Mymichigan Health Medical Center Dermatologic

Summary Statement of Deficiencies D0000 A recertification survey was performed on February 12, 2026 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 493, Laboratory Requirements) for the following condition-level deficiency: 493.1487 Condition: Laboratories performing high complexity testing; testing personnel. D3013 FACILITIES CFR(s): 493.1101(e) Records and, as applicable, slides, blocks, and tissues must be maintained and stored under conditions that ensure proper preservation. This STANDARD is not met as evidenced by: . Based on observation and interview with the senior manager, the laboratory failed to maintain histopathology tissue slides to ensure proper preservation for four (patients 7, 8, 9, and 10) of ten cases reviewed. Findings include: 1. A review of ten histopathology cases performed between 2/13/24 and 12/16/25 showed four cases with significant bubbling between the tissue and the coverslip on slides from the following patients: a. Patient #7 had testing performed on 05/06/2025. b. Patient #8 had testing performed on 07/15/2025. c. Patient #9 had testing performed on 10/14 /2025. This patient had one slide with most of one section of tissue uncovered by the coverslip. d. Patient #10 had testing performed on 12/16/2025. 2. An interview on 2/12 /26 at 11:38 am with the senior manager confirmed the presence of bubbles on patient histopathology slides listed above. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. 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 -- (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. This STANDARD is not met as evidenced by: . Based on record review, observation, and interviews, the laboratory failed to follow its specimen slides labeling policy for four (patients 7, 8, 9, and 10) of ten cases reviewed. Findings include: 1. A review of the the laboratory's "Labeling of Frozen Section Slides" policy revealed a section stating, "Slides are labeled either immediately before or after frozen sections are cut. Information to be written with a slide marking pen (or printed with label maker) on the frosted end of the slide must be obtained from the photo that was delivered with the tissues or the digital photo in the electronic medical record. It is acceptable to first use a marking pen to label slides, then apply the label at the end of the day. At minimum, the following must be included: a. Line 1- Surgery Accession (Case) # b. Line 2- Patient name c. Line 3- Stage # (Roman Numeral)/ Piece # (Number)/ section number (letter) i. A second or third slide on the same piece of tissue is noted with lower case letters (a, b, c etc.) next to the tissue piece # ii. Any other information needed (such as "tumor" or "check" or biopsy" or "CDM" (cut down middle)) can be noted in the free space in the middle of the frosted area." 2. An interview on 2/10/26 at 9:14 am with testing personnel #2 revealed the laboratory puts the printed stickers on the specimen slides at the end of each testing day when testing has concluded. 3. A review of 10 cases revealed slides with the stickers over the frosted section of the slide with marker underneath. The manual labeling lacked the patient's name and was not labeled in accordance with the policy above during the testing process for the following patients: a. Patient #7 had testing performed on 05/06/2025. b. Patient #8 had testing performed on 07/15/2025. c. Patient #9 had testing performed on 10/14/2025. d. Patient #10 had testing performed on 12/16/2025. 4. An interview on 2/12/26 at 10:21 am with the senior manager confirmed the above findings. 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 and interview with the laboratory director, the laboratory failed to ensure testing personnel performing high complexity histopathology testing met education requirements. 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) -- 2 of 4 -- 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 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 and interview with the laboratory director, the laboratory failed to ensure testing personnel performing high complexity histopathology testing met education requirements for three (testing personnel #2, #5, and #6) of six testing personnel listed on Form CMS-209. Findings include: 1. An interview on 2/10/26 at 9: 13 am with testing personnel #2 and #3 revealed they both perform specimen inking, which is considered high complexity testing.. 2. A review of the laboratory's personnel records revealed the following testing personnel listed on Form CMS-209 as performing high complexity testing did not meet the minimum educational requirements: a. Testing personnel #2 started employment in April 2024. Training documentation indicated they were "satisfactory" and "is able to read and understand the map orientation and dye the tissue to properly correlate with the map." An associate of applied science degree and transcript was provided and lacked the minimum number of chemistry credits and combined biology, chemistry, and clinical laboratory science credits. b. Testing personnel #5 started employment in January 2025 and stopped in April 2025. Training documentation stated "observed/shows confidence/competence" for "Tissue inking and orientation" on 1/29/25. An email from a high school noting the graduation date was present. A transcript was provided in a word document with formatting issues including cut off pages, blank pages, and overlapping text. c. Testing personnel #6 had training documentation indicating they were "confident/competent" for "Tissue inking and orientation" on 4/28/25. A transcript was provided and lacked the minimum number of chemistry credits and combined biology, chemistry, and clinical laboratory science credits. 3. The surveyor -- 3 of 4 -- requested additional education documentation for the testing personnel listed above on 2/12/26 at 12:26 pm. 4. An interview on 2/10/26 at 1:24 pm with the laboratory director confirmed testing personnel #2, #5, and #6 had been performing specimen inking. -- 4 of 4 --

Summary Statement of Deficiencies D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: . Based on observation, record review, and interview with the Senior Manager, Practice Manager, Director of Quality and Patient Safety, and the Supervisor of Ambulatory Quality, the laboratory failed to perform and document annual maintenance of the Microscope for 18 (December 2022 to June 2024) of 18 months reviewed. Findings include: 1. The surveyor observed two microscopes during a tour of the laboratory on 6/10/24 at 9:27 am. 2. A review of the laboratory's "Microscope Care" procedure revealed a section stating, "At least annual servicing will be performed and documented per regular service contracts." 3. A review of the laboratory's microscope service records revealed the most recent maintenance performed was in December 2022. 4. An interview on 6/10/24 at 12:07 pm the Senior Manager, Practice Manager, Director of Quality and Patient Safety, and the Supervisor of Ambulatory Quality confirmed the microscopes had not been serviced since December 2022. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) The laboratory director is responsible for the overall operation and administration 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 2 -- the laboratory, including the employment of personnel who are competent to perform test procedures, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: . Based on record review and interview with the Practice Manager, the Laboratory Director failed to ensure compliance with 493.51 Notification requirements for laboratories issued a certificate of compliance for five (January 2024 to June 2024) of five months since the laboratory changed locations. Findings include: 1. The surveyor arrived at the laboratory's address, 2660 W Sugnet Road, at 9:00 am and the laboratory was locked. The surveyor asked a representative about the laboratory and was directed to the new location, at 4201 Campus Ridge Drive. 2. The surveyor requested documentation of the submission the laboratory made to the State Agency on 6/10/24 at 9:20 am to meet the following notification requirements listed at 493.51: a. "Laboratories issued a certificate of compliance must meet the following conditions: (a) Notify HHS or its designee within 30 days of any change in-- (1) Ownership; (2) Name; (3) Location; (4) Director; or (5) Technical supervisor (laboratories performing high complexity only). (b) Notify HHS no later than 6 months after performing any test or examination within a specialty or subspecialty area that is not included on the laboratory ' s certificate of compliance, so that compliance with requirements can be determined. (c) Notify HHS no later than 6 months after any deletions or changes in test methodologies for any test or examination included in a specialty or subspecialty, or both, for which the laboratory has been issued a certificate of compliance." 3. An interview on 6/10/24 at 12:07 pm with the Practice Manager confirmed the laboratory moved locations in January 2024 and had not notified the State Agency with the change in location within 30 days. -- 2 of 2 --