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.
Q: The instruments in our laboratory generate quite a bit of noise. Do the CAP checklists address this issue?
A: Laboratory general checklist question GEN.70824 addresses your concerns. The question reads, “Does the laboratory have a policy to protect personnel from excessive noise levels?” The intent of this checklist item is to ensure that laboratorians are protected from continuous, excessive noise levels over an eight-hour period.
Laboratory policy should include the use of personal protective equipment, such as hearing protectors, when noise levels continuously exceed 85 decibels. (If noise levels exceed 80 decibels, people must speak very loudly to be heard. At noise levels of 85 to 90 decibels, people have to shout.) An initial baseline can determine if the levels are at 85 decibels or above. Baseline testing and monitoring should be repeated when the lab changes processes or equipment. In most facilities, the biomedical or facilities department has equipment to measure noise levels.
In accordance with OSHA guideline 29 CFR 1910.95(d)(1), when information indicates that any employee’s exposure to noise may equal or exceed an eight-hour time-weighted average of 85 decibels, the employer shall develop and implement a monitoring program. OSHA reports that sound levels need only be measured when information indicates that employees will be exposed to 85 decibels of sound continuously over an eight-hour period. The specific guidelines are:
29 CFR 1910.95(d)(2)(i)—All continuous, intermittent, and impulsive
sound levels from 80 decibels to 130 decibels shall be integrated into
the noise measurements.
29 CFR 1910.95(d)(2)(ii)—Instruments used to measure employee noise exposure
shall be calibrated to ensure measurement accuracy.
shall be repeated whenever a change in production, process, equipment, or controls
increases noise exposures. Additional information about workplace noise levels
is available on the OSHA
Q: Can you provide guidance for inspecting for questions TLC.10500 and TLC.10600 in the new team leader checklist?
A: The purpose of this checklist is to emphasize the laboratory director’s role in the overall management of the laboratory.
Checklist question TLC.10500 reads, “Does the director ensure communication of laboratory data?” The team leader should determine if the laboratory director is involved in ensuring that accurate laboratory results are reported and that interpretations are communicated to physicians when requested. Laboratory directors must show documentation that they review annually the format and content of the various types of lab reports. The lab director should ensure that the laboratory regularly tests the transmission of data between instruments, the laboratory and hospital computer systems, and to remote printing devices in physician offices or patient care areas. The lab director should also ensure that communication of critical results, including read backs, are documented per policy. Furthermore, the lab director should investigate if frozen sections were reported in a timely manner.
Checklist question TLC.10600 reads, “Does the director ensure provision of anatomic pathology procedures as appropriate?” The team leader should review the level of anatomic pathology services offered based on the size of the institution and after discussing this with the chief medical officer and chief executive officer. The pathologists must be able to provide adequate coverage for the volume and type of services performed in the institution. The qualifications and skills of the pathologists should be appropriate to the types of cases seen. For difficult cases or testing not offered, the lab should have defined mechanisms for intra- and extra-departmental consultation.
Q: Are we required to validate the pneumatic tube system in our laboratory?
A: The CAP doesn’t have specific checklist items or guidelines addressing the validation of pneumatic tube systems. However, the note to laboratory general checklist item GEN.71000 addresses specimen transport via pneumatic tube systems.
Checklist question GEN.71000 Phase II reads:
Are there documented procedures detailing procurement, transportation, and handling of patient specimens (blood, body fluids, tissue) to ensure that all specimens are submitted in an appropriately labeled and well-constructed container with a secure lid to prevent leakage during transport?
Note: Specimens sent through pneumatic tube systems should be sealed in fluid-tight bags. If pneumatic tube systems are used for transporting specimens, the laboratory must have procedures to respond to a spill within the tube, including appropriate decontamination measures.
Transfusion medicine checklist item TRM.32700 mentions the use of pneumatic tube systems in the note discussing records maintained for issuing blood.
The checklist item reads:
Do records include information about release and/or issuance of all blood components (sign-out record indicating unit, date, time, and the location/person to whom it is released)?
Note: Whether transported manually or by pneumatic tube, the transfusionist should verify that the component is designated for the intended recipient and has been received within the time limit prescribed by the blood bank. The measured interval for component integrity is from time of blood bank release to initiation of transfusion. The central issue is that the component is in acceptable condition before transfusion. If the component is taken from the blood bank by a person, the identity of that person should be recorded in the blood bank record. If the component is taken from the blood bank by pneumatic tube, records of release destination and time should be in the blood bank record.
In general, a laboratory needs to ensure that its pneumatic tube system delivers blood in a timely fashion to the correct location and that there are no adverse effects on the blood products. Most laboratories, when they begin using a pneumatic tube system, typically monitor the temperature of units before and after tubing to show if the units are being exposed to excessive heat. They also visually inspect the units for adverse effects, such as breakage or foaming, due to agitation or impact during transport.
The laboratory needs to develop an action plan for those situations when a specimen or component doesn’t arrive at the correct location due to a malfunction and for maintaining the system in the event that a unit breaks and contaminates it. The lab also needs to evaluate the amount of time it takes for the tube to go from the transfusion service to the patient unit, as well as the amount of time it takes for personnel on the receiving end to retrieve the unit from the tube. A number of processes can be used to retrieve units promptly, including alarms that sound until the unit is retrieved and return verification forms that are sent back to the transfusion service after the unit is removed. Whatever system is used should be audited periodically to ensure the process is working as intended.
Q: Does the CAP require that I revalidate all the rules of my autoverification process?
A: Laboratory general checklist item GEN.43875 states:
Is there documentation that the autoverification process was validated initially and is tested at least annually and whenever there is a change to the system that could affect the autoverification logic?
Note: The range of results for which autoverification is acceptable must be defined for all patient tests subject to autoverification.
This checklist item does not provide guidelines on the extent of the testing needed; therefore, it is up to the laboratory director to establish appropriate procedures for revalidation following good laboratory practice.
Clinical and Laboratory Standards Institute proposed guideline AUTO10-P, “Autoverification of Clinical Laboratory Test Results,” addresses validation and revalidation of algorithms used in the autoverification of laboratory results. The guideline suggests that revalidation can be performed following the same process used for initial validation or that an alternative approach can be developed. An example of an alternative approach mentioned in the guideline involves retrieving patient reports containing autoverified results generated during the period in question that match each of the possible scenarios in which autoverification can occur. The reports can be used to provide evidence that autoverification occurred as planned. The guideline also suggests that scenarios not subject to autoverification be reviewed to verify that the results went through the manual verification process.
Another approach is to print the logic tables annually and verify that they are still set up as validated. The laboratory could then check a representation of patient results to ensure that the tables are working as validated or create test specimens that can be used to test the rules set up for autoverification.
Ed Finkel is a writer in Evanston, Ill.