Bhmg/West Park Pediatrics

Summary Statement of Deficiencies 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). 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 verify the accuracy of Bacteriology test results obtained from the Wisconsin State Laboratory of Hygiene University (WSLH) in WSLH PT 2025-Bacti_Viral 1 event. The findings include: 1. The PT program assigned an artificial score of 100%, sample ST-4 in event 1, 2025 was reported with the comments "Non-consensus - Self-assessment Needed". 2. There was no documented evidence the laboratory evaluated sample ST-4. 3. The TP confirmed on 6/25/25 at 10:20 am that the accuracy of the PT results were not verified and the PT program assigned an artificial score of 100%, D5781

Summary Statement of Deficiencies 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). 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 verify the accuracy of Bacteriology test results obtained from the Wisconsin State Laboratory of Hygiene (WSLH) 3rd event of 2021. The findings include: 1. The PT program assigned an artificial score of 100%, results were reported with the comments "Unable to obtain result". 2. The TP#1 on CMS form 209 confirmed on 9/26/23 at 1:20 pm that the accuracy of the PT results were not verified and the PT program assigned an artificial score of 100%, 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: A) Based on surveyor review of the Procedure Manual (PM), Work Records (WR) 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 -- and interview with the Testing Personnel (TP), the laboratory failed to follow their procedure for "Complete Blood Count (CBC) results with flags"from 7/27/21 to the date of survey. The findings include: 1. The PM states "Should Flags occur on CBC, inform MD repeat test" 2. Three out of five WR for CBC had flags of "M", "3" and "*". 3. There was no documented evidence that the aforementioned procedure was followed. 4. The TP confirmed on 9/26/23 at 2:30 pm that the laboratory failed to follow the aforementioned procedure. B) Based on surveyor review of the Procedure Manual (PM), Quality Control Verification (QVC) procedure and interview with the TP, the laboratory failed to follow their procedure for QVC from 7/27/21 to the date of survey. The findings include: 1. The PM stated "Before using new controls, run 3 daily samples in patient mode to assure values are within the limits for level of control. The mean of the 3 samples must be within control limits." 2. There as no documented evidence that control values obtained by the laboratory were verified against manufactures assayed control value ranges. 3. The TP confirmed on 9/26/23 at 2:30 pm that the laboratory failed to follow the aforementioned procedure. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on surveyor review of the Operators Manual (OM), and interview with the Testing Personnel (TP), the laboratory failed to follow the OM for "Calibration" from 7/27/21 to the date of survey. The findings include: 1. The OM stated to "5.2 BEFORE CALIBRATING Before calibrating, you must first prepare the instrument: 1. Do Heading 5.3, PRECALIBRATION CHECKS. 2. Do Heading 5.4, REPRODUCIBILITY. 3. Do Heading 5.5, CARRYOVER." 2. There was no documented evidence that the "Reproducability" or "Carryover" was completed on the dates that calibration was performed. 3. The TP#1 listed on CMS from 209 confirmed on 9/26/23 at 2:32 pm that the laboratory did not follow the OM. 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 having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on surveyor review of Quality Control (QC) records and interview with the Testing Personnel (TP), the laboratory failed to verify commercial QC material with each new lot and/or shipment of QC used for Hematology tests performed on the Beckman Coulter Act diff II analyzer from 7/27/21 to the date of survey. The finding includes: 1. There was no documented evidence that all levels of QC was verified before being put into use. 2. The TP#1 listed on CMS from 209 confirmed on 9/26/23 at 1:20 pm that the QC material was not verified before putting in use. D5479 CONTROL PROCEDURES CFR(s): 493.1256(e)(5)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (5) Follow the manufacturer's specifications for using reagents, media, and supplies and be responsible for results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyors observation of controls in use and interview with the Testin Personnel (TP), the laboratory failed to follow Manufacturers Specifications (MS) for controls at the time of the survey. The finding includes: 1. Controls in use did not have an open or expiration dates documented as per MS. 2. The TP confirmed on 9/26 /23 at 2:20 pm that MS were not followed. D6074 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(5) Each individual performing moderate complexity testing must be capable of identifying problems that may adversely affect test performance or reporting of test results and either must correct the problems or immediately notify the technical consultant, clinical consultant or director. This STANDARD is not met as evidenced by: Based on the surveyor review of Quality Control (QC) records and interview with the testing Personnel (TP), the Laboratory Director (LD) failed to identify problems that may affect test performance by not reviewing and evaluating trends and/or shifts for tests performed on the Beckman Coulter Act 2 Diff analyzer from 7/27/21 to the date of survey. The TP confirmed on 9/26/23 at 2:35 pm that trends and shifts were not reviewed. -- 3 of 3 --

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Nurse Manager (NM), the laboratory failed to review and evaluate PT results obtained from Wisconsin State Laboratory of Hygiene (WSLH)) for Hematology performed in 2020. The findings include: 1. There was no evidence of evaluation documented. The Proficiency Testing Evaluation was not signed and dated for WSLH PT 2020-HemeReg1 and WSLH PT-HemeReg2 in 2020 2. The NM confirmed on 7/27 /21 at 10:30 am that the laboratory did not review and evaluate all PT results. 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 Nurse Manager (NM), the laboratory failed to review and evaluate results when they received an unacceptable score in Selective Group A Strep agar + Bacitracin disk tests performed with the Wisconsin State Laboratory of Hygiene (WSLH) Proficiency Testing for the first event in the calendar year 2020. The finding includes: 1. The laboratory received an unacceptable score for Selective Group A Strep agar + 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 -- Bacitracin disk test sample ST-1 (Fail) 2 There was no documented evidence that the laboratory investigated the failure. 3. The NM confirmed on 7/27/21 at 10:30 am that the laboratory did not review and document an evaluation of unacceptable PT results. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D5803 TEST REPORT CFR(s): 493.1291(b) Test report information maintained as part of the patient's chart or medical record must be readily available to the laboratory and to CMS or a CMS agent upon request. This STANDARD is not met as evidenced by: Based on the surveyor review of the Patients Medical Records (PMR), Test Results (TR) and interview with the General Supervisor (GS), the laboratory failed to have TR fro Hematology testing on two out of seven PMR reviewed from 1/29/18 to the date of the survey. The GS confirmed on 12/4/18 at 11:20 am that the TR was not in all the PMR . Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --