Your Kids Urgent Care

Summary Statement of Deficiencies D0000 A recertification survey was conducted on January 14, 2021. Your Kids Urgent Care clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on record review and interview, the Laboratory Director failed to attest to the routine integration of the proficiency testing (PT) samples into the patient workload using the laboratory's routine methods by signing the attestation for 1 (2020 3rd) out of 3 (2019 2nd, 3rd, and 2020 3rd) event attestations examined for the specialty of Hematology. Findings: Review of the laboratory's proficiency testing records with American Proficiency Institution (API) for the 2020 3rd event showed the Laboratory Director did not sign the attestation. Review of the laboratory's procedure manual noted, "The "Attestation sheet" must be signed by both the Laboratory Director and the testing personnel in a timely manner." During an interview on 1/14/21 at 5:50 PM, the Testing Personnel - A stated the laboratory director did not sign the attestation. D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to run proficiency testing (PT) samples the same number of times, as it routinely tests patient samples for 3 out of 3 (2019 2nd, 3rd and 2020 3rd) event attestations examined for the specialty of Hematology. Findings: 1. Review of the laboratory's proficiency testing records with American Proficiency Institution (API) for the 2019 2nd event showed the due date to submit results to API was 7/26/19. Review of the attestation for the 2019 2nd event showed Testing Personnel (TP) - A ran sample #6 on 7/25/19 and former TP - E ran sample #6 on 7/25/19. 2. Review of the laboratory's proficiency testing records with API for the 2019 3rd event showed the due date to submit results to API was 12/2/19. Review of the attestation for the 2019 3rd event showed TP - A ran sample #14 and #15 on 11/24/19, former TP - F ran sample #14 and #15 on 11/24/19 and former TP - G ran sample #14 on 11/24/19. 3. Review of the laboratory's proficiency testing records with API for the 2020 3rd event showed the due date to submit results to API was 11/24/20. Review of the attestation for the 2019 3rd event showed TP - A ran sample #11, #12, #13, #14 and #15 on 11/11/20, TP - C ran sample #11, #12, #13, #14 and #15 on 11/16/20, and TP - D ran sample #11, #12, #13, #14 and #15 on 11/22/20. Review of the laboratory's Proficiency Testing procedure noted "The PT samples must be handled exactly like patient specimens, utilizing usual testing methods, instruments and personnel. Repeated analysis of PT samples shall not be permitted unless the lab performs the same repetitive analysis in the routine analysis of patient specimens." During an interview on 1/14/21 at 5:53 PM, TP - A stated patient samples were not routinely run multiple times and some PT samples were run more than once. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to maintain a copy of all proficiency testing program report forms for 2 (2020 1st, 2nd) out of 5 (2019 2nd, 3rd, and 2020 1st, 2nd, 3rd) events for the specialty of Hematology. Findings: Review of the laboratory's proficiency testing records with American Proficiency Institution (API) for the 2020 1st event showed the laboratory did not have the attestation and the record of proficiency testing results. Review of the laboratory's proficiency testing records for the 2020 2nd event showed the laboratory did not have the attestation, the record of proficiency testing results, and the PT performance evaluation form. Review of the laboratory's Proficiency Testing procedure noted ""All records must be maintained for 2 years." During an interview on 1/14/21 at 5:53 PM, Testing Personnel - A stated she was not able to locate the above mentioned PT records. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE -- 2 of 5 -- CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to document the review and evaluation of proficiency testing (PT) for 1 (2020 3rd) out of 4 (2019 2nd, 3rd and 2020 1st, 3rd) event performance evaluations examined for the specialty of hematology. Findings: Review of the American Proficiency Institute (API) PT showed the Laboratory Director failed to sign "Proficiency Testing Performance Evaluation" forms for 3rd event in 2020. Review of the laboratory's Proficiency Testing procedure noted, "The Laboratory Director and testing staff must sign the review and any

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on record review and interview, the laboratory failed to enroll in proficiency testing with an approved proficiency testing program from 11/10/18 to 6/25/19. Findings: Review of the "Laboratory Test Log" showed that the laboratory started testing for White Blood Cell Counts (WBC) on 11/10/18. No documentation of proficiency testing records were available for inspection. During an interview on 6/25 /19 at 1:49 PM, the Administrator stated they had not enrolled in proficiency testing for WBC's. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. 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 7 -- Based on record review and interview, the laboratory's procedure manual failed to have a written procedure on employee competency. Findings: Review of the laboratory's procedure manual, signed by the laboratory directory, showed that there was no procedure on employee competency. During an interview on 6/25/19 at 3:17 PM, the Administrator acknowledged that they did not have a procedure on employee competency. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on observation, record review and interview, the laboratory's quality assessment program failed to monitor and evaluate the overall quality of the analytic system and correct identified problems. Cross Referenec D5403. Based on record review and interview, the laboratory's written procedure manual was incomplete. Cross Referenec D5429. Based on record review and interview, the laboratory failed to document the daily maintenance performed on the HemoCue White Blood Cell (WBC) analyzer from 11/10/18 to 6/25/19. Cross Referenec D5481. Based on record review and interview, the laboratory failed to perform and document the running of daily Quality Controls (QC) on the HemoCue White Blood Cell (WBC) analyzer form 11/10/19 to 6/9/19. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)