Michigan Healthcare Professionals Pc

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 record review and interview with the laboratory manager (LM), the laboratory failed to ensure its established competency assessment policy was followed for 2 (TP1, TP2) of 3 testing personnel (TP) reviewed. Findings include: 1. Review of the CMS-209 form revealed TP1 and TP2 were identified as high complexity testing personnel. 2. A review of the laboratory's personnel competency assessment records revealed: a. A competency assessment for TP1 was performed on June 29, 2023, September 27, 2023, and September 3, 2025. A competency assessment for 2024 was not available for review. b. A competency assessment for TP2 was performed on June 27, 2023, and October 25, 2025. A competency assessment for 2024 was not available for review. 3. On July 29, 2026, a request was made to the Laboratory Manager for the 2024 competency assessments for TP1 and TP2; none were provided for review. 4. Review of the laboratory's policy titled "Competency Assessment of Laboratory Personnel" revealed: "Competency assessment is to be performed once a year. The competency assessment for Grossing Tech, Cytotechnologist and Laboratory Technicians is performed and documented by the lab director or pathology manager." 5. During an interview on July 29, 2026, at 4:45 PM, the LM confirmed the 2024 competency assessments for TP1 and TP2 were not available. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and 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 -- other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: . Based on observation and interview with the laboratory manager (LM), the laboratory failed to ensure expired reagents used in the cytology staining process were not available for use for patient testing. Findings include: 1. During a tour of the laboratory on July 29, 2026, at 11:00 AM, the surveyor observed expired reagents: a. 1 of 1 opened StatLab Methanol, ACS Grade container had an expiration date of July 31, 2025. b. 1 of 1 unopened ThinPrep Stain Nuclear Stain container, Lot 5323FB, had an expiration date of June 19, 2026. 2. During an interview on July 29, 2026, at 11:15 AM, the laboratory manager (LM) confirmed the expired StatLab Methanol and ThinPrep Stain Nuclear Stain were available for use in the laboratory. D6122 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(ii) (b)(8)(ii) Monitoring the recording and reporting of test results; This STANDARD is not met as evidenced by: . Based on record review and interview with the laboratory manager (LM), the technical supervisor failed to ensure the competency assessment form included monitoring the recording and reporting of test results and was not documented for 3 (TP1, TP2, TP3) of 3 testing personnel reviewed. Findings include: 1. Review of the CMS-209 revealed TP1, TP2, and TP3 were identified as high complexity testing personnel. 2. Review of personnel competency assessment records revealed the competency assessment form did not include monitoring the recording and reporting of test results and was not documented for TP1, TP2, and TP3: a. TP1: Competency assessments were performed on June 29, 2023, September 27, 2023, and September 3, 2025. b. TP2: Competency assessments were performed on June 27, 2023, and October 25, 2025. c. TP3: A competency assessment was performed on September 3, 2025. 3. During an interview on July 29, 2026, at 4:45 PM, the LM confirmed the competency assessment form did not include monitoring the recording and reporting of test results and was not documented for TP1, TP2, and TP3. D6123 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(iii) (b)(8)(iii) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records; This STANDARD is not met as evidenced by: . Based on record review and interview with the laboratory manager (LM), the technical supervisor failed to ensure the competency assessment form included review of intermediate test results or worksheets and preventive maintenance records and were not documented for 3 (TP1, TP2, TP3) of 3 testing personnel reviewed. Findings include: 1. Review of the CMS-209 revealed TP1, TP2, and TP3 were identified as high complexity testing personnel. 2. Review of personnel competency assessment records revealed the competency assessment form did not include review of intermediate test results or worksheets and preventive maintenance records and were -- 2 of 3 -- not documented for TP1, TP2, and TP3: a. TP1: Competency assessments were performed on June 29, 2023, September 27, 2023, and September 3, 2025. b. TP2: Competency assessments were performed on June 27, 2023, and October 25, 2025. c. TP3: A competency assessment was performed on September 3, 2025. 3. During an interview on July 29, 2026, at 4:45 PM, the LM confirmed the competency assessment form did not include review of intermediate test results or worksheets and preventive maintenance records and were not documented for TP1, TP2, and TP3. D6124 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(iv) (b)(8)(iv) Direct observation of performance of instrument maintenance and function checks; This STANDARD is not met as evidenced by: . Based on record review and interview with the laboratory manager (LM), the technical supervisor failed to ensure the competency assessment form included direct observation of maintenance and function checks and was not documented for 3 (TP1, TP2, TP3) of 3 testing personnel reviewed. Findings include: 1. Review of the CMS- 209 revealed TP1, TP2, and TP3 were identified as high complexity testing personnel. 2. Review of personnel competency assessment records revealed the competency assessment form did not include direct observation of maintenance and function checks and was not documented for TP1, TP2, and TP3: a. TP1: Competency assessments were performed on June 29, 2023, September 27, 2023, and September 3, 2025. b. TP2: Competency assessments were performed on June 27, 2023, and October 25, 2025. c. TP3: A competency assessment was performed on September 3, 2025. 3. During an interview on July 29, 2026, at 4:45 PM, the LM confirmed the competency assessment form did not include direct observation of maintenance and function checks and was not documented for TP1, TP2, and TP3. -- 3 of 3 --