Mi Health Clinic

Summary Statement of Deficiencies D8100 INSPECTION REQUIREMENTS CFR(s): 493.1771 (a) Each laboratory issued a CLIA certificate must meet the requirements in 493.1773 and the specific requirements for its certificate type, as specified in 493.1775 through 493.1780. (b) All CLIA-exempt laboratories must comply with the inspection requirements in 493.1773 and 493.1780, when applicable. This CONDITION is not met as evidenced by: . Based on observation, record review, and interview with the laboratory director, the laboratory failed to allow reinspection. Refer to D8105. D8105 BASIC INSPECTION REQUIREMENTS CFR(s): 493.1773(e)(f)(g) (e) Reinspection. CMS or a CMS agent may reinspect a laboratory at any time to evaluate the ability of the laboratory to provide accurate and reliable test results. (f) Complaint inspection. CMS or a CMS agent may conduct an inspection when there are complaints alleging noncompliance with any of the requirements of this part. (g) Failure to permit CMS or a CMS agent to conduct an inspection or reinspection results in the suspension or cancellation of the laboratory's participation in Medicare and Medicaid for payment, and suspension or limitation of, or action to revoke the laboratory's CLIA certificate, in accordance with subpart R of this part. This STANDARD is not met as evidenced by: . Based on observation, record review, and interview with the laboratory director, the laboratory failed to allow reinspection on 10/2/25. Findings include: 1. A review of the laboratory's Form CMS-116 indicated the hours of operation to be "08:00 to 18: 00" Monday, Tuesday, Wednesday, Thursday, and Friday. 2. The surveyor arrived at 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 -- the laboratory's address on 10/2/25 at 8:44 am. No cars were in the parking lot, all doors were locked, no laboratory signage was present, and there was a package delivery slip taped on the front door stating "Sorry we missed you" with the date of "9 /26." 3. The surveyor attempted to call the laboratory's phone number as listed on Form CMS-116 on 10/2/25 at 8:47 am and reached an unrelated business. 4. The surveyor called and left a message for the laboratory director on 10/2/25 at 8:50 am. 5. The laboratory director returned the phone call on 10/2/25 at 8:56 am and revealed the laboratory had ceased operations at this location and combined testing with laboratory B "around the end of August, beginning of September." The surveyor requested documentation sent to the laboratory's accreditation organization noting the additions of cytopathology and histopathology. 6. A review of laboratory B's College of American Pathologists "Laboratory Activity Menu" listed non-gynecologic cytopathology and surgical pathology on laboratory B's test menu. -- 2 of 2 --

Summary Statement of Deficiencies D5207 COMMUNICATIONS CFR(s): 493.1234 The laboratory must have a system in place to identify and document problems that occur as a result of a breakdown in communication between the laboratory and an authorized person who orders or receives test results. This STANDARD is not met as evidenced by: . Based on observation, record review, and interview with the laboratory director, the laboratory failed to identify and document issues when receiving urine specimens for testing that was no longer performed by the laboratory because of a breakdown in communication with ordering providers for three (Patient Specimens 1-3) urine specimens with urinalysis testing ordered present in the laboratory. Findings include: 1. A review of the laboratory's allegation of compliance for D5401 revealed a section stating the laboratory has "permanently discontinued all urinalysis testing effective March 27, 2025" and "The LIS has been updated to block test orders. All relevant personnel were informed, and future urinalysis requests are referred externally." 2. The surveyor observed three urine specimens in the refrigerator on 5/14/25 at 11:09 am with urinalysis testing ordered after 3/27/25: a. Patient Specimen 1, order date 4/11 /25 for "Urinalysis complete W Reflex Culture panel- Urine." b. Patient Specimen 2, order date 4/23/25 for "Urinalysis complete W Reflex Culture panel- Urine." c. Patient Specimen 3, order date 5/2/25 for "Urinalysis complete W Reflex Culture panel- Urine." 3. The surveyor requested documentation showing the laboratory referred testing to an external laboratory on 5/14/25 at 11:09 am and it was not provided. 4. An interview on 5/14/25 at 12:21 pm with the laboratory director revealed the laboratory did not notify the ordering providers for the patients listed above that urinalysis testing would not be performed on the specimens submitted. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) 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 -- (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 director, the laboratory failed to ensure its Thermo Scientific Cytoseal 60 coverslipping medium had not exceeded expiration dates for the two bottles observed. Findings include: 1. The surveyor observed the following expired Thermo Scientific Cytoseal 60 coverslipping medium with the expiration date of 11/2022 materials during a tour of the laboratory on 5/14 /25 at 11:08 am. 2. A review of the Siemens Clinitek Status analyzer data revealed a total of seven patients had testing performed using the Siemens Multistix 10 SG urinalysis strips on 3/16/25. 3. An interview on 5/14/25 at 11:08 am with the laboratory director confirmed its Thermo Scientific Cytoseal 60 coverslipping medium was expired. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A validation survey was performed on March 4, 2025 by the State of Michigan Licensing and Regulatory Affairs Department. The laboratory was found to be out of compliance with CLIA regulations (42 CFR Part 93, effective April 24, 2003) for the following condition-level deficiencies: 493.1250 Condition: Analytic systems. 493. 1409 Condition: Laboratories performing moderate complexity technical consultant. 493.1487 Condition: Laboratories performing high complexity testing; testing personnel. D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: . Based on direct observation and interviews, the laboratory failed to operate as a separate laboratory to comply with 493.55 for two (March 2023 to March 2025) of two years reviewed. Findings include: 1. The surveyor observed the laboratory testing area at Laboratory A included equipment and supplies to capture digital images of histopathology and cytopathology patient slides on 3/4/25 at 9:16 am. 2. An interview on 3/4/25 at 9:30 am with technical consultant #2 revealed Laboratory A performed histopathology grossing and slide preparation and cytopathology slide preparation. Some slides or digital images are read at Laboratory A, while most are digitally imaged, and those images are sent to Laboratory B (23D2243041) along with some physical slides to be read. Laboratory B does not have histopathology or cytopathology subspecialties on their certificate. 3. An interview on 3/4/25 at 3:13 pm with the laboratory director confirmed the slide and digital image reading is performed at both locations but indicated on the test report to have been reported under Laboratory 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 5 -- D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: . Based on record review and interviews, the laboratory failed to follow its urinalysis test procedure (refer to D5401) and failed to perform and document immunohistochemical (IHC) stain positive and negative reactivity each time of use (refer to D5475). D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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: . Based on record review and interview with technical consultant #2, the laboratory failed to follow its urinalysis test procedure for four (Patients 1, 2, 3, and 5) of five patient urinalysis test reports reviewed. Findings include: 1. A review of the laboratory's "Routine Urinalysis" test procedure revealed a section stating, "Specimens may be kept for up to 24 hours if refrigerated at 4 degrees C." 2. A review of the patient urinalysis test reports showed patients had testing performed and reports beyond the specimen stability requirements: a. Patient #1 collected 12/19/24 at 5:11 pm and testing was performed on 12/23/24 at 12:15 pm. b. Patient #2 collected 9/26 /24 at 8:43 am and testing was performed on 9/27/24 at 9:20 am. c. Patient #3 collected 1/24/24 at 2:32 pm and testing was performed on 1/25/24 at 3:30 pm. d. Patient #5 collected 5/21/24 at 4:37 pm and testing was performed on 5/23/24 at 4:02 pm. 3. An interview on 3/4/25 at 2:35 pm with technical consultant #2 confirmed the patient testing listed above was performed beyond specimen stability. D5475 CONTROL PROCEDURES CFR(s): 493.1256(e)(3)(g) (e)(3) Check fluorescent and immunohistochemical stains for positive and negative reactivity each time of use. This STANDARD is not met as evidenced by: . Based on record review and interview with the laboratory director, the laboratory failed to perform and document immunohistochemical (IHC) stain positive and negative reactivity each time of use for three (Patients 9, 10, and 11) of three patients with IHC stains reviewed. Findings include: 1. A review of patients with IHC staining -- 2 of 5 -- results on their test reports revealed a lack of documented positive and negative reactivity of stains with each use for the following: a. Patient #9 with the test report date of 6/5/24 for a shave biopsy of the torso back using the MART-1 IHC stain. b. Patient #10 with the test report date of 11/11/24 for a left superior laterial malar cheek shave biopsy with KI67 IHC stain. c. Patient #11 with the test report date of 3/10/24 for a bladder biopsy with p53 and Ki67 IHC stains. 2. An interview on 3/4/25 at 3:13 pm with the laboratory director confirmed the positive and negativity of IHC stains had not been documented each time of use. D6033 TECHNICAL CONSULTANT-MODERATE COMPLEXITY 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 a lack of documentation, the laboratory failed to have a qualified technical consultant to oversee its moderate complexity urinalysis testing. 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 (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 1 year of laboratory training or experience, or both, in nonwaived 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)(A) Hold an earned doctoral or master's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (b)(3)(i)(B) Meet either requirements in 493.1405(b)(3)(i)(B) or (b)(4)(i)(B) or (C); AND (b)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(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)(4)(i)(B) Meet 493.1405(b)(5)(i)(B); and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(5)(i) Have earned an associate degree in medical laboratory technology, medical laboratory science, or clinical laboratory science; and (b)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for -- 3 of 5 -- which the technical consultant is responsible. (b)(6) For blood gas analysis, the individual must- (b)(6)(i) Be qualified under paragraph (b)(1), (2), (3) or (4) of this section; or (b)(6)(ii)(A) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; and (b)(6)(ii)(B) Have at least 2 years of laboratory training or experience, or both, in blood gas analysis; or (b) (7) Notwithstanding any other provision of this section, an individual is considered qualified as a technical consultant under this section if they were qualified and serving as a technical consultant for moderate complexity testing in a CLIA-certified laboratory as of December 28, 2024, and have done so continuously since December 28, 2024. This STANDARD is not met as evidenced by: . Based on record review, the laboratory failed to have a qualified technical consultant to oversee its moderate complexity urinalysis testing for one (technical consultant #2) of two technical consultants listed on Form CMS-209. Findings include: 1. A review of the technical consultant #2's qualification records revealed a Bachelor of Science in Medical Laboratory Science and no evidence of least two years of training or experience or both in nonwaived urinalysis testing. 2. The surveyor requested the additional training or experience documentation for technical consultant #2 on 3/4/25 at 11:19 am and it was not made available. 3. The laboratory was granted an additional seven days to provide missing documentation, and it was not received. D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: . Based on record review, the laboratory failed to ensure testing personnel performing histopathology grossing were qualified. Refer to D6171. D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) 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; or (b)(2)(i) Have earned a doctoral, master's, or bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (b)(2)(ii) Be qualified under the requirements of 493.1443(b)(3) or 493.1449(c)(4) or (5); or (b)(3)(i) Have earned an associate degree in a laboratory science or medical laboratory technology from an accredited institution or (b)(3)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes (b)(3)(ii) (A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, includes either (b)(3)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(3)(ii)(A)(2) 24 semester hours of science courses that include (b)(3)(ii)(A)(2)(i) 6 semester hours of chemistry; (b)(3)(ii)(A)(2)(ii) 6 semester hours of biology; and (b)(3)(ii)(A)(2)(iii) 12 semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(3)(ii)(B) Have -- 4 of 5 -- laboratory training that includes: (b)(3)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES or the CAAHEP (this training may be included in the 60 semester hours listed in paragraph (b)(3)(ii)(A) of this section); or (b)(3)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing; or (b)(4) Successful completion of an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and having held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(5) Notwithstanding any other provision of this section, an individual is considered qualified as a high complexity testing personnel under this section if they were qualified and serving as a high complexity testing personnel in a CLIA-certified laboratory as of December 28, 2024, and have done so continuously since December 28, 2024. (b)(6) For blood gas analysis (b)(6)(i) Be qualified under paragraph (b)(1), (2), (3), (4), or (5) of this section; or (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b) (6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution. (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (f) to perform tissue examinations. This STANDARD is not met as evidenced by: . Based on record review, the laboratory failed to ensure testing personnel performing histopathology grossing were qualified for one (testing personnel #3) of four testing personnel listed on Form CMS-209. Findings include: 1. A review of the testing personnel #3's records revealed a total of 24 total hours of science courses with 12 credits of biology, 11 credits of chemistry, and one credit of medical technology. There was a lack of either clinical laboratory training program completion or at least three months documented training in histopathology prior to performing patient testing. 2. The surveyor requested the additional clinical laboratory training program completion or at least three months documented training in histopathology prior to performing patient testing on 3/4/25 at 12:45 pm and it was not made available. 3. The laboratory was granted an additional seven days to provide missing documentation, and it was not received. -- 5 of 5 --

Summary Statement of Deficiencies D0000 The purpose of this unannounced survey was for complaint #MI00111704. The Department of Licensing and Regulatory Affairs has evaluated this facility and determined that it is not in compliance with CLIA regulations (42 CFR Part 93, effective April 24, 2003). D5014 GENERAL IMMUNOLOGY CFR(s): 493.1208 If the laboratory provides services in the subspecialty of General immunology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: . Based on the number and severity of the deficiencies cited herein, the Condition: General Immunology was not met. Findings include: 1. The laboratory failed to establish performance specifications for the Ray Biotech SARS-CoV-2 IgM and the Healgen SARS-CoV-2 IgM/IgG combination assays to use capillary blood as the specimen source. Refer to D5423. 2. The laboratory failed to perform quality control procedures each day patient testing was performed using the Ray Biotech SARS-CoV- 2 IgM and Healgen SARS-CoV-2 IgM/IgG combination assays. Refer to D5445. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (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. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)