Originally published in CAP TODAY
- TLC.11600: “Is there an agreement defining
the frequency of, and responsibilities for, on-site visits by the
- TLC.11700: “Is there documentation of the activities of the
director during visits to the accredited laboratory and health care
- 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.