North Baldwin Infirmary

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the laboratory's proficiency testing provider, College of American Pathologists (CAP). The laboratory was found to be out of compliance with CONDITION LEVEL DEFICIENCIES, as follows: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director . D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 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 -- 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and PT evaluation reports from the College of American Pathologists (CAP), the laboratory failed to successfully participate (achieve scores of 80% or greater) in proficiency testing for pO2 (partial pressure of oxygen), an analyte in the specialty of Chemistry. The laboratory failed two consecutive PT events in 2024, resulting in initial unsuccessful proficiency testing performance. Refer to D2096. . 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 proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and PT evaluation reports from the College of American Pathologists (CAP), the laboratory failed to successfully participate (achieve scores of 80% or greater) in proficiency testing for pO2 (partial pressure of oxygen). The laboratory failed two consecutive PT events in 2024, resulting in initial unsuccessful proficiency testing performance. The findings include: 1. A review of the CASPER Reports revealed the laboratory received failing scores for pO2 in two consecutive CAP PT events, as follows: A) 2024 Survey kit AQ-B: pO2 60% B) 2024 Survey kit AQ-C: pO2 60% 2. A review of the laboratory's proficiency testing evaluation reports provided by CAP confirmed these 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 proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and proficiency testing evaluation reports from the College of American Pathologists (CAP), the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. 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 proficiency testing (PT) desk reviews of the CASPER Reports 0153D and -- 2 of 3 -- 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and PT evaluation reports from the College of American Pathologists (CAP), the laboratory director failed to ensure the laboratory had successful participation in an HHS approved proficiency testing program for pO2 (partial pressure of oxygen) for two consecutive 2024 CAP PT events. Refer to D2096. SURVEYOR ID #32558 Licensure and Certification Surveyor -- 3 of 3 --

Summary Statement of Deficiencies D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on a review of the calibration and calibration verification (C/V) records for the Roche Cobas e411 Chemistry/ Endocrinology analyzers (Serial #66X211 and #66X212), and an interview with the Quality Assurance Coordinator, the laboratory failed to perform C/V's every six months in early 2021, as required by CLIA regulations. The findings include: 1. A review of the records for the two Roche Cobas e411 analyzers revealed reagents were calibrated with less than three calibrators, and 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 -- required semi-annual C/V, as per CLIA regulations. 2. A review of 2020-2021 Roche Cobas e411 records revealed C/V's were performed on both analyzer in July 2020 and on 7/24/2021, however there was no documentation of C/V's on either analyzer performed in early 2021. 3. In an interview on 11/18/2021 at 1:35 PM, the Quality Assurance Coordinator explained leadership changes caused the laboratory to miss C /V's due in January 2021. . D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on reviews of personnel files and interviews with the Technical Consultant (also the Laboratory Manager) and Testing Personnel #15 (the Respiratory Therapy [RT] Supervisor), the Technical Consultant failed to perform and document the semi- annual competency evaluation due in early 2020 for one of eight new Respiratory Therapy Testing Personnel (TP) who performed patient Arterial Blood Gas (ABG) testing. The findings include: 1. A review of the Form CMS-209 (Laboratory Personnel Report) revealed TP #11, a moderate-complexity TP who performed ABG testing in the Respiratory Therapy Department. 2. A review of the personnel file for TP #11 revealed GEM Premier 3500 training dated 7/31/2019, and training with an examination on the GEM 5000 dated 11/12/2020. There was no documentation of a semi-annual competency assessment for the GEM Premier 3500 due around January 2020. 3. In an interview with the Technical Consultant (also the Laboratory Manager) on 11/17/2021 at approximately 4:00 PM, the Technical Consultant stated she had recently learned testing in the Respiratory Therapy Department was under the main laboratory's CLIA #; the Technical Consultant was not aware Respiratory Therapy testing personnel evaluations had not been performed as per CLIA standards. 4. During an interview on 11/18/2021 at 10:55 AM, the surveyor reviewed the personnel records with the RT Supervisor who explained the previous RT Supervisor had left in May 2019. The current RT Supervisor stated he had not realized one of his responsibilities was to ensure competency evaluations were performed on Respiratory Therapists who performed ABG testing. . D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on reviews of personnel files and interviews with the Technical Consultant (also the Laboratory Manager) and Testing Personnel #15 (the Respiratory Therapy [RT] Supervisor), the Technical Consultant failed to perform and document annual competency assessments due in 2019 for three of three Respiratory Therapy Testing Personnel (TP) who had been performing patient Arterial Blood Gas (ABG) testing since the previous survey on 9/6/2018. The findings include: 1. A review of the Form -- 2 of 3 -- CMS-209 (Laboratory Personnel Report) revealed TP #8, #9, and #10, moderate- complexity TP who had performed ABG testing in the Respiratory Therapy Department since the previous surveyor on 9/6/2018. 2. A review of the personnel files for TP #8, #9, and #10 revealed no documentation of competency assessments performed in 2019. 3. In an interview with the Technical Consultant (also the Laboratory Manager) on 11/17/2021 at approximately 4:00 PM, the Technical Consultant stated she had recently learned testing in the Respiratory Therapy Department was under the main laboratory's CLIA #; the Technical Consultant was not aware Respiratory Therapy testing personnel competency assessments were not being performed as per CLIA standards. 4. During an interview on 11/18/2021 at 10: 55 AM, the surveyor reviewed the personnel records with the RT Supervisor who explained the previous RT Supervisor had left in May 2019. The current RT Supervisor stated he had not realized one of his responsibilities was to ensure competency assessments were performed on Respiratory Therapists who performed ABG testing. . D6066 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(4)(ii) Have documentation of training appropriate for the testing performed prior to analyzing patient specimens. This STANDARD is not met as evidenced by: Based on reviews of personnel files and an interview with Testing Personnel #15 (the Respiratory Therapy [RT] Supervisor), the laboratory failed to ensure training for three of eleven Respiratory Therapy Testing Personnel (TP) was performed and documented before performing patient Arterial Blood Gas (ABG) testing on the new IL (Instrumentation Laboratory) Gem 5000 analyzer in 2020. The findings include: 1. A review of the validation records for the new IL Gem 5000 ABG analyzer, revealed the Laboratory Director reviewed and approved the validation procedures on 6/10 /2020. 2. A review of testing personnel records revealed dates of training on the Gem 5000 ABG analyzer as follows: A) TP #9--11/6/2020 B) TP #10--11/11/2020, and C) TP #11--11/12/2020. 3. During an interview on 11/18/2021 at 10:55 AM, the surveyor reviewed the personnel records with the RT Supervisor who explained the previous RT Supervisor had left in May 2019. The current RT Supervisor stated he had not realized his responsibilities included ensuring the testing personnel had documentation of training on new instruments before performing patient testing. During the exit summation at approximately 4:00 PM on 11/18/2020, the RT Supervisor confirmed the laboratory began using the Gem 5000 for patient testing in June 2020. SURVEYOR ID #32558 Licensure and Certification Surveyor -- 3 of 3 --