Henry Mayo Newhall Urgent Care

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on desk review of CMS proficiency testing (PT) records (i.e. CMS CASPER Reports 0155D entitled, "Individual Laboratory Profile" and CMS CASPER Report 0153D entitled, "Unsuccessful (2 of 3) Report"), it was determined that the laboratory failed to successfully participate in a PT program approved by CMS for each analyte or test in which the laboratory is certified under CLIA. The findings included: The laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events in the specialty of Hematology constituting unsuccessful PT performance. (See 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 desk review of CMS PT records (CMS CASPER Report 0155D and 0153D), it was determined that the laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT events for the analytes, WBC DIFF, RBC, HCT, HGB, WBC, PLT CT, as follows: 2022 Q2 2022 Q3 2023 Q1 WBC DIFF 73% 0% 0% RBC 0% 0% HCT 0% 0% HGB 0% 0% WBC 0% 0% PLT CT 0% 0% Q1 = First testing event Q2 = Second testing event Q3 = Third testing event b. Failure to achieve satisfactory performance for the same analyte or test in two of three consecutive PT resulted in an unsuccessful performance for the analytes, WBC DIFF, RBC, HCT, HGB, WBC, and PLT CT (Note: WBC DIFF is cited as subsequent unsuccessful performance). 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 the severity of the deficiencies cited herein, the Condition: Laboratories Performing Moderate Complexity Testing: Laboratory director was not met. The laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under Subpart H of this part. (See 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: For the analytes, WBC DIFF, RBC, HCT, HGB, WBC, and PLATELETS, the laboratory repeatedly failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events, resulting in unsuccessful PT performances (See D2016 and D2130). -- 2 of 2 --

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy & procedure, American Proficiency Institute (API) testing worksheets, quality control records, and interview with the laboratory Technical Consultant on October 19, 2021 at approx. 12:00 pm, the laboratory failed to perform the repeat testing following the manufacturer's instructions for reporting results on their proficiency testing material. The findings include: l) The Laboratory uses the Horiba ABX for testing Moderate complexity CBC. Manufacturer requires repeat of samples when an error flag is generated while running a sample. 2) Technical Consultant provided policy of laboratory manual which states, "TAB 6: POSTANALYTIC POLICIES AND PROCDURES" reject flags such as $ must be repeated. 3) The laboratory Technical Consultant could not provide proof that one of five API sample was retested when the error flag occured, as required in their policy. 4) Technical Consultant affirmed that the laboratory reported the results for API 2nd event 2020 without rerunning the sample as their protocol states. One of five (20%) API samples observed at the time of survey showed rejection criteria which was not retested. Based on the laboratory's annual test volume declaration, the laboratory analyzed and reportes approximately 251 CBC samples annually. Potentially, one in five (20% ) patients tested or 50 patients, may have been effected in this time. D5463 CONTROL PROCEDURES CFR(s): 493.1256(d)(7)(g) 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 -- 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-- Over time, rotate control material testing among all operators who perform the test. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy & procedure, patient test records, quality control testing records, and interviews with the laboratory Testing Personnel and Technical Consultant the laboratory failed to rotate control material testing, over time, among all operators who perform the test. The findings include: 1). The laboratory has a total of 6 testing persons who perform the testing of patient samples. However, a random review of Quality Control charts and maintenance logs showed that only 2 testing persons had performed all the QC the testing. 2). Interviews with both the Technical Consultant and the laboratory testing person, on 10/19/2021 at 12: 00pm, affirmed that the laboratory did not rotate the quality control material among the testing persons for testing. Two of six competent personel performed QC with an annual volume of 21,568 tests potentially efected annually. D6020 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 program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of the laboratory's records and interview with the laboratory staff, it was determined that the laboratory director failed to ensure that the quality control program was established, documented and maintained to assure the quality of laboratory services provided. the findings included: See D-5463 and D-5411 D6045 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(7) (b) The technical consultant is responsible for-- (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; This STANDARD is not met as evidenced by: Based on observations, review of the QC records, interview with the testing personel and Technical Consultant, it was determined that the laboratory consultant failed to be responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed. The findings included: 1) Two of six testing personal were documented as responsible for all QC on the Istadt. The -- 2 of 3 -- remaining four testing personal have not been provided regular in service education, training, and evaluation. 2) Continuous in service training and education was not provided prior to API 2nd event 2020, which led to reporting of rejected results. See D5411 and D5463 -- 3 of 3 --

Summary Statement of Deficiencies D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on reviews of the third quarter (Q3-2018) of the American Proficiency Institute (API) proficiency testing records, random patient test results, and interview with the laboratory director, it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event. The findings included: a. API reported the following unsatisfactory proficiency testing scores. Analyte: Score: Event/Year: Mono 60% Q3-2018 Abbreviations: Mono= Monocyte b. For eight (8) out of eight (8) random patient test results reviewed covering period from 12/8/2017 to 11/2/2018, the laboratory analyzed and reported White Blood Cells (WBC) Differential which included the above anlyte that failed the proficiency testing. c. The laboratory director confirmed (3/13/2019, 1530) that the laboratory received the above unsatisfactory proficiency testing score. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(iv) Ensure that an approved