Caldwell Memorial Hospital, Inc

Summary Statement of Deficiencies D0000 A Recertification Survey was conducted on April 29, 2024 at Caldwell Memorial Hospital - CLIA # 19D1082041. The laboratory was found in compliance with 42 CFR 493 Requirement for Laboratories; however, standard level deficiencies were cited. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of laboratory policy, proficiency testing records, and interview with personnel, the laboratory failed to ensure the Laboratory Director signed the performance review and attestation form for twelve (12) of twenty two (22) proficiency testing events reviewed in 2023 and 2024. Findings: 1. Review of the laboratory's "Proficiency Surveys" policy revealed "The Proficiency Testing Vendor's attestation statement must be signed by the Laboratory Director and the associates who performed any portion of the survey prior to submission of the results to API. Review of the evaluated survey results is conducted by the Laboratory Director". 2. Review of the laboratory's American Proficiency Institute (API) proficiency testing records for 2023 and 2024 revealed the performance review and attestation forms was 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 -- not reviewed by the Laboratory Director or designee for the following twelve (12) of twenty two (22) proficiency testing events: a) 2023 Chemistry Core 1st event - Performance Review and Attestation forms b) 2023 Chemistry Core 2nd event - Performance Review and Attestation forms c) 2023 Chemistry Core 3rd event - Performance Review and Attestation forms d) 2023 Hematology/Coagulation 1st event - Performance Review e) 2023 Hematology/Coagulation 2nd event - Performance Review f) 2023 Microbiology 1st event - Performance Review and Attestation g) 2023 Microbiology 2nd event - Performance Review and Attestation h) 2023 Immunology/Immunohematology 1st event - Performance Review and Attestation i) 2023 Chemistry Miscellaneous 1st event - Performance Review j) 2023 Chemistry Miscellaneous 2nd event - Performance Review k) 2024 Hematology /Coagulation 1st event - Performance Review and Attestation l) 2024 Microbiology 1st event - Attestation 3. In interview on April 29, 2024 at 1:00 pm, the Laboratory Director confirmed the performance review and attestation forms were not signed as required in 2023 and 2024. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: I. Based on review of the manufacturer's user manual, laboratory maintenance logs, and interview with personnel, the laboratory failed to perform the required maintenance procedures for the Beckman Coulter AU480 chemistry analyzer in 2022, 2023 and 2024. Findings: 1. Review of the manufacturer's user manual for the Beckman Coulter AU480 chemistry analyzer revealed the following maintenance procedures required: a) Weekly: * Clean the Sample Probe and Mix Bars * Perform a W2 * Perform a Photocal * Clean the Pre-Dilution Bottle * Check Selectivity of the Na/K Electrodes (ISE optional unit) * Enhanced Cleaning of ISE Electrode Line (ISE optional unit) b) Every Other Week or 3,000 Samples (ISE optional unit) * Manually Clean ISE Mix Bar, Liquid Level Sensors, Sample Pot, and Sample Pot Tubing c) Monthly * Clean the Sample Probe and Reagent Probe Wash Wells * Clean the Mix Bar Wash Wells * Clean the Wash Nozzle Unit and Check the Tube Mounting Joints * Clean the DI Water Tank, DI Filter, and Sample Probe Filter d) Every Other Month or Every 20,000 Samples (ISE optional unit) * Check and Add REF Electrode Solution e) Quarterly * Clean the Air Filters * Inspect and if needed, Replace the DI Water Filter and Sample Probe Filter * Replace the Wash Solution Roller Pump Tubing f) Quarterly or Every 20,000 Samples (ISE optional unit) * Replace the Mixture Aspiration and MID Standard Roller Pump Tubing * Replace the Tubing between Sample Pot, Electrode Unit, and T-Connector * Replace the REF Electrode Block-side Drain Tube and Pinch Valve Tubing * Manually Clean the Drain Well and if needed, replace the Drain Tube g) Every 6 Months * Clean the Cuvettes and the Cuvette Wheel h) Every 6 Months or Every 40,000 Samples (ISE optional unit) * Replace the Na, K, or Cl Electrode i) Every Two Years or Every 150,000 Samples (ISE optional unit) * Replace the ISE REF Electrode and Packing j) Yearly or As Needed * Replace O-rings in the Water Supply Tube Mounting Joint * Clean the Reagent Probe * Replace a Sample and Reagent Probe * Replace Mix Bars * Replace the Wash Nozzle Joint * Replace Packing in the Wash Nozzle Tube Mounting Joints * Replace Syringes or Syringe Case Heads * Clean the inside of the Reagent -- 2 of 7 -- Refrigerator or STAT Table Compartments * Clean or Replace the Anti-static Brushes * Replace Rack ID Labels * Replace the Sample and Reagent Probe Tubing * Perform a W1 * Clean or Replace Individual Cuvettes * Replace the Photometer Lamp * Save Parameters 2. Review of the laboratory's maintenance logs from November 2022 through April 2024 revealed the following maintenance procedures were not performed as required for the following sixteen (16) of seventeen (17) months reviewed: a) November 2022: Every Other Week or 3,000 Samples (ISE optional unit): * Manually Clean ISE Mix Bar, Liquid Level Sensors, Sample Pot, and Sample Pot Tubing b) December 2022: Every Other Week or 3,000 Samples (ISE optional unit) * Manually Clean ISE Mix Bar, Liquid Level Sensors, Sample Pot, and Sample Pot Tubing c) December 2022: Every Other Month or Every 20,000 Samples (ISE optional unit) * Check and Add REF Electrode Solution d) January 2023: Quarterly or Every 20,000 Samples (ISE optional unit) * Clean the Air Filters * Inspect and if needed, Replace the DI Water Filter and Sample Probe Filter * Replace the Wash Solution Roller Pump Tubing * Replace the Mixture Aspiration and MID Standard Roller Pump Tubing * Replace the Tubing between Sample Pot, Electrode Unit, and T-Connector * Replace the REF Electrode Block-side Drain Tube and Pinch Valve Tubing * Manually Clean the Drain Well and if needed, replace the Drain Tube e) February 2023: Every 6 Months or Every 40,000 Samples (ISE optional unit) * Clean the Cuvettes and the Cuvette Wheel * Replace the Na, K, or Cl Electrode f) April 2023: Quarterly or Every 20,000 Samples (ISE optional unit) * Clean the Air Filters * Inspect and if needed, Replace the DI Water Filter and Sample Probe Filter * Replace the Wash Solution Roller Pump Tubing * Replace the Mixture Aspiration and MID Standard Roller Pump Tubing * Replace the Tubing between Sample Pot, Electrode Unit, and T-Connector * Replace the REF Electrode Block-side Drain Tube and Pinch Valve Tubing g) May 2023: Every Other Week or 3,000 Samples (ISE optional unit): * Manually Clean ISE Mix Bar, Liquid Level Sensors, Sample Pot, and Sample Pot Tubing h) May 2023: Every Other Month or Every 20,000 Samples (ISE optional unit) * Check and Add REF Electrode Solution i) June 2023: Monthly * Clean the Sample Probe and Reagent Probe Wash Wells * Clean the Mix Bar Wash Wells * Clean the Wash Nozzle Unit and Check the Tube Mounting Joints * Clean the DI Water Tank, DI Filter, and Sample Probe Filter j) July 2023: Every Other Week or 3,000 Samples (ISE optional unit): * Manually Clean ISE Mix Bar, Liquid Level Sensors, Sample Pot, and Sample Pot Tubing k) July 2023: Every Other Month or Every 20,000 Samples (ISE optional unit) * Check and Add REF Electrode Solution l) July 2023: Quarterly or Every 20,000 Samples (ISE optional unit) * Clean the Air Filters * Inspect and if needed, Replace the DI Water Filter and Sample Probe Filter * Replace the Wash Solution Roller Pump Tubing * Replace the Mixture Aspiration and MID Standard Roller Pump Tubing * Replace the Tubing between Sample Pot, Electrode Unit, and T-Connector * Replace the REF Electrode Block-side Drain Tube and Pinch Valve Tubing m) August 2023: Every 6 Months or Every 40,000 Samples (ISE optional unit) * Clean the Cuvettes and the Cuvette Wheel * Replace the Na, K, or Cl Electrode n) September 2023: Every Other Month or Every 20,000 Samples (ISE optional unit) * Check and Add REF Electrode Solution o) October 2023: Every Other Week or 3,000 Samples (ISE optional unit): * Manually Clean ISE Mix Bar, Liquid Level Sensors, Sample Pot, and Sample Pot Tubing p) October 2023: Quarterly or Every 20,000 Samples (ISE optional unit) * Clean the Air Filters * Inspect and if needed, Replace the DI Water Filter and Sample Probe Filter * Replace the Wash Solution Roller Pump Tubing * Replace the Mixture Aspiration and MID Standard Roller Pump Tubing * Replace the Tubing between Sample Pot, Electrode Unit, and T-Connector * Replace the REF Electrode Block-side Drain Tube and Pinch Valve Tubing q) November 2023: Weekly * Clean the Sample Probe and Mix Bars * Perform a W2 * Perform a Photocal * Clean the Pre-Dilution Bottle * Check -- 3 of 7 -- Selectivity of the Na/K Electrodes (ISE optional unit) * Enhanced Cleaning of ISE Electrode Line (ISE optional unit) r) November 2023: Every Other Week or 3,000 Samples (ISE optional unit): * Manually Clean ISE Mix Bar, Liquid Level Sensors, Sample Pot, and Sample Pot Tubing s) November 2023: Every Other Month or Every 20,000 Samples (ISE optional unit) * Check and Add REF Electrode Solution t) December 2023: Every Other Week or 3,000 Samples (ISE optional unit): * Manually Clean ISE Mix Bar, Liquid Level Sensors, Sample Pot, and Sample Pot Tubing u) January 2024: Every Other Week or 3,000 Samples (ISE optional unit): * Manually Clean ISE Mix Bar, Liquid Level Sensors, Sample Pot, and Sample Pot Tubing v) January 2024: Every Other Month or Every 20,000 Samples (ISE optional unit) * Check and Add REF Electrode Solution w) February 2024: Every Other Week or 3,000 Samples (ISE optional unit): * Manually Clean ISE Mix Bar, Liquid Level Sensors, Sample Pot, and Sample Pot Tubing x) February 2024: Every 6 Months or Every 40,000 Samples (ISE optional unit) * Clean the Cuvettes and the Cuvette Wheel * Replace the Na, K, or Cl Electrode y) March 2024: Every Other Week or 3,000 Samples (ISE optional unit): * Manually Clean ISE Mix Bar, Liquid Level Sensors, Sample Pot, and Sample Pot Tubing z) March 2024: Every Other