Jefferson County Health Center

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on observations made during the survey, review of blood culture media quality control (QC) certificates and the Media Individualized Quality Control Plan (IQCP) and confirmed by interview with the general supervisor identifier #2 (GS2) at 9:38 am on 10/31/2024, the laboratory failed to retain blood culture media QC certificates for all lot numbers of blood culture media used between 1/1/2023 - 10/31/2024. The findings include: 1. The Media IQCP states the laboratory will retain blood culture media QC certificates as proof of quality control. 2. Observations made during the survey revealed the laboratory used Bactec Peds Plus, Bactec Lytic Anaerobe, and Bactec Lytic Aerobe blood culture media. 3. At the time of the survey, GS2 confirmed the laboratory did not retain the lot numbers and expiration dates of all blood culture media used from 1/1/2023 - 10/31/2024. In addition, the laboratory did not retain the media QC certificates for all blood culture media used from 1/1/2023 - 10/31/2024. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- This STANDARD is not met as evidenced by: Based on review of Wisconsin State Laboratory of Hygiene (WSLH) and College of American Pathologists (CAP) proficiency testing records and confirmed by interview with General Supervisor (GS) #1 at 8:43 am on 10/31/2024, the laboratory failed to perform a self evaluation when the laboratory received four ungraded PT scores from one out of six testing events from 01/01/2023- 10/31/2024. The findings include: 1. For 2023 1st event, the laboratory received ungraded PT test scores for the following: *WSLH PT 2023-Bacti_Viral 1: Cepheid GeneXpert Xpress MVP Bacterial vaginosis- specimen VPM-1; Cepheid GeneXpert Xpress MVP Candida group- specimen VPM-1; Cepheid GeneXpert Xpress MVP Bacterial vaginosis- specimen VPM-2; and Cepheid GeneXpert Xpress MVP Candida group- specimen VPM-3. 2. At the time of the survey, GS #1 confirmed the laboratory did not perform a self evaluation for the ungraded PT test scores listed above. 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 review of Wisconsin State Laboratory of Hygiene (WSLH) and College of American Pathologists (CAP) proficiency testing (PT) records and confirmed by interview with General Supervisor (GS) #1 at 8:43 am on 10/31/2024, the laboratory failed to take and document

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: A. Based on review of MicroScan WalkAway maintenance records and confirmed by laboratory personnel identifier #6 (refer to the Laboratory Personnel Report) at approximately 10:15 am on 12/15/2022, the laboratory failed to perform and document all daily, weekly, and monthly maintenance as defined by the manufacturer on the MicroScan WalkAway instrument for 59 out of 91 days, 13 out of 13 weeks, and three out of three months of patient testing from 09/01/2022- 11/30/2022. The findings include: 1. The laboratory implemented and began using a new Microscan WalkAway instrument in September 2022. 2. According to the MicroScan Instrument /Computer Maintenance Checklist, the manufacturer requires the laboratory to perform the following daily maintenance: *Print QC Diagnostics Report *Print Calibration Report *Perform tasks on QC Diagnostic Report *Back up LabPro Database 3. Records indicated that the laboratory did not document all daily maintenance tasks from 09/01/2022- 09/30/2022 and 11/02/2022- 11/30/2022. 4. According to the MicroScan Instrument/Computer Maintenance Checklist, the manufacturer requires the laboratory to perform the following weekly maintenance: *Clean Photodiode Shield *Clean Diffuser Plate *Verify latest LabPro Database File is on the Backup Media 5. Records indicated that the laboratory did not document all weekly maintenance tasks from 09/01/2022- 11/30/2022. 6. According to the MicroScan Instrument/Computer Maintenance Checklist, the manufacturer requires the laboratory to perform the following monthly maintenance: *Check Renok Dispense Volume *Run Database Optimizer *Restart Computer *Clean Air Intake Filter 7. Records indicated that the laboratory did not perform all monthly 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 -- maintenance tasks from 09/01/2022- 11/30/2022. 8. At the time of the survey, personnel identifier #6 confirmed that the laboratory failed to perform and document maintenance on the MicroScan WalkAway as required by the manufacturer. B. Based on review of the Bactec FX maintenance records and confirmed by laboratory personnel identifier #6 (refer to the Laboratory Personnel Report) at approximately 10: 50 am on 12/15/2022, the laboratory failed to perform and document the monthly air filter clean/change as defined by the manufacturer on the Bactec FX blood culture instrument for 11 out of 11 months of patient testing from 01/01/2022- 11/30/2022. C. Based on review of the microbiology Cepheid GeneXpert instrument maintenance records and confirmed by laboratory personnel identifier #6 (refer to the Laboratory Personnel Report) at approximately 11:30 am on 12/15/2022, the laboratory failed to perform and document any weekly, monthly, and quarterly maintenance as defined by the manufacturer on the microbiology Cepheid GeneXpert instrument for 14 out of 49 weeks, four out of 11 months, and four out of four quarters of patient testing from 01 /01/2022- 12/10/2022. The findings include: 1. The GeneXpert System Maintenance Log indicated that the manufacturer requires the laboratory to perform the following weekly maintenance: *Power down the GeneXpert instrument *Power down the GeneXpert computer 2. Records showed that the laboratory did not perform and document any weekly maintenance during the following weeks: 01/16/22, 01/30/22, 02/13/22, 03/13/22, 04/03/22, 04/24/22, 05/15/22, 06/19/22, 07/10/22, 07/31/22, 09/25 /22, 10/16/22, 10/23/22, and 11/13/22. 3. The Cepheid GeneXpert System Maintenance Log indicated that the manufacturer requires the laboratory to perform the following monthly maintenance: *Archive tests *Purge tests *Replace fan filters 4. Records showed that the laboratory did not perform and document any monthly maintenance during the following months in 2022: January, May, July, and October. 5. The GeneXpert System Maintenance Log indicated that the manufacturer requires the laboratory to perform the following quarterly maintenance: *Clean plunger rod and cartridge bays *Clean instrument surfaces 6. Records showed that the laboratory did not perform and document any quarterly maintenance at any time between 01/01 /2022- 12/10/2022. 7. At the time of the survey, personnel identifier #6 confirmed that the laboratory failed to perform and document maintenance on the microbiology Cepheid GeneXpert as required by the manufacturer. This is a repeat deficiency cited on 09/28/2016, 09/26/2018, and 12/30/2020. D5783

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 review of proficiency testing (PT) records and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 10: 30 am on 12/30/2020, the laboratory failed to take and document

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: (A) Based on review of Cepheid GeneXpert maintenance records from January- September 2018, observations made at 9:30 AM on 09/26/2018 in the microbiology and main laboratory areas, and confirmed by laboratory personnel identifier #5 (refer to Laboratory Personnel Report) at approximately 10:55 AM on 09/26/2018, the laboratory failed to perform and document daily, weekly, monthly and quarterly maintenance on the two Cepheid GeneXpert test systems for 269 out of 269 days, 39 out of 39 weeks, 9 out of 9 months and 3 out of 3 quarters. The findings include: 1. The laboratory had two GeneXpert instruments identified as serial number (S/N) 707563 (microbiology) and S/N 816563 (main laboratory). 2. Records revealed that the laboratory documented maintenance on the GeneXpert System Maintenance Log for one of the two instruments. However, the laboratory failed to identify which instrument on the log. 3. At the time of the survey, the laboratory did not have a maintenance log with instrument identification for each of the GeneXpert systems. (B) Based on review of Microsecond WalkAway maintenance records from January- September 2018 and confirmed by the laboratory personnel identifier #5 (refer to Laboratory Personnel Report) at approximately 10:15 AM on 09/26/2018, the laboratory failed to perform and document weekly and monthly maintenance on the instrument for 21 out of 36 weeks and 5 out of 9 months (February-June). The findings include: 1. According to the MicroScan WalkAway Maintenance Checklist form, the manufacturer requires the laboratory to perform the following weekly maintenance: *Clean photodiode shield; *Clean diffuser plate; *Clean reagent adapters, gaskets and bottles; *Run database optimizer; and *Clean area around 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 -- computer verifying computer fans are not blocked or covered. 2. According to the MicroScan WalkAway Maintenance Checklist form, the manufacturer requires the laboratory to perform the following monthly maintenance: *Verify RENOK dispense volume; *Restart computer; and *Clean air intake filter. 4. Records revealed that the laboratory performed the weekly maintenance during the following weeks in 2018: 1 /4, 1/29, 3/5, 3/12, 3/19, 4/17, 4/24, 5/16, 5/27, 6/8, 6/22, 7/10, 8/31, 9/20 and 9/25. 5. Records revealed that the laboratory performed the monthly maintenance for the following months in 2018: January, July, August and September. 6. The laboratory personnel identifier #5 confirmed that the laboratory failed to perform and document weekly and monthly maintenance on the MicroScan WalkAway as required by the manufacturer. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on lack of Individualized Quality Control Plan (IQCP) records, review of quality control (QC) records for 2018, and confirmed by laboratory personnel identifier #5 (refer to Laboratory Personnel Report) at approximately 1:30 PM on 09 /26/2018, the laboratory failed to perform a positive and negative control each day of patient testing for the following test systems: Immunocard Stat Campy Antigen and MedTox Profile V. The findings include: 1. The laboratory performed controls with each new lot of test kits and reagents for the Immunocard Stat Campy Antigen test and MedTox Profile V urine drug screen test system. 2. Laboratory personnel identifier #5 indicated that the laboratory intended to follow manufacturer's instructions for performing QC for both test systems. 3. At the time of the survey, the laboratory did not have an IQCP for the either test system. -- 2 of 2 --