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 record review and staff interview, the laboratory failed to follow its established policy to ensure positive patient identification from the time of collection through final report in the subspecialty of Histopathology. Findings Include: 1) Record review on 9/4/2024 of the monthly incident reports from 2022 to 2024 revealed 5 of 5 specimen identification and mislabeling incidents. 2) Record review on 9/4/2024 of the laboratory's "Section 6. Quality Assurance" procedure manual revealed the laboratory failed to follow "6.2.2B Specimen Identification and Integrity" procedure. 3) Staff interview with the Laboratory Director on 9/5/2024 at 11:30AM confirmed the above findings. He/She further confirmed that the incidents listed in 1 above were identified prior to reporting of results. 4) The laboratory performs 20,484 tests annually in the subspecialty of Histopathology. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Based on record review and staff interview the laboratory failed to follow the established procedure to monitor and correct problems and when identified in the specimen handling including identification and labeling of the cassettes in the subspecialty of Histopathology. Findings Include: 1. Record review on 9/4/2024 of the laboratory's "Quality Assurance (QA) Binder" revealed total of 5 incident reports documented from 2022 to 2024. 2. Record review on 9/4/2024 of the laboratory's "Incident report, Performance Standards Failure" for the QA in 1 above revealed the below documentation for the following dates: a. 12/30/2022- "Labels swapped during accessioning and not caught during grossing" b. 01/12/2023- "Cassettes swapped at grossing." c. 01/20/2023- "not checking labels at accessioning" d. 07/06/2023- "put the wrong tissue on the slide" e. 04/15/2024- "Patient A tissue got put in a cassette labeled Patient B." 3. Record review on 9/4/2024 of the laboratory's "Incident report" for the QA in 2 above revealed the "Action Plan" for the grosser's to go slow, double check the cassettes, coaching the staff to double check and continue to retrain. 4. Record review on 9/4/2024 of the laboratory's "Quality Assurance Procedure" Section 6.1 General QA Plan revealed the following: a. "F. Actions to Resolve problem: Actions will be taken to resolve problems or improve care. Actions may include in- services, memos to staff, changes in policies and procedure, discussion of issues, acknowledgement e-mails, and/or one-on-one conferences with staff members." b. "G. Assess Actions and Document Improvement: Actions will be assessed for effectiveness. When a problem is resolved or care is improved as demonstrated through statistical data, the resolution or improvement will be documented in the MQAR." 5. Record review on 9/4/2024 of the laboratory's "Quality Assurance Binder", revealed lack of documentation of any