Golden Coast Dermatology, Skin Cancer

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 policies and procedures manuals, personnel competency assessment records, review of eight (8) randomly selected patient test results and interview with the Histology Technician (HT) on April 10, 2025, the laboratory failed to establish and follow written policies and procedures to assess testing personnel competency. The findings include: 1. It was the practice of the laboratory to perform Mohs Micrographic Surgery. The Histology Technician (HT) was responsible for performing grossing and preparing slides for histological analysis. 2. The laboratory's HT affirmed on April 10, 2025, at approximately 1:30 pm, that the laboratory did not have written policies and procedures for assessment of employee competency and maintained no documentation for competency assessment for 1 of 1 HT. 3. The laboratory's testing declaration form, signed by the laboratory director on April 8, 2025, stated that the laboratory performed approximately 200 histopathology tests annually. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. 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 policies and procedures manuals and interview with the Laboratory Director (LD) on April 10, 2025, it was determined that the current laboratory director failed to meet the standard requirement to approve, sign, and date all policies and procedures. The findings include: 1. It was the practice of the laboratory to perform Mohs Micrographic Surgery. 2. On April 10, 2025, at approximately 2:00 pm, the LD affirmed that the laboratory maintained no documentation indicating that written policies and procedures had been approved, signed, and dated by the current laboratory director. 3. The laboratory's testing declaration form, signed by the laboratory director on April 8, 2025, stated that the laboratory performed approximately 200 histopathology tests annually. 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 interview with Laboratory Director (LD), review of Eight (8) random patient sampling, review of laboratory's policies and procedures manuals and personnel competency assessment records on April 10, 2025, it was determined that the Laboratory failed to provide overall management and direction in accordance with 493.1445 of this subpart. The findings include See D5209 and D5407. -- 2 of 2 --

Summary Statement of Deficiencies 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 review of the laboratory's policies and procedures (P&P), the laboratory reports, quality assurance documents, and interview with the laboratory personnel and the laboratory director, it was determined that the current laboratory director failed to approve, review, sign and date the laboratory's procedures. The findings included: a. Based on 8/20/21 interview with the laboratory personnel and the laboratory director, the laboratory's operation activities were found inconsistent with its written policies and procedures. b. The current laboratory owner took control of the laboratory operations on March 1, 2021, and the current laboratory director/owner took directorship effective on May 1, 2021. c. There was no evidence that the current laboratory director approved, signed, and dated the laboratory's policies and procedures or manuals, at the time of the inspection (8/20/21). D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. 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 laboratory's Mohs Surgery Map (MSM) reports along with the tissue slides, written policies and procedures (P&P), and interview with the laboratory personnel, it was determined that the laboratory failed to follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems. The findings included: a. The laboratory performed Mohs surgery and processed histopathology tissue slides for examination onsite. b. At the time of survey, (8/20/21 @ 12:25 PM), review of 6 patient's Mohs Surgery Map (MPS) reports along with the slides, one of the 6 cases identified as GC21-24, was found inconsistent information between the slide labeling and the MPS report date. c. The date indicated 5/5/21 on the MPS report, while the date of 5/27/21 was marked on the slide labeling. d. Further review of the laboratory's "QUALITY ASSURANCE", it stated that "Monthly the nurse or tech will check off the Monthly Quality Assurance Checklist. ..." to perform QA monthly with a checklist. e. There were no QA checklist records available for Monthly Quality Assurance Checklist shown after May 1, 2021, which was the effective date of the current laboratory and the laboratory director took the responsibility for the laboratory operations. f. The laboratory failed to follow the written P&P to perform monthly QA checklist as stated. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures (P&P), the laboratory Mohs Surgery Map reports with tissue slides, quality assurance documents, interview with the laboratory personnel and the laboratory director, it was determined that the current laboratory director failed to ensure that the quality assessment programs were established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. The findings included. a. Based on review of the laboratory's records, interview (8/20/21) with the laboratory personnel and the laboratory director, the laboratory failed to follow its written P&P (see D-5791) b. The current laboratory owner took control of the laboratory operations on March 1, 2021, and the current laboratory director/owner took directorship effective on May 1, 2021, the current laboratory director failed to approve, review, sign, and date of the laboratory's policies and procedures (see D-5407). -- 2 of 2 --