Pharr Kids Clinic

Summary Statement of Deficiencies D0000 Entrance and exit conferences were held with the laboratory representative. The survey process was discussed and survey forms were provided. An opportunity for questions and comments was given. The laboratory was found to be in compliance for the specialties/subspecialties for which it was surveyed. NO DEFICIENCIES were cited. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on review of the manufacturer's instructions, review of patient test records from March 2021 - July 2021 and staff interview, it was revealed the laboratory failed to report 67 SARS negative Antigen test results as required by 400.200 for 51 of 51 days reviewed. Findings include: 1. Review of the Instructions for Use for the Quidel QuickVue SARS Antigen test (1461700 12/20) under the section titled "Intended Use" revealed: "Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities." 2. Review of the laboratory test records from 2021 revealed the laboratory started SARS Antigen patient testing utilizing the Quidel QuickVue cassette March 2021. 3. Review of the laboratory policies available revealed no documentation of a policy/procedure related 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 -- to SARS test result reporting. 4. Review of the laboratory SARS Antigen patient test records from March 2021 to June 2021, 2021 revealed no documentation the laboratory reported 67 of 67 patient negative test records for 51 of 51 days of testing. Refer to SARS Antigen Patient Alias list. a) March 2021 19 negative results not reported 11 test days b) April 2021 21 negative results not reported 14 test days c) May 2021 17 negative results not reported 13 test days d) June 2021 20 negative results not reported 13 test days 5. An interview with the testing personnel number 1 (as listed on Form CMS 209) on 07/06/202 1130 hours in the laboratory revealed the facility reported positive results to State authorities, but did not report negative results. She stated the facility was unaware of the need to report negative results. This confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The laboratory was surveyed on August 29, 2018 and found to be incompliance with the CLIA regulations. Recertification is recommended. 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: Based on review of laboratory policy, review of manufacturer's instructions, review of the laboratory's maintenance records, and confirmed in interview of facility personnel, the laboratory failed to provide documentation of performing 6 month maintenance on the Medonic M series hematology analyzer. The findings were: 1. Review of the laboratory's policy titled, "Maintenance of Equipment and Instruments" approved by the laboratory director on September 13, 2010 stated, "For manufacturer's equipment, instruments or test systems cleared by the FDA, perform maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer; and document all maintenance performed." 2. Review of the manufacturer's instructions for the Medonic M series hematology analzyer (Art. no 1504248, May 20029) under, "Six (6) Month Cleaning" stated, "...Follow the instructions for the Boule Cleaning kit to clean the instrument, and the Six Month Cleaning Procedure takes approximately one hour and 15 minutes to complete." 3. Review of the laboratory's maintenance records from January 2017 to July 2018 revealed the 6 month maintenance as required by the manufacturer had not been documented as being performed. 4. Testing personnel four looked for other areas where the maintenance could have been documented but was unable to locate any other records. 5. An interview with testing personnel four (as listed on Form CMS-209) on 08/29/2018 at 14:30 hours confirmed the findings. Key: CMS - Centers for Medicare and Medicaid Services 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 -- D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on laboratory policy, review of manufacturer's instructions, review of calibration records, and confirmed in interview of facility personnel, the laboratory failed to follow the manufacturer's instructions to print the pre-calibration report for the calibration performed in June 2018. The findings were: 1. Review of the laboratory's policy titled, "Calibration Verification Procedure" approved by the laboratory director on September 13 (year undecipherable) stated, "...For laboratory test procedures that are performed using Instruments, kits, or test systems that have been cleared by the FDA the laboratory must at a minimum, follow the manufacturer's instructions for calibration and calibration verification procedures using calibration materials specified by the manufacturer." 2. Review of the manufacturer's instructions for the Medonic M series hematology analzyer (Article no. 1504248, May 2009) under Section 7, "Calibration" stated, "Prior to calibration print Calibration Log." 3. Review of the laboratory's calibration records from January 2017 to July 2018 revealed the laboratory failed to follow the manufacturer's instructions to print the Calibration log for the calibration performed on December 6, 2017 and June 22, 2018. 4. Interview with testing personnel four (as listed on Form CMS-209) on 08/29/2018 at 15:00 hours confirmed the findings. She confirmed that she was unsure if she had done it right. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of