Redwood Empire Dermatology, Inc

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 the surveyor's review of the laboratory's policy and procedure, proficiency testing (PT) records, patient record documentation, and interviews with the practice manager (PM) and laboratory director (LD); it was determined that the laboratory failed to verify the accuracy of any test or procedure performed at least twice annually for the years 2023 and 2025. The findings include: 1. The laboratory's policy and procedure for proficiency testing stated that provider-performed microscopy (PPM) tests will be performed bi-annually through the use of the American Proficiency Institute or an in-house PT program. However, review of records revealed that it was missed in the years 2023 and 2025. 2. The PM and LD affirmed by interviews on August 27, 2025, at approximately 2:50 p.m., that the laboratory missed the 2023 and 2025 PT assessment as mentioned in statements #1. Thus, the reliability and accuracy of patient tests reported cannot be assured. 3. The laboratory's testing declaration form submitted at the time of the survey stated that 51 tests for PPM were performed and reported annually, including the time when PT was missed for the years 2023 and 2025. D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; and 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 the surveyor's review of the laboratory's policies and procedures, proficiency testing documentation, patient test records and interviews with the practice manager and laboratory director on August 27, 2025, this deficiency is herein cited for failure to perform verification of test accuracy for profiency testing at least twice annually for the years 2023 and 2025 for the testing personnel. See D5217. -- 2 of 2 --

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 2020-2021 laboratory reports and records verifying accuracy of histopathology biopsies and Mohs procedures, it was determined that the laboratory failed to verify the accuracy of testing performed by some of the testing persons. Findings included: 1. The laboratory had a practice of peer review of Biopsy slides and Mohs slides to fulfill the requirement to at least twice annually verify the accuracy of testing performed by each dermatopathologist and each Mohs surgeon. 2. Laboratory records verifying accuracy of Biopsy reports in 2020 - 2021 failed to include peer review of JP and SA. Laboratory reports randomly selected from 2020 - 2021 documented biopsy slides were read, as follows: Biopsy number Report ---------------------------------------- W20 - 035 JP 1/23/20 W20 - 250 SA 4/16/20 W20 - 734 JP 9/25/20 W20 - 898 SA 11/20/20 W21 - 034 JP 1/25/21 3. Laboratory records verifying accuracy of Mohs procedures failed in 2020 to include peer review of KK and HC; and in 2021, at least twice for JC. Laboratory records from 2020 - 2021 documented Mohs procedures, as follows: Mohs Surgeon Mohs Dates --------------------------------------- KK ................ 1/03/20 2/07/20 3/06/20 HC................... 1/10/20 3/02/20 3/16/20 JC....................10/20/21 11/24/21 12/22/21 4. Thus, the reliability and quality of the Biopsy reports and Mohs procedures could not be assured. 5. This continues to be a repeated deficiency, previously cited on 9/04/19. . D5405 PROCEDURE MANUAL CFR(s): 493.1251(c) 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 -- Manufacturer's test system instructions or operator manuals may be used, when applicable, to meet the requirements of paragraphs (b)(1) through (b)(12) of this section. Any of the items under paragraphs (b)(1) through (b)(12) of this section not provided by the manufacturer must be provided by the laboratory. This STANDARD is not met as evidenced by: Based on observation of the Quidel QuickVue SARS-Antigen Test kit (EUA, lot number 707394, expiration date 2022-11-12), review of manufacturer's instructions, the lack of laboratory documents for reporting COVID test results to CalREDIE/ State public health system, which in turn reported to the U.S. Secretary of Health & Human Services, and interview with laboratory personnel, it was determined that the laboratory failed to have a written procedure for reporting COVID test results to CalREDIE. Findings included: 1. Laboratory records titiled "COVID TEST LOG" documented 35 tests performed from 3/02/21 to 7/27/22, including a positive COVID test result on 12/30/21; and that results were reported to CalREDIE from 3/02/21 to 4 /27/21. 2. The laboratory was unable to provide documents/evidence of reporting COVID test results to CalREDIE. 3. The manufacturer omitted instructions for reporting results. The laboratory was unable to provide a written procedure for reporting COVID test results to the State Public Health system/CalREDIE. 4. Testing persons/Medical Assistants affirmed (8/31/22 at 3pm) the lack of a written procedure and that they were unable to provide documents for reporting COVID test results to CalREDIE. 5. The reporting of COVID test results to the Secretary and State Public Health system could not be assured when the laboratory failed to have a written procedure and failed to have evidence of reporting to CalREDIE. . 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: Based on the repeated deficiency of incomplete peer reviews (D5217) and the failure to have a written procedure and retain documents of reporting COVID test results to CalREDIE (D5405), it was determined the laboratory failed to establish ongoing internal audits to monitor, assess, identify, and correct problems to assure continued quality, effectiveness of

