Sths Clinics Fm Edinburg Yarritu

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 Proficiency Institute (API). 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 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 a desk review of proficiency testing records obtained from the CMS (Center 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 -- for Medicare Services) national database and verified with the proficiency testing company, American Proficiency Institute (API), 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 (refer to D2122). D2122 HEMATOLOGY CFR(s): 493.851(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory 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 Proficiency Institute (API), the laboratory failed to successfully participate for overall score in two consecutive testing events or two out of three consecutive testing events in the specialty of Hematology. The findings include: 1. A review of the CMS 155 report revealed the laboratory received the following unsatisfactory scores (passing = >80%) for the specialty of hematology: Second testing event 2023 0% Third testing event 2023 0% 2. A desk review of the laboratory's American Proficiency Institute's results from the first event of 2023 and the third event of 2023 confirmed the proficiency testing scores: Second testing event 2023 0% Third testing event 2023 0% 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 -- 2 of 3 -- failed to ensure successful participation in an HHS approved proficiency testing program (refer to D2122). -- 3 of 3 --

Summary Statement of Deficiencies D0000 The laboratory was found out of compliance with the CLIA regulations. The condition not met was: D6033 - 42 C.F.R. 493.1409 Condition: technical consultant 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. This STANDARD is not met as evidenced by: Based on review of the laboratory's American Proficiency Institute's proficiency testing records from 2023 and staff interview, the laboratory failed to have documentation of participating in 2 of 3 events. The findings included: 1. A review of the laboratory's American Proficiency Institute's hematology proficiency testing records from 2023 determined the laboratory failed to participate in 2 of 3 events. They were: 2023 Event 2 2023 Event 3 2. The laboratory was asked to provide documentation of participating in the required proficiency testing. No documentation was provided. 3. The laboratory ceased hematology testing at the end of June 2023, but failed to notify the proficiency testing agency or the inspecting agency. 4. The practice manager confirmed the findings in an interview conducted on 12/20/2023 at 1000 hours in the conference room. D5441 CONTROL PROCEDURES 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 -- CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's hematology quality control records from January 2023 to June 2023, and staff interview, the facility failed to have documentation of monitoring quality control values over time for 2 of 6 months. The findings included: 1. A review of the laboratory's hematology quality control records from January 2023 to June 2023 determined the facility printed monthly levey-jennings charts to assess quality control results over time to detect shifts and trends. Further review identified 2 of 6 months where the charts were not reviewed. They were: May 2023 June 2023 2. The laboratory was asked to provide documentation of the charts being reviewed to determine if shifts or trends were occurring. No documentation was provided. 3. The practice manager confirmed the findings in an interview conducted on 12/20/2023 at 1215 hours in the conference room. D5779

Summary Statement of Deficiencies D0000 The facility was found to be out of compliance with the conditions of participation of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 493.803 successful participation in a proficiency testing program 493.1403 laboratories performing moderate complexity testing; 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 laboratory's American Proficiency Institute proficiency testing (PT) records and confirmed in interview of laboratory personnel, the laboratory had not successfully participated in a proficiency testing program approved by HHS, for 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 -- each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the specialty of hematology for the analyte White Blood Cell Differential (WBC). See D2130 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 review of the laboratory's American Proficiency Institute proficiency testing (PT) records and confirmed in interview of laboratory personnel, the laboratory failed to attain a score of at least 80% acceptable responses for each analyte in the subspecialty of hematology for the analyte White Blood Cell Differential (WBC). The findings included: 1. API 2021 - 1st event the laboratory received an unsatisfactory score of 67% for WBC Differential. 2. API 2021 - 3rd event the laboratory received an unsatisfactory score of 73% for WBC Differential. 3. The findings were confirmed in interview with the technical consultant on January 12, 2022 at 13:30 hours in the conference room. 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 laboratory's American Proficiency Institute proficiency testing (PT) records and confirmed in interview of laboratory personnel, the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two consecutive testing events or two out of three consecutive testing events in the specialty of Hematology. Two out of three unsatisfactory scores results in unsuccessful PT performance. The findings included: 1. API 2021 - 1st event the laboratory received an unsatisfactory score of 67% for WBC Differential. 2. API 2021 - 3rd event the laboratory received an unsatisfactory score of 73% for WBC Differential. 3. The findings were confirmed in interview with the technical consultant on January 12, 2022 at 13:30 hours in the conference room. Key: WBC - white blood cell 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: -- 2 of 3 -- Based on review of the laboratory's proficiency testing records and confirmed in interview of laboratory personnel, 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 review of the laboratory's proficiency testing records and confirmed in interview of laboratory personnel, the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in a HHS approved proficiency testing program. Refer to D2130 -- 3 of 3 --

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 representative was given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the