Curtis Thompson Md & Associates Pllc

Summary Statement of Deficiencies D0000 A recertification survey was performed on February 25, 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 deficiencies: 493.1459 Condition: Laboratories performing high complexity testing; general supervisor. Based on record review and interview with general supervisor #2, the laboratory failed to operate as a separate laboratory to comply with 493.43 for six (September 2025 to February 2026) of six months since laboratory B started testing. Findings include: 1. The surveyor observed the laboratory director's office on 2/25/26 at 1:00 pm. The office was in suite 307, where laboratory B is located. 2. A review of laboratory B's records revealed this laboratory started testing in suite 307 on 9/24/25. Laboratory A's address is in suite 309. 3. An interview on 2/25/26 at 1:55 pm with general supervisor #2 confirmed the laboratory director is reading digital pathology slides for laboratory A out of his office in suite 307. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: . Based on record review and interview with general supervisor #2, the technical supervisor failed to perform and evaluate testing personnel competency at least semiannually within the first year of testing for one (testing personnel #8) of three testing personnel performing specimen grossing listed on Form CMS-209. Findings include: 1. A review of testing personnel competency assessment records revealed a lack of semiannual competency assessments performed for testing personnel #8, who performs specimen grossing. Testing personnel #8 completed training in April 2024 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 -- and had competency assessments performed on 8/29/24 and 8/29/25. No semiannual competency assessment was present. 2. An interview on 2/25/26 at 3:30 pm with general supervisor #2 confirmed semiannual competency assessments were performed within the first year of testing for testing personnel #8. D6141 GENERAL SUPERVISOR CFR(s): 493.1459 The laboratory must have one or more general supervisors who are qualified under 493.1461 of this subpart to provide general supervision in accordance with 493.1463 of this subpart. This CONDITION is not met as evidenced by: . Based on record review and interview with general supervisor #2, the laboratory failed to ensure general supervisor #2, overseeing histopathology and oral pathology testing, was a state-licensed physician and had, or was a resident seeking the appropriate board certification. Refer to D6143. D6143 GENERAL SUPERVISOR QUALIFICATIONS CFR(s): 493.1461 (a) The general supervisor must possess a current license issued by the State in which the laboratory is located, if such licensing is required; and (b) The general supervisor must be qualified as a-- (b)(1) Laboratory director under 493.1443; or (b)(2) Technical supervisor under 493.1449. (c) If the requirements of paragraph (b)(1) or (2) of this section are not met, the individual functioning as the general supervisor must-- (c)(1)(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 or 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; and (c)(1)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing; or (c)(2)(i) Qualify as testing personnel under 493.1489(b)(3); and (c)(2)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing; or (c)(3) Meet the requirements at 493.1443(b)(3) or 493.1449(c)(4) or (5); or (c)(4) Notwithstanding any other provision of this section, an individual is considered qualified as a general supervisor under this section if they were qualified and serving as a general supervisor in a CLIA-certified laboratory as of December 28, 2024, and have done so continuously since December 28, 2024. (d) For blood gas analysis, the individual providing general supervision must-- (d)(1) Be qualified under 493.1461(b)(1) or (2), or 493.1461(c); or (d)(2)(i) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; and (d)(2)(ii) Have at least one year of laboratory training or experience, or both, in blood gas analysis; or (d)(3) (i) Have earned an associate degree related to pulmonary function from an accredited institution; and (d)(3)(ii) Have at least two years of training or experience, or both in blood gas analysis. (e) The general supervisor requirement is met in histopathology, oral pathology, dermatopathology, and ophthalmic pathology because all tests and examinations, must be performed: (e)(1) In histopathology, by an individual who is qualified as a technical supervisor under 493.1449(b) or (f)(1); (e)(2) In dermatopathology, by an individual who is qualified as a technical supervisor under 493.1449(b) or 493.1449(f)(2); (e)(3) In ophthalmic pathology, by an individual who is qualified as a technical supervisor under 493.1449(b) or 493.1449(f)(3); and (e)(4) -- 2 of 3 -- In oral pathology, by an individual who is qualified as a technical supervisor under 493.1449(b) or (g). This STANDARD is not met as evidenced by: . Based on record review and interview with general supervisor #2, the laboratory failed to ensure general supervisor #2, overseeing histopathology and oral pathology testing, was a state-licensed physician and had, or was a resident seeking the appropriate board certification for one (general supervisor #2) of two general supervisors listed on Form CMS-209. Findings include: 1. A review of general supervisor #2's, overseeing histopathology and oral pathology testing, qualification records revealed a lack of records showing they were a state-licensed physician and either certified in pathology or dermatopathology by the American Board of Pathology or the American Osteopathic Board of Pathology or a resident in a training program leading to certification. There was a lack of documentation showing they were certificed in oral pathology by the American Board of Oral Pathology or a resident in a training program leading to certification. 2. An interview on 2/25/26 at 12:56 pm with general supervisor #2 revealed they were performing competency assessments for testing personnel performing grossing in oral pathology and dermatopathology specialties and confirmed they did not meet the qualification requirements for general supervisor. -- 3 of 3 --

