St Peters Health

Summary Statement of Deficiencies D5207 COMMUNICATIONS CFR(s): 493.1234 The laboratory must have a system in place to identify and document problems that occur as a result of a breakdown in communication between the laboratory and an authorized person who orders or receives test results. This STANDARD is not met as evidenced by: Based on record review and interview with general supervisor (GS) #1, the facility failed to resolve a breakdown in communication between the laboratory and the ordering physician for 13 out of 13 massive transfusion events from December 31, 2021, to March 18, 2024. Findings: 1. A review of event logs revealed the facility failed to implement their policies "#020-0092 for Massive Transfusion Protocol" (MTP) and "#LAB-0013.19 for Emergency Release of Uncross Matched Blood", resulting in the following communication failures: A. Failed to request the correct order based on their protocol triggers between massive transfusion and emergency release for event reports (#) and patient date of service (DOS): #22-879 DOS 5/5/22; #22-1399 DOS 7/10/22; #22-1458 DOS 7/17/22; #22-2239 DOS 10/20/22; #23-1937 DOS 10/18/23; #23-2476 DOS 8/16/23; #23-2401 DOS 12/3/2023. B. Failed to order MTP in their electronic medical records to initiate base line labs and subsequent labs for event reports (#) and patient date of service (DOS): #21-2764 DOS 12/31/21; #22- 1331 DOS 7/3/22; #22-2717 DOS 12/11/22; #23-1348 DOS 7/9/23; #23-2476 DOS 8 /16/23; #24-378 DOS 2/21/24. C. Failed to notify the laboratory's blood bank section to initiate the MTP procedure to prepare blood and blood products for event reports (#) and patient date of service (DOS): #21-2764 DOS 12/31/21; #22-1399 DOS 7/10 /22; #22-2842 DOS 12/29/23; #23-1348 DOS 7/9/23; #23-2476 DOS 8/16/23; #23- 1937 DOS 10/18/23; #23-2401 DOS 12/3/2023. D. Failed to notify the blood bank section to terminate the MTP procedure for event reports (#) and patient date of service (DOS): #22-2717 DOS 12/11/22; #23-1937 DOS 10/18/23 #22-2842 DOS 12 /29/23. E. Failed to deliver or return blood and blood products and/or provide 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 -- completed documentation of blood and blood products transfused for event reports (#) and patient dates of service (DOS): #21-2764 DOS 12/31/21; # 22-1331 DOS 7/3/22; #22-1399 DOS 7/10/22; #23-1348 DOS 7/9/23; #23-2476 DOS 8/16/23; #23-2401 DOS 12/3/2023; # 24-378 DOS 2/21/24. 2. An interview with GS #1 on March 21, 2024, at 10:00 AM confirmed the lack of communication between the ordering physician and laboratory for 13 out of 13 Report Events regarding #020-0092 Massive Transfusion Protocol from December 31, 2021, to March 18, 2024. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of

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 review of 37 laboratory policies and procedures, lack of gynecologic stain maintenance records and interview with the Anatomic Pathology Technical Supervisor the laboratory failed to follow one written procedure. Findings include: 1. The procedure titled PAPINICOLAOU (PAP) STAIN, MODIFIED (Actual Laboratory Title) stated: "8.2 Change the first 95% alcohol after each full rack. 8.3 Change distilled water rinses after each rack. 8.4 Filter hematoxylin weekly, change monthly. 8.5 Change and rotate other alcohols as needed. 8.6 Change Cyto Stain as needed. 8.7 Change and rotate xylene weekly, filter as needed." 2. The Survey Team requested and the laboratory failed to provide gynecologic stain maintenance records for 2021, 2022, and to the date of the survey in 2023. 3. During an interview on January 11, 2023 at 11:00 AM these findings were confirmed by Anatomic Pathology Technical Supervisor. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. 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 -- This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions, morphology certification records and interview with the Anatomic Pathology Technical Supervisor the laboratory failed to follow manufacturer's instructions to evaluate gynecologic cytology specimens using the Becton Dickinson (BD) SurePath Pap Test in 2021, 2022 and to the date of the survey in 2023. Findings include: 1. The BD SUREPATH IMPLEMENTATION GUIDE states: "Training on the preparation and evaluation of BD SurePath test slides is a product labeling requirement." 2. The Survey Team requested and the laboratory failed to provide the required morphology certification for one of three Technical Supervisors who performed diagnostic interpretations of BD SurePath Pap Tests in 2021, 2022 and to the date of the survey in 2023. Technical Supervisor includes: - Technical Supervisor B 3. During an interview on January 9, 2023 at 2:00 PM these findings were confirmed by Anatomic Pathology Technical Supervisor. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the lack of laboratory records and interview with the Anatomic Pathology Technical Supervisor the laboratory failed to test staining materials for intended reactivity of two of two "Diff Quick" stain processes used for nongynecologic slide preparations for each day of use in 2021, 2022 and to the date of the survey in 2023. Findings include: 1. The Survey Team requested and the laboratory failed to provide records documenting that the characteristics of two of two "Diff Quick" stain processes used for nongynecologic slide preparations were assessed each day of use in 2021, 2022 and to the date of the survey in 2023. Locations of the stain processes include: -Fine Needle Aspiration Tray -Under the Hood 2. During an interview on January 9, 2023 at 2:05 PM these findings were confirmed by Anatomic Pathology Technical Supervisor. D5625 CYTOLOGY CFR(s): 493.1274(c)(3) (c) Control procedures. The laboratory must establish and follow written policies and procedures for a program designed to detect errors in the performance of cytologic examinations and the reporting of results. The program must include the following: (c) (3) For each patient with a current HSIL, adenocarcinoma, or other malignant neoplasm, laboratory review of all normal or negative gynecologic specimens received within the previous 5 years, if available in the laboratory (either on-site or in storage). If significant discrepancies are found that will affect current patient care, the laboratory must notify the patient's physician and issue an amended report. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records and -- 2 of 5 -- interview with the Anatomic Pathology Technical Supervisor the laboratory failed to follow written policies and procedures to ensure that the review of prior negative gynecologic cases received within the previous five years for each patient with a current diagnosis of high grade squamous intraepithelial lesion [HSIL] or malignancy was documented. The laboratory failed to document the review of prior negative gynecologic cases for two of two HSIL or malignant cases from January 2021 to June 2022. Findings include: 1. The procedure titled GYN CYTOLOGY RESCREENING AND REVIEW stated: "3.5 Staff Cytotechnologist screens...3.5.5 Negative smears available at this facility from previous five years when there is a current interpretation of HSIL." "4. Evidence of Compliance...4.3 Documentation on HSIL spreadsheet and look back." 2. The Survey Team reviewed records titled 2021 5 YEAR LOOK BACK and 2022 5 YEAR LOOK BACK. The laboratory failed to document the review of prior negative gynecologic cases for two of two HSIL or malignant cases from January 2021 to June 2022. Cases include: -C-270-21 -C-1957-22 3. During an interview on January 9, 2023 at 2:30 PM these findings were confirmed by Anatomic Pathology Technical Supervisor. D5629 CYTOLOGY CFR(s): 493.1274(c)(5) (c) Control procedures. The laboratory must establish and follow written policies and procedures for a program designed to detect errors in the performance of cytologic examinations and the reporting of results. The program must include the following: (c) (5) An annual statistical laboratory evaluation of the number of - (c)(5)(i) Cytology cases examined; (c)(5)(ii) Specimens processed by specimen type; (c)(5)(iii) Patient cases reported by diagnosis (including the number reported as unsatisfactory for diagnostic interpretation); (c)(5)(iv) Gynecologic cases with a diagnosis of HSIL, adenocarcinoma, or other malignant neoplasm for which histology results were available for comparison; (c)(5)(v) Gynecologic cases where cytology and histology are discrepant; and (c)(5)(vi) Gynecologic cases where any rescreen of a normal or negative specimen results in reclassification as low-grade squamous intraepithelial lesion (LSIL), HSIL, adenocarcinoma, or other malignant neoplasms. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory statistical records and interview with the Anatomic Pathology Technical Supervisor the laboratory failed to follow written policies and procedures for an annual statistical evaluation of two of six required gynecologic cytology statistics. The laboratory failed to document two of six required gynecologic statistics for 2021 and 2022. Findings include: 1. The procedure titled GYN CYTOLOGY RESCREENING AND REVIEW stated: "9.3.2.2 For gynecologic cases, records are maintained that include the following: 9.3.2.2.2 Number of cases with significant cytologic-histologic discrepancies. 9.3.2.2.4 Number of cases where histopathology results are unavailable to compare with high-grade or malignant cytopathology results." 2. The Survey Team requested and the laboratory failed to provide two of six required gynecologic annual statistics for 2021 and 2022. Statistics include: -Number of gynecologic cases with a diagnosis of HSIL, adenocarcinoma, or other malignant neoplasm for which histology results were available for comparison -Number of gynecologic cases where cytology and histology are discrepant 3. During an interview on January 9, 2023 at 11:00 AM these findings were confirmed by Anatomic Pathology Technical Supervisor. D5657 CYTOLOGY -- 3 of 5 -- CFR(s): 493.1274(e)(5) (e) The laboratory must establish and follow written policies and procedures that ensure the following: (e)(5) The report contains narrative descriptive nomenclature for all results. This STANDARD is not met as evidenced by: A. Based on review of laboratory policies and procedures and interview with the Anatomic Pathology Technical Supervisor the laboratory failed to establish written policies and procedures for the system of narrative descriptive nomenclature used by the laboratory to report gynecologic cytology test results. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to define the criteria used and the system of narrative descriptive nomenclature used by the laboratory to report gynecologic cytology test results. 2. During an interview on January 11, 2023 at 11:00 AM these findings were confirmed by Anatomic Pathology Technical Supervisor. B. Based on review of laboratory policies and procedures and interview with the Anatomic Pathology Technical Supervisor the laboratory failed to establish written policies and procedures for the system of narrative descriptive nomenclature used by the laboratory to report nongynecologic cytology test results. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to define the criteria used and the system of narrative descriptive nomenclature used by the laboratory to report nongynecologic cytology test results. 2. During an interview on January 11, 2023 at 11:00 AM these findings were confirmed by Anatomic Pathology Technical Supervisor. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions, laboratory certification records and interview with the Anatomic Pathology Technical Supervisor the Laboratory Director failed to ensure that one of three Technical Supervisors who performed diagnostic interpretations of BD SurePath Pap Tests had received the required morphology certification prior to reporting patient specimens in 2021, 2022 and to the date of the survey in 2023. Cross refer to D5411. Findings include: 1. The Survey Team requested and the laboratory failed to provide the required morphology certification for one of three Technical Supervisors who performed diagnostic interpretations of BD SurePath Pap Tests in 2021, 2022 and to the date of the survey in 2023. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical -- 4 of 5 -- phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, lack of competency assessment records and interview the Laboratory Director failed to ensure written policies and procedures were established to assess, monitor and maintain the competency of Technical Supervisors, Anatomic Pathology Technical Supervisors and Cytotechnologists who conduct preanalytic, analytic and postanalytic phases of cytology testing. The Laboratory Director failed to provide documentation of a competency assessment for three of three Technical Supervisors in 2021, 2022 and to the date of the survey in 2023. Findings include: 1. The Survey Team requested and the Laboratory Director failed to provide written policies and procedures to assess, monitor and maintain the competency of Technical Supervisors who conduct analytic and postanalytic phases of cytology testing. a. The Survey Team requested and the Laboratory Director failed to provide documentation of competency assessments for three of three Technical Supervisors in 2021, 2022 and to the date of the survey in 2023. Technical Supervisors include: -Laboratory Director/Technical Supervisor A - Technical Supervisor B -Technical Supervisor C 2. The Survey Team requested and the Laboratory Director failed to provide written policies and procedures to assess, monitor and maintain the competency of Anatomic Pathology Technical Supervisors who conduct preanalytic, analytic and postanalytic phases of cytology testing. 3. The Survey Team requested and the Laboratory Director failed to provide written policies and procedures to assess, monitor, and maintain the competency of Cytotechnologists who conduct preanalytic, analytic and postanalytic phases of testing. 4. During an interview on January 11, 2023 at 11:00 AM these findings were confirmed by Director of Laboratory Services and Anatomic Pathology Technical Supervisor. D9999 By agreement between ASCT Services, Inc. and CMS, information provided for CMS's completion of CMS Form 670 are ASCT Services, Inc. averages only. This information is confidential and proprietary to ASCT Services, Inc., is exempt under the Freedom of Information Act (5 U.S.C. 552 et seq.), and shall be used for federal government purposes only. -- 5 of 5 --

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 record review of chemistry, hematology, molecular, laboratory procedures and product inserts, the laboratory failed to verify the manufacturer's reference intervals (normal ranges) are appropriate for the laboratory's patient population for complete blood counts (refer to D5421); failed to perform calibration verification for the i-STAT analyzers (refer to D5439); failed to follow manufacturer's instructions for the number, type, and frequency of the external controls for ePlex Respiratory Pathogen Panel 2 (refer to D5445); and failed to evaluate and define twice a year the relationship between test results using different methodologies or instruments (refer to D5775). 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 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 -- the laboratory's patient population. This STANDARD is not met as evidenced by: Based on record review, patient results reports, and interview with the technical supervisor (TS) #8, the laboratory failed to verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population for complete blood counts (CBC) with differential performed on the Sysmex XN 9000 hematology analyzer. Findings: 1. A review of CBC Auto Diff patient results report 0310:H00001R listed reference ranges for the following analytes: Red blood cell count (RBC), White blood cell count (WBC), Platelet count, Hemoglobin (Hgb), Hematocrit (Hct), Mean corpuscular volume (MCV), Mean corpuscular hemoglobin (MCH), Mean corpuscular hemoglobin concentration (MCHC), Red cell distribution width (RDW), Mean platelet volume (MPV), Reticulocyte count, WBC (white blood cell) differential, including Neutrophil Percent (NEUT%), Neutrophil number (NEUT#), Lymphocyte Percent (LYMPH%), Lymphocyte Number (LYMPH#), Monocyte Percent (MONO%), Monocyte Number (MONO#), Eosinophil Percent (EOS%), Eosinophil Number (EOS#), Basophil Percent (BASO%), Basophil Number (BASO#), Immature Granulocyte Number (IG#) and Immature Granulocyte Percent (IG%) 2. No patient population studies to support the reference ranges listed in the CBC Auto Diff patient results report were available for review. 3. Interview with the TS #8 on June 15, 2022, at 11:30 AM, confirmed the laboratory failed to verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population for complete blood counts (CBC) with differential performed on the Sysmex XN 9000 hematology analyzer. 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 calibration records for the Abbott i-STAT Analyzers using CHEM 8+ and CG4+, cartridges for analytes sodium, potassium, chloride, ionized calcium, -- 2 of 4 -- glucose, blood urea nitrogen, creatinine, hematocrit, total carbon dioxide, pH, PCO2 and PO2, and interview with the Testing Supervisor (TS) #9, 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 16, 2022. Findings: 1. Review of calibration records for Abbott i-STAT analyzer 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 15, 2022. 2. Review of Point of Care Testing Procedure i-STAT and IQCP lacked instruction for Calibration and Calibration Verification. 3. Interview with the TS #9 on June 16, 2022, at 9:30 AM, 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 16, 2022. 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, product inserts, procedures and interview with the technical supervisor (TS) #2, the laboratory failed to follow manufacture's instruction and include in their IQCP the number, type and frequency of external controls for the ePlex Respiratory Pathogen Panel 2 (RP2) nucleic acid multiplex diagnostic test intended for use on the GenMark Dx ePlex Instrument from November 18, 2020 to June 15, 2022. Findings: 1. Review of RP2 external controls records for patient testing revealed ePlex RP2 Positive A and ePlex RP2 Positive B being rotated every other month, new shipment or lot number. 2. Review of ePlex RP2 Control M451 product insert revealed: a. ePlex RP2 Control M451 is composed of 3 controls: ePlex RP2 Positive A, ePlex RP2 Positive B and ePlex RP2 Negative. b. INTENDED USE: The ePlex RP2 Control M451 is intended for use as an external positive and negative quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of pathogens ... RP2 Control M451 is composed of synthetic DNA and RNA specifically designed for and intended to be used solely with the ePlex RP2 Panel on the ePlex System. 3. Review of ePlex Respiratory Pathogen Panel 2 Package Insert revealed, "B. Authorized laboratories using the ePlex RP2 Panel will use the ePlex RP2 Panel as outlined in the Instructions for Use. Deviations from the authorized procedures, including the authorized instruments, authorized extraction methods, authorized clinical specimen types, authorized control materials, authorized other ancillary reagents and authorized materials required to use the ePlex RP2 Panel are not permitted." 4. Review of St Peter's Hospital Laboratory Internal Quality Control Plan (IQCP) for Test System: GenMark Dx ePlex Respiratory Panel 2 revealed, "The frequency of External Control testing has been established using the Individualized Quality Control Plan (IQCP), and reflects the requirements listed in the package insert." 5. Interview with the TS #1 -- 3 of 4 -- on June 15, 2022, at 5:00 PM, confirmed the laboratory failed to follow manufacture's instruction and include in their IQCP the number, type and frequency of external controls for the ePlex RP2 Panel intended for use on the GenMark Dx ePlex Instrument from November 18, 2020 to June 15, 2022. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on record review of College of American Pathologists (CAP) Proficiency Testing (PT) instrument comparison studies, procedure, and interview with Technical Supervisor (TS) # 9, the laboratory failed to evaluate and define twice a year the relationship between test results using different methodologies or instruments, to include comparison of six out of six Abbott i-STAT analyzers to each other and comparison of Abbott i-STAT with Siemens Dimension Vista (chemistry analytes), Siemens Rapid Point 500 (blood gas analytes), and Sysmex 5100 (coagulation analytes) from January 1, 2020 to June 16, 2022. Findings: 1. Review of CAP chemistry comparison studies lacked instrument comparison studies between the Siemens Dimension Vista and Abbott i-STAT for analytes sodium, potassium, chloride, ionized calcium, glucose, blood urea nitrogen, creatinine, hematocrit, and total carbon dioxide. 2. Review of CAP chemistry comparison studies lacked instrument comparison between Siemens Rapid Point 500 and Abbott i-STAT for analytes lactate, pH, PCO2, and PO2. 3. No instrument comparison studies for Sysmex 5100 and Abbott i-STAT for analytes Prothrombin Time and International Normalized Ratio (PT/INR) were available to review. 4. Review of Point of Care Testing Procedure i-STAT lacked comparison studies parameters and instructions. 5. Interview with TS #9 on June 16, 2022 at 9:40 AM, confirmed the above findings. -- 4 of 4 --

Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation, record review and interviews, the Pathology section failed to provide a safe environment in which employees are protected from chemical hazards with a certified fume hood. Findings: 1. Observation of the Pathology Section showed a lack of ventilation to remove xylene vapors on 11/17/20 and 11/18/20. A strong chemcial smell could be detected in the Pathology section of the laboratory by both state surveyors. 2. Interview with Staff Member D, Testing Personnel (TP) confirmed the laboratory failed to provide proper ventilation to ensure personnel are protected from chemical hazards. 3. Observation of Pathology section showed the Biological Safety Hood II was being used for staining and excessive storage of chemical reagents on 11/17/20 and 11/18/20. Although the hood was not a fume hood and could not be certified, the storage of so many items under the hood can impact the performance of the hood operation. 4. Review of a hired hood certification contractor documentation for yearly certification states the NuAire Biological Safety Cabinet II located in the Pathology Laboratory, failed certification on 11/13/2020. There was no visiable certification sticker on the hood. 5. During an interview on 11/18/20 with Staff Member B, General Supervisor (GS), he stated the levels for Xylene vapor monitoring badges had spiked above unacceptable ppm levels 14 months prior. 6. Review of Material Safety Data Sheet (MSDS) CSD/Startex (2010, January 20) Xylene, Technical DGSC pd 6810-1; Section 7 and Section 8 states to use Xylene with adequate ventilations; store in structures made for OSHA Class I C liquids and in containers that tightly close; ventilate to keep vapors below 50 ppm. 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 -- D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on record review and interview, the Pathology section failed to document reagent expiration dates on reagent log(s). Findings: 1. Review of document labeled "Reagent 3D Hematoxylin Stain" lacked a column for recording expiration dates. 2. During an interview on 11/17/20 at 3:00 p.m. with the Staff Member C, technical supervisor (TS), confirmed the lack of documenting of the reagent expiration date. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Based on an on-site initial survey conducted on 10/1/18-10/3/18, deficiencies were cited for St Peters Health in Helena, MT. 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 observation, record review, and interview, the laboratory failed to retain the quality control (QC) data for urine drug screens (UDS) performed on the Siemens Vista from 5/23/18 to 10/2/18. The findings include: 1. On 10/1/18 at 10:45 a.m., two Siemens Vista analyzers were observed in the laboratory. 2. A review on 10/1/18 at 10:45 a.m. of the list of tests performed on each analyzer included UDS performed on the second Vista analyzer. 3. A review on 10/2/18 at 12:15 p.m. of the QC for UDS was not located in Meditech. QC for only the nine previous calendar days was retained on the Siemens Vista analyzer. QC data older than nine calendar days was not located. 4. On 10/2/18 at 12:15 p.m., staff member A stated the QC data was not printed or retained electronically. D5553 IMMUNOHEMATOLOGY CFR(s): 493.1271(b)(f) (b) Immunohematological testing and distribution of blood and blood products. Blood and blood product testing and distribution must comply with 21 CFR 606.100(b)(12); 606.160(b)(3)(ii) and (b)(3)(v); 610.40; 640.5(a), (b), (c), and (e); and 640.11(b). (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. 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 -- This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the laboratory failed to document visual inspection of blood during storage from 5/23/18 through 10/2/18. The findings include: 1. On 10/2/18 at 1:00 p.m., blood was observed in the laboratory blood bank refrigerator. 2. A review on 10/2/18 at 1:00 p.m. of the blood bank review logs lacked documentation of visual inspection of the blood during storage. 3. On 10/2/18 at 1:00 p.m., staff member B stated the units are counted daily but are not visually inspected. -- 2 of 2 --