Summary:
Summary Statement of Deficiencies 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: Based on review of the laboratory's policies and procedures, review of 2020, 2021, and 2022 monthly QA (quality assessment) forms, random review of patient requisitions and test reports (accession #6416, #6419, #6459, #6466, #6590, #6870), and interview with the owner and TS (technical supervisor) 12/6/22, the laboratory's quality assessment program failed to identify problems identified during the survey in the preanalytic systems. Review of the "SLP 13 ... : Specimen Collection and Handling" procedure revealed " ... Specimen Transport ... Note: Every patient sample must have two identifiers and be properly packaged with the correct patient information. All writing on the requisition form and sample must be legible and complete. The following needs to be on the requisition form: Date of collection Collector's initials Two proper identifiers ... The sample must match the clinical ID /requisition form ... Sample Processing: Accessioning and Order Entry ... Accession the sample. Check the specimen and accompanying documents again to ensure patient identifiers (see EasyTox User Manual) match. ... If a discrepancy is found, the specimen will be placed aside for further investigation. ... Specimen Rejection Criteria If it is determined that the specimen is unlabeled or mislabeled (For example - no sample collection date, missing patient identifiers and/or mismatching information with test requisition), the specimen must be discarded and recollected. ...". Review of the "General Laboratory Systems Quality Management Policy" revealed "... Specimen Identification and Integrity Specimens are collected and handled according to manufacturer's specifications. ... Specimens that do not meet acceptable criteria are rejected according to our specimen rejection policy. ... These issues are maintained Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- and reviewed on our monthly QA form. ... Patient Test Management All CLIA required information is obtained on the requisition as specified in the patient test management policy. ...". Review of monthly QA forms revealed no problems noted during 2020, 2021, and 2022. Review of random patient requisitions and test reports revealed missing information on requisitions and information on requisitions that did not match information on test reports. Examples: a. Accession #6416 - date of collection not legible, time of collection missing b. Accession #6419 - missing date and time of collection c. Accession #6459 - collection date of 10/6/22 on requisition, test report lists collection date as 10/11/22 d. Accession #6466 - missing date and time of collection, collector initials e. Accession #6590 - missing date and time of collection, collector initials f. Accession #6870 - missing date of collection During interview at approximately 2:30 p.m., the owner and TS stated that specimens would not be rejected if some of the information was missing from the requisition. They stated that specimen collectors are supposed to ensure all information is present on requisitions and personnel who accession the specimens should try to obtain any missing information overlooked by the collector. 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)