Pinnacle Dermatology

Summary Statement of Deficiencies D0000 A recertification survey was performed on August 7, 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 493, Laboratory Requirements) for the following Condition-level deficiency: 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director 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 laboratory manager, the laboratory failed to verify its ectoparasite testing at least twice annually for two (August 2023 to August 2025) of two years reviewed. Findings include: 1. A review of the laboratory's Form CMS-116 revealed the laboratory listed "Mohs Dermatopathology" and "KOH prep" as testing performed at the laboratory under the specialties of histopathology and mycology respectively. 2. During the survey entrance conference, the surveyor asked if the laboratory was performing parasitology testing in addition to the Potassium Hydroxide (KOH) testing listed on Form CMS-116 on 8/7/25 at 8:59 am with the laboratory manager and they confirmed the laboratory had not been performing ectoparasite testing. 3. A review of patient test reports revealed patient #5 had KOH testing ordered and performed on 4/18/25 with the result of "demodex", an ectoparasite. 4. A review of the laboratory's "Ectoparasites" test procedure revealed a section titled "Quality Control Procedures" stating, "Since there do not seem to be any suitable, commercially available control materials for this procedure or routine methods for culture of ectoparasites, one or more of the following options may be used to perform the required analysis of the quality of the results obtained. Test each patient specimen in duplicate as well as having second provider (MD, RN, PA) review 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 -- specimen. Bi-annual minimum secondary evaluation mandatory per CLIA standard." 5. A review of the laboratory's procedure manual revealed a test procedure titled "Ectoparasites" with the following laboratory director approval dates: a. 5/22/22 b. 5 /30/23 c. 5/25/24 d. 5/26/25 6. A review of the laboratory's twice annual verification of accuracy documentation revealed a lack of twice annual verification of accuracy testing performed in 2023, 2024, and 2025. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies D3043 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(7) The laboratory must retain cytology slide preparations for at least 5 years from the date of examination (see 493.1274(f) for proficiency testing exception). The laboratory must retain histopathology slides for at least 10 years from the date of examination. The laboratory must retain pathology specimen blocks for at least 2 years from the date of examination. The laboratory must preserve remnants of tissue for pathology examination until a diagnosis is made on the specimen. This STANDARD is not met as evidenced by: . Based on record review and interview with the Mohs Technician, the laboratory failed to retain its histopathology slides for at least 10 years for slides examined between July 2013 and December 2013. Findings include: 1. A review of the laboratory's previous survey documentation showed the laboratory had been performing histopathology testing during the 6/11/13 and the 4/9/15 surveys. 2. The surveyor requested histopathology slides from 2013 on 7/25/23 at 2:12 pm and were not made available. 3. An interview on 7/25/23 at 3:08 pm with the Mohs Technician confirmed the laboratory had not retained histopathology slides from examinations performed in 2013. 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 2 -- (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)

