Originally published in CAP TODAY
Q: For tests in the chemistry laboratory, is it permissible to validate new lots of reagent by running quality control material on the new lot in parallel with the old lot?
A: Since the laboratory is testing patient specimens, the ideal way to validate a new lot of reagent is by running patient specimens. QC material may be acceptable for this purpose, but the laboratory should be aware that QC material may be subject to between-lot matrix effects. Thus, it is possible that a change in reagent lots could introduce a calibration inconsistency in patient specimens that is not detected by the QC validation studies. If the laboratory suspects a problem with calibration under these circumstances, it should consider running patient specimens on the old and new lots of reagent.
Other products that are preferable to QC material for validation of new lots of reagent include:
Reference material provided by the instrument manufacturer, with method-specific and, where appropriate, reagent-lot-specific target values.
Proficiency testing materials with mean values determined by reference methods or established by an appropriate peer group.
Third-party reference materials if documented by the manufacturer to be commutable with patient specimens for the method-in other words, if there is documented absence of matrix effects.
The December 2003 edition of the chemistry and toxicology checklist discusses these alternatives in checklist question CHM.12900.
Q: It is our interpretation that CLIA regulations require that all instrument print-outs be kept for at least two years. Does this apply to the clinical lab, where instruments are interfaced with a laboratory information system and results can be easily accessed through the LIS? If the intent is to have the print-outs available as a record of instrument errors or messages, is it possible to save this information on disk when storage space is limited?
A: Laboratory general checklist item GEN.41480 states, "Are laboratory records and materials retained for an appropriate time?"
For data transmitted by computer interface (online system), it is not necessary to retain paper worksheets or print-outs if the computer retains the data for at least two years. Manual entry of patient result data requires that all worksheets and print-outs be retained by the laboratory for at least two years. (Reference: College of American Pathologists. Guidelines for the retention of laboratory records and materials. Northfield, Ill.: CAP, current edition.)
If the results are entered via download or direct interface to the LIS, the instrument print-outs need not be saved. If, however, results are transcribed from instrument print-outs into the computer or into the patient report, the print-outs need to be retained for two years. In the event that the interface is down and the results are manually entered, a hard copy or original must be kept in case there is a question about the transcription. Report retention requirements apply in all cases. The original result report must be retained for two years in hard copy or in the computer if it can be retrieved and reprinted.
The minimum guidelines for the retention of laboratory records and materials can also be found on the CAP Web site (www.cap.org) under "Laboratory Improvement/Laboratory Accreditation Program-Inspection Checklists and Other Accreditation Documents."
Q: We are part of a health care network consisting of a main laboratory and three remote labs. Our policy states that if the remote laboratory has an abnormal blood smear on a patient, the technologist must confirm it with the on-site supervisor. If there are questions, or leukemia cells need to be confirmed, the technologist is to submit the smear to the main laboratory for pathology review and confirmation. We have a written procedure and criteria for pathology review on patient samples. If the technologist at a remote lab has a question on a CAP proficiency kodachrome slide for a blood smear, would the CAP consider it a violation of GEN.12258 if we were to consult the pathologist at the main laboratory? And, if patient specimens are initially reviewed at a remote site and then sent to the main laboratory for confirmation, which laboratory's name and address should appear on the final report?
A: Laboratory general checklist question GEN.12258 is a phase II question that requires laboratories to have a written policy that prohibits interlaboratory communication about proficiency testing samples before data are submitted to the proficiency testing provider. CLIA '88 regulations [42CFR493.801(b)(3)] also strictly prohibit laboratories from communicating about proficiency testing samples before data are submitted to the proficiency testing provider.
The Centers for Medicare and Medicaid Services and the College of American Pathologists specifically prohibit the referral of a PT specimen to any other laboratory. Upon discovering such a referral, CMS could impose sanctions, such as revocation of the laboratory's CLIA certificate or civil monetary penalties, or both. Furthermore, the director may be prohibited from directing a laboratory for two years.
If the laboratory receives a CAP proficiency testing sample such as you have described, it should use code 11, test not performed, since the testing could not be completed within that laboratory.
It is acceptable to refer patient samples to another laboratory, such as your main laboratory. If the specimen is referred, however, the final report should reflect the name and address of the laboratory where the testing was completed and reported.
The Commission on Laboratory Accreditation continually revises the CAP checklists to keep checklist content state-of-the-art in laboratory medicine and make the checklists as user-friendly and easy to interpret as possible. The commission welcomes input from laboratories and inspectors regarding potential improvements to the checklists. E-mail suggested checklist changes to email@example.com.