High Desert Dermatology

Summary Statement of Deficiencies D0000 An onsite recertification survey conducted at High Desert Dermatology on February 13, 2024, found the laboratory to be out of compliance with the CLIA regulations found at 42 CFR, Part 493 Laboratory Requirements, with the following condition not met: 493.1441 - Laboratory Director (high complexity) D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of laboratory records, and staff interview, the laboratory director failed to provide overall management and direction as evidenced by: 1. The laboratory director failed to establish a written quality assessment program. Refer to D6094 2. The laboratory director failed to provide an approved procedure manual. Refer to D6106 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 review of laboratory records and staff interview, the laboratory director failed to establish a quality assessment program for 3500 of 3500 patient tests in 2023. 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 -- Findings included: 1. The laboratory was asked to provide documentation indicating a quality assessment program has been established to ensure the quality of laboratory services provided and to identify failures in quality as they occur. No documentation was provided. 2. A review of laboratory records revealed an annual volume of 3500 histopathology patient tests performed. 3. During an interview on 02/13/2024 at 9:00 am with the lead Medical Assistant, confirmed above findings and stated the laboratory does not have written policies and procedures related to the laboratory's quality assessment program. 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 review of laboratory records and staff interview, the laboratory director failed to provide approved procedure manuals available for personnel responisble for the testing process for 3500 of 3500 patients in 2023. Findings included: 1. The laboratory was asked to provide an approved procedure manual available to staff for any aspect of the testing process. No procedures were provided. 2. A review of laboratory records revealed an annual volume of 3500 histopathology tests performed in 2023. 3. During an interview on 02/13/2024 at 9:00 am with the lead Medical Assistant, confirmed above findings and stated the laboratory does not have written policies and procedures related to the laboratory's testing processes. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The following standard deficiences were cited as the results of a recertification survey on 07/11/2022. This facility was found NOT to be in compliance with the CLIA regulations found at 42 CFR for the specialties/subspecialties in which it was surveyed. D5219 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(2) At least twice annually, the laboratory must verify the accuracy of any test or procedure listed in subpart I of this part for which compatible proficiency testing samples are not offered by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on the review of laboratory policy, quality control records, and interview with the laboratory staff, the laboratory failed to perform the twice a year verification of the microscopic evaluation of frozen tissue sections for 2 of 2 assessments in 2020 and 2021. This is a repeat deficiency from 2019. Findings included: A. Review of the laboratory policy revealed the laboratory had no written policy regarding the twice a year verification process. B. Review of quality control/quality assurance records revealed no documentation of the accuracy verification for the microscopic evaluation for 2 of 2 assessments in 2020, and 2 of 2 assessments in 2021. C. During an interview on 07/11/2022 at 3:00 pm, the lead medical assistant stated that she is still learning her job and was not aware of the twice a year verification process. This confirmed the above findings. 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 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 -- 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 laboratory policy, quality logs for the stain, and confirmed in staff interview, the laboratory failed to define intended reactivity for the Hematoxylin and Eosin (H & E) stain to ensure predictable staining characteristics for 6 months reviewed in 2020, and 6 months reviewed in 2021. Findings included: A. Review of the laboratory policy revealed the laboratory had no written policy defining the intended reactivity for the H & E stain to ensure predictable staining characteristics. B. Review of a sampling of the Stain Quality Logs for 6 of 12 months reviewed (June through December), in 2020 and 2021, revealed the Slide Quality was documented as "Excellent". The laboratory failed to define the specific staining characteristics that constitutes a grade of "Excellent" on the log. C. During an interview on 07/11/2022 at 2:30 pm, the lead medical assistant confirmed these findings. -- 2 of 2 --

Summary Statement of Deficiencies D5219 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(2) At least twice annually, the laboratory must verify the accuracy of any test or procedure listed in subpart I of this part for which compatible proficiency testing samples are not offered by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on the review of 2018 - 2019 quality control/quality assurance records and interviews with laboratory staff, the laboratory failed to perform an assessment of the histopathology test system. The laboratory reported reading 3600 histopathology slides per year. Findings are: A. Review of 2017-2019 quality control/quality assurance records revealed no documentation of participation in a twice per year assessment of reading H & E (Hematoxylin & Eosin - a general stain used in the examination of tissues) since 01/22/18 when the Laboratory Director participated in an exam by the New Mexico Dermatological Society. B. During interview on 09/19 /19 at 10:43 am, the Laboratory Director confirmed that he had not participated in a quality assessment activity such as a slide exchange or another test by the New Mexico Dermatological Society. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --