Canyon Dermatology

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and recertification is recommended. Standard level deficiencies were cited. 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 review of the laboratory's policies and procedures, reagent log, interview, and presurvey paperwork, the laboratory failed to retain the open date of the chemicals and stains used in the laboratory in Mohs processing for two of two years reviewed. Findings follow. A. Review of the laboratory's policy and procedure titled Laboratory Procedure Manual Histopathology- Mohs Surgery under 4.3.3 stated "Do not use reagent after expiration date." B. Review of the reagent log from 08/22/2022 - 08/21/2024 was missing the open date of the chemicals and stains. Without the open date, the laboratory cannot ensure reagents were used within their expiration date. C. Interview with the Office Manager on August 21, 2024 at 0945 hours in the breakroom confirmed the laboratory did not retain the open date for the chemicals and stains. D. Review of the CMS Form 116 showed an estimated annual volume of 420 Mohs stages. 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. 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 -- This STANDARD is not met as evidenced by: Based on review of Mohs accuracy assessments, interview, and presurvey paperwork, the laboratory failed to access accuracy of its Mohs testing for one of two years reviewed. Findings follow. A. Review of the laboratory's accuracy assessment records from 2022 and 2023 showed the 2023 peer reviews did not state the peer agreed with clear margins on the final stage, accurate maps and slides, and slide quality. B. Interview with the Office Manager on August 21, 2024 at 0930 hours confirmed there was no written statement from the peer stating her assessment of the case for the peer reviews in 2023, and the office manager filled in the form showing "matched diagnosis= yes" on the peer review summary. C. Review of the CMS Form 116 showed an estimated annual volume of 420 Mohs stages. 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 review of the laboratory's policies and procedures, Mohs logs, presurvey paperwork, and interview, the laboratory failed to follow its own policy to document the number of slides per case for two of two years reviewed. Findings follow. A. Review of the laboratory's policy and procedure titled Laboratory Procedure Manual Histopathology- Mohs Surgery under 3.4 Specimen Handling, Storage, Preservation and Identification stated, "3.4.6 Patient name, site, date, Mohs surgeon and laboratory technician is written on Mohs log, along with total number of slides processed." B. Review of the Mohs logs from 08/22/2022 - 08/21/2024 showed the number of slides per case was not recorded. C. Review of the CMS Form 116 showed an estimated annual volume of 420 Mohs stages. D. Interview with the Office Manager on August 21, 2024 at 1155 hours in the breakroom confirmed the findings. 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 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 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 review of quality control procedures, H&E quality control records, patient test records and interview of facility personnel, the laboratory failed to document the negative and positive reactivity of quality control slides for Hematoxylin and Eosin (H &E) staining on each day of patient testing between June 2021 and August 2022. THIS IS A REPEAT DEFICIENCY FROM THE MARCH 2021 INSPECTION. The findings included: 1. Review of the procedure titled 493.1705 QUALITY CONTROL ASSESSMENT FOUND: "1. Quality control values are documented every working day. 2. These values are reviewed individually and consecutively by the doctor. 3. If a failure of a control value occurs, the source of the failure is determined and corrective measures will be taken and documented. 4. There are logs for all equipment (microscope, room temperature, centrifuge and Mohstech equipment). These are to be updated each working day and reviewed by the doctor." 2. Based on review of H and E stain quality control records between June 2021 and September 22, 2022 found 0 entries of quality control reactivity documentation. The form contained information regarding the lot numbers for the Hematolylin (lot 1915730 expiration 06/12/21) and Eosin (lot 2019607 expiration 07/28/2022). No additional records were available for review. 3. Review of patient test records found 741 patient specimens tested with no documentation of quality control procedures as follows: June 23, 2021 - 17 patients had Mohs surgical procedures with no documentation of negative and positive staining reactivity for the H and E stains. June 24, 2021 - 25 patients had Mohs 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 -- surgical procedures with no documentation of negative and positive staining reactivity for the H and E stains. July 15, 2021 - 22 patients had Mohs surgical procedures with no documentation of negative and positive staining reactivity for the H and E stains. July 16, 2021 - 12 patients had Mohs surgical procedures with no documentation of negative and positive staining reactivity for the H and E stains. August 23, 2021 - 24 patients had Mohs surgical procedures with no documentation of negative and positive staining reactivity for the H and E stains. August 24, 2021 - 20 patients had Mohs surgical procedures with no documentation of negative and positive staining reactivity for the H and E stains. September 22, 2021 - 24 patients had Mohs surgical procedures with no documentation of negative and positive staining reactivity for the H and E stains. September 23, 2021 - 22 patients had Mohs surgical procedures with no documentation of negative and positive staining reactivity for the H and E stains. October 20, 2021 - 21 patients had Mohs surgical procedures with no documentation of negative and positive staining reactivity for the H and E stains. October 21 - 26 patients had Mohs surgical procedures with no documentation of negative and positive staining reactivity for the H and E stains. November 17, 2021 - 22 patients had Mohs surgical procedures with no documentation of negative and positive staining reactivity for the H and E stains. November 18, 2021 - 32 patients had Mohs surgical procedures with no documentation of negative and positive staining reactivity for the H and E stains. December 15, 2021 - 30 patients had Mohs surgical procedures with no documentation of negative and positive staining reactivity for the H and E stains. December 16, 2021 - 35 patients had Mohs surgical procedures with no documentation of negative and positive staining reactivity for the H and E stains. January 19, 2022 - 28 patients had Mohs surgical procedures with no documentation of negative and positive staining reactivity for the H and E stains. January 20, 2022 - 20 patients had Mohs surgical procedures with no documentation of negative and positive staining reactivity for the H and E stains. February 23, 2022 - 36 patients had Mohs surgical procedures with no documentation of negative and positive staining reactivity for the H and E stains. February 24, 2022 - 20 patients had Mohs surgical procedures with no documentation of negative and positive staining reactivity for the H and E stains. March 23, 2022 - 9 patients had Mohs surgical procedures with no documentation of negative and positive staining reactivity for the H and E stains. March 24, 2022 - 27 patients had Mohs surgical procedures with no documentation of negative and positive staining reactivity for the H and E stains. April 20, 2022 - 12 patients had Mohs surgical procedures with no documentation of negative and positive staining reactivity for the H and E stains. April 21, 2022 - 31 patients had Mohs surgical procedures with no documentation of negative and positive staining reactivity for the H and E stains. May 25, 2022 - 14 patients had Mohs surgical procedures with no documentation of negative and positive staining reactivity for the H and E stains. May 26, 2022 - 31 patients had Mohs surgical procedures with no documentation of negative and positive staining reactivity for the H and E stains. June 16, 2022 - 37 patients had Mohs surgical procedures with no documentation of negative and positive staining reactivity for the H and E stains. July 20, 2022 - 13 patients had Mohs surgical procedures with no documentation of negative and positive staining reactivity for the H and E stains. July 21, 2022 - 42 patients had Mohs surgical procedures with no documentation of negative and positive staining reactivity for the H and E stains. August 18, 2022 - 47 patients had Mohs surgical procedures with no documentation of negative and positive staining reactivity for the H and E stains. September 21, 2022 - 42 patients had Mohs surgical procedures with no documentation of negative and positive staining reactivity for the H and E stains. 3. Review of the procedure titled MOH's section procedure found: " once slide is stained and coverslipped check quality under Mohs scope and deliver to testing personnel for review ". There was no legend of symbols used for quality control -- 2 of 3 -- responses in the procedure. 4. Interview of office staff conducted on September 22, 2022 at 9:53 AM confirmed that she had no other records available for review that might document intended reactivity of negative and positive control tissues each day of patient testing for H and E staining. 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: The laboratory director failed to establish and maintain the quality control program for Hematoxylin and Eosin staining of tissue specimens to include intended reactivity of positive and negative staining materials used in Histopathology testing. (see D5473 ) -- 3 of 3 --

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: Review of facility peer review records, and interview of facility personnel found that the laboratory failed to verify the accuracy of results for two of two peer reviews for Mohs surgical procedures in 2020. The findings included: 1. Review of the document titled Peer reviews (for 2019 and 2020) found the laboratory provided columns for documenting the case sent for review, the performing physician and the reviewing physician, as well as a column for matched diagnosis. Information recorded for 2019 and 2020 peer reviews on this document: PID 021519-07 Site L Cheek performed by Testing person 2, Peer review testing person 1 date reviewed 02/19/2019, Matched PID 052419-02 Site Ldist pretib performed by Testing person 2, Peer review testing person 1, date reviewed 05/29/2019, Matched PID 013120-22 Site L inflat neck performed by Testing person 2, Peer review Testing Person 1date reviewed 02/04 /2020, no documentation of results matching or not PID 101620-04 Site L sup helix performed by Testing person 2, Peer review Testing Person 1, date reviewed 10/21 /2021 no documentation of results matching or not Review of the Pathology reports for the cases submitted for peer review found: PID 021519-07 Site L Cheek performed by Testing person 2, Peer review testing