Jasper Memorial Hospital

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on May 30, 2023. 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] D6076 - 42 CFR 493.1441 Condition: 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 American Association of Bioanalysts (AAB) reports, the laboratory failed to maintain satisfactory 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 -- proficiency testing (PT) participation for Antibody Detection in 2022 event 3 and 2023 event 1 resulting in an initial unsuccessful participation for Antibody Detection. Refer to D2164 D2164 UNEXPECTED ANTIBODY DETECTION CFR(s): 493.861(a) 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 review of the Centers for Medicare and Medicaid (CMS) CASPER 155 report and review of American Association of Bioanalysts (AAB) reports, the laboratory failed to maintain satisfactory participation in the following testing events (3rd event of 2022 and 1st event of 2023), resulting in an initial unsuccessful participation for Antibody Detection. Findings: 1. A review of Casper Report 155 revealed the laboratory failed Antibody Detection on the following: - 2022 Event 3 Score 60% - 2023 Event 1 Score 0% 2. A review of the laboratory's AAB Reports confirmed the laboratory failed Antibody Detection with the aforementioned score. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of the CMS CASPER 155 report and review of American Association of Bioanalysts (AAB) 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 D6089 D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure 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 American Association of Bioanlysts (AAB) 2022 event 3 and 2023 event 1 PT evaluation reports, the laboratory director failed to ensure successful proficiency testing performance in Antibody Detection in two consecutive testing events (2022 event 3 and 2023 event 1), resulting in the initial unsuccessful participation for Antibody Detection. - 2022 event 3 score 60% - 2023 event 1 score 0% -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on June 27, 2022. 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: 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 document review of the Sysmex CA-500 Coagulation (Coag) Analyzer documents, the laboratory failed to provide documentation for the Platelet Poor Plasma procedure, to verify speed and time of centrifugation for coag. specimens for years 2020, 2021, or 2022 to date. Findings: 1. Review of the coag. documents for years 2020, 2021, and 2022 ( to date) revealed there was no documentation to support the Platelet Poor Plasma procedure was verified for the correct speed and time on the centrifuge, in the processing of coag.specimens, for Platelet Poor Plasma. 2. Interview with the general supervisor (CMS 209 #3), on June 28, 2022, at approximately 1:30 pm, in the conferance room, confirmed the aforementioned statement. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on May 23, 2022. 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 deficiencies were cited: 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's American Association of Bioanalysts (AAB) proficiency testing (PT) report, the laboratory failed to maintain satisfactory performance in event 2 of 2021 and event 1 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 -- of 2022 resulting in the first and second unsuccessful occurrence for Compatibility Testing analyte # 895. Findings include: Refer to D 21 D2173 COMPATIBILITY TESTING CFR(s): 493.863(a) Failure to attain an overall testing event score of at least 100 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two testing events (2nd event of 2021 and 1st event of 2022), resulting in the second unsuccessful occurrence for Compatibility testing analyte # 895. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte #895 on event 2 of 2021 with a score of 80% and event 1 of 2022 with a score of 60%. 2. Desk review of the laboratory's proficiency testing reports from American Association of Bioanalysts(AAB)confirmed the laboratory failed two testing events (2nd event of 2021 and 1st event of 2022), resulting in the second unsuccessful occurrence for Compatibility testing analyte # 895. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of the Centers for Medicare and Medicaid Casper Report 155 (CMS 155) and review of the laboratory's 2021 and 2022 proficiency testing (PT) evaluation reports from the American Association of Bioanalysts (AAB) , the laboratory director failed to ensure the laboratory maintained satisfactory performance in two proficiency testing events for Compatibility Testing resulting in the second unsuccessful PT occurrence for Compatibility Testing #895. The findings include: Refer to D6079 for details D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(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, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 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. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a desk review of the Centers for Medicare and Medicaid Casper Report 155 (CMS 155) and review of the laboratory's 2021 and 2022 proficiency testing (PT) evaluation reports from the American Association of Bioanalysts (AAB) , the laboratory director failed to ensure the laboratory maintained satisfactory performance in two proficiency testing events for Compatibility Testing resulting in the second unsuccessful PT occurrence for Compatibility Testing #895. The findings include: 1. Review of the CMS 155 revealed the following unsatisfactory Compatibility Testing scores: 2021 event two 80%, 2022 event one 60%. 2. Review of the 2021 AAB event two evaluation report confirmed unacceptable result for sample 8. 3. Review of the AAB 2022 event one evaluation report confirmed unacceptable results for samples 1 and 3. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on January 25, 2021. 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 deficiencies were cited: 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 153 and 155 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two out of three events (Events 1 & 2 of 2020), resulting in the first 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 -- unsuccessful occurrence for Theophylline analyte #0735 in the specialty of Toxicology. Findings include: Refer to D2118 D2118 TOXICOLOGY CFR(s): 493.845(f) Failure to achieve satisfactory performance for the same analyte or test in 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 153 and 155 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two out of three events (Events 1 & 2 of 2020), resulting in the first unsuccessful occurrence for Theophylline analyte #0735 in the specialty of Toxicology. 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte Theophylline #0735, on Events 1 & 2 of 2020 with a score of 0% for both events. 2. The criteria for acceptable performance for the specialty of Toxicology is 80%. 3. Desk review of the laboratory's proficiency testing reports from the American Association of Bioanalysts (AAB) confirmed the laboratory failed analyte #0735 Theophylline for Events 1 and 2 of 2020 resulting in the first unsuccessful performance. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on an in-office desk review of proficiency testing (PT) records, the Laboratory Director failed to ensure the laboratory successfully participated in two out of three proficiency testing events (Events 1 and 2 of 2020) for analyte #0735 Theophylline in the specialty of Toxicology. Findings include: Refer to D6089 D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two out of three events (1st and 2nd events of 2020), resulting in the first unsuccessful occurrence for Theophylline #0735. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed #0735 -- 2 of 3 -- Theophylline on Events 1 and 2 of 2020 with 0%. 2. The criteria for acceptable performance for the specialty of Toxicology is 80%. 3. Desk review of the laboratory's proficiency testing reports from American Association of Bioanalysts (AAB) confirmed the laboratory failed Theophylline #0735 Events 1 and 2 of 2020 resulting in the first unsuccessful performance. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on February 26, 2020. 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: 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's American Association of Bioanalysts (AAB) proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two out of 3 events (Events 1 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 -- and 3 of 2019), resulting in the first unsuccessful occurrence for Activated Partial Thromboplastin Time (PTT). The findings include: Refer to D2130 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's American Association of Bioanalysts (AAB) proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two out of 3 events (Events 1 and 3 of 2019), resulting in the first unsuccessful occurrence for Activated Partial Thromboplastin Time (PTT). Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte PTT #0835 on Event 1 of 2019 with a score of 60% and Event 3 of 2019 with a score of 20%. 2. The criteria for acceptable performance for the specialty of Hematology is a score of 80%. 3. Desk review of the laboratory's proficiency testing reports from American Association of Bioanalysts (AAB) confirmed the laboratory failed PT on Events 1 and 3 of 2019 resulting in the first unsuccessful performance. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on testing personnel document review and staff interview, the laboratory failed to perform competencies for 3 out of 14 testing personnel as required. Findings include: 1. Personnel record review revealed there were no annual competencies performed for the following TP (CMS 209) for 2018: TP #2, TP #3, and TP #6. 2. An interview with the general supervisor, in a front office on February 26, 2020 at approximately 1:45 p.m. confirmed there were no competency documents available at the time of survey for 3 out of 14 staff for 2018. D6007 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(1) 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)(1) Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on the review of the Implementation Documents for the Beckman Coulter Unicell DxH 600 (DxH) Hematology Analyzer, and staff interview, there was no documentation that the Laboratory Director(LD) had reviewed and approved for the use of the DxH before patient testing was performed. Findings: 1. Review of the Implementation Documents for the DxH there was no documentation that the LD had reviewed and approved the use of the DxH before patient testing was performed. 2. Interview with the Technical Supervisor, on February 26, 2020, at approximately 1 pm in the front office, confirmed that there was no documentation that the LD had reviewed and approved the use of the DxH, Hematology Analyzer before patient testing was performed. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's American Association of Bioanalysts (AAB) proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two out of 3 events (Event 1 and 3 of 2019), resulting in the first unsuccessful occurrence for Activated Partial Thromboplastin Time (PTT). The findings include: Refer to D6089 D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's American Association of Bioanalysts (AAB) proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two out of 3 events (Events 1 and 3 of 2019), resulting in the first unsuccessful occurrence for Activated Partial Thromboplastin Time (PTT). Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte PTT #0835 on Event 1 of 2019 with a score of 60% and Event 3 of 2019 with a score of 20%. 2. The criteria for acceptable performance for the specialty of Hematology is a score of 80%. 3. Desk review of the laboratory's proficiency testing reports from American Association of Bioanalysts (AAB) confirmed the laboratory failed PT on Events 1 and 3 of 2019 resulting in the first unsuccessful performance. -- 3 of 3 --