Summary:
Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on surveyor observation, record review, and interview with the laboratory director (LD), the laboratory did not follow written policies and procedures that ensure positive identification and optimum integrity of a patient ' s specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. Findings: 1. During the survey, a patient specimen (patient #1, case # 20M516) was chosen in order to track it through the pre-analytical, analytical, and post-analytical stages of Mohs testing. While locating the stained slides for review, the histotech found a second set of slides for patient #1. It was observed that these slides were labeled with a different case number (# 20M515). 2. Review of the "Advanced Dermatology Mohs Log" showed that another patient (patient #2) was listed under case # 20M515. Further observation showed that the laboratory had slides for patient #2 which were also labeled with case # 20M515. The information on these slides matched the documentation on the "Advanced Dermatology Mohs Log" for patient #2. 3. During the survey at 11:00 AM on 1/6/2022 the LD performed an investigation and determined that the second set of slides for patient #1 was labeled with the wrong case number. The LD confirmed that the laboratory did not follow procedures to ensure positive identification of patient specimens through each step of testing. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --