Dowling Medical Clinic

Summary Statement of Deficiencies D0000 During a routine recertification survey conducted on 04/14/25, the laboratory was found out of compliance with the following condition: 493.1409 Condition: Laboratories performing moderate complexity testing; technical consultant. 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. In addition, retain the following: This STANDARD is not met as evidenced by: Based on laboratory observation, review of quality control records and staff interview, the laboratory failed maintain to records of quality control ranges used for three of three primary lots (nine of nine sub-lots) reviewed from 2024 and 2025. The findings include: 1. Laboratory observation on 04/14/25 at 10:05 a.m. revealed the Sysmex XP- 300 instrument used for performing patient testing for Complete Blood Count with automated white blood cell differential (CBC w/Diff). 2. A review of the laboratory's quality control records revealed the following: The laboratory's CBC w/Diff quality control ranges did not match the manufacturer's package insert ranges for three of three primary lots (4051, 4219, and 4303), nine of nine individual lots (40510710, 40510711, 40510712, 42190710, 42190711, 42190712, 43030710, 43030711, 43030712). Lot 4051 was used from 03/07/24 to 05/29/24, lot 4219 was used from 08 /02/24 to 11/13/24, lot 4303 was used from 11/14/24 to 2/4/25. 3. The lead testing person stated the following during an interview on 04/14/25 at 2:30 p.m.: The laboratory scanned the manufacturer's ranges at the beginning of the lot's use, but no record of scanned ranges was retained. When the laboratory finished with quality control lots, the auto-set button was hit, and quality control targets and ranges were recalculated based on the values obtained during the lot's use. Then, the quality Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- control reports were printed for retention and review. She stated the control records did not reflect the quality control ranges that the laboratory entered at the beginning of the lot use. This confirmed the survey findings. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) (a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on direct observation, review of the Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing records, lack of documentation and staff interview, the laboratory failed to retain three of four proficiency testing performance evaluations from 2024 and 2025. The findings include: 1. Laboratory observation on 04/14/25 at 10:05 a.m. revealed the Sysmex XP-300 instrument used for performing patient testing for Complete Blood Count with automated white blood cell differential (CBC w/Diff). 2. A review of the laboratory's WSLH CBC w/Diff proficiency testing records revealed no performance evaluation reports for 2024 events one, two and three. 3. The lead testing person confirmed the survey findings during an interview on 04/14/25 at 11:30 a.m. 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 direct observation, review of proficiency testing records, lack of documentation and staff interview, the laboratory failed to print and review three of four proficiency testing performance evaluations from 2024 and 2025. This deficiency was cited on the previous recertification survey conducted in February 2024 and compliance was not maintained. The findings include: 1. Laboratory observation on 04 /14/25 at 10:05 a.m. revealed the Sysmex XP-300 instrument used for performing patient testing for Complete Blood Count with automated white blood cell differential (CBC w/Diff). 2. A review of the laboratory's proficiency testing records revealed the laboratory had not printed and reviewed the performance evaluation reports for 2024 events one, two, and three. 3. The lead testing person confirmed the survey findings during an interview on 04/14/25 at 11:30 a.m. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, -- 2 of 6 -- and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of the laboratory's American Academy of Family Physicians (AAFP) proficiency testing (PT) records and staff interview, the laboratory failed to retain the attestation statement and performance evaluation for 2022 Event Three (one of five reviewed). The findings include: 1. A review of the laboratory's AAFP PT records revealed the attestation statement and performance evaluation for 2022 Event Three were not available on the date of the survey (02/20/2024). 2. An interview with testing person one on 02/20/2024 at 11:30 am confirmed the laboratory failed to retain the attestation statement and performance evaluation for 2022 Event Three. 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. 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 a review of the laboratory's Wisconsin State Laboratory of Hygiene (WSLH) PT records and staff interview, the laboratory failed to review performance evaluations for PT in 2023 (two of five events reviewed). The findings include: 1. A review of the laboratory's WSLH PT records revealed the performance evaluations for 2023 Events One and Two did not have documented reviews performed by the laboratory director. 2. An interview with the testing person one on 02/20/2024 at 11: 30 am confirmed the laboratory failed to document a review of the performance evaluations for the PT Events One and Two in 2023. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on a review of the laboratory's procedure, WSLH PT records, and staff interviews, the laboratory failed to follow its' procedure for signing attestation statements in 2023 (three of five events reviewed). The findings include: 1. A review of the laboratory's procedure titled "Quality Assurance Program Outline" section "Proficiency Testing" revealed testing personnel and the laboratory director would sign the attestation statements for each event. 2. A review of the laboratory's WSLH PT records revealed the attestations statements not signed by the testing personnel or the laboratory director for 2023 Events One, Two, or Three. 3. An interview with the testing person one on 02/20/2024 at 11:30 am confirmed the laboratory failed to follow its' policy for Proficiency testing when the laboratory director and testing personnel failed to sign PT attestation statements for 2023 Events One, Two, or Three. -- 2 of 2 --