Mono/Other Hemoglobin Neutrophils/Granulocytes Leukocytes (WBC) Platelets

These specimens are compatible with the following instruments: Sysmex E series, F-800, K series (includes the KX-21 and KX-21N), poocHi-100i. XP-300 and Royco Cell Counters

The specimens must reach room temperature (15 -30°C) before being re-suspended. To re-suspend contents, roll the vials between the palms of the hands for 20 seconds in upright, then inverted positions. Place the vials on a mechanical mixer or gently invert manually for 5 minutes.

This program is intended for instruments with a 3-part differential therefore only total granulocytes are reported. Do not separately report eosinophils and basophils with this program.

Participants with 2-part diff instruments must report one part on the “Lymphocytes” line and the remaining part on the “Granulocytes” line, regardless of more inclusive terms on their instruments (such as “MO+GR”). 2-Part differential instrument users must not use the second line designated “MD/MID/ Mixed/Mono /Other” in the differential section of their forms.

29

HEMATOLOGY – continued HEMATOLOGY w/DIFF E, 5-part Five whole blood specimens per testing event for the following analytes:

Basophils Leukocytes (WBC) Eosinophils Lymphocytes Erythrocytes (RBC) Monocytes Hematocrit Neutrophils Hemoglobin Platelets

These specimens are compatible with the following instruments: Sysmex SF-3000, XE-2100, XE-5000, XN-1000 and XS-800i/-1000i, and XT series

Allow vial to stand at room temperature for 20 minutes before mixing. Hold the vial horizontally between the palms of the hands. Briskly roll the vial back and forth for 60 seconds, then gently invert 10 times. Continue to mix in this manner until the cells are completely and uniformly suspended (i.e., no cell button is observed on the bottom of the vial). Do not shake the vial or use a mechanical mixer.

Sample from the vial using the same technique as a patient specimen.

Note: For all Sysmex 5 part differential instruments, specimens must be analyzed in the QC (control Key) program to obtain WBC differential, unless otherwise specified by the manufacturer. Read and follow the sample handling instructions before analyzing the samples. Perform analysis of all samples using the aspiration mode that the majority of your patient samples are processed in: either closed vial (primary) or open vial (secondary) mode. Process specimens in the QC (“Control Key”) mode.

HEMATOLOGY w/DIFF G, 5-part Five whole blood specimens per testing event for the following analytes:

Basophils Leukocytes (WBC) Eosinophils Lymphocytes Erythrocytes (RBC) Monocytes Hematocrit Neutrophils Hemoglobin Platelets

These specimens are compatible with the following instruments: HORIBA ABX Pentra 6OC+ series, 80, 120 Coulter Ac•T-5 and Ac•T-8

Allow vial to stand at room temperature for 20 minutes before mixing. Hold the vial horizontally between the palms of the hands. Briskly roll the vial back and forth for 60 seconds, then gently invert 10 times. Continue to mix in this manner until the cells are completely and uniformly suspended (i.e., no cell button is observed on the bottom of the vial). Do not shake the vial or use a mechanical mixer.

Primary Mode Sampling (Closed vial mode) – Place premixed vial in sample rack and test.

Secondary Mode Sampling (Open vial mode) – Allow the vial to rest undisturbed about 15 seconds for dispersion of small air bubbles. Immediately prior to use, gently invert vial 10 times.

NOTE: Per manufacturer’s instructions, specimens MUST be analyzed in QC mode to obtain an accurate WBC differential.

HEMOGLOBIN & HEMATOCRIT, WAIVED 2 challenges per testing event Whole blood samples for waived testing of hemoglobin and hematocrit only. The specimens must reach room temperature (15 -30°C) before being re-suspended. To re-suspend contents, roll the vials between the palms of the hands for 20 seconds in upright, then inverted positions. Place the vials on a mechanical mixer or gently invert manually for 5 minutes.

Abbott i-STAT users As per manufacturer recommendations, use the Proficiency Test Path. See Technical Bulletin 17 -Mar-11.

30

HEMATOLOGY – continued HEMOGLOBIN & HEMATOCRIT, 5-VIAL 5 challenges per testing event Whole blood samples for testing of hemoglobin and hematocrit only.

The specimens must reach room temperature (15 -30°C) before being re-suspended. To re-suspend contents, roll the vials between the palms of the hands for 20 seconds in upright, then inverted positions. Place the vials on a mechanical mixer or gently invert manually for 5 minutes.

Abbott i-STAT users As per manufacturer recommendations, use the Proficiency Test Path. See Technical Bulletin 17 -Mar-11.

ROUTINE HEMATOLOGY WITH MANUAL DIFFERENTIALS Two digital slide images provided online.

This program uses DigitalScopeTM, using internet access. Please review computer system requirements for using the DigitalScopeTM. This program is based on electronic slide images found at http://aab-pts.org on the results entry page for Routine Hematology with Manual Differentials. You will need a computer with access to the internet and Microsoft Internet Explorer 6.0 or later or Fire Fox 2.0 or later with Microsoft Silverlight plug -in installed.

This is a supplemental program for labs that only report the automated differential for patients, performing only supplemental slide reviews or for moderate complexity labs reporting routine differentials only. This program requires the participant to perform a limited differential and will also focus on the microscopic review that would routinely follow an instrument flag or high/low value requiring further investigation. This program will not be reported to CMS. Enrollees will have to report their Automated White Blood Cell Differential or sign up for Blood Cell ID for CMS reporting.

RETICULOCYTE COUNT Two specimens per testing event, 1.0 mL

Specimens are for manual counts and automated instruments. Samples are compatible with the following instruments: Abbott Cell-Dyn 3200, 3500, 3700, 4000 Beckman Coulter HMX, LH, XL, STKS, MAXM Becton Dickinson FACS Series Horiba ABX Pentra Siemens Advia Sysmex Series

Samples are not compatible with the: Beckman Coulter Gen-S

Specimens do not require reconstitution. Prior to testing mix as follows: 1. Refrigerate specimens upon arrival and until ready to test. 2. Mix specimens by gentle inversion between thumb and index finger until the red blood cells are completely resuspended. Do not mix mechanically. Do not rub between palms of hands. 3. Perform testing as you would patient samples.

SICKLE CELL SCREEN Two whole blood specimens per testing event, 2.5 mL Specimens are human cells in a preservative media, for manual, semi-automated and automated instruments for testing the presence of Hemoglobin S using solubility tests or hemoglobin electrophoresis.

Samples are compatible with the following sickle cell solubility kits: Streck SICKLEDEX® Dade® Behring Sickle-Sol™ Solubility Test, Pacific Hemostasis SickleScreen® Sickling Hemoglobin Screening Kit Chembio Diagnostic System Sickle-STAT Columbia Calibre® Sickle Cell Reagent

31

HEMATOLOGY – continued SICKLE CELL SCREEN, continued Specimens do not require reconstitution. Prior to testing mix as follows: 1. Refrigerate specimens upon arrival. 2. Allow to equilibrate to room temperature (18-30°C) for approximately 15 min. prior to use. 3. To mix: (Do not mix mechanically.)

a. Hold vial horizontally between the palms of the hands and roll the vial back and forth for 20 to 30 seconds. b. Mix by rapid inversion to ensure the cells are suspended. c. Vials stored for an extended period of time may require extra mixing.

4. Perform testing as you would patient samples. IMMUNOHEMATOLOGY IMMUNOHEMATOLOGY TESTING GENERAL INSTRUCTIONS 1. Cell vials contain approximately 1.5 mL of a 3% red cell suspension. These cells have been prewashed. The

corresponding serum vials contain approximately 1.5 mL of serum. 2. These samples represent separate individuals where the serum and cells have been separated for transport and

storage. The numbered serum and the corresponding numbered cell suspension should be treated as one patient or donor.

3. Non-gel method (manual users) should gently resuspend the cells by repeated inversion of the vial. DO NOT SHAKE. These cells are ready for use and washing them prior to use is not necessary.

4. Gel method (manual) users should spin the cells down and remove the supernatant. Resuspend the cells back up to 3% using the appropriate diluent required by your method for ABO/Rh testing. For IgG gel card testing, spin down the 3% red cell suspension, remove the supernatant and resuspend to 0.8% solution using the appropriate diluent required by your method.

IMMUNOHEMATOLOGY, BASIC Five paired, washed cells and serum per testing event for the following analytes:

ABO Group D (Rho) Typing ABO Group - D (Rho) Typing 1. The paired cells and serum should be used for forward and reverse typing. 2. Code all your answers using only the numbers available on the reporting form. 3. Laboratories not performing sub-grouping of A should use code 443 in ABO Grouping. 4. Laboratories not performing the weak D (Du) test on D (Rho) negative specimens must report code 451 for Negative,

weak D (Du) not performed. Laboratories performing the weak D (Du) test on D (Rho) negative specimens must report either code 010 for negative or code 4 for weak D (Du) positive.

5. If code 010 (negative) is reported, it is assumed the weak D test was performed. A flag representing an incorrect answer will result, when the specimen is a weak D.

IMMUNOHEMATOLOGY, COMPREHENSIVE Five paired, washed cells and serum (simulated recipient) and a single washed cells (simulated donor) per testing event for the following analytes:

ABO Group Compatibility Testing (Crossmatch) D (Rho) Typing Unexpected Antibody Detection and Identification

ABO Group - D (Rho) Typing As noted above in the IMMUNOHEMATOLOGY, BASIC program. Unexpected Antibody Detection and Identification 1. Perform unexpected antibody detection and identification on the 5 serum samples. 2. If the ANTIBODY SCREEN is negative or you do not routinely perform ANTIBODY ID, leave the ANTIBODY ID boxes blank. 3. Do not report code 015 (would refer) for ANTIBODY ID unless you routinely perform ID in house but would refer this sample out.

32

IMMUNOHEMATOLOGY - continued IMMUNOHEMATOLOGY, COMPREHENSIVE, continued Compatibility Testing 1. For compatibility testing, assume the 5 paired cell/serum samples are 5 patients. The single compatibility cell sample is the donor unit. Perform compatibility testing using these samples. Results will be graded on the basis of serological compatibility, not whether the blood would actually be released for transfusion, a decision that often depends on clinical circumstances and local protocol. 2. If you perform immediate spin only, you must report codes 015, 510, or 511 only. Do not report codes 508 or 509 as you risk being flagged as wrong. 3. If you do not perform compatibility testing, then leave the Compatibility Testing blank. Leaving the result blank will not count against your grade. Do not extrapolate a compatibility result from other test results.

IMMUNOHEMATOLOGY, COMPREHENSIVE, PLUS Five paired, washed cells and serum (simulated recipient) and a single washed cells (simulated donor) per testing event for the following analytes:

ABO Group Compatibility Testing (Crossmatch) D (Rho) Typing Unexpected Antibody Detection and Identification RBC Antigen Typing

ABO Group - D (Rho) Typing As noted above in the IMMUNOHEMATOLOGY, BASIC program. Unexpected Antibody Detection and Identification and Compatibility Testing As noted above in the IMMUNOHEMATOLOGY, COMPREHENSIVE program. Compatibility Testing As noted above in the IMMUNOHEMATOLOGY, COMPREHENSIVE program. RBC Antigen Typing Perform antigen typing on washed cells according to your laboratory protocol.

DIRECT ANTIGLOBULIN TEST Two red cell suspensions. Suspension of red blood cells for direct antiglobulin testing.

1. Remove vials from refrigerator and allow to warm at room temperature for 15 minutes. 2. Mix vial by rolling back and forth between the palms of the hands with occasional gentle inversion. Do not use a

mechanical mixer. 3. Red cell suspensions are pre-washed. Washing prior to testing is not required unless hemolysis is noted. 4. Vials contain a 3 - 4% Red Blood Cell suspension. If your method requires a lower percentage of Red Cells, dilute

accordingly. Typical Gel methods require a 0.8% suspension. 5. Proceed with testing specimens as you would patient material.

Code all your answers using only the result code numbers available on the reporting form.

33

IMMUNOHEMATOLOGY - continued D (Rh) TYPING ONLY BY SLIDE OR TUBE METHOD Five washed red cells in suspension. This program is for performing D (Rh) Typing only by slide or tube method. Samples are red cells in a 30-45% concentration. Five simulated whole blood specimens per testing event 1. Treat this sample as whole blood. The red blood cell suspension is intended to simulate whole blood with a 30-45% c oncentration. For tube testing, adjust % red cells concentration per lab protocol. 2. Code all your answers using only the numbers available on the reporting form. 3. Laboratories NOT performing the weak D (Du) test on D (Rho) negative specimens must report code 451 for Negative, weak D (Du) not performed. 4. Laboratories performing the weak D (Du) test on D (Rho) negative specimens must report either code 010 for negative or code 452 for weak D (Du) positive. 5. If code 010 (negative) is reported, it is assumed the weak D test was performed and should the specimen be a weak D, a flag representing an incorrect answer will result. FETAL RBCs Two whole blood samples per testing event for the following: F cell (flow cytometry) Fetal Screen Hemoglobin F, quantitative

These materials are made from human blood values used to determine fetal RBCs in maternal blood samples. The fetal RBCs in the product are Rho or D antigen positive and the adult RBCs are Rho or D antigen negative.

Materials can be used with both flow cytometry assays and manual stains (KB) for the detection of RBCs containing Hb-F or Rho (D antigen).

Specimen Preparation 1. Allow tube to warm at ambient temperature for 15 minutes. Do not mix during this period. 2. Mix by rolling the vial horizontally between the palms of your hands 10 to 20 times and gently inverting the vial

about 10 times. Continue to mix until the cells are completely and evenly resuspended. Do not shake the vial or use a mechanical mixer.

3. Handle materials exactly as you would a patient sample. Pipette an aliquot from the vial and follow your laboratory’s established procedure for the detection of fetal cells. (KB users must dilute this product).

4. After sampling, carefully wipe the rim of the vial and the inside of the cap with a lint-free wipe. Replace the cap, ensuring it is tight. Return the vial to the refrigerator within 30 minutes of use.

