Pinnacle Dermatology Grand Blanc

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 Mohs Tech (MT), the laboratory failed to verify the accuracy of its testing at least twice annually for two (July 2024 to December 2024, January 2025 to June 2025) of four periods reviewed. Findings include: 1. A review of the laboratory's records revealed a lack of twice annual verification of accuracy for microscopic histopathology testing had not been performed for two periods: a. July 2024 - December 2024 b. January 2025 - June 2025 2. An interview on 7/7/25 at 2:00 pm with the MT confirmed the laboratory had not performed verification of accuracy testing for 1 year. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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 Mohs Tech (MT), the laboratory failed to ensure reagents were not used beyond the expiration date for 1 of 1 bottle of reagent (Vintage Bluing). Findings include: 1. During a tour of the laboratory on 07/07/2025 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 -- at 1:30 pm, the surveyor observed 1 bottle of Vintage Bluing reagent with an expiration date of 04/30/2025. 2. An interview conducted on 07/07/2025 at 3:45 p.m., the MT confirmed expired reagent was available for use. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; This STANDARD is not met as evidenced by: Based on record review and interview with Mohs Tech (MT), the laboratory failed to follow established quality assessment policies and procedures for six (2nd quarter 2024, 3rd quarter 2024, 4th quarter 2024) of eight quarters reviewed. Findings include: 1. A record review of the laboratory's quality assessment documentation revealed a lack of quality assessments documentation for four quarters in 2024 and two quarters in 2025 2. A review of the laboratory's "Policy on Quality Assurance - Quarterly Checklist" states in section titled "QUALITY ASSURANCE PLAN," first sentence," Quarterly, the technician will select on Mohs surgical case for a process quality assurance check...," ..."the approved quality assurance checklist will be filled out for this case.... These forms will be kept.... for two years." 3. An interview conducted on 07/07/2025 at 2:00 pm with the MT confirmed that the laboratory quality assessment checklists were not present. -- 2 of 2 --

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 Mohs Technician, the laboratory failed to verify the accuracy of its Mohs surgery histopathology testing at least twice annually for 1 (2022) of 2 years reviewed. Findings include: 1. A review of the laboratory's twice annual verification of accuracy documentation revealed one event was performed reviewing the accuracy of its Mohs surgery histopathology testing from June 2022 to December 2022. 2. A review of the laboratory's "Quality Assurance- Proficiency Testing" policy revealed a section stating, "Each Mohs surgeon will have 6 slides from each year (3 from Jan-June and 3 from July-Dec) in which Mohs surgery is performed pulled at random. These slides will be checked for accuracy." 3. An interview on 6/5/23 at 3:20 pm with the Mohs Technician revealed the laboratory did not have documentation of the January to June 2022 verification of accuracy testing for its Mohs surgery histopathology testing. 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. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other 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 -- 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)

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 Mohs Supervisor, the laboratory failed to perform and document microscope maintenance annually as specified in the laboratory's policy for 11 (November 2021 to October 2022) of 11 months since microscope maintenance was due to be performed. Findings include: 1. The surveyor observed the microscope in the mohs laboratory on 10/3/22 at 1:33 pm. The microscope had a sticker noting the service date was 11/30/20 and the next service was due 11/21. 2. A review of the laboratory's "Policy on Quality Assurance and Procedure- Mohs Surgery" revealed a section stating, "Microscope, cleaning of ocular eye pieces and stage. Preventative maintenance annually." 3. An interview with the Mohs Supervisor on 10/3/22 at 1:56 pm confirmed the laboratory had not performed and documented annual preventative maintenance for the microscope according to its policy. 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 --

