Benson Hospital

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of Proficiency Testing (PT) records from 2023 and interview with the technical supervisor (TS-1), the laboratory failed to provide a documented review of the PT results for testing events in the specialty of Chemistry. Findings include: 1. The laboratory performs patient testing in the specialty of Chemistry with an approximate annual test volume of 15,673. 2. The laboratory participates in PT testing through American Proficiency Institute (API) for all reported analytes. It participates in three events annually for all regulated analytes. 3. No evidence, either by written comment or signature, was presented during the survey conducted on 9/11/24 to indicate the laboratory director or the designated technical supervisor reviewed the PT results for the first and second Chemistry Core testing events of 2023. 4. The TS-1 interviewed on 9/11/24 at 10:10 AM confirmed that the review of the PT results indicated above were not documented. 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 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) reports for 2023 and 2024 sent to the State Agency by the PT provider, the laboratory failed to successfully participate in a PT program for the subspecialty of Toxicology and for the regulated analyte, Digoxin. Findings include: 1. The laboratory's PT performance was unsatisfactory for the third event of 2023 as indicated below: - Subspecialty of Toxicology - 76% - Digoxin - 60% 2. The laboratory's PT performance was unsatisfactory for the first event of 2024 as indicated below: - Subspecialty of Toxicology - 73% - Digoxin - 40% 3. Unsatisfactory participation in the third event of 2023 and the first event of 2024 (two consecutive testing events) for the regulated analyte, Digoxin, constitutes 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 PT performance. 4. Unsatisfactory participation in the third event of 2023 and the first event of 2024 (two consecutive testing events) for the subspecialty of Toxicology constitutes unsuccessful PT performance. D2116 TOXICOLOGY CFR(s): 493.845(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on information the Proficiency Testing (PT) provider furnishes to the State Agency for 2023, it could not be determined if the laboratory underwent training and technical assistance and if remedial action was taken to correct the PT failures for the subspecialty of Toxicology, and for the regulated analyte, Digoxin, for the third event of 2023 and the first event of 2024. See D2016 for findings. 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 information furnished to the State Agency by the Proficiency Testing (PT) provider, the laboratory failed to achieve satisfactory performance for the regulated analyte, Digoxin, for the third event of 2023 and the first event of 2024. See D2016 for findings. D2119 TOXICOLOGY CFR(s): 493.845(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 information the PT provider furnished to the State Agency, the laboratory failed to achieve satisfactory performance in the subspecialty of Toxicology for the third event of 2023 and the first event of 2024. See D2016 for findings. . D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 -- 2 of 3 -- 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: The Condition of Laboratory Director was found to be not met based on the failure to provide overall management and direction as evidenced by D6016 - ensuring that the proficiency testing samples are tested as required under Subpart H. 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 information furnished to the State Agency by the Proficiency Testing (PT) provider, it was determined that the laboratory director failed to ensure that PT samples are tested in a manner that results in successful participation in a proficiency testing program for the subspecialty of Toxicology, and for the regulated analyte, Digoxin, for the third event of 2023 and the first event of 2024. See D6000 for findings. -- 3 of 3 --

Summary Statement of Deficiencies 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) reports for 2022 and 2023 sent to the State Agency by the PT provider, the laboratory failed to successfully participate in a PT program for the following regulated analyte: PO2 Blood Gas. Findings include: 1. The laboratory's PT performance was unsatisfactory for the third event of 2022 for the regulated analyte, PO2 Blood Gas, with a score of 60%. 2. The laboratory's PT performance was unsatisfactory for the first event of 2023 for the regulated analyte, PO2 Blood Gas, with a score of 40%. D2094 ROUTINE CHEMISTRY 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 -- CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on the information furnished to the State Agency by the Proficiency Testing (PT) provider, it could not be determined if the laboratory underwent training and technical assistance and if remedial action was taken to correct the PT failures for the third event of 2022 and the first event of 2023 for the regulated analyte, PO2 Blood Gas. See D2016 for findings. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 information furnished to the State Agency by the Proficiency Testing (PT) provider, the laboratory failed to achieve satisfactory performance for the third event of 2022 and the 1st event of 2023 for the regulated analyte, PO2 Blood Gas, resulting in unsuccessful PT performance. See D2016 for findings. 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: The Condition of Laboratory Director was found to be not met based on the failure to provide overall management and direction as evidenced by D6016 - ensuring that proficiency testing samples are tested as required under Subpart H. 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 -- 2 of 3 -- required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on information furnished to the State Agency by the Proficiency Testing (PT) provider, it was determined that the laboratory director failed to ensure that PT samples are tested in a manner that results in successful participation in a proficiency testing program for the regulated analyte, PO2 Blood Gas. See D6000 for findings. -- 3 of 3 --

Summary Statement of Deficiencies D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies 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 proficiency testing (PT) records from 2018 and 2019 and interview with the facility personnel, the laboratory director failed to sign the PT attestation statements for Hematology and Chemistry. Findings include: 1. The laboratory participates in PT for testing performed in the specialties of Hematology and Chemistry. The laboratory's approximate annual test volume for these specialties is 308,777. 2. The PT attestation statement presented for review for the second event of 2019 for Hematology lacked the director's signature. 3. The PT attestation statement presented for review for the second event of 2019 for Chemistry lacked the director's signature. 4. The PT attestation statements presented for review for Blood Gas testing for the 3rd event of 2018 and 1st event of 2019 lacked the director's signature.** 5. The facility personnel confirmed that the PT attestation statements indicated above were not signed by the laboratory director. ** - This is a repeat deficiency from the previous survey conducted on June 21, 2017. 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, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- 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) reports for 2018 and 2019 sent to the State Agency by the PT provider, the laboratory failed to successfully participate in a PT program for the regulated analyte, PTT, under the specialty of Hematology. Findings include: 1. The laboratory's PT performance was unsatisfactory for the 3rd event of 2018 for the regulated analyte, PTT, with a score of 40%. 2. The laboratory's PT performance was unsatisfactory for the 1st event of 2019 for the regulated analyte, PTT, with a score of 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 information furnished to the State Agency by the Proficiency Testing (PT) provider, the laboratory failed to achieve satisfactory performance for the regulated analyte, PTT, for the 3rd event of 2018 and 1st event of 2019 resulting in unsuccessful PT performance. See D2016 for findings. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on lack of manufacturer's assay information sheets for review for quality control (QC) material used and interview with the facility personnel, the laboratory failed to retain the records described above for body fluid testing performed. Findings include: 1. The laboratory performs body fluid counts using a Hemacytometer in the specialty of Hematology. It is the practice of the laboratory to perform 2 levels of Strek Cell-Chex QC each day of patient testing. 2. No manufacturer's package insert or assay information sheet was presented for review for the QC lot currently in use at the time of the survey that was performed on June 27, 2019. 3. The facility personnel confirmed that the laboratory could not produce evidence of the manufacturer's -- 2 of 7 -- package insert to coincide with the Strek Cell-Chex QC that was in use at the time of the survey. 4. The facility personnel confirmed that the manufacturer's QC information sheets were not being retained by the laboratory. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies 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) reports for 2018 sent to the State Agency by the PT provider, the laboratory failed to successfully participate in a PT program for the regulated test, Compatibility Testing, under the specialty of Immunohematology. Findings include: 1. The laboratory's PT performance was unsatisfactory for the 2nd event of 2018 for the regulated test, Compatibility Testing , with a score of 40%. 2. The laboratory's PT performance was unsatisfactory for the 3rd event of 2018 for the regulated test, Compatibility Testing, with a score of 80%. D2179 COMPATIBILITY TESTING 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 -- CFR(s): 493.863(d) (1) For any unsatisfactory testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unsatisfactory testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on information the Proficiency Testing (PT) provider furnishes to the State Agency, it could not be determined if the laboratory underwent training and technical assistance and if remedial action was taken to correct the PT failure for the regulated test, Compatibility Testing, for the 2nd event of 2018 and 3rd event of 2018. See D2016 for findings. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory 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 information furnished to the State Agency by the Proficiency Testing (PT) provider, the laboratory failed to achieve satisfactory performance for the regulated test, Compatibility Testing, for the 2nd event of 2018 and 3rd event of 2018 resulting in unsuccessful PT performance. See D2016 for findings. 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: The Condition of Laboratory Director was found to be not met based on the failure to provide overall management and direction as evidenced by D6089 - ensuring that proficiency testing samples are tested as required under Subpart H. 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 information furnished to the State Agency by the Proficiency Testing (PT) -- 2 of 3 -- provider, it was determined that the laboratory director failed to ensure that PT samples are tested in a manner that results in successful participation in a proficiency testing program for the sub-specialty of Compatibility Testing. See D2016 for findings. -- 3 of 3 --

Summary Statement of Deficiencies 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) reports for 2017 sent to the State Agency by the PT provider, the laboratory failed to successfully participate in a PT program for the regulated analyte, Partial Thromboplastin Time (PTT), under the specialty of Hematology. Findings include: 1. The laboratory's PT performance was unsatisfactory for the 1st event of 2017 for the regulated analyte, PTT, with a score of 60%. 2. The laboratory's PT performance was unsatisfactory for the 3rd event of 2017 for the regulated analyte, PTT, with a score of 60%. D2128 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 -- CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on information the Proficiency Testing (PT) provider furnishes to the State Agency, it could not be determined if the laboratory underwent training and technical assistance and if remedial action was taken to correct the PT failure for the analyte, PTT, for the 1st and 3rd events of 2017. See D2016 for findings. 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 information furnished to the State Agency by the Proficiency Testing (PT) provider, the laboratory failed to achieve satisfactory performance for the regulated analyte, PTT, for the 1st and 3rd event of 2017 resulting in unsuccessful PT performance. See D2016 for findings. 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: The Condition of Laboratory Director was found to be not met based on the failure to provide overall management and direction as evidenced by D6016 - ensuring that the proficiency testing samples are tested as required under Subpart H. 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; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on information furnished to the State Agency by the Proficiency Testing (PT) provider, it was determined that the laboratory director failed to ensure that PT samples are tested in a manner that results in successful participation in a proficiency testing program for the regulated analyte, PTT. See D2016 and D6000 for findings. -- 3 of 3 --