Note to KB users: Since this material is a stabilized blood product, it may appear to stain darker or be more resistant to elution. While the adult and fetal cells are still distinguishable, using fresh eluting reagent, using room temperature fluids (25ºc), and increasing the eluting time may improve the stained appearance. Handling and Storage Store vials upright, tightly capped, and at 2-8°C when not in use. Avoid unnecessary cycles of warming and cooling. Protect product from freezing, from temperatures above 30°C and from prolonged time at room temperature (20-25°C). Indications of Deterioration The supernatant solution should be straw-colored to pink or light red. Discoloration of the supernatant fluid due to excessive hemolysis may be caused by excessive heat or freezing and may indicate product deterioration. Inability to recover expected values may also indicate product deterioration. Incomplete mixing, instrument malfunction, or defective stains are other potential causes of unacceptable results. Do not use the product if deterioration is suspected

34

IMMUNOLOGY ANTINUCLEAR ANTIBODY Five liquid serum specimens per testing event, 0.6 mL Participants may report results from any of the four types of screening methods: classical (IEA/IFA), anti-DNP (LA) or anti-ENA (EIA) or Algorithm based; but they must not report results from more than one screening method in the same testing event. Code either the absence or presence of antinuclear antibody, using either code 010 for negative (or for normal patterns in the case of IEA/IFA methods) or code 011 for positive (... for positive or for abnormal patterns in the case of IEA/IFA methods). Code the method used by entering the appropriate numeric code from the corresponding list on the reporting form. For CLIA purposes, you must report all five samples for one of the screening methods.

Report IFA patterns and individual antibodies on the appropriate reporting line, including the method code where applicable. ANTISTREPTOLYSIN O Five liquid serum specimens per testing event, 1.0 mL Code your qualitative answers using only the codes provided on the “Antistreptolysin O” line of the Diagnostic Immunology reporting form and code the method used by entering the appropriate numeric code from the list on the form.

C-REACTIVE PROTEIN Two liquid serum specimens per testing event, 1.0 m Code your qualitative answers using only the codes provided on the “C-Reactive Protein qualitative” line of the Diagnostic Immunology reporting form and code the method used by entering the appropriate numeric code from the list on the form. Quantitative results are to be entered on the subsequent line.

HELICOBACTER PYLORI ANTIBODY Two liquid serum specimens per testing event, 0.5 mLs These specimens are also designed to work with whole blood methods, but participants must use their method’s collection tubes just as they would for testing patients. Fill the collection tube directly from the specimen vial, then follow your routine testing protocol. Code your qualitative answers as either 010 for negative or 011 for positive and code the method used by entering the appropriate numeric code from the list on the form.

HEPATITIS MARKERS Five liquid serum specimens per testing event, 1.5 mL, for the following analytes:

Anti-HBc (IgG+IgM or IgM) Anti-Hepatitis A Anti-HBs HBeAg Anti-HCV HBsAg

Code your qualitative answers only with the result codes on each line of the reporting form and code your methods using the reagent codes included on the form.

If your method is immunoglobulin (Ig)-nonspecific or its specificity is not known, report results on the IgG line. Roche Elecsys Anti-HCV Based on the reagent package insert for the anti-HCV test performed on the Roche Cobas Elecsys, those participants reporting this test in our Hepatitis Markers proficiency testing program using method code 0826 can report the result code “015 Would Refer” for specimens with COI between 1.00 and 149.99. You must add a comment to your report form stating that the COI fell within that range when reporting that result code. You must retain your instrument printout in your records for reference when audited. Ref: Roche Diagnostics Anti-HCV document 05587166001V4, page 3/10

35

IMMUNOLOGY continued HEPATITIS MARKERS, continued Special Safety Precautions-These specimens should be handled as though they are capable of transmitting disease. Follow CDC and FDA recommendations as well as the Occupational Safety and Health Administration (OSHA) Final Rule on Occupational Exposure to Bloodborne Pathogens published December 6, 1991 (Federal Register Volume 56, Number 235, pages 64175-64182).

These specimens should be handled in a biological safety cabinet while wearing impermeable gloves. Remove the specimens from the can using forceps that are long enough to avoid cutting or scratching your hands on the can. Cover the caps of the vials with gauze while removing or replacing to prevent splashing. Do not pipet by mouth or use a needle and syringe with these specimens. Wash your hands after removing the gloves. These specimens should be autoclaved and disposed of as biohazardous waste.

HIV ANTIBODIES, Waived Two liquid samples, 1.0 mL for waived methods only For oral fluid methods, inoculate the samples to the specimen collection and transport device before testing.

HIV ANTIBODIES, ORAL FLUID Five liquid samples per testing event. Inoculate the samples to the specimen collection and transport device before testing. Western Blot may be performed on these specimens. The presence of any band along the prerequisite bands should be interpreted as positive.

HIV MARKERS Five liquid serum specimens per testing event, 1.0 mL, for the following analytes:

Anti-HIV-1 Screening Anti-HIV-1 Confirmation HIV p24 Antigen

These specimens are compatible for serum, plasma or whole blood methods.

Code your qualitative answers only with the result codes on each line of the reporting form and code your methods using the reagent codes included on the form.

To avoid false positive results, participants using membrane-based methods must centrifuge specimens prior to testing.

Screening and/or confirmatory results may be reported for anti-HIV-1, but only one method can be used for CMS subspecialty scoring in general immunology, the one pre-designated as such by participants, which, according to CMS, should be your routine (highest volume) method. Since scoring discrepancies may occur between methods, ensure that you report all five results for any of these HIV markers from the same method, whether your routine method is a screening method or a confirmatory method. Important Information - If your laboratory offers both screening and confirmatory testing for HIV, then you may choose to report either the EIA or western blot results to meet regulatory requirements.

Those who report confirmatory (rather than their screening) anti-HIV results that may not routinely perform confirmatory testing on patient specimens which are negative on initial screen, per CMS requirements must report results on all five HIV Marker specimens to avoid being penalized for missing results. If you do not routinely perform confirmatory testing on negative specimens, please use the result code indicating that this is the case.

Special Safety Precautions-Specimens testing positive for anti- HIV have been heat treated. Even so, all these specimens should be handled as though they are capable of transmitting disease. Follow CDC and FDA recommendations as well as the Occupational Safety and Health Administration (OSHA) Final Rule on Occupational Exposure to Bloodborne Pathogens published December 6, 1991 (Federal Register Volume 56, Number 235, pages 64175-64182). These specimens should be handled in a biological safety cabinet while wearing impermeable gloves.

Remove the specimens from the can using forceps that are long enough to avoid cutting or scratching your hands on the can. Cover the caps of the vials with gauze while removing or replacing to prevent splashing. Do not pipet by mouth or use a needle and syringe with these specimens. Wash your hands after removing the gloves. These specimens should be autoclaved and disposed of as biohazardous waste.

36

IMMUNOLOGY continued IMMUNOPROTEINS Five liquid serum specimens per testing event, 1.0 mL, for the following analytes:

C3 IgE C4 IgG IgA IgM

Where appropriate, all participants must report results which are calibrated against the International Federation of Clinical Chemistry (IFCC)’s Reference Preparation for Proteins in Human Serum (RPPHS). Code the method(s) used by entering the appropriate numeric codes from the list(s) on the form.

LYME DISEASE Two liquid serum specimens per testing event, 0.6 mL Important Information - If your laboratory offers both screening and confirmatory testing for Lyme disease then you may choose to report either the EIA or western blot results to meet regulatory requirements.

If you choose to report your screening results, then you may select “Confirmatory testing not performed” in accordance with your laboratory’s procedures. If you choose to report your confirmatory results to meet the regulatory requirements then you must report testing result for all five specimens in order to satisfy the CLIA requirement that you test five samples per proficiency event.

Be careful to enter results on the proper line (lines are provided for both screening and immunoblot results). Code your qualitative answers as either 010 for negative or 011 for positive and code the method used by entering the appropriate numeric code from the list on the form.

MONONUCLEOSIS, INFECTIOUS, WAIVED Two liquid serum specimens per testing event, 0.65 mL

MONONUCLEOSIS, INFECTIOUS, 5-VIAL Five liquid serum specimens per testing event, 0.65 mL

These specimens are for infectious mononucleosis (IgG or IgM) procedures. Code your qualitative answers using only the codes provided on the “Infectious Mononucleosis” line of the Diagnostic Immunology reporting form and code the method used by entering the appropriate numeric code from the list on the form.

RHEUMATOID FACTOR Five liquid serum specimens per testing event, 1.0 mL

These specimens are for qualitative rheumatoid factor (IgG or IgM) procedures. Code your qualitative answers using only the codes provided on the “Rheumatoid Factor” line of the Diagnostic Immunology reporting form. For quantitative methods, report your results as greater than or less than your methods cutoff.

Code the method used by entering the appropriate numeric code from the list on the form. Follow the manufacturer’s instructions for the pretreatment of serum specimens just as you would for any patient specimen.

RUBELLA Five liquid serum specimens per testing event, 1.0 mL

Code your answers as either 010 (not immune or negative) or 011 (immune or positive). If using a quantitative method, use the upper cutoff value of your normal range to distinguish not immune from immune status. Code the method used by entering the appropriate code from the list provided on the form.

SYPHILIS SEROLOGY Five liquid serum specimens per testing event, 1.0 mL

Code your answers using only the codes listed on the line of the reporting form which is appropriate to the method used. Code the methods used by entering the appropriate codes from the list provided on the form. Separate lines are provided to accommodate participants’ results from more than one method. Procedures for which results are preformatted includes RPR Card, RST, TRUST, VDRL, USR, FTA-ABS, FTA-ABS DS, MHA-TP/TP-PA, and EIA, but

37

IMMUNOLOGY continued SYPHILIS SEROLOGY, continued only one method can be used for CMS subspecialty scoring in syphilis serology, the one pre-designated as such by participants. Do not attempt to use the same line to report results from more than one procedure. Participants who request that we report their confirmatory (rather than their screening) syphilis results to the regulatory authorities, even those who may not routinely perform confirmatory testing on patient specimens which are negative on a screening procedure, should report results on all five Syphilis specimens to avoid being penalized for missing results. Important Information - If your laboratory offers both screening and confirmatory testing for Syphilis, then you may choose to report either the EIA or western blot results to meet regulatory requirements. If you choose to report your screening results, then you may select “Confirmatory testing not performed” in accordance with your laboratory’s procedure. If you choose to report your confirmatory results to meet the regulatory requirements then you must report testing result for all five specimens in order to satisfy the CLIA requirement that you test five samples per proficiency event.

ToRCH Test Three liquid samples per testing event, 2 testing events per year, 1.0 mL.

Cytomegalovirus Rubella IgM HSV1 IgG/IgM Toxoplasmosis HSV2 IgG/IgM

Note: This program is a Rubella IgM supplemental program only. For CLIA reporting purposes you must enroll in and report the regular Rubella program.

Sample is 1.0 mL of serum, mix by gentle inversion before testing. Samples should be tested the same as patient specimens.

For methods that do not differentiate between HSV I and HSV II, please enter results under HSV II results using result code "714" for positives. For methods that are Ig non-specific, report results as IgG using result code "715" for positives.

These specimens should be handled as though they are capable of transmitting disease. Follow CDC and FDA recommendations as well as the Occupational Safety and Health Administration (OSHA) Final Rule on Occupational Exposure to Bloodborne Pathogens published December 6, 1991 (Federal Register Volume 56, Number 235, pages 64175-64182). Do not pipet by mouth or use a needle and syringe with these specimens. Wash your hands after removing the gloves. These specimens should be autoclaved or disposed of as hazardous waste. These specimens will only be included in the first and third event shipments.

38

MICROBIOLOGY ACID-FAST SMEARS Five slides per testing event, 2 testing events per year

These specimens will only be included in the first and third shipments. The specimens are prepared, unstained slides.

Perform your normal staining procedures and code either the absence or presence of acid-fast bacilli, using only the code 012 (for acid-fast bacilli absent) or code 013 (for acid-fast bacilli present). The Acid-fast Smears program is limited to Mycobacteriology Type 1 (Extent 1) laboratories only (those which only report acid-fast smear results). Therefore, extent coding is not relevant for this program.

AFFIRM MICROBIAL SCREEN Five Affirm Nucleic Acid Probe Assays for analysis of the following:

Candida Gardnerella Trichomonas

Swabs contain simulated clinical material and proper precautions should be taken for handling of etiologic agents. Perform testing for the presence of Trichomonas, Gardnerella, or Candida using the Affirm VP III Identification Test system. 1. Open each foil pouch at the tear slit and remove the swab from the foil pouch. 2. Place the swab into the Sample Collection Tube provided by the manufacturer. 3. Add 12 drops of Lysis Solution to the tube. 4. Rotate the swab to dislodge as much material as possible, snap or cut the shaft so that the swab fits into the tube. Note: These swabs have not been pre-scored

Place the cap back onto the Sample Collection Tube containing the swab and proceed following the manufacturer’s instructions for extraction and automated processing.

Code the reagent and instrument used by entering the appropriate codes from the lists provided on the reporting form.

BACTERIOLOGY GC CULTURE THROAT CULTURE THROAT/URINE CULTURE URINE CULTURE Five specimens per testing event, Diluents packaged separately

Inspect the fiberboard container carefully for all inclusions. Five specimens are provided for each culture program. After inventorying the contents of the container, store them in a refrigerator until ready for use. Special Safety Precautions-These specimens contain pathogens or potential pathogens and should be considered infectious and handled as though they are capable of transmitting disease. They should be handled and disposed of only by personnel trained to work with pathogenic bacteria. All laboratory precautions and safety measures appropriate to handling live cultures should be practiced when working with these specimens. In addition to the Precautions section on page 4, one should be especially careful to avoid aerosol creation, inhalation, ingestion or injection of bacteria. These specimens should be autoclaved and disposed of as biohazardous waste.

Instructions for Culture Specimens-One swab, lyophilized sample swab and rehydration fluid is provided for each specimen 1. Remove the tube from the outside packaging. No warming is required, samples may be used cold. 2. Remove the cap that holds the swab and rehydrate using the fluid provided, then inoculate media. If rehydration

fluid is missing or leaked during transport, use 0.5 mL sterile broth, or sterile saline to rehydrate swab. 3. For single plate inoculation: For heavy growth, rotate the swab while streaking the entire plate in all quadrants. For

isolated colonies, rotate the swab over the first quadrant only. Utilize a sterile loop to streak the remaining quadrants as per your normal laboratory procedure.

