Belleville Health Care Pc

Summary Statement of Deficiencies D0000 . An unannounced complaint investigation for complaint MI00154706 was performed on November 3, 2025. The Department of Licensing and Regulatory Affairs has evaluated this facility and it was found to be out of compliance with CLIA regulations (42 CFR Part 493, Laboratory Requirements) for the following condition-level deficiencies: 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on record review and interview with the laboratory director, the laboratory failed to have a qualified laboratory director. Refer to D6003. D6003 LABORATORY DIRECTOR QUALIFICATIONS CFR(s): 493.1405 AND 493.1406 The laboratory director must be qualified to manage and direct the laboratory personnel and the performance of moderate complexity tests and must be eligible to be an operator of a laboratory within the requirements of subpart R of this part. (a) The laboratory director must possess a current license as a laboratory director issued by the State in which the laboratory is located, if such licensing is required; and (b) The laboratory director must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of 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 -- Pathology; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (b)(2)(ii) Have had laboratory training or experience consisting of: (b)(2)(ii)(A) At least one year directing or supervising non- waived laboratory testing; and (b)(2)(ii)(B) Have at least 20 CE credit hours in laboratory practice that cover the laboratory director responsibilities defined in 493. 1407; or (b)(3)(i)(A) Hold an earned doctoral degree in a chemical, biological, clinical or medical laboratory science or medical technology from an accredited institution; or (b)(3)(i)(B) Hold an earned doctoral degree; and (b)(3)(i)(B)(1) Have at least 16 semester hours of doctoral level coursework in biology, chemistry, medical technology (MT), clinical laboratory science (CLS), or medical laboratory science (MLS); or (b)(3)(i)(B)(2) An approved thesis or research project in biology/chemistry /MT/CLS/MLS related to laboratory testing for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings; and (b)(3)(ii) Have at least 20 CE credit hours in laboratory practice that cover the laboratory director responsibilities defined in 493.1407; and (b)(3)(ii)(A) Be certified and continue to be certified by a board approved by HHS; and (b)(3)(ii)(B) Have had at least 1 year of experience directing or supervising nonwaived laboratory testing; or (b)(4)(i)(A) Have earned a master's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (b)(4)(i)(B)(1) Meet bachelor's degree equivalency; and (b)(4)(i)(B)(2) Have at least 16 semester hours of additional graduate level coursework in biology, chemistry, medical technology, clinical or medical laboratory science; or (b)(4)(i)(C)(1) Meet bachelor's degree equivalency; and (b)(4)(i)(C)(2) Have at least 16 semester hours in a combination of graduate level coursework in biology, chemistry, medical technology, clinical or medical laboratory science coursework and an approved thesis or research project related to laboratory testing for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings; and (b)(4) (ii) Have at least 1 year of laboratory training or experience, or both, in nonwaived testing; and (b)(4)(iii) Have at least 1 year of supervisory laboratory experience in nonwaived testing; and (b)(4)(iv) Have at least 20 CE credit hours in laboratory practice that cover the director responsibilities defined in 493.1407; or (b)(5)(i)(A) Have earned a bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (b)(5)(i) (B) At least 120 semester hours, or equivalent, from an accredited institution that, at a minimum, includes either- (b)(5)(i)(B)(1) 48 semester hours of medical laboratory science or medical laboratory technology courses; or (b)(5)(i)(B)(2) 48 semester hours of science courses that include- (b)(5)(i)(B)(2)(i) 12 semester hours of chemistry, which must include general chemistry and biochemistry or organic chemistry; and (b) (5)(i)(B)(2)(ii) 12 semester hours of biology, which must include general biology and molecular biology, cell biology or genetics; and (b)(5)(i)(B)(2)(iii) 24 semester hours of chemistry, biology, or medical laboratory science or medical laboratory technology in any combination; and (b)(5)(ii) Have at least 2 years of laboratory training or experience, or both, in nonwaived testing; and (b)(5)(iii) Have at least 2 years of supervisory laboratory experience in nonwaived testing; and (b)(5)(iv) Have at least 20 CE credit hours in laboratory practice that cover the director responsibilities defined in 493.1407. (b)(6) Notwithstanding any other provision of this section, an individual is considered qualified as a laboratory director of moderate complexity testing under this section if they were qualified and serving as a laboratory director of moderate complexity testing in a CLIA-certified laboratory as of December 28, 2024, and have done so continuously since December 28, 2024. -- 2 of 3 -- This STANDARD is not met as evidenced by: . Based on record review and interview with the laboratory director, the laboratory failed to have a qualified laboratory director for two (9/1/25 to 11/3/25) of two months since the current laboratory director started providing services. Findings include: 1. A phone interview on 11/3/25 at 11:17 am with the laboratory director and they started serving in this role on 9/1/25. During the phone interview, the surveyor requested documentation showing the laboratory director had met the moderate complexity laboratory director qualification requirements. 2. A review of the documentation received from the laboratory director showed a "Bachelor of Science in Biomedical Diagnostic and Therapeutic Sciences with Specialization in Medical Laboratory Science" without documentation to support at least two years of laboratory training or experience or both in nonwaived testing or at least two years of supervisory laboratory experience in nonwaived testing. 3. The laboratory was given an additional seven days to provide the missing qualification records and it was not provided. -- 3 of 3 --

Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: . A. Based on record review and interviews, the laboratory failed to establish a policy for the conditions of specimen transportation for its urine toxicology specimens received from outside locations for 2 (May 2021 to May 2023) of 2 years reviewed. Findings include: 1. An interview on 5/24/23 at 9:07 am with Testing Personnel #1 and #2 revealed specimens tested in the laboratory are collected in the neighboring clinic and a clinic in Rochester, MI. 2. A review of the laboratory's policies and procedures revealed a lack of specimen transportation policy. 3. An interview on 5/24 /23 at 9:43 am with the Technical Consultant confirmed a specimen transportation policy had not been established. B. Based on record review and interviews, the laboratory failed to follow the manufacturer's instructions for specimen acceptability and rejection for its qualitative urine amphetamine testing for 4 (Patients PR25882, BW206548, DE826015, and CM224097) of 10 patient test records reviewed. Findings include: 1. A review of the laboratory's "Thermo Scientific DRI Amphetamines Assay" manufacturer's instructions revealed a section titled, "Specimen Collection and Handling" stating, "The Clinical and Laboratory Standards Institute Toxicology and Drug Testing in the Clinical laboratory; Approved Guideline recommends that prior to analysis, urine specimens may be stored at 2 to 8 degrees C for five working days." 2. An interview on 5/24/23 at 11:23 am with Testing Personnel #2 revealed the laboratory only stores urine specimens refrigerated, between 2 to 8 degrees C. 3. A 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 -- review of 10 patient test records revealed the following 4 patients had qualitative urine amphetamine testing performed more than 5 days after the specimens were collected: a. Patient PR25882 had their specimen collected on 7/21/22 and testing performed on 8/3/22, 13 days after collection. b. Patient BW206548 had their specimen collected on 1/10/23 and testing performed on 2/8/23, 29 days after collection. c. Patient DE826015 had their specimen collected on 4/14/23 and testing performed on 4/25/23, 11 days after collection. d. Patient CM224097 had their specimen collected on 4/24/23 and testing performed on 5/10/23, 16 days after collection. 4. An interview on 5/24/23 at 12:20 pm with the Technical Consultant confirmed the laboratory had reported results on specimens that had exceeded specimen stability. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: . Based on record review and interview with the Technical Consultant, the laboratory failed to ensure Technical Consultant had met the qualification requirements at 493.1411. Refer to D6035. D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (b)(2)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i) Hold an earned doctoral or master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (b)(3)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. Note: The technical consultant requirements for "laboratory training or experience, or both" in each specialty or subspecialty may be -- 2 of 3 -- acquired concurrently in more than one of the specialties or subspecialties of service, excluding waived tests. For example, an individual who has a bachelor's degree in biology and additionally has documentation of 2 years of work experience performing tests of moderate complexity in all specialties and subspecialties of service, would be qualified as a technical consultant in a laboratory performing moderate complexity testing in all specialties and subspecialties of service. This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Consultant, the laboratory failed to ensure the Technical Consultant had met the qualification requirements at 493.1411 for 1 of 1 Technical Consultant listed on Form CMS-209. Findings include: 2. A review of the laboratory's personnel files revealed a lack of documentation showing the Technical Consultant's Bachelor of Science degree had been in a chemical, physical or biological science of medical technology. 3. The surveyor requested additional documentation showing the Technical Consultant's major of study on 5/24/23 at 9:49 am and it was not made available. 4. The laboratory was given an additional 7 days to provide documentation showing the Technical Consultant met the qualification requirements and it was not made available. D6047 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b(8)(i) The procedures for evaluation of the competency of the staff must include, but are not limited to direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Consultant, the Technical Consultant failed to perform direct observations as part of testing personnel competency assessments for 2 (Testing Personnel #1 and #2) of 2 testing personnel listed on Form CMS-209. Findings include: 1. An interview on 5/24/23 at 9:58 am with the Technical Consultant revealed competency assessments are performed remotely. 2. A review of the laboratory's competency assessment documentation revealed testing personnel had been assessed remotely on the following dates: a. Testing Personnel #1 on 10/26/22. b. Testing Personnel #2 on 1/20/22 and 7/18/22. 3. A review of the laboratory's "Proficiency Testing and Employee Competency" policy revealed a section titled "Employee Competency" stating, "Employee competency assessment will measure the following points to determine and measure the employee competency to perform the testing performed by the laboratory. 1. The direct observation of each test performed by the employee." 4. An interview on 5/24/23 at 12:20 pm with the Technical Consultant confirmed the competency assessment observations had not been direct. -- 3 of 3 --

Summary Statement of Deficiencies D3027 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(1) Test requisitions and authorizations. Retain records of test requisitions and test authorizations, including the patient's chart or medical record if used as the test requisition or authorization, for at least 2 years. This STANDARD is not met as evidenced by: . Based on record review and interview with the Laboratory Director (LD) and Testing Personnel (TP) #1, the laboratory failed to retain test requisitions for at least 2 years for 14 (patient #1 - #14) of 14 patient results reviewed. Findings include: 1. Record review for 14 of 14 patient test results reviewed revealed a lack of documentation of the requesting test requisitions. 2. We queried, testing personnel #1 stated that the requisitions are shredded once the testing is completed and results turned out. 3. A phone interview on 10/19/2021 at approximately 11:47 am, the LD confirmed the laboratory did not retain test requisitions for 2 years. 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. This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- . Based on record review, lack of documentation, and interview with the Laboratory Director (LD), the laboratory failed to monitor and document the refrigerator temperature each day of operation for 6 (May to October in 2021) of 13 months of operation. Findings include: 1. A record review of the laboratory's temperature monitoring logs revealed for 6 of 13 months of operation the refrigerator that stores the urine specimens for the toxicology testing, lack of documentation of the temperatures from May 18 to October 19, 2021. 2. A phone interview on 10/19/2021 at approximately 11:47 am, the LD confirmed the laboratory did not document the refrigerator temperature each day of operation. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and 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 Directory (LD), the laboratory stored expired calibration material in the laboratory refrigerator for 9 (February to October) of 9 months observed. Findings include: 1. An observation by the surveyor on 10/19/2021 at 9:45 am during a tour of the laboratory revealed the following expired calibration material stored in the refrigerator: a. DRI Tetrahydrocannabinol (THC) Urine Calibrator 50 ng/ml material - lot 73758925 expired 2/28/2021 and lot 73995868 expired 9/30/2021 b. DRI Multi-Drug Urine Calibrator 2 - lot 73955420 expired 5/31/2021 and lot 74013950 expired 7/31/2021 c. DRI Drugs of Abuse Low Calibrator - lot 73861352 expired 7/31/2021 2. A phone interview on 10/19/2021 with the LD at approximately 11:47 am confirmed calibration materials had exceeded the expiration date. ***Repeat Deficiency from 11 /25/2019 survey *** D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: . A. Based on record review, lack of documentation, and interview with the Laboratory Director (LD), the laboratory failed to perform and document the monthly eyewash maintenance for 2 months ( September and October) of 12 months reviewed. Findings include: 1. A record review of the "Eye wash Monthly Log" revealed a lack of documentation for the following 2 months (September and October) of 12 months reviewed: a. September 2021 - lack of documentation b. October 2021 - lack of documentation 2. A phone interview on 10/19/2021 at approximately 11:47 am, the LD confirmed the eyewash monthly maintenance was not performed and documented. B. Based on record review, lack of documentation, and interview with the Laboratory Director (LD), the laboratory failed to perform and document the monthly Indiko Plus maintenance for 4 ( June, July, September, and October 2021) of 12 months reviewed. Findings include: 1. Record review revealed for 4 (June, July, September, and October -- 2 of 4 -- 2021) of 12 months reviewed, the lack of documentation of the monthly maintenance for decontaminating all the reservoirs and tubing on the Indiko Plus toxicology analyzer. 2. A phone interview on 10/19/2021 at approximately 11:47 am, the LD confirmed the monthly maintenance was not performed and documented. D5785

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Consultant (TC), the laboratory failed to verify the accuracy at least twice annually for 1 (2018) of two years reviewed. Findings include: 1. A record review of the laboratory's "Split Specimen Analysis Reports" revealed the following analytes did not have verification of accuracy performed in 2018: a. Buprenorphine b. Cannabinoid c. Creatinine d. pH 2. A record review of the laboratory's established "Proficiency Testing (PT) and Split- Specimen Testing" procedure revealed a section stating, "Split-Specimen testing is required on five specimens twice each year for all unregulated analytes not enrolled in PT." 3. An interview on 11/25/19 at 9:47 am with the TC confirmed the laboratory did not perform verification of accuracy for the analytes listed above. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and 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 record review and interviews, the laboratory failed to ensure expired calibration materials were not used for the current lot in use. Findings include: 1. An observation by the surveyor on 11/25/19 at 9:18 am revealed cannabinoid calibration 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 -- materials with the lot number 73207055 and expiration date of August 2019 in use. 2. An interview on 11/25/19 at 9:18 am with Testing Personnel #1 revealed the last cannabinoid calibration took place on 11/20/19. 3. An interview on 11/25/19 at 9:18 am with the Technical Consultant confirmed calibration materials had exceeded the expiration date. -- 2 of 2 --