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: . Based on observation, record review, and interview with the General Supervisor, the laboratory failed to include the storage requirements, preparation, and expiration dates on 2 (12% Acetic Acid and 100% Ethanol [ETOH]) of 2 reagent bottles in use. Findings include: 1. The surveyor observed on 2/20/2024 during a tour of the laboratory at 9:20 am 2 of 2 reagent bottles lacking the storage requirements, preparation, and expiration date as follows: a. 12% Acetic Acid b. 100% "ETOH" (ethyl alcohol). 2. A review of the laboratory's "Reagent Labeling and Expiration Date Policy" states the following: "1. All reagents, working solutions and stains that are made in-house and placed into secondary containers (a container that is different than a manufacturer's container) are labeled with the chemical name. 2. In addition these containers must also show the date when the reagent was placed in the secondary container. Furthermore, the container must also be labeled with the chemical's National Fire Protection Association ratings for health, flammability, reactivity, and personal protective equipment requirements (the "HMIS" label). 3. All reagents are used by the manufacturer's stated expiration date. Any reagent that is not used by that date is disposed of in a manner that is consistent with the chemical handling procedures described in the Safety Manual. Reagents that are made in-house are used within one month." 3. An interview on 2/20/2024 at 9:30 am, the General Supervisor acknowledged the laboratory had not included the storage requirements, preparation, and expiration dates on the reagents listed above. 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 -- 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, procedure review, and interview with the General Supervisor, the laboratory failed to establish, perform, and document maintenance for the eyewash for 4 (November 2023 to February 2024) of 4 months from the start of the laboratory. Findings include: 1. On February 20, 2024, at 9:20 am during a tour of the laboratory, the surveyor observed a Water Saver eye wash hose attached to the side of the utility sink. 2. Procedure review of multi manuals revealed the laboratory did not have a policy and procedure established for the operation and maintenance of the Water Saver eye wash hose in place for 4 (November 2023 to February 2024) of 4 months since the start of the laboratory. 3. An interview on February 20, 2024, at 2:45 pm, the General Supervisor acknowledged the laboratory had not developed or implemented a policy and procedure for the use and care of the Water Saver eye wash hose. -- 2 of 2 --

Summary Statement of Deficiencies D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on record review and interview with the Laboratory Director (LD), the processing laboratory failed to document the intended quality of the hematoxylin and eosin (H & E) stain each day of testing for three ( #3, #5, and #6) of 11 patient chart audited. Findings include: 1. Record review for three (#3, #5, and #6) of 11 patient charts reviewed revealed there was no documentation from the processing laboratory to show the quality of the H & E stain was acceptable. 2. On November 10, 2020 at 11: 46 am when queried, the LD was unable to provide the surveyor with the documentation requested. 3. During the interview on November 10, 2020 at 11:46 am, the LD confirmed the quality of the H & E stain from the processing laboratory was not documented each day of testing. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --