Bhmg/West Park Pediatrics

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records, Procedure Manual (PM) and interview with the Laboratory Manager (LM), the laboratory failed to ensure that all Testing Personnel (TP) who perform Hematology and Bacteriology testing participated in the Wisconsin State Laboratory of Hygiene (WSLH) PT events in the calendar year of 2023. The findings include: 1. The PM states "Clinical staff /testing personnel will randomly rotate and perform WSLH proficiency testing for in office laboratory testing." 2. A review of PT attestation records showed that one out of ten TP performed all Hematology and Bacteriology WSLH PT events in 2023. 3. The LM confirmed on 2/20/24 at 11:45 am that the laboratory failed to rotate all TP to participate for Hematology and Bacteriology WSLH PT events in 2023. D3033 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3)(i) In addition, the laboratory must retain records of test system performance specifications that the laboratory establishes or verifies under 493.1253 for the period of time the laboratory uses the test system but no less than 2 years. This STANDARD is not met as evidenced by: Based on the lack of Performance Specifications (PS) for the Beckman Coulter AcT diff 2 and interview with the Laboratory Manager (LM) the laboratory failed to retain 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 -- PS records for the Beckman Coulter AcT diff 2 analyzer used to perform Hematology Testing from 2/20/2022 to 2/20/24. The findings include: 1. The laboratory failed to retain test PS for the Beckman Coulter AcT diff 2 analyzer and was not available for review. 2. The LM stated the PS for the Beckman Coulter AcT diff 2 analyzer were performed in 2009. 3. The LM confirmed on 2/20/24 at 10:45 am the laboratory failed to retain the PS for the Beckman Coulter AcT diff 2 analyzer and was not available for review. 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 the Proficiency Testing (PT) records and interview with Laboratory Manager (LM), the laboratory failed to document the evaluation of all unacceptable scores and

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 the Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to evaluate results when they received an unacceptable score in Hematology tests performed on the Act Diff 2 analyzer with the Wisconsin State Laboratory of Hygiene (WSLH) in the 2017- HemReg 3, and 2018-HemReg1 events. The findings include: 1. The laboratory received "Fail" in 2017-HemReg3 on sample AT-13 Lymphocytes % 2. The laboratory received "Fail" in 2018-HemReg1 on sample AT-10 Hematocrit % 3. There was no documented evidence that the laboratory investigated the failures. 4. The TP #1 listed on CMS form 209 confirmed on 7/18/19 at 10:42 am that the laboratory did not perform and document an evaluation of unacceptable PT results. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials 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 -- having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of Quality Control (QC) records, Manufactures Package Insert (MPI) and interview with the Testing Personnel (TP), the laboratory failed to verify commercially assayed QC material with each new lot and/or shipment for Hematology testing performed on the AcT Diff 2 analyzer from June 2019 on the date of survey. The TP #1 listed on CMS form 209 confirmed on 7/18/19/18 at 10:00 am that the assayed values of QC material were not verified before putting in use. 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 Perseonnel (TP), the laboratory failed to check each lot number and shipment of Bacitracin Discs for negative reactivity from 6/17/2019 to the date of the survey. The TP #1 listed on CMS form 209 confirmed on 7/18/19 at 11:05 am that the above QC was not performed. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the surveyor review of the Quality Control (QC) records and interview with the Testing Personnel (TP), the laboratory failed to check each new lot number and shipment of culture media for sterility, ability to support growth and select or inhibit organisms from 6/13/19 to the date of the survey. The findings Include: 1) Selective Strep Agar plates Lot # 440748 and 123668 were not checked for sterility, ability to support growth and ability to select or inhibit organisms. 2) Approximately 24 patients were run and reported. 3) The TP #1 list on CMS form 209 confirmed on 7/18 /2019 at 11:30 am the laboratory did not perform the above QC. -- 2 of 2 --