Month or Every 20,000 Samples (ISE optional unit) * Check and Add REF Electrode Solution aa) April 2024: Every Other Week or 3,000 Samples (ISE optional unit): * Manually Clean ISE Mix Bar, Liquid Level Sensors, Sample Pot, and Sample Pot Tubing 3. In interview on April 29, 2024 at 2:47 pm, the Laboratory Director confirmed the maintenance identified was not performed per manufacturer's requirements. II. Based on review of the manufacturer's user manual, laboratory maintenance logs, and interview with personnel, the laboratory failed to perform the weekly or monthly required maintenance procedures for the Sysmex XS 1000i hematolgy analyzer in 2023 and 2024. Findings: 1. Review of the manufacturer's user manual for the Sysmex XS 1000i hematolgy analyzer revealed the following maintenance procedures required: a) Weekly: Weekly Rinse b) Monthly: Monthly Rinse 2. Review of the laboratory's maintenance logs from November 2022 through April 2024 revealed the following maintenance procedures were not performed as required for the following two (2) of seventeen (17) months reviewed: a) February 2023: * Weekly: Weekly Rinse b) June 2023: * Monthly: Monthly Rinse 3. In interview on April 29, 2024 at 2: 47 pm, the Laboratory Director confirmed the maintenance identified was not performed per manufacturer's requirements. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: -- 4 of 7 -- Based on observation by surveyor, review of the manufacturer's package inserts, laboratory policy and quality control records as well as interview with personnel, the laboratory failed to establish their own mean and ranges for Quality Control (QC) material utilized for chemistry testing as required by the manufacturer. Findings: 1. Observation by surveyor during laboratory tour on April 29, 2024 at 2:14 pm revealed the laboratory utlilizes the following quality control (QC) material for the Beckman Coulter AU480 chemistry analyzer: a) BioRad Liquid Assayed Multiqual Control: Lot 45960 Exp 10/31/2025 Sodium (NA), Potassium (K), Chloride (CL), Blood Urea Nitrogen (BUN), Glucose (GLUC), Calcium (CA), Total Protein (TP), Albumin (ALB), Magnesium (MG), Aspartate Transferase (AST), Creatinine (CREA), Alanine Transaminase (ALT), Total Bilirubin (TBIL), Amylase (AMY), Alkaline Phosphatase (ALP), Lipase (LIP), Cholesterol (CHOL), High Density Lipoprotein (HDL), Triglyceride (TRIG) b) BioRad Liquichek Urine Chemistry Control: Lot 97440 Exp 09 /30/2025 Urine Sodium (UR NA) 2. Review of the BioRad QC package inserts under "Assignment of Values" section revealed "It is recommended that each laboratory establish its own acceptable ranges and use those provided only as guides". 3. Review of the laboratory's policy manual revealed the laboratory did not have a policy for establishment of quality control materials for chemistry testing. 4. Review of the laboratory's quality control records revealed the laboratory was utilizing the manufacturer's mean and ranges. 5. In interview on April 29, 2024 at 2:14 pm, the Laboratory Director stated the laboratory uses the manufacturer's ranges and the ranges are monitored by the Unity BioRad tracking system. The Laboratory Director confirmed the laboratory does not establish their own means and ranges for chemistry quality control materials. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D0000 A Recertification survey was performed on May 17, 2022 through May 18, 2022 at Caldwell Memorial Hospital, CLIA ID # 19D1082041. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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's personnel records, policy and procedure manual and interview with personnel, the laboratory failed to ensure written policies and procedures to assess competency for the Clinical Consultant was complete. Findings: 1. Review of the laboratory's policy for the Clinical Consultant revealed the laboratory did not include the frequency for performance of assessment of duties for the Clinical Consultant. 2. Review of the laboratory's personnel records revealed that Personnel 6 serves as Clinical Consultant 3. Further review of personnel records for Personnel 6 revealed a competency assessment for the duties of Clinical Consultant was not performed. 4. In interview on May 17, 2022 at 11:11 am, the Laboratory Director confirmed the Clinical Consultant policy did not include the frequency of performance of competency assessment. The Laboratory Director further confirmed that a competency assessment was not performed for the duties of the Clinical Consultant. D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) 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 -- If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in paragraphs (a)(1) through (a)(7) of this section. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure manual and interview with laboratory personnel, the laboratory failed to establish current written instructions for providers to maintain the integrity of samples. Findings: 1. Review of the laboratory's policy manual revealed the laboratory did not include detailed written instructions for specimen requirements for outside providers. 2. In interview on May 17, 2022 at 12: 19 pm, the Laboratory Director stated the laboratory is currently in the process of updating the speicmen requirements due to change of instrumentation. The Laboratory Director confirmed the policy manual did not include specimen requirements for outside providers. 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 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D0000 A Complaint Survey was performed at Caldwell Memorial Hospital - CLIA ID 19D1082041 on January 14, 2021. Caldwell Memorial Hospital was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1250 CONDITION: Analytic Systems 42 CFR 493.1403 CONDITION: Laboratories performing moderate complexity testing, Laboratory Director 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, record review, and interview with personnel, the laboratory failed to ensure the quality of testing within the analytic systems. Findings: 1. The laboratory failed to have complete verification studies for the Healgen COVID-19 IgG /IgM Rapid Test Cassette. Refer to D5421. 2. The laboratory failed to document positive and negative controls for the Healgen COVID-19 IgG/IgM Rapid Test Cassette. Refer to D5449. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on observation, record review and interview with personnel, the laboratory failed to have complete verification studies for the Healgen COVID-19 IgG/IgM Rapid Test Cassette. Findings: 1. Observation of the testing platform for Covid-19 testing on January 14, 2021 at 2:45 pm revealed the laboratory utilizes the Healgen COVID-19 IgG/IgM Rapid Test Cassette for patient testing. 2. In interview on January 14, 2021 at 3:02 pm, the new Laboratory Director stated she had only been in this position since December 7, 2020. The Laboratory Director further stated that based on review of records the laboratory started patient testing utilizing the Healgen Test Cassette in April 2020. 3. Review of laboratory's records for the Healgen COVID-19 IgG/IgM Rapid Test Cassette revealed the laboratory did not have documentation for performance verification studies to include the following: a) Accuracy b) Complete Precision 4. In interview on January 14, 2021 at 3:02 pm, the previous Laboratory Director stated the laboratory has been utilizing the Healgen test kit for screening of symptomatic patients only and was sending a confirmation swab for each patient test to a reference lab but did not keep a record of the documentition. The Laboratory Director confirmed the laboratory did not have documentation for the above cited studies. 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 record review and interview with personnel, the laboratory failed to document positive and negative controls for the Healgen COVID-19 IgG/IgM Rapid Test Cassette. Findings: 1. Review of the laboratory's policy and procedure manual revealed the laboratory did not have a policy stating the frequency of which the Healgen COVID-19 IgG/IgM Rapid Test Cassette Quality Control (QC) is performed. 2. In interview on January 14, 2021 at 4:00 pm, the Laboratory Director stated there is not any commercial QC material available for the Healgen test kit. She further stated the only QC samples performed since the start of patient testing in April of 2020 was an American Proficiency Institute (API) sample on October 27, 2020 which included a positive and negative sample. 3. Review of patient records revealed a "COVID-19 Kit Testing" log which was put into use on September 17, 2020. 4. In further interview on January 14, 2021 at 4:58 pm, the Laboratory Director stated the laboratory did not keep a cumalative report for patient testing prior to September 17, 2020. 5. Review of patient records from September 17, 2020 through January 14, 2021 revealed the laboratory did not document external positive and negative quality controls (QC) each day of patient testing for the following four hundred three (403) of four hundred three (403) patients reviewed: a) Acct# 1020357 performed on -- 2 of 9 -- September 17, 2020 at 11:31 am b) Acct# 1020362 performed on September 17, 2020 at 17:47 pm c) Acct# 1020156 performed on September 17, 2020 at 17:51 pm d) Acct# 1020139 performed on September 18, 2020 at 10:29 am e) Acct# 1019881 performed on September 18, 2020 at 10:53 am f) Acct# 1020369 performed on September 18, 2020 at 11:08 am g) Acct# 1020265 performed on September 18, 2020 at 12:25 pm h) Acct# 1020574 performed on October 1, 2020 at 11:20 am i) Acct# 1020571 performed on October 1, 2020 at 10:53 am j) Acct# 1020572 performed on October 1, 2020 at 10:57 am k) Acct# 1020570 performed on October 1, 2020 at 10: 50 am l) Acct# 1020577 performed on October 1, 2020 at 13:11 pm m) Acct# 6000111 performed on October 1, 2020 at 13:36 pm n) Acct# 1020576 performed on October 1, 2020 at 16:19 pm o) Acct# 1020584 performed on October 2, 2020 at 4:20 am p) Acct# 1020588 performed on October 5, 2020 at 9:31 am q) Acct# 1020596 performed on October 5, 2020 at 10:03 am r) Acct# 1020593 performed on October 5, 2020 at 10:00 am s) Acct# 1020591 performed on October 5, 2020 at 9:39 am t) Acct# 1020592 performed on October 5, 2020 at 9:30 am u) Acct# 1020595 performed on October 5, 2020 at 9:35 am v) Acct# 1020594 performed on October 5, 2020 at 10:12 am w) Acct# 1020597 performed on October 5, 2020 at 9:36 am x) Acct# 1020590 performed on October 5, 2020 at 9:41 am y) Acct# 1020593 performed on October 5, 2020 at 10:00 am z) Acct# 1020598 performed on October 5, 2020 at 10:05 am a2) Acct# 1020675 performed on October 12, 2020 at 12:07 pm b2) Acct# 1020676 performed on October 12, 2020 at 10:20 am c2) Acct# 1020681 performed on October 12, 2020 at 11:48 am d2) Acct# 1020696 performed on October 13, 2020 at 10:45 am e2) Acct# 1020699 performed on October 13, 2020 at 11:19 am f2) Acct# 1020695 performed on October 13, 2020 at 11:38 am g2) Acct# 1020706 performed on October 14, 2020 at 9:14 am h2) Acct# 1020707 performed on October 14, 2020 at 9:14 am i2) Acct# 1020717 performed on October 14, 2020 at 10: 21 am j2) Acct# 1020713 performed on October 14, 2020 at 10:50 am k2) Acct# 1020724 performed on October 14, 2020 at 11:40 am l2) Acct# 1020723 performed on October 14, 2020 at 11:40 am m2) Acct# 1020725 performed on October 14, 2020 at 11:40 am n2) Acct# 1020726 performed on October 14, 2020 at 12:00 pm o2) Acct# 1020727 performed on October 14, 2020 at 12:27 pm p2) Acct# 1020712 performed on October 14, 2020 at 12:58 pm q2) Acct# 1020736 performed on October 15, 2020 at 09:10 am r2) Acct# 1020745 performed on October 15, 2020 at 10:20 am s2) Acct# 1020756 performed on Ocotber 15, 2020 at 11:35 am t2) Acct# 1020757 performed on October 15, 2020 at 11:37 am u2) Acct# 1020754 performed on October 15, 2020 at 12:47 pm v2) Acct# 1020801 performed on October 20, 2020 at 14:52 pm w2) Acct# 1020822 performed on October 21, 2020 at 08:35 am x2) Acct# 1000579 performed on October 21, 2020 at 16:05 pm y2) Acct# 1020848 performed on October 22, 2020 at 09:35 am z2) Acct# 1020853 performed on October 22, 2020 at 09:54 am a3) Acct# 1020855 performed on October 22, 2020 at 11:00 am b3) Acct# 1020856 performed on October 22, 2020 at 11:10 am c3) Acct# 1020864 performed on October 22, 2020 at 11:44 am d3) Acct# 1020866 performed on October 22, 2020 at 12:43 pm e3) Acct# 1020867 performed on October 22, 2020 at 12:43 pm f3) Acct# 1020868 performed on October 22, 2020 at 13:12 pm g3) Acct# 1020875 performed on October 23, 2020 at 09:37 am h3) Acct# 1020879 performed on October 23, 2020 at 09:57 am i3) Acct# 1020878 performed on October 23, 2020 at 09:42 am j3) Acct# 1020881 performed on October 23, 2020 at 10:20 am k3) Acct# 1020882 performed on October 23, 2020 at 10:54 am l3) Acct# 1020887 performed on October 23, 2020 at 12:20 pm m3) Acct# 1020891 performed on October 25, 2020 at 06:25 am n3) Acct# 1020906 performed on October 26, 2020 at 11:12 am o3) Acct# 1020907 performed on October 26, 2020 at 11:15 am p3) Acct# 1020908 performed on October 26, 2020 at 11:17 am q3) Acct# 1020911 performed on October 26, 2020 at 09:03 am r3) Acct# 1020904 performed on October 26, 2020 at -- 3 of 9 -- 11:40 am s3) Acct# 1020913 performed on October 26, 2020 at 12:01 pm t3) Acct# 1020914 performed on October 26, 2020 at 13:00 pm u3) Acct# 1020916 performed on October 26, 2020 at 13:06 pm v3) Acct# 1020917 performed on October 26, 2020 at 13:32 pm w3) Acct# 1021017 performed on October 30, 2020 at 08:50 am x3) Acct# 1021019 performed on October 30, 2020 at 09:19 am y3) Acct# 1021018 performed on October 30, 2020 at 09:21 am z3) Acct# 1021020 performed on October 30, 2020 at 09:20 am a4) Acct# 1021021 performed on October 30, 2020 at 09:17 am b4) Acct# 1021022 performed on October 30, 2020 at 09:25 am c4) Acct# 1021027 performed on October 30, 2020 at 10:24 am d4) Acct# 1021029 performed on October 30, 2020 at 12:52 pm e4) Acct# 1021028 performed on October 30, 2020 at 12:56 pm f4) Acct# 1021033 performed on November 2, 2020 at 08:21 am g4) Acct# 1021052 performed on November 3, 2020 at 07:45 am h4) Acct# 1021053 performed on November 3, 2020 at 07:45 am i4) Acct# 1021054 performed on November 3, 2020 at 07:45 am j4) Acct# 1021055 performed on November 3, 2020 at 07:45 am k4) Acct# 1021056 performed on November 3, 2020 at 07:45 am l4) Acct# 1021058 performed on November 3, 2020 at 08:47 am m4) Acct# 1021061 performed on November 3, 2020 at 10:02 am n4) Acct# 1021062 performed on November 3, 2020 at 10:25 am o4) Acct# 1021067 performed on November 3, 2020 at 13:04 pm p4) Acct# 1021068 performed on November 3, 2020 at 13:48 pm q4) Acct# 1021069 performed on November 3, 2020 at 14:27 pm r4) Acct# 1021070 performed on November 3, 2020 at 15:28 pm s4) Acct# 1021074 performed on November 4, 2020 at 08:46 am t4) Acct# 1021078 performed on November 4, 2020 at 09:18 am u4) Acct# 1020976 performed on November 4, 2020 at 08:50 am v4) Acct# 1021079 performed on November 4, 2020 at 09:20 am w4) Acct# 1021096 performed on November 5, 2020 at 09:00 am x4) Acct# 1021109 performed on November 5, 2020 at 12:58 pm y4) Acct# 1021127 performed on November 6, 2020 at 13:01 pm z4) Acct# 1021129 performed on November 6, 2020 at 13:46 pm a5) Acct# 1021131 performed on November 6, 2020 at 14:50 pm b5) Acct# 1021132 performed on November 6, 2020 at 15:35 pm c5) Acct# 1021137 performed on November 9, 2020 at 08:41 am d5) Acct# 1021136 performed on November 9, 2020 at 08:41 am e5) Acct# 1021138 performed on November 9, 2020 at 09:13 am f5) Acct# 1021116 performed on November 5, 2020 at 13:42 pm g5) Acct# 1021118 performed on November 6, 2020 at 08:26 am h5) Acct# 1021120 performed on November 6, 2020 at 10:04 am i5) Acct# 1021124 performed on November 6, 2020 at 10:37 am j5) Acct# 1021123 performed on November 6, 2020 at 10:38 am k5) Acct# 1021122 performed on November 6, 2020 at 10:38 am l5) Acct# 1021126 performed on November 6, 2020 at 10:42 am m5) Acct# 1021139 performed on November 9, 2020 at 09:13 am n5) Acct# 1021141 performed on November 9, 2020 with no time documented o5) Acct# 1021140 performed on November 9, 2020 09:27 am p5) Acct# 1021143 performed on November 9, 2020 at 09:43 am q5) Acct# 1021145 performed on November 9, 2020 at 10:04 am r5) Acct# 1021148 performed on November 9, 2020 at 10:36 am s5) Acct# 1021150 performed on November 9 , 2020 at 10:15 am t5) Acct# 1021155 performed on November 9, 2020 at 11:00 am u5) Acct# 1021154 performed on November 9, 2020 at 11:09 am v5) Acct# 1021156 performed on November 9, 2020 at 11:10 am w5) Acct# 1021160 performed on November 9, 2020 at 11:31 am x5) Acct# 1021159 performed on November 9, 2020 at 11:36 am y5) Acct# 1021176 performed on November 10, 2020 at 09:59 am z6) Acct# 1021182 performed on November 10, 2020 at 10:32 am a7) Acct# 1021186 performed on November 10, 2020 at 11:22 am b7) Acct# 1021188 performed on November 10, 2020 at 12:19 pm c7) Acct# 1021184 performed on November 10, 2020 at 12:34 pm d7) Acct# 1021185 performed on November 10, 2020 at 15:10 pm e7) Acct# 1021193 performed on November 10, 2020 at 1550 pm f7) Acct# 1021205 performed on November 11, 2020 at 12:51 pm g7) Acct# 1021214 performed on November 11, -- 4 of 9 -- 2020 at 11:49 am h7) Acct# 1021215 performed on November 11, 2020 at 11:27 am i7) Acct# 1021220 performed on November 12, 2020 at 07:40 am j7) Acct# 1021218 performed on November 12, 2020 at 07:45 am k7) Acct# 1021219 performed on November 12, 2020 at 07:50 am l7) Acct# 10212222 performed on November 12, 2020 at 08:41 am m7) Acct# 1021229 performed on November 12, 2020 at 10:45 am n7) Acct# 1021228 performed on November 12, 2020 at 09:28 am o7) Acct# 1021230 performed on November 12, 2020 at 09:34 am p7) Acct# 1021231 performed on November 12, 2020 at 09:35 am q7) Acct# 1021234 performed on November 12, 2020 at 10:23 am r7) Acct# 1021238 performed on November 12, 2020 at 11:07 am s7) Acct# 1021241 performed on November 12, 2020 at 11:11 am t7) Acct# 1021242 performed on November 12, 2020 at 11:31 am u7) Acct# 1021239 performed on Novemer 12, 2020 at 11:37 am v7) Acct# 1021247 performed on November 12, 2020 at 14:08 pm w7) Acct# 1021248 performed on November 12, 2020 at 15:04 pm x7 Acct# 1021249 performed on November 12, 2020 at 15:03 pm y7) Acct# 1021251 performed on November 12,2020 at 15:40 pm z7) Acct# 1021252 performed on November 12, 2020 at 15:45 pm a8) Acct# 1021253 performed on November 12, 2020 at 15:50 pm b8) Acct# 1021250 performed on November 12, 2020 at 17:34 pm c8) Acct# 1021266 performed on November 13, 2020 at 10:51 am d8) Acct# 1021268 performed on November 13, 2020 at 11:05 am e8) Acct# 1021267 performed on November 13, 2020 at 12:26 pm f8) Acct# 1021256 performed on November 13, 2020 at 12:21 pm g8) Acct# 1021257 performed on November 13, 2020 at 12:25 pm h8) Acct# 1021276 performed on November 13, 2020 at 10:42 am i8) Acct# 1021275 performed on November 13, 2020 at 10:54 am j8) Acct# 1021277 performed on November 13, 2020 at 11:06 am k8) Acct# 1021278 performed on November 13, 2020 at 12:15 pm l8) Acct# 1021282 performed on November 16, 2020 at 09:26 am m8) Acct# 1021285 performed on November 16, 2020 at 09:10 am n8) Acct# 1021286 performed on November 16, 2020 at 09:13 am o8) Acct# 1021293 performed on November 16, 2020 at 09:48 am p8) Acct# 1021294 performed on November 16, 2020 at 10:45 am q8) Acct# 1021290 performed on November 16, 2020 at 10:53 am r8) Acct# 1021157 performed on November 16, 2020 at 11:19 am s8) Acct# 1021296 performed on November 16, 2020 at 11:36 am t8) Acct# 1021299 performed on November 16, 2020 at 12:04 pm u8) Acct# 1021305 performed on November 16, 2020 at 13:14 pm v8) Acct# 1021306 performed on November 16, 2020 at 16:21 pm w8) Acct# 1021311 performed on November 17, 2020 at 09:03 am x8) Acct# 1021316 performed on November 17, 2020 at 09:34 am y8) Acct# 1021317 performed on November 17, 2020 at 09:34 am z8) Acct# 1021319 performed on November 17, 2020 at 09:42 am a9) Acct# 1021320 performed on November 17, 2020 at 10:35 am b9) Acct# 1021328 performed on November 17, 2020 at 11:00 am c9) Acct# 1021329 performed on November 17, 2020 at 11:21 am d9) Acct# 1021318 performed on November 17, 2020 at 13:36 pm e9) Acct# 1021335 performed on November 17, 2020 at 14:43 pm f9) Acct# 1021336 performed on November 17, 2020 at 14:54 pm g9) Acct# 1021337 performed on November 17, 2020 at 15:24 pm h9) Acct# 1021338 performed on November 17, 2020 at 15:24 pm i9) Acct# 1021340 performed on November 18, 2020 at 07:55 am j9) Acct# 1021343 performed on November 18, 2020 at 09:27 am k9) Acct# 1021353 performed on November 18, 2020 at 10:25 am l9) Acct# 1021354 performed on November 18, 2020 at 10:36 am m9) Acct# 1021349 performed on November 18, 2020 at 12:00 pm n9) Acct# 1021362 performed on November 18, 2020 at 14:43 pm o9) Acct# 1021370 performed on November 19, 2020 at 09:34 am p9) Acct# 1021390 performed on November 19, 2020 at 11:58 am q9) Acct# 1021399 performed on November 20, 2020 at 09:45 am r9) Acct# 1021400 performed on November 20, 2020 at 09:50 am s9) Acct# (no number identified only name of patient) performed on November 20, 2020 at 09:40 am t9) Acct# 1021401 performed on November 20, 2020 at 12:00 pm -- 5 of 9 -- u9) Acct# 1021398 performed on November 20, 2020 at 13:35 pm v9) Acct# 1021406 performed on November 20, 2020 at 15:52 pm w9) Acct# 1021408 performed on November 23, 2020 at 08:21 am x9) Acct# 1021409 performed on November 23, 2020 at 08:54 am y9) Acct# 1021411 performed on November 23, 2020 at 09:24 am z9) Acct# 1021415 performed on November 23, 2020 at 10:36 am a10) Acct# 1021420 performed on November 23, 2020a t 11:18 am b10) Acct# 1021419 performed on November 23, 2020 at 11:18 am c10) Acct# 1021431 performed on November 24, 2020 at 08:02 am d10) Acct# 1021430 performed on November 24, 2020 at 08:00 am e) Acct# 101021428 performed on November 24, 2020 at 07:54 am f10) Acct# 1021427 performed on November 24, 2020 at 07:55 am g10) Acct# 1021355 performed on November 24, 2020 at 08:25 am h10) Acct# 1021438 performed on November 24, 2020 at 09:26 am i10) Acct# 1021440 performed on November 24, 2020 at 13:25 pm j10) Acct# 1021441 performed on November 24, 2020 at 15:12 pm k10) Acct# 1021442 performed on November 24, 2020 at 15:14 pm l10) Acct# 1021446 performed on November 25, 2020 at 09:03 am m10) Acct# 1021447 performed on November 25, 2020 at 09:29 am n10) Acct# 1021450 performed on November 25, 2020 at 10:02 am o10) Acct# 1021452 performed on November 25, 2020 at 11:48 am p10) Acct# 1021456 performed on November 25, 2020 at 13:26 pm q10) Acct# 1021255 performed on November 25, 2020 at 13:50 pm r10) Acct# 1021459 performed on November 25, 2020 at 13:48 pm s10) Acct# 1021255 performed on November 25, 2020 at 13:55 pm t10) Acct# 1021457 performed on November 25, 2020 at 14:30 pm u10) Acct# 1021466 performed on November 30, 2020 at 08:44 am v10) Acct# 1021468 performed on November 30, 2020 at 09:02 am w10) Acct# 1021469 performed on November 30, 2020 at 09:02 am x10) Acct# 1021471 performed on November 30, 2020 at 09:53 am y10) Acct# 1021476 performed on November 30, 2020 at 11:55 am z10) Acct# 1021481 performed on November 30, 2020 at 11:41 am a11) Acct# 1021484 performed on November 30, 2020 at 11:58 am b11) Acct# 1021483 performed on November 30, 2020 at 12:58 pm c11) Acct# 1021490 performed on November 30, 2020 at 15:00 pm d11) Acct# 1021491 performed on November 30, 2020 at 15:05 pm e11) Acct# 1021494 performed on November 30, 2020 at 16:01 pm f11) Acct# 10215555 performed on December 4, 2020 at 06:11 am g11) Acct# 1021563 performed on December 4, 2020 at 09:19 am h11) Acct# 1021564 performed on December 4, 2020 at 09:54 am i11) Acct# 1021565 performed on December 4, 2020 at 10:05 am j11) Acct# 1021567 performed on December 4, 2020 at 10:41 am k11) Acct# 1021569 performed on December 4, 2020 at 10:42 am l11) Acct# 1021571 performed on December 4, 2020 at 14:57 pm m11) Acct# 10215555 performed on December 5, 2020 at 05:41 am n11) Acct# 1021457 performed on December 7, 2020 at 06:25 am o11) Acct# 1021547 performed on December 7, 2020 at 09:11 am p11) Acct# 1021587 performed on December 7, 2020 at 10:30 am q11) Acct# 1021590 performed on December 7, 2020 at 11:10 am r11) Acct# 1021592 performed on December 7, 2020 at 11:07 am s11) Acct# 1021579 performed on December 7, 2020 at 11:26 am t11) Acct# 1021595 performed on December 7, 2020 at 11:45 am u11) Acct# 1021596 performed on December 7, 2020 at 11:54 am v11) Acct# 1021597 performed on December 7, 2020 at 12:17 pm w11) Acct# 1021594 performed on December 7, 2020 at 12:09 pm x11) Acct# 1021601 performed on December 7, 2020 at 12:58 pm y11) Acct# 1021603 performed on December 7, 2020 at 13:36 pm z11) Acct# 1021604 performed on December 7, 2020 at 13:36 pm a12) Acct# 1021598 performed on December 7, 2020 at 13:50 pm b12) Acct# 1021605 performed on December 7, 2020 at 15:02 pm c12) Acct# 1021602 performed on December 7, 2020 at 15:08 pm d12) Acct# 1021613 performed on December 8, 2020 at 08:06 am e12) Acct# 1021621 performed on December 8, 2020 at 09:44 am f12) Acct# 1021622 performed on December 8, 2020 at 09:44 am g12) Acct# 1021623 performed on December 8, -- 6 of 9 -- 2020 at 09:44 am h12) Acct# 1021629 performed on December 8, 2020 at 10:21 am i12) Acct# 1021635 performed