Alamitos Dermatological Medical Clinic, Inc

Summary Statement of Deficiencies 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: Based on review of policies and procedures manuals and interview with the Medical Biller on December 23, 2024, the laboratory failed to follow its own written policies and procedures for Quality Assurance (QA) in 2022, 2023 and 2024. The findings include: 1. According to the laboratory's written policies and procedures for QA, the office meetings are to be held every quarter to review QA finding and staff attendance is to be recorded. 2. On December 23, 2024, at approximately 11:30 am, the laboratory Medical Biller affirmed that the laboratory maintained no documentation for the office meetings for 3 of 3 years. 3. The laboratory's testing declaration form, signed by the laboratory director on December 18, 2024, stated that the laboratory performed approximately 3500 histopathology tests annually. 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 policies and procedures manuals and interview with the Medical 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 -- Biller on December 23, 2024, the laboratory director failed to meet the standard requirement to approve, sign, and date all policies and procedures. The findings include: 1. On December 23, 2024, at approximately 11:30 am, the laboratory Medical Biller affirmed that the laboratory maintained no documentation indicating that written policies and procedures had been approved, signed, and dated by the current laboratory director. 2. The laboratory's testing declaration form, signed by the laboratory director on December 18, 2024, stated that the laboratory performed approximately 3500 histopathology tests annually. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of policies and procedures manuals and Quality Control (QC) records and interview with the Medical Biller on December 23, 2024, the laboratory failed to provide QC procedures and QC record for monitoring the accuracy of the complete analytic process when performing histopathology examinations. 1. It was the practice of the laboratory to perform histopathology testing. the laboratory is responsible for having control procedures that monitor the accuracy of histopathology testing. 2. On December 23, 2024, at approximately 11:45 am, the laboratory Medical Biller affirmed that the laboratory maintained no documentation for control procedures and no records of monitoring the accuracy of histopathology testing in 2022, 2023 and 2024. 3. The laboratory's testing declaration form, signed by the laboratory director on December 18, 2024, stated that the laboratory performed approximately 3500 histopathology 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 laboratory's policies and procedures manuals, Quality Control (QC) and Quality Assurance (QA) records, review of 5 randomly selected patient test results and interview with Medical Biller on December 23, 2024, it was determined -- 2 of 3 -- that the Laboratory director of high complexity testing failed to ensure that testing systems developed and used for histopathology procedure provide quality laboratory services for all aspects of test performance. See D5291, D5407, D5441. -- 3 of 3 --

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 the laboratory's evaluation of proficiency testing performance (Eval) records, and interview with the laboratory staff, it was determined that the laboratory failed to perform the evaluation of proficiency testing performance at least twice annually to assure the accuracy of the histopathology diagnosis. The findings included: a. This survey was performed virtually on 2/3/2022 started at 10 am with ML, an Office Manager. b. This office had requested the laboratory emailed records pertaining Eval for the years of 2020 and 2021. c. Reviewed the documents the laboratory submitted before the starting of the virtual survey. d. The laboratory had failed to perform the Eval according to CLIA rules and regs, at least twice annually to verify the accuracy of the test system performed. e. The records indicated that the peer review was performed on the same date of 12/1/2021 by ML for 4 patient cases dated in 2020 and 2021. f. The four cased randomly pulled were: 1) 4/30/20 case # RM 982- 20 thru RM 986-20. 2) 10/15/20 case #RM 2827-20 thru 2831-20. 3) 1/14/21 case # 204-21 thru 208-21; and 4) 4/8/21 case #1075-21 thru 1079-21. 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. 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 the laboratory's Quality Assurance (QA) Procedure, and interview with the laboratory staff (LS), it was determined that the laboratory failed to follow written policies and procedures for an ongoing mechanism to monitor, assess in the analytic systems. The findings included: a. This survey was performed virtually on 2/3 /2022 started at 10 am with ML, an Office Manager. b. This office had requested the laboratory emailed records pertaining to Eval for the years of 2020 and 2021 prior to the virtual survey. c. Reviewed the Eval documents and the interview with the LS for the laboratory's QA procedure. d. The QA procedure states that "We will randomly pull 5 slides to check the accuracy of our work twice a year." as well as "When you have check all the items date and sign the notes", and "The peer will also need to date and sign the charts as well" e. Based on interview virtually and review the "QA" procedure, the laboratory failed to follow its written QA Procedure. f. The laboratory failed to perform Eval twice annually, with different dates, not on one date for two years' Eval. g. The laboratory failed to "date" all for their QA taken. h. The laboratory affirmed 2/3/2022 @10:25 am that the laboratory failed to follow its written QA Procedure. 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 evaluation of proficiency testing performance (Eval) records, Quality Assurance (QA) Procedure, and interview with the laboratory staff (LS), it was determined that the laboratory director failed to ensure that the quality assessment programs were established and maintained to assure the quality of laboratory services provided. The findings included: a. This survey was performed virtually on 2/3/2022 started at 10 am with ML, an Office Manager. b. This office had requested the laboratory emailed records pertaining to Eval for the years of 2020 and 2021, and written QA procedure. c. Reviewed the Eval documents and the interview with the LS for the laboratory's QA procedure, the laboratory failed to perform Eval twice annually, see D-5217, and failed to follow its written policy and procedure, see D-5791. -- 2 of 2 --