Every patient GOLD STANDARD Checklist of Director … Deficiencies that directly affect patient safety, ... relationship with the medical staff and are effectively supporting patient

Every patientdeserves theGOLD STANDARD ...

Master

Team Leader Assessmentof Director & QualityChecklist

CAP Accreditation Program

College of American Pathologists325 Waukegan RoadNorthfield, IL 60093-2750www.cap.org 07.28.2015

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Team Leader Assessment of Director & Quality Checklist 07.28.2015

Disclaimer and Copyright NoticeOn-site inspections are performed with the edition of the Checklists mailed to a facility at the completionof the application or reapplication process, not necessarily those currently posted on the website. Thechecklists undergo regular revision and a new edition may be published after the inspection materialsare sent.

For questions about the use of the Checklists or Checklist interpretation, email [email protected] or call800-323-4040 or 847-832-7000 (international customers, use country code 001).

The Checklists used for inspection by the College of American Pathologists' Accreditation Programshave been created by the CAP and are copyrighted works of the CAP. The CAP has authorized copyingand use of the checklists by CAP inspectors in conducting laboratory inspections for the Commissionon Laboratory Accreditation and by laboratories that are preparing for such inspections. Except aspermitted by section 107 of the Copyright Act, 17 U.S.C. sec. 107, any other use of the Checklistsconstitutes infringement of the CAP's copyrights in the Checklists. The CAP will take appropriate legalaction to protect these copyrights.

All Checklists are ©2015. College of American Pathologists. All rights reserved.

[email protected]

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Team Leader Assessment ofDirector & Quality Checklist

TABLE OF CONTENTS

SUMMARY OF CHANGES....................................................................................................................4UNDERSTANDING THE CAP ACCREDITATION CHECKLIST COMPONENTS................................ 6INSTRUCTIONS..................................................................................................................................... 6DEFINITION OF TERMS....................................................................................................................... 9LABORATORY DIRECTOR ASSESSMENT...................................................................................... 13

QUALIFICATIONS AND GENERAL REQUIREMENTS.................................................................................................... 14LABORATORY DIRECTOR RESPONSIBILITY AND OVERSIGHT................................................................................. 16LABORATORY DIRECTOR NOT ON-SITE FULL TIME.................................................................................................. 21

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ON-LINE CHECKLIST AVAILABILITY

Participants of the CAP accreditation programs may download the checklists from the CAP website(www.cap.org) by logging into e-LAB Solutions. They are available in different checklist types and formattingoptions, including:

● Master — contains ALL of the requirements and instructions available in PDF, Word/XML or Excelformats

● Custom — customized based on the laboratory's activity (test) menu; available in PDF, Word/XML orExcel formats

● Changes Only — contains only those requirements with significant changes since the previous checklistedition in a track changes format to show the differences; in PDF version only. Requirements that havebeen moved or merged appear in a table at the end of the file.

SUMMARY OF CHECKLIST EDITION CHANGESTeam Leader Assessment of Director & Quality Checklist

07/28/2015 Edition

The information below includes a listing of checklist requirements with significant changes in the current editionand previous edition of this checklist. The list is separated into three categories:

1. New2. Revised:

● Modifications that may require a change in policy, procedure, or process for continuedcompliance; or

● A change to the Phase3. Deleted/Moved/Merged:

● Deleted● Moved — Relocation of a requirement into a different checklist (requirements that have been

resequenced within the same checklist are not listed)● Merged — The combining of similar requirements

NOTE: The listing of requirements below is from the Master version of the checklist. The customized checklistversion created for on-site inspections and self-evaluations may not list all of these requirements.

NEW Checklist Requirements

Requirement Effective DateTLC.10475 07/28/2015TLC.11485 04/21/2014

REVISED Checklist Requirements

Requirement Effective DateTLC.10100 07/28/2015TLC.10440 07/28/2015TLC.10700 07/28/2015TLC.11300 07/28/2015TLC.11425 07/28/2015TLC.11475 04/21/2014TLC.11600 07/28/2015TLC.11800 07/28/2015

DELETED/MOVED/MERGED Checklist Requirements

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Requirement Effective DateTLC.12550 04/20/2014TLC.12650 04/20/2014

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UNDERSTANDING THE CAP ACCREDITATIONCHECKLIST COMPONENTS

All checklist requirements contain a requirement number, subject header, phase, and a declarative statement.Some requirements also contain a NOTE and/or Evidence of Compliance.

The NOTE portion of a checklist requirement provides additional detail to assist in interpreting the requirement.

Evidence of Compliance (EOC) is intended to:● Suggest specific examples of acceptable records; some elements are required● Assist in inspection preparation and for managing ongoing compliance● Drive consistent understanding of requirements

If a policy or procedure is referenced within a requirement, it is only repeated in the Evidence of Complianceif such statement adds clarity. All policies or procedures covered in the CAP checklists must be a writtendocument. A separate policy or procedure may not be needed for items in EOC if it is already addressed by anoverarching policy.

The Master version of the checklist also contains references and the inspector R.O.A.D. instructions (Read,Observe, Ask, Discover), which can provide valuable insight for the basis of requirements and on howcompliance will be assessed.

INSTRUCTIONS

This checklist will help you evaluate the qualifications of the laboratory director and the effectivenessof the director in implementing the Standards of the Laboratory Accreditation Program, including thelaboratory's quality management plan. Record any major or systemic deficiencies detected during theon-site inspection that reflect lack of director oversight in areas such as QC, QM, proficiency testing,employee qualifications and records, competence and training, and the maintenance of a safe workenvironment. Record any major or systemic issues identified, and elaborate on these findings in theInspector's Summary Report, Part A (ISR-A).

This checklist must be completed by the team leader or a team member who is qualified and trainedto be a team leader. It is important to cite IN THIS CHECKLIST, any systemic issues identified, and toelaborate on these findings in the Inspector's Summary Report, Part A (ISR-A).

The following activities provide the information needed to complete the requirements in this checklist:

1. Interview the laboratory director.2. Interview laboratory supervisory personnel and other laboratory personnel as appropriate.3. Observe the operation of the laboratory during your time on-site.4. Review the laboratory organizational chart, quality management plan and records,

committee minutes, and other relevant documents for appropriate director involvement.5. Interview the hospital administrator. If the laboratory is an independent organization,

interview an executive from the organization.6. Interview the chief of the medical staff (for laboratories associated with a medical staff).7. Discussion with members of the inspection team to assess the extent of deficiencies.

Deficiencies that directly affect patient safety, or are pervasive in the laboratory, may warranta deficiency in the Director Oversight Responsibilities section of this checklist.

Interviews with the laboratory director, hospital or organization administrator, and representative ofthe medical staff are essential parts of the inspection. If for any reason one of these interviews was notperformed, discuss the circumstances in the Inspector's Summation Report.

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Meeting with the Laboratory Director

Purpose: To help determine if the laboratory director has sufficient responsibility and authority for operation ofthe laboratory. Allow a minimum of 15-20 minutes for the meeting.

The interview is an opportunity to:

● Evaluate the director's activities as listed in the Standards for Laboratory Accreditation● Review any problems that the inspection experience might serve to resolve (e.g. space problems,

staffing shortages)● Determine whether the laboratory director also functions as a technical supervisor, clinical consultant,

general supervisor, or as a testing personnel. If so, review the Personnel section of the LaboratoryGeneral Checklist for qualifications and responsibilities.

Meeting with the Organization/Hospital Administrator/Chief Executive Officer (CEO)

For hospital-based laboratories, the inspector should meet with the hospital administrator/CEO. Allow atleast 15-20 minutes for the meeting. Avoid scheduling the meeting early in the inspection to have a senseof the laboratory's operations first. For independent laboratories, meet with an executive from the laboratoryorganization.

Purpose: To extend the College's appreciation for participating in the accreditation program, to record anevaluation of the laboratory from the administration's viewpoint, and help assess the director's involvement inthe administration of the laboratory.

Points to communicate during the interview are:

● The goals of the CAP Laboratory Accreditation Program: education and laboratory improvement;establishing best practices in laboratory medicine, based on input from national experts

● Inspection method: two-year accreditation cycle; use of active laboratorians as inspectors; educationalvalue to inspector and inspected laboratory

● The role of proficiency testing in the program● Laboratory director: the laboratory director is responsible for the overall operation of the laboratory,

under the requirements of the CAP Laboratory Accreditation Program


● Ascertain the administration's perception of the laboratory service● Discuss administration's view of the laboratory director's role in ensuring high quality laboratory services

to fulfill the needs of the institution's patients and clinicians● Determine if the institution gives the director the authority to fulfill the director's responsibilities under

CAP● Address the effectiveness of the working relationship among the laboratory, its director and

administration● Identify any areas of conflict

Discuss all laboratories being inspected. Do not discuss any financial and/or contractual arrangements.

When speaking with the hospital administrator, ask if the laboratory service level is appropriate to the needsof the institution. Ask how the pathologists participate in hospital-wide committees, how effective theyare in working with the medical and administrative staffs, and whether they meet the expectations of theadministration.

Record key findings from this interview in Part A of the Inspector's Summation Report.

Meeting with a Representative of the Medical Staff

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For laboratories associated with organized medical staffs, it is important for the team leader to interview thechief of the medical staff (or other knowledgeable medical staff representative, such as the chief medical officer,or a physician who uses the laboratory's services frequently).

Allow for a 15-20 minute discussion, and come prepared with a general understanding of the laboratory'soperations beforehand.

Purpose: To determine whether the director and the laboratory staff have established an effective workingrelationship with the medical staff and are effectively supporting patient care.


● Evaluate how effectively the scope, quality, and timeliness of laboratory services meet the patient careneeds of the hospital

● Assess the contribution of the pathologist and laboratory staff to teaching conferences and meetings● Determine the cooperation of medical staff and pathologist in problem resolution● Judge the medical community's perception of the effectiveness of the laboratory director and other

pathologists, and determine if the laboratory director has sufficient authority to fulfill the needs of themedical staff and patients

When meeting with the chief or other active member of the medical staff, ask questions about the scope,quality and timeliness of laboratory services. The team leader should ask the medical staff representative forinput on pathologist participation in medical staff committees, participation in institutional quality management(performance improvement) and patient safety activities, and participation in teaching conferences. Include alllaboratories being inspected, including special function and satellite laboratories.