4. For multiple plates or Uricult users: Submerge the swab portion only into the provided rehydration broth for 15 to 30 seconds. Remove the moist swab and use it to streak plates as per your laboratory’s procedure. The broth may be capped and stored as you would any other stock broth. Uricult users should use the inoculated broth to wet the test paddle.

39

MICROBIOLOGY continued CULTURES, continued Determining Type (Extent) of Laboratory Service-All participants, regardless of the extent of their laboratory practice, evaluate the same specimens. In order to be graded appropriately, you must report the extent of laboratory practice (Extent 0, 1, 2, 3, 4 or 5) for each specimen. Determine your extent as follows:

1. Subject each specimen to your protocol for each source as described at each specimen number on your reporting form.

2. Based on what you would report in the context of your specific laboratory practice, determine your extent for each specimen independently of each other, according to the definitions on the reporting form and clarified in the following table:

Results Reported Extent of Laboratory Service 0 1 2 3 4 5

Gram Stain must not rpt

must report

may report

may report

may report

may report

Antigen Screen must not rpt

may report

must report

may report

may report

may report

Antimicrobial Susceptibility Testing (ASTs)*

may report

may report

may report

may report

may report

may report

Identification to Genus Only

must not rpt

may report

may report

must report

must not rpt

must not rpt

Speciation of Aerobes

must not rpt

may report

may report

may report

must report

must report

Identification of Anaerobes

must not rpt

may report

may report

may report

may report

must report

*Reporting ASTs applies only to Specimen 1 and assumes the use of pure isolates. Participants performing ASTs without identifications, even presumptive ones, must use Extent 0 to avoid being given a score of zero for missing culture results.

We are required to categorize participants who fail to report their extent(s) as Extent 5 and to grade accordingly.

Coding for Presumptive Culture Identification-Participants reporting presumptive identifications by culture must not use result codes 750 to 911. If performing isolations only with selective media, these participants might need to report code 948 (No pathogen isolated), but should not report either code 949 (No aerobic growth) or 951 (No aerobic or anaerobic growth). CMS requires that we challenge many common pathogens found in a specific sample type. When reporting a negative result, select an answer which reflects the organisms you would normally detect (I.e. select code 927 if you only screen for Strep A and do not test for N. gonorrhoeae with throat cultures.)

Coding Extent 3, 4 and 5 Results-For Specimens 1, 2, 3 and 4, participants using Extent 3, 4 or 5 must report only the organism(s) which they consider to be the significant pathogen(s) that is/are clearly responsible for the illness described, excluding immunocompromised patients. Opportunistic pathogens occurring in immunocompromised patients, when included, will always appear in Specimen 5. All organisms, nonpathogens as well as pathogens, must be identified in Specimen 5. Code your answers using the Result Code list on the Microbiology Instructions.

Antimicrobial susceptibility tests (ASTs) are to be performed on the most significant pathogen in Specimen 1 only, using the AST codes listed on the Microbiology Instructions. Caution: if you code extent 0 or 1 (culture ID referred) for Specimen 1 and want to be exempt from reporting ASTs on this specimen, you must also code your AST method as 0 (“susceptibilities not routinely performed on this organism”) and leave the AST results blank. Due to CMS requirements, participants will be flagged for inappropriate selection of AST’s, as listed in the latest version of CLSI guidelines for Microbiology: M02-11, M07A9, M100S24E.

40

MICROBIOLOGY continued BACTERIOLOGY COMPLETE GRAM STAIN, BACTERIOLOGY COMPLETE Participant generated Gram Stain. This supplemental form allows you to report additional Bacteriology results using the samples/cultures from the regular Bacteriology program.

All culture IDs and antimicrobial sensitivities must be reported using the regular Bacteriology form.

Gram Stain: As part of the Bacteriology, Complete Program, you are permitted to make and report your own Gram Stain slide from the cultured organism. For CMS credit you must report gram stains on all 5 organisms regardless of culture source. Perform your normal staining procedure, including fixing of smears, and code your answers as either 401 (gram-negative) or 402 (gram-positive). Code the organism morphology from the list provided on the forms.

Report gram stain results and organism morphology for the significant organism from each Bacteriology sample. To receive full credit, you must report a result for each specimen regardless of source or laboratory procedure for a specific type of sample. Per CLIA requirements for Bacteriology there will be occasional samples that are either completely negative or contain no pathogen. For completely negative samples you may always report the code 986 for "No organism found on gram stain". If there are only normal flora present, you may report the gram stain results for the normal flora and will receive credit. Do not report the gram stain results for normal flora if there is a pathogen present.

BLOOD CULTURE, BACTERIOLOGY COMPLETE Two specimens supplemental per testing event, Diluents packaged separately Inspect the fiberboard container carefully for all inclusions. Two specimens are provided for each culture program. After inventorying the contents of the container, store them in a refrigerator. 1. Remove the tube from the outside packaging. No warming is required, samples may be used cold. 2. Remove the cap that holds the swab and rehydrate using the fluid provided, then inoculate media. If rehydration

fluid is missing or leaked during transport, use 0.5 mL sterile broth, or sterile saline to rehydrate swab. 3. For single plate inoculation: For heavy growth, rotate the swab while streaking the entire plate in all quadrants. For

isolated colonies, rotate the swab over the first quadrant only. Utilize a sterile loop to streak the remaining quadrants as per your normal laboratory procedure.

4. For multiple plates users: Submerge the swab portion only into the provided rehydration broth for 15 to 30 seconds. Remove the moist swab and use it to streak plates as per your laboratory’s procedure. The broth may be capped and stored as you would any other stock broth.

Special Safety Precautions-These specimens contain pathogens or potential pathogens and should be considered infectious and handled as though they are capable of transmitting disease. They should be handled and disposed of only by personnel trained to work with pathogenic bacteria. All laboratory precautions and safety measures appropriate to handling live cultures should be practiced when working with these specimens.

STREP A SCREEN AND CAMPYLOBACTER, BACTERIOLOGY COMPLETE Step A Screen and Camplyobacter are supplemental programs for Bacterial Antigens. For CLIA purposes you must be enrolled in and report a Bacterial Antigen from one of the following programs; Strep A Antigen Screen, Chlamydia/GC/Strep B, or C. difficile Antigen. Per CLIA requirements for Bacteriology there will be occasional samples that are either completely negative or contain no pathogen. You should report "010 Negative" for such samples.

Strep A Screen: Report results only for Bacteriology Sample 2. In performing a rapid Group A antigen screen on these specimens, follow the same procedure used on patient specimens, unless you use the Quidel QuickVue In-Line product or the BioStar OIA method. Quidel QuickVue In-Line participants must follow special instructions for proficiency testing found in the kit's package insert. BioStar OIA participants must pre-wet each swab with 3-4 drops of Reagent 4 (Wash Solution) or sterile saline prior to testing. If the specimen's fluid content is inadequate for other procedures, add sterile saline (generally 1 -2 drops) to the swab and express the fluid. Code your answers as either 010 for negative or 011 for positive. Code the method used by entering the appropriate code from the list below.

41

MICROBIOLOGY continued BACTERIOLOGY COMPLETE, continued Campylobacter screen is intended primarily for Rapid Campy screens; however, you may report any Campylobacter test method here. Two separate Campylobacter screen samples are provided. Perform screening test per your patient testing protocol.

C. DIFFICILE TOXIN ANTIGEN DETECTION Five lyophilized specimens per testing event

Special Safety Precautions-These specimens contain pathogens or potential pathogens and should be considered infectious and handled as though capable of transmitting disease. Specimens should be handled and disposed of by personnel trained to work with pathogenic organisms. All laboratory precautions and safety measures appropriate to handling live cultures should be practiced when working with these specimens, see Program Guide - General Instructions for more precautions. Be especially careful. to avoid aerosol creation, inhalation, ingestion or injection of organisms. These specimens should be autoclaved and disposed of as biohazardous waste. If the kit contains broken specimens, autoclave the kit with minimal exposure of the contents to the atmosphere and immediately request replacement samples.

Specimen Analysis-Resuspend each specimen by adding 1.0 mL of sterile distilled water. Use a sterile syringe and needle to add the water into the vial. Gently swirl the vial to dissolve the contents. Allow 1-3 minutes for the contents to completely dissolve. Process the specimens according to your kit manufacturer’s instructions.

Report a code 010 for negative and 011 for positive. Code the instrument by entering the appropriate code from the list on the reporting form.

CHLAMYDIA/GC/STREP GROUP B ANTIGEN SCREEN Five 0.5 mL antigen suspension specimens per testing event for the following analytes:

Chlamydia Trachomatis Antigen Screen Neisseria Gonorrhoeae Antigen Screen Streptococcus sp., Group B Antigen Screen

Each specimen may contain one or more bacteria, but no attempt should be made to culture or stain these specimens. Special Safety Precautions-These specimens contain pathogens or potential pathogens and should be considered infectious and handled as though they are capable of transmitting disease. They should be handled and disposed of only by personnel trained to work with pathogenic bacteria. All laboratory precautions and safety measures appropriate to handling live cultures should be practiced when working with these specimens see Program Guide - General Instructions for more precautions. Be especially careful to avoid aerosol creation, inhalation, ingestion or injection of bacteria. These specimens should be autoclaved and disposed of as biohazardous waste.

Specimen Analysis-Follow the instructions for reconstitution as indicated below: 1. Pour the liquid into the vial containing the pellet. 2. Resuspend gently by flicking the vial. 3. Use immediately after the pellet has dissolved. 4. Refrigerate any unused portion. It should be stable for at least 24 hours. Use the swab to absorb a portion of the rehydrated sample. If testing more than one antigen, be sure to apportion the specimen accordingly (about 2 drops per swab is sufficient). For users of gender specific methods, this sample is intended to be used with the female collection kit. Do not omit inoculation of transport media with the wetted swab if this step is applicable to patient material. Follow your manufacturer’s recommendations for this final step. If the manufacturer’s directions for incubation time in the transport media are not clear, please allow a minimum of 30 minutes.

Code your answers as either code 010 for negative or code 011 for positive. Code the method(s) used by entering the code(s) from the appropriate list(s) of methods provided on the reporting form. Specimens compatible with the DNA probe test kit.

42

MICROBIOLOGY continued CRYPTOSPORIDIUM/GIARDIA IMMUNOASSAY Five 1.0 mL formalin specimens per testing event for the following analytes:

Cryptosporidium Immunoassay Giardia Immunoassay

Perform your normal procedure and code results as code 010 for negative and 011 for positive. Code the method used by entering the appropriate code from the list on the form. These samples are formalin preserved and are not compatible with methods requiring fresh specimens.

GRAM STAIN Five unstained samples per testing event Perform your normal staining procedure, including fixing of smears, and code your answers as either 401 (gram-negative) or 402 (gram-positive).

Code the organism morphology from the list provided on the forms.

MYCOPLASMA ANTIBODY DETECTION Two liquid serum samples per testing event

Sample is 1.0 mL of serum, mix by gentle inversion before testing. Samples should be tested the same as patient specimens. Code your answers as either code 010 for negative or code 011 for positive. Code the method used by entering the code from the appropriate list of methods provided on the reporting form.

PARASITOLOGY Five specimens per testing event This program will be reported to CMS. Sample 1 is a paired formalin preserved feces (1A) and a PVA slide (1B) for direct examination and concentration procedures. Do not report both (1A) (1B) samples. Specimens 2 and 3 are formalin preserved feces for direct examination and concentration procedures. Occasionally, blood smears will be substituted for fecal specimens.

For liquid samples, if you choose to shake/mix the vial, be sure to allow material to settle and concentrate at least 5 minutes before sampling. Pipette sample from the concentrated material at the bottom of the vial. For participants using stool fixatives that contain a mercuric chloride substitute (zinc sulfate, etc.), remember that the proficiency testing specimens you receive for permanent staining have been preserved in PVA using the mercuric chloride fixative base. If you use the Trichrome or iron hematoxylin staining method for your mercuric chloride substitute fixatives, you may have eliminated the 70% alcohol/iodine step and the following 70% alcohol rinse step from your method. However, when you stain the proficiency testing fecal smears, you will need to incorporate the iodine step plus the next 70% alcohol rinse back into your staining protocol prior to placing your slides into the Trichrome stain or iron hematoxylin stain. These two steps are designed to remove the mercury from the smear and then to remove the iodine; therefore, when your slide is placed into the Trichrome or iron hematoxylin stain, both the mercury and iodine are no longer present in the fecal smear. If you fail to incorporate these two steps into your staining protocol, the quality of your proficiency testing stained smears will be poor.

Specimens 4 and 5 are digital images; therefore, do not report frequencies on specimens 4 and 5. This program uses DigitalScopeTM, using internet access. Please review computer system requirements for using the DigitalScopeTM. This program is based on electronic slide images found at http://aab -pts.org on the online reporting form for Parasitology. You will need a computer with access to the internet and Microsoft Internet Explorer 6.0 or later or Fire Fox 2.0 or later with Microsoft Silverlight plug-in installed.

Enter the extent of your laboratory for parasitology using the following criteria: Extent 0. Those that do not process or would refer this specimen to another laboratory appropriately certified for the subspecialty of parasitology for identification. Extent 1. Those that are able to determine the presence or absence of parasites by direct observation (wet mount) and refer specimens to another laboratory appropriately certified in the subspecialty of parasitology for identification. Extent 2. Those that identify parasites using concentration preparations and/or permanent stains.

43

MICROBIOLOGY continued PARASITOLOGY, continued Report the extent of your parasitology practice for each specimen based on the definitions above.

Participants that report Extent 0 on all five samples, will receive a “DC” (discontinued testing) on their graded report for that testing event.

Code your answers with the Parasitology Organism Codes listed on the reporting form. Code 524 [parasite(s) found, not identified] is appropriate only for Extent 1 specimens.

Laboratories receiving specimens which are not routinely processed (such as blood smears) should report Extent 0 (laboratories which do not process or would refer specimen). We are required to categorize participants who fail to report their extent(s) as Extent 2 and to grade accordingly.

Specimen Instructions Specimen 1 is a paired formalin preserved feces (1A) and a PVA slide in a foil pouch (1B) from the same patient for direct examination and concentration procedures.

For the PVA specimen sent, remember that the proficiency testing specimens you receive for permanent staining have been preserved in PVA using the mercuric chloride free fixative base. If you use the Trichrome or iron hematoxylin staining method for your mercuric chloride substitute fixatives, you may eliminate the iodine step and the following 70% alcohol rinse step from your method.

Specimens 2 and 3 are formalin preserved feces for direct examination and concentration procedures. Occasionally, blood smears will be substituted for a fecal specimen.

Specimens 4 and 5 are Digital Images – Stool, 1000X maximum magnification. Use micrometer embedded in viewer to measure organisms. The links to the slides and case histories can be found by navigating to your online Parasitology reporting form. You may navigate throughout the slide to look for additional examples of organisms. However, report only the identity of the selected organisms inside the selection box.

Under no circumstances should you ever send any proficiency testing sample to another laboratory for testing. Per CMS requirement, this emphatically includes samples that you would normally send out for confirmation or follow up identification. This is to be followed REGARDLESS of your laboratory policy on such follow up testing. CMS will immediately revoke the license of any laboratory found to be referring proficiency testing samples, even if they are following their laboratory procedures for confirmation. Equally, CMS requires that you not perform testing on any sample that you suspect may be a proficiency testing sample received from another laboratory. You also must report laboratories you suspect of such activity. Severe penalties will apply to laboratories that perform proficiency testing for other laboratories or sites as well.

STREP GROUP A ANTIGEN SCREEN, WAIVED Two specimens per testing event

STREP GROUP A ANTIGEN SCREEN Five specimens per testing event

Specimens are inoculated with killed bacteria and therefore no attempt should be made to culture or stain these specimens. Participants reporting results of bacterial culture or staining techniques must subscribe to the Bacteriology, GC Culture, Gram Stain, Throat Culture, Throat/Urine Culture or Urine Culture programs. DNA Probe methods or any other method requiring live bacteria should be tested with the Throat Culture program.

In performing a rapid Group A antigen screen on these specimens, follow the same procedure used on patient specimens.

If you use the Quidel QuickVue In-Line product or the BioStar OIA method then you must follow special instructions for proficiency testing found in the kit’s package insert. BioStar OIA participants must pre-wet each swab with 3-4 drops of Reagent 4 (wash solution) or sterile saline prior to testing. If the specimen’s fluid content is inadequate for other procedures, add sterile saline (generally 1-2 drops) to the swab and express the fluid. Code your answers as either code 010 for negative or code 011 for positive. Code the method used by entering the appropriate code from the list on the form.

44

MICROBIOLOGY continued SHIGA TOXIN Two specimens per testing event

Perform testing according to your laboratory protocol for patient samples. ROTAVIRUS, 2-VIAL ADD-ON Two lyophilized vials per event – Supplemental testing only. Must be ordered in addition to another CMS acceptable viral antigen screen program

ROTAVIRUS, 5-VIAL Two lyophilized vials per event Special Safety Precautions - These specimens contain inactivated pathogens or potential pathogens and should be handled and disposed of as though they are capable of transmitting disease. They should be handled and disposed of only by personnel trained to work with pathogenic organisms at BSL-2.

Specimen Analysis – Resuspend each specimen by adding 1.0 mL of sterile distilled water. Use a sterile syringe and needle to add the water into the vial. Gently swirl the vial to dissolve the contents. Allow 1-3 minutes for the contents to completely dissolve. Process the specimens according to the manufacturer’s instructions, of your kit. URINE COLONY COUNT Two lyophilized pellets (containing pure and mixed cultures) and two dilution fluids for bacterial colony counts This program is for supplemental testing only. You must enroll in one of our 5 vial Microbiology Culture programs for CMS reporting. Instructions Each Colony Count specimen consists of a lyophilized pellet in a vial contained in a foil pouch and a 99 mL dilution fluid. Before testing, warm all appropriate media, the vial specimen and the dilution fluid to room temperature.

1. Open the lyophilized sample vial. Empty the pellet from the vial into the dilution fluid bottle. 2. Reseal the dilution fluid container and mix the contents of the container vigorously. Mix until the pellet is

completely dissolved and the suspension is homogenous in appearance. 3. The entire contents of the dilution bottle (which now contains the dissolved lyophilized pellet) simulates a urine

sample.

Proceed to test as you would a patient sample in your laboratory (The bottle will accommodate dip paddles)

Under no circumstances should these samples be referred to another laboratory for further work regardless of your laboratory’s procedures. CMS mandates that any laboratory referring proficiency testing specimens will lose their license regardless of intent!

Perform identification as per your standard laboratory procedure. If you do not perform IDs, simply leave this line blank. Select an identification which reflects the level to which you would typically report results. That is do not report Staphylococcus epidermidis when you would typically only identify the organism as a general Staph species or even as normal flora.

Special Safety Precautions-These specimens contain pathogens or potential pathogens and should be considered infectious and handled as though they are capable of transmitting disease. They should be handled and disposed of only by personnel trained to work with pathogenic bacteria. All laboratory precautions and safety measures appropriate to handling live cultures should be practiced when working with these specimens. In addition to the Precautions section on page 4, one should be especially careful to avoid aerosol creation, inhalation, ingestion or injection of bacteria. These specimens should be autoclaved and disposed of as biohazardous waste.

45

MICROBIOLOGY continued UREASE, RAPID (Campylobacter Like Organism – CLO) Two lyophilized specimens per testing event Store specimens at 2-8 degrees C.

1. Allow sample and rehydration vials to warm to room temperature for 15 – 20 minutes. 2. Remove caps from the vials and aseptically transfer the pellet to the vial of Rehydration Fluid. 3. Shake to dissolve. Hold for 5 minutes if necessary for pellet to completely disolved. 4. Follow test manufacturer’s instructions for performing the test.

VIRAL ANTIGEN SCREEN, WAIVED Two lyophilized vials for WAIVED METHODS ONLY, 2 events per year Adenovirus Influenza Type A and Influenza Type B Respiratory Syncytial Virus (RSV) Antigen This program is for waived methods only. Non-Waived methods must enroll in the Viral Antigen Screen Program.

Special Safety Precautions - These specimens contain inactivated pathogens or potential pathogens and should be handled and disposed of as though they are capable of transmitting disease. They should be handled and disposed of only by personnel trained to work with pathogenic organisms at BSL-2.

Specimen Analysis - Resuspend each specimen by adding 1.0 mL of sterile distilled water. Use a sterile syringe and needle to add the water into the vial. Gently swirl the vial to dissolve the contents. Allow 1-3 minutes for the contents to completely dissolve. Process the specimens according to the manufacturer’s instructions, of your kit.

Users of Sekisui OSOM A&B should use the following special instructions. Add 135 μL of sample and 135 μL (maximum of 300 μL) of extraction buffer to one of the testing tube provided in the OSOM test kit. Add strip and allow to sit for 10 minutes, then read.

For Influenza methods that do not discriminate between Type A and Type B, please report results as Influenza Type A only as either Positive results as 514 or Negative results as 010.

These samples are for non-IF antigen detection methods only.

VIRAL ANTIGEN SCREEN Five specimens per testing event for analysis of the following analytes: Adenovirus Influenza Type A and Influenza Type B Respiratory Syncytial Virus (RSV) Antigen

These samples are for non-IF antigen detection methods only

Special Safety Precautions-These specimens contain pathogens or potential pathogens and should be considered infectious and handled as though they are capable of transmitting disease. They should be handled and disposed of only by personnel trained to work with pathogenic bacteria. All laboratory precautions and safety measures appropriate to handling infectious materials should be practiced when working with these specimens. In addition to the Precautions section on page 4, one should be especially careful to avoid aerosol creation, inhalation, ingestion or injection of bacteria. These specimens should be autoclaved and disposed of as biohazardous waste.

Specimen Analysis-Resuspend each specimen by adding 1.0 mL of sterile distilled water. Use a sterile syringe and needle to add the water into the vial. Gently swirl the vial to dissolve the contents. Allow 1-3 minutes for the contents to completely dissolve. Process the specimens according to the manufacturer’s instructions, of your kit.

Users of Sekisui OSOM A&B should use the following special instructions. Add 135 μL of sample and 135 μL (maximum of 300 μL) of extraction buffer to one of the testing tube provided in the OSOM test kit. Add strip and allow to sit for 10 minutes, then read.

For Influenza methods that do not discriminate between Type A and Type B, please report results as Influenza Type A only as either Positive results as 514 or Negative results as 010.

46

MICROBIOLOGY continued Code your answers using the result codes on the reporting form. Code your method(s) used by entering the appropriate code(s) from the lists on the reporting form.

CLIA requires a total of 5 viral antigen challenges. Be sure to test all 5 samples. Partial results or blanks will be scored as misses. Your accrediting agency may require you to perform proficiency testing for all antigen tests done in your laboratory.

These samples are for non-IF antigen detection methods only. MYCOLOGY CYRPTOCOCCAL ANTIGEN Two specimen challenges per event. Storage and Stability: Store specimens at 2-8 °C until testing can be performed. Detailed Testing Instructions: 1. Etiologic agents that may be present in these specimens have been treated to render them noninfectious; however,

because no method can offer complete assurance that all organisms are nonviable, handle specimens as if capable of transmitting disease.

2. Test each specimen for the presence or absence of Cryptococcal antigen as you would test a routine patient specimen. These specimens are not suitable for culture.

INDIA INK PREPARATION Two specimen challenges per event. Storage and Stability: Store specimens at 2-8 °C until testing can be performed. Detailed Testing Instructions: 1. Etiologic agents that may be present in these specimens have been treated to render them noninfectious; however,

because no method can offer complete assurance that all organisms are nonviable, handle specimens as if capable of transmitting disease.

2. Test each specimen for the presence or absence of a capsule as you would test a routine patient specimen by India Ink. These specimens are not suitable for culture.

KOH PREPARATION Two specimen challenges per event. Storage and Stability: Store specimens at 2-8 °C until testing can be performed. Detailed Testing Instructions:

1. Etiologic agents that may be present in these specimens have been treated to render them noninfectious; however, because no method can offer complete assurance that all organisms are nonviable, handle specimens as if capable of transmitting disease.

2. Test each specimen for the presence or absence of a capsule as you would test a routine patient specimen by India Ink. These specimens are not suitable for culture.

47

EMBRYOLOGY, ANDROLOGY & FETAL FIBRONECTIN . ANTISPERM ANTIBODIES Two liquid serum specimens per testing event. These specimens are for qualitative IgG evaluation and have been heat inactivated. Test samples immediately upon receipt or store these specimens below -10°C upon arrival. If stored, thaw specimens to room temperature just prior to testing. Perform antisperm antibody testing according to your protocol. Code your answers as either 010 for negative or 011 for positive and code the method used by entering the appropriate numeric code from the list on the form.

EMBRYO GRADING Two sets of digital images provided online. Participants will report the following parameters based on SART reporting requirements: Embryo Grade Inner Cell Mass Embryo Stage Inner Cell Mass Compaction Cell Number Symmetry % Fragmentation Trophectoderm

Click on the link corresponding to Day 1, Day3 and Day 5 for samples 1 & 2. Please grade each embryo displayed in the appropriate video file following the SART reporting requirements for transferred embryos. Please report using the result code listed for each parameter. This program requires access to the AAB Website via the internet. Additionally it requires Internet Explorer ver. 6.0 or later, FireFox ver. 3.0 or later, Chrome 4, or Safari 3.

FETAL FIBRONECTIN (fFN) Two liquid simulated cervicovaginal specimens per testing event. Samples are to be performed in patient mode. Follow your test method’s specimen preparation instructions, except do not filter the proficiency test specimen. Report 010 for negative and 011 for positive.

FETAL MEMBRANE RUPTURE TEST Two samples for the detection of Placental alpha 1 microglobulin *Important: since no human sample is collected, the polyester vaginal swab should not be used to perform this procedure. Storage and Stability:

1) Unopened materials must be stored in a dry place at room temperature, or under refrigeration, at 4°- 24°C until expiration date.

2) Test as soon as possible following reconstitution. 3) Reconstituted specimens may be stored up to 24 hours a 4 -8°C.

Detailed Testing Instructions: 1) Bring proficiency materials to room temperature prior to reconstitution. 2) Remove the filled vial containing 0.5mL solution from your AmniSure test strip. Use 1 vial of this solution to

reconstitute each vial of proficiency testing material. 3) Mix the resulting solution vigorously to ensure proper suspension of proficiency testing material. 4) Test each vial by following the steps below

a. Tear open foil pouch at the tear notches and remove the AmniSure test strip. b. Dip the white end of the test strip (marked with arrows) into the vial containing the proficiency testing

material. c. At 10 minutes precisely, remove the test strip from the vial, if two lines are clearly visible. Read the

results by placing the test on a clean, dry, flat surface. Do not read or interpret the results after 15 minutes have passed since the initial dipping of the test strip into the vial.

d. Interpret results according to instructions on AmniSure kit insert.

48

EMBRYOLOGY, ANDROLOGY & FETAL FIBRONECTIN - continued . IVF EMBRYO CULTURE MEDIA Two culture media specimens per testing event for the following bioassays: Mouse Embryo Human Sperm Survival Hamster Sperm Motility

Each vial contains 100 mL of culture media. Also included is 5 mL of dialyzed human serum albumin (100 mg/mL) labeled HSA.

Perform your preferred bioassay on both specimens to determine their suitability for in vitro embryo culture. The media should be tested with and without 5 mg/mL HSA. To obtain 5 mg/mL HSA, aseptically add 0.5 mL of the HSA solution to 9.5 mL of each medium and test.

SPERM COUNT Two stabilized sperm specimens per testing event. These specimens are for quantitative and qualitative (post-vasectomy) evaluation. Before testing, allow the specimens to warm to room temperature. Vortex for a minimum of 10 seconds or until completely in solution. You may need to repeat this process 3-5 times. Perform the count according to your usual method. Code the method used by entering the appropriate numeric code from the list on the form.

SPERM MORPHOLOGY Two unstained slides and two digitalslide images for overall percent normal morphology, and one digital slide image for individual sperm cell ID per testing event.

Morphology We suggest that you remove the slide labels prior to staining, taking care to reaffix the appropriate label to the corresponding slide after staining.

Code the method and stain used by entering the appropriate numeric codes from the list on the form.

Spermac Users: Spermac fixative for 10 minutes, rinse as per protocol, complete staining protocol.

These unstained slides are not compatible with the TestSimplet method.

Both unstained slides and digital images are included, you may report either or both as they will be graded separately.

The digital image requires access to a computer with internet access. This program uses DigitalScopeTM, using internet access. Please review computer system requirements for using the DigitalScopeTM. This program is based on electronic slide images found at http://aab-pts.org on the results entry page for Sperm Morphology. You will need a computer with access to the internet and Microsoft Internet Explorer 6.0 or later or Fire Fox 2.0 or later with Microsoft Silverlight plug-in installed.

Sperm Cell ID The individual sperm categorization will consist of an online digital image with individual sperm annotated. Each annotated sperm should be identified as normal or as to the type of abnormality seen using the result codes listed on the reporting form. If more than one sperm is contained within an annotation, they all represent the same sperm type.

SPERM MOTILITY Two digital challenges per testing event, available online. Perform the sperm motility assessment according to your usual method. Two digital video files are found on the online reporting form. Participants will report the percentage of motile sperm seen in each of two video files. This program requires access to the AAB Website via the internet. Additionally it requires Internet Explorer ver. 6.0 or later, FireFox ver. 3.0 or later, Chrome 4, or Safari 3.

49

EMBRYOLOGY, ANDROLOGY & FETAL FIBRONECTIN – continued SPERM VIABILITY Two Eosin-Nigrosin stained slides and two digital slide images per testing event. You may report results from either the Traditional Slide, Digital Slide, or both. Please be sure to report the results on the line matching the slide type.

Traditional Slides – Two slides stained with Eosin-Nigrosin are included and are labeled sperm viability 1 and 2.

Digital Slides – Two DigitalScope® slides are included on the online reporting. You can view these slides on your online reporting form. Logon to your account at www.aab-pts.org using your account number and password. Click the event link in the green highlighted section and then click on the Andrology form link. There are two links at the top of the form labeled Viability Slides 1 and 2.

The digital slide images require access to a computer with access to the AAB-PTS website via the internet. Additionally, it requires Internet Explorer ver. 6.0 or later, FireFox ver. 3.0 or later, Chrome 4 or Safari 3. Microsoft Silverlight plug in must also be installed.

Perform sperm viability assessment according to your usual method.

50

GRADING PROCEDURES INTRODUCTION Grading procedures must conform to the February 28, 1992 Final Rule which implements the CLIA ‘88. This rule retains two practices previously mandated regulations from CMS:

1. The principle of peer grading (participant consensus) determines target values (satisfactory performance), especially for quantitative results.

2. The principle of medical (fixed) performance standards primarily determines grading limits, but not to the total exclusion of the principle of methodological (statistical) performance standards.

CONSENSUS GRADING The grading of all results depends on the existence of a consensus of acceptable results. For most analytes or procedures, CMS defines consensus as acceptable performance among 80% or more of results from all participants or referees. Per CMS guidelines, if 80% consensus is achieved laboratories or referee laboratories, then the analyte must be graded. Exceptions to this rule exist for all CMS-scored procedures in Immunohematology, in which consensus is defined as agreement among 95% or more of results from all participants or referees.

SPECIAL GRADING FORMULAS IN MICROBIOLOGY When consensus grading is applied to microbiology modules in which more than one response may be reported for a given procedure in the same specimen, special formulas for generating percent scores for each specimen are mandated by the February 28 Rule of 1992. These formulas thus govern the grading of organism identifications and/ or antimicrobial susceptibilities in Bacteriology, GC Culture, Parasitology, Throat, Throat/Urine and Urine Culture programs.

For scoring organism identifications in a given specimen, the following ratio of responses is multiplied by 100: 1. The numerator is the sum of all gradable correct participant responses. Only one participant response per

organism is counted, and, in cases in which more than one response is given per organism, only the most definitive answer is used. For example, a species name takes precedence over a genus name which, in turn, takes precedence over an antigen screen result which, in turn, takes precedence over a gram stain result.

2. The denominator is the sum of all incorrect responses for the presence of organisms plus the total number of gradable correct responses for the specimen.

Since AAB determines which organism(s) to place in each specimen, AAB determines the total number of gradable correct responses for the presence of organisms.

For scoring antimicrobial susceptibilities in a given specimen, the following ratio of responses is multiplied by 100: 1. The numerator is the sum of all gradable correct responses. 2. The denominator is the sum of all responses.

Since each participant determines which antimicrobials to report on their patient specimens, each participant determines the total number of antimicrobial susceptibilities to report on PT specimens. The only reporting requirement is that the susceptibilities reported on a proficiency test specimen reflect the same list of drugs which would be tested by the laboratory on patient material in the same clinical context as that of the proficiency specimen.

PEER GROUPS FOR QUANTITATIVE RESULTS To provide optimal peer grading, quantitative results are grouped initially by coupling reagent and instrument. After outlier removal, if the group shows poor precision, a second grouping by reagent alone is applied. If a third group is required, method principle or calibration type is employed. If no information is provided concerning reagent and instrument, or if the group is not statistically viable, results are graded by total population. This style of grading is used for Alcohol, Basic/Comprehensive Chemistry, Coagulation, Direct Bilirubin, Fertility Endocrinology, Fructosamine, Glycohemoglobin, Isoenzymes, Lipids, Special Chemistry, Therapeutic Drug Monitoring and Urine Microalbumin. Other quantitative modules are grouped initially by instrument or method, second by method principle and finally by total population. This scheme applies to Activated Clotting Time, Blood Gases, Centrifugal Hematology (QBC), C-Reactive Protein, Hematology, Immunoproteins, Urinalysis, Whole Blood Glucose, Whole Blood Prothrombin Time, Andrology and Embryology programs.

51

GRADING PROCEDURES - comtinued PEER GROUPS FOR QUANTITATIVE RESULTS, continued

WOULD REFER “Would Refer” is a special response available for some interpretive programs such as Microbiology, Clinical Microscopy or Hematology with Manual Differential. It represents the situation where you would refer a non-routine result on to another entity such as a reference laboratory or pathologist for further interpretation or for a final result. You may only enter this response if this is your laboratory’s standard procedure for handling patient samples with similar results. You may not enter “Would Refer” for all 5 specimens in these programs. If you do report “Would Refer” for all 5 specimens, the grading record will be deleted from the current testing event only.

ANALYTE INDEX INTRODUCTION “Fixed” grading limits use either a constant concentration (type C limits) or a constant percentage of the target value (type P limits) to define a range of acceptable performance above and below the target value.

The target value for qualitative or semi-quantitative results is the most frequently reported (consensus) value(s) of all valid results.

The target value for quantitative results is the mean of all results after removal of outliers. In contrast to fixed limits, limits based on standard deviations (SDs) can lead to different grading ranges for the same analyte, even when different peer groups have the same means.

The limits required by CMS consist of all three types discussed above; fixed concentration (type C), fixed percentage (type P), and 3SD (type S): type C-plus/minus a fixed concentration from the mean; used in the absence of type P limits or when these limits exceed type P limits type P-the mean plus/minus a fixed percentage of the mean; used in the absence of type C limits or when these limits exceed type C limits type S-plus/minus three standard deviations (SDs) from the mean; mandated by CMS in the absence of type C and/or type P limits

All three types of CMS grading limits are used. Not all analytes listed have CMS limits.

Proficiency testing is not required by CMS or other agencies for analytes/procedures which have no CMS-mandated grading limits. Such analytes/procedures are identified in the Analytes Index as well as on the reporting forms.

Results for these CMS-unscored analytes are not included in computing participants’ overall CMS subspecialty scores. Therefore these scores do not appear on CMS Cumulative Summary reports; they appear only on graded reports (which do not go to CMS).

In the interest of uniformity, the limits used for CMS-unscored analytes are derived from those used for CMS-scored analytes which are similar.

A listing of the limits used for all analytes/procedures, both CMS-scored (regulated analytes) and CMS-unscored, follows.

52

CMS

Regulated CAP

Accepted Program Analyte SD Grading Limits Concentration %

Body Fluids, etc

Amniotic Fluid

NR Interpretation, Amniotic Fluid correct/incorrect NR pH, Amniotic Fluid 0.5 (+/- 1pad)

Body Fluid Count (NRBC/RBC)-Streck

Cell Count, Body Fluid 15

Body Fluid Microscopy (DigitalScope) Formed Elements Only

NR Microscopy, Body Fluid correct/incorrect

Body Fluids, Automated

Cell Count, Body Fluid 15

Body Fluids, Manual

Cell Count, Body Fluid 15

Chemistry/Microscopy, Body Fluids

NR Albumin, Body Fluid 0.3 mg/dL 12 NR Amylase, Body Fluids 30 NR Chloride, Body Fluids 5 NR Cholesterol, Body Fluids 10 NR Creatinine, Body Fluids 3 mg/dL 15

NR Lactate Dehydrogenase (LD/LDH), Body Fluids 20

NR Lactic Acid, Body Fluids 0.3 mmol/L 25

NR Microscopic Identification, Body Fluids

correct/incorrect

NR pH, Body Fluids 0.5 NR Protein, Total, Body Fluids 1 g/dL 25 NR Sodium, Body Fluids 4 mEq/L 4 NR Triglycerides, Body Fluids 25 NR Uric Acid, Body Fluids 0.3 mg/dL 17

Lactoferrin, Fecal

Fecal Lactoferin pos/neg

Occult Blood, Fecal

NR Occult Blood, Fecal (FOB) pos/neg

Occult Blood, Gastric

NR Occult Blood, Gastric pos/neg

Sweat Analysis

Chloride 5 Osmolality 1 mOsm Sodium 4 mEq/L 4

Urinalysis

CAP Bilirubin, Urine pos/neg, +/- 1 pad CAP Creatinine, Urine pos/neg, +/- 1 pad CAP Glucose, Urine pos/neg, +/- 1 pad CAP Hemoglobin/Blood, Urine pos/neg, +/- 1 pad CAP Ketones pos/neg, +/- 1 pad CAP Leukocyte Esterase pos/neg, +/- 1 pad CAP Nitrite pos/neg, +/- 1 pad CAP pH, Urine pos/neg, +/- 1 pad CAP Protein, Total, Urine pos/neg, +/- 1 pad CAP Specific Gravity, Urine 0.01 CAP Urine Sediment (Microscopic ID) correct/incorrect Urobilinogen pos/neg, +/- 1 pad

53

CMS Regulated

CAP Accepted

Program Analyte SD Grading Limits Concentration %

Urinalysis Sediment

Urine Sediment (Microscopic ID) correct/incorrect

Urinary Eosinophils (DigitalScope)

NR Eosinophils, Urine present/absent Chemistry

Adulterated Urine

NR Creatinine, Urine 3 mg/dL 15 NR Nitrite, Urine pos/neg, +/- 1 pad NR pH, Urine 0.5 (+/- 1pad) NR Specific Gravity, Urine 0.01

Alcohol

CAP Acetone pos/neg, +/- 1 pad CMS CAP Alcohol (Ethanol) 25

Beta Hydroxybutyrate (qualitative) 0.1 mmol/L 20

Ammonia

NR Ammonia, Serum 10 umol/L 10

Bilirubin, Direct/Neonatal, 2 vial add-on

CAP Bilirubin, Direct 0.4 mg/dL 20 CAP Bilirubin, Neonatal 0.4 mg/dL 20 Bilirubin, Total 0.4 mg/dL 20

Bilirubin, Direct/Neonatal, 5 vial

CAP Bilirubin, Direct 0.4 mg/dL 20 CAP Bilirubin, Neonatal 0.4 mg/dL 20

CMS Bilirubin, Total 0.4 mg/dL 20

Blood Gases

CAP Calcium, Ionized 0.25 mmol/L CMS CAP Chloride 5 CMS CAP Glucose 6 mg/dL 10

Lactate (Lactic Acid), Whole Blood 2 mg/dL 25 CMS CAP pCO2 5.0 mm Hg 8 CMS CAP pH, Blood Gas 0.04 CMS CAP pO2 3SD CMS CAP Potassium 0.5 mmol/L CMS CAP Sodium 4 mmol/L

Cardiac Markers

CAP BNP 3SD 20 pg/mL CMS CAP CK-2/CKMB 3SD CMS CAP CK-2/CKMB. Qual pos/neg

NR D-Dimer, Qual pos/neg CAP D-Dimer, Quant, ng/mL 3SD 30 ng/mL CAP D-Dimer, Quant, ugFEU/mL 3SD 0.3 ugFEU/mL Myoglobin, Qualitative pos/neg Myoglobin, Quantitative 15 ng/mL 30 CAP NT-proBNP 3SD 20 pg/mL CAP Troponin I 0.9 ng/mL 25 Troponin I, Qual pos/neg Troponin T 0.1 ng/mL 30 Troponin T, Qual pos/neg

54

CMS Regulated

CAP Accepted

Program Analyte SD Grading Limits Concentration %

Cardiac Markers, 2-vial

BNP 3SD 20 pg/mL NR D-Dimer, Qual pos/neg CAP D-Dimer, Quant, ng/mL 3SD 30 ng/mL D-Dimer, Quant, ugFEU/mL 3SD 0.3 ugFEU/mL Myoglobin, Qualitative pos/neg Myoglobin, Quantitative 15 ng/mL 30 NT-proBNP 3SD 20 pg/mL Troponin I 0.9 ng/mL 25 Troponin I, Qual pos/neg Troponin T 0.1 ng/mL 30 Troponin T, Qual pos/neg

Chemistry, Basic

CMS CAP Albumin 10 CMS CAP Alkaline Phosphatase 30 CMS CAP ALT/SGPT 20 CMS CAP AST/SGOT 20

CAP Bicarbonate (CO2) 4 mEq/L 20 CMS CAP Bilirubin, Total 0.4 mg/dL 20 CMS CAP Calcium 1.0 mg/dL CMS CAP Chloride 5 CMS CAP Cholesterol, Total 10 CMS CAP Creatinine 0.3 mg/dL 15 CMS CAP Glucose 6 mg/dL 10

CAP Phosphorus 0.4 mg/dL 15 CMS CAP Potassium 0.5 mmol/L CMS CAP Pregnancy, Serum Qualitative pos/neg CMS CAP Protein, Total 10 CMS CAP Sodium 4 mmol/L CMS CAP Triglycerides 25 CMS CAP Urea Nitrogen, Blood 2 mg/dL 9 CMS CAP Uric Acid 17

Chemistry, Comprehensive

CMS CAP Alpha-fetoprotein (AFP) 3SD CMS CAP Amylase, Serum/Plasma 30 CMS CAP Cortisol 25 CMS CAP Creatine Kinase, Total (CK or CPK) 30

CAP Gamma-Glutamyl Transferase (GGT)

10 IU/L 20

CMS CAP hCG Test, Serum Quantitative 3SD CMS CAP Iron 20 CMS CAP Lactate Dehydrogenase, Total (LD/LDH)

20

CAP Lactic Acid, Serum 0.3 mmol/L 25 CAP Lipase 30

CMS CAP Magnesium, mg/dL 25 CMS CAP Magnesium, mEq/L 25 CMS CAP T Uptake 3SD CMS CAP T3 (Triiodothyronine), Total 3SD CMS CAP T4 (Thyroxin), Free 3SD CMS CAP T4 (Thyroxin), Total 1.0 ugdL 20 CMS CAP Thyroid Stimulating Hormone (TSH) 3SD

55

CMS Regulated

CAP Accepted

Program Analyte SD Grading Limits Concentration %

Chemistry, i-STAT waived

Bicarbonate (CO2) 4 mEq/L 20 Calcium, Ionized 0.25 mmol/L Chloride 5 Creatinine 0.3 mg/dL 15 Glucose 6 mg/dL 10 Hematocrit 6 Hemoglobin 7 Potassium 0.5 mEq/L Sodium 4 mEq/L Urea Nitrogen, Blood 2 mg/dL 9

Chemistry, i-STAT, non-waived

CAP Bicarbonate (CO2) 4 mEq/L 20 CAP Calcium, Ionized 0.25 mmol/L

CMS CAP Chloride 5 CMS CAP Creatinine 0.3 mg/dL 15 CMS CAP Glucose 6 mg/dL 10 CMS CAP Hematocrit 6 CMS CAP Hemoglobin 7

Lactate (Lactic Acid), Whole Blood 2 mg/dL 25 CMS CAP pCO2 5.0 mm Hg 8 CMS CAP pH, Blood Gas 0.04 CMS CAP pO2 3SD CMS CAP Potassium 0.5 mmol/L CMS CAP Sodium 4 mmol/L CMS CAP Urea Nitrogen, Blood 2 mg/dL 9

Chemistry, Special

CAP Ferritin 4.5 ng/mL 30 CAP Folate 0.9 ng/mL 30 CAP Homocysteine 2.5 umol/L 20 CAP Pre-albumin 25 CAP Prolactin 3.6 ng/mL 30 CAP Prostate-specific Antigen (PSA), Total 0.9 ng/mL 30 CAP T3 (Triiodothyronine), Free 0.3 ng/mL 30 CAP Testosterone,Total 0.3 ng/mL 30 CAP Transferrin 10 mg/dL 7 CAP Vitamin B12 60 pg/mL 30

Chemistry, Urine

CAP Amylase, Urine 30 CAP Calcium, Urine 1.0 mg/dL CAP Chloride, Urine 5 CAP Creatinine, Urine 3 mg/dL 15 CAP Glucose, Urine 6 mg/dL 10 CAP Magnesium, Urine 25 Osmolality, Urine 9 mOsm/kg 10 CAP Phosphorus, Urine 3mg/dL 15 CAP Potassium, Urine 3mmol/L 15 CAP Protein, Total, Urine 1 mg/L 25 CAP Sodium, Urine 4 mmol/L 4 CAP Urea Nitrogen, Urine 9 CAP Uric Acid, Urine 17

56

CMS Regulated

CAP Accepted

Program Analyte SD Grading Limits Concentration %

Chemistry, waived

Albumin 10 Alkaline Phosphatase 30 ALT/SGPT 20 AST/SGOT 20 Bicarbonate (CO2) 4 mEq/L 20 Bilirubin, Total 0.4 mg/dL 20 Calcium 1.0 mg/dL Chloride 5 CAP Cholesterol, HDL 30 CAP Cholesterol, Total 10 Creatine Kinase, Total (CK or CPK) 30 Creatinine 0.3 mg/dL 15 Gamma-Glutamyl Transferase (GGT) 10 IU/L 20 CAP Glucose 6 mg/dL 10

Phosphorus

0.4 mg/dL 15

Potassium 0.5 mmol/L Protein, Total 10 Sodium 4 mmol/L Triglycerides 25 Urea Nitrogen, Blood 2 mg/dL 9 Uric Acid 17

C-Reactive Protein, high sensitivity (hs-CRP)

CAP C-Reactive Protein, high sensitivity (hsCRP) 3SD

Cystatin C

Cystatin C 3SD 0.1 mg/L

D-dimer

NR D-Dimer, Qual pos/neg CAP D-Dimer, Quant, ng/mL 3SD 30 ng/mL CAP D-Dimer, Quant, ugFEU/mL 3SD 0.3 ugFEU/mL

Drug Monitoring, Therapeutic

CAP Acetaminophen 2.5 mg/mL 25 CMS CAP Carbamazepine 25 CMS CAP Digoxin 0.2 ng/mL 20 CMS CAP Gentamamicin 25

Lidocaine 0.2 ug/mL 20 CMS CAP Lithium 0.3 mmol/L 20 CMS CAP Phenobarbital 20 CMS CAP Phenytoin 25

CAP Salicylates -mg/dL 0.2 mg/dL 25 CAP Salicylates - mg/L 2 mg/L 25

CMS CAP Theophylline 25 CMS CAP Tobramycin 25 CMS CAP Valproic Acid 25

CAP Vancomycin 1.5 ug/mL 25

Drug Monitoring, Therapeutic, Unbound

Carbamazepine 25

Digoxin 0.2 ng/mL 20

Phenytoin 25

Valproic Acid 25

57

CMS Regulated

CAP Accepted

Program Analyte SD Grading Limits Concentration %

Drug Screen, Urine

CAP Acetaminophen pos/neg Alcohol (Ethanol) pos/neg CAP Amphetamines pos/neg CAP Barbiturates pos/neg CAP Benzodiazepines pos/neg NR Buprenorphine pos/neg CAP Cannabinoids / Marijuana pos/neg CAP Cocaine Metabolites pos/neg NR Cotinine pos/neg NR Ecstasy (MDMA) pos/neg NR LSD (Lysergic Acid Diethylamide) pos/neg NR MDMA (Ecstasy) pos/neg CAP Methadone pos/neg NR Methadone Metabolite pos/neg CAP Methamphetamine pos/neg CAP Methaqualone pos/neg CAP Opiates pos/neg NR Oxycodone pos/neg CAP Phencyclidine (PCP) pos/neg CAP Propoxyphene pos/neg CAP Tricyclic Antidepressants (TCA) pos/neg

Fertility Endocrinology

CAP DHEA-S 6.0 ug/dL 15 CAP Estradiol 3 pg/mL 30 Estriol (unconjugated) 3.0 ng/mL 25 CAP Follicle Stimulating Hormone (FSH) 2 mIU/mL 25 CAP Luteinizing Hormone (LH) 2 mIU/mL 25 CAP Progesterone 0.3 ng/mL 30

Fructosamine

NR Fructosamine, DMF 0.45 mmol/L 30

NR Fructosamine, Polylysine 45 mmol/L 30

Glucose & Hemoglobin, Hemocue, 5 vial

Glucose 6 mg/dL 10 Hematocrit 6 Hemoglobin 7

Glucose & Hemoglobin, Hemocue, waived

Glucose 6 mg/dL 10 Hematocrit 6 Hemoglobin 7

Glycohemoglobin

Glycohemoglobin, 2 vial 1 percentage unit 15 CAP Glycohemoglobin, 5 vial 1 percentage unit 15

Hemoglobin A1C, Afinion

Hemoglobin A1c, Afinion (HbA1c) 1 percentage unit 15

Immunochemistry

C-Peptide 1.0 ng/mL 30 CAP Insulin 1.5 uIU/mL 30 CAP PTH (Parathyroid Hormone) 0.9 ng/mL 25 CAP Vitamin D 3SD 2 ng/mL

58

CMS Regulated

CAP Accepted

Program Analyte SD Grading Limits Concentration %

Lead, Blood, waived

CAP Lead, Blood 4ug/dL 10

Lipids

CAP Apolipoproteins, A1 25 mg/dL 30 CAP Apolipoproteins, B 20 mg/dL 25

CMS CAP Cholesterol, HDL 30 CAP Cholesterol, LDL (Direct) 15 mg/dL 20 CAP Lipoprotein (a) 10 mg/dL 30

Microalbumin/Creatinine, Urine

CAP Creatinine, Urine 3 mg/dL 15 CAP Creatinine, Urine, Semiquantitative pos/neg CAP Microalbumin, Quantitative 10 mg/L 25 CAP Microalbumin, Semiquantitative & qualitative pos/neg

Oximetry, Blood

Carboxyhemoglobin 3 percentage units 25 CAP Hemoglobin 7 Methemoglobin 2 percentage units 10 Oxyhemoglobin 3 percentage units 7

Pregnancy, Serum/Urine

CAP Pregnancy, Urine pos/neg

Procalcitonin

NR Procalcitonin 3SD +/- 0.02 ug/L

SHBG & Testosterone

Sex Hormone Binding Globulin (SHBG) 3SD 10 nmol/L Testosterone, Bioavailable 0.3 ng/mL 30 Testosterone, Free 0.3 ng/mL 30

Testosterone, Total 0.3 ng/mL 30

TIBC/UIBC

CAP Iron, Binding Capacity, Total (TIBC) 25 CAP Iron, Binding Capacity, Unsaturated (UIBC) 25 CAP Transferrin 10 mg/dL 7

Tumor Markers

Beta-2- microglobulin 0.06 mg/L 30

CAP CA 125 9 U/mL 30 CAP CA 15-3 3SD 2 IU/mL CAP CA 19-9 3SD 1.5 IU/mL CAP CA 27.29 3SD 3 IU/mL CAP Carcinoembryonic Antigen (CEA) 1.2 ng/mL 30 Prostate-specific Antigen (PSA), Free 0.9 ng/mL 30 Prostatic Acid Phosphatase (PAP) 1.2 ng/mL 30 Thyroglobulin 3SD 1 ng/mL Thyroglobulin Antibody 3SD 2 IU/mL

Urease, Rapid

Urease pos/neg

WB Glucose, Basic

CAP Glucose, Whole Blood 6 mg/dL 20

WB Glucose, Comprehensive

CAP Glucose, Whole Blood 6 mg/dL 10

59

CMS Regulated

CAP Accepted

Program Analyte SD Grading Limits Concentration %

PPM

Clinical Microscopy

CAP Fern(ing) Test present/absent CAP KOH Skin Preparation pos/neg CAP Nasal Eosinophils pos/neg CAP Pinworm Preparation pos/neg CAP Sperm, Qualitative (Digital Image) pos/neg CAP Vaginal Wet Mount correct/incorrect

Provider Performed Microscopy

CAP Fern(ing) Test present/absent CAP KOH Skin Preparation pos/neg CAP Nasal Eosinophils pos/neg CAP Pinworm Preparation pos/neg CAP Sperm, Qualitative (Digital Image) pos/neg CAP Urine Sediment correct/incorrect CAP Vaginal Wet Mount correct/incorrect Embryology/Andrology

Antisperm Antibody

CAP Antisperm Antibody pos/neg

Embryo Grading

NR Embryo Grading correct/incorrect

Fetal Fibronectin (fFN)

CAP Fetal Fibronectin (fFN) pos/neg

Fetal Membrane Rupture Test

NR Fetal Membrane Rupture (PAMG-1) pos/neg

IVF Embryo Culture Media

NR IVF, Human Sperm Cell Survivial, Media Acceptability acceptable (yes/no)

NR IVF, Mouse Embryo, Media Acceptability acceptable (yes/no)

Sperm Count

CAP Sperm Count, Qualitative (Post Vasectomy) pos/neg NR Sperm Count, Quantitative 7 million/mL 30

Sperm Morphology

NR Sperm Morphology, % 3SD 5 percentage units NR Sperm Morphology, Cell ID correct/incorrect

Sperm Motility

NR Sperm Motility 12 percentage units 25 NR Sperm Motility, Forward Progression % 12 percentage units 25

NR Sperm Motility, Forward Progression, semi-quantitative correct/incorrect

Sperm Viability

CAP Sperm Viability 10 percentage units 20 Coagulation

Activated Clotting Time (ACT), 2 vial

CAP Activated Clotting Time 20

Activated Clotting Time (ACT), 5 vial

CAP Activated Clotting Time

20

CoaguChek XS/XS Plus, Basic

INR 20 CAP Prothrombin Time 15

60

CMS Regulated

CAP Accepted

Program Analyte SD Grading Limits Concentration %

CoaguChek XS/XS Plus, Comprehensive

INR 20 CMS CAP Prothrombin Time 15

Coagulation, Plasma

CMS CAP Activated Partial Thrombin Time (APTT) 15 CMS CAP Fibrinogen 20

CAP INR 20 CAP INR Calculation 0.2 percentage units

CMS CAP Prothrombin Time 15

Prothrombin Time, WB

CAP INR 20 CAP INR Calculation 0.2 percentage units

CMS CAP Prothrombin Time 15

Prothrombin Time, WB, Hemachron

INR 20 CMS Prothrombin Time 15

Prothrombin Time, WB, Hemachron, waived

INR 20 Prothrombin Time 15 Hematology

Advanced Hematology w/ Manual Diff

NR Erythrocyte (RBC) Morphology correct/incorrect NR Leukocyte (WBC) Differential, Manual 3SD +/- one cell NR Leukocyte (WBC) Morphology correct/incorrect NR Platelet Morphology correct/incorrect

