Barnes-Kasson County Hospital

Summary Statement of Deficiencies D0000 A routine recertification survey was conducted by the Pennsylvania State Agency for Barnes Kasson County Hospital on 9/23/2025 and 9/24/2025. The laboratory was found out of compliance with the following conditions: 493.1250 Condition: Analytic Systems 493.1441 Condition: Laboratories performing high complexity testing; laboratory director. D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: A. Based on record review, lack of documentation, and interview with Technical Supervisor (TS)#1, the laboratory failed monitor and document temperature and humidity to ensure operating conditions were met when 1 of 1 chemistry test (Whole Blood Glucose) was performed from 9/27/2023 to 9/24/2025. Findings include: 1. On the day of the survey, 9/24/2025 at 11:00 am, review of the laboratory's Glucose Meter policy stated, " Use the test strips at temperatures between 16 to 35 degrees Celcius. Use the test strips between 10 - 80% relative humidity." 2. The laboratory failed to provide documentation for temperature and humidity readings taken to ensure operating conditions were met for 1 of 1 chemistry test (Whole Blood Glucose) performed in the emergency room from 9/27/2023 to 09/25/2025. 3. TS #1 confirmed the findings above on 9/24/2025 at 12:00 pm. B. Based on lack of documentation, and interview with Technical Supervisor (TS) #1, the laboratory failed to document the Quality Control (QC) performed for 1 of 1 chemistry test and 3 of 3 virology tests performed from 9/27/2023 to 9/24/2025:. Findings include: 1. On the days of the survey, 9/23/2025 and 9/24/2025, the laboratory failed to provide documentation of QC performed for the following 1 of 1 chemistry test and 3 of 3 virology tests performed from 9/27/2023 to 9/24/2025: -Icotest: Siemens - COVID: Cobas Liat - Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- Influenza (Flu): Cobas Liat - Respiratory Synctical Virus (RSV): Cobas Liat 2. Review of laboratory records revealed the laboratory performed the following examinations: - 2: Ictotest from 9/27/2023-9/23/2025. -53: COVID from 1/17/2025 to 9/24/2025 -6: COVID/Flu/RSV from 1/17/2025 to 9/25/2025. 3. TS #1 confirmed the findings above on 9/23/2025 at 12:45 pm. 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 lack of documentation and interview with Technical Supervisor (TS) #1, the laboratory failed to establish and follow a written policy or procedure to assess employee competency for 2 of 2 TS for their supervisory duties performed (493.1413) from 9/27/2023 to 9/23/2025. Findings include: 1. On the day of survey, 9/23/2025 at 10:00 am, the laboratory failed to provide a written policy to assess the supervisory duties performed for 2 of 2 TS from 9/27/2023 to 9/23/2025. 2. TS #1 confirmed the above findings on 9/23/2025 at 1:00 pm. 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 observation of the laboratory, record review, lack of documentation, and interview with Technical Supervisor (TS) #1, the laboratory failed to meet applicable analytic systems requirements in 493.1251 through 493.1283 from 9/27/2023 to 9/23 /2025. Refer to 5413, 5435, 5449, and 5775. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. -- 2 of 7 -- This STANDARD is not met as evidenced by: Based on observation in the laboratory, review of laboratory temperature records, and interview with Technical Supervisor (TS) #1, the laboratory failed to monitor room temperatures and humidity to ensure proper operating conditions for 2 of 2 instruments used to perform hematology and chemistry examinations from 9/27/2023 to 9/23/2025. Findings include: 1. On the day of survey, 9/23/2025, at 11:00 am, during the tour of the laboratory, the surveyor observed the following instruments in use in the laboratory: - Siemens Sysmex CA-600: system requirements 15C to 35C and humidity 30 to 85%. - Siemens Dimension EXL: system requirements 18C to 30C and humidity 20 to 80%. 2 . Review of the temperature records revealed the laboratory failed to monitor and document room temperatures and humidity to ensure operating conditions were met for 2 of 2 used for hematology and chemistry examinations from 9/27/2023 to 9/23/2025. 3. TS #1 confirmed the findings above on 9/23/2025 at 11:30 am. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) (b)(2)(i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(2)(ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and interview with Technical Supervisor (TS) #1, the laboratory failed to establish and maintain a maintenance /function check policy to ensure equipment used in the laboratory for patient testing provided accurate and reliable test results for 2 of 2 years from 9/26/2023 to 9/23 /2025. Findings include: 1. On the day of survey, 9/23/2025 at 12:30 pm, review of laboratory procedures revealed the laboratory failed to establish a policy for maintenance/function checks performed for equipment used in the laboratory for patient testing for 2 of 2 years from 9/26/2023 to 9/23/2025. 