Aspen Dermatology

Summary Statement of Deficiencies 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. This CONDITION is not met as evidenced by: Based on personnel record review and interview with the histotechnician, the laboratory failed to employ qualified testing personnel that meet the educational requirements for high complexity grossing examination in histopathology testing. (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 (b)(2)(i) Have earned a doctoral, master's, or bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (b)(2)(ii) Be qualified under the requirements of 493.1443(b)(3) or 493.1449(c)(4) or (5); or (b)(3)(i) Have earned an associate degree in a laboratory science or medical laboratory technology from an accredited institution or (b)(3)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes (b)(3)(ii) (A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, includes either (b)(3)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(3)(ii)(A)(2) 24 semester hours of science courses that include (b)(3)(ii)(A)(2)(i) 6 semester hours of chemistry; (b)(3)(ii)(A)(2)(ii) 6 semester hours of biology; and (b)(3)(ii)(A)(2)(iii) 12 semester hours of chemistry, 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 -- biology, or medical laboratory technology in any combination; and (b)(3)(ii)(B) Have laboratory training that includes: (b)(3)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES or the CAAHEP (this training may be included in the 60 semester hours listed in paragraph (b)(3)(ii)(A) of this section); or (b)(3)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing; or (b)(4) Successful completion of an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and having held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(5) Notwithstanding any other provision of this section, an individual is considered qualified as a high complexity testing personnel under this section if they were qualified and serving as a high complexity testing personnel in a CLIA-certified laboratory as of December 28, 2024, and have done so continuously since December 28, 2024. (b)(6) For blood gas analysis (b)(6)(i) Be qualified under paragraph (b)(1), (2), (3), (4), or (5) of this section; or (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. (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (f) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on an interview with the histotechnician and review of education records, the laboratory failed to employ qualified personnel to perform gross examinations for high complexity histopathology testing since the last survey performed on 2/27/2024. Findings include: 1. Review of education records for three of seven testing personnel revealed educational requirements were not met for high complexity grossing examination in histopathology testing. 2. During an interview with the histotechnician on 3/26,/2025 at approximately 11:55 a.m. it was confirmed personnel did not meet the high complexity educational requirements for grossing histopathology specimens. -- 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 histopathology frozen section slide review, slide labeling procedure review, and interview with staff, the laboratory failed to follow procedures for the labeling process to follow for multiple sections of specimens for one case for 1 of 11 cases reviewed. Findings include: 1. Histopathology slides for case EM19-04-08 review included 47 slides. The slides were reviewed failed to include the letter for the specimen section and the number of the slide made for each section for stage IV of the case. 2. Procedure review for Mohs frozen section surgery case slide included instruction to labeled each stage with the section number as A, B, C. and each cut from the section as 1,2,3...etc. 3. In an interview with staff on 02/03/2021 at approximately 12:10 P.M. staff confirmed the procedure was not followed for labeling each stage of testing for case EM19-04-08. 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. 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 direct observation and confirmation by staff the laboratory failed to ensure histopathology tissue marking dyes were not used past their expiration dates for 2 of 4 marking dye stains available for use on 02/03/2021 at approximately 9:15 A.M. The laboratory performed approximately 15 to 20 frozen section histopathology cases per week. Findings include: 1. Direct observation of marking dyes lot number 066247 (black) expiration date 05- 2020 and lot number 67796 (orange) expiration date 2020- 06-01. 2. In an interview conducted on 02/03/2020 staff at approximately 12:20 P.M. confirmed the tissue marking dyes were expired. -- 2 of 2 --