Raymondville Pediatrics

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. 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 review of the laboratory's submitted Form CMS 209, review of the laboratory's American Proficiency Institute (API) proficiency testing records from 2021 (events 1, 2, and 3) and 2022 (events 1 and 2), and confirmed in laboratory staff interview, the laboratory failed to ensure 2 of 3 testing personnel performing patient testing in 2021 participated in proficiency testing. The findings included: 1. A review of the laboratory's submitted Form CMS 209 found the laboratory identified 3 testing personnel who performed patient testing from January 1, 2021 to December 31, 2021. 2. A review of the laboratory's API proficiency testing records from 2021 (events 1, 2, and 3) and 2022 (events 1 and 2) found the laboratory failed to have documentation of 2 of 3 testing personnel participating in proficiency testing in 2021. They were (as listed on Form CMS 209) as follows: Testing personnel number 2 Testing personnel number 3 3. The laboratory was asked to provide documentation of the identified personnel participating in proficiency testing in 2021. No documentation was provided. 4. An interview with the technical consultant on November 17, 2022 at 09: 30 hours in the patient exam room 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 2 -- D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on surveyor observation, review of laboratory policies, and confirmed in interview of laboratory personnel, the laboratory failed to follow its own policy for specimen labeling for 10 of 11 samples observed on November 17, 2022 (the date of the onsite inspection). The findings included: 1. Surveyor observation on November 17, 2022 at 09:09 hours in the laboratory found 11 pediatric samples located in a specimen rack on top of the Sysmex analyzer. - 2 samples were labeled with first name - 8 samples were not labeled - 1 sample was labeled according to policy 2. Review of the laboratory's policy titled, "Specimen Identification" approved by the laboratory director on January 31, 2005, stated, "Each specimen must have unique patient identifiers such as patient name, birth date, social security number, or other identifying number. The identification should be used throughout the testing process, so that results can be confidently used in patient care ...) 3. The findings were confirmed with the technical consultant on November 17, 2022 at 09:12 hours in the laboratory. -- 2 of 2 --

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 review of laboratory policies, review of patient reports, and confirmed in interview of facility personnel, the laboratory's policy for resolving abnormal CBC results did not reflect the laboratory's current practice. The findings were: 1. Review of the laboratory's policy titled, "Policy for Abnormal Differentials" approved by the laboratory director on July 24, 2013 stated, "If your CBC instrumentation is showing alarms (R1, R2, M#, etc.) in the differential section of the report, it will be considered an abnormal differential and Laboratory Director must be notified for further instruction." 2. The policy did not reflect how to the laboratory resolves flags on its current analyzer, the Sysmex. 3. Interview with testing personnel one (as listed on Form CMS 209) on October 19, 2018 at 10:30 hours in Room 5 confirmed the findings. 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 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 -- 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 review of laboratory policy, review of calibration records, and confirmed in interview of facility personnel, the laboratory failed to perform calibrations on the Sysmex every 6 months. The findings were: 1. Review of the laboratory's policy titled, "Calibration Validation" (no approval date) stated, "It is the policy of this lab to validate calibrations: every 6 months, following a complete reagent change, following major preventative maintenance, following replacement of a critical part or when shifts or trends in QC are seen." 2. Review of the laboratory's calibration records for 2017 and 2018 revealed calibrations were performed as follows: March 2, 2017 July 28, 2017 October 25, 2017 July 10, 2017 (9 months later) September 19, 2018 3. Interview with the technical consultant on 10/19/2018 at 11:00 hours in Room 5 confirmed the findings. 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: Based on review of the FDA and CLIA Complexity website, review of manufacturer's instructions, review of the laboratory's Individualized Quality Control Plan (IQCP) procedure, and interview with facility personnel, the laboratory failed to have a complete IQCP. The findings included: 1. Based on review of Food and Drug Administration (FDA) decision summary K162451, the analyte Streptococcus Group A & G is moderate complexity. 2. Review of the manufacturer's instructions for Quidel Molecular Strep A + G Control Set (PIM111000EN00 12/15) under, "Quality Control" it stated, " ...Each laboratory should establish their own Quality Control ranges and frequency of QC testing based on applicable local laws, regulations and standard good laboratory practice." 3. Review of the IQCP, signed by the laboratory director on March 20, 2017, revealed the laboratory failed to retain the data and documentation of quality control to support its plan to reduce quality control frequency to running a positive and negative external control per each lot and shipment and monthly thereafter. 4. Review of the risk assessment portion of the IQCP for the Quidel Solana Strep Molecular included potential sources of error and mitigation strategies. a. The Risk Assessment DID NOT include the frequency with which the laboratory defined potential sources of error had occurred or were likely to occur. b. As a potential risk, the laboratory identified "Patient and Specimen Identification." The laboratory failed to identify the frequency of improperly collected specimens for the Quidel Solana Strep Molecular test. 5. The Risk Assessment DID NOT include an assessment of the potential impact on patient results for each laboratory defined potential source of error. a. The lab defined "Training" as a -- 2 of 3 -- potential risk of error. The laboratory did not define the potential impact on patient testing when testing personnel have not been trained in all aspects of the test method. 6. In an interview at 12:00 hours on 10/19/2018 in Room %, the Technical Consultant stated that the quality control study could not be found and agreed the frequency and impact of each source of error as part of the IQCP risk assessment was missing as part of the IQCP. 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