Medical Specialists Of Texarkana

Summary Statement of Deficiencies D0000 An onsite survey conducted 12/15/2022 found the laboratory in compliance with 42 CFR Part 493, Requirements for Laboratories. D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on a review of laboratory policy, proficiency testing (PT) records, and confirmed in interview, the laboratory failed to test proficiency testing samples the same number of times that it routinely tests patient samples for five out of five samples reviewed for hematology PT event three in 2022. The findings include: 1. Review of the laboratory policy titled "Proficiency Testing" stated the following: "Laboratory personnel are to perform proficiency testing in the same manner as patient specimens." 2. Review of proficiency testing analytical records for the hematology/coagulation 2022 event 3 had the following PT specimens that were ran multiple times: HEM-11 - ran 3 times HEM-12 - ran 5 times HEM-13 - ran 4 times HEM-14 - ran 3 times HEM-15 - ran 3 times Surveyor queried testing person (TP) 2, on 12/15/2022 at 11:30 hours in the laboratory, as to why they were run multiple times, and do they test patients in the same manner. TP2 stated they ran it multiple times to obtain an average value for test submission, and that patients were only run once before they were resulted. 3. In an interview on 12/15/2022 at 11:32 hours, in the laboratory, the laboratory director confirmed that the laboratory had not tested the PT samples the same number of times that it routinely tested patients. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) 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 -- A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a review of laboratory policy, quality control (QC) records, laboratory documents, and confirmed in an interview, the laboratory failed to follow its own policy for QC troubleshooting on the Cell-Dyn Emerald hematology analyzer for 3 of 28

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: I. Based on surveyor observation, review of manufacturer's instructions, and confirmed in interview of laboratory personnel, the laboratory failed to follow the manufacturer's instructions for storage of 1 of 1 boxes of Hemoccult ICT controls. The findings included: 1. Surveyor observation on December 1, 2021 at 8:50 hours in the storage room refrigerator found 1 box of Hemoccult ICT controls. Lot #M101127 Expiration date: 07-31-2022 2. Review of manufacturer's instructions for the Hemoccult ICT controls under "Storage and Stability" stated, "Store product at controlled room temperature 15 to 30 degrees Celsius; DO NOT FREEZE." 3. The laboratory was asked to provide documentation of following the manufacturer's instructions for storage of the controls. No documentation was provided. 4. Interview with the office manager and the technical consultant on December 1, 2021 at 11:30 hours in the storage room confirmed the findings. II. Based on review of laboratory personnel records, review of manufacturer's instructions, and confirmed in interview of laboratory personnel, the laboratory failed to provide documentation of following the manufacturer's instructions for ensuring testing personnel were trained to perform Covid 19 testing on the BD Veritor prior to patient testing for 2 of 2 testing personnel. The findings included: 1. Review of the laboratory's personnel files for testing personnel 1 and testing personnel 2 (as listed on Form CMS-209) found no documentation of training for the BD Veritor used by the laboratory to perform Covid 19 patient testing. 2. Review of the manufacturer's instructions for the BD Veritor authorized for Emergency Use Authorization for Covid 19 testing under CONDITIONS OF AUTHORIZATION FOR THE LABORATORY, it stated, "All 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 -- operators using your product must be appropriately trained in performing and interpreting the results of your product, use appropriate personal protective equipment when handling this kit, and use your product in accordance with the authorized labeling." 3. The laboratory was asked to provide documentation of following the manufacturer's instructions to ensure testing personnel are trained prior to testing patients on the BD Veritor for Covid 19 testing. No documentation was provided. 4. Interview with the office manager and the technical consultant on December 1, 2021 at 11:30 hours in the storage room confirmed the findings. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on surveyor observation, review of laboratory policies, and confirmed in interview of laboratory personnel, the laboratory did not have a policy to address flags on the Abbott Cell Dyn Emerald analyzer installed in May 2019. The findings included: 1. Surveyor observation on December 1, 2021 at 08:50 hours in the laboratory found the laboratory had installed an Abbott Cell Dyn Emerald in May 2019 (serial #7349). 2. Review of the laboratory's policies found the laboratory did not have a current policy for testing personnel to follow when flags on patient samples for CBCs arise for the Cell Dyn Emerald. The policy found in the manual was for the D3 hematology analyzer which was no longer in use by the laboratory. 