Unmh Dermatology

Summary Statement of Deficiencies D0000 An offsite paper revisit conducted on August 5, 2025, for UNMH Dermatology found the laboratory to be in compliance with the CLIA regulations found at 42 CFR, Part 493 Laboratory Requirements. 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 a review of the facility's test menu, Centers for Medicare and Medicaid (CMS) 209 personnel form, lack of documentation, and interview with the Unit Director, the laboratory failed to verify the accuracy at least twice annually for mineral oil scabies testing in 2024 and 2025. Findings Included: 1. A review of the facility's test menu listed the facility performing mineral oil scabies testing. 2. A review if the CMS 209 personnel form listed two personnel (TP 2 and TP3) performing mineral oil scabies testing. 3. The laboratory failed to provide documentation verifying the accuracy at least twice annually for mineral oil scabies testing. 4. An interview on 07/17/2025 at 9:30 am with the Unit Director confirmed the above findings. 5. The laboratory reported performing 10 mineral oil scabies tests annually. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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. 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 review of the Mohs Micrographic Surgery policy, the Lecia Cryostat operator's manual, Mohs Lab Temp Log, and interview with the Unit Director, the laboratory failed to follow their own policies by not recording humidity for 2024 and 2025 and not recording daily temperature for six days in 2024 and 3 days in 2025. Findings included: 1. Review of the Mohs Micrographic Surgery policy, under section 11 Maintenance, stated, "Daily record temperatures of the cryostat and the room, and record humidity" 2. A review of the Lecia Cryostat operator's manual listed the relative humidity for operation as 20 to 60 % and for storage and transport as 10 to 85 %. 3. A review of the Mohs Lab Temp Log revealed the laboratory failed to document humidity in 2024 and 2025 4. A review of the Mohs Lab Temp Log also revealed the laboratory failed to document temperatures for the cryostat and room for the following days. - 07/24/2024 - 08/15/2024 - 08/21/2024 - 08/22/2024 - 08/28/2024 - 11/23/2024 - 05/21/2025 - 05/22/2025 - 05/26/2025 5. An interview on 07/17/2025 at 10:30 am with the Unit Director confirmed the above findings. 6. The laboratory reported performing 2,340 mohs tests annually D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. The procedures for evaluation of the competency of the staff must include, but are not limited to-- This STANDARD is not met as evidenced by: Based on a review of the facility's test menu, Centers for Medicare and Medicaid (CMS) 209 personnel form, the Mineral Oil Preparation: Scabies Testing procedure, lack of documentation, and interview with the Unit Director, the technical consultant failed to perform annual competency assessments for mineral oil scabies testing for two of two testing personnel in 2024 and 2025. Findings Included: 1. A review of the facility's test menu listed the facility performing mineral oil scabies testing. 2. A review of the CMS 209 personnel form listed two personnel (TP 2 and TP3) performing mineral oil scabies testing. 3. A review of the Mineral Oil Preparation: Scabies Testing procedure, under section 5 Competency, stated, "There is no competency." 4. The laboratory failed to provide documentation of annual competency assessments being done for mineral oil scabies testing. 5. An interview on 07/17/2025 at 10:00 am with the Unit Director confirmed the above findings. 6. The laboratory reported performing 10 mineral oil scabies tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An onsite initial survey conducted at UNM Dermatology on February 22, 2024, found the laboratory to be out of compliance with the CLIA regulations found at 42 CFR, Part 493 Laboratory Requirements, with the following conditions not met: D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of CMS 209 form, American Proficiency Institute (API) proficiency testing (PT) records and interview, the laboratory failed to ensure KOH (potassium hydroxide) PT samples were entered into routine testing workload and tested by different personnel for 2 of 3 PT events in 2023. Findings included: 1. Review of CMS 209 form showed 5 testing personnel listed as moderate complexity performing KOH testing. 2. Review of the API proficiency testing attestation forms from 2023 revealed the following: 1. Event 2 of 2023: Only signed by testing personnel #2. No other testing personnel indicated. 2. Event 3 of 2023: Only signed by testing personnel #2. No other testing personnel indicated. 3. Interview on 2/22/2024 at 10:00am with Unit Director confirmed the findings. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. 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 -- This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) proficiency testing (PT) records and interview, the laboratory failed to have the laboratory director or assigned designee sign the attestation forms for 2 of 3 PT events in 2023. Findings included: 1. Review of the API proficiency testing attestation forms from 2023 revealed the following: 1. Event 2 of 2023: Only signed by testing personnel #2, not laboratory director or designee 2. Event 3 of 2023: Only signed by testing personnel #2, not laboratory director or designee 2. Interview on 2/22/2024 at 10:53am with Unit Director confirmed the findings. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of American Proficiency Institute (API) proficiency testing (PT) records and interview, the laboratory failed to achieve satisfactory performance of 80% or greater for potassium hydroxide (KOH) testing for 2 of 3 consecutive PT events in 2023. Refer to D2046. D2046 MYCOLOGY CFR(s): 493.827(e) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) proficiency testing (PT) records and interview, the laboratory failed to achieve satisfactory performance of 80% or greater for potassium hydroxide (KOH) testing for 2 of 3 consecutive PT events in 2023. Findings included: 1. Review of the API proficiency testing records from 2023 revealed the following unsatisfactory PT scores for KOH testing. 1. Event 1 of 2023: KOH PT not submitted; facility received score of 0% 2. Event 2 of 2023: -- 2 of 5 -- KOH PT score of 0% 2. Interview on 2/22/2024 at 10:00am with Unit Director confirmed the 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 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 Mohs (micrographically oriented histographic surgery) Micrographic Surgery Procedure and interview, the laboratory failed to list intended reactivity for their hematoxylin and eosin (H&E) stain for 2340 of 2340 patient slides in 2023 Findings included: 1. Review of Mohs Micrographic Surgery Procedure showed general requirements for quality control of slides but no mention of intended reactivity for the H&E stain. 2. Laboratory was asked to provided documentation of intended reactivity. None was provided. 3. Interview on 2/22/2023 at 10:30 with the histotechnician confirmed the findings. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of Patient and Quality Control: KOH (potassium hydroxide) and Mineral Oil log, and interview, the laboratory failed to ensure the quality control (QC) for KOH was acceptable prior to reporting patient results for 12 (P1, P2, P3, P7, P8, P9, P10, P11, P13, P14, P15, P16) of 16 (P1-P16) patients from May through July of 2023. Findings included: 1. Review of Patient and Quality Control: KOH and Mineral Oil log, showed the following patients missing QC results for KOH testing: 1.P1: 802171 2.P2: 4258847 3.P3: 4462773 4. P7: 4805556 5. P8: 5758816 6. P9: 4158550 7. P10: 4260910 8. P11: 5522574 9. P13: 5226077 10. P14: 5078731 11. P15: 165397947 12. P16: 5423063 Log also revealed 5 undated entries and missing initials of providers performing testing. 2. Interview on 02/22/2024 at 11:00 am with Unit Director confirmed the findings. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the -- 3 of 5 -- condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on patient reports and interview, the laboratory failed to include the facility name and address on 2 of 2 patient reports for December of 2023. Findings included: 1. Record review of 2 (P17, P18) dermatology patient reports pulled from December of 2023 showed the facility name and address were not included in the report. 2. Interview on 02/22/2024 at 2:00 pm with Unit Director confirmed the findings. 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 American Proficiency Institute proficiency testing (PT) records, CMS 209 form, and interview, the Laboratory Director failed to provide overall management and direction as evidenced by: 1. The Laboratory Director failed to ensure successful participation for potassium hydroxide (KOH) testing for 2 of 3 consecutive PT events in 2023. Refer to D6089. 2. The Laboratory Director failed to ensure competency assessments were completed for 5 of 5 testing personnel performing KOH testing in 2023. Refer to D6103. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute proficiency testing (PT) records, and interview, the laboratory director failed to ensure successful participation for potassium hydroxide (KOH) testing for 2 of 3 consecutive PT events in 2023. Refer to D2046 D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must 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: -- 4 of 5 -- Based on review of CMS 209 form and interview, the laboratory director failed to ensure competency assessments were being done for 5 of 5 testing personnel performing KOH (potassium hydroxide) testing in 2023. Findings included: 1. Review of CMS 209 form showed 5 testing personnel listed as moderate complexity performing KOH testing. 2. The laboratory was asked to provide documentation of competency assessments being completed for testing personnel annually. None were provided. 3. During a phone interview on 02/22/2024 at 1:35 pm the laboratory director, confirmed findings and stated they were unaware of any competency assessments taking place and had not been signing off on any. -- 5 of 5 --

