Summary:
Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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 review of 2025 maintenance logs, review of 2025 patient logs, review of patient test reports and review of laboratory procedures 02/12/26, the laboratory procedures for urine cultures did not include the current method for documenting the 24 hour reading of urine cultures. Findings: Review of laboratory daily maintenance logs revealed "Read cultures @ 18-24 hrs.". Review of 2025 maintenance and patient logs for February, June and November revealed the following; a. 02/12/25 - MR# 74494-1W - Urine culture set up at 10:00 a.m. - no documentation of "read cultures @ 18-24 hrs" on the maintenance log until 02/14/25. b. 06/19/25 - MR# 14347-1 - Urine culture set up at 12:25 p.m. - no documentation of "read cultures @ 18-24 hrs" on the maintenance log until 06/25/25. c. 11/05/25 - MR# 74907-2W - Urine culture set up at 1:50 p.m. - no documentation of "read cultures @ 18-24 hrs" on the maintenance log until 11/07/25. d. 11/05/25 - MR# 74794-4W - Urine culture set up at 3:30 p.m. - no documentation of "read cultures @ 18-24 hrs" on the maintenance log until 11/07/25. e. 11/13/25 - MR# 62284-1W - Urine culture set up at 1:09 p.m. - no documentation of "read cultures @ 18-24 hrs" on the maintenance log until 11/17/25. f. 11/13/25 - MR# 79406-1W - Urine culture set up at 1:45 p.m. - no documentation of "read cultures @ 18-24 hrs" on the maintenance log until 11/17/25. Review of patient test reports for a, b, c, d, e and f above revealed all urine cultures were read between 18-24 hrs of set up. Review of laboratory procedure for "Responsibilities:" revealed "Daily:... Read cultures, log results on in-house log, enter results in EMR. The procedure fails to include documenting the reading of cultures on the daily maintenance log. Review Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- of laboratory procedure for "CULTURES:" revealed "URINE:...Urine cultures are read 18-24 hrs after set up...Enter final urine culture results in the EMR under the patient's chart...". The procedure fails to include documenting the reading of cultures on the daily maintenance log. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. This STANDARD is not met as evidenced by: Based on deficiency cited at D5401, lack of documentation and review of 2025 monthly quality assessment (QA) monitors 02/12/26, the laboratory's established monthly QA monitors failed to identify and correct the documentation of reading urine cultures on the daily maintenance log and failed to ensure laboratory procedures were current. 1. The laboratory's monthly QA monitors failed to identify and correct the failure of the laboratory to document the reading of urine cultures on the daily maintenance log. Findings: Review of 2025 maintenance and patient logs for February, June and November revealed the laboratory failed to document the reading of urine cultures on the daily maintenance log. See D5401. Review of 2025 monthly QA monitors for February, June and November revealed under the section "Quality Control...Required controls, calibrations, and maintenance have been performed and documented where appropriate". The monthly monitors had a check mark for all 3 months reviewed. There was no documentation the laboratory had identified or corrected the failure to document the reading of urine cultures on the daily maintenance log. 2. The laboratory's monthly QA monitors failed to identify the procedures "Responsibilities:" and "CULTURES:" were not current for the documentation of the reading of cultures. See D5401. Review of monthly QA monitors revealed under section "Procedure Manual", "New procedures have been reviewed and signed by the director". The monthly QA monitor fails to include a periodic review of laboratory procedures to ensure they are current. -- 2 of 2 --