Fall River Family Medicine

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, training and competency assessment records and an interview with the laboratory lead on 9/11/2024, the laboratory failed to follow written policies and procedures to assess testing personnel competency in 2023 and 2024. The findings include: 1. The CMS 209 form identified eight (8) testing personnel (TP) performing moderate complexity testing of which five (5) were new since the last inspection on 12 /1/2022. 2. A review of training and competency assessment records identified that the laboratory failed to have initial training for five (5) of five (5) new TP. 3. A review of training and competency assessment records identified that the laboratory failed to have an annual competency assessment for one (1) TP in 2023. 4. A review of training and competency assessment records identified that the laboratory failed to have an annual competency assessment for one (1) TP in 2024. 6. An interview with the laboratory lead on 9/11/2024 at 8:40 am confirmed the above findings. 7. The laboratory reports performing 25,000 moderate complexity tests annually. 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 proficiency testing (PT) documentation from Wisconsin State Laboratory of Hygiene (WSLH), and an interview with the laboratory lead on 9/11 /2024, the laboratory director or delegated designee failed to review PT results in 2023. The findings include: 1. A review of PT documents for 2023 from WSLH identified that the laboratory director failed to review results for Hematology event three. 2. An interview with the laboratory lead on 9/11/2024 at 9:20 am confirmed that the laboratory director failed review the above PT results. 3. The laboratory reports performing 25,000 tests annually. D5781

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 a record review of proficiency testing (PT) from American Academy of Family Physicians (AAFP) and an interview with the laboratory lead on 2/24/2021, the laboratory failed to review PT and evaluate results that were less than 100% but greater than or equal to 80% for 2019 and 2020. The Findings include: 1. A review of PT records from AAFP for 2019 event A identified that the laboratory failed to evaluate the results for red blood cell count with and overall score of 80%. 2. A review of PT records from AAFP for 2020 event A identified that the laboratory failed to evaluate the results for cell identification/white blood cell differential with and overall score of 80%. 3. An interview with the laboratory lead on 2/24/2021 at 9:20 confirmed that the laboratory failed to evaluate PT results that were less than 100% but greater than or equal to 80% for 2019 and 2020. 4. The laboratory reports performing 5000 CBC tests annually. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. 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 observation, record review of temperature logs and an interview with the laboratory lead on 2/24/21, the laboratory failed to document temperatures in their reagent and quality control (QC) storage refrigerator as required by the manufacturer for proper storage of reagents and QC. The findings include: 1. An observation of a refrigerator downstairs and review of temperature logs identified that the laboratory did not document temperatures for this refrigerator containing Cell-Dyn 18 plus controls, with a manufacturer storage requirement of 2C-10C, Piccolo reagents and A1C reagents. 2. An interview with the laboratory lead on 2/24/21 at 10:10 am confirmed that the laboratory failed to document the temperature of the reagent and QC storage refrigerator. 3. The laboratory reports performing 13,000 tests annually. D5781

Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(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 a record review and an interview with the laboratory lead, the laboratory failed to retain all proficiency testing documents from the American Academy of Family Physicians (AAFP) in the specialty of hematology since the last survey on July 22, 2017. Findings: 1. A review of proficiency testing (PT) results from the AAFP revealed the laboratory failed to retain the signed attestation statements, PT results and scores from AAFP, Cell-Dyn analyzer print-outs, and documents of review and