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How to Avoid Inspection Anxiety

Reprint from Focus On, 2000, Issue 4

The amount time devoted to pre-inspection preparation can be minimal if you are organized. However, maintaining current documentation can be overwhelming in light of the busy daily workload facing most laboratories. The inspection process is a thorough review of your procedure manuals, proficiency test performance, quality control, safety compliance, result reporting, and record keeping practices. Included in this article is an abbreviated list of the most important factors for procedures, proficiency testing, and a few general guidelines for quality control. Along with recapping the regulations for procedures and quality control, we will include some tips for streamlining the organization. A complete listing of the CLIA regulations can be found online.

Procedure Manual

HCFA requires that the laboratory must have a written procedure manual. Manufacturer package inserts may be used in the manual as long as the procedures include:

  • Specimen Requirements
  • Procedures for microscopic examinations
  • Step by step instructions on procedure performance
  • How to prepare slides, reagents, controls or any other materials needed for the testing
  • When applicable, calibration and calibration verification procedures
  • Reportable patient result ranges
  • Quality control and remedial actions when controls fail
  • Limitations of the methodology (interfering substances)
  • Normal values
  • Panic values
  • Supporting literature references
  • Specimen storage until testing is completed
  • Details about the laboratory's reporting system including the process for handling panic values
  • Outline the course of action necessary if a test system becomes inoperable
  • Criteria for referral of specimens including details about submission and handling

If any of the material listed above is not included in the manufacturer's insert, the laboratory must supplement the information. All procedures must be approved, signed and dated by the director. If the director of the laboratory changes, the procedures must be re-approved, signed and dated by the new director. If a procedure is discontinued, the laboratory must date and initial the discontinuance and maintain these procedures in a file for two years.

Tips: Placing the package insert inside a plastic sheet protector and typing an addendum page of laboratory specific guidelines can save you a great deal of time. At the bottom of the addendum page include an area for the director's signature and date. Remember to update this addendum page if there are any changes in the procedure. When you retire a procedure, write the date retired on the procedure before filing.

Proficiency Test Data

Your MLE binder is designed to allow for an organized presentation of all data documenting your proficiency test performance. The binder is in three sections: 1) Enrollment Records/Order Form; 2) Test Result Forms and Evaluations/A1, A2, and A3 Shipments; and 3) Test Result Forms and Evaluations/ B1, B2, and B3 Shipments. The binder is designed as an interactive component of your record keeping.

The very first section divider in your annual MLE binder is labeled "Enrollment Records/ Order Form and Order Verification." By placing a copy of your order form and the MLE order verification in this section, when you receive them, you will have an easy access presentation for your enrollment. Keep in mind that an inspector does not have a great deal of time to spend in each laboratory, therefore, the more organized the better your outcome.

The shipment specific sections are designed to provide an organized method of storing the photograph challenges (yes they are yours to keep), copies of submitted test result forms along with the evaluation reports, participant summary reports, Focus On newsletters, and continuing education questionnaires.

HCFA requires that laboratories maintain documentation about the handling, preparation, processing, examination, and each step of the testing and reporting of results for all proficiency testing samples. Laboratories must also keep a copy of the submitted Attestation Statement page with signatures for the director and testing personnel. These records must be maintained for a minimum of two years from the date of the proficiency testing event.

Tip: Prior to submitting your proficiency test results to MLE, make copies of each page of results and the test result book cover page. Attach your instrument printouts and file these sheets in the MLE binder behind the specific section for the shipment. Upon receipt of the MLE Evaluation Report:

  • Review the report;
  • Review the data tapes as necessary for corrective actions;
  • Obtain the authorized signatures on the evaluation report;
  • Attach any corrective action (if necessary);
  • File in the MLE binder behind the specific section for the shipment.

The amount of time spent maintaining this binder is minimal when considering the anxiety of being unable to locate the information in preparation for an inspection.

Quality Control and Calibration Records

For moderate or high complexity testing, HCFA requires that laboratories perform and document calibration procedures at least once every six months. They further require that you perform and document quality control for at least two levels of control materials each day of testing. When the quality control is not within range, they require that you have documentation of any remedial action that has been taken. These records are to be maintained for two years in hematology, chemistry, and microbiology. The immunohematology records are maintained for five years and pathology records are held for 10 years. Control procedures are performed on a routine basis to monitor the stability of the method or test system; control and calibration materials provide an indirect means to assess the accuracy and precision of patient test results. The minimal quality control requirement is to follow the manufacturer's instructions for control procedures.

The inspection process monitors that each test has proper frequency of control and documented corrective actions for out of range controls. Any time there is a failure in either the control system or proficiency testing you must have a detailed outline of the corrective action that was taken to resolve the failure. This corrective action may include repeat testing patient samples that were included in the unsuccessful test run.

Tip: If you are maintaining a manual (non-computer) records system, use a system of individual sheets for each month's quality control records. Record all quality control remedial actions on the back of the monthly sheet. This allows easy review of the failure and the remedial action.

Summary

This brief overview offers a few tips to streamline a very involved process. If your laboratory has an orderly and organized presentation of the above information, you will be on your way towards a successful inspection. Be sure to review and organize other areas of your laboratory such as patient test management and quality assurance. OSHA requirements for safety and handling of hazardous materials will be topics of future Focus On articles.

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