Surepoint Emergency Center Pantego

Summary Statement of Deficiencies D0000 Laboratory representatives were present at the entrance conference conducted 05/11 /2021. The survey process was discussed. An opportunity for questions and comments was given. The exit conference was held with the laboratory representatives on 05/11 /2021. The laboratory was found to be in substantial compliance for the specialties /subspecialties for which it was surveyed. The standard level deficiencies cited were discussed. The process for submitting the corrections was explained. CMS form 2567 will be emailed from the Texas State Health and Human Services Commission, Health Facility Compliance Arlington Group. 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 laboratory SARS-Co-V-2 patient testing records, review of laboratory SARS-Co-V-2 result reporting records, and staff interview, it was revealed that the laboratory failed to report SARS-Co-V-2 negative test results for 38 of 38 days reviewed from 02/11/2021 through 05/10/2021. Findings: 1. Review of SARS- Co-V-2 patient tests records (test performed using the Sofia 2 SARS Antigen FIA COVID-19 Test kit and instrumentation) from 02/11/2021 through 05/10/2021 revealed 47 patients tested for SARS-CoV-2. 2. Further review of the SARS-Co-V-2 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 -- patient tests results revealed of the 47 patients tested for SARS-Co-V-2, 43 patients tested negative. 3. Review of the laboratory's SARS-Co-V-2 result reporting documentation revealed the laboratory faxed SARS-Co-V-2 positive patient results Sunday through Saturday from 02/11/2021 through 05/10/2021 to the County Health Department. Further review of the laboratory's SARS-Co-V-2 reporting documentation revealed the laboratory failed to report the 43 negative test results to the County Health Department or to the Department of State Health Services. 4. During an interview on 05/11/2021 at 12:40 pm, the Technical Consultant and Nurse Manager confirmed that only positive SARS-Co-V-2 results were reported. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) 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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions, laboratory's Individualized Quality Control Plan (IQCP), quality control (QC) records, patient records, and confirmed in interview, the laboratory failed to support its reduction in frequency to every 30 days and failed to perform two levels of liquid QC material each 8 hours of operation for the D-Dimer analyte on the Alere Triage analyzer for 11 of 11 days in 2021 (random sampling 02/2021-05/2021). Findings: 1. Review of the Alere Triage user's manual stated: "TOTAL QUALITY ASSURANCE ... QUALITY CONTROL SAMPLES It is still valuable to apply the traditional approach to quality control by testing quality control samples. These controls will check the total intergrety of the system. The interval for analyzing these controls, however, can be extended due to the many other Total Quality Assurance features inherent in the Alere Triage tests. The Alere Triage tests have been designed to maximize Total Quality Assurance in any testing environment. The combination of the QC features of the Alere Triage tests reduce the impact of procedural errors, ensure reagent integrity, and assurance that patient results are accurate each and every time a test is performed. Based on CLIA guidelines and other regulating bodies, Alere makes the following QC recommendations: Run two levels of POS and NEG external liquid control samples as appropriate with each new lot of reagents and once every thirty days with continued use of the reagent lot number. Run the QC Device daily." 2. Review of the laboratory's IQCP revealed: "IQCP LABORATORY RISK ASSESSMENT-TRIAGE ... The QCP Actions Required to Address Known Limitations ... Laboratory-implemented control processes: Analyze QC samples in triplicate for five days to monitor for calibration drift. This also allows the laboratory to collect sufficient data to establish confidence with measuring system stability over time ... IQCP PLAN The Individualized Quality Control Plan Developed from the Individual Components of the Quality Control Strategies described above. TRIAGE METER A. ELECTRONIC SIULATOR [sic] Run Electronic Simulator upon system arrival and every day of testing to check internal quality control. B. QC SAMPLES Analyze two levels of QC samples that were not in the same shipment as the reagents on receipt of new reagents; when a new -- 2 of 3 -- lot number is opened; and every 30 days. Ensure QC sample acceptance criteria are appropriate for the clinical setting. Analyze two levels of QC samples before newly trained testing personnel start to run patient samples." The IQCP failed to support its reduction in frequency to every 30 days for D-Dimer on the Alere Triage analyzer. 3. A random sampling of QC and patient records from February through May 2021, revealed the following dates QC was not performed each 8 hours of testing using two levels of control materials on each day of patient testing and patients were analyzed for the D-Dimer analyte on the Alere Triage meter: 03/03/2021 Patient ID: E35763 03 /07/2021 Patient ID: E15480 03/13/2021 Patient ID: E36463 03/15/2021 Patient ID: E36660 QC was last performed on 02/25/2021 at 11:06 am 04/05/2021 Patient ID: E38117 04/13/2021 Patient ID: E06857 04/14/2021 Patient ID: E02307 04/17/2021 Patient ID: E14959 QC was last performed on 03/26/2021 at 8:15 am 05/07/2021 Patient ID: E41236 05/10/2021 Patient ID: E41524 05/11/2021 Patient ID: E35799 QC was last performed on 04/24/2021 at 11:50 am The laboratory failed to include two levels of liquid QC material and electronic QC each 8 hours of operation for the D-Dimer analyte on the Alere Triage analyzer. 4. During an interview on 05/11/2021 at 1:30 pm, the technical consultant confirmed the above findings. -- 3 of 3 --

Summary Statement of Deficiencies D0000 Laboratory representatives were present at the entrance conference conducted 05/11 /2021. The survey process was discussed. An opportunity for questions and comments was given. The exit conference was held with the laboratory representatives on 05/11 /2021. The laboratory was found to be in substantial compliance for the specialties /subspecialties for which it was surveyed. The standard level deficiencies cited were discussed. The process for submitting the corrections was explained. CMS form 2567 will be emailed from the Texas State Health and Human Services Commission, Health Facility Compliance Arlington Group. 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 laboratory SARS-Co-V-2 patient testing records, review of laboratory SARS-Co-V-2 result reporting records, and staff interview, it was revealed that the laboratory failed to report SARS-Co-V-2 negative test results for 38 of 38 days reviewed from 02/11/2021 through 05/10/2021. Findings: 1. Review of SARS- Co-V-2 patient tests records (test performed using the Sofia 2 SARS Antigen FIA COVID-19 Test kit and instrumentation) from 02/11/2021 through 05/10/2021 revealed 47 patients tested for SARS-CoV-2. 2. Further review of the SARS-Co-V-2 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 -- patient tests results revealed of the 47 patients tested for SARS-Co-V-2, 43 patients tested negative. 3. Review of the laboratory's SARS-Co-V-2 result reporting documentation revealed the laboratory faxed SARS-Co-V-2 positive patient results Sunday through Saturday from 02/11/2021 through 05/10/2021 to the County Health Department. Further review of the laboratory's SARS-Co-V-2 reporting documentation revealed the laboratory failed to report the 43 negative test results to the County Health Department or to the Department of State Health Services. 4. During an interview on 05/11/2021 at 12:40 pm, the Technical Consultant and Nurse Manager confirmed that only positive SARS-Co-V-2 results were reported. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) 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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions, laboratory's Individualized Quality Control Plan (IQCP), quality control (QC) records, patient records, and confirmed in interview, the laboratory failed to support its reduction in frequency to every 30 days and failed to perform two levels of liquid QC material each 8 hours of operation for the D-Dimer analyte on the Alere Triage analyzer for 11 of 11 days in 2021 (random sampling 02/2021-05/2021). Findings: 1. Review of the Alere Triage user's manual stated: "TOTAL QUALITY ASSURANCE ... QUALITY CONTROL SAMPLES It is still valuable to apply the traditional approach to quality control by testing quality control samples. These controls will check the total intergrety of the system. The interval for analyzing these controls, however, can be extended due to the many other Total Quality Assurance features inherent in the Alere Triage tests. The Alere Triage tests have been designed to maximize Total Quality Assurance in any testing environment. The combination of the QC features of the Alere Triage tests reduce the impact of procedural errors, ensure reagent integrity, and assurance that patient results are accurate each and every time a test is performed. Based on CLIA guidelines and other regulating bodies, Alere makes the following QC recommendations: Run two levels of POS and NEG external liquid control samples as appropriate with each new lot of reagents and once every thirty days with continued use of the reagent lot number. Run the QC Device daily." 