Valley Day And Night Clinic

Summary Statement of Deficiencies D0000 The laboratory was surveyed and failed to meet the following conditions of the CLIA regulations found at CFR 42 493.1 through 493.1780. The condition cited was: 493. 1421 Condition: Laboratories Performing Moderate Complexity Testing; Testing Personnel 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 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 procedures, review of patient test records from July 2024, and staff interview, the laboratory failed to have documentation of following its procedure for resolving flags on 11 of 11 patient hematology results. The findings were: 1. A review of the laboratory's policy titled "CBC Flags and Panic Values (Medonic M Series)" (effective date: 07/2024) determined: "

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the CMS (Centers for Medicare and Medicaid Services) national database and verified with the proficiency testing company, American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE). The laboratory was found to be NOT in compliance with the conditions of participation of the CLIA program based on the following CONDITION LEVEL DEFICIENCIES: 493.803 Successful participation [proficiency testing] 493.1403 Laboratories performing moderate complexity testing; laboratory director 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 a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing company, American Association of Bioanalyists Medical Laboratory Evaluation (AAB-MLE), the laboratory had not successfully participated in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory had unsuccessful participation in the specialty of hematology for the analyte White Blood Cell differential (refer to D2130). 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 -- D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of the CMS 155 report and proficiency testing records from American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE), the laboratory failed to successfully participate for the same analyte in two consecutive testing events or two out of three consecutive testing events in the specialty of Hematology for the analyte White Blood Cell Differential resulting in an initial proficiency testing failure. The findings include: 1. A review of the CMS 155 report revealed the laboratory received the following unsatisfactory scores (passing = >80%) for the analyte White Blood Cell Differential: Third testing event 2023 73% First testing event 2024 67% 2. A desk review of the laboratory's American Association of Bioanalysts Medical Laboratory Evaluation's (AAB-MLE) results from the third event of 2023 and the first event of 2024 confirmed the proficiency testing scores: Third testing event 2023 73% First testing event 2024 67% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of laboratory proficiency testing performance, the laboratory director failed to provide overall management and direction of the laboratory services (refer to D6016). D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing results, the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program (refer to D2130). -- 2 of 2 --

Summary Statement of Deficiencies D0000 The laboratory was surveyed for recertification and found to be in compliance with the conditions of participation found in the CLIA regulations at 42 CFR 493 and recertification is recommended. 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 laboratory's test menu, review of manufacturer's instructions, patient test records, and staff interview, the laboratory failed to have documentation of reporting 70 SARS-CoV-2 antigen positive results from April 1, 2022 to June 3, 2022 and 335 SARS-CoV-2 antigen positive results from June 15, 2022 to July 27, 2022 as required. The findings included: 1. A review of the laboratory's test menu found the laboratory utilized the Quidel QuickVue antigen SARS-CoV-2 kit for patient testing. 2. A review of the manufacturer's instructions for use for the Quidel Quick-Vue antigen SARS-CoV-2 antigen assay under the section titled "Conditions for Authorization for the Laboratory and Patient Care Settings" stated, "Authorized laboratories using your product must have a process in place for reporting test results to healthcare providers and relevant public health authorities, as appropriate." 3. A review of laboratory policies found no documentation of a policy or 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-CoV-2 test reporting to public health authorities. 4. Review of patient test records found the following SARS-CoV-2 antigen positive results were not reported to any public health authority (patient alias list provided to technical consultant on July 28, 2022). April 2, 2022 - June 3, 2022: 70 positive antigen results not reported June 15, 2022 - July 27, 2022: 335 positive antigen results not reported 5. An interview with the office clerk on July 29, 2022 at 10:05 hours in the front office confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative at the entrance and exit conferences. The facility representatives were given an opportunity to provide evidence of compliance with the noted deficiency, and no such evidence was provided prior to survey exit. Based upon the onsite survey conducted 09/172018, this facility was found NOT to be in compliance with the CLIA regulations found at 42 CFR 493.1250 Analytic Systems 493.1441 Laboratory Director, (high complexity) 493.1487 Testing Personnel (high complexity) The laboratory's failure to be in compliance with these regulations was found to pose IMMEDIATE JEOPARDY to the patients served by the laboratory. NOTE: The laboratory was asked to cease glucose testing using the Quintet AC Blood Glucose Monitoring System on patients without a known history of diabetes. The laboratory voluntarily ceased glucose testing on patients without a history of diabetes. See letter dated 09/18/2018 and signed by the laboratory director. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the