Grafton Dermatology & Cosmetic Surgery

Summary Statement of Deficiencies D0000 A Recertification survey was performed on October 17, 2023 at Grafton Dermatology & Cosmetic Surgery, CLIA ID # 19D0960403. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure manual and twice a year verification records as well as interview with laboratory personnel, the laboratory failed to follow their quality assessment policy for twice a year verification of the accuracy of Moh's (Histopathology) testing for three (3) of three (3) events reviewed. Findings: 1. Review of the laboratory's "Proficiency Testing" policy revealed "Semi- annually, dated 6 months apart on each case, the tech or Risk Manager will send two cases containing the original slides, label it with only the surgical case number, and send it our {sic} for a microscopic examination by a Board Certified Dermatopathologist." 2. Review of the laboratory's 2022 Moh's proficiency testing records revealed the laboratory sent two (2) cases from February 2022 and two (2) cases from August 2022 out for verification of accuracy, but the four cases were not sent for verification until January 2023. 3. In interview on October 17, 2023 at 10:57 a. m., the Lab Supervisor stated for 2022 she pulled two (2) cases from the first half of the year and two (2) cases from the second half of the year and sent them out together in January 2023 to the outside Dermatopathologist for verification. 4. Further review of the laboratory's 2022 proficiency testing records revealed the cases were not 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 -- reviewed by the outside Dermatopathologist until September 2023. 5. Review of the laboratory's 2023 Moh's proficiency testing records revealed the laboratory did not send cases for verification for the first half 2023. 6. In interview on October 17, 2023 at 10:57 a.m., the Lab Supervisor stated she was waiting to send four (4) cases from 2023 together. She confirmed she did not send the cases semi-annually for 2022 and the first half of 2023. D5821 TEST REPORT CFR(s): 493.1291(k) When errors in the reported patient test results are detected, the laboratory must do the following: (k)(1) Promptly notify the authorized person ordering the test and, if applicable, the individual using the test results of reporting errors. (k)(2) Issue corrected reports promptly to the authorized person ordering the test and, if applicable, the individual using the test results. (k)(3) Maintain duplicates of the original report, as well as the corrected report. This STANDARD is not met as evidenced by: Based on review of patient test records and interview with personnel, the laboratory failed to ensure the correct patient case number was recorded on patient test results for one (1) of eight (8) patients reviewed. 1. Review of the laboratory's patient logs, slides, and Moh's maps revealed the following one (1) patient had an incorrect case number recorded on the Moh's map: June 29, 2022 - Case M22-151 recorded in patient log book and on slides. Moh's map case number recorded as M22-155 2. In interview on October 17, 2023 at 11:41 a.m., the Lab Supervisor confirmed the case number on the Moh's map was incorrect. She confirmed the Moh's map case number did not match the case number in the log book and on the slides. D5893 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(b)(c) (b) The postanalytic systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D0000 A Special focus survey was performed at Grafton Dermatology and Cosmetic Surgery- CLIA ID 19D0960403 on February 8, 2022. Grafton Dermatology and Cosmetic Surgery was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1100 CONDITION: Facility Administration D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on observation by surveyor, review of test logs, and interview with personnel, the laboratory failed to report sixteen (16) SARS COV-2 results to the state as required. Findings: 1. Observation by surveyor during the laboratory tour on February 8, 2022 at 10:15 am revealed the labotory utilized Quidel Quickvue and Celltrion Distrust COVID-19 Antigen Rapid test kits. 2. In interview on February 8, 2022 at 11: 00 am, the Office Manager stated the laboratory utilizes the identified COVID tests for employees. The Office Manager further stated the results are not reported to the state. 3. In further interview on February 8, 2022 at 11:00 am, the Office Manager stated in 2021 and 2022 a total of sixteen (16) tests were performed. D5401 PROCEDURE MANUAL Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- 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: I. Based on review of the laboratory's policies, proficiency testing records, and interview with personnel, the laboratory failed to establish and follow policy for twice a year verification of the accuracy of Moh's (Histopathology) testing for one (1) of two (2) years reviewed. Findings: 1. Review of the laboratory's "Proficiency Testing Mohs Micrographic Surgery Skin Specimens" policy revealed "Semi-annually, the tech or Risk Manager will send two cases containing the original slides, label it with only the surgical case number, and send it our [sic]for a microscopic examination by a Board Certified Dermatopathologist." 