The inspector may record information from this interview in Part A of the Inspector's Summation Report.

Pre-Summation Conference

Prior to the summation conference, allow 30-60 minutes to meet privately as a group with the inspection teammembers to discuss and record inspection findings. The goal of the meeting is to ensure that both verbal andwritten inspection reports are complete and consistent. During the meeting:

● Resolve team members' questions● Ensure consistency in recording similar findings (e.g. deficiency versus recommendation)● Identify serious deficiencies that may jeopardize patient care and systemic problems where inspectors

cited the same or related deficiencies in multiple laboratory sections● Review the Part A Questions in the Inspector's Summation Report● If serious deficiencies or systemic issues are identified or any question from Part A is answered

"NO," cite the appropriate checklist requirements relating to the issue and the TLC Checklistrequirement for the laboratory director responsibility.

Common examples include:

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Issue Observed Related TLC RequirementLack of laboratory director involvement TLC.10430QM plan not properly implemented TLC.10440

Inconsistent quality control/lack of corrective action TLC.10460Improper handling of proficiency testing materials/lack of follow-up forunacceptable results

TLC.10460

Lack of validation/verification records for new tests or instruments TLC.10475Insufficient numbers of personnel or incomplete records for personnelqualifications and/or training

TLC.11300

Unsafe laboratory practices compromise the safety of personnel TLC.11400

Incomplete records for delegation of duties or duties not effectivelycarried out by designee(s) (e.g. competency assessments notperformed as required by designee) or delegation of functions toindividuals who lack the necessary qualifications

TLC.11425

Summation Conference

Citations in this checklist are optional for discussion at the summation conference to which laboratory staff,hospital administration, and others may be invited. The team leader may instead choose to discuss them withthe laboratory director in a private summation meeting.

DEFINITION OF TERMS

Alternative assessment - A system for determining the reliability of laboratory examinations for which nocommercial proficiency testing products are available, are not appropriate for the method or patient populationserved by the laboratory, or participation is not required by the accrediting organization.

Analytical validation - The process used to confirm with objective evidence that a laboratory-developed ormodified FDA-cleared/approved test method or instrument system delivers reliable results for the intendedapplication.

Analytical verification - The process by which a laboratory determines that an unmodified FDA-cleared/approved test performs according to the specifications set forth by the manufacturer when used as directed.

Annual - Every 12 calendar months

Biennial - Every 24 calendar months

Authority - The power to give orders or make decisions: the power or right to direct someone or control aprocess

Calibrator, historical - The set of archived results of a single-point calibrator that demonstrates stability of theassay over time

Check - Examination to determine the accuracy, quality or presence of any attribute of a test system

Clinical validation - The determination of the ability of a test to diagnose or predict risk of a particular healthcondition or predisposition, measured by sensitivity, specificity, and predictive values

Confirmation - Substantiation of the correctness of a value or process

Corrective Action - Action taken to eliminate the cause of a detected nonconformity or other undesirablesituation

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Correlation - Establishment of agreement between two or more measured values

Credentialing - The process of obtaining, verifying, and assessing the qualifications of a practitioner to providecare in a health care organization

Device - Any reagent, reagent product, kit, instrument, apparatus, equipment or related product, whether usedalone or in combination, intended by the manufacturer to be distributed for use in vitro for the examination ofhuman specimens

Digital image analysis - The computer-assisted detection or quantification of specific features in an imagefollowing enhancement and processing of that image, including immunohistochemistry, DNA analysis,morphometric analysis, and in situ hybridization

Equipment - Single apparatus or set of devices or apparatuses needed to perform a specific task

Examination - In the context of checklist requirements, examination refers to the process of inspection oftissues and samples prior to analysis. An examination is not an analytical test.

FDA - In the context of checklist requirements, FDA should be taken to mean the national, state, or provincialauthority having jurisdiction over in vitro diagnostic test systems.

Function Check - Confirmation that an instrument or item of equipment operates according to manufacturer'sspecifications before routine use, at prescribed intervals, or after minor adjustment (e.g. base line calibration,balancing/zero adjustment, thermometer calibration, reagent delivery).

High complexity - Rating given by the FDA to commercially marketed in vitro diagnostic tests based on theirrisks to public health. Tests in this category are seen to have the highest risks to public health.

Instrument - An analytical unit that uses samples to perform chemical or physical assays (e.g. chemistryanalyzer, hematology analyzer)

Instrument platform - Any of a series of similar or identical analytical methods intended by their manufacturerto give identical patient results across all models

Laboratory Director - The individual who is responsible for the overall operation and administration ofthe laboratory, including provision of timely, reliable and clinically relevant test results and compliance withapplicable regulations and accreditation requirements. This individual is listed on the laboratory's CAP and CLIAcertificate (as applicable).

Maintenance - Those activities that prolong the life of an instrument or minimize breakdowns or mechanicalmalfunctions. Examples include cleaning, changing parts, fluids, tubing, lubrication, electronic checks, etc.

