Dr Tai's Clinic

Summary Statement of Deficiencies 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 a review of the Procedure Manual and an interview with Testing Personnel #1, the Laboratory Director failed to approve the Procedures being used in the Laboratory by signature. The findings include: 1. A review of the Procedure for Drawing Blood, Quality Assurance Program, and User Manuals for Afinion and Cell- Dyn Emerald revealed the Laboratory Director had not approved Procedures by indication of signature. 2. During an interview on 06/22/2021 at 2:00 PM, Testing Personnel #1 confirmed the Procedures located during the survey were not signed by the Laboratory Director. 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: 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 -- Based on a review of the IQCP (Individualized Quality Control Plan), the Quality Control (QC) records and the patient logs for the Afinion AS 100 (used for urine Microalbumin/Creatinine (ACR) testing), and an interview with Testing Personnel #1, the laboratory failed to ensure two levels of quality control (QC) were performed and documented every 30 days of patient testing as per the IQCP. This was noted three times from January 2019 to June 2021. This is a repeat citation. The findings include: 1. A review of the IQCP for the Afinion AS 100 (used for urine Mircoalbumin /Creatinine) revealed a QC Plan which specified two levels of QC should be performed and documented every 30 days of patient testing, and with each new lot number of reagent cartridges, as per manufacturer's instructions. 2. A review of the January 2019 to June 2021 Afinion QC data log revealed QC had been performed most months (except May 2019, July 2019, and October 2019), however the QC testing exceeded the 30 day frequency specified in the IQCP during those months. a) QC was performed on 04/03/2019, next QC run was 05/07/2019 (only level 2 passed on this day) and 05/09/2019 (both levels passed) during this time 3 patients were performed. b) QC was performed on 06/12/2019, next QC run was 08/02/2019 during this time 40 patients were performed. c) QC was performed on 09/04/2019, next QC run was 10/02/2019 (only level 1 passed on this day) and 10/14/2019 (both levels passed) during this time 21 patients were performed. 3. During an interview on 06/22 /2021 at 11:45 AM, Testing Personnel #1 confirmed the laboratory failed to follow IQCP and failed to verify that QC passed on 05/07/2019 and 10/02/2019. D6022 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 the quality control and quality assessment programs are established and maintained to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on a review of the IQCP (Individualized Quality Control Plan), the Quality Control (QC) records and the patient logs for the Affinion AS 100 (used for urine Microalbumin/Creatinine (ACR) testing), and an interview with Testing Personnel #1, the Laboratory Director failed to ensure the IQCP was maintained to identify failures in quality control. The findings include: Refer to D5445. -- 2 of 2 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on reviews of the AAFP (American Academy of Family Physicians) Proficiency Testing (PT) records, personnel records, and an interview with Testing Personnel #4, the laboratory failed to ensure proficiency testing samples were rotated between all personnel who routinely performed moderate complexity testing on patients; and the laboratory further failed to ensure PT samples were tested during times when regular patient testing occurred. This was noted on six of seven surveys reviewed. The findings include: 1. A review of AAFP attestation statements revealed Testing Personnel (TP) #4 had performed all the testing on six out of seven surveys performed from 10/19/2016 to 10/7/2018 (the most recent survey). One survey (Survey B-2018) had been performed by TP #1. 2. A review of the personnel files revealed TP #1 was full time, and had been qualified to perform moderate complexity testing since the previous survey (on 10/20/2016). (Two other testing personnel were recently hired in 2018.) 3. A review of instrument printouts of the PT results further revealed the the PT samples were run in the evenings after the clinic was closed at 5: 00 PM. 4. During an interview with TP #4 on 12/20/2018 at 11:30 AM, the surveyor explained the CLIA requirement of integrating PT samples in with the normal patient workloads, and ensuring PT specimen testing was rotated among all personnel who performed patient testing. Testing Personnel #4 confirmed she had performed six out of seven surveys herself after hours to prevent interruptions in patient care and testing. Thus the above noted findings were confirmed. . D5445 CONTROL PROCEDURES 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): 493.1256(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 a review of the IQCP (Individualized Quality Control Plan), the Quality Control (QC) records and the patient logs for the Affinion AS 100 (used for urine Microalbumin/creatinine [ACR] testing), and interviews with Testing Personnel (TP) #1, the surveyor determined the laboratory failed to ensure two levels of quality control (QC) were performed and documented every 30 days of patient testing as per the IQCP which was implemented after the previous survey in 2016. The findings include: 1. A review of the IQCP for the Affinion AS 100 (used for urine Microalbumin/creatinine or "ACR" testing) revealed a QC Plan which specified two levels of QC should be performed and documented every 30 days of patient testing, and with each new lot number of reagent cartridges, as per manufacturer's instructions. 2. A review of the November 2016 thru December 2018 Affinion QC data log revealed QC had been performed most months (except December 2017 and April 2018), however the QC testing exceeded the 30 day frequency specified in the IQCP thirteen times in the review period. 3. During an interview on 12/20/2018 at 2: 15 PM, the surveyor and TP #1 reviewed the QC Plan in the IQCP, and the dates the testing personnel had performed the ACR QC. TP #1 realized the laboratory had failed to follow the manufacturer's instructions and their IQCP by running the QC "Monthly", which often exceeded the required 30 day QC performance frequency. 4. A review of the November 2016 thru December 2018 Affinion ACR patient log revealed thirteen periods exceeding the required 30 day QC performance frequency when 339 patient tests were run, as follows: A. 12/16 thru 12/29/2016: 29 patients tested B. 2/5 thru 2/16/2017: 26 patients tested C. 3/19 thru 3/28/2017: 27 patients tested D. 8/11 thru 8/24/2017: 38 patients tested E. 9/24 thru 9/28/2017: 13 patients tested F. 11/23 thru 11/28/2017: 6 patients tested G. 12/29/2017 thru 1/3/2018: 10 patients H. 2/2 thru 2/12/2018: 25 patients tested I. 3/15 thru 3/28/2018: 34 patients tested J. 4/23 thru 5/14/2018: 26 patients tested K. 6/14 thru 6/28/2018: 29 patients tested L. 8/4 thru 8/19/2018: 40 patients tested M. 10/12 thru 10/24/2018: 36 patients tested 5. During the exit summation on 12/20/2018 at approximately 3:10 PM, the above noted dates and number of patients affected were reviewed and confirmed with TP #1 with the Clinic Supervisor present. Surveyor ID#32558 Licensure and Certification Surveyor -- 2 of 2 --