Kim Tang Md 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 review of laboratory testing records, the lack of records, and interview with laboratory administrative personnel, it was determined the laboratory failed to verify the accuracies of pathology reported for Biopsies and Mohs procedures to clear tumors in 2023. Findings included: a. The Biopsy Log Books recorded procedures performed during the timeframe 2022 - 2024. Cases randomly selected for review for this survey included the following: Report Date Slide ID Testing person -------------------------------------------------------- 1/11/23 KT23-39A Dr C 1/26/23 KT23-131A Dr C 1. The laboratory failed to have any records documenting Peer Review of Biopsy slides reported by Dr. "C" in 2023. b. The Mohs Log Books recorded procedures performed during the timeframe 2022 - 2024. Cases randomly selected for review for this survey included the following: Date ID Testing person ---------------------------------------------------------- 1/20/23 A, S Dr KT 1. The laboratory failed to have records documenting at least twice Peer Review of Mohs procedures performed by Dr. "KT" in 2023. c. Laboratory administrative personnel affirmed (8/15/24 at 1:00 PM) the aforementioned findings; and thus the laboratory's failure to verify the accuracy of Biopsy pathology reports and Mohs procedures for all testing persons. d. The quality and reliability of testing in 2023 could not be assured. Laboratory administrative personnel affirmed (8/15/24 at 2:50 PM) the total annual volume of Biopsies and Mohs procedures performed in 2023, as follows: Testing person Test volumes, 2023 -------------------------------------------------------- Dr "C" 168 Biopsies Dr "KT" 606 Mohs procedures . D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT 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 -- CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on review of laboratory records, the lack of records, and interview with the laboratory administrative person, it was determined the laboratory had failed to establish a written policy and procedure for an ongoing process to regularly monitor the peer review process, assess for completion, and correct problems as they occur. Findings included: a. The laboratory failed to identify in 2023 that peer reviews were not completed for all testing persons reporting Biopsy pathology reports and performing Mohs procedures. b. The laboratory administrative person affirmed (8/15 /24) there was no practice or written quality assessment policy and process for monitoring the records of peer review to identify problems as they occurred. . D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on the deficiencies cited, it was determined the Laboratory Director was deficient in providing overall administration to ensure that a written policy and practice was established and maintained to monitor and assess the quality of the peer review process. Findings included: a. Peer review was incomplete for 2023 and the laboratory had no process to identify this. The Laboratory Director was unaware of the problem in 2023. -- 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 lack of laboratory documents, and interview with the laboratory personnel, it was determined that the laboratory failed to ensure, at least twice annually, the accuracy of the PPM and general histopathology testing which are not included the subpart I of CFR part 493 and failed to document all proficiency testing evaluations and verification activities in CFR 493.1236 (d)). The findings included: a. The laboratory performed Provider Performed Microscope (PPM), a moderate complexity testing, and general Histopathology, a high complexity testing, which are not included in subpart I of CFR part 493. b. In order to ensure the accuracy of the testing systems, the laboratory may: 1) enroll in a proficiency testing (PT) programs, 2) blind testing of material with known results, 3) other external assessment programs (provided in a professional workshop), 4) peer review with a CLIA qualified peer, or etc. c. The laboratory failed to document all proficiency testing evaluation and verification activities required in CFR 493.1236 (d), D-5221, and failed to ensure the accuracy, at least twice annually, of the testing for PPM and general Histopathology CFR493.1236 (c)(1). 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. 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 lack of laboratory's peer review documents, and interview with the laboratory personnel and the laboratory director, it was determined that the laboratory failed to follow its written policies and procedures (P&P) for an ongoing mechanism to monitor, assess, the proficiency of testing performance, and failed to document its monthly quality assurance (QA) by peer review for evaluation of proficiency testing performance of the general pathology. The laboratory failed to establish its P&P for an ongoing mechanism to monitor, assess and document the PPM testing system at least twice annually to ensure the accuracy of the PPM testing proerfomance. The findings included: a. The laboratory performed general pathology (GP), Mohs surgery, and PPM by KOH/Wet mount procedures. b. In order to ensure the accuracy, reliability of the GP testing performance, the laboratory established its written P&P to evaluate the proficiency testing performance at least twice annually for accuracy verification (CFR 493.1236 (c) (1)). c. The laboratory's QA P&P state that "General Path: All Drs reviewed by Dr. Bell except Dr. Tang review Dr. Bell. Routine is minimum one biopsy per doctor monthly". d. At the time of survey (08/30/2019 @ 11:45 AM), the laboratory director affirmed that the doctors exchanged second opinions for their general GP cases when they met in the clinic hallway, but failed to document the review activities between peers what they had agreed upon or followed its written QA P&P in item (c) mentioned above. e. The laboratory failed to follow written P&P, and failed to document all QA activities, and failed to ensure the evaluation of proficiency testing performance for GP monthly as stated in itswritten QA procedures. f. The laboratory also performed KOH/Wet mount for the examination of presence or absence of fungi or scabies in their medical practice. g. The laboratory failed to establish its P&P for an ongoing mechanism to monitor, assess its KOH/Wet mount testing performance, and failed to document all activities. h. See D-5217 for failure to ensure and document the accuracy of the PPM testing system. 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 on lack of laboratory's procedure manual (PM), and interview with the laboratory personnel, it was determined that the laboratory failed to establish a written PM for Provider Performed Microscopy (PPM) using potassium hydroxide (KOH)/Wet mount to examine for presence or absence of fungi or parasites from skin samples, and failed to make PM available to, and followed by, laboratory personnel. The findings included: a. The laboratory performed KOH/Wet mount to examine skin samples for presence or absence of fungi or parasites. b. FDA (Food and Drug Administration) categorizes KOH/Wet mount as moderate complexity testing. c. There were no written PPM procedures pertaining to KOH/Wet mount examinations available, and followed by laboratory personnel at the time of survey (8/28/2019 @ 11:15 am). d. The current laboratory director must approve, sign, and date the procedures 493.1251 (d). -- 2 of 3 -- D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control 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's testing procedure manual (PM) and laboratory operation activity documents, and interview with the laboratory director and the laboratory personnel, it was determined that the laboratory director failed to be responsible for the overall operation including but not limited to assurance of compliance with the applicable CLIA regulations, proficiency of testing performance, and ensuring the establishment and maintenance of acceptable levels of analytical performance for KOH/Wet mount and general histopathology testings. The findings included: a. The laboratory failed to establish written PM and QA programs for KOH /Wet mount testing, a moderate complexity testing, to examine the presence or absence of fungi or parasite (see D-5401) b. The laboratory failed, at least twice annually, to ensure and document the accuracy of the KOH/Wet mount testing activities, a moderate complexity testing (see D-5217) c. The laboratory performed general pathology/histopathology, which is not included in the subpart I of CFR part 493, and failed to follow its written QA procedures, and failed to document the peer review activities to ensure and evaluate the accuracy of general pathology performances, a high complexity testing, at least twice annually (see D-5217 and D- 5291) -- 3 of 3 --