Forefront Dermatology - Mohs Clinic

Summary Statement of Deficiencies D0000 The Montana CLIA Program conducted an announced CLIA recertification survey on January 8, 2026. The laboratory was surveyed under 42 CFR part 493 CLIA regulations and was found to be in compliance with condition-level CLIA requirements. However, the following standard-level deficiencies were identified during the survey. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) (b)(9) 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 a review of 2025 testing personnel records and an interview with the Clinic Supervisor (not listed on the CMS-209 Laboratory Personnel Report form), the technical supervisor failed to perform semiannual competency evaluations for three of three testing personnel (TP) during their first year of high-complexity testing from January 8, 2024, to January 8, 2026. Findings: 1. A review of testing personnel records revealed the laboratory failed to complete the required six-month Mohs Technician evaluation for TP #1, TP #8, and TP #10, as stated in the "Personnel Competency Testing" policy: "initially, 6 months after the start date, and annually thereafter." 2. An interview conducted on January 8, 2026, at 9:30 AM with the Clinic Supervisor (not listed on the CMS-209 form) confirmed the lack of a second evaluation by the technical supervisor for three testing personnel during their first year of high complexity grossing from January 8, 2024, to January 8, 2026. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) 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 -- (b)(9) Thereafter, evaluations must be performed at least annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individuals 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 a review of 2025 testing personnel records and an interview with the Clinic Supervisor (not listed on the CMS-209 Laboratory Personnel Report form), the technical supervisor failed to perform annual competency assessments for three of ten testing personnel (TP) in 2025. Findings: 1. A review of the testing personnel records lacked a 2025 annual Mohs Technician Evaluation for TP #2, TP #3, and TP #10 as stated in the "Personnel Competency Testing" policy: "initially, 6 months after the start date, and annually thereafter." 2. An interview conducted on January 8, 2026, at 9:30 AM with the Clinic Supervisor (not listed on the CMS-209 form) confirmed that three of ten testing personnel did not have a 2025 annual competency assessment completed by the technical supervisor. -- 2 of 2 --

Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on observation, procedures, and an interview with the manager (not listed on the CMS-209 Laboratory Personnel Report (CLIA) form), the laboratory failed to follow their written procedures to label three out of three patient specimen slides prior to processing on June 26, 2024. Findings: 1. Observed in the laboratory on June 26, 2024, at 9:15 AM, a patient's specimen being sectioned and placed onto an unlabeled slide and two unlabeled slides being stained by the automated slide stainer. 2. Laboratory staff failed to follow their procedure and label patient slides with the patient's name, accession number, stage number, and quadrant number prior to processing per their "MOHS Specimen Handling Procedure and Mapping Procedure." 3. An interview with the manager (not listed on the CMS-209 form) on June 26, 2024, at 9:25 AM confirmed the two testing personnel failed to label three out of three patient specimen slides prior to processing on June 26, 2024. D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. 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 -- This CONDITION is not met as evidenced by: Based on a record review of personnel files, procedures, and an interview with the manager (not listed on the CMS-209 Laboratory Personnel Report (CLIA) form), the laboratory failed to ensure testing personnel were qualified prior to performing high complexity testing on patient specimens. (Refer to D6171). D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control -- 2 of 3 -- values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on a review of personnel files, the CMS-209 Laboratory Personnel Report (CLIA) form, and an interview with the manager (not listed on the CMS-209 form), the laboratory failed to ensure three out of fifteen testing personnel (TP) had the appropriate educational background prior to performing high complexity testing from January 4, 2024, to June 26, 2024. Findings: 1. A review of the "Mohs Pros" job description for Mohs Histotechnician included orientation, inking, and specimen grossing, and a review of the MOHS Tech competency evaluation included grossing and mapping. 2. A review of TP #1, TP #11, and TP #14 personnel records lacked an associate degree or higher in a chemical, physical, biological science, or medical laboratory technology prior to performing high complexity testing as authorized by their initial competency assessments from January 4, 2024, to June 26, 2024. 3. An interview with the manager (not listed on the CMS-209 form) on June 26, 2024, at 9: 45 AM stated "testing personnel were contracted through a private company" and confirmed three out of fifteen TP lacked the minimal educational requirement to perform high-complexity testing (grossing, mapping, orientation, and inking) from January 4, 2024, to June 26, 2024. -- 3 of 3 --