Southwest Kidney Institute, Plc

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on April 2, 2025, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful Participation D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity 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 Certification and Survey Enhanced Reporting (CASPER) 155 report and the API-American Proficiency Institute, the laboratory failed to successfully participate in two out of three consecutive testing events for the regulated 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 -- analyte, Triglycerides (TRIGL), in 2024 and 2025, resulting in an initial unsuccessful performance. Refer to D2096. 1. The laboratory's PT performance was unsatisfactory for the third event of 2024 as indicated below: - Triglcerides (TRIGL) - 40% 2. The laboratory's PT performance was unsatisfactory for the first event of 2025 as indicated below: - Triglycerides (TRIGL) - 20% D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (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 review of the CASPER 155 report and the American Proficiency Institute (API) Proficiency Testing (PT) records from 2024 and 2025, the laboratory failed to achieve satisfactory performance (80% or greater) for two out of three consecutive testing events for the regulated analyte, Triglycerides (TRIGL). Findings include: 1. A review of the CASPER 155 report revealed the following unsatisfactory scores: 2024 event 3, Triglycerides (TRIGL) 40% 2025 event 1, Triglycerides (TRIGL) 20% 2. A review of the proficiency testing scores from API. (2024 and 2025) confirmed the above 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: Based on a proficiency testing desk review of the CASPER-0155 Individual Laboratory Report and the API-American Proficiency Institute 2024 and 2025 records, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) 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 proficiency testing desk review of the CASPER-0155 and the API- American Proficiency Institute 2024-3 and 2025-1 evaluation reports, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Based on the on-site survey performed on 7/17/24, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful Participation D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity D6063 - 42 C.F.R. 493.1421 Condition: Laboratory Testing Personnel 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 Certification and Survey Enhanced Reporting (CASPER) 155 report and American Proficiency Institute's (API) proficiency testing records, the laboratory failed to successfully participate in two of three consecutive testing events 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 -- in the subspecialty of Routine Chemistry for the regulated analyte, Total Bilirubin, in 2022 resulting in an initial unsuccessful performance. Refer to D2096. 1. The laboratory's PT performance was unsatisfactory for the second event of 2022 as indicated below: - Total Bilirubin - 40% 2. The laboratory's PT performance was unsatisfactory for the third event of 2022 as indicated below: - Total Bilirubin - 20% 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 review of the Certification and Survey Enhanced Reporting (CASPER) 155 report and American Proficiency Institute's (API) proficiency testing records, the laboratory failed to achieve satisfactory performance (80% or greater) for two of three consecutive testing events in the subspecialty of Routine Chemistry for the regulated analyte, Total Bilirubin. Findings include: 1. A review of the CASPER 155 report revealed the following unsatisfactory scores: 2022 event 2, Total Bilirubin - 40% 2022 event 3, Total Bilirubin - 20% 2. A review of the proficiency testing scores from API confirmed the above 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: Based on a review of the Certification and Survey Enhanced Reporting (CASPER) 155 report and American Proficiency Institute's (API) proficiency testing records, the laboratory director failed to provide overall management and direction of the laboratory services. 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 a review of the Certification and Survey Enhanced Reporting (CASPER) 155 report and the American Proficiency Institute's (API) proficiency testing records from the second and third events of 2022, the laboratory director failed to ensure -- 2 of 3 -- successful participation in an HHS approved proficiency testing program. Refer to D2096. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on review of personnel records and interview with the facility personnel, the laboratory failed to provide documentation of academic credentials to qualify one out of three testing personnel for moderate complexity testing. Refer to D6065 D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on review of personnel records and interview with the technical consultant (TC- 1), the laboratory failed to provide documentation of academic credentials to qualify one out of three testing personnel (TP-1) for moderate complexity testing. Findings include: 1. The laboratory performs 413,760 patient tests annually under the specialties of Chemistry and Hematology. 2. Review of the personnel records for one out of three testing personnel showed the laboratory failed to have academic credentials to qualify TP-1. 3. No documentation was presented for review during the survey to indicate the laboratory had the diploma and corresponding transcripts of the testing personnel indicated above evaluated by a foreign transcript evaluation agency to ensure the equivalent education requirements. 4. Interview with TC-1 on 7/17/24 at 9:00 AM confirmed the laboratory failed to provide the required documentation to qualify TP-1 for moderate complexity testing. -- 3 of 3 --

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 2020 for testing performed by the laboratory and interview with the facility personnel, the laboratory director and testing personnel failed to sign the PT attestation statements. Findings include: 1. The laboratory performs testing in the specialties of Chemistry and Hematology, with an approximate annual test volume of 300,000. 2. The PT attestation statements presented for review for the first event of 2020 for Chemistry lacked the laboratory director's and testing personnel signature. 3. The PT attestation statements presented for review for the first event of 2020 for Miscellaneous Chemistry lacked the laboratory director's and testing personnel signature. 4. The facility personnel confirmed that the PT attestation statements indicated above were not signed by the laboratory director and testing personnel. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on lack of a proficiency testing (PT) attestation statement for review from 2020 for Hematology testing and interview with the facility personnel, the laboratory failed to provide evidence of the testing personnel and director's attestations to the routine integration of PT samples into the workload using the laboratory's routine methods . Findings include: 1. The attestation statement for testing performed under the specialty of Hematology for the 2nd event of 2020 was not provided to the surveyor for review. 2. The facility personnel acknowledged that the attestation statement indicated above was not available for review at the time of the survey. 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 2021 sent to the State Agency by the PT provider, (A) the laboratory failed to successfully participate in a PT program for the regulated analyte, Cell ID/WBC Diff, under the specialty of Hematology, resulting in subsequent unsuccessful PT performance and (B) the laboratory failed to successfully participate in a PT program for the regulated analyte, Glucose, under the specialty of Chemistry. Findings include: A1. The laboratory's PT performance was unsatisfactory for the 1st event of 2021 for the regulated analyte, Cell ID/WBC Diff, with a score of 76%. A2. The laboratory's PT performance was unsatisfactory for the 2nd event of 2021 for the regulated analyte, Cell ID/WBC Diff, with a score of 20%.* A3. The laboratory's PT performance was unsatisfactory for the 3rd event of 2021 for the regulated analyte, Cell ID/WBC Diff, with a score of 56%** A4. *Unsatisfactory participation in the 1st event of 2021 and the 2nd event of 2021 (two consecutive testing events) for the regulated analyte, Cell ID/WBC Diff, constitutes an initial unsuccessful PT performance. A5. **Unsatisfactory participation in the 2nd event of 2021 and 3rd event of 2021 (two consecutive testing events) for the regulated analyte, Cell ID/WBC Diff, constitutes an unsuccessful PT performance -- 2 of 6 -- and a subsequent unsuccessful PT to the initial unsuccessful PT as outlined above in #A4. B1. The laboratory's PT performance was unsatisfactory for the 2nd event of 2021 for the regulated analyte, Glucose, with a score of 20%. B2. The laboratory's PT performance was unsatisfactory for the 3rd event of 2021 for the regulated analyte, Glucose, with a score of 60%. 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 regulated analyte, Glucose, for the 2nd event of 2021 and 3rd event of 2021 resulting in unsuccessful PT performance. See D2016 for findings. D2128 HEMATOLOGY 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 review of proficiency testing (PT) scores supplied by the PT agency, review 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) attestation statements for the first and second event of 2019 and interview with the laboratory director, the laboratory failed to have the director or a qualified designee sign the attestation statements for the 1st event of PT performed under the specialty of Chemistry and the 2nd event of PT performed under the specialty of Hematology. Findings include: 1. The PT attestation statements noted above did not have the signature either of the director or an individual that would qualify as a designee; a technical consultant meeting the qualifications under CLIA regulation 493.1409. 2. The laboratory director acknowledged that the individual that signed the attestation statements indicated above did not qualify as a designee. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of quality assessment (QA) policies and interview with the facility Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- personnel, the laboratory failed to perform and document quality assessment activities as indicated in laboratory policy. Findings include: 1. The laboratory's QA policy at the time of the survey included a monthly review of laboratory records including Quality Control, Proficiency Testing, Problems, Maintenance logs and temperature logs. 2. No monthly QA documentation was presented for review to indicate the laboratory performed and documented QA activities as indicated above from September 2017 through December 2018 and from April 2019 through the date of the survey conducted on September 26, 2019. 3. The facility personnel confirmed that the laboratory could not locate documentation of QA activities stated above. 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 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 and 2018 sent to the State Agency by the PT provider, the laboratory failed to successfully participate in a PT program for the regulated analyte, Platelets, under the specialty of Hematology. Findings include: 1. The laboratory's PT performance was unsatisfactory for the 3rd event of 2017 for the regulated analyte, Platelets, with a score of 0%. 2. The laboratory's PT performance was unsatisfactory for the 2nd event of 2018 for the regulated analyte, Platelets, with a score of 60%.* 3. The laboratory's PT performance was unsatisfactory for the 3rd event of 2018 for the regulated analyte, Platelets, with a score of 0%** 4. *Unsatisfactory participation in the 3rd event of 2017 and the 2nd 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 -- event of 2018 (two out of three testing events) for the regulated analyte , Platelets, constitutes an initial unsuccessful PT performance. 5. **Unsatisfactory participation in the 2nd event of 2018 and 3rd event of 2018 (two consecutive testing events) for the regulated analyte, Platelets, constitutes an unsuccessful PT performance and a subsequent unsuccessful PT to the initial unsuccessful PT as outlined above in #4. D2128 HEMATOLOGY 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 regulated analyte, Platelets, for the 3rd event of 2017, 2nd event of 2018 and 3rd event of 2018. 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, Platelets, for the 3rd event of 2017, 2nd event of 2018 and 3rd event of 2018 resulting in subsequent 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) -- 2 of 3 -- 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 regulated analyte, Platelets. See D2016 and 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 2017 and 2018 sent to the State Agency by the PT provider, the laboratory failed to successfully participate in a PT program for the regulated analyte, Platelets, under the specialty of Hematology. Findings include: 1. The laboratory's PT performance was unsatisfactory for the 3rd event of 2017 for the regulated analyte, Platelets, with a score of 0%. 2. The laboratory's PT performance was unsatisfactory for the 2nd event of 2018 for the regulated analyte, Platelets, 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, Platelets, for the 3rd event of 2017 and 2nd event of 2018. 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, Platelets, for the 3rd event of 2017 and 2nd event of 2018 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, Platelets. See D2016 and D6000 for findings. -- 3 of 3 --