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: . Based on record review and interview with the Office Manager, the laboratory failed to establish policies and procedures to assess employee competency for 2 (December 2019 to December 2021) of 2 years reviewed. Findings include: 1. A review of the laboratory's policies and procedures revealed a lack of policies for the performance of competency assessments. 2. A review of the laboratory's personnel records revealed a lack of competency assessments for the following personnel listed on the CMS-209 form: a. Testing Personnel #1 was hired August 16, 2021 and had no competency assessments present. b. Testing Personnel #2 was hired July 10, 2012 and had no competency assessments present. c. Testing Personnel #3 was hired September 15, 2021 and had no competency assessments present. 3. An interview on 12/21/21 at 12: 03 pm with the Office Manager confirmed the laboratory did not establish a competency assessment policy. ***This is a repeated deficiency from the 9/24/19 recertification survey*** 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 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 -- rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: . Based on record review and interview with the Office Manager, the laboratory failed to properly label slides with the correct case number for 1 (Case LMP20-0052) of 6 patient cases reviewed. Findings include: 1. A review of the laboratory's patient test records revealed LMP20-0052 was a tissue specimen collected from the left superior lateral malar check. 2. The surveyor requested the slides for LMP20-0052 on 12/21/21 at 9:45 am and they were not made available. 3. An interview on 12/21/21 at 10:31 am with the Office Manager revealed slides for case LMP20-0052 were incorrectly labeled as the case LMP20-0049 performed on the same patient, but a different site. 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 record review and interview with the Office Manager, the laboratory failed to follow its Potassium Hydroxide (KOH) procedure for 1 (Patient #1) of 1 patient receiving testing. Findings include: 1. A review of the laboratory's "KOH Procedure Protocol" revealed a section stating, "Document on the KOH log form the control slide details including Lot# and exp date. If readings of control slide do not coincide, a third provider is brought in to evaluate slides." and "Following examination by the provider, another provider is asked to blindly read the KOH specimen (and control, if applicable) and verify the appropriate presence or absence of spores or hyphae. The results are documented on the KOH log form, as well as entered in the patient's electronic medical record." 2. A review of the laboratory's records revealed a lack of KOH log forms. 3. An interview on 12/21/21 at 12:03 pm with the Office Manager confirmed the laboratory did not follow its KOH testing procedure. 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: . Based on record review and interview with the Office Manager, the laboratory failed to document temperature and humidity conditions for 4 (August 2021 to December 2021) of 24 months reviewed. Findings include: 1. A review of the laboratory's "Room Temperature/Humidity" logs revealed a lack of documentation of temperature -- 2 of 4 -- and humidity conditions from August 2021 to December 2021. 2. An interview on 12 /21/21 at 12:03 pm with the Office Manager confirmed the laboratory did not have documentation of the temperature and humidity conditions for the dates 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 interview with the Office Manager, the laboratory failed to ensure Potassium Hydroxide (KOH) reagent did not exceed its expiration date for 1 (Patient #1) of 1 patient recieving KOH testing. Findings include: 1. A review of patient records revealed Patient #1 had KOH testing performed on a specimen collected from the left superior upper back on 9/20/21. 2. The surveyor observed the laboratory's "Health Link Potassium Hydroxide 10%" bottle with the expiration date of 9/12/21. 3. A review of the laboratory's "KOH Procedure Protocol" revealed a section stating, "Document on the KOH log form the control slide details including Lot# and exp date." 4. An interview on 12/21/21 at 11:36 am with the Office Manager confirmed the laboratory used expired reagent to perform patient KOH testing. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: . Based on record review and interview with the Office Manager, the laboratory failed to include the results of testing performed for 1 (Patient #1) of 10 patient test reports reviewed. Findings include: 1. A review of patient test reports revealed Patient #1 had Potassium Hydroxide (KOH) testing performed on 9/20/21. The test report stated, "Examination of the slide showed: +/- results." 2. A review of the laboratory's "KOH Procedure Protocol" revealed a section stating, "Documentation of the presence (POSITIVE) or absence (N EGATIVE) of spores or hyphae is recorded in the patient's chart, along with the site from where the specimen was obtained." 3. An interview on 12/21/21 at 10:45 am with the Office Manager confirmed the patient did not have a result present on the test report. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) The laboratory director is responsible for the overall operation and administration of -- 3 of 4 -- the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: . Based on record review and interview with the Office Manager, the Laboratory Director failed to ensure testing personnel received the appropriate training prior to testing patient samples for 1 (Testing Personnel #3) of 3 testing personnel listed on the CMS-209 form. Findings include: 1. A review of the laboratory's personnel records revealed a lack of documentation of training and competency assessments for Testing Personnel #3 hired on 9/15/21. 2. A review of patient test reports revealed Testing Personnel #3 performed Potassium Hydroxide (KOH) testing on Patient #1 on 9/20/21. 3. An interview on 12/21/21 at 11:17 am with the Office Manager confirmed Testing Personnel #3 did not have documented training prior to testing patients. -- 4 of 4 --

Summary Statement of Deficiencies D3033 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3)(i) In addition, the laboratory must retain records of test system performance specifications that the laboratory establishes or verifies under 493.1253 for the period of time the laboratory uses the test system but no less than 2 years. This STANDARD is not met as evidenced by: . Based on record review and interview with the Quality Assurance Manager, the laboratory failed to retain Leica Cryostat operating temperatures for 2 (September 2017 to September 2019) of 2 years. Findings include: 1. A record review of laboratory maintenance logs revealed a lack of Leica Cryostat operating temperatures between September 2017 to September 2019. 2. A record review of the Leica Cryostat operating manual revealed the required temperature range is 0 to -30 degrees Celsius. 3. An interview on 9/23/19 at 10:25 am with the Quality Assurance Manager confirmed the Leica Cryostat temperature logs were not retained by the laboratory. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: . Based on record review and interview with the Quality Assurance Manager, the laboratory failed to follow policies to assess testing personnel competencies for 1 (testing personnel #1) of 1 testing personnel listed on the CMS-209 form. Findings include: 1. A record review of employee competency files revealed a lack 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 -- documented competency for testing personnel #1. 2. An interview on 9/23/19 at 11:24 am with the Quality Assurance Manger confirmed competency was not available for testing personnel #1. 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 Quality Assurance Manager, the laboratory failed to verify the accuracy of histopathology testing for 1 (2018) of 2 years reviewed. Findings inclued: 1. A record review of twice a year verification of accuracy records for MOHS histopathology testing revealed a lack of records for 2018. 2. An interview on 9/23/19 at 11:49 am with the Quality Assurance Manager confirmed twice a year verification of accuracy records were not available for 2018. 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 Quality Assurance Manager, the laboratory failed to include the name and address of the laboratory location where testing was performed for 2 (September 2017 to September 2019) of 2 years. Findings include: 1. A review of patient MOHS maps revealed a lack of name and address of the testing location. 2. An interview on 9/23/19 at 10:41 am with the Quality Assurance Manager confirmed the MOHS maps used by the laboratory did not have the name or address of the laboratory. -- 2 of 2 --