Orange Urgent Care, Pllc

Summary Statement of Deficiencies D0000 Based on a proficiency testing (PT) desk review survey performed on September 12, 2024, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation. D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity. 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 review of Centers for Medicare & Medicaid Services (CMS) Proficiency Testing (PT) Certification and Survey Provider Enhanced Reporting system (CASPER 0155D) and American Proficiency Institute (API) PT summary reports, the 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 -- laboratory failed to successfully participate in the CMS approved PT program for two of three consecutive testing events in the Hematology subspecialty for the Cell ID (Identification) or WBC (White Blood Cell) Diff, Red Blood Cell (RBC), Hematocrit (HCT) (Non-Waived), Hemoglobin (HGB) (Non-Waived), WBC Count, and Platelets test analytes in 2024, resulting in non-initial unsuccessful performance. Refer to D2130. 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 CMS PT CASPER 0155D and API PT summary reports from 2024, the laboratory failed to achieve satisfactory performance (80% or greater) for two of three consecutive testing events in the Hematology subspecialty for the Cell ID or WBC Diff, RBC, HCT (Non-Waived), HGB (Non-Waived), WBC Count, and Platelets test analytes. FINDINGS: 1. A review of the CASPER 155 report revealed the following unsatisfactory scores: Hematology Subspecialty: 2024 First Event = 0% 2024 Second Event = 0% Cell ID or WBC Diff Test Analyte: 2024 First Event = 0% 2024 Second Event = 0% RBC Test Analyte: 2024 First Event = 0% 2024 Second Event = 0% HCT (Non-Waived) Test Analyte: 2024 First Event = 0% 2024 Second Event = 0% HGB (Non-Waived) Test Analyte: 2024 First Event = 0% 2024 Second Event = 0% WBC Count Test Analyte: 2024 First Event = 0% 2024 Second Event = 0% Platelets Test Analyte: 2024 First Event = 0% 2024 Second Event = 0% 2. A review of the proficiency testing scores from API (2024) confirmed the above findings. 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 review of CMS PT CASPER 0155D and API PT summary reports from 2024, the laboratory director (LD) failed to failed to provide overall management and direction of the laboratory services. Refer to D2016. 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; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on review of CMS PT CASPER 0155D and API PT 2024-1 and 2024-2 summary reports, the LD failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2130. -- 3 of 3 --

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 a proficiency testing (PT) desk review of Center for Medicaid and Medicare Service (CMS) PT data reports, the laboratory failed to enroll in an approved PT program for the specialty Hematology/Complete Blood Count (CBC) for the calendar year 2020. D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. 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 -- This STANDARD is not met as evidenced by: Based on PT desk review of the CMS PT data reports and the 2019 American Proficiency Institute (API) PT program reports, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the specialty Hematology and the test analytes Red Blood Cell Count (RBC), White Blood Cell Count (WBC), Hematocrit (Hct), Hemoglobin (Hgb), Cell Identification (Cell I.D.) /WBC Differential (WBC Diff.) and Platelets. 2019 third event = 0% [non- participation] This is considered unsatisfactory PT 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 PT desk review of CMS PT data reports and the 2019 API PTprogram reports, the laboratory director failed to provide overall management of the laboratory. The laboratory director failed to ensure that the laboratory: 1. Enrolled in an HHS approved PT program for Hematology/CBC, refer to D6015; 2. Reported the proficiency test results within the cut-off date, refer to D6016. D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) 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) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on PT desk review of the CMS PT data reports, the laboratory director failed to enroll the laboratory in an approved HHS PT program for Hematology/CBC in the calendar year 2020. Refer to D2000. 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; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on PT desk review of the PT CMS data reports and the 2019 API PT program records, the laboratory director failed to fulfill the laboratory director's responsibilities and ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program for the specialty Hematology and the test analytes RBC, WBC, Hct, Hgb, Cell I.D./WBC Diff. and Platelets. The following score was assigned: 2019 third event = 0% [non-participation] This is considered unsatisfactory PT performance. -- 3 of 3 --