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 Contracted Consultant, the laboratory failed to ensure predictable staining characteristics of hematoxylin and eosin staining for 1 (3/30/20) of 10 testing dates reviewed. Findings include: 1. A review of the laboratory's Mohs surgery logs revealed 7 patients had histopathology testing performed on 3/30/20. 2. A review of the laboratory's "Histopathology- Mohs Surgery" revealed a section stating, "QC is done on the days of pt. testing". 3. A review of the laboratory's "Quality Control and Temperature Log" revealed a lack of documentation of testing personnel evaluating the staining characteristics on 3/30/20 for hematoxylin and eosin staining. 4. A review of the laboratory's "Quality Control and Temperature Log" on the remaining 9 testing dates (10/5/21, 7/28/21, 5/26/21, 5 /12/21, 3/31/21, 2/1/21, 11/18/20, 7/8/20, and 1/29/20) revealed the initials of the personnel reviewing staining characteristics did not belong to testing personnel. 5. An interview on 11/18/21 at 1:39 pm with the Contracted Consultant revealed mohs technicians, performing slide preparation only, document staining characteristics, not testing personnel. 6. An interview on 11/18/21 at 1:52 pm with the Contracted Consultant confirmed staining characteristics were not documented on 3/30/20 when 7 patients had testing performed. 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 --

Summary Statement of Deficiencies D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: . Based on record review, interview and email correspondence with the Office Manager, the Laboratory Director failed to assure personnel performing gross tissue examinations were competent for 1 (Testing Personnel #3) of 3 testing personnel listed on the CMS 209 form. Findings include: 1. A review of the laboratory's "Competency Assessment Policy" revealed a section stating, "For a new employee, competency assessment evaluations will be performed upon hire, and will be repeated at 6 months, then annually thereafter." 2. An interview on 11/30/20 at 10:03 am with the Office Manager revealed Testing Personnel #3 starting performing patient testing in June or July 2020. 3. A review of the competency assessment for Testing Personnel #3 dated 11/2020 revealed it was a self-assessment. 4. Email correspondance with the Office Manager sent on 11/30/20 at 2:03 pm confirmed the competency assessment for Testing Personnel #3 had been a self-assessment. 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 --

Summary Statement of Deficiencies D0000 The purpose of this unannounced survey was for complaint #MI00113648. 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). D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on record review and interview with Testing Personnel #5 (TP5), the laboratory failed to provide the educational requirements for 1 (TP5) of 5 testing personnel performing moderately complex testing. Refer to D6065 D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned 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 4 -- high school diploma or equivalent; and This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel #5 (TP5), the laboratory failed to ensure personnel performing fungal culture testing using Dermatophyte Test Media were qualified for 1 (TP5) of 5 testing personnel listed on the CMS-209 form. Findings include: 1. An interview with TP5 on 8/19/2020 at 11:24 am revealed TP5 performs testing of fungal cultures using Dermatophyte Test Media. 2. A record review of the laboratory's personnel records revealed a lack of documentation of education for TP5. 3. A request by the surveyor for TP5's education documents was made on 8/19/2020 at 11:24 am and the documents were not made available. 4. The laboratory was given an additional 7 days to supply the necessary education documents. The documents were 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 and interview with Testing Personnel #5 (TP5), the laboratory failed to provide the educational requirements for 1 previously employed testing personnel performing highly complex testing. 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 have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have -- 2 of 4 -- either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (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; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel #5 (TP5), the laboratory failed to ensure personnel performing gross examinations of Mohs micrographic surgery tissue specimens were not qualified for 1 testing personnel employed from July 2019 to June 2020. Findings include: 1. An interview with TP5 on 8/19/2020 at 10:42 am revealed a testing personnel previously employed by the laboratory from July 2019 to June 2020 had performed gross examination of Mohs micrographic surgery tissue specimens during the duration of their employment and was not qualified. 2. A record review of the laboratory's personnel records revealed a lack of documentation of education for the previously employed testing personnel. 3. A request by the surveyor for the previously employed testing personnel's education documents was made on 8/19/2020 at 10:42 am and the documents were not made available. 4. The laboratory was given an additional 7 days to supply the necessary education documents. The documents were not received. D8103 BASIC INSPECTION REQUIREMENTS CFR(s): 493.1773(b)(c)(d) (b) General Requirements. As part of the inspection process, CMS or a CMS agent may require the laboratory to do the following: (b)(1) Test samples, including proficiency testing samples, or perform procedures. (b)(2) Permit interviews of all personnel concerning the laboratory's compliance with the applicable requirements of -- 3 of 4 -- this part. (b)(3) Permit laboratory personnel to be observed performing all phases of the total testing process preanalytic, analytic, and postanalytic). (b)(4) Permit CMS or a CMS agent access to all areas encompassed under the certificate including, but not limited to, the following: (b)(4)(i) Specimen procurement and processing areas. (b)(4) (ii) Storage facilities for specimens, reagents, supplies, records, and reports. (b)(4)(iii) Testing and reporting areas. (b)(5) Provide CMS or a CMS agent with copies or exact duplicates of all records and data it requires. (c) Accessible records and data. A laboratory must have all records and data accessible and retrievable within a reasonable time frame during the course of the inspection. (d) Requirement to provide information and data. A laboratory must provide, upon request, all information and data needed by CMS or a CMS agent to make a determination of the laboratory's compliance with the applicable requirements of this part. This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel #5 (TP5), the laboratory failed to include all testing personnel performing both moderate and high complexity testing on the CMS-209 form when requested during the 10/7/2019 survey. Findings include: 1. A review of the surveyor notes from the 10/7/2019 survey revealed the surveyor requested pre-survey paperwork, including the CMS-116 and CMS-209 forms, to be completed on 10/7/2019 at 8:53 am. 2. An interview with TP5 on 8/19/2020 at 10:42 am revealed a previously employed testing personnel employed from July 2019 to June 2020 was performing gross tissue examinations for Mohs micrographic surgery during this time. 3. An interview with TP5 on 8/19/2020 at 11: 24 am revealed TP5 was performing fungal culture readings of Dermatophyte Test Media at the time of the 10/27/19 survey. 4. A review of the 10/7/19 survey CMS-209 form revealed a section titled "Instructions" stating, "List below all technical personnel, by name, who are employed by the laboratory. Check the appropriate column for each position held." 5. A review of the 10/7/19 survey CMS-209 document revealed it did not include two testing personnel (TP5 and the testing personnel employed from July 2019 to June 2020) employed by the laboratory during the time of the survey. -- 4 of 4 --

