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Everything you need to know to run an effi cient laboratory.

9881 Broken Land Parkway, Suite 200Columbia, MD 21046-1195www.cola.org | 1.800.981.9883

©COLA, Inc. 2016. All Rights Reserved.


Section 1: 11 Steps to opening your new lab 3

Section 2: Quality Systems: what every lab needs to know 5

Section 3: Responsibilities of the Laboratory Director and the 15 steps to follow 6

Section 4: The Importance of Profi ciency Testing 8

Section 5: COLA. A trusted accreditor and advisor to laboratories. 10

Section 6: Contacting COLA 12

Overview

Opening a new laboratory is a big responsibility. This handy resource

guide highlights the key areas in opening a lab, maintaining quality

and compliance, and delivering accurate test results.


11 Steps to Opening Your New Lab

Laboratories that perform testing on human specimens for the diagnosis, prevention, or treatment of disease, or for the assessment of health must comply with all applicable CLIA ’88 regulations. Here are the 11 key steps for obtaining accreditation:

1. Determine the complexity of the tests you will perform in the laboratory.

• Waived Tests

• Provider Performed Microscopy Procedures (PPMP)

• Non-waived (Moderate or High Complexity) Tests

2. Complete the CMS-116 form to apply for the appropriate certifi cate type.

Section I: Indicate that the application is for a new laboratory by marking the box next to Initial Application.

Section II: Select the certifi cate type that matches the highest level of testing performed and the choice of

inspection agency, if applicable.

Sections VI, VII and VIII: Using the instructions provided, estimate the expected annual test volume for

Waived tests and Non-waived tests (including PPMP)

3. Submit the completed CMS-116 form (as well as any state-specifi c paperwork) to your local

CLIA/state agency.

· Certifi cate of Waiver labs will be billed $150.

· Certifi cate of PPMP labs will be billed $200.

· Certifi cate of Compliance or Certifi cate of Accreditation labs will be billed $100 for an interim

Certifi cate of Registration.

4. If you selected Certifi cate of Accreditation, enroll your laboratory with your chosen agency now.

Accredited labs are still required to pay CMS to maintain a valid CLIA certifi cate.

5. Enroll in an approved profi ciency testing program for all regulated analytes on your test menu.

6. Set up your laboratory using the applicable CLIA requirements. For non-waived testing, establish a

policy and procedure manual and a quality assessment plan, perform test method validation, train

employees, and prepare for inspection.

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©COLA, Inc. 2016. All Rights Reserved. 4

7. Pay any inspection fees owed to the state/CLIA program and/or your accrediting agency

when you receive a bill.

Government inspection fees are based on your estimated annual test volume, which will be verifi ed at the

time of inspection.

8. Schedule your on-site inspection.

Your local state agency or accrediting agency will contact you to schedule your inspection.

Unannounced inspections are also allowed, so it is important to always be prepared.

9. Complete the inspection process and correct any defi ciencies within the required timeframe.

10. When your laboratory has successfully completed the inspection process, CMS will issue a bill for the

Certifi cate of Compliance or Certifi cate of Accreditation.

11. Maintain a valid and current CLIA certifi cate that matches the level of testing performed.

You must renew your CLIA certifi cate every two years for as long as you perform testing.

Use the CMS-116 form to change your certifi cate type if you change the level of testing performed.


Quality Systems: how you can ensure patient safety

Quality Systems is a term that refers to all of a laboratory’s policies, processes, procedures, and resources needed to achieve quality testing.

If a laboratory performs non-waived testing, it must establish, maintain and implement written policies and procedures that monitor all phases of the total testing process (pre-analytic, analytic, and post-analytic) as well as general laboratory practices.

The various components of a laboratory’s quality systems are used to meet CLIA requirements and should be appropriate for the specialties and sub-specialties of testing the lab performs, the services offered, and the clients the lab serves.

Quality Assessment (QA) emphasizes the need to assess quality throughout the total testing system by

incorporating these practices into the daily routine of the laboratory.

General Laboratory Practices

General laboratory practices include those processes

that are not particular to a specifi c phase of testing.

These include:

• Confi dentiality of Patient Information

• Specimen identifi cation and integrity

• Complaint investigations

• Communications

• Personnel Competency Assessment Policies

• Evaluation of Profi ciency Testing Performance

The laboratory must establish and follow written policies and procedures to actively monitor, assess, and correct

problems identifi ed in each of the general laboratory practices.

For full details visit www.cola.org

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Responsibilities of the Laboratory Director and meeting CLIA requirements

The Laboratory Director is responsible for the overall operation and administration of the laboratory. Most importantly, the labratory director must select and employ laboratory personnel competent to perform testing, and accurately and profi ciently record and report test results.

CLIA requires the Laboratory Director to:

1. Ensure test systems provide quality services.

2. Ensure the physical laboratory is safe for personnel and they are protected from physical, chemical,

or biological hazards.

3. Ensure test methods used in the laboratory provide appropriate results required for patient care and that lab

personnel are performing the tests as required.

4. Ensure the laboratory is enrolled in a CMS-approved profi ciency testing program.

5. Ensure profi ciency testing samples are tested and reported as required by CLIA.

6. Review and evaluate profi ciency testing (PT) results and check with staff on any corrective actions which may

be needed if PT results are unsatisfactory.

7. Ensure quality control (QC) and quality assessment (QA) programs are established and maintained to ensure

quality of laboratory services and to identify failures in quality as they occur.

8. Establish and maintain acceptable levels of performance for each test system.

9. Ensure all necessary remedial actions are taken and documented whenever problems are identifi ed, and

patient results are reported only when the system is functioning properly.

10. Ensure test reports include information required for interpretation.

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11. Ensure consultation is available to patients on matters relating to the quality of test results reported and

their interpretation.

12. Employ a suffi cient number of laboratory personnel and, prior to testing, ensure employees have the

appropriate education, experience, or training.

13. Ensure policies and procedures are established to monitor personnel performing tests to make certain

they are competent to process specimens, perform test procedures, and report test results promptly and

profi ciently.

14. Ensure an approved procedure manual is available to all personnel responsible for any aspect of testing.

15. Specify, in writing, the responsibilities and duties of each person engaged in the testing process and identify

which examinations and procedures each individual is authorized to perform.



Mitigate your risk with Profi ciency Testing

Profi ciency Testing (PT) is an important aspect of a laboratory’s overall assessment of quality. PT serves as an external check to verify the accuracy of a laboratory’s test results by providing unknown specimens for analysis by the laboratory.

When all of the participating laboratories submit results to the PT program, the results are grouped, statistically analyzed, and reported back to the laboratories.

Requirements:

Regulated Analytes

Labs are required to participate in profi ciency testing for all

regulated analytes on your test menu.

Unregulated Analytes

Twice a year, labs are required to verify the accuracy of the

remaining, non-waived unregulated analytes on your test menu.

Successful Performance

To meet the requirements of CLIA, laboratories must pass two

consecutive, or two out of three consecutive testing events to

achieve successful participation.

To pass, laboratories must receive a score of at least 80% for the specialties and sub-specialties of Microbiology,

Immunology, Chemistry, Hematology, and Immunohematology.

Unsuccessful Performance

Unsuccessful PT performance is the failure of two consecutive or two out of three events for an analyte. The

CLIA regulations require that a laboratory with unsuccessful PT performance must cease patient testing for the

analyte, specialty, or sub-specialty. Reinstatement by successful performance for two events is required before

patient testing may resume.

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PT Documentation

It is important to maintain accurate records for each testing event and to retain that documentation for two

years. Document the handling, preparation, processing, and examination of the PT specimens and document

each step in the testing process.

Testing PT Specimens

CLIA requires that laboratories test PT specimens in the same manner as patient specimens. This means that

the same laboratory staff who routinely perform patient testing should test the PT specimens using routine test

methods. No repeat testing and averaging of results is allowed.

PT Review

The Laboratory Director should review PT data on a regular basis with the staff to address any failures and

evaluate PT performance. Take corrective action to resolve any issues and document all steps taken. It is

important to understand how to read and interpret PT reports and summary data, especially when self-

evaluation is required. The laboratory must determine if their results are within acceptable limits, or if corrective

action is needed.



COLA. A trusted accreditor and advisor to laboratories.

COLA provides an accreditation program that mentors its partners and provides peace of mind. Our instructional approach assists laboratorians with navigating CLIA regulations, maintaining compliance, and running successful and effi cient labs. Our approach is supported through access to our lab management portal and educational resources.

The 7 Key Reasons laboratorians like you choose COLA:

1. An Educational Approach to Compliance: COLA Accreditation

COLA will help you maintain high standards in the laboratory through our education-oriented on-site surveys,

easy to understand checklist, and bi-monthly newsletters.

2. A Self-Assessment Checklist

This is a useful preparation tool for a lab’s inspection. The self-assessment allows you to evaluate the lab at

your convenience. And can help you identify and correct defi ciencies before your on-site survey.

3. Your COLA Survey

COLA surveys are educational, straightforward and consistent.

COLA Surveyors are trained to educate and help. Our surveyors

will provide you with prompt feedback immediately after the

survey.

4. COLAcentral® – The ideal Client Portal

Through www.colacentral.com, you will have access to:

• Educational tools and resources

• Regulatory alerts and compliance notifi cations

• Online Laboratory Management with a Document Repository

5. Technical Support

COLA members receive technical support from experienced medical technologists when they call our toll free

help line 800-981-9883. You can also email us at [email protected] to get answers to lab-related questions.

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6. Seamless Transition for Laboratories Switching From Another Organization

COLA makes your switching process easy. Your initial application can be completed over the phone with a

COLA representative in a matter of minutes. Your CLIA ID Number will not change when switching to COLA;

therefore, your reimbursements through Medicare will not be effected.

7. Federally Approved and Joint Commission Recognized

COLA’s Lab Accreditation Program has been approved by the federal government to meet CLIA regulations

for clinical laboratories of all types, nationwide. COLA’s Lab Accreditation Program is also fully recognized by

The Joint Commission.

Working with COLA leads to success

To get started with the partner that laboratories rave about for its educational and consultative approach, contact Rachael Kelly, COLA’s Manufacturer Liaison, at 410-423-3763 or [email protected].

9881 Broken Land Parkway, Suite 200 Columbia, MD 21046-1195www.cola.org | 1.800.981.9883
