Pinnacle Dermatology Brighton

Summary Statement of Deficiencies D0000 A recertification survey was performed on September 30, 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 493.1487 Condition: Laboratories performing high complexity testing; testing personnel. 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, record review, and interview with testing personnel #2, the laboratory failed to ensure its Vintage Bluing staining reagent was not used beyond expiration dates for three (6/30/25 to 9/30/25) of three months since the reagent expired on 6/30/25. Findings include: 1. The surveyor observed an expired bottle of Vintage Bluing with the expiration date of 6/30/25 on 9/30/25 at 9:01 am. 2. A review of the laboratory's reagent tracking log revealed a lack of information to show the expired bottle was taken out of use at this laboratory after it expired. 3. An interview on 9/30/25 at 9:06 am with testing personnel #2 confirmed the bottle of Vintage Bluing had expired. 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. 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 -- This CONDITION is not met as evidenced by: . Based on record review and a lack of documentation, testing personnel #2 failed to meet high complexity testing personnel qualifications for the tissue specimen grossing performed. 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 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 a lack of documentation, testing personnel #2 failed to meet high complexity testing personnel qualifications for the tissue specimen grossing performed for 14 (July 2024 to September 2025) of 14 months since testing personnel #2 started testing. Findings include: 1. A review of testing personnel #2's training and competency records revealed both training and competency were completed on 7/3 /24. 2. A review of testing personnel #2's education documentation showed transcripts. The transcripts failed to include the name of the institution, at least 60 -- 2 of 3 -- completed semester hours, at least six semester hours of chemistry, at least 24 semester hours of science courses, and either completion of a training program approved or accredited by the ABHES or the CAAHEP or at least three months documented laboratory training in histopathology testing. 3. The surveyor requested additional institutional information, educational credits, training program information or documentation of applicable training on 9/30/25 at 10:21 am and it was not made available. 4. The laboratory was granted seven days to provide the missing qualification records, and none were provided. -- 3 of 3 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: . Based on record review and interview with the Mohs Technician, the laboratory failed to retain its cryostat temperature monitoring documentation at least two years for 6 (January 2022 to June 2022) of 24 months reviewed. Findings include: 1. A review of the laboratory's cryostat temperature monitoring documentation revealed a lack of documentation between January 2022 and June 2022. 2. An interview on 9/12 /23 at 4:15 pm with the Mohs Technician confirmed the cryostat temperature monitoring documentation from January 2022 to June 2022 was not available. D5008 PARASITOLOGY CFR(s): 493.1204 If the laboratory provides services in the subspecialty of Parasitology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1264, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: . Based on record review and interviews, the laboratory failed to establish competency assessment policies to assess testing personnel performing scabies testing (refer to D5209) and establish policies and procedures for its scabies testing (refer to D5401). D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES 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 -- 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 Laboratory Director, the laboratory failed to establish competency assessment policies to assess testing personnel performing scabies testing for 2 (one previously employed testing personnel and Testing Personnel #5) 5 testing personnel. Findings include: 1. A review of the laboratory's "KOH Log" revealed scabies testing was performed for four patients between January 2023 and August 2023 by one previously employed testing personnel and Testing Personnel #5. 2. An interview on 9/12/23 at 2:27 pm with the Laboratory Director revealed testing personnel had not been assessed for their competency for scabies testing. 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 Laboratory Director, the laboratory failed to perform verification of accuracy testing at least twice annually for its Potassium Hydroxide (KOH) preparation testing in 2022. Findings include: 1. A review of the laboratory's "Potassium Hydroxide (KOH)" policy revealed a section titled "Quality Control Procedures" stating, "Semi-annually test one patient in duplicate and have a second provider (MD, RN, PA) examine specimen as well. This should be testing personnel listed on CMS form 209." 2. A review of the laboratory's "KOH Log secondary evaluation to be completed semiannually" log revealed a lack of documentation showing the laboratory verified the accuracy of its KOH preparation testing in 2022. 3. An interview on 9/12/23 at 4:15 am with the Mohs Technician confirmed the laboratory did not have documentation of twice annual verification of accuracy testing for its KOH preparation testing in 2022. 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 Laboratory Director, the laboratory failed to establish policies and procedures for its scabies testing since testing began on 11/9/22. Findings include: 1. A review of the laboratory's "KOH log" revealed four patients had been tested for scabies between 11/18/22 and 6/13/23. 2. The surveyor -- 2 of 5 -- requested the laboratory's scabies test procedure on 9/12/23 at 4:15 pm and it was not made available. 3. An interview on 9/12/23 at 4:15 pm with the Mohs Technician confirmed the laboratory did not establish a scabies test procedure. 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 observation and interview with the Mohs Technician, the laboratory failed to ensure its tissue marking dye had not exceeded its expiration date since 8/31/23. Findings include: 1. The surveyor observed Blue Tissue Marking dye with the expiration date of 8/31/23 on 9/12/23 at 2:16 pm during a tour of the laboratory. 