St Peters Health

Summary Statement of Deficiencies 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 a review of chemistry and hematology procedures, the laboratory failed to verify chemistry and blood gas reference intervals (normal values) are appropriate for the laboratory's patient population (refer to D5421); and failed to perform at least a three-point calibration verification every six months (refer to D5439); failed to include the number, type, and frequency of testing for the i-STAT external electronic simulator in the Individual Quality Control Plan (IQCP) (refer to D5441); and failed to perform two levels of external quality controls as per their IQCP (refer to D5445). 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- This STANDARD is not met as evidenced by: Based on record review, patient results reports, and interview with the technical consultant (TC) # 1, the laboratory failed to verify that the reference intervals (normal values) are appropriate for the laboratory's patient population for Chem8+ and CG4+ cartridges performed on the i-STAT analyzer from June 17, 2020 to June 22, 2022. Findings: 1. Review of three of three patient results reports for chemistry, blood gas with lactate listed reference ranges for analytes: creatinine, BUN, glucose, sodium, potassium, chloride, ionized calcium, TCO2, hemoglobin, hematocrit, pH, PO2, PCO2, HCO3, Base Excess, O2 saturation, and lactate. 2. Review of Intended For Use (IFU) for i-STAT CG4+ Cartridge and i-STAT CHEM8+ Cartridge revealed the reference range values differed from the patient results report's reference range values. 3. The review of the laboratory's i-STAT Point of Care Testing Procedure lacked reference intervals (normal values). 4. No patient population studies to support the reference ranges listed in the "POC CHEM 8 PLUS" and "POC BLOOD GAS W /LAC" patient results reports were available for review. 5, An interview with TC # 1 on June 22, 2022 at 10:00 AM confirmed these findings. 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 review of i-STAT calibration records and interview with the Testing Consultant (TC) #1, the laboratory failed to perform at least a three-point (a minimal, mid-point, and maximum) calibration verification every six months or after CLEW software updates from January 1, 2020 to June 22, 2022. Findings: 1. Review of calibration records for CHEM 8+ and CG4+ cartridges performed on the Abbott i- STAT analyzer for analytes: sodium, potassium, chloride, ionized calcium, glucose, blood urea nitrogen, creatinine, hematocrit, total carbon dioxide, pH, PCO2 and PO2, lacked documentation of a calibration verification including, at least, a minimal, midpoint, and maximum value for each analyte performed every six months or after CLEW software updates from January 1, 2020 to June 22, 2022. 2. Review of the test -- 2 of 4 -- volume report dated 5/18/22 revealed one blood gas (CG4+) patient and five chemistry (CHEM 8+) patients were tested from May 18, 2021 to May 18, 2022. 3. Review of Point of Care Testing Procedure i-STAT and IQCP lacked instruction for Calibration and Calibration Verification. 4. Interview with the TC #1 on June 22, 2022, at 12:30 PM, confirmed the laboratory failed to perform at least a three-point calibration verification for analytes performed on the i-STAT analyzer every six months or after CLEW software updates from January 1, 2020 to June 22, 2022. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review of procedures, and interview with Technical Consultant (TC) #1, the laboratory failed to include the number, type, and frequency of testing for the external electronic simulator for the i-STAT Individual Quality Control Plan (IQCP) from January 1, 2020 to June 22, 2022 . Findings: 1. The laboratory's i-STAT Point of Care Testing Procedure and i-STAT IQCP failed to include instructions for the external electronic simulator. 2. Review of Abbott's i-STAT 1 System Manual revealed that the laboratory failed to verify the thermal probe checks with the external electronic simulator every six months. 3. No documentation of external electronic simulator checks were available for review. 4. Interview with the TC #1 on June 22, 2022 at 11:50 AM confirmed these 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 laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review, procedures, and interview with the technical consultant (TC) #1, the laboratory failed to perform two levels of external quality controls (QC) on CHEM 8+, CG4+ and PT/INR cartridges as per their laboratory procedure from December 1, 2021 to April 30, 2022. Findings: 1. Review of the i-STAT Point of Care -- 3 of 4 -- Testing Procedure and the CoaguChek XS Pro PT/INR Point of Care Testing Procedure revealed, "Liquid Quality Control Material (normal and abnormal) is used when each new lot or shipment of cartridge is put into use." 2. Review of i-STAT1 Quality Control Plan and CoaguChek Quality Control Plan revealed, "External Controls: Two levels of control material are run monthly or upon start of a new lot of reagents." 3. A review quality control logs for the i-STAT and CoaguChek lacked documentation of two levels of external liquid QC checks from December 1, 2021 to April 30, 2022. 4. Interview with the TC #1 on June 5, 2022, at 11:40 AM, confirmed the laboratory failed to perform either monthly QC or QC on new lot or shipment of cartridges before being put into use from December 1, 2021 to April 30, 2022. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: . THIS IS A REPEAT DEFICIENCY Based on review of patient results reports and interview with the Technical Consultant (TC) # 1, the laboratory failed to include the testing facility's name and address on the patient results report. Findings: 1. Review of three of four patient results reports lacked the testing facility's (St. Peters Health in Townsend) name and address on the report. 2. Interview with TC #1 on June 22, 2022, at 11:30 PM, confirmed the laboratory reports failed to include the testing facility's name and address. -- 4 of 4 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to follow policies and procedures to asses personnel competency of the Technical Consultant (one of one). Findings: 1. Review of personnel competency evaluations revealed that the Technical Consultant (TC#1) lacked documentation for training and competency. 2. Review of two laboratory IQCP Quality Control Plan for Coagucheck and i-STAT revealed "Non-waived testing: Training will be annually by Healthstream, running of quality controls and six levels of competency bi-annually for the first year and annually thereafter with documentation on file". 3. Confirmed during interview with the Technical Consultant (TC #1) and Laboratory Services Operations Manager (LSOM #1) the laboratory failed to perform training and competency evaluation for TC #1 for specialties Hematology and Routine Chemistry platforms, on 9/22/20 at 12:04 PM. 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 record review and interview, the laboratory procedures lacked St Peters Health, Townsend's current laboratory director's (LD) signature and date for approval 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 -- prior to patient testing. Findings: 1. Review of procedure manuals revealed the lack of Townsend's Laboratory Director's approval. 2. Review of "Ordering and Resulting Point of Care Testing" contained the laboratory director signature and date from the St Peters Health, Helena location. 3. Confirmed during interview with TC#1 the report's lack of Townsend's LD signature and date for approval prior to patient testing. 9/22 /2020 at 10:05 AM. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory report failed to contain the name and address of the laboratory location where the test was performed. Findings: 1. Review of three out of three laboratory reports lacked the testing facility's (St. Peters Health in Townsend) address on the report. 2. Confirmed during interview with TC#1 and Laboratory Services Operations Manager (LSOM#1) the laboratory reports failed to include the facility's address, on 9/22/20 at 10:48 AM. D6045 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(7) (b) The technical consultant is responsible for-- (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; This STANDARD is not met as evidenced by: Based on record review and interview, the TC#1 failed to ensure Testing Personnel (TP#1 and TP#2) received training prior to testing patients' specimens. 1. Review of personnel training evaluations revealed the lack of training records for TP #1 and TP#2. prior to testing patient's specimens. 2. Review of the laboratory IQCP Quality Control Plan: CoaguCheck: revealed: "Quality Assessment Plan: New hires will have to complete Coagu Chek training and competency prior to testing." 3. Review of the laboratory IQCP Quality Control Plan: i-STAT revealed: "Quality Assessment Plan: New hires will have to complete i-STAT training and competency prior to testing." 4. Confirmed during interview with TC# 1, LSOM#1, and LD#1, the laboratory failed to perform training for TP#1 and TP#2 prior to patient's testing, on 9/22/20 at 12:04 PM. -- 2 of 2 --