Dermatology Associates

Summary Statement of Deficiencies D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of Histopathology records and interview with the Laboratory Director (LD) during survey 10/17/2022, the laboratory failed to document the dates and cases used to evaluate microscopic proficiency for the two (2) providers performing Mohs surgery and interpretation of the slides prepared during Mohs surgery. Findings include: 1. Upon review of the proficiency records for the two (2) Mohs surgeons performing Mohs surgery, there were no dates or case numbers documented to meet the bi-annual verification requirements required for unregulated analytes for 2021 or 2022. 2. The LD confirmed during interview on 10/17/2022 at approximately 12:00 pm that there was no written documentation of the dates and case numbers used to ensure Mohs slide interpretation provider proficiency bi- annually for 2021 and 2022. 3. This facility had zero (0) out of four (4) required bi- annual verification written documentation with case numbers and dates of assessment for the two (2) providers performing Mohs surgery for 2021 and 2022. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. 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 the Quality Assurance (QA) policy/procedure adopted by this laboratory and interview with the Laboratory Director (LD) during survey 10/17 /2022, the laboratory failed to follow and document in writing their QA activities at least twice per year. Findings include: 1. Upon review of the QA procedure and discussion with the LD, the laboratory failed to follow the procedure with written activities / records as dictated by this procedure for the years 2021 and 2022. 2. Interview with the Histotechnician during survey at approximately 1100 am revealed that he was unaware of any written QA activities for the years 2021 and 2022. 3. Interview with the LD during survey at approximately 1:00 pm confirmed there was no written documentation of QA activities as listed in their QA procedure (#C numbers 1 - 7). 4. At least two monitoring events are required per year for QA. The laboratory had zero (0) out of four (4) QA activities documented in writing for 2021 and 2022. -- 2 of 2 --

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on inspection of 20% potassium hydroxide (KOH) reagents and discussion with one of the providers present during the survey 08/06/2018, the laboratory was using expired KOH material. Findings include: 1. Upon inspection of the two (2) dropper bottles of 20% KOH stored in the drawer by the microscope used by providers performing KOH wet mounts, both were found to be expired. Dropper bottle #1 expired 01/13/2018 (lot #293554). Dropper #2 expired 05/17/2018 (lot # 335254). 2. One of the providers present at survey confirmed using the expired reagent 08/06 /2018 at approximately 1430. 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 records and discussion with staff, the Laboratory Director (LD) failed to fulfill the responsibilities required of the LD. This is a repeat citation. See D6079. 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 -- D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on review of records and discussion with staff, the Laboratory Director (LD) failed to follow the