2. Review of the laboratory's "Quality Assurance Program" under "Histopathology" section revealed "Proficiency testing is required for this service provided by our physician. It is suggested to submit 3 cases every 6 months to an outside Pathologist." 3. Review of the Mohs proficiency testing records for 2020 and 2021 revealed in 2021 the laboratory submitted one (1) case from February and one (1) from March 2021, not semi-annually per laboratory policy. 4. In interview on February 8, 2022 at 12:06 pm, the Medical Assistant stated she thought as long as two were done a year that was acceptable. The Medical Assistant confirmed the proficiency testing for Mohs was not performed on cases semi- annually. II. Based on review of the laboratory's policies, test menu, and interview with personnel, the laboratory failed to establish written procedures for reporting SARS COV-2 results to the state. Findings: 1. Review of the laboratory's policies and procedures revealed the laboratory did not have written procedures for reporting SARS COV-2 results, to include, but not limited to who is responsible, and frequency of reporting to the state. 2. In interview on February 8, 2022 at 11:00 am, the Medical Assistant confirmed the laboratory did not have a written procedure for the reporting of positive and negative SARS COV-2 results to the state. 3. Review of the laboratory's test menu revealed the laboratory performs twenty five (25) SARS COV- 2 tests annually. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedures and interview with personnel, the laboratory failed to have the procedures approved and signed by the Laboratory Director. Findings: 1. Review of the laboratory's policies and procedures revealed the Laboratory Director did not approve/sign the procedures. 2. In intereview on February 8, 2022 at 12:40 pm, the Medical Assistant stated the policy manual was updated and confirmed the Laboratory Director did not sign the policy book. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) -- 2 of 6 -- 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 observation by surveyor, review of manufacturer storage requirements, and interview with personnel, the laboratory failed to monitor the room temperature of the office where SARS COV-2 test kits were stored per manufacturer requirements. Findings: 1. Observation by surveyor during the laboratory tour on February 8, 2022 at 10:50 am revealed the laboratory did not monitor the office where the following supplies were stored: a) Quidel Quickvue SARS Antigen test kits b) Celltrion Diatrust COVID-19 Antigen Rapid test kits 2. Review of the manufacturer storage requirements for the identified test kits revealed the following: a) Quidel Quickvue SARS Antigen test kits: storage requirement 15-30 degrees Celsius b) Celltrion Diatrust COVID-19 Antigen Rapid test kits: 2-30 degrees Celsius 3. In interview on February 8, 2022 at 10:55 am, the Office Manager stated the laboratory does not monitor the temperature of the office where the identified supplies are stored. 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 by surveyor and interview with personnel, the laboratory failed to ensure laboratory supplies did not exceed their expiration dates. Findings: 1. Observation by surveyor during laboratory tour on February 8, 2022 at 10:50 am revealed the following expired items: a) Cancer Diagnostics Tissue Marking Dye, Orange, Lot 9255, Expiration date: 2021-09-30, Quantity: One (1) bottle b) Cancer Diagnostics Tissue Marking Dye, Yellow, Lot 9252, Expiration date: 2021-09-30, Quantity: one (1) bottle c) Cancer Diagnostics Tissue Marking Dye, Red, Lot 9249, Expiration date: 2021-09-30, Quantity: one (1) bottle d) Cancer Diagnostics Tissue Marking Dye, Violet, Lot 9246, Expiration date: 2021-09-30, Quantity: one (1) bottle e) Cancer Diagnostics Tissue Marking Dye, Green, Lot 9254, Expiration date: 2021- 09-30, Quantity: one (1) bottle f) Cancer Diagnostics Tissue Marking Dye, Blue, Lot 9252, Expiration date: 2021-09-30, Quantity: one (1) bottle g) Cancer Diagnostics Tissue Marking Dye, Black, Lot 9253, Expiration date: 2021-09-30, Quantity: one (1) bottle 2. In interview on February 8, 2022 at 11:16 am. the Medical Assistant confirmed the identified marking dyes were expired. D5609 HISTOPATHOLOGY CFR(s): 493.1273(e)(f) (e) The laboratory must use acceptable terminology of a recognized system of disease -- 3 of 6 -- nomenclature in reporting results. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of the laboratory's CMS-209 form, quality control records, policies and procedures, test menu, and interview with personnel, the laboratory failed to ensure testing personnel documented the stain quality for Hematoxylin and Eosin (H&E) stains for six (6) of eight (8) months reviewed. Findings: 1. Review of the laboratory's CMS-209 form (Laboratory Personnel Report) revealed the Laboratory Director serves as the Testing Personnel for Mohs (Histopathology). 2. Review of the laboratory's "Quality Control Policies and Documentation" revealed "stains are checked each day for intended reactivity. A control slide is prepared and approved by the physician prior to any testing. The approval is recorded on a QC log." 3. Review of the laboratory's quality control logs for random selection of eight (8) months revealed the laboratory's testing personnel did not document the stain quality for the following six (6) months reviewed: September 2020 December 2020 February 2021 July 2021 November 2021 January 2022 4. Further review of the laboratory's quality control logs revealed the Laboratory Director discontinued documentation of his review of the slides stain quality in September 2020. 5. In interview on February 8, 2022 at 12:40 pm, the Medical Assistant confirmed the Laboratory Director did not document his review of stain quality for the identified months. The Medical Assistant stated it appeared the Laboratory Director stopped documenting his review in 2020. 6. Review of the laboratory's test menu revealed the laboratory performs 1258 Mohs (Histopathology) tests annually. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) 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)(12) 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 and interview with personnel, the Laboratory Director failed to ensure policies and procedures for assessing personnel competency were maintained. Refer to D6054. 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 -- 4 of 6 -- 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 with laboratory personnel, the Laboratory Director failed to ensure that an approved procedure manual was available to all personnel. Refer to D5407. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on review of policies, personnel records, and interview with personnel, the Technical Consultant failed to evaluate competency annually in 2020 for one (1) of six (6) personnel and six (6) of six (6) personnel in 2021. Findings: 1. Review of the laboratory's policies and personnel records revealed a "KOH Yearly Evaluations by Laboratory Director" form is utilized. 2. Review of personnel records revealed annual KOH competency assessments were not performed for the following: 2020: a) Testing Personnel 2 2021: a) Laboratory Director b) Testing Personnel 1 c) Testing Personnel 2 d) Testing Personnel 3 e) Testing Personnel 4 f) Testing Personnel 5 3. In interview on February 8, 2022 at 12:11 pm, the Medical Assistant stated she did not find the 2021 KOH yearly evaluations for Testing Personnel. D6087 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(iii) The laboratory director must ensure that laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on observation by surveyor, record review, and interview with personnel, the Laboratory Director failed to ensure the laboratory personnel were performing test methods as required. 1. The laboratory failed to monitor the room temperature of the office where SARS COV-2 test kits were stored per manufacturer requirements. Refer to D5413. 2. The laboratory failed to ensure laboratory supplies did not exceed their expiration dates. Refer to D5417. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control 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: -- 5 of 6 -- Based on record review and interview with personnel, the Laboratory Director failed to ensure that a quality control program was maintained to assure the quality of laboratory testing. Refer to D5609. D6106 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(14) The laboratory director must 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 with laboratory personnel, the Laboratory Director failed to ensure that an approved procedure manual was available to all personnel. Findings: 1. the laboratory failed to establish and follow policy for twice a year verification of the accuracy of Moh's (Histopathology) testing for one (1) of two (2) years reviewed. Refer to D5401 I. 2. The laboratory failed to establish written procedures for reporting SARS COV-2 results to the state. Refer to D5401 II. 3. The laboratory failed to have the procedures approved and signed by the Laboratory Director. Refer to D5407. -- 6 of 6 --