Summary Statement of Deficiencies D0000 The following deficiencies were cited as the result of a recertification survey on 12/09 /2020 for 42 CFR part 493 Laboratory Requirements. D2039 MYCOLOGY CFR(s): 493.827(b) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3)The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on the review of 2019-2020 proficiency test records and interviews with laboratory staff, the laboratory failed to submit test results for KOH (Potassium Hydroxide) tests (used to identify fungal elements under a microscope) for 2 events in 2019. Findings are: A. Review of 2019 proficiency test records from American Proficiency Institute (API) revealed the laboratory failed to submit test results for the 1st and 3rd events. 1. 2019 - 1; results printed on 03/26/2019 Note on results: "Plan - enter results the same day the test is returned to me. Acknowledge reminder emails." 2. Notes for the 2019 - 3 event indicated the proficiency agency (API) had sent 2 photos with the same name for the event. "Received two specimens/slides both labeled API-2019 KOH-05" "KOH - 06 replacement rec'd later than 05" B. Review of the "[Facility Name] Dermatology Clinic Laboratory Procedure" and "Quality Improvement Plan" signed by the previous Laboratory Director (now Testing Person #1) on 12/04/20 revealed no process for Proficiency Testing including corrective 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 -- actions. C. During interview on 12/08/2020 at 03:36 pm, Testing Person #1 stated that "perhaps" the Director of Dermatology didn't get the proficiency testing modules to her on time. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on the review of 10 (PT#1-PT#10) of 10 (PT#1-PT#10) Patient Final Reports, the Mohs (surgical procedure that uses the microscope to examine removed tissue for cancer cells) patient log for 2019 and 2020, and interview with the Laboratory Director, the laboratory failed to ensure positive patient identification from the specimens unique (Slide ID number and Mohs case number) collection through reporting of results. Findings are: A. Review of 10 (PT#1-PT#10) Final Operative Reports revealed; 1. Patient Final reports did not contain the unique identifier (Mohs Case number) on the slide and on the Mohs patient log, linking the slide to the operative report. 2. Two patient reports (PT#1, PT#10) out of 10 reviewed were collected from multiple (2) sites and (2) separate operative reports, one for each site. The Final Reports for PT#1 and PT#10 did not include the Mohs case number found on the slide. The slides were also labeled with the level (the depth of the surgical incision) as indicated by a letter/number system such as A1, A2, B1 or B2, In order to locate the site-specific sample slide for each site, a map indicating the location of excision and the slide ID numbering pattern, a separate document, had to be retrieved from the patient electronic record. PT#1 - tested on 2/6/2019, MRN (Medical Record Number )#4358847 - Excision site #1 (forehead) - Mohs# D19-25 - Slide # A1-2, A2- 3 (multiple slides prepared for this site) PT#1 - tested on 2/6/2019, MRN#4358847 - Excision site #2 (left eyelid) - Mohs#D19-26 - Slide # A3-2, A4-2 (multiple slides prepared for this site) PT#10 - tested on 11/18/2020, MRN#5280127 - Excision site #1 (Left Lower leg) - Mohs#D20-179 - Slide # A1-3, A2-3 (multiple slides prepared for this site) PT#10 - tested on 11/18/2020, MRN#5280127 - Excision site #2 (Right Lower leg) - Mohs#D20-180 - Slide # A3-4 (multiple slides prepared for this site) 4. Eight other patient electronic records also did not contain the unique identifier (Mohs Case number) on the slide and on the Mohs patient log, linking the slide to the operative report. PT#2 - tested on 4/3/2019, MRN#5501877 - Excision site #1 (Left Ala (nasal) - Mohs#D19-60 - Slide # A1-2, A2-2, B1-4, C1-2 (multiple slides prepared for this site). PT#3 - tested on 6/19/2019, MRN#5503632 - Excision site #1 (Right Lower eyelid) - Mohs#D19-98 - Slide # A1-6, B1-2, B2-2, B3-2, B4-2 (multiple slides prepared for this site). PT#4 - tested on 08/21/2019, MRN#4588530 - Excision site #1 (Left Dorsal Hand) - Mohs#D19-129 - Slide # A1-3, A2-5 (multiple slides prepared for this site). PT#5 - tested on 10/09/2019, MRN#561861 - Excision site #1 (Left Forehead) - Mohs#D19-150 - Slide # A1-3, A2-3 (multiple slides prepared for this site). PT#6 - tested on 12/04/2019, MRN#275757 - Excision site #1 (Left Nose) - Mohs#D19-174 - Slide # A1-4, A2-2, A3-3 (multiple slides prepared for this site). PT#7 - tested on 04/15/2020, MRN#4963966 - Excision site #1 (Right Nasal Rim (ala)) - Mohs#D20-62 - Slide # A1-2, A2-2, B1-3, B2-2 (multiple slides prepared for this site). PT#8 - tested on 07/08/2020, MRN#4617299 - Excision site #1 (left temple) - Mohs#D20-109 - Slide # A1-2, A2-3, B1-3, B2-4 (multiple slides prepared -- 2 of 5 -- for this site). PT#9 - tested on 08/12/2020, MRN#5269471 - Excision site #1 (left nasal labial fold) - Mohs#126 - Slide # A1-3 (multiple slides prepared for this site). 2. During interview on 12/09/20 at 4:00 pm, the Laboratory Director acknowledged that the patient final reports did not contain the unique slide# identifier. 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 the review of 2019-2020 proficiency test records and interviews with laboratory staff, the laboratory failed to have a proficiency testing