Block Island Health Services

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to test proficiency testing (PT) samples in the same manner as routine patient samples in the specialty of Chemistry. Findings include: 1. Record review on 3/07/2023 of the laboratory's Medical Laboratory Evaluation (MLE) 2021 and 2022 Troponin PT records revealed, 2 of 3 testing personnel (TP) did not participate in PT in 2021 and 2022. 2. Staff interview with TP#1 on 3/07/2023 at 9:30 AM confirmed the above findings. TP#1 stated, "I am the only one that tests MLE PT samples." 3. The laboratory performs 100 Troponin tests annually in the specialty of 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 1 --

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on record review and staff interview conducted on 05/25/2021, the laboratory failed to perform calibration verification at least once every 6 months for the i-Stat cTnl (Troponin) test system as stated in their approved Quality Control Plan (QCP). Findings include: 1. Record review of the Block Island Medical Center Quality Control Plan (QCP) approved by the Laboratory Director on 2/28/2021 stated revealed "Calibration Verification: Frequency: Every 6 months with software update. On each meter prior to use". 2. Record review of 2020 and 2021 calibration verification documentation for the i-Stat cTnl revealed that the i-Stat cTnl (Troponin) calibration verification was last performed on 4/24/2020. 3. Staff interview with the Laboratory Director and Testing Personnel #1 on 5/25/2021 at 12:20 pm confirmed the above findings. 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 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 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 record review and staff interviews conducted on 04/30/2019, the laboratory failed to maintain copies of Medical Laboratory Evaluation (MLE) Proficiency Testing (PT) records for a minimum period of two years from the date of the PT testing event. Missing records included PT program report forms to record PT results, and attestation statements signed by the laboratory director (LD) and analyst documenting that PT samples were tested in the same manner as patient specimens. Findings include: 1. Record review of 2017 and 2018 PT records revealed that copies of PT program report forms and signed attestation statements were not maintained by the laboratory for 2017 MLE Events 2 and 3, 2018 MLE Events 1, 2, and 3, and 2019 MLE Event 1. 2. Interviews with the LD and Testing Personnel #1 (TP1) on 04/30 /2019 at 11:00 AM confirmed the above findings. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- 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 record review and staff interview conducted on 4/30/2019, the laboratory failed to retain quality control and patient test records (instrument printouts) from the Abbott i-Stat Handheld test system for a period of at least 2 years. Findings include: 1. Record review of 15 patient test records revealed that seven (7) of the fifteen (15) test records did not include i-Stat instrument result printouts. 2. Interview with the Testing Personnel #1 on 04/30/2019 at 3:00 PM confirmed this finding and further revealed that the hard copies of the instrument printouts are maintained because the i-Stat instrument is not interfaced with a laboratory information system. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on record review and staff interview conducted on 4/30/2019, the laboratory failed to review and evaluate unacceptable Medical Laboratory Evaluation (MLE) Proficiency Test (PT) scores the laboratory received for four (4) out of six (6) PT events. Findings include: 1. Record review of 2017, 2018, and 2019 MLE PT result evaluation reports revealed that the laboratory reported the following unacceptable PT sample results: 2017 MLE-M2: sample BG-9- PCO2 2017 MLE-M3: samples BG-14 Lactate & BG 11- PCO2 2018 MLE-M1: samples BG-4 PCO2 & PO2 2018 MLE- M3: samples BG-14 PCO2 & BG-14 Lactate 2. Record review of 2017 and 2018 PT records revealed no documented review or evaluation of the unacceptable PT results for the events listed above. 3. Interview with the Laboratory Director and Testing Personnel #1 on 04/30/2019 at 11:15 AM confirmed the above findings. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review and staff interviews, the laboratory failed to perform established i-Stat control procedures as stated in the laboratory-specific quality control procedure (QCP) (refer to 5445); failed to perform calibration verification at least -- 2 of 8 -- once every 6 months for the i-Stat cTnl and CG4+ test systems (refer to D5439); and failed to verify and approve the reportable range of test results for the i-Stat cTnl (Troponin) and the i-Stat CG4+ (Lactate) test systems prior to patient use (refer to D5421). D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on staff interview and record review conducted on 4/30/2019, the iStat cTnl and CG4+ systems procedure dated 23-Apr14 was not signed and approved by the laboratory director (LD) prior to implementing the test systems for routine patient testing. Findings include: 1. Record review of the Procedure Manual for the i-Stat System, revision date 23-Apr-14 revealed that the i-Stat System procedures were not signed and approved by the current LD prior to use for patient testing. 2. Interview with the LD and Testing Personnel #1 04/30/2019 at 3:30 PM confirmed this findings. 3. Record review of the Abbott Point of Care website further revealed updated versions of the iStat System procedure was not in use at the laboratory. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on record review and staff interview conducted on 04/30/2019 the laboratory failed to verify and approve the reportable range of test results for the i-Stat cTnl (Troponin) and the i-Stat CG4+ (Lactate) test systems prior to implementing the systems for routine patient testing. Findings include: 1. Record review of the i-Stat Cardiac Troponin I Performance Verification Report dated 05/16/2018 revealed precision and accuracy data for cTnl (Troponin) using Control Levels 1 and 2. The review revealed a mean value of .264 ng/mL for Control Level I and 1.341 ng/mL for Control Level 2. 2. Record review of the Abbott Point of Care i-Stat 1 User Guide, Rev. Date: 10/12/2016 used by the laboratory revealed a reportable range of 0.00 - 50.0 ng/mL for cTnl (Troponin). 3. Record review of the i-Stat Cardiac CG4+ (Lactate) Performance Verification Report dated 04/30/2018 revealed precision and accuracy data for CG4+ (Lactate) using Control Levels 1 and 3. The review revealed a mean value of 6.75 mmol/L for Control Level 1 and 0.68 mmol/L for Control Level 3. 4. Record review of the Abbott Point of Care i-Stat 1 User Guide, Rev. Date: 10/12 /2016 used by the laboratory revealed a reportable range of 0.30 -20.0 mmol/L for Lactate/Lac. 5. The record review further revealed that the i-Stat cTnl (Troponin) and the i-Stat CG4+ (Lactate) verifications studies were not signed and approved by the -- 3 of 8 -- laboratory director (LD) prior to implementing test systems for routine patient testing. 6. Staff interview with the LD and Testing Personnel #1 conducted on 04/30/2019 at 2: 30 PM confirmed the above findings. 7. The laboratory performs 20-30 cTnl (Troponin) and 10-20 CG4+ (Lactate) tests annually. 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 record review and staff interview on 04/30/2019, the laboratory failed to perform calibration verification at least once every 6 months for the i-Stat cTnl and CG4+ test systems. Findings include: 1. Record review of the Block Island Medical Center Quality Control Plan (QCP) approved by the LD on 05/01/2018 revealed "Calibration Verification: Frequency: Every 6 months with software update on each meter prior to use". 2. Record review of 2017 and 2019 calibration verification documentation for the i-Stat cTnl and CG4+ test systems revealed the following: i- Stat cTnl (Troponin) calibration verification performed on 4/4/2019 and 4/29/2019 and no documentation for 2018. i-Stat CG4+ (Lactate) calibration verification performed on 3/30/2019 and 4/27/2019 and no documentation for 2018. 3. Staff interview with the Laboratory Director and Testing Personnel #1 on 4/30/2019 at 11: 30 am confirmed the above findings. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The -- 4 of 8 -- laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and staff interview conducted on 04/30/2019, the laboratory failed to perform i-Stat control procedures stated in its laboratory-specific quality control procedures (QCP) approved by the laboratory director (LD) on 05/01/2018. Findings include: 1. Record review of the Block Island Medical Center Quality Control Plan (QCP) approved by the LD on 05/01/2018 revealed the following i-Stat Quality Control (QC) policies and procedures: Liquid QC: a. Frequency: monthly b. Assayed or unassayed: assayed c. Must be performed with each change in reagent lots, new shipment, change in storage conditions, and replacement of any major part of instrumentation. d. Process for determining the acceptable results for controls: manufacturer provides acceptable range. Manufacturer's Recommendations for QC: Check one cartridge from each newly received lot. Check storage conditions by testing one cartridge from refrigerated storage. 2. Record review of QC 2018 and 2019 QC records revealed the following: i-Stat Chem 8 QC conducted on 2/11/2018, 5 /3/2018, 11/4/2018, 3/27/2019, 4/3/2019, and 4/24/2019 i-Stat CG4+ (Lactate) QC: 2 /18/2018, 5/5/2018, 3/27/2019, 4/3/2019, and 4/27/2019. i-Stat cTnl (Troponin) QC: 2 /10/2018, 5/5/2018, 11/6/2018, 3/27/2019, 4/3/2019, and 4/24/2019 3. Interview with Testing Personnel #1 on 4/30/2019 at 12:30 PM 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 documentation review and interview with the Laboratory Director (LD) and Testing Personnel #1 (TP1) on 04/30/2019 at 3:15 PM, the LD failed to ensure established i-Stat control procedures were performed as stated in the laboratory- specific quality control procedure (QCP) (Refer to D6020); failed to ensure calibration verification was performed at least once every 6 months for the i-Stat cTnl and CG4+ test systems (Refer to D6020); failed to verify and approve the reportable range of test results for the i-Stat cTnl (Troponin) and the i-Stat CG4+ (Lactate) test systems prior to patient use (Refer to D6013); failed to review and evaluate unacceptable Medical Laboratory Evaluation (MLE) Proficiency Test (PT) scores (Refer to 6018); and failed approve and sign the iStat cTnl and CG4+ test systems procedures prior to implementing the test systems for routine patient testing (Refer to 6031). D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance -- 5 of 8 -- characteristics of the method; This STANDARD is not met as evidenced by: Based on documentation review and interview with the Laboratory Director (LD) and Testing Personnel #1 (TP1) on 04/30/2019, the LD failed to verify and approve the reportable range of test results for the i-Stat cTnl (Troponin) and the i-Stat CG4+ (Lactate) test systems prior to patient use. Findings include: 1. Record review of the i- Stat Cardiac Troponin I Performance Verification Report dated 05/16/2018 revealed precision and accuracy data for cTnl (Troponin) using Control Levels 1 and 2. The review revealed a mean value of .264 ng/mL for Control Level I and 1.341 ng/mL for Control Level 2. 2. Record review of the Abbott Point of Care i-Stat 1 User Guide, Rev. Date: 10/12/2016 used by the laboratory revealed a reportable range of 0.00 - 50.0 ng/mL for cTnl (Troponin). 3. Record review of the i-Stat Cardiac CG4+ (Lactate) Performance Verification Report dated 04/30/2018 revealed precision and accuracy data for CG4+ (Lactate) using Control Levels 1 and 3. The review revealed a mean value of 6.75 mmol/L for Control Level 1 and 0.68 mmol/L for Control Level 3. 4. Record review of the Abbott Point of Care i-Stat 1 User Guide, Rev. Date: 10/12 /2016 used by the laboratory revealed a reportable range of 0.30 -20.0 mmol/L for Lactate/Lac. 5. The record review further revealed that the i-Stat cTnl (Troponin) and the i-Stat CG4+ (Lactate) verifications studies were not signed and approved by the laboratory director (LD) prior to implementing test systems for routine patient testing. 6. Staff interview with the LD and Testing Personnel #1 conducted on 04/30/2019 at 2: 30 PM confirmed the above findings. 7. The laboratory performs 20-30 cTnl (Troponin) and 10-20 CG4+ (Lactate) tests annually. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require