Summary Statement of Deficiencies D0000 A Recertification survey was performed on February 8, 2022 at Grafton Dermatology and Cosmetic Surgery, CLIA ID # 19D0960403. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on observation by surveyor, review of test logs, and interview with personnel, the laboratory failed to report sixteen (16) SARS COV-2 results to the state as required. Findings: 1. Observation by surveyor during the laboratory tour on February 8, 2022 at 10:15 am revealed the labotory utilized Quidel Quickvue and Celltrion Distrust COVID-19 Antigen Rapid test kits. 2. In interview on February 8, 2022 at 11: 00 am, the Office Manager stated the laboratory utilizes the identified COVID tests for employees. The Office Manager further stated the results are not reported to the state. 3. In further interview on February 8, 2022 at 11:00 am, the Office Manager stated in 2021 and 2022 a total of sixteen (16) tests were performed. D5401 PROCEDURE MANUAL Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- 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: I. Based on review of the laboratory's policies, proficiency testing records, and interview with personnel, the laboratory failed to establish and follow policy for twice a year verification of the accuracy of Moh's (Histopathology) testing for one (1) of two (2) years reviewed. Findings: 1. Review of the laboratory's "Proficiency Testing Mohs Micrographic Surgery Skin Specimens" policy revealed "Semi-annually, the tech or Risk Manager will send two cases containing the original slides, label it with only the surgical case number, and send it our [sic]for a microscopic examination by a Board Certified Dermatopathologist." 2. Review of the laboratory's "Quality Assurance Program" under "Histopathology" section revealed "Proficiency testing is required for this service provided by our physician. It is suggested to submit 3 cases every 6 months to an outside Pathologist." 3. Review of the Mohs proficiency testing records for 2020 and 2021 revealed in 2021 the laboratory submitted one (1) case from February and one (1) from March 2021, not semi-annually per laboratory policy. 4. In interview on February 8, 2022 at 12:06 pm, the Medical Assistant stated she thought as long as two were done a year that was acceptable. The Medical Assistant confirmed the proficiency testing for Mohs was not performed on cases semi- annually. II. Based on review of the laboratory's policies, test menu, and interview with personnel, the laboratory failed to establish written procedures for reporting SARS COV-2 results to the state. Findings: 1. Review of the laboratory's policies and procedures revealed the laboratory did not have written procedures for reporting SARS COV-2 results, to include, but not limited to who is responsible, and frequency of reporting to the state. 2. In interview on February 8, 2022 at 11:00 am, the Medical Assistant confirmed the laboratory did not have a written procedure for the reporting of positive and negative SARS COV-2 results to the state. 3. Review of the laboratory's test menu revealed the laboratory performs twenty five (25) SARS COV- 2 tests annually. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedures and interview with personnel, the laboratory failed to have the procedures approved and signed by the Laboratory Director. Findings: 1. Review of the laboratory's policies and procedures revealed the Laboratory Director did not approve/sign the procedures. 2. In intereview on February 8, 2022 at 12:40 pm, the Medical Assistant stated the policy manual was updated and confirmed the Laboratory Director did not sign the policy book. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) -- 2 of 6 -- 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 observation by surveyor, review of manufacturer storage requirements, and interview with personnel, the laboratory failed to monitor the room temperature of the office where SARS COV-2 test kits were stored per manufacturer requirements. Findings: 1. Observation by surveyor during the laboratory tour on February 8, 2022 at 10:50 am revealed the laboratory did not monitor the office where the following supplies were stored: a) Quidel Quickvue SARS Antigen test kits b) Celltrion Diatrust COVID-19 Antigen Rapid test kits 2. Review of the manufacturer storage requirements for the identified test kits revealed the following: a) Quidel Quickvue SARS Antigen test kits: storage requirement 15-30 degrees Celsius b) Celltrion Diatrust COVID-19 Antigen Rapid test kits: 2-30 degrees Celsius 3. In interview on February 8, 2022 at 10:55 am, the Office Manager stated the laboratory does not monitor the temperature of the office where the identified supplies are stored. 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 by surveyor and interview with personnel, the laboratory failed to ensure laboratory supplies did not exceed their expiration dates. Findings: 1. Observation by surveyor during laboratory tour on February 8, 2022 at 10:50 am revealed the following expired items: a) Cancer Diagnostics Tissue Marking Dye, Orange, Lot 9255, Expiration date: 2021-09-30, Quantity: One (1) bottle b) Cancer Diagnostics Tissue Marking Dye, Yellow, Lot 9252, Expiration date: 2021-09-30, Quantity: one (1) bottle c) Cancer Diagnostics Tissue Marking Dye, Red, Lot 9249, Expiration date: 2021-09-30, Quantity: one (1) bottle d) Cancer Diagnostics Tissue Marking Dye, Violet, Lot 9246, Expiration date: 2021-09-30, Quantity: one (1) bottle e) Cancer Diagnostics Tissue Marking Dye, Green, Lot 9254, Expiration date: 2021- 09-30, Quantity: one (1) bottle f) Cancer Diagnostics Tissue Marking Dye, Blue, Lot 9252, Expiration date: 2021-09-30, Quantity: one (1) bottle g) Cancer Diagnostics Tissue Marking Dye, Black, Lot 9253, Expiration date: 2021-09-30, Quantity: one (1) bottle 2. In interview on February 8, 2022 at 11:16 am. the Medical Assistant confirmed the identified marking dyes were expired. D5609 HISTOPATHOLOGY CFR(s): 493.1273(e)(f) (e) The laboratory must use acceptable terminology of a recognized system of disease -- 3 of 6 -- nomenclature in reporting results. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of the laboratory's CMS-209 form, quality control records, policies and procedures, test menu, and interview with personnel, the laboratory failed to ensure testing personnel documented the stain quality for Hematoxylin and Eosin (H&E) stains for six (6) of eight (8) months reviewed. Findings: 1. Review of the laboratory's CMS-209 form (Laboratory Personnel Report) revealed the Laboratory Director serves as the Testing Personnel for Mohs (Histopathology). 2. Review of the laboratory's "Quality Control Policies and Documentation" revealed "stains are checked each day for intended reactivity. A control slide is prepared and approved by the physician prior to any testing. The approval is recorded on a QC log." 3. Review of the laboratory's quality control logs for random selection of eight (8) months revealed the laboratory's testing personnel did not document the stain quality for the following six (6) months reviewed: September 2020 December 2020 February 2021 July 2021 November 2021 January 2022 4. Further review of the laboratory's quality control logs revealed the Laboratory Director discontinued documentation of his review of the slides stain quality in September 2020. 5. In interview on February 8, 2022 at 12:40 pm, the Medical Assistant confirmed the Laboratory Director did not document his review of stain quality for the identified months. The Medical Assistant stated it appeared the Laboratory Director stopped documenting his review in 2020. 6. Review of the laboratory's test menu revealed the laboratory performs 1258 Mohs (Histopathology) tests annually. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) 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)(12) 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 and interview with personnel, the Laboratory Director failed to ensure policies and procedures for assessing personnel competency were maintained. Refer to D6054. 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 -- 4 of 6 -- 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 with laboratory personnel, the Laboratory Director failed to ensure that an approved procedure manual was available to all personnel. Refer to D5407. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on review of policies, personnel records, and interview with personnel, the Technical Consultant failed to evaluate competency annually in 2020 for one (1) of six (6) personnel and six (6) of six (6) personnel in 2021. Findings: 1. Review of the laboratory's policies and personnel records revealed a "KOH Yearly Evaluations by Laboratory Director" form is utilized. 2. Review of personnel records revealed annual KOH competency assessments were not performed for the following: 2020: a) Testing Personnel 2 2021: a) Laboratory Director b) Testing Personnel 1 c) Testing Personnel 2 d) Testing Personnel 3 e) Testing Personnel 4 f) Testing Personnel 5 3. In interview on February 8, 2022 at 12:11 pm, the Medical Assistant stated she did not find the 2021 KOH yearly evaluations for Testing Personnel. D6087 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(iii) The laboratory director must ensure that laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on observation by surveyor, record review, and interview with personnel, the Laboratory Director failed to ensure the laboratory personnel were performing test methods as required. 1. The laboratory failed to monitor the room temperature of the office where SARS COV-2 test kits were stored per manufacturer requirements. Refer to D5413. 2. The laboratory failed to ensure laboratory supplies did not exceed their expiration dates. Refer to D5417. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control 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: -- 5 of 6 -- Based on record review and interview with personnel, the Laboratory Director failed to ensure that a quality control program was maintained to assure the quality of laboratory testing. Refer to D5609. D6106 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(14) The laboratory director must 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 with laboratory personnel, the Laboratory Director failed to ensure that an approved procedure manual was available to all personnel. Findings: 1. the laboratory failed to establish and follow policy for twice a year verification of the accuracy of Moh's (Histopathology) testing for one (1) of two (2) years reviewed. Refer to D5401 I. 2. The laboratory failed to establish written procedures for reporting SARS COV-2 results to the state. Refer to D5401 II. 3. The laboratory failed to have the procedures approved and signed by the Laboratory Director. Refer to D5407. -- 6 of 6 --

Summary Statement of Deficiencies D0000 A Certification survey was performed on September 18, 2019 at Grafton Dermatology and Cosmetic Surgery, CLIA ID # 19D0960403. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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 personnel, the laboratory failed to verify the accuracy of Mycology and Histopathology testing at least twice annually. Findings: 1. Review of the laboratory's test menu revealed the laboratory performs Potassium Hydroxide (KOH) preps and Histopathology testing. 2. Review of the laboratory's records revealed the laboratory did not verify the accuracy of testing for the following: a) KOH preps: verification not performed in 2018 b) Histopathology: verification not performed in 2018 3. In interview on September 18, 2019 at 2:15 pm, the Medical Assistant Supervisor stated the Laboratory Director thought the twice a year verification for Mohs (Histopathology testing) was no longer needed since the laboratory no longer does the diagnosis portion. 4. In further interview on September 18, 2019 at 2:18 pm, the Medical Assistant Supervisor stated the laboratory was unaware KOH preps required a verification of accuracy of its performance. 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 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 -- 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 personnel, the laboratory failed to have a complete policy and procedure manual. Findings: 1. Review of the laboratory's policy and procedure manual revealed the laboratory did not include the following: a) Twice a year verification for accuracy of KOH testing to include frequency, acceptability criteria, and

Summary Statement of Deficiencies D0000 A Certification Survey was conducted on January 24, 2018 at Grafton Dermatology and Cosmetic Surgery-CLIA ID # 19D0960403. The laboratory was found in compliance with 42 CFR 493 Requirement for Laboratories; however, standard deficiencies were cited. 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: ***REPEAT DEFICIENCY from survey November 11, 2015*** Based on observation, record review and interview with personnel, the laboratory failed to document the temperature of the Cryostats for three (3) of seven (7) days reviewed. Findings: 1. Observation by surveyor during laboratory tour on January 24, 2018 revealed the laboratory utilizes the following Cryostats: Leica CM 1510S Leica Avantik QS 11 2. Review of the laboratory's 2017 Cryostat temperature logs revealed the laboratory did not document the temperature in December 2017 for the following three (3) of seven (7) days: December 18, 2017 December 20, 2017 December 22, 2017 3. In interview on January 24, 2018 at 11:30 am, Personnel 7 stated she did not know how documentation after December 15, 2017 was missed. Personnel 7 confirmed the laboratory did not document the Cryostat temperatures for the identified dates. 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 -- D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to document the performance of a control slide for Hematoxylin and Eosin (H&E) Staining utilized for Histopathology slides for three (3) of seven (7) days reviewed. Findings: 1. Review of the laboratory's "Stain Maintenance" policy revealed "A QC worksheet is documented daily on the stain quality and any corrections or changes made." 2. Review of H&E quality control records and MOHS patient logs for December 2017 revealed the laboratory did not document the performance of H&E quality control (QC) for the following three (3) days involving seventeen (17) patients: December 18, 2017: Patients 1 -4 December 20, 2017: Patients 5-12 December 22, 2017: Patients 13-17 3. In interview on January 24, 2018 at 11:30 am, Personnel 7 stated she reviews the books and did not know how documentation after December 15, 2017 was missed. Personnel 7 confirmed the laboratory did not document H&E QC performance for the identified dates. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of