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(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 observation, record review, and interview with the office manager, the laboratory failed to establish a written procedure for the use of Chlorazol Black E Fungal Stain for 1 (September 2019) of 24 months reviewed. Findings include: 1. An observation on 10/7/19 at 9:09 am by the surveyor revealed a bottle of Healthlink Chlorazol Black E Fungal Stain dated September 2019. 2. A record review of the laboratory's established procedures revealed a lack of a procedure for the use of Chlorazol Black E Fungal Stain. 3. An interview on 10/7/19 at 9:39 am with the office manager revealed the laboratory purchased the Healthlink Chlorazol Black E Fungal Stain in September 2019. 4. An interview on 10/7/19 at 9:39 am with the office manager confirmed the laboratory had not established a procedure for the use of Chlorazol Black E Fungal stain. 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. 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 -- This STANDARD is not met as evidenced by: . Based on observation, record review, and interview with the office manager, the laboratory failed to label Histoclear reagents with the expiration date for the current bottle in use. Findings include: 1. An observation on 10/7/19 at 9:09 am by the surveyor revealed an open bottle of Histoclear reagent without an expiration date. 2. A record review of the laboratory's established "Reagent Labeling" procedure revealed a section stating, "Labels must include: Name of reagent, expiration date, preparation date, warning if reagent is hazardous, strength, concentration or dilution of reagent, and storage requirements." 3. An interview on 10/7/19 at 9:09 am with the office manager confirmed an expiration date was missing from the current bottle of Histoclear reagent in use. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: . Based on record review and interview with the office manager, the laboratory failed to include the address of the facility where testing was performed for 8 (patients #3, #4, #5, #6, #7, #10, #11, #12) of 10 patient charts reviewed. Findings include: 1. A patient chart review revealed MOHS maps did not include the address of the facility where testing was performed for the following patients: a. Patient #3 performed on 2 /12/19 b. Patient #4 performed on 4/23/19 c. Patient #5 performed on 6/18/19 d. Patient #6 performed on 8/27/19 e. Patient #7 performed on 10/2/19 f. Patient #10 performed on 5/9/18 g. Patient #11 performed on 8/28/18 h. Patient #12 performed on 11/8/18 2. An interview on 10/7/19 at 10:15 am with the office manager confirmed the MOHS maps for the patients above did not include the address of the facility. -- 2 of 2 --