Moderate complexity - Rating given by the FDA to commercially marketed in vitro diagnostic tests based ontheir risks to public health

Modification of manufacturer's instructions - Any change to the manufacturer's supplied ingredients ormodifications to the assay as set forth in the manufacturer's labeling and instructions, including specimen type,instrumentation or procedure that could affect its performance specifications for sensitivity, specificity, accuracy,or precision or any change to the stated purpose of the test, its approved test population, or any claims relatedto interpretation of the results

Nonwaived - Tests categorized as either moderately complex (including provider-performed microscopy) orhighly complex by the US Food and Drug Administration (FDA), according to a scoring system used by the FDA

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Performance verification - The set of processes that demonstrate an instrument or an item of equipmentoperates according to expectations upon installation and after repair or reconditioning (e.g. replacement ofcritical components)

Policy - 1) Set of basic principles or guidelines that direct or restrict the facility's plans, actions, and decisions;2) Statement that tells what should or should not be done

Preventive action - Action taken to eliminate the cause of a potential nonconformity or any other undesirablepotential situation

Primary specimen - The body fluid, tissue, or sample submitted for examination, study or analysis. It may bewithin a collection tube, cup, syringe, swab, slide, data file, or other form as received by the laboratory.

Procedure - 1) Specified way to carry out an activity of a process (also referred to by ISO as "work instructions";2) Set of steps performed that tells "how to do it" to achieve a specified outcome, including decisions to be made

Process - 1) Set of interrelated or interacting activities that transforms inputs into outputs; 2) Series of events,stages, or phases that takes place over time that tells "what happens" or "how it works"

Proficiency testing - Evaluation of participant (laboratory or individual) performance against pre-establishedcriteria by means of interlaboratory comparisons. In some countries, the PT programs for clinical laboratoriesare called "external quality assessment" programs.

Reagent - Any substance in a test system other than a solvent or support material that is required for the targetanalyte to be detected and its value measured in a sample.

Report errors - A report element (see GEN.41096) that is either incorrect or incomplete

Responsibility - A duty or task that an individual is required or expected to do

Secondary specimen - Any derivative of the primary specimen used in subsequent phases of testing. It maybe an aliquot, dilution tube, slide, block, culture plate, reaction unit, data extract file, image, or other form duringthe processing or testing of a specimen. (The aliquots or images created by automated devices and tracked byinternal electronic means are not secondary specimens.)

Section Director - The individual who is responsible for the medical, technical and/or scientific oversight of aspecialty or section of the laboratory.

Semiannual - Every 6 calendar months

Subject to U.S. Regulations - Laboratories located within the United States and laboratories located outside ofthe US that have obtained or applied for a CLIA certificate to perform laboratory testing on specimens collectedin the US for the assessment of the health of human beings.

Telepathology - The practice in which the pathologist views digitized or analog video or still image(s), andrenders an interpretation that is included in a formal diagnostic report or is recorded in the patient record.

Testing personnel - Individuals responsible for performing laboratory assays and reporting laboratory results

Test - A qualitative, semiqualitative, quantitative, or semiquantitative procedure for detecting the presence of, ormeasuring an analyte

Test system - The process that includes pre-analytic, analytic, and post-analytic steps used to produce a testresult or set of results. A test system may be manual, automated, multi-channel or single-use and can includereagents, components, equipment or instruments required to produce results. A test system may encompassmultiple identical analyzers or devices. Different test systems may be used for the same analyte.

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Waived - A category of tests defined as "simple laboratory examinations and procedures which have aninsignificant risk of an erroneous result." Laboratories performing waived tests are subject to minimal regulatoryrequirements.

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LABORATORY DIRECTOR ASSESSMENTInspector Instructions:

● Laboratory director’s qualifications● Laboratory director's licensure as applicable● Laboratory director’s job description● Laboratory director’s record of delegation of responsibilities● Organizational chart● Agreement and records for the frequency of and duties performed during onsite visits

(if director is off-site). Ensure actual practice matches agreement.

● Interaction of laboratory director with laboratory supervisory personnel and laboratorystaff

● Whether the entire laboratory is included in this inspection● Technical staff recognition of the role and involvement of the laboratory director in

setting expectations and service needs

Laboratory Director:● What quality improvement initiatives have been most successful during the past two

years? Which are works in progress?● What educational programs have been made available to staff during the past two

years?● Have you had any complaints that would indicate the laboratory is perceived as an

unsafe working place for personnel and the patients it serves?● How did your laboratory conduct the mid-cycle self-inspection?● How do you ensure the laboratory meets the expectations of hospital administration

and medical staff?● When was the last time your laboratory provided an inspection team? How did you

ensure that all team members were trained?● How do you ensure that the laboratory has adequate numbers of properly trained

staff?

Organization Administrator:● What level of involvement do pathologists have in organization-wide committees?● How does the laboratory communicate important laboratory information to

administration?● How well does the laboratory meet the operational, financial and clinical needs of the

organization?

Medical Staff Representative:● How is the laboratory involved in hospital-wide quality management activities,

including patient care improvements, patient safely activities and teachingconferences?

● What level of involvement do pathologists have in medical staff committees?● How does the laboratory communicate important laboratory information to medical

staff?● How well does the laboratory meet the patients care needs (TAT, accuracy,

responsiveness) of the organization?

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● If the administrator and/or the medical staff representative gave examples indicatingthe laboratory did not meet their expectations, further evaluate laboratory leadership’sresponses, corrective actions and resolutions.

● Whether QC failures reflect systemic problems or involve patient safety; if so, was thelaboratory director involved in the resolution?

● How well the laboratory director is involved in key quality processes (proficiencytesting, root cause analysis, procedure manual review, etc.)

QUALIFICATIONS AND GENERAL REQUIREMENTS

**REVISED** 07/28/2015TLC.10100 Laboratory Director Qualifications Phase II

The laboratory director satisfies the personnel requirements of the College of AmericanPathologists.

NOTE: The qualifications required by the CAP for the position of laboratory director depend onthe testing performed in the laboratory.* The qualifications are also dependent upon whether thelaboratory is subject to US regulations.

The following table contains the laboratory director qualifications based on complexity of testingand US regulatory status:

Laboratories Subject to US RegulationComplexity of Testing Qualifications1. High complexity testing or Moderatelycomplex and/or waived testing with test volumeexceeding 500,000 tests/year

a. MD, DO, or DPM licensed to practice (ifrequired) in the jurisdiction where the laboratoryis located, and have one of the following:

i. Certification in anatomic or clinicalpathology, or both, by the AmericanBoard of Pathology or AmericanOsteopathic Board of Pathology, orpossess qualifications equivalent tothose required for certification; or

ii. Have at least one year of laboratorytraining during residency; or

iii. Have at least two years ofexperience supervising highcomplexity testing;

ORb. Doctoral degree in a chemical, physical,biological, or clinical laboratory science froman accredited institution, and have currentcertification by a board approved by HHS**

2. High complexity testing limited to a particularspecialty (e.g. hematology, dermatopathology,oral pathology, neuromuscular pathology,ophthalmic pathology)

a. MD or DO certified in that specialty by oneof the following boards, or who possessesqualifications equivalent to those required forcertification:

● A board that is a member of theAmerican Board of Medical Specialties

● The American Board of Oral andMaxillofacial Pathology

● An American Osteopathic board

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3. Moderately complex (including provider-performed microscopy (PPM) and/or waivedtesting with test volume not exceeding 500,000tests/year:

a. Qualified as in (1) aboveOR

b. MD, DO or DPM, licensed to practice in thejurisdiction where the laboratory is located (ifrequired) and have one of the following:

i. At least 20 hours of continuingmedical education credit hours inlaboratory medicine; or

ii. Equivalent training during medicalresidency; or

iii. At least one year of experiencesupervising nonwaived laboratorytesting

ORc. Doctoral degree with one of the following:

i. At least one year of experiencesupervising nonwaived laboratorytesting; or

ii. Certified by a board approved byHHS**

4. Waived testing and provider-performedmicroscopy (PPM) with annual test volume notexceeding 500,000 tests/year

a. Qualified as in (1), (2) or (3) aboveOR

b. MD or DO, or DPM, licensed to practicein the jurisdiction in which the laboratory islocated, if required

Laboratories not subject to US regulations

All Complexity Levels a. MD, DO, PhD or have commensurateeducation and experience necessary to meetpersonnel requirements as determined by theCAP

For laboratories subject to US regulations, additional qualifications for grandfatheredindividuals and for the subspecialty of oral pathology may be found in the CLIA regulation42CFR493.1443(b)(6).

For laboratories subject to US regulations that perform moderately or highly complex tests, asingle individual may direct no more than five such laboratories.

For laboratories subject to US regulations, credentials for all personnel trained outside of theUS must be reviewed to ensure that their training and qualifications are equivalent to CLIArequirements, with records of the review available onsite. The equivalency evaluations should beperformed by a nationally recognized organization.

*Qualifications for director of the embryology laboratory and for scientific director of the forensicdrug testing laboratory are given in the Reproductive Laboratory and Forensic Drug Testingchecklists, respectively. Qualifications for histocompatibility laboratory directors, includingcontinuing clinical laboratory education requirements, can be found in the HistocompatibilityChecklist.

**A list of boards approved by CMS for doctoral scientists may be found athttp://www.cms.hhs.gov/CLIA/16_Certification_Boards_Laboratory_Directors.asp

http://www.cms.hhs.gov/CLIA/16_Certification_Boards_Laboratory_Directors.asp

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Evidence of Compliance:✓ Records of director qualifications appropriate to the type of laboratory and level of complexity

REFERENCES1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement

amendments of 1988; final rule. Fed Register. 1992(Feb 28):7175 [42CFR493.1443].2) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement

amendments of 1988; final rule. Fed Register. 2004(Oct 1):1050 [42CFR493.1405]3) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement

amendments of 1988; final rule. Fed Register. 2004(Oct 1):1049 [42CFR493.1357]4) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement

amendments of 1988; final rule. Fed Register. 2004(Oct 1):979 [42CFR493.19]5) College of American Pathologists, Commission on Laboratory Accreditation. Standards for laboratory accreditation; Standard I.

Northfield, IL: CAP, 19986) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement

amendments of 1988; final rule. Fed Register. 2004(Oct 1):1052 and 1057 [42CFR493.1407(d) and 1445(d)]7) http://www.wes.org (information on non-US boards)

TLC.10150 Provision of AP Services Phase II

Anatomic pathology services are provided by a pathologist certified in anatomicpathology or possessing qualifications equivalent to those required for certification.

NOTE: In facilities where anatomic pathology services are provided, a pathologist certified inanatomic pathology (or possessing qualifications equivalent to those required for certification)must perform such services. The services of a consulting anatomic pathologist shall be retained ifnecessary.

At the discretion of the director, subspecialties of anatomic pathology may be provided byphysicians who are qualified under paragraph 2 of the Note to TLC.10100, above.

Evidence of Compliance:✓ Records of director qualifications (e.g. current CV, degree, license, board certification,

training and experience) AND✓ Listing of AP services provided by the institution


amendments of 1988; final rule. Fed Register. 2004(Oct 1):1059 42CFR493.1449(l)

TLC.10200 Section Director Qualifications Phase II

If the laboratory director is not qualified to direct any of the individual sections of thelaboratory, the laboratory retains the services of individuals qualified to direct thosesections.

Evidence of Compliance:✓ Records of section director qualifications (e.g. current CV, degree, license, board

certification, training and experience) appropriate for the specialty

LABORATORY DIRECTOR RESPONSIBILITY AND OVERSIGHT

NOTE TO THE INSPECTOR: Appropriate checklist requirements in this subsection should be cited if theinspection reveals serious deficiencies that may impact patient care or systemic problems where inspectorscited the same or related deficiencies in multiple laboratory sections. If the Team Leader marks "NO" to any ofthe Part A questions in the Inspector's Summation Report, one or more related TLC requirements must also becited.

TLC.10430 Director Responsibility/Authority Phase II

The laboratory director has sufficient responsibility and authority to implement andmaintain the standards of the College of American Pathologists.

http://www.wes.org

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NOTE: Examples of how the team leader may obtain information on the laboratory director'sresponsibility and authority include: interviews with the laboratory director, institution'sadministration, medical staff, laboratory management and laboratory supervisory staff; reviewof the laboratory organizational chart; and review of minutes of quality management and otherlaboratory meetings.


amendments of 1988; final rule. Fed Register. 1992(Feb 28):7173 [42CFR493.1407], 7175 [42CFR493.1443]2) College of American Pathologists, Commission on Laboratory Accreditation. Standards for laboratory accreditation; Standard I.

Northfield, IL: CAP, 1998

**REVISED** 07/28/2015TLC.10440 Effective QM Phase II

The laboratory director ensures an effective quality management program for thelaboratory.

NOTE: The laboratory director must be involved in the design, implementation and oversightof the laboratory's quality management program. This includes all aspects of test performance,including the preanalytic, analytic, and postanalytic phases of testing.

Evidence of Compliance:✓ Written QM plan covering all areas of the laboratory AND✓ Records of laboratory director approval of the QM plan and the selection of quality indicators

AND✓ Records (e.g. reports, QM meeting minutes) of laboratory director review of quality

indicators, annual assessment of QM plan, complaints, and incidents with development andimplementation of plans of corrective action


amendments of 1988; final rule. Fed Register. 1992(Feb 28):7173 [42CFR493.1407(e)(5-6), 7176 [42CFR493.1445(e)(5,13)]2) Clinical and Laboratory Standards Institute. Quality Management System: A Model for Laboratory Services; Approved Guideline. 4th

ed. CLSI Document QMS01-A4. Clinical and Laboratory Standards Institute, Wayne, PA; 2011.

TLC.10460 Director Responsibility - PT/QC Phase II

The laboratory director ensures proficiency testing, alternative assessment, and QCprocedures are sufficient for the extent of testing performed in the laboratory.

Evidence of Compliance:✓ Records of PT and alternative assessment data attesting to completeness AND✓ Records of investigation and corrective action, as applicable AND✓ Written QC procedures for all areas of the laboratory AND✓ Records of laboratory director or designee review of QC and corrective actions

**NEW** 07/28/2015TLC.10475 Director Responsibility - New Method Validation/Verification Phase II

The laboratory director ensures that the performance specifications for new tests,instruments, and methods introduced to the laboratory have been properly validated orverified prior to being used for patient testing.

NOTE: Specific requirements are in the All Common Checklist (Instruments & Equipment, TestMethod Validation/Verification, and Method Performance Specifications sections) and in otherchecklists.

Evidence of Compliance:✓ Written procedures for validation/verification studies AND✓ Records of new method validation/verification approval and supporting data

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amendments of 1988; final rule. Fed Register. 1992(Feb 28): 7173[42CFR493.1407(e)(3), 7175[42CFR493.1445(e)(3)].2) College of American Pathologists, Commission on Laboratory Accreditation. Standards for laboratory accreditation; Standard III.

Northfield, IL: CAP, 1998.

TLC.10500 Director Responsibility - Communication Phase II

The laboratory director ensures communication of laboratory data and appropriate patientresult reporting.

Evidence of Compliance:✓ Records of oversight of computer services and changes AND✓ Evidence of chart review AND✓ Lab communications, newsletters, etc.


amendments of 1988; final rule. Fed Register. 1992(Feb 28):7173 [42CFR493.1407(c), (e)(809)], 7175 [42CFR493.1445]2) College of American Pathologists, Commission on Laboratory Accreditation. Standards for laboratory accreditation; Standard I.

Northfield, IL: CAP, 1998

**REVISED** 07/28/2015TLC.10700 Director Responsibility - Consultations Phase II

The laboratory director provides for intralaboratory consultations and clinicalconsultations regarding the ordering of appropriate tests and the medical significance oflaboratory data.

NOTE: Only physicians or doctoral scientists may provide clinical consultations.

The laboratory director must be accessible to the laboratory for on-site, telephone, or electronicconsultations, as needed, or ensure that a qualified designee is available in the director'sabsence.

Evidence of Compliance:✓ Laboratory director's authorization for activities of consultant(s) AND✓ Listing of laboratory contacts/consultant(s) available to the clinical services AND✓ Records of laboratory director's involvement in resolution of problems relating to

inappropriate test ordering practice AND✓ Records of discussions between consultants and clinical services


amendments of 1988; final rule. Fed Register. 1992(Feb 28):7173 [42CFR493.1407(e)(8-9)], 7175 [42CFR493.1445]2) College of American Pathologists, Commission on Laboratory Accreditation. Standards for laboratory accreditation; Standard I.

Northfield, IL: CAP, 19983) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement

amendments of 1988; final rule. Fed Register. 2004(Oct 1):1067 [42CFR493.1457]

TLC.11200 Director Responsibility - Education/R&D Phase II

The laboratory director ensures provision of educational programs, strategic planning,and research and development appropriate to the needs of the laboratory and institution.

Evidence of Compliance:✓ Schedule or description of available educational activities AND✓ Records or minutes from strategic planning sessions demonstrating participation and role of

laboratory director AND✓ Policy for assessing clinical needs, implementing and evaluating solutions


amendments of 1988; final rule. Fed Register. 1992(Feb 28):7173 [42CFR493.1407(e)(12)], 7176 [42CFR493.1445(e)(12)]

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2) Clinical and Laboratory Standards Institute. Training and Competence Assessment; Approved Guideline. 3rd ed. CLSI DocumentQMS03-A3. Clinical and Laboratory Standards Institute, Wayne, PA, 2009.

**REVISED** 07/28/2015TLC.11300 Director Responsibility - Personnel Phase II

The laboratory director ensures sufficient numbers of personnel with appropriateeducational qualifications, documented training and experience, and adequatecompetency to meet the needs of the laboratory.

NOTE: For laboratories subject to US regulations, all personnel must meet the personnelrequirements of CLIA or other US equivalent regulations (e.g. Clinical Laboratory ImprovementProgram Procedures for Department of Defense laboratories, Veterans Health AdministrationHandbook). For laboratories not subject to US regulations, all personnel requirements must bedefined and met.

Staffing should be considered insufficient if there is clear evidence from quality monitoringrecords, data derived from complaints or concerns, turnaround time, and error statistics, etc.

Evidence of Compliance:✓ Records indicating personnel meet requirements for the level of testing (complexity)

performed AND✓ Records of employee training, competency assessment, and continuing education in

personnel files


amendments of 1988; final rule. Fed Register. 1992(Feb 28):7173 [42CFR493.1407(e)(10-11)], 7176 [42CFR493.1445(e)(12)]2) Clinical and Laboratory Standards Institute. Training and Competence Assessment; Approved Guideline. 3rd ed. CLSI Document

QMS03-A3. Clinical and Laboratory Standards Institute, Wayne, PA, 2009.3) Boyd JC, Savory J. Genetic algorithm for scheduling of laboratory personnel. Clin Chem. 2001;47:118-123

TLC.11400 Director Responsibility - Safe Environment Phase II

The laboratory director ensures implementation of a safe laboratory environment incompliance with good practice and applicable regulations.

NOTE: The laboratory director must ensure compliance with OSHA and national, state, and localregulations, as well as other applicable safety regulations. Details may be found in the Safety andTransport Services sections of the Laboratory General checklist.

Evidence of Compliance:✓ Records of review of safety procedures AND✓ Records of safety audits with corrective action taken to correct violations, as applicable AND✓ Safety meeting minutes AND✓ Chemical hygiene plan up-to-date with annual evaluation for effectiveness


amendments of 1988; final rule. Fed Register. 1992(Feb 28):7173 [42CFR493.1407(e)(2)], 7176 [42CFR493.1445(e)(2)]

**REVISED** 07/28/2015TLC.11425 Director Responsibility - Delegation of Functions Phase II

Delegation of the laboratory director's functions or responsibilities is in writing.

NOTE:

1. Functions that may be delegated include review of QC data, proficiency testing performance,and test methodology performance studies. The laboratory director remains responsible [A] that

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all persons performing delegated functions are qualified to do so; and [B] that the delegatedfunctions are properly carried out.

2. Functions that may not be delegated include provision of appropriately trained supervisoryand technical staff and the identification of their responsibilities. The laboratory director mustdocument personal, on-site assessment of physical and environmental conditions and theadequacy of staffing.

3. The responsibilities and duties of supervisors, consultants, and testing personnel involved inpreanalytic, analytic, and postanalytic phases of testing must be defined in writing, with recordsof authorization to perform testing, and the level of supervision required, as applicable.

4. If a delegated duty is not being properly performed by the designee, with no evidence ofcorrective action, the team leader should cite this requirement as a deficiency, in addition to thespecific checklist requirement(s) that relates to the duty not being performed (e.g. monthly QCreview, approval of method validation/verification studies).

Evidence of Compliance:✓ Policy or statement signed by the laboratory director authorizing individuals by name or job

title to perform tasks on behalf of the laboratory director AND✓ Records showing that delegated tasks are performed by designee, as required

TLC.11450 Director Responsibility - Interaction with Government or RegulatoryInteraction

Phase II

The laboratory director or designee interacts with government and other agencies asappropriate.

NOTE: The laboratory director or designee must interact with agencies such as national, stateand local health departments, as appropriate, for laboratory-related matters.

Evidence of Compliance:✓ Records of any required reports of infectious diseases to the federal, state or local health

department AND✓ Response to any inquiry by government and other agencies, as appropriate AND✓ Reports to OSHA, FDA or other agency, as required

**REVISED** 04/21/2014TLC.11475 Director Responsibility - Equipment/Services Phase I

The laboratory director or designee is directly involved in the selection of all laboratoryequipment, supplies, and services with respect to quality.

NOTE: The intent is to ensure that the laboratory director has appropriate control over theprocess. The fact that economic issues are a major factor in these selections does not relievethe laboratory director of responsibility for ensuring the quality of the technical, clinical andoperational aspects of the laboratory. The director must ensure that reagents, fluids, parts,materials, and other items supplied by the laboratory meet the requirements for use withinstruments and equipment.

Evidence of Compliance:✓ Meeting minutes indicating the laboratory director's presence when purchases are discussed

OR✓ Written approval from the laboratory director to purchase equipment


amendments of 1988; final rule. Fed Register. 2003(Jan 24): [42CFR493.1252(a)]

**NEW** 04/21/2014

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TLC.11485 New Director Procedure Approval Phase II

Following a change in laboratory directorship, the new laboratory director approves thelaboratory policies and procedures over a reasonable period of time.

NOTE:1. The approval of the policies and procedures must be recorded.2. The format of such documentation is at the discretion of the laboratory director. It

must include an itemization of the documents reviewed and approved, signaturesand dates, and demonstrate that all procedure manuals have been approved.

3. The approval should be completed within three months of the change of directorshipfor most laboratories.

4. Different requirements for approval of new and substantially changed policiesand procedures and for routine reviews (at least every 2 years) appear in the AllCommon Checklist.


amendments of 1988; final rule. Fed Register. 2003(Jan 24): [42CFR493.1251(d)], [42CFR493.1445(e)]

LABORATORY DIRECTOR NOT ON-SITE FULL TIME

NOTE TO THE TEAM LEADER: The following two requirements apply to laboratory directors who arenot present full-time at the laboratory. Off-site laboratory directors must ensure that all laboratory directorresponsibilities defined in the other sections of the checklist are carried out as required. Refer to TLC.11425 forinformation on delegation of duties and duties that may not be delegated.

**REVISED** 07/28/2015TLC.11600 Director Off-Site Phase II

There is a written agreement or policy defining the frequency of, and responsibilities foractivities to be performed by the laboratory director during on-site visits and remotely,with records of the director's activities.

NOTE: If activities are conducted remotely, the policy or agreement must define thecommunication mechanisms that will be used and how records of the communications will bemaintained.

Evidence of Compliance:✓ Records for frequency of on-site visits AND✓ Meeting minutes showing director participation AND✓ Laboratory director review of quality management records AND✓ Records of electronic review or consultation

**REVISED** 07/28/2015TLC.11800 Director Visits and Remote Consultation Phase II

The involvement of the laboratory director, including activities conducted during on-sitevisits and remote consultation, follows the written policy or agreement and is consideredadequate by the laboratory and medical staff and the inspection team.

NOTE: The requirement is not met if the hospital administrator, the chief of staff, laboratorysupervisors, or most technical staff desire greater personal involvement on the part of thelaboratory director. If activities are conducted remotely, the laboratory director must ensure thatthere is an effective communication mechanism in place between the laboratory director andlaboratory management and staff.

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The requirement is also not met if the laboratory director is not performing duties as defined inthe policy or agreement or if the inspector identifies that the visits and remote involvement arenot sufficient to carry out the laboratory director responsibilities or provide sufficient oversight ofthe laboratory. Such situations may include, but are not limited to, serious quality or safety issuesthat are not addressed in a timely manner, duties delegated by the laboratory director to otherstaff that are not being carried out in an effective manner, and improper implementation of newlaboratory practices.

Documents

Every patient GOLD STANDARD Checklist of Director … Deficiencies that directly affect patient safety, ... relationship with the medical staff and are effectively supporting patient