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 a record review, and an interview with the Technical Consultant #2 (TP-2) on 05/25/2023, the laboratory failed to ensure there was a procedure established to document and record patient test requests for point-of-care testing (POCT) on the Abbott i-STAT and the Werfen GEM 5000. Findings include: 1. Review and request for POCT testing analytic quality assessments for the Abbott i-STAT and the Werfen GEM 5000 during a validation survey on 05/25/2023, revealed a lack of documentation for test requests for POCT tests. 2. Review of the laboratory's policies and procedures reveal a lack of establishment of a procedure for documenting POCT tests. 3. The TC-2 confirmed by an interview on 05/25/2023, at 11:55 AM, the lack of procedure for documentation and reporting of POCT test requisitions, and the lack of a policy or procedure to ensure all POCT test requisitions are retained for two years. 4. The laboratory reports performing 86,208 patient POCT tests annually. D5307 TEST REQUEST CFR(s): 493.1241(d) The patient's chart or medical record may be used as the test requisition or authorization but must be available to the laboratory at the time of testing and available to CMS or a CMS agent upon request. 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 the lack of documentation of laboratory test requests, and an interview with the Technical Consultant #2 (TP-2) on 05/25/2023, the laboratory failed to ensure there was a policy and procedure established to document and retain a record of patient test requisitions for point-of-care testing (POCT) on the Abbott i-STAT and the Werfen GEM 5000. Findings include: 1. Request for patient test requisitions for POCT testing on the Abbott i-STAT and the Werfen GEM 5000 during the validation survey on 05/25/2023, revealed a lack of documentation for requisition and time of order for POCT tests. 2. The TC-2 verbally stated that POCT test requests are entered into the EPIC nursing orders, and once the test is marked collected, the order disappears. 3. The TC-2 confirmed the lack of retention of POCT test requests by interview on 05/25/2023, at 11:55 AM. 4. The laboratory reports performing 86,208 patient POCT tests annually. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)