The Clinical Laboratory Improvement Amendments of 1988 (CLIA '88), enforced by the Department of Health and Human Services (DHHS), require biennial inspections for clinical laboratories performing non-waived tests. However, laboratories may also be inspected for compliance by a myriad of other agencies, including the Occupational Safety and Health Administration (OSHA); COLA; the Office of Civil Rights (OCR), which is responsible for enforcing the Health Insurance Portability and Accountability Act (HIPAA); The Joint Commission; the College of American Pathologists; and the Food and Drug Administration. For the purposes of this article, we will primarily address laboratory-specific regulations under CLIA. Most laboratory inspections, even for other agencies, are based on these regulations.
Although the CLIA surveyors (also known as “State” inspectors) and COLA surveyors usually notify laboratories up to two weeks in advance of an inspection, they have the authority to enter and inspect the laboratory at any time, even with no advance notice. All OSHA inspections are conducted without notice. This means that every laboratory must treat every day as if they know an inspector is on the way.
The outcome of a survey is based on the laboratory's condition and documentation at the time of the inspection. Below is a summary of the documents that a compliant laboratory must have to be prepared for an inspection by its accrediting agency.
Pre-survey information is required.Along with the notification of the date and time of the survey, CLIA or the accrediting agency will request certain basic information, including the laboratory's business hours, test menu and test volumes, and directions to the facility. To make your survey go more smoothly, provide the requested information immediately, using the method suggested in their letter.
Previous survey report and corrective actions must be available. The surveyor doesn't need to see the previous report, but she or he must review the corrective actions and all associated documentation, so have that material ready to present when requested.
Personnel files (paper or electronic) must be available for everyone involved with working in the laboratory. For the physician director, this includes the license to practice medicine in the state where the laboratory is located, plus documentation of experience or training to serve as director. For any director, there must be documentation of the level of education and experience required for the position. For the technical consultant, credentials (college degree and proof of experience) and a performance evaluation should suffice. For testing personnel, files must contain laboratory-specific training records, an annual competency evaluation, and documentation of the highest level of formal education. This may be a college degree, high school diploma or transcript, or GED. Licenses and certificates, other than state-required laboratory licenses (if any), do not count. For example, for a medical technologist, the state medical technologist license or national registry is nice, but it does not fulfill this requirement, even though a college degree is required for that position. If any staff cannot locate their high school diploma, they can request an official transcript from the school's county Board of Education. Individuals should make the same request of their colleges.
For an individual educated outside the United States, a translation of that education must be available as well. This is not a literal language translation, but an equivalency statement. An equivalency statement can be obtained from a business dedicated to this service; there are several translation businesses to choose from.
Documentation of hepatitis B vaccination must be available, but it should be in a confidential file, such as OSHA-required employee medical files. Annual continuing education records may be in personnel files or elsewhere; they are not confidential. Training attendance sheets are generally accepted.
Installation records should be readily available for all instruments acquired since the most recent inspection, even if the new instrumentis areplacement or an exact duplicate. Installation records are now much more involved than previously, and they must show that your testing personnel participated in the calibrations and validation studies.
Manuals and test procedures must be current, comprehensive, and signed by the laboratory director. This includes the laboratory's procedure manual, package inserts, manufacturer's user guides, quality assessment plan, and a current manual from the reference laboratory(s). The procedures must include site-specific information, such as corrective actions for unacceptable QC results and the course of action to take if you are unable to run a patient test for any reason.
All procedures that have been discontinued since the last inspection should be dated (i.e., “Discontinued month/date/year”) and separated from the active procedures. They could be filed in a section of the procedure manual labeled “Discontinued Procedures,” placed in a pocket of the binder, or stored in a file cabinet. They must be kept for a minimum of two years after the date the procedures have been discontinued. This also applies to the package inserts for those procedures.
Calibration and calibration verification plus maintenance records and service reports should be readily located, perhaps filed with calibration records or in a maintenance file. Printouts of maintenance or background counts should be kept if the information cannot be retrieved electronically. Include temperature and humidity logs and documentation of water quality checks and electricity if applicable.
Quality control records must be retainedfor at least two years and may be organized by test, by specialty, or by date. They may be kept electronically, in binders. or in folders. Make sure you include corrective actions for those incidents when control values are unacceptable.
Have your proficiency testing records organized and ready for the surveyor to evaluate. Each laboratory should have the proficiency testing provider send a copy of the report to the surveyor, but must also keep all signed attestation statements, handwritten records, and instrument printouts, even after you get your grade of 100%. If the laboratory scored less than 100%, it must show documentation of investigation and corrective actions, even if only one point was missed. For unregulated analytes, split-specimen testing must be done at least twice each year, so be prepared to show documentation of that as well.
The surveyor will review some patient records, whether they are paper charts or electronic health records. The surveyor must be able to verify that you havewritten requests for all tests and that all tests ordered have been resulted and charted. Instrument printouts may be placed in the charts or stored in the laboratory. This is a required government function, a part of quality improvement, and is specifically allowed by the HIPAA regulations.
After the surveyor has toured the laboratory and reviewed the documents, he or she will summarize the findings and will provide guidance concerning any required corrective actions. The laboratory will receive a written report within a few business days. Detailed instructions for the required Plan of Corrective Actions/Plan of Required Improvements will be provided, including which corrections require submission of documentation. The laboratory MUST respond within the specified time frame. This doesn't necessarily mean the corrective actions must be completed by that time, but that you must submit your plan.
The plan of corrective actions must specify how the laboratory plans to correct the problem, what has been done for any patient tests affected by the incident, what the laboratory will do for any other patient tests that may have been affected by the incident, what the laboratory will do to prevent recurrence, and when the corrective actions will be completed. Unless the report specifies that the corrective actions must be completed by a certain date, the laboratory should give itself ample time. For example, if the laboratory must revise its procedure manual, it should allow up to three months for that revision. Be aware that the surveyor may revisit on the very day specified in the response.
Laboratory surveyors are there to look after your patients' best interests. The proof is in the paperwork, so get organized and stay organized. Don't be frightened by a laboratory inspection, but do consider it an opportunity to find areas for improvement.
Besides personal experience, I consulted the following in creating this article:
- COLA Accreditation Manual
- Publication 7, Appendix C, Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services
- CMS- 2226-F: 42 CFR 493 Medicare, Medicaid, and Clinical Laboratory Improvement Amendments (CLIA) Programs; Laboratory Requirements Relating to Quality Systems and Certain Personnel Qualifications; Final Rule on January 24, 2003
- Waived/PPMP Laboratory Project
M. Ann Bachman, MT(ASCP), CLC (AMT) is Executive Director of the American Association of Physician Offices and Laboratories (AAPOL). She has worked in the medical field for more than 30 years, primarily in the clinical laboratory. Ann presents workshops nationwide on OSHA, CLIA, and HIPAA, and assists healthcare practices in navigating the maze of regulatory compliance.