New Pennsylvania Clinical Laboratory Guidance Updates Lab Supervision Requirements
The Pennsylvania Department of Health, Bureau of Laboratories (the Bureau) recently issued a host of new guidance and forms related to licensure and operation of clinical laboratories located in Pennsylvania and/or receiving specimens originating in Pennsylvania. We examine key updates to laboratory supervision and oversight standards, among other changes, and their impact on Pennsylvania clinical laboratories.
Laboratory Director Supervision Standards
The most substantial updates relate to the supervision and oversight requirements applicable to laboratory directors. As a general matter, under Pennsylvania’s Clinical Laboratory Act, all clinical laboratories must be overseen by a qualified laboratory director who “provides direct and personal supervision of the laboratory’s operation.” More specifically, the regulations (under 28 Pa. Code § 5.22(g)) require that the director “shall be present for a reasonable period of each working day in each laboratory for which he is director.” The new interpretative guidelines clarify that, especially with respect to laboratories performing only waived testing, such “presence” does not require physical presence:
The Department has previously interpreted the term “present” as including a remote/virtual (i.e. telephonic, email, video conferencing) presence in combination with an intermittent on-site physical presence. Historically, the Department has considered quarterly visits to the laboratory to be the appropriate minimum. However, the Department has updated this interpretation to allow laboratory directors to maintain a “remote/virtual” only presence in laboratories that perform only waived testing. For laboratories that perform moderate/high complexity testing, the Department requires the director to be on-site once every 6 months, with at least 4 months between the minimum two on-site visits. The director’s on-site visits may not be delegated.
The new application instructions go on to explain the importance of remote/physical oversight (including the ability of the director to delegate daily supervision to a qualified supervisor) and documentation of on-site visits:
The on-site visits combined with the daily remote presence enables the director to participate and actively oversee the planning, organization, direction and review of all laboratory operations to the extent necessary to ensure compliance with the regulations, including ensuring the proper storage and quality of reagents, supplies. The director is required to provide documentation of the on-site visits, including evidence of performing activities that are part of the laboratory director’s responsibilities, upon request by the Department of Health.
The Clinical Laboratory Act regulations define a supervisor as “[a] properly qualified individual, who, under the direction of an authorized director, may supervise the general activities of a clinical laboratory, or a properly qualified individual who under the direction of an authorized director, may supervise the technical work in a laboratory category.” If the Director will not be on-site during all hours of testing, then the Director must employ a qualified general supervisor who will be on the premises during all normal scheduled working hours in which tests are being performed.
Changes/Clarifications to Director Attestation Process
The Bureau also replaced the requirement that laboratory directors submit written statements regarding monthly visits with an attestation form regarding supervision. Going forward, laboratory directors need to submit an attestation form for each laboratory that they supervise. However, directors that have already submitted a written statement for monthly on-site visits or an attestation form for quarterly visits are not required to submit the new attestation form. The new attestation is only required for a change in director or as part of an initial survey or compliance recertification. For more details on the updated guidance, please consult the FAQs on Interpretive Guidance on Directors On-site visits and Email Notifications.
Paperless Transition
Notably, the Bureau has committed to going paperless in 2026, at least with respect to forms, notices and invoices. All laboratories will be able to elect to receive annual renewal invoices for clinical lab permits electronically, as well as email notifications, user fee coupons and other Bureau correspondence. Laboratories can switch to paperless (and/or update their contact email) by sending an email to the Bureau’s resource account including the laboratory name, Pennsylvania lab permit ID and CLIA number. Pennsylvania laboratories and their owners and directors should confirm that their email contact information is up to date to ensure a seamless transition to the new paperless model.
Pennsylvania laboratories should closely review the new administrative and supervisory requirements to ensure that their current practices and procedures are compliant. Laboratories may also consider reworking director supervision expectations in light of the loosened requirements and increased flexibility for virtual oversight.
