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September 2008
Laboratory Accreditation News

From the files of the CAP’s checklist-related questions. Answers reviewed by Stephen J. Sarewitz, MD, chair of the Checklists Committee and staff pathologist, Valley Medical Center, Renton, Wash.

Question Q. Does anatomic pathology checklist question ANP.11820, on frozen section turnaround time requirements, mean that if the laboratory is able to meet the 20-minute time limit for at least 90 percent of cases, there is no need to document the cause of delay for frozen section diagnoses where the 20-minute limit is exceeded? If the 20-minute time limit is exceeded for more than 10 percent of cases, does the cause of the delay have to be documented separately for each frozen section diagnosis, or is it sufficient to give a general reason, such as temporary staffing shortage or equipment failure? Furthermore, is the time limit intended to apply only to frozen sections that are performed during normal business hours, when the pathologist is on site and technical staff are available? We have on-call pathologists during off hours who perform frozen sections when paged. Finally, can the collection of TAT data be assigned to technical staff, or does the pathologist have to certify TATs by initials or signature?

A. Checklist question ANP.11820 asks, “Does the laboratory periodically evaluate turnaround time for intraoperative frozen sections?” The accompanying note, which states that 90 percent of frozen sections should be completed within 20 minutes, applies only to cases with a single specimen requiring a single block. These cases should be monitored, and if there are delays, the reason should be documented. The documentation should be sufficient to identify the problem, or problems, if the 10 percent threshold is exceeded. It may or may not be necessary to document the reason for all delayed cases. Technical staff can collect the data, at the laboratory director’s discretion. The laboratory director should review the results. I would recommend that this be incorporated into your quality management plan as a monitor for the surgical pathology department. This checklist item applies only to frozen sections performed during regular business hours, when a pathologist is on site.

Question Q. Our nursing department runs skills fairs where nursing staff demonstrate proficiency in various areas, such as specimen collection. However, it is difficult to enforce our lab’s written policies and procedures for nonlaboratory staff collecting specimens. How much responsibility does a CAP-accredited lab have for specimen collection competency assessments for nursing or other nonlaboratory personnel who collect test specimens?

A. Competency assessment and the training of nonlaboratory personnel to collect samples would not be subject to the CAP inspection process. In such cases, the responsibility of proper phlebotomy training and competency could be shared and may require a collaborative effort among departments.

Skills fairs and execution of the related training/competency program may fall under the purview of nursing staff. However, it is important that the laboratory be able to determine the program’s effectiveness. The laboratory can do this by collecting quality management monitoring data for quality improvement purposes and sharing it with those departments collecting specimens or with the appropriate hospital committees. The data can pinpoint areas that need improvement, allowing the departments involved to take corrective actions.

This is addressed in laboratory general checklist item GEN.40505, phase I, which reads:

Is there a mechanism to provide feedback to phlebotomists on issues relating to specimen quality?

Note: The accuracy of an analytic result depends upon the initial quality of the specimen. Proper phlebotomy procedures are essential.

Another approach would be to share the appropriate CAP checklist questions with these other areas of the hospital and collaborate on the details of competency and training that align with the checklist questions.

Question Q. What information do I need to include in our laboratory’s technical personnel records? What type of documentation are inspectors looking for in laboratory general checklist question GEN. 54750, which asks, “For laboratories subject to U.S. federal regulations, do all testing personnel meet CLIA ’88 requirements?”

A. The note to GEN.54750 says, “There must be evidence in personnel records that all testing personnel have been evaluated against CLIA ’88 requirements and that all individuals qualify.” Therefore, the laboratory must ensure that technical personnel records are current, particularly for recently hired staff. The records should include a summary of training and experience; formal certification or license, if required by the state; description of current duties, which may be generic to a position; records of continuing education; records of radiation exposure where applicable, such as for in vivo radiation testing, but not for low exposure levels, such as certain in vitro testing; work-related incident or accident records, or both; and dates of employment.

Documentation of employees’ academic degrees, such as a high school or college degree or credential documentation, must also be included to ensure these staff members meet the CLIA requirements pertaining to testing complexity. For testing personnel trained outside the United States, it may be necessary to use a credentialing service to confirm the equivalency of the foreign program completed.

The CLIA laboratory personnel report for moderate and high-complexity testing is a useful tool to record the qualification evaluation of testing staff. The form is available on the Centers for Medicare and Medicaid Services’ Web site at www.cms.hhs.gov/cmsforms/downloads/CMS209.pdf.

Question Q. Chemistry checklist question CHM.10200 asks, “Does the laboratory integrate all proficiency testing samples within the routine workload, and are those samples analyzed by personnel who routinely test patient/client samples, using the same primary method systems as for patient/client samples?” Does this checklist item require us to rotate proficiency testing specimens to staff performing testing on the second and third shifts? Our second- and third-shift technologists perform the same patient testing using the primary method as the day shift and typically on a stat or ASAP basis. Proficiency testing samples are only analyzed on the first shift during the routine workload using the primary method. It is our opinion that we are treating proficiency testing samples in the same manner as patient samples by rotating them only within the routine workload. If we are required to rotate the proficiency testing material to all shifts, can we split up the Survey challenges (vials) among staff? Furthermore, is it acceptable to run proficiency testing samples in duplicate and, if so, when?

A. Proficiency testing samples must be rotated to all staff performing patient testing, including second- and third-shift employees. CAP inspectors will review laboratory records to determine if all shifts are participating in the PT program. Inspectors will also check the proficiency testing result forms for attestation signatures for all staff that participated. Some laboratories devise a rotation schedule to ensure that each technologist has a chance to perform such testing. Proficiency testing records can be used as part of the ongoing competency and continuing education programs in the laboratory. While the PT material can be divided up, technologists must be able to report their results without consulting or conferring with other staff.

Duplicate or replicate analysis of PT samples is acceptable only if patient or client specimens are routinely analyzed in the same manner. The laboratory must have well-written procedures that describe the proper handling, analysis, review, and reporting of PT materials.

Question Q. How often should we document hematology competencies to ensure consistency of morphologic observations for manual differentials and fluids? Should we do this every six months or annually? It would be helpful if this were defined in the hematology and urinalysis checklists. How do laboratories typically address checklist items HEM.34400, HEM.35566, and URN.30800?

A. It has been proposed for the next edition of the checklists that the phrase “at least annually” be added to those checklist questions that require a documented system to ensure consistency of morphologic observations among all personnel performing blood cell microscopy (HEM.34400), body fluid cell differentials (HEM.35566), morphologic classification of sperm and other cells, and urine sediment microscopy (URN.30800). For now, however, no defined frequency is specified.

Including these elements as part of your competency program can aid efforts to quantify and identify cells and sediment consistently. The program should describe thoroughly how to achieve consistency using competency assessments. The key is for the lab to follow a documented system. In other words, it should generate employee records to show it is striving for consistency among staff members.

Proficiency testing materials, such as photomicrographs, from PT pro­viders or the laboratory’s own alternative performance assessment program are often used to meet the intent of these questions. They also may be used as part of the ongoing competency and continuing education programs in the laboratory.

Laboratorians too should document and share with staff instances when they encounter rare or unusual cells and rare urine sediment elements from patient samples. The laboratory can foster consistency, as well, by including definitions of semi-quantitative measures, such as 1+, 2+, and 3+, in its policies and procedures. Having these defined measures posted and readily available to employees helps lab staff make consistent morphologic observations.