Forefront Dermatology - Pacific, Pc

Summary Statement of Deficiencies D3041 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(6) Test reports. Retain or be able to retrieve a copy of the original report (including final, preliminary, and corrected reports) at least 2 years after the date of reporting. (i) In addition, retain immunohematology reports as specified in 21 CFR 606.160(d) (ii) and pathology test reports for at least 10 years after the date of reporting. This STANDARD is not met as evidenced by: Based on review of Mohs surgery histopathology slides for five (5) randomly chosen patients, the lack of one patient Mohs surgery histopathology slides, and interview with laboratory's manager; the laboratory failed to retain Mohs histopathology slides at least 10 years from the date of examination. No Mohs records and reports for the same patient were able to be retrieved. Findings included: 1. No Mohs histopathology slides and confidential records from the chart for patient JD Mohs surgery on October 27, 2021, as recorded on the Mohs Pro log, could be retrieved on 12/20/2023 (survey date). 2. The laboratory manager affirmed on December 20, 2023, at approximately 3: 00 p.m. that the patient Mohs slides and reports were not found. 3. The laboratory reported volume of 318 Mohs surgeries per year was signed and dated by the laboratory director on 12/20/2023. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. 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 the laboratory's policies and procedures, lack of documentation, and interview with the laboratory's manager (LM), it was determined that the laboratory failed to perform and document preventive maintenance and calibration of the Cryostat as defined by the manufacturer and with at least the frequency specified by the manufacturer for the laboratory equipment. The findings included: 1. The laboratory's policies and procedures and Mohs logs indicated that annual maintenance and calibration according to manufacturer's requirements be performed on the Cryostat used to process Mohs surgery samples. 2. The LM confirmed on December 20, 2023, at approximately 3:00 p.m. that the laboratory failed to follow policies and procedures for maintenance and calibration of the Cryostat for the years 2021, 2022, and 2023 indicated by the lack of preventive maintenance documentation. 3. According to the annual test volume declared by the laboratory LD the laboratory performs approximately 318 Mohs tests annually. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's quality control records, five (5) randomly chosen patient records, and interview with the laboratory manager (LM); it was determined that the laboratory failed to perform control procedures using the number and frequency specified by the manufacturer to support control procedures for the Mohs test used in the laboratory. Findings included: 1. The laboratory used Mohs Pro as Mohs surgery sample processing for patients' samples. 2. At the time of the survey on 12/20/2023 at approximately 2:30 p.m. the LM could not retrieve quality control slides and records for patients' samples processed for Mohs on 10/27/2021. 4. Based on the laboratory testing declaration submitted at the time of the survey, the laboratory cultured and reported approximately 318 Mohs surgery testing samples 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 the surveyor's review of the laboratory's records for policies and procedures, patients' test results records, preventive maintenance and quality control documentation, and interviews with the laboratory's manager on December 20, 2023; -- 2 of 3 -- it was determined that the laboratory director failed to ensure that several aspects of the preanalytic, analytic, and postanalytic phases of the laboratory testing were monitored. See D3041, D5429, and D5445. -- 3 of 3 --

Summary Statement of Deficiencies D3043 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(7) The laboratory must retain cytology slide preparations for at least 5 years from the date of examination (see 493.1274(f) for proficiency testing exception). The laboratory must retain histopathology slides for at least 10 years from the date of examination. The laboratory must retain pathology specimen blocks for at least 2 years from the date of examination. The laboratory must preserve remnants of tissue for pathology examination until a diagnosis is made on the specimen. This STANDARD is not met as evidenced by: Based on random dermatopathology record review and interview with the laboratory staff on June 24, 2021, the laboratory failed to have a document retention policy and follow it to retain documentation at least 2 years from the date of examination. The findings included: 1. On the day of survey, June 14, 2021 at approximately 11:45 a. m.; a random sampling of the laboratory's dermatopathlogy patient logs were reviewed for a patient sample selection of Mohs procedure mapping and record review. 2. For five (5) dermatopatholgy cases selected, the laboratory could not retrieve two (2) patients' Mohs documentation and mapping notes. 3. The laboratory staff confirmed by interview on June 24, 2021 at approximatelyb 12: 15 p.m. that the laboratory did not find the records requested. 4. The laboratory reports performing approximately 830 dermatopathology patient tests annually. 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 the surveyors' observation, examination of laboratory reagents, and interview with the practice administrator (PA), it was determined that the laboratory failed to not use reagents when they have exceeded their expiration date. The findings included: 1. On the day of inspection, June 24, 2021 at approximately 11:00 a.m., the surveyor found the following reagents being used beyond its expiration date: Reagent Lot number Expiration date Acetone 5339-00 20/2019 Scoffs Water J080-01 03/23 /2021 KOH 1909814 04/07/2020 2. The PA affirmed on 06/24/2021 at approximately 11:10 a.m. using the reagents listed in (1) beyond its expiration date. 3. Based on the laboratory's submitted testing declaration volume, the laboratory tests and reports approximately 830 tests 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 the laboratory's records for evaluation of patient reporting, policies and procedures, expiration date of reagents in use, and interview with laboratory staff on June 24, 2021; it was determined that the laboratory director failed to ensure that several aspects of the preanalytical and post analytic phases of laboratory testing were monitored. see D3043 and D5417. -- 2 of 2 --

Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on review of a patient chart, doctor's order, patient Mohs slide label and a final report of a Mohs micrographic surgery, the laboratory failed to establish and follow written policy and procedure to ensure that a positive identification of patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. The findings included: a. On 1/17/2018 patient (TR) had an order of a Mohs micrographic surgery from; "Left anterior base of neck" location. b. The Mohs slides labels indicated as' " Right anterior base neck " for both slide #1 and slide #2. c. The anatomic sites described on the patient's plan and the slides labels revealed discrepancies. There was no documentation of