Houston Healthcare Bonaire Med Stop

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification Survey was completed on October 22, 2025. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: A review of 2023 - 2025 Personnel Record confirmed that the Laboratory Director (LD) failed to provide oversight on the performance personnel competencies. THE FINDINGS INCLUDE: 1. A review of 2023 - 2025 Personnel Records revealed that unqualified Testing Personnel (TP) performed competencies on each other. 2. A review of the aforementioned records confirmed that the LD failed to perform a competency on the Technical Supervisor. 3. A review of the 2023 - 2025 Personnel Records revealed that the dates in which the annual competencies were performed was not documented. 4. The review of 2023- 2025 Personnel Records revealed that a letter of designation, from the LD, was not available on the date of survey. 5. An exit 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 -- interview, with Lab Team, on October 22, 2025, at 2:00pm, confirmed that the Laboratory Director (LD) failed to provide oversight on the performance personnel competencies. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on June 16, 2025. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following condition deficiencies were cited: D2016 - 42 CFR 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 CFR 493.1403 Condition: Moderate Complex Laboratory Director 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 the Centers for Medicare and Medicaid Services (CMS) CASPER 155 report and review of the laboratory 's AAB -MLE proficiency testing (PT ) 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 -- reports, the laboratory failed to maintain satisfactory participation in PT in the specialty of Hematology for the analyte of White Blood Cell Count (WBC) for 3 out of 4 events for events 1 & 3 of 2024, and event 1 of 2025. Refer to D 2130 D2130 HEMATOLOGY CFR(s): 493.851(f) (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 review of the CMS CASPER 155 report and review of the laboratory 's AAB -MLE proficiency testing (PT )reports, the laboratory failed to maintain satisfactory participation in PT in 3 out of 4 events in the specialty of Hematology for the analyte of White Blood Cell Count (WBC) . Findings include: 1. Desk review of the CMS CASPER 155 report revealed the laboratory failed WBC count on: 2024 Event 1 score: 60% 2024 Event 3 score: 40% 2025 Event 1 score: 20% 2. Desk review of the laboratory's proficiency testing reports from AAB-MLE confirms the laboratory failed WBC count on the aforementioned events resulting in the non-initial 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 review of the CMS CASPER 155 report and review of the laboratory 's AAB -MLE PT reports, the laboratory director failed to provide overall management and direction for proficiency testing to ensure successful participation in PT for the specialty of Hematology. Refer to D6016 and D6019. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on review of the CMS CASPER Report 155 and the AAB-MLE 2024 events 1 & 3 and 2025 event 1 PT evaluation reports, the laboratory director failed to ensure successful proficiency testing performance in WBC count in three of four testing events, resulting in the non-initial unsuccessful participation for WBC count. Refer to D2130 D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) -- 2 of 3 -- (e)(4)(iv) An approved

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on December 26, 2024. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following condition deficiencies were cited: D2016 - 42 CFR 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 CFR 493.1403 Condition: Moderate Complex Laboratory Director 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 the CASPER 155 report and review of the Medical Laboratory Evaluation (MLE) reports, the laboratory failed to maintain satisfactory proficiency 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 -- testing (PT) participation for White blood cell count (WBC ct.) in 2024 events 1 & 3, resulting in an initial unsuccessful participation for WBC ct. Refer to D 2130 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 review of the Centers for Medicare and Medicaid (CMS) CASPER 155 report and review of MLE reports, the laboratory failed to maintain satisfactory participation in two of three testing events ( 1st and 3rd events of 2024), resulting in an initial unsuccessful participation for WBC count. Findings: 1. A review of Casper Report 155 revealed the laboratory failed WBC ct. on the following: 2024 Event 1 Score 60% 2024 Event 3 Score 40% 2. A review of the laboratory's MLE Reports confirmed the laboratory failed WBC count with the aforementioned scores. 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 the CMS CASPER 155 report and review of the MLE reports, the laboratory director failed to provide overall management and direction for proficiency testing performance. The laboratory director failed to ensure proficiency testing samples were tested as required. 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 review of the CMS CASPER Report 155 and the MLE 2024 events 1 & 3 evaluation reports, the laboratory director failed to ensure successful proficiency testing performance in WBC count in two of three testing events of 2024, resulting in the initial unsuccessful participation for WBC count. -- 2 of 2 --