2. Review of the laboratory's IQCP revealed: "IQCP LABORATORY RISK ASSESSMENT-TRIAGE ... The QCP Actions Required to Address Known Limitations ... Laboratory-implemented control processes: Analyze QC samples in triplicate for five days to monitor for calibration drift. This also allows the laboratory to collect sufficient data to establish confidence with measuring system stability over time ... IQCP PLAN The Individualized Quality Control Plan Developed from the Individual Components of the Quality Control Strategies described above. TRIAGE METER A. ELECTRONIC SIULATOR [sic] Run Electronic Simulator upon system arrival and every day of testing to check internal quality control. B. QC SAMPLES Analyze two levels of QC samples that were not in the same shipment as the reagents on receipt of new reagents; when a new -- 2 of 3 -- lot number is opened; and every 30 days. Ensure QC sample acceptance criteria are appropriate for the clinical setting. Analyze two levels of QC samples before newly trained testing personnel start to run patient samples." The IQCP failed to support its reduction in frequency to every 30 days for D-Dimer on the Alere Triage analyzer. 3. A random sampling of QC and patient records from February through May 2021, revealed the following dates QC was not performed each 8 hours of testing using two levels of control materials on each day of patient testing and patients were analyzed for the D-Dimer analyte on the Alere Triage meter: 03/03/2021 Patient ID: E35763 03 /07/2021 Patient ID: E15480 03/13/2021 Patient ID: E36463 03/15/2021 Patient ID: E36660 QC was last performed on 02/25/2021 at 11:06 am 04/05/2021 Patient ID: E38117 04/13/2021 Patient ID: E06857 04/14/2021 Patient ID: E02307 04/17/2021 Patient ID: E14959 QC was last performed on 03/26/2021 at 8:15 am 05/07/2021 Patient ID: E41236 05/10/2021 Patient ID: E41524 05/11/2021 Patient ID: E35799 QC was last performed on 04/24/2021 at 11:50 am The laboratory failed to include two levels of liquid QC material and electronic QC each 8 hours of operation for the D-Dimer analyte on the Alere Triage analyzer. 4. During an interview on 05/11/2021 at 1:30 pm, the technical consultant confirmed the above findings. -- 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 NOT in compliance with the CLIA conditions for specialties/subspecialties surveyed for 45 CFR 493.803 Successful Participation 493.1403 Moderate Complexity Laboratory Director 493.1421 Testing Personnel (moderate complexity) Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing company, American Proficiency Institute (API). 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: 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 -- 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 Proficiency Institute (API), it was determined 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 did not successfully participate in the specialty of hematology. Refer to 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 a proficiency testing desk review of CMS form 155 and American Proficiency Institute records found that the laboratory failed to attain a score of at least 80% acceptable responses for each analyte in the subspecialty of hematology for the analyte Cell I.D. or WBC (white blood cells) differential. Findings: 1. API 2017 - 3rd event the laboratory received an unsatisfactory score of 67% for Cell I.D. 3. API 2018 - 1st event the laboratory received an unsatisfactory score of 67% for Cell I.D. 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 proficiency testing records, it was determined 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. Findings: 1. API 2017 - 3rd event the laboratory received an unsatisfactory score of 67% for Cell I.D. 3. API 2018 - 1st event the laboratory received an unsatisfactory score of 67% for Cell I.D. 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 it was revealed that the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016 D6016 LABORATORY DIRECTOR RESPONSIBILITIES -- 2 of 3 -- 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 it was revealed that 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 --