Routine Hematology w/ Manual Diff

NR Leukocyte (WBC) Differential, Manual 3SD +/- one cell NR Leukocyte (WBC) Differential, Verification Review correct/incorrect

Blood Cell Identification

CMS CAP Blood Cell Identification correct/incorrect

Erythrocyte Sedimentation Rate (ESR)

NR Erythrocyte Sedimentation Rate (ESR) 3SD

Erythrocyte Sedimentation Rate (ESR), Rapid

NR Erythrocyte Sedimentation Rate (ESR), Rapid 3SD

Hematology w/Diff A

CMS CAP Erythrocyte (RBC) Count 6 CMS CAP Hematocrit 6 CMS CAP Hemoglobin 7 CMS CAP Leukocyte (WBC) Count 15 CMS CAP Leukocyte (WBC) Differential, Auto 3SD CMS CAP Platelet Count 25

Hematology w/Diff B

CMS CAP Erythrocyte (RBC) Count 6 CMS CAP Hematocrit 6 CMS CAP Hemoglobin 7 CMS CAP Leukocyte (WBC) Count 15 CMS CAP Leukocyte (WBC) Differential, Auto 3SD CMS CAP Platelet Count 25

Hematology w/Diff C

CMS CAP Erythrocyte (RBC) Count 6 CMS CAP Hematocrit 6 CMS CAP Hemoglobin 7 CMS CAP Leukocyte (WBC) Count 15

61

CMS Regulated

CAP Accepted

Program Analyte SD Grading Limits Concentration %

Hematology w/Diff C, continued

CMS CAP Leukocyte (WBC) Differential, Auto 3SD CMS CAP Platelet Count 25

Hematology w/Diff Centrifugal (QBC)

CMS CAP Erythrocyte (RBC) Count 6 CMS CAP Hematocrit 6 CMS CAP Hemoglobin 7 CMS CAP Leukocyte (WBC) Count 15 CMS CAP Leukocyte (WBC) Differential, Auto 3SD CMS CAP Platelet Count 25

Hematology w/Diff D

CMS CAP Erythrocyte (RBC) Count 6 CMS CAP Hematocrit 6 CMS CAP Hemoglobin 7 CMS CAP Leukocyte (WBC) Count 15 CMS CAP Leukocyte (WBC) Differential, Auto 3SD CMS CAP Platelet Count 25

Hematology w/Diff E

CMS CAP Erythrocyte (RBC) Count 6 CMS CAP Hematocrit 6 CMS CAP Hemoglobin 7 CMS CAP Leukocyte (WBC) Count 15 CMS CAP Leukocyte (WBC) Differential, Auto 3SD CMS CAP Platelet Count 25

Hematology w/Diff G

CMS CAP Erythrocyte (RBC) Count 6 CMS CAP Hematocrit 6 CMS CAP Hemoglobin 7 CMS CAP Leukocyte (WBC) Count 15 CMS CAP Leukocyte (WBC) Differential, Auto 3SD CMS CAP Platelet Count 25

Hemoglobin & Hematocrit

CMS Hematocrit 6 CMS Hemoglobin 7

Hemoglobin & Hematocrit, waived

CAP Hematocrit 6 CAP Hemoglobin 7

Reticulocytes

CAP Reticulocytes, Automated 0.5 30 CAP Reticulocytes, Manual 2.5 30 Reticulocytes, Manual - Digital Image 2.5 30

Reticulocytes for Sysmex

Erythrocyte (RBC) Count 6 Reticulocytes, Automated 0.5 30

Sickle Cell Screen

CAP Sickle Cell Screen pos/neg

Immunohematology

Antibody Elution

NR Antibody Elution, Unexpected pos/neg

62

CMS Regulated

CAP Accepted

Program Analyte SD Grading Limits Concentration %

Antibody Titer

NR Antibody Titer, Unexpected A/D +/- 1 dilution

D (Rh) Typing Only

CMS CAP D (Rh) Typing pos/neg

Direct Antiglobulin Test (DAT)

CAP Direct Antiglobulin pos/neg

Fetal RBC

Fetal Screen pos/neg Hemoglobin F, Qualitative pos/neg Hemoglobin F, Quantitative 3SD +/- 0.3 percentage units

Immunohematology, Basic

CMS CAP ABO Typing correct/incorrect grouping CMS CAP D (Rh) Typing pos/neg

Immunohematology, Comprehensive

CMS CAP ABO Typing correct/incorrect grouping CMS CAP Compatibility Testing (Crossmatch) compatible/incompatible CMS CAP D (Rh) Typing pos/neg CMS CAP Unexpected Antibody Detection detected/ undetected CMS CAP Unexpected Antibody Identification correct/incorrect

Immunohematology, Comprehensive, Automated

CMS ABO Typing correct/incorrect grouping CMS Compatibility Testing (Crossmatch) compatible/ incompatible CMS D (Rh) Typing pos/neg CMS Unexpected Antibody Detection detected/ undetected CMS Unexpected Antibody Identification correct/incorrect

Immunohematology, Comprehensive, Plus

CMS CAP ABO Typing correct/incorrect grouping CMS CAP Compatibility Testing (Crossmatch) compatible/incompatible CMS CAP D (Rh) Typing pos/neg CMS NR RBC Antigen Typing correct/incorrect CMS CAP Unexpected Antibody Detection detected/ undetected CMS CAP Unexpected Antibody Identification correct/incorrect

Immunology

Antinuclear Antibody (ANA)

CMS CAP Antinuclear Antibody (ANA) pos/neg

Anti-Streptolysin O (ASO)

CMS CAP Antistreptolysin O (ASO) pos/neg

C-Reactive Protein (CRP)

CAP C-Reactive Protein (CRP), Qualitative pos/neg CAP C-Reactive Protein (CRP), Quantitative 3SD 0.4 mg/dL

Diagnostic Immunology

CMS CAP Antistreptolysin O (ASO) pos/neg CAP C-Reactive Protein (CRP), Qualitative pos/neg CAP C-Reactive Protein (CRP), Quantitative 3SD 0.4 mg/dL

CMS CAP Infectious Mononucleosis pos/neg CMS CAP Rheumatoid Factor (RF), Qualitative pos/neg CMS Rheumatoid Factor (RF), Quantitative, titer +/- 2 dilution

Rheumatoid Factor (RF), Quantitative, u/mL 2 U/L 25

H. Pylori Antibody

CAP Helicobacter Pylori Antibody pos/neg

63

CMS Regulated

CAP Accepted

Program Analyte SD Grading Limits Concentration %

Hepatitis Markers

CMS CAP Hepatitis, Anti-HAV, IgM pos/neg CMS CAP Hepatitis, Anti-HAV, Total pos/neg CMS CAP Hepatitis, Anti-HBc, IgM pos/neg CMS CAP Hepatitis, Anti-HBc, Total pos/neg

CAP Hepatitis, Anti-HBs pos/neg CAP Hepatitis, Anti-HCV pos/neg

CMS CAP Hepatitis, HBeAg pos/neg CMS CAP Hepatitis, HBsAg pos/neg

HIV Antibodies, Oral Fluid

CMS HIV, Oral Fluids (confirmation) pos/neg CMS CAP HIV, Oral Fluids (screening) pos/neg

HIV Antibodies, Rapid/Waived

CAP HIV, Waived pos/neg

HIV Markers

CMS CAP HIV, Anti-HIV 1 (confirmation) pos/neg CMS CAP HIV, Anti-HIV 1 or 1/2 (screening) pos/neg

HIV, p24 Antigen pos/neg

Immunoproteins

CMS CAP Complement C3 3SD CMS CAP Complement C4 3SD CMS CAP IgA 3SD CMS CAP IgE 3SD CMS CAP IgG 25 CMS CAP IgM 3SD

Lyme Disease

NR Lyme Disease pos/neg

Mononucleosis, Infectious

CMS CAP Infectious Mononucleosis pos/neg

Mononucleosis, Infectious, Waived

CAP Infectious Mononucleosis pos/neg

Rheumatoid Factor

CMS CAP Rheumatoid Factor (RF), Qualitative pos/neg CMS Rheumatoid Factor (RF), Quantitative, titer +/- 2 dilution

Rheumatoid Factor (RF), Quantitative, u/mL 2 U/L 25

Rubella

CMS CAP Rubella, IgG pos/neg

Syphilis Serology

CMS CAP Syphilis, Qualitative pos/neg CMS CAP Syphilis, Quantitative +/- 1 dil

ToRCH

Cytomegalovirus, IgG pos/neg Cytomegalovirus, IgM pos/neg Herpes Simplex Virus, Type I, IgG pos/neg Herpes Simplex Virus, Type I, IgM pos/neg Herpes Simplex Virus, Type I/II, IgG pos/neg Herpes Simplex Virus, Type I/II, IgM pos/neg Rubella, IgM pos/neg Toxoplasma, IgG pos/neg Toxoplasmosis, IgM pos/neg

64

CMS Regulated

CAP Accepted

Program Analyte SD Grading Limits Concentration %

Microbiology

Acid Fast Smears

CMS CAP Acid-Fast Bacteria/Smears pos/neg

Affirm Microbial Screen

CAP Candida pos/neg CMS CAP Gardnerella pos/neg

CAP Trichomonas pos/neg

Bacteriology

CMS CAP Antimicrobial Susceptibility correct/incorrect CMS CAP Organism Identification, Stool Culture correct/incorrect CMS CAP Organism Identification, Blood Culture correct/incorrect CMS CAP Organism Identification, CSF Culture correct/incorrect CMS CAP Organism Identification, Genital Culture correct/incorrect CMS CAP Organism Identification, Throat Culture correct/incorrect CMS CAP Organism Identification, Urine Culture correct/incorrect CMS CAP Organism Identification, Wound Culture correct/incorrect

Bacteriology, Complete

CMS CAP Antimicrobial Susceptibility correct/incorrect CAP Campylobacter pos/neg CAP Colony Count, Urine growth/ no growth

CMS CAP Gram Stain Identification pos/neg CAP Gram Stain Organism Morphology correct/incorrect

CMS CAP Organism Identification, Stool Culture correct/incorrect CMS CAP Organism Identification, Blood Culture correct/incorrect CMS CAP Organism Identification, CSF Culture correct/incorrect CMS CAP Organism Identification, Genital Culture correct/incorrect

CMS CAP Organism Identification, Throat Culture correct/incorrect CMS CAP Organism Identification, Urine Culture

correct/incorrect

CMS CAP Organism Identification, Wound Culture correct/incorrect CAP Strep Group A, Antigen Screen pos/neg

Blood Culture, add-on

Organism Identification, Blood Culture correct/incorrect

C. Difficile Toxin Antigen, 2-vial add-on

C Difficile Toxin A Antigen Detection pos/neg C Difficile Toxin B Antigen Detection pos/neg

C. Difficile Toxin Antigen, 5 vial

CMS CAP C Difficile Toxin A Antigen Detection pos/neg CMS CAP C Difficile Toxin B Antigen Detection pos/neg

Campylobacter Antigen, 2 vial, 2 event

Campylobacter pos/neg

Chlamydia

CMS CAP Chlamydia Antigen Screen pos/neg

Chlamydia, 2-vial add-on

Chlamydia Antigen Screen pos/neg

Chlamydia/CG/Strep Group B Antigen Screen

CMS CAP Chlamydia Antigen Screen pos/neg CMS CAP GC, Antigen Screen pos/neg CMS CAP Strep Group B, Antigen Screen pos/neg

Colony Count, Urine

CAP Colony Count, Urine correct/incorrect

65

CMS Regulated

CAP Accepted

Program Analyte SD Grading Limits Concentration %

Genital Culture

CMS CAP Organism Identification, Genital Culture correct/incorrect

Genital Culture, add-on

Organism Identification, Genital Culture correct/incorrect

Gram Stain

CMS CAP Gram Stain Identification pos/neg CAP Gram Stain Organism Morphology correct/incorrect

Legionella

Legionella pos/neg

MRSA/VRE, add-on

MRSA/VRE pos/neg

Rotavirus, 2 vial add-on

Rotavirus Antigen Screen pos/neg

Rotavirus, 5 vial

CMS CAP Rotavirus Antigen Screen pos/neg

S. pneumoniae Antigen

S. pneumoniae Antigen pos/neg

Shiga Toxin

Shiga Toxin pos/neg

Step Group A, Antigen Screen

CMS CAP Strep Group A, Antigen Screen pos/neg

Step Group A, Antigen Screen, waived

CAP Strep Group A, Antigen Screen pos/neg

Throat Culture

CMS CAP Organism Identification, Throat Culture correct/incorrect

Throat/Urine Culture

CMS CAP Antimicrobial Susceptibility correct/incorrect CAP Colony Count, Urine correct/incorrect

CMS CAP Organism Identification, Throat Culture correct/incorrect CMS CAP Organism Identification, Urine Culture correct/incorrect

Viral Antigen Screen

CMS CAP Adenovirus Antigen Screen pos/neg CMS CAP Influenza, Type A. Antigen Screen pos/neg CMS CAP Influenza, Type B, Antigen Screen pos/neg CMS CAP Respiratory Syncytial Virus (RSV) Antigen pos/neg

Viral Antigen Screen, Waived

Adenovirus Antigen Screen, Waived pos/neg CAP Influenza, Type A, Antigen Screen, Waived pos/neg CAP Influenza, Type B, Antigen Screen, Waived pos/neg Respiratory Syncytial Virus (RSV) Antigen, Waived pos/neg

