With humidity monitoring required on each day the test system is used but not throughout the day, Dr. Gagnon says, laboratories should identify a time, a person, or a process for monitoring and recording the humidity level on particular days. When it’s out of range, the action taken must be documented, “and this is where labs have to work with their local hospital engineers to make sure the HVAC system and humidifiers are working properly.”
If the test system is FDA approved and the manufacturer has defined a humidity range that the laboratory consistently exceeds, Dr. Gagnon says, “you can’t accept the values you’re getting without revalidating your test system as a modified FDA-approved test.” In effect, he says, the test becomes a modified FDA-approved test requiring separate validation and putting it into a high-complexity category. (For questions and answers about humidity, go to “Checklist Resources” in the CAP’s eLab Solutions Suite, www.cap.org, login required.)
The temperature checks requirement, COM.30750, remains unchanged in the new edition. It requires the laboratory to monitor and record temperatures using a calibrated thermometer as defined in written procedure for temperature-dependent storage devices, equipment, and environments.
COM.30700 Thermometric Standard Device has been revised. To be in compliance with this requirement, an appropriate thermometric standard device of known accuracy (certified to meet or traceable to National Institute of Standards and Technology standards) must be available, and it must be recalibrated, recertified, or replaced prior to the date of expiration of the guarantee of calibration. If not, it is subject to the requirements for noncertified thermometers. Added to this requirement in the new checklist edition is that a thermometer without a defined expiration date must be treated as a noncertified thermometer after two years from the certificate date.
Most certified thermometers come with an expiration date, Dr. Gagnon notes, but some do not. In the latter case, Dr. Mahmoud says, “a two-year interval seems like a reasonable interval” to recertify the device or begin to treat it as noncertified.
To address the expansion of testing performed on specimens collected within or outside the laboratory or in other health care settings, COM.06050 Instructions for Specimen Self-collection has been added to the all common checklist.
It requires written instructions to be provided to patients, and it applies to specimens that are self-collected or collected with the assistance of a caregiver and to specimens self-collected outside a health care setting. The examples provided are urine, stool, semen, fingerstick blood, buccal swabs, and vaginal specimens.
Other requirements for self-collection predated COM.06050, but the latter was added to the all common checklist, Dr. Mahmoud says, because “we are seeing a trend of more types of testing beyond the classic ones, like urine and semen analysis, offered with specimen self-collection.” SARS-CoV-2 testing during the pandemic made unsupervised oral specimen self-collection more common, and the FDA in 2024 approved two HPV self-collection devices for use in clinic settings. Self-collection will expand further, he says, “so we needed something in the all common checklist so all disciplines would be covered.”
In committee discussions, it became clear, Dr. Gagnon says, “that we already had a [self-collection] precedent with clean-catch urines and semen samples, either at home or at a medical facility.” What was needed was a generic requirement applicable to the different types of specimens that might be self-collected now or in the future, he says. COM.06050 was added for that purpose; it requires the following: collection instructions written in terms easily understood by the patient and consistent with manufacturer-provided instructions; instructions on how to use the supplied specimen container and labeling requirements for each container; information on appropriate storage times and conditions, timing of specimen collection, and transportation requirements; and safety instructions for collection devices containing preservatives.
Self-collection requirements in other checklists have been eliminated, such as URN.22000/LSV.42050 for urines and HEM.35680/LSV.43776 for semen. Their content has been “wrapped into the single checklist requirement in the all common checklist,” Dr. Gagnon says.