Summary:
Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records from 2022 for testing performed by the laboratory and interview with the testing personnel, the laboratory director and testing personnel failed to sign the PT attestation statements. Findings include: 1. The laboratory performs testing in the specialties of Chemistry and Hematology, with an approximate annual test volume of 240,292. 2. The PT attestation statement presented for review for the first event of 2022 for Chemistry lacked the laboratory director's and testing personnel signature. 3. The PT attestation statements presented for review for the first, second and third event of 2022 for Hematology lacked the laboratory director's signature. 4. The testing personnel interviewed on 11/10/22 at 10:45am confirmed that the PT attestation statements indicated above were not signed by the laboratory director and testing personnel. 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: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- Based on review of patient test requisitions, review of patient test reports and interview with the facility personnel, the laboratory failed to establish policies and procedures to ensure positive identification of a patient's specimen from the time of collection through completion of testing and reporting of results. Findings include: 1. The laboratory began patient testing on May 4, 2020, with an approximate annual test volume of 240,292. The laboratory performs testing in the specialties of Chemistry and Hematology. 2. It is the practice of the laboratory to receive hand-labeled specimens. During the sample accessioning process, the laboratory matches the hand- labeled sample with the corresponding test requisition and generates a printed label. The printed label is then affixed to the sample prior to testing. The printed label is also affixed to the patient's test requisition. 3. The test requisition reviewed during the survey for patient P.L. (DOB 3/07/1947) - patient ID# 10177, contained the affixed printed label for patient S.B. (DOB 11/29/1946) - patient ID# 10177. 4. The testing personnel (TP-1) and accessioning personnel interviewed on 11/10/22 at 1:10pm stated that the specimens received by the laboratory with the test requisition referenced above belonged to patient P.L., however the specimens were mislabeled with S.B.'s patient label. They stated that both patients had the same patient ID number due to an error in the laboratory's patient record system, however the error was not identified during the sample accessioning process. 5. No documentation was presented for review during the survey to indicate the laboratory established policies and procedures to ensure positive patient identification on patient specimens from the time of collection or receipt of the specimen through completion of testing and reporting of results. 6. The TP-1 interviewed on 11/10/22 at 1:15pm confirmed that the laboratory failed to establish policies and procedures to ensure positive patient identification throughout the entire testing process. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of Proficiency Testing (PT) records from 2022 and interview with the facility personnel, (A) the laboratory failed to document