Dermatology Associates

Summary Statement of Deficiencies 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: Based on review of laboratory policies and procedures, review of laboratory records, lack of documentation, and interview with the laboratory representative, the laboratory failed to perform bi-annual method accuracy (proficiency testing/peer reviewed histopathology interpretations) at least twice annually for histopathology testing in the year of 2024. Findings include: 1. Review of laboratory policies and procedures revealed the procedure, "Quality Assurance Procedure of Histopathology Interpretation", which stated: a. Under "Procedure", "Twice a year, six randomly selected slides with common histopathological diagnoses, previously reviewed by [the LD], are sent to another physician after the initial diagnostic interpretation has been made." b. Under "Corrective Maintenance", "If staff fail to set up histopathology interpretation every 6 months, our lab director will review the procedure with them, emphasize the importance of conducting the required quality assurance check, and ensure consistent documentation is maintained." 2. Review of laboratory records, including that of bi-annual peer reviewed histopathology interpretations, revealed only one peer reviewed histopathology case was sent out in the year of 2024. Date: Case #: 10/11/2024 24-012 3. Interview with the laboratory representative on 02/06/2025, at 1: 42 pm, confirmed the laboratory failed to perform bi-annual method accuracy at least twice annually for histopathology testing in the year of 2024. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. 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 STANDARD is not met as evidenced by: Based on review of laboratory records, lack of documentation, and interview with the laboratory representative, the laboratory failed to evaluate results of bi-annual method accuracy (proficiency testing/peer reviewed histopathology interpretations) for three of three events from the beginning of 2023 to the date of survey, 02/06/2025. Findings include: 1. Review of laboratory records revealed a lack of documentation of evaluations of results upon receipt of peer reviewed histopathology interpretations for three of three reviewed bi-annual method accuracy events. 2. Interview with the laboratory representative on 02/06/2025, at 1:42 pm, confirmed the laboratory failed to document evaluation of results of peer reviewed histopathology interpretations from the beginning of 2023 to the date of survey, 02/06/2025. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, review of laboratory records, lack of documentation, and interview with the laboratory representative, the laboratory failed to follow policies and procedures regarding bi-annual method accuracy (proficiency testing/peer reviewed histopathology interpretations) for one of three events from the beginning of 2023 to the date of survey, 02/06/2025. Findings include: 1. Review of laboratory policies and procedures revealed the procedure, "Quality Assurance Procedure of Histopathology Interpretation", which stated: a. Under "Procedure", "Twice a year, six randomly selected slides with common histopathological diagnoses, previously reviewed by Dr. Iyengar, are sent to another physician after the initial diagnostic interpretation has been made." b. Under "Corrective Maintenance", "If staff fail to set up histopathology interpretation every 6 months, our lab director will review the procedure with them, emphasize the importance of conducting the required quality assurance check, and ensure consistent documentation is maintained." 2. Review of laboratory records, including that of bi- annual peer reviewed histopathology interpretations, revealed only one peer reviewed histopathology case was sent out in the year of 2024. Date(s): # of Cases: January - June, 2023 Six July - December, 2023 Six October 11, 2024 One 3. Interview with the laboratory representative on 02/06/2025, at 1:42 pm, confirmed the laboratory failed to follow policies and procedures regarding bi-annual method accuracy (proficiency testing/peer reviewed histopathology interpretations) for one of three events from the beginning of 2023 to the date of survey, 02/06/2025. D5805 TEST REPORT CFR(s): 493.1291(c) (c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test -- 2 of 3 -- performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the laboratory representative, the laboratory failed to include the address of the laboratory that performed the histopathology testing for four of four Mohs surgical patient reports reviewed from the beginning of 2023 to the date of testing, 02/06/2025. Findings include: 1. Review of four of four Mohs surgical patient reports for histopathology testing found the laboratory failed to indicate the address of the performing laboratory on the final reports. Patient Accession #: Date of Testing: 146336 02/07/2023 117694 07/25/2023 121541 12/08/2023 174326 10/11/2024 2. Interview with the laboratory representative on 02/06/2025, at 1:13 pm, confirmed the laboratory failed to include the address of the laboratory that performed the histopathology testing for four of four Mohs surgical patient reports reviewed from the beginning of 2023 to the date of testing, 02/06/2025. D6092 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iv) (e)(4)(iv) An approved

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 laboratory records and interview with a laboratory representative; the laboratory failed to establish policies and procedures to assess competency for personnel involved in pathology testing. Findings Include: 1. Review of the laboratory's policy and procedure manual found no policy had been established to assess the competency of all personnel involved in pathology testing. 2. On survey date 08-27-2019 at 1:52 pm, the office manager confirmed the laboratory failed to establish a competency assessment policy for personnel involved in pathology testing. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with a laboratory representative; the laboratory failed to establish a procedure manual for all tests performed in the specialty of pathology. Findings Include: 1. Review of laboratory's policy and procedure manual revealed the laboratory failed to have procedure in place for the 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 -- interpretation of pathology slides. 2. On survey date 08-27-2019, at 1:52 pm, the office manager confirmed the laboratory failed to have a procedure for the interpretation of pathology slides. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on review of laboratory records, direct observation, and interview with a laboratory representative; the laboratory failed to establish and document preventative maintenance for the microscope used for the specialty of pathology. Findings Include: 1. Direct observation of the laboratory testing facility on 08-27-2019 at 11:50 am identified an Olympus BX43 microscope used for pathology slide reading. 2. Review of the laboratory's policy and procedure manual revealed the laboratory failed to establish a preventative maintenance protocol and document maintenance activities for the Olympus BX43 microscope. 3. Interview with the office manager at 1:52 pm on 08-27-2019 confirmed the laboratory failed to establish a maintenance protocol for the microscope and document maintenance activities. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with a laboratory representative; the laboratory's test reports failed to indicate the name and address of where testing was performed for 5 of 5 pathology test reports reviewed. Findings Include: 1. Review of 5 of 5 patient test reports (Patient Identifiers: P1, P2, P3, P4, P5) for pathology testing failed to indicate the following: a. The name and address of the laboratory location where the grossing and interpretation of pathology slides was performed. 2. During survey date on 08-27-2019, at 1:52 pm, the above findings were confirmed by the office manager. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) -- 2 of 3 -- 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 laboratory records and interview with a laboratory representative; the laboratory director (LD) failed to ensure a quality assessment program was established and maintained to assure the quality of laboratory services provided. Findings Include: 1. Review of the laboratory's policy and procedure manual revealed the laboratory failed to establish quality assessment program. 2. On survey date 08-27- 2019 at 1:52 pm the office manager confirmed the LD failed to establish a quality assessment program. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the laboratory director (LD); the laboratory director failed to specify, in writing, the responsibilities and duties for all personnel engaged in the preanalytic, analytic, and postanalytic phases of testing for pathology. Findings Include: 1. Review of the laboratory's policy and procedure manual revealed the LD failed to specify, in writing, the responsibilities and duties of each person engaged in the performance of pathology testing. 2. On survey date 08-27-2019 at 1:52 pm, the office manager confirmed the LD failed to specify, in writing, the responsibilities and duties for all the personnel involved in pathology testing. -- 3 of 3 --