View source for The Comprehensive Guide to Physician Office Laboratory Setup and Operation/Education, staffing, accreditation, and other considerations/Other considerations for the POL

===4.4 Other considerations for the POL===
[[File:LabEqx–test tube.svg|right|250px]]Before closing out this guide, a few odds and ends remain in regards to the POL.

Though it has been hinted at throughout the guide, it should be explicitly stated that the POL running CLIA-waived testing is not exempt from professional, standardized conduct simply because it is only performing "simple tests with a low risk for an incorrect result."<ref name="CDCTestCom">{{cite web |url=https://www.cdc.gov/clia/test-complexities.html |title=Clinical Laboratory Improvement Amendments (CLIA): Test complexities |author=Centers for Disease Control and Prevention |date=06 August 2018 |accessdate=31 May 2022}}</ref> This is best highlighted by the AACC advocacy letter mentioned at the beginning of this chapter. POLs and other CLIA-waived labs "are not subject to CLIA personnel, quality control (QC), and proficiency testing (PT) requirements, nor do they undergo regular inspections," they note.<ref name="AACCModern21" /> They add that these types of labs have been documented by CMS as having numerous deficiencies, including not properly maintaining manufacturer's instructions for test kits, improperly performing [[quality control]], not reporting patient test results correctly, and not handling and storing reagents properly.<ref name="AACCModern21" /> The AACC also suggests several guidance documents for these types of labs to better avoid these deficiencies, including the [[Centers for Disease Control and Prevention]]'s (CDC's) 2015 guidance ''To Test or Not to Test? Considerations for Waived Testing''. The introduction of that guide highlights the AACC's point: "Although some of the recommendations in this booklet exceed CLIA requirements for waived testing, following these good testing practices will likely lead to reliable, high-quality test results and will enhance patient safety."<ref name="CDCToTest15">{{cite web |url=https://www.cdc.gov/labquality/docs/waived-tests/15_255581-test-or-not-test-booklet.pdf |format=PDF |title=To Test or Not to Test? Considerations for Waived Testing |author=Centers for Disease Control and Prevention |publisher=Centers for Disease Control and Prevention |date=July 2015 |accessdate=31 May 2022}}</ref> 

Both the AACC and the CDC highlight several additional considerations for POLs seeking to provide quality services<ref name="AACCModern21">{{cite web |url=https://www.aacc.org/advocacy-and-outreach/position-statements/2021/modernization-of-clia-certificate-of-waiver |title=Modernization of CLIA: Certificate of Waiver Testing Sites |publisher=American Association for Clinical Chemistry |date=25 October 2021 |accessdate=30 May 2022}}</ref><ref name="CDCToTest15" />:

* Develop, distribute, review, and curate a "best practices" document (or collection of documents) that, among other things, examines the instruments and tests used, common sources of error, and troubleshooting methods for them. This usually comes in the form of a policies and procedures manual, which is highly encouraged, though it can also be a stand-alone document.
* Encourage continuing education and certification in using the current and future instruments and tests used in the lab, and document that training.
* Ensure policy and procedure manuals document test and reagent preparation, test performance, quality control procedures, result interpretation, result reporting, test referrals, training processes, environmental monitoring, inventory management, equipment and instrument maintenance, hazardous waste management, sterilization and disinfection, protective equipment, workspace assessments, and incident reporting.
* Ensure that for any point-of-care and other waived tests, the manufacturer's instructions are available in the testing area, any changes to instructions are reflected in updated procedures and training, and any old versions are removed from the manual/testing space/etc.
* Hold the lab to a high, yet realistically maintainable, level of standards through regular internal and/or external quality assessment and corrective action activities.
* Have the lab participate in an official proficiency testing program that documents quality and reliability of test results.
* Recognize that quality and responsibility for quality must start with management that embraces and promotes good laboratory practices.
* Recognize that safety is just as important in a CLIA-waived lab and develop a site-specific safety plan that describes health hazards involved in testing and how to prevent them.

The CDC's ''[https://www.cdc.gov/labquality/docs/waived-tests/15_255581-test-or-not-test-booklet.pdf To Test or Not to Test?]'' document also contains many example documents and forms that relate to the above considerations; your POL may find them useful.