Laboratory of Pathology - Staff

Resolution of Problems with Specimen Procurement, Transportation, or Handling

If a problem is identified in specimen transportation or quality, notify the Section Chief or Supervisor of the laboratory. It is the responsibility of the Section Chief or Supervisor to attempt to improve performance of clients or offices that frequently submit specimens improperly. Problems and corrective actions should be documented in the Quality Improvement Report of the individual section/unit involved.

Occurrences may be reported to the NIH Clinical Center Quality Assurance (QA) Department and Nursing Department Administration using the Web-based Occurrence Reporting System (ORS). This system provides a mechanism for communication and problem resolution of occurrences. Occurrence reporting and analysis are intended to prevent damage/risk from occurring, to reduce damage when adverse events have already occurred, and to prevent future adverse events. Occurrence reporting and analysis are integral components of the Nursing Department Quality Assurance Program. When occurrences are reported, a copy of the report is automatically sent to Clinical Center QA Department. The Clinical Center QA Coordinator makes a request for follow-up from Nursing to the Head Nurse. When this occurs, the Head Nurse completes follow-up and circulates the information to the Service Chief and sends a copy to the Nursing QA Specialist. A password and training on the system is required to initiate a report. The Clinical Laboratory Manager may initiate a report for anyone without a password.

If laboratory personnel become aware of a potential error in patient identification or other information (e.g., phlebotomist initials, date/time of collection) on a specimen label, the best practice is to recollect the specimen. There may be circumstances when recollection is not possible or practical, and every attempt to analyze irreplaceable specimens should be made. The following circumstances under which correction of the information on specimen labels is permitted, provided the circumstance is reviewed and approved by the Clinical Chief or designate at the time of correction or before the patient's report is issued if the Clinical Chief is not immediately available, and if the specimen(s) is impossible or difficult to recollect, include:

• Cerebrospinal fluid

• Bone marrow aspirate

• Peripheral blood of child under 13 years-old

• Radiological-guided FNA (deep FNA)

• Brain biopsy or other surgical specimens

• Any anatomic pathology specimen that can not be recollected (e.g., resections, mastectomy, etc.).

• Anatomic pathology specimens requiring correction of information not related to the patient's identity (e.g., date or time of collection, nurse's initials, description of anatomic site, specimen source, etc.).

• Specimen slide label information that can be corrected based on written information located under the label.

• Broken slides that can be repaired.

• Irreplaceable specimen - a specimen that is difficult to collect (invasive and/or surgically removed) and cannot be replaced by a repeat specimen, such as a lymph node or spleen. Such specimens may be analyzed even when there is poor viability since another identical diagnostic specimen can not be obtained. This is in contrast to peripheral blood which can be easily replaced with minimal impact on the patient's health. There are instances in which a peripheral blood sample may be considered irreplaceable such as when recollection may delay diagnosis of an acute leukemia, or therapy may already have been initiated based on presumptive clinical diagnosis.

• If it is possible for a clinician or nurse to personally identify the specimen they may re-label it.

Note: Each Section may independently establish written procedures indicating circumstances under which correction of the information on specimen labels are permitted, provided they are approved by the Clinical Chief.

A record of all such corrections must be maintained within the Section, including the name and title of the person that corrected the patient identification or other information. The pathologist signing out the case should also be notified. For risk management purposes, it is highly recommended that the pathologist(s) signing out the case indicate the potential error, circumstances, and how the information was corrected (e.g., title or name of person who identified the specimen, etc.) within the information in the patient report.

Each Section must investigate errors in specimen labeling, and develop corrective/preventive action as appropriate, including education of personnel who collect or label specimens. All incidents shall be reported on the Quality Improvement and Assessment Log.