Summary:
Summary Statement of Deficiencies D3027 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(1) Test requisitions and authorizations. Retain records of test requisitions and test authorizations, including the patient's chart or medical record if used as the test requisition or authorization, for at least 2 years. This STANDARD is not met as evidenced by: Based on lack of test requisitions for review from 2021 and interview with the facility personnel, the laboratory failed to retain test requisitions and test authorizations for at least two years. Findings include: 1. The laboratory performs testing in the subspecialty of Histopathology, with an annual test volume of 32,500. 2. It is the practice of the laboratory to store records offsite from prior years. 3. At the time of the survey on 10/26/23, the laboratory failed to provide test requisitions from 2021 when requested. 4. The facility personnel interviewed on 10/26/23 at 11:00 AM confirmed test requisitions from 2021 were not available for review at the time of the survey. 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 review of the laboratory's Case Discrepancy Form and interview with the facility personnel, the laboratory failed to ensure positive identification of 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 -- Histopathology specimens from the time of collection through completion of testing and reporting of test results. Findings include: 1. The laboratory performs testing under the subspecialty of Histopathology, with an annual test volume of 32,500. 2. The laboratory's established procedure titled "Case Rejection and Discrepancy Reference Chart"(approved on 11/05/2020) states the laboratory must Reject the Case and complete a Case Rejection Letter if the patient name is not on the container, patient name is not on requisition or patient name on requisition and container do not match. 3. The Case Discrepancy Form presented for review for case# AS23-657 from 02/01/2023 indicated 7 specimen jars were received by the laboratory, but jar #6 was unlabeled and jar #7 was labeled with only the specimen site. 4. The facility personnel interviewed on 10/26/2023 at 11:30 AM stated that the laboratory personnel who accessions the specimens contacted the facility who submitted the specimens for case# AS23-657 by phone, confirmed the identity of the specimen and requested patient labels to be faxed over. The laboratory personnel then labeled jars #6 and #7 with the labels that were faxed to the laboratory by the ordering facility. 5. The laboratory failed to 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, as evidenced for case# AS23-657. 6. The laboratory failed to follow the established procedure indicated above (see #2) by allowing laboratory personnel to accept and label specimens which were received without the proper patient and specimen identification. 7. The facility personnel interviewed on 10 /26/2023 at 11:40 AM acknowledged that the laboratory failed to ensure positive identification of the patient's specimens from the time of collection through completion of testing and reporting of results. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on lack of documentation of a semiannual competency evaluation for two out of four testing personnel and interview with facility personnel, the technical supervisor failed to evaluate and document the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. Findings include: 1. No evidence of a semiannual competency evaluation was presented for review for two out of four testing personnel (TP-1 and TP-4)who perform the gross description on patient specimens. 2. Facility personnel interviewed on 10/26/2023 at 10:30 AM confirmed the technical supervisor failed to document a semiannual competency evaluation for the testing personnel indicated above. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on lack of documentation of an annual competency evaluation and interview with facility personnel, the technical supervisor failed to evaluate and document the performance of one out of four individuals responsible for high complexity testing at least annually after the first year the individual tested patient specimens. Findings include: 1. No evidence of an annual competency evaluation was presented for review for one out of four testing personnel (TP-4) who performs the gross description on patient specimens. 2. Facility personnel interviewed on 10/26/23 at 10:30 AM confirmed the technical supervisor failed to document an annual competency evaluation for the testing personnel indicated above. -- 3 of 3 --