2. The laboratory failed to provide maintenance/function check records for 1 of 1 centrifuge used for coagulation testing (platelet poor plasma) and 2 of 2 timers used for critical steps in patient testing. 3. TS #1 confirmed the findings above on 9/23/2025 at 12:45 pm. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) (d)(3)(ii) Each qualitative procedure, include a negative and positive control material; This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with Technical Supervisor (TS) #1, the laboratory failed to document the positive and negative control each day of patient testing for 22 of 22 serum ketone examinations performed from 2/8/2024 to 9/9 /2025. Findings include: 1. On day of survey, 9/23/2025 at 10:50 am, review of testing logs revealed the laboratory failed to document the positive and negative controls each day of use for 22 of 22 serum acetone examinations performed from 2/8 /2024 to 9/9/2025. 2. TS #1 confirmed the findings above on 9/24/2025 at 11:15 am. -- 3 of 7 -- 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. This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and interview with Technical Supervisor (TS) #1, the laboratory failed to evaluate twice a year the relationship between test results using different methodologies and instruments for 2 of 2 studies performed from 9/27/2023 to 9/23/2025. Findings include: 1. On the day of the survey, 9/23/2025 at 11:30 am, the laboratory failed to provide documentation to define and evaluate the relationship between methodologies/instruments for the following 2 of 2 studies performed from 9/27/2023 to 9/23/2025: - Sure-Vue serum HcG kit vs Siemens Dimension EXL HcG - Manual and automated differential (Sysmex CA600) 2. The laboratory failed to provide documentation for the written criteria established for acceptable differences in test values when comparison studies are performed. 3. TS # 3 confirmed the findings above on 9/23/2025 at 1:30 pm. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) (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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: A. Based on record review, lack of documentation, and interview with Technical Supervisor (TS) #1, the laboratory failed to establish and maintain written policies for an ongoing mechanism to monitor, assess and when indicated, correct problems identified in the postanalytic systems specified in 493.1291 for 2 of 2 years from 9/27 /2023 to 9/23/2025. Findings include: 1. On the day of survey, 9/24/2025 at 12:15 pm, the laboratory could not provide a procedure for the ongoing mechanism to monitor, assess, and correct problems found in the postanalytic system specified in 493.1291 for 2 of 2 years from 9/27/2023 to 9/23/2025. 2. The laboratory failed to provide records for the following periodic checks performed to verify the accuracy of the Laboratory's Information System (LIS) from 09/27/2023 to 09/23/2025: - Calculated Data - Patient results transmitted between instruments and LIS - Patient Specific data. 3. TS #1 confirmed during interview on 9/23/2025 at 12:50 pm, the laboratory did not have a process in place to monitor and evaluate the accuracy of information provided to clients. B. Based on policy and record review, lack of documentation, and interview with Technical Supervisor (TS) #1, the laboratory failed to follow written policies for an ongoing mechanism to monitor and ensure the integrity of test results reported for 2 of 2 testing personnel (TP) from 9/27/2023 to 9/24/2025. Findings include: 1. On the day of survey, 9/24/2025 at 9:30 am, review of the laboratory's Procedural Guidelines policy stated, "All lab work will be reviewed by laboratory supervisor that is performed by persons not qualified to work as a general supervisor". 2. The -- 4 of 7 -- laboratory failed to provide documentation of the review of 2 of 2 TP (CMS 209, #5 and #6, dated 9/9/2025) lab work as per policy. 3. TS #1 confirmed the above findings on 9/24/2025 at 12:30 pm. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on record review and interview with Technical Supervisor (TS) #1, the Laboratory Director (LD) failed to provide overall management and direction of the laboratory in accordance with 493.1445 from 9/27/2023 to 9/23/2025. Refer to D6091, D6092, and D6106. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) (e)(4)(iii) All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratorys performance and to identify any problems that require

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: A. Based on interview with general supervisor (GS) #1 and review of the Pennsylvania's Department of Health ( PA DOH) proficiency testing (PT) records the laboratory failed to provide 3 of 4 attestation statements for chemistry testing events performed in 2021 and 2022. Findings Include: 1. On the days of the survey, 09/26 /2023 and 09/27/2023, the laboratory could not provide the following PA DOH attestation statements for 2021 and 2022: - 1 of 1 DOH attestation for Serum Ethanol 2021 (Event 3) - 2 of 3 DOH attestation for Serum Ethanol 2022 (event 2 and 3) 2. GS #1 confirmed the findings above on 09/27/2023 around 10:30 am. B. Based on review of the American Association of Bioanalysts Association and Medical Laboratory Evaluations (AAB-MLE), and College of American Pathologists (CAP) proficiency testing (PT) records, the laboratory director (LD)/designee and testing personnel (TP) failed to sign 2 of 2 PT agencies attestation statements from 2021, 2022, and 2023. Findings include: 1. On the days of the survey, 09/26/2023 and 09/27/2023, review of AAB-MLE and CAP PT records revealed, the following PT attestation statements were not signed by the LD/ designee and testing personnel in 2021, 2022, and 2023: - Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 16 -- AAB-MLE Non Chem M1 2023 - AAB-MLE Non Chem Q1 2022 (immunohematology) - AAB-MLE Non Chem Q3 2021 (urinalysis, syphilis serology) - AAB-MLE Non Chem Q2 2022 (immunohematology, heme with differential) - AAB-MLE Non Chem Q3 2022 (immunohematology) - CAP IDR A 2023 - CAP IDR R 2022 - CAP IDR C 2022 - CAP IDR C 2021 - CAP GIP B 2023 - CAP GIP C 2023 - CAP GIP C 2022 - CAP GIP B 2022 - CAP GIB A 2022 2. GS #1 confirmed the findings above on 09/27/2023 at 10:30 am. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on record review and interview with general supervisor (GS) #1, the laboratory failed to meet the requirements under 493.1101 through 493.1105. Findings include: 1. Failure to comply with the state of Pennsylvania code Chapter 5.23 for Supervisor Qualifications . Refer to D3009. 2. Failure to document all transfusion-related activities. Refer to D3015. 3. Failure to appropriately monitor temperature of blood products when power outages occurs. Refer to D3021. 4. Failure to document all appropriate transfusion reaction activities. Refer to D3025. D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: A. Based on lack of documentation, record review and interview with testing personal (TP)#1, the laboratory director (LD) failed to be present in the laboratory for a reasonable period of each day of patient testing from 10/28/21 to the day of survey. Findings include: 1. The laboratory's staffing policy states, " A qualified pathologist is the director of the laboratory and responsible for the total operation of the department. The pathologist is available on call and is present in the laboratory a minimum of one day per month for consultation." 2. Review of the Application for Approval to Direct More Than Two Clinical Laboratories (Exception to 5.22) form signed by the LD on 02/21/2022 revealed the LD currently oversees 5 laboratories. 3. On the days of survey, 09/26/2023 and 09/27/2023. the laboratory could not provide evidence of monthly on site visits by the LD to the laboratory from 10/27/21 to the date of the survey. 4. TP #1 confirmed the findings above on 09/27/2023 at 10:30 am. B. Based on review of the application for Approval To Direct More Than Two Laboratories (Exception to Section 5.22(f)) form, personnel credentials and interview with testing -- 2 of 16 -- personnel (TP) #1, the Laboratory Director (LD)/owner failed to ensure a qualified supervisor was onsite every hour of patient testing from 10/28/2021 to 09/27/2023. Findings include: 1. On the days of survey, 09/26/2023 and 09/27/2023, review of personnel credentials revealed that 1 of 3 supervisors (state personnel form personnel #2) has an Associates of Applied Science degree in Medical Laboratory Technology (obtained in May 2003). 2. The application for Exception to Section 5.22(f) form signed by the LD on 02/21/2022 states the LD will "Appoint a qualified general supervisor for each laboratory who will be on-site to oversee laboratory operations during all hours in which testing is being performed and who will review quality control records on a weekly basis". 3. The laboratory could not provide the acceptable credentials needed for personnel #2 in order to perform the duties of a supervisor in the state of Pennsylvania. 4. During an interview on 09/27/2023, personnel # 2 confirmed that there was not a qualified supervisor on site all hours of patient testing. D3015 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103 A facility that provides transfusion services must meet all of the requirements of this section and document all transfusion-related activities. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedures, review of immunohemtalogy records, and interview with general supervisor (GS) #1, the laboratory failed to document all transfusion related activities performed on 02/22/2023. Finding include: 1. The laboratory's procedure states: "Vital signs (temperature, pulse, respirations, blood pressure, oxygen saturations and site observations) and patient assessment should be measured and recorded" : - "At the start of each transfusion" - "15 minutes after commencement of each unit" - "30 minutes after commencement of each unit" - "60 minutes after commencement of each unit" - "Then every 60 minutes until conclusion" - "At completion of transfusion" 2. On the day of survey, 09/27/2023 at 9: 00 am, review of the blood transfusion flow chart revealed the laboratory failed to document the following vitals for 1 of 1 patient reviewed that received a transfusion of red blood cells on 02/22/2023: - Patient's vital signs every 60 minutes until conclusion per laboratory procedure 3. GS #1 confirmed the findings above on 09/27 /2023 at 10:30 am. D3021 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(c)(1) Blood and blood products storage and distribution. If a facility stores or maintains blood or blood products for transfusion outside of a monitored refrigerator, the facility must ensure the storage conditions, including temperature, are appropriate to prevent deterioration of the blood or blood product. This STANDARD is not met as evidenced by: Based on review of temperature records, and interview with general supervisor #1 (GS), the laboratory failed to ensure that refrigerator temperatures for the storage of blood products were monitored and documented when power outages occurred for 3 of 24 hours on 03/23/2022. Findings include: 1. On the day of the survey, 09/26/2023 at 10:45 am, review of temperature records revealed that the laboratory failed to monitor and document the hourly temperature of the temporary refrigerator where -- 3 of 16 -- blood was stored for 3 of 24 hours (01:00 am-04:00 am) on 03/23/2023 when a power outage occurred. 2. The laboratory performs patient testing 24/7 per the information listed on the CMS-116 form. 3. During an interview on 09/26/2023 at 10:32 am, GS #1 stated that the laboratory did not have personnel onsite all hours of operation. Personnel are scheduled on an on-call basis from 01:30-05:30 am . D3025 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(d) Investigation of transfusion reactions. The facility must have procedures for preventing transfusion reactions and when necessary, promptly identify, investigate, and report blood and blood product transfusion reactions to the laboratory and, as appropriate, to Federal and State authorities. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedures, review of immunohematology records, and interview with general supervisor (GS) #1, the laboratory failed to properly investigate 1 of 1 transfusion reaction investigation performed on 06/30 /2020. Finding include: 1. The laboratory's procedure for performing an extended investigation states: "Culture blood from pilots and administration tubing: bap, mac, choc, and incubate remaining media. Cultures are read at 24hrs, 48 hrs. and 7 days." 2. On the day of survey, 09/27/2023 at 9:00 am, review of a ransfusion reaction investigation records revealed the laboratory failed to properly investigate per the laboratory's policy for 1 of 1 transfusion reaction that was performed on 06/30/2020 for the following: - Cultures from pilots and administration tubing 3. GS #1 confirmed the findings above on 09/27/2023 at 10:30 am. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with general supervisor (GS) #1, the laboratory failed to verify twice annually the accuracy of Direct Antiglobulin Test (DAT) and Serum Ketones performed from 10/28/2021 through the days of survey. Findings include: 1. On the days of survey, 09/26/2023 and 09/27/2023, the laboratory could not provide documentation of verification of accuracy for DAT and Serum Ketones performed from 10/28/2021 through the days of survey. 2. The laboratory performed 670 immunohematology examinations and 149,622 Chemistry examinations from 09/07/2022 to 09/07/2023. 3. GS #1 confirmed the findings above on 09/27/2023 at 10:30 am. 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 -- 4 of 16 -- 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 observation of the laboratory, review of laboratory records, and interview with general supervisor (GS) #1, the laboratory failed to meet applicable analytic systems requirements in 493.1251 through 493.1283 from 10/28/2021 to 09/27/2023. Finding include: 1. Failure to label aliquoted solutions with pertinent information and failure to ensure proper storage of acids and bases. Refer to D5415. 2. Failure to ensure appropriate International Normalized Ratio (INR) calculations for Prothrombin Time (PT) test. Refer to D5423. 3. Failure to perform comparison studies in hematology and chemistry. Refer to D5775. 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 observation of the laboratory and interview with general supervisor (GS) #1, the laboratory failed to label 3 of 3 aliquoted reagents with the pertinent information required for proper use and failed to ensure the proper storage of 4 of 4 bottles of acids and 3 of 3 bottles of bases from 10/28/2021 to 09/27/2023. Findings Include: 1. On the day of survey, 09/27/2023, observation of reagents and stains in use, revealed the laboratory did not label pertinent information regarding 3 of 3 unlabeled aliquoted solutions, thought to be Hema3 Quik stains. 2. During the laboratory tour it was observed that 3 of 3 bottles of methyl alcohol (fixative) solution, 3 of 3 bottles of bleach, and 1 of 1 bottle of isopropyl alcohol were stored together under a sink. 3. Flammable reagents were not stored in a flammable cabinet. 4. The flammable cabinet in the laboratory was empty. 5. GS #1 confirmed the findings above on 09/27/2023 around 10:30 am. D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. -- 5 of 16 -- This STANDARD is not met as evidenced by: Based on lack of documentation, record review and interview with general supervisor (GS) #1, the laboratory failed to establish and verify each new thromboplastin lot used for 1 of 1 Sysmex CA-600 coagulation analyzer before reporting patient test results from 10/28/2021 to 09/27/2023. Findings include: 1. On the days of survey, 09/26 /2023 and 09/27/2023, review of the laboratory's hemostasis reagent new lot number roll over verification data revealed the laboratory failed to establish and verify the following for each new lot of thromboplastin reagent used on 1 of 1 Sysmex CA-600 analyzer from 10/28/2021 to 09/27/2021: - Establish a normal patient Prothrombin time mean with each new thromboplastin lot number. - Verify that the normal patient Prothrombin time mean study has been performed according to the manufacturer's instructions. - Incorporate the current and pertinent normal patient Prothrombin time mean for each lot of thromboplastins. - Document the manual check of the INR calculation for each new lot number. - Periodically verify, for each thromboplastin lot number in use, the correct normal patient Prothrombin time mean, and the International Sensitivity Index (ISI) value are being used for calculating the INR value. - Periodically verify the accuracy of the INR calculation. - Periodically verify centrifuge for platelet poor plasma. 2. The laboratory could not provide records of the new lot number roll over verification studies performed per the laboratory's procedure for the Sysmex CA-600 coagulation analyzer. 3. GS #1 confirmed the findings above on 09/27/2023 at 10:30 am 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 lack of documentation and interview with general supervisor #1 (GS), the laboratory failed to have a system that twice a year evaluates and defines the relationship between test results using different methodologies and instrumentation for examinations performed in hematology and chemistry from 10/28/2021 to the date of the survey. Findings include: 1. On the days of the survey, 09/26/2023 and 09/27 /2023, the laboratory failed to provide documentation of the biannual comparison of test results for the following 2 of 2 tests performed in chemistry and hematology from 10/28/2021 to 09/27/2023: -White blood cell differentials: manual microscopic vs. automated (Sysmex XS-1000i) - Serum Human Chorionic Gonadotropin (hCG): Fisher Healthcare SureVue Serum hCG test kit vs. Siemens Dimension EXL w/LM analyzer 2. The laboratory performed 82,739 hematology tests and 149,622 chemistry test in 2022 (CMS 116 annual volume from 09/22/2022 to 09/22/2023). 3. GS #1 confirmed the findings above on 09/27/2023 at 10:00 am. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. -- 6 of 16 -- This CONDITION is not met as evidenced by: Based on observation of the laboratory, record review, and interview with general supervisor (GS) #1, the laboratory director failed to provide overall management and direction of the laboratory in accordance with 493.1445 from 10/28/2021 to 09/27 /2023. Findings include: 1. The laboratory director failed to ensure that verification procedures were adequate for new test/methodologies that were introduced to the laboratory. Refer to D6086. 2. The laboratory director failed to ensure an approved

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 a review of the CASPER Report 155 report and graded results from the proficiency testing organization American Association of Bioanalysts (AAB), the laboratory failed to successfully participate in proficiency testing for the overall testing testing score for Sub-specialty Bacteriology. Refer to D2028. D2028 BACTERIOLOGY CFR(s): 493.823(e) Failure to achieve an overall testing event score of satisfactory performance for 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 2 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the CASPER 155 report and graded results from the proficiency testing organization American Association of Bioanalysts (AAB), the laboratory failed to successfully participate in the Sub - specialty Bacteriology. The laboratory had unsatisfactory scores for the 3rd event of 2021, the 1st event of 2022, and the 3rd event of 2022. Findings include: Subspecialty Year Event Score 1. Bacteriology 2021 3rd 75%. 2. Bacteriology 2022 1st 75%. 3. Bacteriology 2022 3rd 71%. -- 2 of 2 --

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 a review of the CASPER Report 155 report and graded results from the proficiency testing organization American Associates of Bioanalysts (AAB), the laboratory failed to successfully participate in proficiency testing for the subspecialty and specialty Bacteriology. Refer to D2028 D2028 BACTERIOLOGY CFR(s): 493.823(e) Failure to achieve an overall testing event score of satisfactory performance for 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 2 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the CASPER 155 report and graded results from the proficiency testing organization American Association of Bioanalysts (AAB), the laboratory failed to successfully participate in the subspecialty: Bacteriology. The laboratory had unsatisfactory scores for the 3rd event of 2021, and the 1st event of 2022. Findings include: Subspecialty Year Event Score 1. Bacteriology 2021 3rd 75%. 2. Bacteriology 2022 1st 75%. -- 2 of 2 --

Summary Statement of Deficiencies D3021 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(c)(1) Blood and blood products storage and distribution. If a facility stores or maintains blood or blood products for transfusion outside of a monitored refrigerator, the facility must ensure the storage conditions, including temperature, are appropriate to prevent deterioration of the blood or blood product. This STANDARD is not met as evidenced by: Based on observation of the Blood Bank refrigerator and interview with General Supervisor (GS) #1, the laboratory failed to ensure that an area was designated in the blood bank refrigerator for quarantine blood products from 10/27/2019 to the date of survey. findings include: 1. On the day of survey, 10/27/2019, observation of the blood bank refrigerator revealed, there was no designated area for quarantine blood products in the blood bank refrigerator. 2. The GS#1 confirmed the finding above on 10/27/2021 at 11:35 a.m. 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 review of the laboratory procedure manual and interview with the general supervisor (GS) #1, the laboratory failed to establish a competency assessment procedure to assess the competency of 3 of 3 technical consultants from 10/27/2019 to the day of survey. Findings include: 1. On the day of survey, 10/27/2021, review of 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 -- the laboratory clinical staff competency assessment policy revealed, the policy did not include the assessment of competency for 3 of 3 TC from 10/27/2019 to 10/27/2021. 2. The laboratory could not provide competency assessment records for 3 of 3 TC performed in 2019, 2020 and 2021. 3. The GS #1 confirmed the findings above on 10 /27/2021 around 9:20 a.m. 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: A. Based on review of the laboratory procedure manual and interview with the General Supervisor (GS)#1, the laboratory failed to include a general procedure for the validation of new test /analytes introduced to the laboratory from 10/27/2019 to the day of survey Findings include: 1. On the day of survey 10/27/2021, the laboratory could not provide a procedure for the validation of new test /analytes introduced to the laboratory From 10/27/2019 to the day of survey 2. The GS#1 confirmed the finding above on 10/28/2021 around 10:30 a.m. B. Based on review of the laboratory procedure manuals and interview with the General Supervisor (GS)#1, the laboratory failed to follow their microbiology procedures for sputum and wound cultures from 10/27/2019 to the day of survey. Findings include: 1. The procedures for sputum, wound cultures, and Collection, transport, and handling specimens state the following: - The sputum culture procedure under procedure states: "Heat Fix and stain gram stain smear. Read and report the gram stain." - The wound culture procedure under specimen set-up and procedure states: "Make a gram stain from swab" and "read gram stain". - The Collection, transport, and handling specimens under respiratory tract cultures state:"Sputum gram stains showing greater than 10 epithelial cells per low field is commented as a poor specimen". 2. On the day of survey, 10/27/2021, the laboratory could not provide documentation of gram stains performed from 10/27/2019 to 10/27/2021 . 3. The laboratory performed the following number of tests: - sputum cultures: From 10/27/2019 to 12/31/2019: 6. From 01/01/2020 to 12/31/2020: 22. From 01/01/2021 to 10/27/2021: 16. - wound cultures: From 10/27/2019 to 12/31/2019: 31. From 01/01/2020 to 12/31/2020: 98. From 01/01/2021 to 10/27/2021: 116. 4. The GS#1 confirmed the findings above on 10 /27/2021 at 09:15 a.m. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in -- 2 of 6 -- 493.1253. (7) Control procedures. (8)

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 a review of the CASPER Report 155 report and graded results from the proficiency testing organization American Association of Bioanalysts (AAB), the laboratory failed to successfully participate proficiency testing for the analyte Antibody Identification. Refer to D2191. D2191 ANTIBODY IDENTIFICATION CFR(s): 493.865(f) Failure to achieve an overall testing event score of satisfactory for two consecutive 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 -- testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of CASPER 155 report and performance evaluations from the proficiency testing organization American Association of Bioanalysts (AAB), the laboratory failed to successfully participate in proficiency testing for the analytes: Antibody ID. The laboratory had unsatisfactory scores for the 3rd event of 2018 and 1st event of 2019. Findings include: Antibody ID Year Event Score Antibody ID 2018 3 40 Antibody ID 2019 1 40 -- 2 of 2 --

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 review of Laboratory procedure manuals, testing personnel (TP) competency assessment documents and interview with general supervisor (GS) #1, the laboratory failed to establish a competency assessment policy to assess the competency of testing personnel of TP (6 of 6) who perform Microbiology, Chemistry, Hematology, Immunohematology, Immunology, Toxicology and Urinalysis testing and consultant competency (5 of 5) from 09/06/2017 to the date of survey. Findings include: 1. On the day of survey, 04/16/2019, the laboratory failed to provide a competency assessment policy to assess the competency of TP, technical consultants (TC), technical supervisors (TS) and for GS. 2. In 2018, TP #6 competency assessment was not assessed. 3. In 2018, TP #5 competency assessment document was missing points 1, 4, 5 and 6. 4. In 2018, TP #1- #4 competency assessment documents were missing points 5 and 6. 5. The laboratory could not provide documentation of competency assessed for 3 of 3 TC, 1 of 2 TS, and 5 of 5 GS. 6. In 2017 ( 09/06/2017 to 12/31/2019), approximately 8,000 specimen were analyzed. 7. In 2018, approximately 35,500 specimen were analyzed. 8. In 2019 (01/01 /2019 to 04/16/2019), approximately 19,500 specimen were analyzed. 9. The GS #1 confirmed the findings above on 04/16/2019 around 09:30 am. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the 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 -- 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 the calibration verification records and interview with the general supervisor (GS) #1, the laboratory failed to perform calibration verification at least each 6 months on the Siemens Dimension ExL Chemistry analyzer for Hemoglobin A1C from 2018 to the date of survey. Findings include: 1. On the day of survey, 04/16 /2019, the GS could not provide documentation of calibration verification performed at least every 6 months on the Siemens Dimension ExL Chemistry analyzer for Hemoglobin A1C testing in 2018 to 2019. 2. The GS confirmed on 04/16/2019 around 11:15 am, that calibration verification was performed on 03/21/2018 and again on 02 /04/2019, but was not performed every 6 months. ***Repeat Deficiency*** D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of Bacteriology and Toxicology quality control (QC) records, and interview with general supervisor (GS) #1, the laboratory failed to perform a negative and positive control material each day of patient testing for Bio Rad Tox-See Urine drug analysis and Remel Xpect cdiff toxin A+B from 2017 to the date of survey. Findings Include: 1. On the day of survey, 04/16/2019, review of Bio Rad Tox-See Urine drug analysis and Remel Xpect cdiff toxin A+B QC records revealed the laboratory did not document a negative and positive control material each day of patient testing from 09/06/2017 to 04/16/2019. 2. In 2017 (09/06/2017 to 12/31/2017), 46 Bio Rad Tox-See Urine drug analysis and 23 Remel Xpect cdiff toxin A+B from were analyzed. 3. In 2018 (01/01/2018 to 12/31/2018), 127 Bio Rad Tox-See Urine drug analysis and 26 Remel Xpect cdiff toxin A+B from were analyzed. 4. In 2019 (01 -- 2 of 5 -- /01/2019 to 04/16/2019), 77 Bio Rad Tox-See Urine drug analysis and 9 Remel Xpect cdiff toxin A+B from were analyzed. 5. GS #1 confirmed on 04/16/2019 around 12:30 pm, that QC was performed on a each new lot, not each day of patient testing. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on Blood Bank record review and interview with the general supervisor (GS) #1, the laboratory failed to follow policy and monitor proper blood and blood product storage temperatures from September 2017 to April 2019. Findings Include: 1. The previous