Valerie Neff Newitt
February 2025—Some of the CAP accreditation program requirements in the 2024 microbiology and transfusion medicine checklists, in the edition released Dec. 26, have been revised to simplify, clarify, and conserve resources. In transfusion, one new requirement was added to define policy requirements for the use of low-titer group O whole blood.
In the microbiology checklist, MIC.11038 Media QC—Purchased/Acquired requires that an appropriate sample from each lot and shipment of each medium for culture be checked before or concurrent with its initial use. The check is for sterility, biochemical reactivity where appropriate, and its ability to support the growth of organisms intended to be isolated on the medium by means of stock cultures or by parallel testing with previous lots and shipments. Removed from this requirement are the comments that differentiated quality control requirements for exempt and nonexempt culture media.
“The CAP had always allowed laboratories to perform an IQCP [Individualized Quality Control Plan] for the exempt media, but now they can do the same for nonexempt media,” says Christina Wojewoda, MD, immediate past chair of the CAP Microbiology Committee and director of clinical microbiology at the University of Vermont Medical Center. “This allows laboratories to do less quality control if they go through the IQCP process and prove it is appropriate for those nonexempt media.”
The exempt and nonexempt designations will not be used because the Clinical and Laboratory Standards Institute M22-A3 standard that defined exempt media has been archived, and the Centers for Medicare and Medicaid Services is no longer recognizing the two distinct categories for the purposes of quality control. “Going forward, all media are considered the same,” says Dr. Wojewoda, who is also network medical director of clinical microbiology for the University of Vermont Health Network and professor and vice chair of education, Department of Pathology and Laboratory Medicine, Larner College of Medicine.
The requirement says laboratories that supply uninoculated media to labs referring specimens to them are responsible for the QC of the media and must provide media QC records with each shipment. If the supplying lab uses an IQCP for media, it says, it may instead provide a copy of the applicable IQCP or IQCP summary statement to the lab receiving the media. The supplying lab need not provide the data used to develop the plan.
The CAP encourages use of the IQCP media templates it created jointly with the CLSI and American Society for Microbiology (available with other related resources in the CAP e-Lab Solutions Suite). “All media now can undergo an IQCP to define the appropriate quality control practices,” Dr. Wojewoda says.
Also revised is MIC.11375 Review of Nomenclature, which requires the laboratory to maintain consistent nomenclature across testing platforms and consider use of contemporary nomenclature. “What we want to accomplish with this checklist requirement is to make sure that if a lab is reporting an organism from multiple different instruments or tests, it is reporting it in the same way,” Dr. Wojewoda explains.
There is no intent to require laboratories to know all of the new names for each organism, she says, because “there isn’t necessarily one true name. Different groups publish different names for the same organism.” Instead, a laboratory should look at how it reports an organism and report it identically throughout the laboratory. “This will help their clinical teams know if their patient has an infection with one organism or multiple organisms,” she says, “and exactly what it means when this name is used by this laboratory.”
The first step, Dr. Wojewoda says, would be to review the databases for all of the different instruments and assays to see how the same organism is reported. “Harmonize that reporting. Establish that when you report this organism, you will always report it by this specific name.” And then communicate it to those who need to know. “In my laboratory, we changed some of the reporting of the fungal organisms based on an update to our MALDI-TOF identification system,” and notified the infectious disease practice committee. “But the basic requirement is making sure that if you’re reporting one organism, it has just one name.”
In the transfusion medicine checklist, TRM.40300 Historical Record Check says ABO, Rh, and antibody screen test results must be compared with results of the same tests recorded previously to detect discrepancies and identify patients requiring specially selected units.
“New language was added to this existing requirement to clarify what is acceptable ABO and Rh historical records,” says Matthew Karafin, MD, MS, chair of the CAP Transfusion, Apheresis, and Cellular Therapy Committee and clinical professor of transfusion medicine services at the University of North Carolina at Chapel Hill. The revised requirement now says the acceptable ABO and Rh historical records for transfusion purposes are only those generated or entered by laboratory personnel into the health system’s laboratory information system and performed by an accredited lab or certified by the relevant government agency in its jurisdiction.
“We learned that assessors have encountered facilities that were using blood types from other institutions, such as from Epic Care Everywhere,” Dr. Karafin says. “Moreover, we were made aware that blood typing information from these other institutions was sometimes being added by non-blood bank personnel, so we had concerns about the reliability of this information.” For patient safety, the CAP wants to ensure that the ABO and Rh used for transfusion are the ones that laboratory personnel have entered into an LIS. This “implies that a transfusion service reviewed the information and was responsible for its data entry,” Dr. Karafin says.
TRM.40700 Selection of Blood Components also was revised. It requires the laboratory to have selection criteria for ABO group-specific or compatible red blood cell-containing components, ABO group-specific whole blood, group O whole blood with low anti-A/B titers if given to non-O patients, and components containing plasma or platelets.
“We added language to include whole blood and to more clearly break out the different types of blood components that need written criteria for safe and appropriate selection,” Dr. Karafin says.
TRM.40705 Use of Low-titer Group O Whole Blood is a new requirement, one that was added to provide additional detail, he says. If low-titer group O whole blood is used, the laboratory must follow written policies and procedures for its use, and it must define the following: indications for use, product specifications, administration instructions, indications to switch to component therapy and ABO type selection, and the limit on the number of units to be transfused for each patient during a bleeding event or within a time period.
If each of those items is defined in a policy, Dr. Karafin says, “we believe the laboratory will be in compliance with this new requirement so long as there is evidence that its policy is being followed.” This requirement is aligned with other standards for the use of whole blood, he adds, including that of the AABB.
TRM.44850 Platelet Preparation is an existing requirement that now includes a note about cold-stored platelets, which says the unit must be placed in storage at 1°–6°C no later than four hours from the end of collection if an FDA-approved pathogen reduction device is not used. If a reduction device is used, cold-stored platelets must be placed at 1°–6°C no later than four hours after pathogen reduction is completed.
The addition to the requirement was made in response to new FDA guidance on cold-stored platelets (https://bit.ly/FDA-2023-D-2034).
Overall, Dr. Karafin says, the transfusion medicine checklist revisions ensure that CAP-accredited laboratories remain current with new developments in the field, such as new blood products. “We also edited checklist requirements to improve clarity regarding the safest practices for transfusion services and their transfusion recipients.”
Valerie Neff Newitt is a writer in Audubon, Pa.