Associated Dermatology & Skin Cancer Clinic

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 a review of records and interview with the testing personnel (TP #1), laboratory staff failed to document the intended staining characteristics for each day Tzanck stain was performed on 34 out of 34 patient smears from January 9, 2023, to October 16, 2024. Findings: 1. The laboratory failed to provide documentation of the intended staining characteristics for each day Tzanck stain was performed on patient smears from January 9, 2023, to October 16, 2024. 2. Based on the test volume sheet dated January 9, 2024, 34 patient smears were stained with Tzanck stain. 3. An interview on October 16, 2024, at 10:30 AM with TP #1 confirmed the laboratory staff failed to perform and document the intended staining characteristics for each day Tzanck stain was performed on 34 out of 34 patient smears from January 9, 2023, to October 16, 2024. 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 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of personnel files for 2019 and 2020, General Laboratory Quality Systems Procedure, and interview with testing personnel (TP#6) the laboratory failed to perform competency of 4 out of 6 testing personnel semiannually during the 1st year of employees tests patient specimens and annually thereafter. Findings include: 1. Review of Personnel Records lacked documentation to prove either semiannually competency during the 1st year of patient testing or annual competency of testing personnel for years 2019 and 2020 for 4 out of 6 testing personnel (TP#2, TP#3, TP#5 and TP#6). 2. Review of General Laboratory Quality Systems Procedure states "Training: All new employee training will be documented and competency evaluation at 6 months and 1 year. All laboratory employees will be evaluated every year unless requested earlier by the laboratory manager or laboratory director." 3. Interview on March 4, 2021 at 1:30 PM with testing personnel (TP#6) verified lack of documentation to prove competency assessments. 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: 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 -- Based on review of personnel files and proficiency records for 2019, 2020 revealed, and interview with testing personnel (TP#6) confirmed, the laboratory failed to establish a means to verify the accuracy of its MOHS testing procedures twice a year. Findings include: 1. Review of proficiency records of 2019 and 2020 revealed the laboratory failed to enroll and establish a means to prove accuracy twice a year for MOHS testing procedures. 2. Review of personnel files lacked correlation documentation for 2019 and 2020 to prove twice a year accuracy of MOHS testing procedures. 3. Interview on March 4, 2021 at 2:30 PM with testing personnel (TP#6) verified lack of documentation to prove accuracy twice a year for MOHS testing procedures. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Based on an on-site recertification survey conducted on 4/10/18, deficiencies were cited for Associated Dermatology and Skin Cancer Clinic in Helena, MT. D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on observation, record review, and interview, the laboratory failed to enroll for proficiency testing for dermatophyte test media (DTM) media from 5/6/16 to 4/10/18. The findings include: 1. A review on 4/10/18 at 2:30 p.m. of patient reports with growth on DTM were reported as "Growth on DTM consistent with Corynebacterium, Negative for Dermatophytosis" and "Growth on DTM consistent with Corynebacterium. Negative for fungus." 2. On 4/10/18 at 3:00 p.m., a box of Troy Biologicals DTM media vials (lot number 1713101) was observed in a laboratory refrigerator for growth and identification of yeast, dermatophytes, and fungi. 3. A review on 4/10/18 at 3:30 p.m. of the reportable options programmed into the computer for patient test reports included: a. "Growth on DTM consistent with T- Mentag." b. "Growth on DTM consistent with T-Rubrum." c. "Growth on DTM consistent with Penicillium Mold." d. "Growth on DTM consistent with T. Mentagraphytes." e. "Growth on DTM consistent with Microsporum species." f. "Growth on DTM consistent with Trichophyton species." g. "Growth on DTM 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 -- consistent with Mustelus Canis." h. "Growth on DTM consistent with Corynebacterium." i. "Growth on DTM consistent with Saccharomyces." j. "Growth on DTM consistent with Bacterial Growth." k. "Growth on DTM consistent with Yeast." l. "2nd opinion requested. Sent to State Lab." m. "Positive. Sent to State Lab for identification." n. "No Growth/Negative." o. "Contaminant." p. "Color Change on DTM False Positive." q. "Bacterial over Growth." 4. On 4/10/18 at 3:37 p.m., staff member A stated staff member B and C read the DTM media. Staff member B reports the organism using one of the reportable options while staff member C sends all vials with positive growth to the state lab for identification. 5. A review on 4/10/18 at 4:10 p.m. of the proficiency testing documentation from the American Society of Dermatopathology lacked documentation of proficiency testing for DTM when genus and species levels of yeasts, dermatophytes, and fungi are identified. -- 2 of 2 --