Northeast Louisiana Health Center

Summary Statement of Deficiencies D0000 A Certification survey was performed on October 31, 2023 at Northeast Louisiana Health Center, CLIA ID # 19D0464416. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and proficiency testing records as well as interview with personnel, the laboratory failed to ensure testing personnel and laboratory director signed the attestation statements for two (2) of six (6) proficiency testing (PT) events reviewed in 2022 and 2023. Findings: 1. Review of the laboratory's "Proficiency Testing" policy under "Reporting of Results" revealed "After testing is completed and reports are generated, the result forms included in the proficiency testing kit should be completed by the individual assigned to that event. After result forms are completed the individual should sign the attestation statement to document that he/she actually performed testing on the samples in question. The laboratory director must also sign the attestation statement verifying that all samples have been handled in the same manner as patient samples". 2. Review of the laboratory's American Association of Bioanalysts (AAB) proficiency testing (PT) records from 2022 and 2023 revealed the attestation statements were not signed by the laboratory director and/or testing personnel for the following two (2) of six (6) PT events reviewed: a) AAB NonChemistry M1 2022: Laboratory Director and Testing Personnel did not sign attestation) b) AAB NonChemistry M2 2022: Laboratory Director did not sign attestation) 3. In interview on October 31, 2023 at 3:20 pm, 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 -- technical consultant confirmed the attestations were not signed by the appropriate personnel as required by the laboratory policy. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation by surveyor, review of the manufacturer's instructions and laboratory temperature records and interview with personnel, the laboratory failed to monitor the humidity of the laboratory where the Horiba ABX Micros 60 Hematology analyzer was located. Findings: 1. Observation by surveyor during the laboratory tour on October 31, 2023 at 1:10 pm revealed the laboratory utilizes the Horiba ABX Micros 60 analyzer for Complete Blood Count (CBC) testing. 2. Review of the Horiba ABX Micros 60 analyzer's manufacturer requirements under "Humidity and Temperature conditions" revealed the following: * The ABX micros 60 must operate in a temperature range between 18 to 32 degrees celsius (65 to 90 degrees fahrenheit) * Humidity: Up to 95% without condensation 3. Review of the laboratory's temperature records revealed the laboratory did not document the humidity for 2022 and 2023. 4. In interview on October 31, 2023 at 3:20 pm, the technical consultant confirmed the laboratory did not monitor the humidity where the Micros 60 analyzer was located. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) 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)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on observation by surveyor, review of laboratory policy and temperature records as well as interview with personnel, the Laboratory Director failed to ensure laboratory personnel performed test methods as required. Findings: 1. The laboratory failed to monitor the humidity of the laboratory where the Horiba ABX Micros 60 Hematology analyzer was located. Refer to D5413. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of -- 2 of 3 -- 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D0000 A PT Desk Review was performed on August 17, 2020 for Northeast Louisiana Health Center - 19D0464416 was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.803 CONDITION: Successful Participation 42 CFR 493.807 CONDITION: Reinstatement of laboratories performing nonwaived testing 42 CFR 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 review of proficiency testing (PT) results from the CASPER 155D report, the laboratory failed to successfully participate in proficiency testing for Hematology. 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 -- Findings: 1. The laboratory failed to attain a score of at least 80% for all Hematology analytes. Refer to D2121. 2. The laboratory failed to acieve an overall score of at least 80% for three of four consecutive testing events in the specialty of Hematology. Refer to D2131. 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 review of the CASPER 0155D report, the laboratory failed to achieve a satisfactory score for the specialty of Hematology for three (3) of four (4) proficiency testing events resulting in non-initial unsuccessful participation. Refer to D2131. 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 CASPER 0155D Report, the laboratory failed to attain a score of at least 80% for all Hematology analytes. Findings: 1. Review of the CMS 155D records revealed the laboratory did not achieve a score of at least 80% for analytes in the second event in 2020 for the specialty of Hematology for the following: a) The laboratory received a score of 73% for White Blood Cell Differential (WBC DIFF) b) The laboratory received a score of 20% for White Blood Cell (WBC) c) The laboratory received a score of 60% for Platelets (PLT) D2131 HEMATOLOGY CFR(s): 493.851(g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: -- 2 of 3 -- Based on review of the CASPER Report 0155D, the laboratory failed to acieve an overall score of at least 80% for three of four consecutive testing events in the specialty of Hematology. Findings: 1. Review of the Casper Report 0155D revealed the laboratory received an overall score of less than 80% for the following three consecutive events in Hematolgy: a) 2019 Event 2: Score of 0% for Hematology b) 2019 Event 3: Score of 0% for Hematology c) 2020 Event 2: Score of 75% for Hematology 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 record review, the Laboratory Director failed to provide overall management and direction for the laboratory. 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 record review, the laboratory director failed to ensure that proficiency testing samples are satisfactory as required. Findings: 1. The laboratory failed to attain a score of at least 80% for all Hematology analytes. Refer to D2121. 2. The laboratory failed to acieve an overall score of at least 80% for three of four consecutive testing events in the specialty of Hematology. Refer to D2131. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A PT Desk Review was performed on December 09, 2019. Northeast Louisiana Health Center - 19D0464416 was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.803 CONDITION: Successful Participation 42 CFR 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 review of proficiency testing results from the CMS-153, CMS-155D and American Association of Bioanalysts (AAB), the laboratory failed to successfully participate in proficiency testing as evidence by: 1. The laboratory failed to achieve 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 -- score of at least 80% for Hematology analytes in two consecutive events, resulting in initial unsuccessful performance. Refer to D2130. 2. The laboratory failed to acieve an overall score of at least 80% for two consecutive events in the specialty of Hematology. Refer to D2131 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 proficiency testing results from the CMS-155D and American Association of Bioanalysts (AAB), the laboratory failed to achieve a score of at least 80% for Hematology analytes in two consecutive events, resulting in initial unsuccessful performance. Findings: 1. Review of proficiency testing records and the CMS 155D Report revealed the laboratory received a score of 0% for the following analytes resulting in initial unsuccessful performance: a. 2019 Event 3: Score of 0% for Cell ID or WBC Diff b. 2019 Event 2: Score of 0% for Cell ID or WBC Diff c. 2019 Event 3: Score of 0% for Red Blood Cell (RBC) d. 2019 Event 2: Score of 0% for Red Blood Cell (RBC) e. 2019 Event 3: Score of 0% for Hematocrit f. 2019 Event 2: Score of 0% for Hematocrit g. 2019 Event 3: Score of 0% for Hemoglobin e. 2019 Event 2: Score of 0% for Hemoglobin h. 2019 Event 3: Score of 0% for White Blood Cell (WBC) i. 2019 Event 2: Score of 0% for White Blood Cell (WBC) j. 2019 Event 3: Score of 0% for Platelets k. 2019 Event 2: Score of 0% for Platelets D2131 HEMATOLOGY CFR(s): 493.851(g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing records and CMS Report 0155D, the laboratory failed to acieve an overall score of at least 80% for two consecutive events in the specialty of Hematology. Findings: 1. Review of proficiency testing records and Casper Report 0155D revealed the laboratory received an overall score of 0% for the following two consecutive events in Hematolgy: a. 2019 Event 2: Score of 0% for Hematology b. 2019 Event 3: Score of 0% for Hematology 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. -- 2 of 3 -- This CONDITION is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to provide overall management and direction for the laboratory. 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: The laboratory director failed to ensure that proficiency testing samples are satisfactory as required. Findings: 1. The laboratory failed to achieve a score of at least 80% for Hematology analytes in two consecutive events, resulting in initial unsuccessful performance. Refer to D2130. 2. The laboratory failed to acieve an overall score of at least 80% for two consecutive events in the specialty of Hematology. Refer to D2131 -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Certification Survey was performed on August 8, 2019 at Northest Louisiana Health Center, CLIA ID # 19D0464416. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to perform an assessment for unsatisfactory Hematology proficiency test (PT) results. Findings: 1. Review of proficiency testing performance summary revealed the laboratory was enrolled with American Association of Bioanalysts (AAB) for Hematology. 2. Review of proficiency testing records for four (4) events from 2018 and 2019 revealed the laboratory did not perform assessments for the following "unacceptable" results for the following two (2) of four (4) events reviewed: a) Q1 Nonchemistry 2019 Hematology with Differential A with total score of eighty-six percent (86%) *WBC: Sample 2, "unacceptable" - 80% *RBC: Sample 2, "unacceptable" - 80% *HGB: Sample 2, "unacceptable" - 80% *HCT: Sample 2, "unacceptable" - 80% b) Q2 Nonchemistry 2018 Hematology with Differential A with total score of ninety-three percent (93%) *RBC: Sample 2, "unacceptable" - 80% *HCT: Sample 2, "unacceptable" - 80% 3. In interview on August 8, 2019 at 02:53 pm, the Technical Consultant stated she was unaware that