Summary Statement of Deficiencies D3027 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(1) Test requisitions and authorizations. Retain records of test requisitions and test authorizations, including the patient's chart or medical record if used as the test requisition or authorization, for at least 2 years. This STANDARD is not met as evidenced by: Based on record review of a random patient sampling from January 1, 2018 through August 29, 2019, and interview with the laboratory director on September 04, 2019, the laboratory failed to retain records of test requisitions for at least 2 years. The findings included: a. A random sampling of six (6) patients from1/11/2018 through 8 /29/2019 histopathology testing records revealed that the laboratory failed to retain requisitions for histopathology patients for (4) of (6) patients reviewed. Date Patient ID Requisition 01/11/2018 W18-040 Present 06/05/2018 W18-521 Present 08/22 /2018 W18-812 Not Retained 04/16/2019 W19-255 Not Retained 07/23/2019 W19- 649 Not Retained 08/29/2019 W19-791 Not Retained b. The laboratory director confirmed by interview on September 04, 2019 at approximately 10:00 a.m. that the laboratory failed to retain the patient histopathology testing requisitions as required by federal regulations for two years, and state law for three years. c. The laboratory reports performing 2000 histopathology patients annually. 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: 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 -- Based on record review of the laboratory's dermatopathology and tissue histopathology testing records and interview with the laboratory director on September 04, 2019, the laboratory failed to establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1), "to at least twice annually verify the accuracy of any test or procedure it performs that is not included in subpart I". The findings included: a. The laboratory performs histopathology and Moh's dermatopathology patient testing. For the survey review period January 1, 2018 through August 29,2019 the laboratory failed to verify the accuracy of its tissue histopathology and dermatopathology Moh's testing performed. b. The laboratory reports on the CMS-209 to have six (6) dermatopathology surgeons, of which (5) perform Moh slide evaluations for determining clearing of cancerous cells and tissue histopathology slide reviews. c. For (6) of (6) testing personnel the laboratory did not have documentation of verification of accuracy for its tissue histopathology or dermatopathology Moh's testing. d. The laboratory Peer Review Policy states, "Surgical Pathology: ...at least 5 cases per Redwood Empire Dermatology physician (at least 25 per half year) will be reviewed for correlation with diagnosis". The laboratory did not have documentation of 50 patient cases reviewed for 2018 or 25 cases for 2019. e. The laboratory Peer Review Policy states, "Mohs: ...at lease (3) cases per Redwood Empire Dermatology physician (total of at least 15 per half year) will be reviewed for correlation with diagnosis". The laboratory had no documentation of (for physicians who had performed Mohs surgurys), (30) cases reviewed for the years 2018 or 2019. f. The laboratory director confirmed by interview on September 04, 2019 at approximately 10:30 a.m. that failure to perform and document twice annual verification for dermatopathology patient testing. g. The laboratory reports performing approximately 2000 dermatopathology patient tests annually. D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of the histopathology patient log and interview with the laboratory director and staff on September 04,2019, the laboratory failed to document all control procedures performed, as specified in this section. The findings included: a. The laboratory sends dermatopathology tissue samples to an outside laboratory to prepare and stain histopathology tissue slides. b. A random sampling of (6) patient histopathology records revealed that the laboratory had not documented the quality of the stains for (6) of (6) patients reviewed from 01/11/2018 through 08/29/2019. c. The laboratory did not have documentation regarding the acceptability of the staining quality from the contracted service, or a control slide for the dates of preparation, for (6) out of (6) patients reviewed, the list included: Date Patient ID 01/11/2018 W18- 040 06/05/2018 W18-521 08/22/2018 W18-812 04/16/2019 W19-255 07/23/2019 W19-649 08/29/2019 W19-791 d. The laboratory director confirmed by interview on -- 2 of 3 -- September 04, 2019 that the laboratory did not have documentation of slide reactions as specified in 42 C.F.R. 493.1256(e)(3). e. The laboratory reports performing annually 2000 histopathology patient slide reviews annually. D6082 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(1) The laboratory director must ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing. This STANDARD is not met as evidenced by: Based on review of a random sampling of patient dermatopathology and tisse pathology records, and interview with the laboratory staff and the laboratory director on September 04, 2019, the laboratory director failed to ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing. The findings included: a. The laboratory director failed to ensure that all test requisitions are retained as required by federal and state regulations. See D3027 b. The laboratory director failed to ensure that a quality control process was in place to ensure that stain reactivity for special stains and differential stains are performed and documented. See D5601 c. The laboratory director failed to ensure that verifcation of accuracy is performed and documented for those tests not included in subpart I of 42 C.F.R. 493 laboratory testing. See D5217 -- 3 of 3 --