Revised Pennsylvania Lab Requirements
The Bureau of Laboratories is changing several of its policies concerning the regulation of laboratories under Pennsylvania’s Clinical Laboratory Act. Please review the following information carefully as these changes are likely to have a significant impact on the operation of your laboratory. All changes are effective as of the date of this letter, and are intended to remove barriers that limit the availability of testing without sacrificing the health and safety of patients while maintaining the Bureau’s ability to ensure that laboratories produce accurate and reliable results.
§ Proficiency testing will no longer be required for CLIA-waived tests except for those used for blood lead analyses. This change affects all types of fixed location laboratories (Hospital, Independent, Nursing Home, Out-of-State, and Physician’s Office), mobile laboratories, and screening sites.
§ The Bureau’s Pennsylvania Limited Survey proficiency testing program, which was designed to aid laboratories in complying with the previous requirement that laboratories participate in proficiency testing for CLIA-waived tests, will be discontinued in 2013. In October 2012, laboratories currently enrolled in the program will receive a reminder of its discontinuation rather than an invoice for a 2013 enrollment fee.
§ Laboratories performing tests classified as moderate or high complexity under CLIA will need to participate in proficiency testing only when the test is included on CLIA’s regulated analyte list. Laboratories must continue to verify the performance of tests which are not included on the regulated analyte list twice yearly as required by CLIA.
§ The Bureau may establish future proficiency testing requirements for tests classified as waived, moderately complex, or highly complex by CLIA. Laboratories will be notified of any such changes before they become effective and a notice will be published in the Pennsylvania Bulletin.
§ The Bureau may require specific laboratories to participate in proficiency testing when it feels this is necessary to more closely monitor the laboratory or as a requirement under a plan of correction.
§ Any documents previously released by the Bureau stipulating the need for quality control requirements beyond those required by the test kit/instrument manufacturer are no longer valid. Laboratories should follow the manufacturer’s instructions regarding quality control. A laboratory may adopt more stringent quality control requirements if it feels this is necessary.
§ Organizations that wish to operate screening sites will no longer be required to have an existing fixed-location laboratory.
§ Laboratories were previously limited to performing CLIA-waived testing at screening sites. The Bureau will now consider requests to perform tests classified as moderately complex under CLIA. Approval will be dependent upon the difficultly of performing the requested test, its suitability as a screening tool, and the Bureau’s assessment of the technical capabilities of the laboratory.
Referral of Specimens to Out-of-State Laboratories
§ The Bureau will no longer register out-of-state laboratories. Laboratories within Pennsylvania that refer specimens to out-of-state laboratories will no longer be required to select laboratories which the Bureau has licensed or registered. Laboratories will be responsible for ensuring their referral labs are CLIA-certified. The Bureau will continue to license out-of-state laboratories that wish to obtain Pennsylvania permits.
§ Physician’s Office Laboratories will no longer be classified as Level 1, Level 2, and Level 3. The Bureau will identify these laboratories as simply Physician’s Office Laboratories.
§ Physician’s Office Laboratories and Nursing Homes will no longer be limited in the types of tests they perform provided they comply with all associated Pennsylvania and CLIA requirements. This change does not apply to screening sites. As stated above only CLIA-waived and moderately complex tests may be performed at screening sites.
§ Laboratory types will no longer be printed on Pennsylvania clinical laboratory permits. Permits will continue to show the testing a laboratory is approved to perform.
§ Whether or not a laboratory will be inspected will no longer be based on its laboratory type. The need for on-site inspections will be decided on a case-by-case basis. Laboratories may be inspected before receiving their Pennsylvania clinical laboratory permit regardless of the type of testing performed. The Bureau will continue to conduct biannual inspections when required by CLIA regulations. It will also inspect laboratories upon receipt of a complaint or when it otherwise determines there is a need. Each year a number of laboratories will be randomly selected for inspections. This will allow the Bureau to assess the quality of laboratories that are not subject to routine inspections. Inspections may be announced or unannounced.
Please note that laboratories must still notify the Bureau of intended changes to their test menu. The Bureau must approve requests to perform new tests and issue an updated permit before patient testing may be performed. Laboratories that are dropping tests must also notify the Bureau. An updated permit will be issued when tests are dropped however the laboratory may discontinue testing before the new permit is received. The change of status form available on the Bureau’s website www.health.state.pa.us/labs should be used for requests to add or drop tests.
The documentation on the Clinical Laboratory Licensure page of Bureau’s website is being updated to reflect the changes above. Once updated laboratory permit application forms and change of status forms are available, please use the new versions.
If you have any questions please e-mail me at firstname.lastname@example.org so that I can provide you with written clarification on these changes.
Division of Laboratory Improvement