by outside physician, date reviewed 02/19/2019, Matched PID 052419-02 Site Ldist pretib performed by Testing person 2, Peer review testing person 1, date reviewed 05/29/2019, Matched PID 013120-22 Site L inflat neck performed by Testing person 2, Peer review Testing Person 1date reviewed 02/04/2020, no documentation of results matching or not PID 101620-04 Site L sup helix performed by Testing person 2, Peer review Testing Person 1, date reviewed 10/21/2021 no documentation of results matching or not Additional records were requested to support the peer review records but 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 -- provided. Interview of office personnel conducted on March 23, 2021 at 09:00 AM found that testing person 1 left in the summer of 2019 to assume the responsibilities of a political appointment. He contracted with a local physician to continue offering Mohs surgical procedures in his absence. She went on to say that these were "the records faxed from California and this was all she had". 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: Observations made during the tour of the facility found that the laboratory failed to ensure that expired marking dyes were not available for use in patient testing. The findings included: 1. Observations made during the tour of the laboratory conducted March 23, 2021 at 10: 03 AM found expired tissue Marking Dyes StatLab Red tissue Marking Dye lot 076456 expiration 2021-02-01 StatLab Blue Tissue Marking Dye lot 076195 expiration 2021-01-01 and CDI Tissue Marking Dye lot 6137 expiration 2017- 10-01 2. Interview of the office staff conducted on March 23, 2021 learned that she had no idea what they were used for or if they were used in patient testing. 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 review of quality control records, patient test records, MOHS procedures and interview of facility personnel, the laboratory failed to document the negative and positive reactivity of quality control slides for Hematoxylin and Eosin (H and E) staining on each day of patient testing between January 2019 and March 2021. The findings included: 1. Based on review of H and E stain quality control charts between January 2019 through December 2020 the laboratory documented acceptability of stain reactivity using the initials CD in the column titled acceptable for each date represented. There was no key to define the CD response. Review of the 2021 H&E Stain Quality Control Chart found 0 entries of quality control documentation. The form contained information regarding the lot numbers for the Hematolylin (lot 1915730 expiration 06/12/21) and Eosin (lot 2019607 expiration 07/28/2022). 2. Review of patient test records for 2021 found patients tested with no documentation of quality control procedures as follows: January 29, 2021 - 15 patients had Mohs surgical procedures with no documentation of negative and positive staining reactivity for the H and E stains. March 5, 2021 - 11 patients had Mohs surgical procedures with no documentation of negative and positive staining reactivity for the H and E stains. March 19, 2021 - 14 patients had Mohs surgical procedures with no documentation of negative and positive staining reactivity for the H and E stains. 3. Review of the -- 2 of 3 -- procedure titled MOH's section procedure found: " once slide is stained and coverslipped check quality under Mohs scope and deliver to testing personnel for review ". There was no legend of symbols used for quality control responses in the procedure. 4. Interview of office staff conducted on March 23, 2021 at 10:28 AM confirmed that testing person returned from his political assignment in March 2021, with his first surgical date on March 5, 2021. She went on to explain that she assumed the CD documented in the acceptable column of the H& E stain charts was the initials of the testing personnel. She continued to say the she had no other documents that might document intended reactivity of negative and positive control tissues each day of patient testing for H and E staining. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of testing personnel files, and interview of facility personnel, the Technical Supervisor failed to evaluate and document personnel competency at least semiannually during the first year the individual tests patient specimens for one of two testing personnel performing Mohs histopathology procedures. The findings included: 1. Review of personnel files found testing person two (hired January 2019) had no record of semiannual competency evaluation during the first year of testing. 2. Interview of the office staff conducted on March 23, 2021 at 10:15 AM confirmed that competency assessments had not been performed and documented at least semiannually for the first year of testing for testing person two. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on review of testing personnel files, and interview of facility personnel, the Technical Supervisor failed to evaluate and document personnel competency at least annually after the first year the individual tests patient specimens for one of two testing personnel performing Mohs histopathology procedures. The findings included: 1. Review of personnel files found testing person two (hired January 2019) had no record of annual competency evaluation in 2020. 2. Interview of the office staff conducted on March 23, 2021 at 10:15 AM confirmed that competency assessments had not been performed and documented at least annually for each year after the first year of testing for testing person two. -- 3 of 3 --