Urine Culture

CMS CAP Antimicrobial Susceptibility correct/incorrect

CAP Colony Count, Urine

correct/incorrect

CMS CAP Organism Identification, Urine Culture correct/incorrect Mycology

Candida Culture

Candida Culture pos/neg

Cryptococcal Antigen

Cryptococcal Antigen pos/neg

India Ink Preparation

NR India Ink Preparation pos/neg

66

CMS Regulated

CAP Accepted

Program Analyte SD Grading Limits Concentration %

KOH Preparation

KOH Preparation correct/incorrect

Mycology Culture

Mycology Culture correct/incorrect Parasitology

Cryptosporidium/Giardia Immunoassay

CMS CAP Cryptosporidium Immunoassay pos/neg CMS CAP Giardia Immunoassay

pos/neg

Cryptosporidium/Giardia Immunoassay, 2-vial add-on

Cryptosporidium Immunoassay pos/neg Giardia Immunoassay

pos/neg

Cryptosporidium/Giardia/E. histolytica Immunoassay

CMS Cryptosporidium Immunoassay pos/neg CMS E. histolytica Immunoassay pos/neg CMS Giardia Immunoassay pos/neg

Parasitology

CMS CAP Parasitology correct/incorrect Specialty

Circulating Tumor Cells (CTC)

Circulating Tumor Cells (CTC) correct/incorrect

Cholesterol Certification

Cholesterol, Total Certificate

eGFR Monitoring

Creatinine optimal/desirable/acceptable eGFR calculation Certificate

WB Glucose, Basic-EQAS (Multi-site) CAP Glucose, Whole Blood 6 mg/dL 20

2015 PROGRAM GUIDE I Proficiency Testing Service I AAB

2015 PROGRAM GUIDE | Proficiency Testing Service | AAB 67

General Attestation Form

2015 PROGRAM GUIDE I Proficiency Testing Service I AAB

2015 PROGRAM GUIDE | Proficiency Testing Service | AAB 68

Proficiency Testing Action Form LABORATORY NAME: ____________________________________________________________________________ Section: __________________________________________________________________________________ Completed by: ___________________________________________________________________________________ Core lab Manager / Department Supervisor: ____________________________________________________________ Problem: _______________________________________________________________________________________ Attach documents as needed Corrective Action/Preventive Action: _______________________________________________________________ Attach documents as needed Reviewed by: Laboratory Manager ____________________________________________________________ Date: ______________ Medical Director _______________________________________________________________ Date: ______________ ------------------------------------------------------------------------------------------------------------------------------------------------------------------

PROFICIENCY TEST CORRECTIVE ACTION CHECKLIST FORM

Laboratory Name: ___________________________________________________________ CLlA #: __________________ Testing Event: ______________________________________________________________ Year: ____________________ Proficiency Testing Module: ___________________________________________________ Analyte: __________________ Date PT Sample Rcvd __/__/___ Test Date: __/__/___ Report Date: __/__/___ Sample #:___________________ Reported Results: ___________________ Expected Range: ___________ Expected Results: ____________ Repeat Analysis Result _______________ (Original or new specimen) Sample #:___________________ Reported Results: ___________________ Expected Range: ___________ Expected Results: ____________ Repeat Analysis Result _______________ (Original or new specimen) Sample #:___________________ Reported Results: ___________________ Expected Range: ___________ Expected Results: ____________ Repeat Analysis Result _______________ (Original or new specimen) Sample #:___________________ Reported Results: ___________________ Expected Range: ___________ Expected Results: ____________ Repeat Analysis Result _______________ (Original or new specimen) Sample #:___________________ Reported Results: ___________________ Expected Range: ___________ Expected Results: ____________ Repeat Analysis Result _______________ (Original or new specimen) I. Does this failure represent unsatisfactory performance for this analyte, specialty, or subspecialty? Y / N 2. Does this failure represent unsuccessful performance for this analyte, specialty, or subspecialty? Y / N (Unsatisfactory performance for two events in a row or two out of three consecutive testing events: ------------------------------------------------------------------------------------------------------------------------------------------------------------------ PT Failure Classification: Submitted Late Lack of Consensus Failure to Submit

Clerical Error Equipment Error Educational Challenge Trend / Bias Other

FINDINGS:_____________________________________________________________________________________________________________________________________________________________________________________________________________ CORRECTIVE ACTION: _______________________________________________________________________________________ ___________________________________________________________________________________________________________ COULD THIS ERROR AFFECT PATIENT RESULTS? Y / N If yes, state course of action: ___________________________________________________________________________________ [Review process to be modified by each lab to what is appropriate for that lab] Investigated by: ______________________________________________________________________ Date: ___/___/____ Technical Consultant/Supervisor: ________________________________________________________ Date: ___/___/____ Laboratory Director: ___________________________________________________________________ Date: ___/___/____

2015 PROGRAM GUIDE I Proficiency Testing Service I AAB

2015 PROGRAM GUIDE | Proficiency Testing Service | AAB 69

This form is to be used as a guide to assist in investigating, documenting, and correcting proficiency test failure or unacceptable results. Identify the reasons for failure or unacceptable results in proficiency testing and take appropriate corrective measure. Complete Proficiency Testing Corrective Action Form and attach copies of all records reviewed to this form. 1) SPECIMEN HANDLING

a) Were proficiency test specimens checked for acceptability when received? (Review notes made at the time proficiency test was received). Y / N / NA

b) Were the specimens handled properly? (Review instruction for specimen preparation). Y / N / NA 2) CLERICAL ERRORS

a) Verify correct value was transcribed from instrument printout to report form, or that the correct response was entered from the list of results. Y / N / NA

b) Verify that decimal point and units of measure were honored on the report form. Y / N / NA c) Verify that the correct code from the instrument or reagent list was entered on the report form. Y / N / NA d) Verify that the correct testing method information was provided. Y / N / NA e) Verify that any calculations were performed correctly. (even if automated calculation) Y / N / NA f) Check summary report to verify value on report form was honored by the PT service. Y / N / NA

3) QUALITY CONTROL

a) Were quality control materials within the acceptable range on the date of PT testing? (Verify the quality control acceptable range in use.) Y / N / NA

b) Any evidence of trends or shifts in the periods just before and just after PT was tested? Y / N / NA

4) CALIBRATION a) What was the date of the last calibration? ___/___/____ b) How often is calibration to be performed? ___/___/____ c) When was last calibration verification performed? ___/___/____ d) Were any calibration problems noted? Y / N / NA

5) INSTRUMENT

a) Were instrument parameters entered correctly? Y / N / NA b) Was daily maintenance performed on the date of PT testing? Y / N / NA c) Was special maintenance performed just prior to PT? Y / N / NA d) Were instrument problems noted when PT was performed? Y / N / NA

6) REAGENTS

a) Check reagent / instrument log for notation of recent problems. Y / N / NA b) Check reconstitution instructions in package insert versus procedure -any changes? Y / N / NA c) Verify that open stability of reagent was not exceeded by reviewing procedure with testing personnel.

Y / N / NA 7) TESTING PERSONNEL

a) Date of last competency assessment for testing personnel. ___/___/____ b) Review assay procedure and proficiency test sample preparation instructions with testing personnel to ensure that instructions

were followed. Y / N / NA c) Review with testing personnel how samples were loaded to rule out misidentification or transposition of samples.

Y / N / NA d) Was retraining of testing personnel required and if so is this completed? Y / N / NA

8) PROCEDURE

a) Review procedure versus manufacturer’s most current recommendation for any changes. Y / N / NA b) If retained frozen or refrigerated specimens were retested, were the results the same as those reported?

Y / N / NA c) Call instrument or reagent manufacturer for input if cause is not readily identified. Y / N / NA

9) INTERPRETATION ERRORS

a) Was PT challenge beyond the scope and extent of the testing routinely performed in your lab? Y / N / NA b) Has summary report been reviewed for an explanation of key features of the element presented in the photomicrographs

and/or pictures? Y / N / NA c) Have textbook references been consulted for additional information? Y / N / NA d) (Microbiology) Compare the test characteristics found in your laboratory with the characteristics of the

correct identification. Review your results and procedure for the key to distinguish the correct identification from the incorrect identification. Y / N / NA

2015 PROGRAM GUIDE I Proficiency Testing Service I AAB

2015 PROGRAM GUIDE | Proficiency Testing Service | AAB 70

Evaluating Proficiency Testing Results Suggested Process The role of proficiency testing (PT) has traditionally been one of an external quality assurance check. However, since successful PT performance has become an assessment tool for determining regulatory compliance, effectively evaluating your PT results is imperative. This sheet suggests a process to follow when evaluating your PT results. Feel free to incorporate this outline into your policy/procedure manual and use it to evaluate previous PT reports or when you get your next set of PT results. If you aren't already preserving your PT specimens, then consider retaining them for use in this evaluation process. A Beneficial Process for Evaluating Your PT Results Once you receive your PT results, review the CMS summary page to determine if all regulated analytes were scored for CLIA (regulatory) purposes. If you performed PT on a regulated analyte and this analyte does not appear on the summary page contact AAB-PTS. Check to be sure the CLIA number for the lab is included and/or correct on the report, along with the name and identifier of any other regulatory or accrediting body (I.e., CMS/State/COLA) that should receive copies of your PT report. If the CLIA number and/or regulatory information are lacking or incorrect your regulatory or accrediting agency will have problems receiving and monitoring your PT enrollment and scores. Notify AAB-PTS of any corrections to this information. Review your scores for the individual analytes and review the overall specialty scores. The criterion for satisfactory performance is a minimum score of 80% for all analytes (except a minimum score of 100% for ABO/Rh and compatibility testing). For analytes in the same specialty, the scores are averaged to obtain the overall specialty score. "Unsatisfactory" PT performance occurs when there is a failure in one event. PT performance is "unsuccessful” if there are two consecutive PT event failures or two out of three PT event failures. If repeated analyte / specialty scores indicate unsuccessful PT performance, then the lab is at risk of losing its ability to continue to test the analyte and/or specialty. After completing this initial review, continue with the more extensive review that follows: I. All results were passing; you should:

A. Review the report. 1. Are three of five results for an analyte outside +/-1.5 Standard Deviations, if this information is provided? 2. Are three results for an analyte outside +/-50% of mean? 3. Do the five results for the analyte range from -50 to +50% of mean? 4. Did any analytes receive an automatic 100% because they could not be graded?

B. If conditions 1, 2, or 3 exist, then take corrective action since it identifies gradual long term trends and indicates test instability.

C. If condition 4 exists, perform a self evaluation, since the score does not reflect actual laboratory performance. D. If none of these conditions exist, document this review.

[Stop review here.] II. If PT results for any analytes are unsatisfactory:

A. Check your original documentation for discrepancies. Look for: 1. Clerical errors (transcription, transposition, method coding). 2. PT program errors.

B. Check testing records for technical processing errors. Look for: 1. Misidentification of specimen. 2. Misinterpretation of results. 3. Results mistakenly reported outside the reportable range or when QC was out of range.

C. If any of the above appear to be the reason for the PT problems: 1. Document the causes and the corrective action taken to prevent them from happening in the future.

[Stop review here.] III. If the reason for the problems is still not apparent, then evaluate the test systems affected.

A. Expand the scope of the inquiry by asking: 1. Is the problem affecting more than one test on an instrument?

a. If yes, expect an instrument-related problem.

2015 PROGRAM GUIDE I Proficiency Testing Service I AAB

2015 PROGRAM GUIDE | Proficiency Testing Service | AAB 71

2. Is the problem affecting only tests results in a certain range, e.g., only specimens with high values are affected? a. If yes, this could be due to a linearity/calibration problem.

3. Are several tests affected from the same PT specimen? a. If yes, it could be a problem of PT specimen integrity or reconstitution.

B. Evaluate status of the affected tests at the time of initial testing and determine: 1. Has maintenance been performed appropriately? 2. Are controls in range, or starting to trend or shift? 3. When was the last calibration? 4. Is temperature a factor? 5. Are all reagents or controls in date?

C. Retest PT specimens retained specifically for this purpose. Serum specimens may be frozen; however, check to determine the time period your PT program's hematology specimens will be stable when refrigerated (they cannot be frozen). If the results in question are now in range and: 1. One test or specimen was affected, it is termed "random analytical error" that may have been due to:

a. Aliquot evaporation. b. Pipetting error/dilution error c. Instrument instability/power surge.

2. Two or more poor results for the same test were biased in the same direction, it is referred to as short-term systematic analytical error" that may have been due to: a. Improper instrument maintenance. b. Reagent deterioration. c. Improper calibration.

3. If all of the PT problems were explained by the above, then check for possible effects on patient results since the PT specimens were done. If the effect could have been clinically significant, then document appropriate corrective action. Take steps to prevent the problems from recurring.

[Stop review here.] IV. If the results of the retest are NOT in range, obtain a new sample of the PT material in question from your PT program

and test it Availability of these specimens varies greatly. If they aren't available, then consider performing split specimen testing on several patient specimens instead. A If the new specimens are in range, then the problem could have been due to:

1. Problems with the PT material specimen itself, such as: a. Bacterial/fungal contamination. b. Delay or temperature damage in shipment. c. Hemolysis of specimen. d. Evaporation of the specimen. e. Reconstitution error or delay in testing.

B. Document the cause of the errors and the corrective action taken to prevent future problems. [Stop review here.] V. If the results of these newly obtained specimens are out of range as well, then it's most likely due to a Iong-term

systematic error." A. Examples of some of these problems and their solutions are:

1. Miscalibration-recalibrate the instrument. 2. Repetitive procedural error-reread procedure / retrain staff. 3. Infrequent performance of the test-retrain staff or consider discontinuing the test. 4. Major instrument maintenance problem··call for service. 5. Matrix effect /incompatibility with your method-call AAB-PTS.

B. If the problems are corrected by any of the above reasons, then check the effect of the problem on patient results since the PT was originally performed. If the effect was clinically significant, then take appropriate corrective action. Document the corrective action taken to prevent them from happening again.

VI. Perform a scheduled QA follow-up review of the effectiveness of all corrective actions taken to prevent future PT

problems. Document this review. [Stop review here.] Proficiency Testing is a well-justified laboratory expense. Taking the time to evaluate the results according to the above outline will aid in your efforts to attain successful proficiency testing results, as well as produce quality laboratory test results.

PROFICIENCY TESTING SERVICE205 West Levee Street · Brownsville, Texas 78520800.234.5315 or 281.436.5357 · Fax 956.542.4041Web Site: www.aab-pts.org · E-mail: customerservice@aab-pts.org

2015 Program Guide Cover - 14831PTS.indd 2 12/18/14 2:18 PM