Vincent C Hung Md

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 quality assurance (QA) policies and procedures (P&P), peer review of the Mohs map records, interview with the laboratory staff, it was determined that the laboratory failed to perform evaluation of proficiency testing performance (Eval) at least twice annually to ensure accuracy, reliability and timely of the patient test result reports. The findings included. a. The laboratory performed evaluation of proficiency testing performance (Eval) twice annually in April and October (the laboratory staff verbally affirmed). b. Two cases of Mohs slides were sent to outside a qualified testing personnel on 4/20/21 and were received and returned with "Yes" agree for the final diagnoses of the slides on 6/29/2021. c. There were no other send out for peer review in 2021. d. The laboratory staff affirmed that the cases to be send out were in Dr.'s office not yet sent. e. The laboratory performed histopathology in approximately 85 patient samples monthly. f. The laboratory failed to perform evaluation of proficiency testing performance for the testing personnel required by CLIA rules and regulation in 2021 and 2022 and failed to follow its policies and procedures. g. The laboratory staff affirmed (7/13/2022 @ 11:05 am) that the laboratory failed to perform evaluation of proficiency testing performance at least twice annually. 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 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 -- 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 the laboratory's "Equipment Quality Control-Cryostat" policies and procedures (P&P), "Cryostat Temperature and Maintenance Log", and interview with the laboratory staff, it was determined that the laboratory failed to follow its written policies and procedures (P&P) to perform and operate its analytical systems. The findings included as follows: a. The laboratory performs Mohs surgery and process histological preparation and staining procedures onsite. b. A Cryostat device was used to cutting the tissue and the Cryostat acceptable (optimal) temperature range was set between -20 to -30 Celsius in its written "Equipment Quality Control- Cryostat" c. The day use of Cryostat temperature recording on the chart, Cryostat Temperature and Maintenance Log" indicates the acceptable Cryostat temperature for cutting the tissues between -15 to -29 degree Celsius, which is inconsistent with its written P&P of -20 to -30 degree Celsius. d. Review of "Cryostat Temperature and Maintenance Log" between 3/24/22 thru 7/12/22, there noted that 13 out of total of 28 recorded below -19 degree Celsius which were out of its written acceptable temperature range of -20 to -30 degree Celsius. Date Temp Date Temp (Date in 2022; Temp = temperature in Celsius) 3/31 -19 4/5 -17 4/12 -19 4/14 -19 4/19 -19 4/21 -18 4 /26 -18 4/28 -18 5/3 -19 5/12 -19 5/19 -19 6/16 -19 7/12 -15 e. The laboratory failed to take remedial actions and investigate the Cryostat temperature conditions out of acceptable temperature range toward its histology process each day when used. 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 the laboratory's "QUALITY ASSURANCE MANUAL" for VINCENT C. HUNG, MD NEWPORT OFFICE, and interview with the laboratory staff, it was determined that the laboratory failed to provide evidence to show the current laboratory director had approved, signed, and date the procedures and changes in procedures of "QUALITY ASSURANCE MANUAL". The findings included: a. Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. b. The current laboratory director failed to approve, sign and date the current procedure manual, "QUALITY ASSURANCE MANUAL". 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: -- 2 of 3 -- Based on review of the laboratory's written policies and procedures (P&P) and laboratory temperature records, and interview with the laboratory staff, it was determined that the laboratory failed to follow its written P&P for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems. The findings included: a. The laboratory performed Mohs surgery and histopathology onsite for skin tissues diagnoses. b. The laboratory had established written P&P for its evaluation of proficiency testing performance for the qualified testing personnel. c. The laboratory failed to follow its written P&P, see D-5217. d. The laboratory had established written P&P for Cryostat's acceptable temperature range for its cutting skin tissue. e. The laboratory failed to follow its written P&P, see D-5401 f. The current laboratory director failed to approve, sign and date the laboratory procedures., see D-5407 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 written policies and procedures (P&P) and laboratory temperature records, and interview with the laboratory staff, 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 and to identify failures in quality as they occur. The findings included: a. The laboratory performed Mohs surgery and histopathology onsite for skin tissues diagnoses. b. The laboratory director failed to follow its Quality Assessment /Assurance to assess Evaluation of Proficiency Testing Performance for histopathology and failed to ensure the accuracy, reliability and timely of the patient test result reports. See D-5217 d. The laboratory director failed to follow Quality Assessment/Assurance to monitor Cryostat's acceptable temperature range records and take remedial actions as they are out of the range. See D-5401 -- 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 the surveyor's review of the laboratory's records for evaluation of proficiency testing performance and an interview with laboratory personnel (LP) on 9 /25/2020 between 10:30 a.m. and 12:00 p.m., it was determined that the laboratory failed to at least twice annually, document their quality assurance/proficiency testing for the year 2018. Findings include: 1. On 9/25/2020, an inspection was conducted between 10:30 a.m. and 12:00 p.m. 2. During a review of the laboratory documentation, it was noted at approximately 11:00 that the laboratory failed to document peer proficiency testing for MOHS Histopathology in 2018.The LP recognized that this documentation was missing. 3. MD peer review documentation was present for 2019. 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. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's testing reagent expiration dates, and an interview with laboratory personnel (LP) on 9/25/2020 between 10:30 a.m. and 12: 00 p.m., it was determined several reagents used for tissue staining were expired. 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 -- Findings include: 1. On 9/25/2020, an inspection was conducted between 10:30 a.m. and 12:00 p.m. 2. During a review of the reagent expiration dates , it was noted at approximately 11:15, that several reagents had expired dates.. The LP recognized that several of these reagents were expired. These reagents are currently in use. 3. The vendor, reagent, lot # and expiration dates are indicated below Vendor Reagent Lot# Expiration Date MCC Bluiing Sol. 8449 00 6/3/2020 MCC Harris H&E 8670 00 2/28 /2020 MCC Acid Alch. 8165 01 4/30/2020 D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) 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: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's records for evaluation of testing performance and the associated stain QC, and an interview with laboratory personnel (LP) on 9/25/2020 between 10:30 am and 12:00 p.m., it was determined there was a time gap in which there was no record of daily slide stain QC. Findings include: 1. On 9/25/2020, an inspection was conducted between 10:30 am and 12:00 p.m. 2. Records were available for daily H&E daily stain QC through most of April, 2018, but there were no daily QC records for May of 2018 through July of 2020. The LP recognized this gap in the log sheets. 3. Records were available beginning in August of 2020. 4. There was limited or no testing in the March/2020-July/2020 timeframe due to reduced activity related Covid-19 associated reduction in patient activity. 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 an audit of 5 patient reports as part of the quality assessment review (in the date range of 1/1/2018-2/4/2020) and the associated tissue slides, the laboratory failed to establish/monitor an ongoing mechanism to detect mistakes of slide labeling (analytic process). Findings include: 1. On 9/25/2020, an audit was conducted from 10: 30 a.m. to 12:00 p.m. with a review of 5 randomly selected MOHS patients 2. One of the audit cases demonstrated an inconsistency in the procedure date on the slide vs. the patient report. The patient under review indicated a procedure date of 11/13/18 on the MOHS report, and the slide label indicated a date of 11/6/18. 3.A representative of the laboratory (LP) confirmed on (9/25/2020 at 10:45 a.m. that the above descriptions were inconsistent. No