College of American Pathologists
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  CAP fine-tunes unannounced inspection process


December 2006
Originally published in CAP TODAY

Stephen J. Sarewitz, MD

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: What is required of a laboratory with regard to providing blood and blood components in a timely manner? Does the laboratory have to have a written contract to ensure that appropriate transfusion support is occurring?

A: The laboratory should have a system that allows it to communicate to members of the medical staff and hospital administration the transfusion support it will provide. This system, based on agreement between staff from the transfusion service and clinical areas, should address turnaround time, notifications that should occur if there is a delay in obtaining or transporting a suitable blood product, and processes that should take place when the patient needs special blood products.

These issues do not need to be addressed in a contract. If there is a committee in your organization that discusses transfusion issues with representatives from the medical staff, these issues could be discussed in these meetings and agreement obtained. This could be documented in minutes from such meetings. This could also be accomplished by documenting in a written policy or procedure the processes the laboratory will undertake and ensuring that members of the medical staff can review and provide their input on the issues in the policy. To demonstrate that the appropriate personnel have reviewed the policy, it could be signed by the medical director, representative of the medical staff, and a member of the hospital administration.

CAP transfusion medicine checklist question TRM.30688 reads:

    Is there an agreement or understanding between the transfusion service and the clinical areas for which it provides transfusion support (e.g., surgery, emergency room, patient care units) to ensure provision of blood and blood components on a timely basis?
    Note: The agreement or understanding should define the expectations for turnaround time, requests for patients with special transfusion needs (e.g., CMV negative, leukoreduced), notifications of delays in obtaining suitable products, and transportation of products. Agreements should be approved by the medical staff, transfusion service medical director, and hospital administration.

Q: Must the laboratory monitor activities related to all CAP patient safety goals?

A: The CAP’s patient safety goals are to improve the following: patient and sample identification at specimen collection, analysis, and resulting; verification and communication of life-threatening or life-altering information regarding malignancies, HIV and other serious infectious diseases, cytogenetic abnormalities, and critical results; identification, communication, and correction of errors in a timely manner; and the coordination of the laboratory’s patient safety role within health care organizations.

The CAP’s laboratory general checklist item GEN.20365, phase II, asks, “Does the laboratory address the current CAP patient safety goals?” The note to this checklist item reads, “The laboratory must document that these goals have been addressed by evaluation and/or monitoring of the processes involved.” So the laboratory is not necessarily required to monitor each goal.

Other phase II checklist requirements in the laboratory general checklist also address monitoring. Checklist item GEN.20316 requires that the laboratory monitor key indicators of quality in its quality management program. Items GEN.20348 and GEN.20364 require monitoring of pre- and postanalytic processes.

The checklist question addressing patient safety, GEN.20365, is not necessarily intended to require additional monitoring beyond that required by the aforementioned checklist items. Rather, its purpose is to emphasize important patient safety activities the laboratory may wish to monitor as part of the monitoring activities defined by questions GEN.20316, 20348, and 20364. It also requires that laboratories review their processes that affect patient safety goals at least annually to determine if they can be improved. An end point of this review is the determination of whether monitoring is necessary.

For example, a laboratory evaluated its system for reporting unexpected diagnoses of malignancy in surgical pathology as part of its review of patient safety goals. The department’s procedure requires the pathologist to phone the diagnosis to the clinician and document the phone conversation in the patient report. An audit of surgical pathology reports revealed no lapses in this system of documenting phone calls. The surgeons expressed their satisfaction with this system at a surgery department meeting. Consequently, the laboratory determined that it was not necessary to alter the procedure and decided not to pursue monitoring at this time because it would contribute little to the quality of the process.

In another example, a laboratory monitored the rate of specimen-labeling errors and determined that the error rate was higher in the emergency department than in other departments. As part of its review of processes related to patient safety goals, the laboratory investigated how specimens are labeled in the ED. They learned that nurses draw the blood and place the unlabeled tubes of blood on the counter outside the patient room. The ward clerk then affixes patient labels to the tubes. The laboratory determined that this process carries a high risk of error. The laboratory, working with the emergency department, developed a new identification procedure in which the nurse labels the tubes before leaving the patient’s bedside. The laboratory continues to monitor the rate of labeling errors.

The objective of improving the coordination of the laboratory’s patient safety goal within the organization may not be amenable to monitoring. Rather, the laboratory should ensure that its patient safety activities are integrated into the overall patient safety activities of the institution—for example, by having laboratory representation on the appropriate institutional committee and having laboratory personnel attend clinical department meetings. Reviewing this goal annually allows the laboratory to assess the effectiveness of its interaction with the institution overall and address barriers to communication and cooperation with other departments.

The annual review of the CAP patient safety goals should be documented in a report, meeting minutes, or other record.

Q: If a laboratory director is not a full-time employee or located on site, how is that person expected to fulfill the director responsibilities in the CAP team leader assessment of director and quality checklist?

A: The following team leader checklist questions apply to laboratory directors who are not present full time at the laboratory:

  • TLC.11600: “Is there an agreement defining the frequency of, and responsibilities for, on-site visits by the laboratory director?”
  • TLC.11700: “Is there documentation of the activities of the director during visits to the accredited laboratory and health care institution?”
  • TLC.11800: “Is the frequency/duration of on-site visits, and involvement of the laboratory director in the laboratory’s activities, considered adequate by the laboratory and medical staff?”

These checklist items are intended to apply to those situations where the laboratory director makes infrequent visits to the lab. For checklist item TLC.11600, the frequency of laboratory visits and responsibilities of the director should be defined. To determine the appropriate number of visits, the laboratory must define the laboratory director’s responsibilities and related tasks that can be delegated to other qualified individuals in his or her absence. A communication mechanism, such as fax or phone, must be in place to keep the laboratory director apprised of all laboratory activities and to communicate those tasks that cannot wait until the director’s next on-site visit. The complexity of the laboratory testing and qualifications of the testing personnel should also be considered when determining the frequency of on-site visits.

For checklist questions TLC.11700 and TLC.11800, the inspection team leader will be looking for evidence of director involvement in the laboratory to show that the director is fulfilling the responsibilities defined in the team leader checklist and the Laboratory Accreditation Program Standards for Accreditation. These are the same requirements that are applicable to full-time laboratory directors. Documented evidence may consist of meeting minutes showing the director’s attendance, signatures of the director for procedure review, quality control, quality management documentation, or documented medical consultations. It may also consist of other forms of communication, such as e-mail, fax, or phone consultations, when the director is off-site. If the laboratory director has delegated some functions to others, a policy that details who is authorized to act on his or her behalf for those activities should be provided to the LAP inspector. During the inspection team leader’s interviews with the medical staff, hospital administrator, and laboratory personnel, the team leader will ask questions to assess the quality of the laboratory services and determine whether the laboratory director’s involvement meets the needs of the laboratory.