Summary:
Summary Statement of Deficiencies D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on surveyor review of Proficiency Testing (PT) results and interview with the Testing Personnel (TP), the laboratory failed to review Unacceptable result for Urine Colony Count Combination performed with the College of American Pathologists (CAP) in 2021. The finding includes: 1. The laboratory received a "Unacceptable" result 3rd event 2021 for Urine Colony Count specimen MC-8. 2. There was no documented evidence that Unacceptable PT result was reviewed. 5. The TP confirmed on 9/29/22 at 10:33 am that the laboratory did not review Unacceptable PT result. . D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM), and interview with the Testing Personnel (TP), the laboratory failed to follow all procedures written for "Chart Audits" from 3/11/16 to the date of the survey. The findings include: 1. There was no documented evidence the below mentioned procedure was followed: a. "Every six months 6 random charts are selected to check for agreement between test ordered and test results reported, agreement between test records and those on reports, 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 -- consistency of results to patient information, the effectiveness of our critical value protocol.". 2. The TP confirmed on 9/29/22 at 10:30 am that the laboratory did not follow the PM. D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e)(i) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of the Quality Control (QC) records and interview with the Testing Personnel (TP), the laboratory failed to check each lot number and shipment of Bacitracin Discs for positive and negative reactivity from 1/8/21 to the date of the survey. The finding includes: 1. There was no record of Bacitracin QC in the QC log after 12/15/20 expiration date: 1/8/21. 2. The TP confirmed on 9/29/22 at 10:50 am that the laboratory did not perform QC on Bacitracin disc as stated above. D5781