Everything you need to know to run an effi cient ?· Everything you need to know to run an effi cient…

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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.

  • 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


    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.

  • COLA, Inc. 2016. All Rights Reserved.

    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.

    S E C T I O N 1


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    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.

  • COLA, Inc. 2016. All Rights Reserved.

    Quality Systems: how you can ensure patient safety

    Quality Systems is a term that refers to all of a laboratorys 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 laboratorys 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


    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

    S E C T I O N 2


  • COLA, Inc. 2016. All Rights Reserved.

    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.

    S E C T I O N 3


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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.

    For full details visit www.cola.org

  • COLA, Inc. 2016. All Rights Reserved.

    Mitigate your risk with Profi ciency Testing

    Profi ciency Testing (PT) is an important aspect of a laboratorys overall assessment of quality. PT serves as an external check to verify the accuracy of a laboratorys 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.


    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 tes