Valerie Neff Newitt
December 2022—Laboratories that provide only waived testing will now have a CAP accreditation program laboratory general (GEN) checklist tailored to waived test procedures, beginning with the 2022 checklist edition released in October.
Customized checklists have been the focus of a CAP effort to simplify and streamline inspections by matching accreditation requirements to the laboratory being inspected. “Not too much, not too little, just right,” says Denise Driscoll, CAP senior director of accreditation and regulatory affairs, in describing the checklists that are now customized to the specific work a laboratory performs.
The CAP has provided customized discipline-specific and all common checklists for several years, including customized point-of-care testing checklists for laboratories that perform waived testing. Customized GEN checklists that meet the needs of other laboratory types, such as Mohs-only labs and anatomic and cytopathology interpretation-only labs, have also been rolled out. The feedback from laboratories and inspectors has been positive, so steps have been taken to introduce additional customization options for the GEN checklist.
The CAP’s more than 8,000 accredited laboratories “want to provide the safest and most accurate tests for their patients, but without the bulk,” Driscoll says of the slimmed down checklists.
For laboratories that perform waived testing, “the essential elements of the program are still required in terms of quality, record keeping, procedures, and personnel,” among other things, says Stephen Sarewitz, MD, vice chair of the CAP Checklists Committee. “But they are less complex in order to be a good fit for laboratories that do less complex testing.” Some of the instrumentation used in waived laboratories is so robust now and the probability of error so low that many of the traditional requirements are no longer necessary, he says.
The requirements in customized checklists are no less stringent, says Harris Goodman, MD, chair of the CAP Checklists Committee and a member of the CAP Council on Accreditation. “They’re just more appropriate and designed to make the accreditation process more efficient.” While four new requirements were added to the GEN checklist for waived testing only laboratories, the average waived-only lab will see a reduction of more than 100 requirements in its customized checklist, he says.
One of the four new requirements written specifically for labs performing only waived testing is GEN.13750 Quality Management System (QMS). It says the QMS must include processes for the following: monitoring the quality of the testing performed; recording and investigating non-conforming events; having a mechanism for employees and patients to report quality and safety concerns; recording corrective and preventive actions to address problems; managing recalls and notifications from vendors; and ensuring compliance with applicable federal, state, and other laws and regulations.
“Fifteen checklist requirements have been replaced by this one simplified requirement,” Dr. Sarewitz says. “It has all the critical elements of those 15 but in a simplified form.”
Another new requirement for waived-only labs, GEN.20385 Record Retention, says the laboratory’s records are retained for an appropriate time and that retention policies must comply with applicable laws and regulations and with minimum retention periods listed in an accompanying table, whichever is most stringent. “This requirement doesn’t replace a lot of other requirements but it’s more specific for waived labs,” Dr. Sarewitz says, referring to the now shorter table that is more pertinent to waived-only laboratories.
GEN.40625 Test Orders, also new for waived-only laboratories, says the lab must obtain paper or electronic orders to perform waived testing from an authorized requestor. The orders must include adequate data to confirm patient ID, tests requested, and the authorized requestor. If test orders are received orally, the lab needs a read-back process to verify transcription accuracy.
The fourth and final new requirement is GEN.73150 Safety Program, which, like the test orders requirement, is a distillation of previously extensive sections to what’s relevant for waived-only laboratories. It says the safety program, for patients and personnel, must include training of personnel in safety policies, procedures, and practices; availability of PPE for personnel and visitors in areas where blood or other potentially infectious materials are handled and in circumstances when exposure is likely to occur; an emergency preparedness program; infection control and TB exposure plans; and fire prevention and control plans.
[dropcap]M[/dropcap]aking the customized checklists possible is the laboratory’s activity menu and the organization profile general questionnaire (available on www.cap.org), says Dr. Goodman, who is chief of the Department of Pathology, Alameda Health System Highland Hospital, Oakland, Calif. “Now that the checklists are further customized, if the activity menu and general questionnaire are not exact, the laboratory may not get the appropriate checklist requirements.” The activity menu also determines the appropriate number of inspectors, he says.
COM.01200 Activity Menu requires that the laboratory’s current CAP activity menu accurately reflect the testing performed. For labs with a CLIA certificate, it includes all testing and activities performed under that certificate. For labs not subject to CLIA, it includes all testing and activities that are performed under the same lab director, under the same lab name, and on the same physical premises. “It’s very important that laboratories keep that up to date and correct,” and not doing so, Dr. Goodman says, is the most commonly cited deficiency.
The activity menu has always driven customization of the checklists produced for the laboratory’s inspection, Dr. Sarewitz says, “and it will now drive more precise customization as we move forward. It also drives proficiency testing and describes the scope of testing to the inspector. So it’s the driver of the whole program.”
Waived-only laboratories should be aware of what could jeopardize eligibility for a customized GEN checklist. One is modifying a waived test, making the procedure no longer waived. It could be something as simple as modifying a swab or collection container, Dr. Goodman notes. The laboratory would lose its eligibility to receive the waived-only GEN requirements, Dr. Sarewitz says, and all it would take is a single modified waived test. In such a case, Driscoll says, there would likely be additional requirements that become applicable. Once the activity menu is updated to reflect the modification, “our system will automatically give them the additional requirements they need.”
Dr. Goodman advises caution too as test menus are expanded: “Make sure you don’t adopt a test that may seem simple but is not waived”—to avoid becoming ineligible for the customized GEN checklist. “When we say waived only,” Driscoll says, “we mean only.”
[dropcap]B[/dropcap]eginning in November 2022, the CAP also introduced GEN checklist customization for arterial blood gas laboratories that perform only blood gases and other critical care tests included on the ABG cartridges. Others with a GEN customization option beginning in November are fine-needle aspiration adequacy assessment only labs, provider-performed microscopy only labs, and labs that perform remote data assessment—that is, cytogeneticists who perform only primary karyotype image review remotely. These laboratories, like waived testing only laboratories, will see in their customized GEN checklists a reduction in the number of laboratory general checklist requirements.
“There is more to this journey,” Driscoll says of the customization work. In the next few years the CAP will modernize the activity menu in a way that will give it even greater ability to right-size, she says. “So it is a journey. And as new technologies emerge, we will have more and more options for matching requirements to the scope of services.” Says Dr. Goodman, “The big push here is to continue the customization of the checklists, making them the most efficient they can be for the laboratory and inspector while the quality remains high.”
Being able to right-size checklists makes it possible for the CAP to work with laboratories of varying size and complexity, “especially those within a system or network looking to standardize on a single accreditor,” says Amanda Souza, CAP senior manager of marketing program management. And laboratories don’t have any extra manpower to try to prepare for something that is not necessarily applicable, Driscoll adds. “For everything, we’re eliminating the excess.”
Valerie Neff Newitt is a writer in Audubon, Pa.