Mississippi Urology Clinic Pllc

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of urinalysis proficiency testing records since the last survey and interview with the technical supervisor, listed on the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, the laboratory failed to verify the accuracy of the automated microscopic urinalysis performed on the Beckman Coulter DxU 840m Iris analyzer at least twice annually, since it was put in use for patient testing in December 2022. Findings include: 1. Review of urinalysis proficiency testing records since the last survey on 11/30/2022 revealed no documentation of performance of proficiency testing for the microscopic urinalysis performed on the Beckman Coulter DxU 840m Iris analyzer, in order to verify accuracy. 2. In an interview on 10/1/2024 at 4:30 p.m., the technical supervisor, listed on the CMS 209 personnel form, confirmed no verification of accuracy had been performed since December 2022 for the automated microscopic urinalysis testing. 3. There was no documentation of accuracy for the automated microscopic urinalysis testing performed on the Beckman Coulter DxU 840m Iris analyzer for one year and nine months of patient testing, from December 2022 through the day of the survey on 10/1 /2024. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. 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 -- This STANDARD is not met as evidenced by: Based on review of maintenance logs for the Beckman Coulter DxU 840m Iris microscopic urinalysis analyzer and the Arkray Aution MAX AX-4030 urine chemistry analyzer and interview with the technical supervisor, the laboratory failed to document, as performed, daily, weekly, and monthly maintenance, as defined by the manufacturer, for ten of twenty-two months. Findings include: 1. Review of maintenance logs, from December 2022 through September 2024, for the Beckman Coulter DxU 840m Iris microscopic urinalysis analyzer revealed no documentation of the following daily and monthly maintenance procedures for ten months, from January 2023 through October 2023: Daily Clean instrument surfaces. Clean sampler. Check lamina supply. Monthly Clean iQclear adapter & rinse waste tube. Perform backup. 2. Review of maintenance logs, from December 2022 through September 2024, for the Arkray Aution MAX AX-4030 urine chemistry analyzer revealed no documentation of the following daily, weekly, and monthly maintenance procedures for ten months, from January 2023 through October 2023: Daily Clean strip waste box. Wash introduction tray. Clean strip feeders. Clean test strip stopper. Weekly S.G. cell wash. Clean transport tray. Monthly Clean the wash bath. Clean the air filter. Replace washing solution filter. 3. In an interview on 10/1/2024 at 3:30 p.m., the technical supervisor confirmed there was no documentation of maintenance for the Beckman Coulter DxU 840m Iris microscopic urinalysis analyzer and the Arkray Aution MAX AX-4030 urine chemistry analyzer for ten of twenty-two months. -- 2 of 2 --

Summary Statement of Deficiencies 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 review of quality control (QC) records for the MicroScan Walkaway 40 Plus microbial identification/susceptibility system since the last survey on 3/18/2021 and manufacturer's instructions for Beckman Coulter MicroScan Dried Gram Positive and Dried Gram Negative panels, the laboratory failed to document positive and negative reactivity for each of the biochemical reagents for three new lots of Positive Combo (PC) 33 panels and three new lots of Negative Urine Combo (NUC) 73 panels put in use since 3/18/2021. Findings include: Review of QC records for the MicroScan Walkaway 40 Plus microbial identification/susceptibility system since the last survey on 3/18/2021 and manufacturer's instructions for Beckman Coulter MicroScan Dried Gram Positive and Dried Gram Negative panels revealed the laboratory failed to include the recommended organisms listed below to produce positive and negative reactivity for each biochemical reagent on the new lots of PC 33 panels and NUC 73 panels listed. A. For the Gram Positive Combo 33 panel, the following recommended organisms were not included in quality control testing for the new lots listed below: (1) Lot #2022-04-22, put in use 9/29/2021: Micrococcus (M.) luteus American Type Culture Collection (ATCC) 49732 and Streptococcus (S.) pneumoniae ATCC 49136 were not included. (2) Lot #2022-11-10, put in use 3/23/2022: S. pneumoniae ATCC 49136 and Escherichia (E.) coli ATCC 35218 were not included. (3) Lot #2023-05- 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 -- 11, put in use 8/24/22--S. pneumoniae ATCC 49136 and E. coli ATCC 35218 were not included. B. For the Gram Negative Urine Combo 73 panel, the following recommended organisms were not included in quality control testing for the new lots listed below: (1) Lot #2022-07-28, put in use 9/29/2021: Shewanella putrefaciens ATCC 49138 was not included. (2) Lot #2022-12-15, put in use 3/23/2022: Staphylococcus (S.) aureus ATCC 29213, Enterococcus (E.) faecalis ATCC 29212, and Shewanella putrefaciens ATCC 49138 were not included. (3) Lot #2023-05-13, put in use 8/24/2022: S. aureus ATCC 29213, E. faecalis ATCC 29212, and Shewanella putrefaciens ATCC 49138 were not included. -- 2 of 2 --

Summary Statement of Deficiencies 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)