2. An interview on 9/12/23 at 2:16 pm with the Mohs Technician confirmed the Blue Tissue Marking dye had been expired. 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: . A. Based on record review and interview with the Mohs Technician, the laboratory failed to ensure the anatomical site was accurately documented on the test report for 1 (Patient M22-253) of 7 patients reviewed. Findings include: 1. A review of patient test records revealed Patient M22-253 had mohs surgery histopathology testing performed on 9/13/22 with the site of "Nose" listed on the mohs surgery map and "Nasal Dorsum" listed on the visit note and the biopsy test report prior to mohs surgery. 2. An interview on 9/12/23 at 3:41 pm with the Mohs Technician confirmed the sites "Nose" and "Nasal Dorsum" were used interchangeably for the same site for the patient listed above. B. Based on record review and interview with the Mohs Technician, the laboratory failed to ensure results for a Potassium Hydroxide (KOH) preparation test were accurately entered in the final report for 4 (Patients #1-#4) of 4 KOH testing patients reviewed. Findings include: 1. A review of the laboratory's "Potassium Hydroxide (KOH)" policy revealed a section titled "Diagnosis Value" stating, "Superficial fungal disease or dermatophytosis of the skin, hair, nails including Candidasis, Tinea Versicolor, Chromomycosis, and fiberglass dermatitis are commonly diagnosed using the KOH exam." 2. A review of patient test records revealed the following patients had KOH testing performed or ordered had missing or discrepant results on the test reports: a. Patient #3 had KOH preparation testing performed and documented on the KOH log on 2/24/22. No results were indicated on -- 3 of 5 -- the patient test report. b. Patient #2 had KOH preparation testing performed on 8/11 /22 with the result of "branching hyphae" and "the KOH Slide was NEGATIVE" on the same test report. c. Patient #1 had KOH preparation testing ordered on 11/18/22 with the result of "scabies." d. Patient #4 had KOH preparation testing ordered on 6/3 /23 with the result of "no mites or scybala." 3. An interview on 9/12/23 at 4:15 pm with the Mohs Technician confirmed the patient test reports above with KOH preparation testing performed or ordered had missing or discrepant results. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: . Based on record review and interviews, the Laboratory Director failed to ensure a quality assessment program was established to include its Potassium Hydroxide (KOH) preparation and scabies testing (refer to D6021), ensure results for Potassium Hydroxide (KOH) preparation tests were accurately entered in the final report (refer to D6026), ensure competency assessment policies were established to assess testing personnel performing scabies testing (refer to D6029), and ensure policies or procedures for its scabies testing had been established and approved (refer to D6031). D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: . Based on record review and interview with the Mohs Technician, the laboratory failed to ensure a quality assessment program was established to include its Potassium Hydroxide (KOH) preparation and scabies testing for 2 (September 2021 to September 2023) of 2 years reviewed. Findings include: 1. A review of the laboratory's quality assessment documentation revealed a lack of a documentation of quality assessments performed for its KOH preparation and scabies testing between September 2021 and September 2023. 2. An interview on 9/12/23 at 4:15 pm with the Mohs Technician confirmed a process for quality assessments for KOH preparation and scabies testing had not been established. D6026 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(8) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently -- 4 of 5 -- and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(8) Ensure that reports of test results include pertinent information required for interpretation. This STANDARD is not met as evidenced by: . Based on record review and interview, the Laboratory Director failed to ensure results for Potassium Hydroxide (KOH) preparation tests were accurately entered in the final report. Refer to D5801 B. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) The laboratory director is responsible for the overall operation and administration of 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, the Laboratory Director failed to ensure competency assessment policies were established to assess testing personnel performing scabies testing. Refer to D5209. D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) The laboratory director is responsible for the overall operation and administration of 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)(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; This STANDARD is not met as evidenced by: . Based on record review and interview, the Laboratory Director failed to ensure policies or procedures for its scabies testing had been established and approved. Refer to D5401. -- 5 of 5 --

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 Clinical Manager, the laboratory failed to ensure Potassium Hydroxide (KOH) preparations for 2 (January 2020 to January 2022) of 2 years. Findings include: 1. A review of the laboratory's "KOH Competency Log Sheet" revealed the secondary results were initialed by staff not listed on the CMS-209 form. 2. An interview on 1/13/22 at 10:14 am with the Clinical Manager revealed the secondary results were initialed by staff that ensured the results were entered into the patients' charts and the staff did not review the test for accuracy at least twice annually. ***This is a repeated deficiency from the 12/16/19, 7/27/17, and 8/22/13 recertification surveys*** 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. 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 record review and interview with the Clinical Manager, the laboratory failed to ensure mohs surgery maps used in histopathology testing were sent to the final report destination for 1 (Patient M20-186) of 9 patient test reports reviewed. Findings include: 1. A review of patient test records revealed Patient M20-186 did not have a mohs surgery map used in histopathology testing for surgery performed on 8/31 /20. 2. An interview on 1/13/22 at 10:37 am with the Clinical Manager confirmed the laboratory did not have the mohs surgery map for the patient listed above. -- 2 of 2 --

Summary Statement of Deficiencies D5006 MYCOLOGY CFR(s): 493.1203 If the laboratory provides services in the subspecialty of Mycology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1263, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on document review and interview with the office manager, the laboratory failed to meet the subspecialty of mycology requirements as specified in 493.1230 through 493.1256, 493.1263, and 493.1281 through 493.1299. Findings include: 1. The laboratory failed to verify the accuracy of Potassium Hydroxide (KOH) preparations at least twice annually. Refer to D5217. 2. The laboratory failed to ensure Chlorazol Black E fungal stain used in Potassium Hydroxide (KOH) preparations had not exceeded its expiration date. Refer to D5417. 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 assess employee competency for Testing Personnel #1 (TP1) performing Mohs histopathology testing for 2 (December 2017 to December 2019) of 2 years. Findings include: 1. A record review of employee competency records revealed the most recent Mohs histopathology competency assessment for TP1 was performed on 10/18/16. 2. 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 -- A record review of the laboratory's established "Quality Assessment Policy" revealed a section stating, "The quality systems (QA) for Brighton Dermatology Laboratory will be reviewed on an ongoing basis every six months to monitor, assess and when indicated, correct problems identified in all four quality systems stated below using the following documentation page: General Laboratory System (493.1231 to 493.1236) Patient confidentiality, Complaint investigations, Specimen identification and integrity, Communication, Personnel competency and assessment policies." 3. An interview on 12/16/19 at 11:50 with the office manager confirmed TP1 did not have documented competency assessments for Mohs histopathology testing available. 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 office manager, the laboratory failed to verify the accuracy of Potassium Hydroxide (KOH) preparations at least twice annually for 2 (December 2017 to December 2019) of 2 years. Findings include: 1. A record review of the laboratory's "KOH Competency Log Sheet", used for twice annual verification of accuracy documentation, revealed it was most recently performed on 1/25/17. 2. An interview on 12/16/19 at 11:45 am with the office manager confirmed the laboratory did not verify accuracy at least twice annually for KOH testing. ***Repeat deficiency from surveys on 7/27/17, 7/29/15, and 8/22/13*** 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 observation, record review, and interview with the office manager, the laboratory failed to ensure Chlorazol Black E fungal stain, used in Potassium Hydroxide (KOH) preparations, had not exceeded its expiration date for 77 patient specimens tested after it had been expired. Findings include: 1. An observation by the surveyor on 12/16/19 at 12:07 pm revealed a bottle of Healthlink Chlorazol Black E Fungal Stain, lot number 6349, with the expiration date of 12/14/18. 2. A record review of the laboratory's "KOH Log" sheets, used in recording patient results, revealed 77 patients had been tested since the expiration date. 3. An interview on 12 /16/19 at 12:07 am with the office manager confirmed the laboratory had been using the expired Chlorazol Black E fungal stain on patient specimens. 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 -- 2 of 3 -- 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 record review and interview with the office manager, the laboratory failed to perform and document microscope and cryostat annual maintenance activities for 2 (December 2017 to December 2019) of 2 years. Findings include: 1. A record review of the laboratory's established "Quality Assurance Program" revealed a section stating, "All equipment within the laboratory will be properly maintained according to the manufacturer's specifications. The Laboratory Director will be responsible for ensuring that all maintenance and repairs will be recorded and maintained by the laboratory personnel and will be reviewed by the Laboratory Director on a periodic basis." 2. A record review of the laboratory's established "Quality Assurance Program" revealed a section titled "Equipment Quality Control for Microscopes" stating, "Grounding check is monitored and recorded yearly." 3. A record review of the laboratory's established "Quality Assurance Program" revealed a section titled "Equipment Quality Control for Cryostats" stating, "Temperature calibration check is done annually and recorded. Preventative maintenance and grounding check are done yearly." 4. A record review of the laboratory's maintenance logs revealed a lack of documentation of required annual maintenance for the following equipment used by the laboratory: a. Leica DM 1000 microscope b. Avantik QS17 cryostat c. Nikon microscope 5. An interview on 12/16/19 at 12:32 pm with the office manager confirmed annual maintenance for the equipment listed above was not performed and documented. ***Repeat deficiency from surveys on 8/22/13 and 9/30/11*** D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the 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 the office manager, the laboratory director failed to ensure quality assessment programs were maintained to assure the quality of laboratory services for 2 (December 2017 to December 2019) of 2 years. Findings include: 1. A review of the laboratory's established "Quality Assurance Checklist" revealed a lack of completed checklists to assess the quality of laboratory services. 2. A review of the laboratory's established "Quality Assessment Policy" revealed a section stating, "The quality systems (QA) for Brighton Dermatology Laboratory will be reviewed on an ongoing basis every six months to monitor, assess and when indicated, correct problems identified in all four quality systems stated below using the following documentation page." 3. An interview on 12/16/19 at 12:23 pm with the office manager confirmed the laboratory director did not maintain the laboratory's quality assessment programs. -- 3 of 3 --