Wednesday, April 21, 2021

by Irwin Z. Rothenberg, MBA, MS, CLS (ASCP), Technical Writer /Quality Advisor

 
Introduction

The Clinical Laboratory Improvement Amendments (CLIA), passed by Congress in 1988, mandate that all test sites performing non-waived testing must undergo an inspection every two years.  These inspections are designed to evaluate compliance with the quality standards set for all testing performed, to ensure the accuracy, reliability and timeliness of patient test results.  All laboratories issued a CLIA certificate and all CLIA-exempt laboratories must comply with the applicable inspection requirements. 

The laboratory will either be inspected by CMS/CLIA (generally by state inspectors) or by an accrediting organization (AO) that has been granted deeming authority by CMS. There are currently seven CMS-approved accreditation organizations: AABB, American Association for Laboratory Accreditation (A2LA), American Osteopathic Association (AOA), American Society of Histocompatibility and Immunogenetics (ASHI), COLA, CAP, and The Joint Commission (TJC). 

Regardless of the agency, all inspections focus on essentially the same areas. While being “ready” can’t guarantee a stress-free inspection, it will indicate the laboratory has already adopted the culture of quality patient care, and that it can continue to improve from there.

CLIA follows a biennial inspection schedule.  Some private Accrediting Organizations follow a more general 18-24 month schedule, so it would be prudent for laboratories to be additionally vigilant during these time frames. 

Inspections may or may not be announced in advance, depending on the Accrediting Organization. It is also important to be aware of how notification is provided: on-line, email, postal mail, telephone or fax. Make sure that the notifications go to the proper individuals.  It should be noted that if there has been a complaint against a laboratory, the inspection/survey may be unannounced.

Preparing For an Inspection:  General   Guidelines For Operating a Compliant Laboratory

• Be familiar with the regulatory requirements for your laboratory as determined by your inspection agency, reflecting the type of CLIA certificate required; the complexity of your test menu; the specialties represented in your test menu; the type(s) of instrumentation, and whether outside reference work is performed by your laboratory.
• Ensure that all positions in the laboratory are filled by qualified personnel; have complete documentation of education, experience, training, and competency assessments; all job descriptions current.
• Establish and maintain written policy, process, and procedure manuals. These must include procedures for all phases of testing performed by the laboratory; define quality control by the frequency, type and number used; include corrective action protocols; list critical values when appropriate, with follow up actions; and specimen acceptability requirements.   All manuals must include the Laboratory Director’s signed and dated review and approval[i].
• Be enrolled and participate in a proficiency testing program appropriate for your test menu and specialties.
• Instrument calibration, maintenance, and quality control are performed as required.
• Instrument performance specifications have been verified.
• Verify the security of your Laboratory Information System (LIS); as well as the accuracy of data entered and stored.
• Incorporate quality assessment into the daily routine of the laboratory. This includes assessing the quality throughout the testing process; taking corrective actions when needed; and following up on the effectiveness of corrective actions. 
• Ensure that all required documentation is maintained in accordance with CLIA requirements.

The Day of the Inspection[ii]

The inspector will need documentation of all laboratory functions described below, including patient charts when requested, for the past two-years, or from the date of the last AO / CMS CLIA inspection.  These records should be collected prior to the inspection and placed in a room with an electrical outlet. The list below is not all-inclusive, but represents the basic items required.  Depending on individual circumstances, the surveyor may request additional records.   

Proof of education according to CLIA ‘88 requirements. The following documents are acceptable: High school diploma, GED, Transcripts (must have date graduated), college degrees (AS, BS, MS, and PhD), and MD/DO Licenses. 

1. MT & MLTS must have either copies or transcripts of the advanced degrees (AS, BS, MS).  ASCP or other professional society cards or certificates cannot be accepted as the only proof of qualification.
2. Medical Assistants, LPNs, and RNs must have either high school diplomas or advanced degrees available. Licenses cannot be accepted as the only proof of qualification. 
3. Those employees with only foreign educational documents must have them evaluated for equivalency to a US high school diploma, or college degree by an officially recognized education evaluation organization.
4. In those states that license laboratory personnel, a copy of a current state license can be accepted.  It is advisable to have copies of the corresponding educational degree as well.

• Written performance evaluations and/or technical skill competencies.  New employees must be evaluated at six months and also one year after their hire; other employees must be evaluated yearly.
• Training documents for all new employees or some proof of their previous experience, such as resumes and prior instrument training.
• Job descriptions for all employees.
• Policy & Procedure Manual(s) including all Instrument Operator’s Manuals.
• Current package inserts for all kit tests and reagents (including all waived methods).
• Package inserts for all controls and calibration materials used during the survey period. 
• Proficiency testing (PT) records including instrument tapes, test report forms, attestation statements, graded results, and corrective actions taken for all unsatisfactory scores.
• Instrument/equipment/pipette calibration, maintenance, and function check records for current and discontinued instruments used during the survey period. 
• Temperature and humidity records.
• All quality control (QC) records, graphical representations, charts, and any other documentary logs involved.
• IQCP studies
• Test requisitions and report forms used for all laboratory testing. The inspector may ask to review several patient charts.
• Incident Management Plan and any reports. 
• Quality Assessment (QA) Plan and documentation of implementation - QA reviews. 

Once the inspection has been completed and an exit conference or interview has occurred with the inspector, the laboratory director should share all findings with the laboratory personnel. Sharing the ­information in a timely fashion will allow the laboratory the opportunity to begin addressing deficiencies immediately and prepare for subsequent inspections.

Conclusion

Preparing for a laboratory inspection brings anxiety and stress above and beyond those of a normal work day.  Optimizing quality laboratory medicine and quality patient care is the goal for all clinical laboratories, but being prepared and doing well on your laboratory inspection should also bring a special sense of satisfaction.