3. The laboratory was asked to provide documentation of a policy for testing personnel to follow when flags on patient CBCs arise. No documentation was provided. 4. Interview with the office manager and the technical consultant on December 1, 2021 at 11:30 hours in the storage room confirmed the findings. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedures, review of the laboratory's verification studies on the Abbott Cell Dyn Emerald, and staff interview, the laboratory failed to have documentation of verifying 1 of 1 patient normal values currently in use. The findings included: 1. A review of the laboratory's procedures for the Abbott Cell Dyn Emerald hematology analyzer revealed the laboratory defined patient normal values for 1 samples type used for males and females Complete Blood Cell Count (CBC). 2. A review of the laboratory's verification studies performed on the Abbott Cell Dyn -- 2 of 3 -- Emerald (placed into use on in May 2019) found the laboratory did not have a complete patient normal range study. 3. The laboratory was asked to provide documentation of verifying the identified patient normal values. No documentation was provided. 4. Interview with the office manager and the technical consultant on December 1, 2021 at 11:30 hours in the storage room confirmed the findings. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on review of the laboratory verification studies performed on the Abbott Cell Dyn Emerald hematology analyzer installed in May 2019, and staff interview, the laboratory director failed to document her review of the studies to assess their acceptability. The findings included: 1. A review of the laboratory's verification studies performed the Abbott Cell Dyn Emerald (serial #7349) installed in May 2019 found the laboratory director failed to document his review of the studies to assess their acceptability. 2. The laboratory was asked to provide documentation of the review of the studies for acceptability. No documentation was provided. 3. Interview with the office manager and the technical consultant on December 1, 2021 at 11:30 hours in the storage room confirmed the findings. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. 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: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D2017 - 42 C.F.R. 493.807 (a) - Reinstatement After Failure D6000 - 42 C.F.R. 493.1403 Condition: 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 review of the CMS (Center for Medicare Services) national database and a proficiency desk review of the American Proficiency Institute (API) proficiency testing records from 2020 and 2021, it was determined the laboratory has not successfully participated in a proficiency testing program, 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 for the analyte Red Cell Count (RBC) in three of five PT events in 2020 and 2021. Refer to D2130 D2017 REINSTATEMENT OF NONWAIVED LABORATORIES CFR(s): 493.807(a)(b) (a) If a laboratory's certificate is suspended or limited or its Medicare or Medicaid approval is cancelled or its Medicare or Medicaid payments are suspended because it fails to participate successfully in proficiency testing for one or more specialties, subspecialties, analyte or test, or voluntarily withdraws its certification under CLIA for the failed specialty, subspecialty, or analyte, the laboratory must then demonstrate sustained satisfactory performance on two consecutive proficiency testing events, one of which may be on site, before CMS will consider it for reinstatement for certification and Medicare or Medicaid approval in that specialty, subspecialty, analyte or test. (b) The cancellation period for Medicare and Medicaid approval or period for suspension of Medicare or Medicaid payments or suspension or limitation of certification under CLIA for the failed specialty, subspecialty, or analyte or test is for a period of not less than six months from the date of cancellation, limitation or suspension of the CLIA certificate. This CONDITION is not met as evidenced by: Based on a review of the CMS (Center for Medicare Services) national database, the 2020 and 2021 API (American Proficiency Institute) proficiency testing (PT) scores and confirmed in interview, the laboratory failed to participate successfully for the analyte Red Blood Cell (Hematology) for three of five consecutive testing events and has not demonstrated sustained satisfactory performance on two consecutive proficiency events since the unsuccessful scores. Findings were: 1. The laboratory received the following failing scores (passing = >80%) for the analyte Red Blood Cell (Hematology) for three of five PT events in 2020 and 2021: 2020 1st event RBC - 60 % 2020 3rd event RBC - 20% 2021 2nd event RBC - 40% The 2020 first and third testing event resulted in first time unsuccessful performance addressed on a proficiency testing desk review on 2/10/21. The 2021 second testing event constituted non-initial unsuccessful performance. 2. In an interview of the office manager on 09 /21/21 at 1105 hours via phone confirmed the above findings. The laboratory ceased hematology testing on 3/25/21. 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 a review of the CMS (Center for Medicare Services) national database and a proficiency desk review of the American Proficiency Institute (API) proficiency -- 2 of 3 -- testing records from 2020, it was determined the laboratory failed to achieve satisfactory performance (at least 80%) in the specialty of hematology for the analyte Red Cell Count (RBC), for three of five consecutive testing events in 2020 and 2021, resulting in an unsuccessful PT performance for RBC. Findings were: 1. A review of the CMS national proficiency testing database revealed the following scores for the analyte RBC for three of five consecutive testing events in 2020 and 2021: 2020 API 1st event RBC - 60 % 2020 API 3rd event RBC - 20% 2021 API 2nd event RBC - 40% 2. A proficiency desk review of the API proficiency testing records from 2020 and 2021 confirmed that the laboratory received the following scores for the analyte RBC for three of five testing events in 2020 and 2021. 2020 API 1st event RBC - 60 % 2020 API 3rd event RBC - 20% 2021 API 2nd event RBC - 40% 3. Two out of three unsatisfactory scores of the same analyte result in unsuccessful 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 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. Findings were: 1. A review of the laboratory proficiency testing results revealed that the laboratory director failed to ensure that the laboratory participated successfully. (refer to D6016) By not providing overall management and direction of the laboratory, the laboratory director could not ensure the accuracy or reliability of all laboratory services provided by the facility. 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 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 an approved proficiency testing program. (refer to D2130) -- 3 of 3 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. 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: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: 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 review of the CMS (Center for Medicare Services) national database and a 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 -- proficiency desk review of the American Proficiency Institute (API) proficiency testing records from 2020, it was determined the laboratory has not successfully participated in a proficiency testing program, 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 for the analyte Red Cell Count (RBC) in 2 of 3 PT events in 2020. 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 review of the CMS (Center for Medicare Services) national database and a proficiency desk review of the American Proficiency Institute (API) proficiency testing records from 2020, it was determined the laboratory failed to achieve satisfactory performance (at least 80%) in the specialty of hematology for the analyte Red Cell Count (RBC), for 2 of 3 consecutive testing events in 2020. Findings were: 1. A review of the CMS national proficiency testing database revealed the following scores for the analyte RBC for 2 of 3 consecutive testing events in 2020: 2020 API 1st event RBC - 60 % 2020 API 3rd event RBC - 20% 2. A proficiency desk review of the API proficiency testing records from 2020 confirmed that the laboratory received the following scores for the analyte RBC for 2 of 3 testing events in 2020. 2020 API 1st event RBC - 60 % 2020 API 3rd event RBC - 20% 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 a review of the CMS (Center for Medicare Services) national database and a proficiency desk review of the American Proficiency Institute (API) proficiency testing records from 2020, it was determined the laboratory failed to achieve satisfactory performance (at least 80%) in the specialty of hematology for the analyte Red Cell Count (RBC), for 2 of 3 consecutive testing events in 2020, resulting in an unsuccessful PT performance for RBC. Findings were: 1. A review of the CMS national proficiency testing database revealed the following scores for the analyte RBC for 2 of 3 consecutive testing events in 2020: 2020 API 1st event RBC - 60 % 2020 API 3rd event RBC - 20% 2. A proficiency desk review of the API proficiency testing records from 2020 confirmed that the laboratory received the following scores for the analyte RBC for 2 of 3 testing events in 2020. 2020 API 1st event RBC - 60 % 2020 API 3rd event RBC - 20% 3. Two out of three unsatisfactory scores of the same analyte result in unsuccessful PT performance. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. -- 2 of 3 -- 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. Findings were: 1. A review of the laboratory proficiency testing results revealed that the laboratory director failed to ensure that the laboratory participated successfully. (refer to D6016) By not providing overall management and direction of the laboratory, the laboratory director could not ensure the accuracy or reliability of all laboratory services provided by the facility. 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 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 an approved proficiency testing program. (refer to D2130) -- 3 of 3 --