on December 8, 2020 at 10:43 am j12) Acct# 1021637 performed on December 8, 2020 at 10:56 am k12) Acct# 1021633 performed on December 8, 2020 at 11:10 am l12) Acct# 1021645 performed on December 8, 2020 at 11:39 am m12) Acct# 1021664 performed on December 9, 2020 at 09:51 am n12) Acct# 1021665 performed on December 9, 2020 at 09:39 am o12) Acct# 1021672 perforned on December 9, 2020 at 10:35 am p12) Acct# 1021674 performed on December 9, 2020 at 10:35 am q12) Acct# 1021675 performed on December 9, 2020 at 10:40 am r12) Acct# 1021679 performed on December 9, 2020 at 11:37 am s12) Acct# 1021670 performed on December 9, 2020 at 12:25 pm t12) Acct# 1021684 performed on December 9, 2020 at 13:12 pm u12) Acct# 1021685 performed on December 9, 2020 at 13:10 pm v12) Acct# 1021727 performed on December 11, 2020 at 14:40 pm w12) Acct# 1021728 performed on December 11, 2020 at 14:50 pm x12) Acct# 1021729 performed on December 11, 2020 at 15:05 pm y12) Acct# 1021732 performed on December 11, 2020 at 16:07 pm z12) Acct# 1021736 performed on December 14, 2020 at 09:30 am a13) Acct# 1021739 performed on December 14, 2020 at 10:28 am b13) Acct# 1021738 performed on December 14, 2020 at 10:28 am c13) Acct# 1021741 performed on December 14, 2020 at 10:29 am d13) Acct# 1021740 performed on December 14, 2020 at 10:29 am e13) Acct# 1021747 performed on December 14, 2020 at 10:06 am f13) Acct# 1021689 performed on December 14, 2020 at 11:35 am g13) Acct# 1021688 performed on December 14, 2020 at 11:48 am h13) Acct# 1021751 performed on December 14, 2020 at 13:19 pm i13) Acct# 1021752 performed on December 14, 2020 at 13:20 pm j13) Acct# 1021753 performed on December 14, 2020 at 13:40 pm k13) Acct# 1021754 performed on December 14, 2020 at 14:30 pm l13) Acct# 1021757 performed on December 14, 2020 at 15:53 pm m13) Acct# 1021758 performed on December 14, 2020 at 16:32 pm n13) Acct# 1021765 performed on December 15, 2020 at 09:06 am o13) Acct# 1021780 performed on December 15, 2020 at 09:43 am p13) Acct# 1021778 performed on December 15, 2020 at 12:30 pm r13) Acct# 1021779 performed on December 15, 2020 at 12:36 pm s13) Acct# 1021783 performed on December 15, 2020 at 13:34 pm t13) Acct# 1021786 performed on December 15, 2020 at 14:15 pm u13) Acct# 1021787 performed on December 15, 2020 at 14:25 pm v13) Acct# 1021766 performed on December 15, 2020 at 15:02 pm w13) Acct# 1021788 performed on December 15, 2020 at 15:37 pm x13) Acct# 1021789 performed on December 15, 2020 at 16:12 pm y13) Acct# 1021791 performed on December 16, 2020 at 08:28 am z13) Acct# 1021794 performed on December 16, 2020 at 08:56 am a14) Acct# 1021795 performed on December 16, 2020 at 09:09 am b14) Acct# 1021796 performed on December 16, 2020 at 09:05 am c14) Acct# 1021798 performed on December 16, 2020 at 09:26 am d14) Acct# 1021803 performed on December 16, 2020 at 10:07 am e14) Acct# 1021810 performed on December 16, 2020 at 10:59 am f14) LAB 57839 performed on on December 16, 2020 at 11:07 am g14) Acct# 1021813 performed on December 16, 2020 at 12:30 pm h14) Acct# 1021816 performed on December 16, 2020 at 14:55 pm i14) LAB 57891 performed on December 16, 2020 at 15:47 pm j14) Acct# 1021833 performed on December 17, 2020 at 10:21 am k14) Acct# 1021842 performed on December 17, 2020 at 11:23 am l14) Acct# 1021845 performed on December 18, 2020 at 08:48 am m14) Acct# 1021846 performed on December 18, 2020 at 09:03 am n14) Acct# 1021847 performed on December 18, 2020 at 12:34 pm o14) Acct# 1021852 performed on December 18, 2020 at 12:59 pm p14) Acct# 1021853 performed on December 18, 2020 at 14:48 pm q14) Acct# 1021854 performed on December 18, 2020 at 15:55 pm r14) Acct# 1021860 performed on December 21, 2020 at 09:58 am s14) Acct# 1021861 performed on December 21, 2020 at 10:33 am t14) Acct# 1021862 performed on December 21, 2020 at 10:38 am u14) Acct# 1021869 -- 7 of 9 -- performed on December 21, 2020 at 15:56 pm v14) Acct# 1021874 performed on December 22, 2020 at 09:15 am w14) Acct# 1021873 performed on December 22, 2020 at 09:31 am x14) Acct# 1021879 performed on December 22, 2020 at 13:20 pm y14) Acct# 1021881 performed on December 23, 2020 at 11:25 am z14) Acct# 1021885 performed on December 23, 2020 at 12:11 pm a15) Acct# 1021887 performed on December 23, 2020 at 12:15 pm b15) Acct# 1021888 performed on December 23, 2020 at 12:42 pm c15) Acct# 1021889 performed on December 23, 2020 at 14:40 pm d15) Acct# 1021890 performed on December 23, 2020 at 15:27 pm e15) Acct# 1021891 performed on December 23, 2020 at 16:45 pm f15) Acct# 1021897 performed on December 24, 2020 at 09:54 am g15) Acct# 1021899 performed on December 24, 2020 at 10:43 am h15) Acct# 1021898 performed on December 24, 2020 at 10:40 am i15) Acct# 1021906 performed on December 28, 2020 at 09:04 am j15) Acct# 1021908 performed on December 28, 2020 at 10:10 am k15) Acct# 1021909 performed on December 28, 2020 at 11:07 am l15) Acct# 1021910 performed on December 28, 2020 at 11:22 am m15) Acct# 1021905 performed on December 28, 2020 at 11:50 am n15) Acct# 1021908 performed on December 28, 2020 at 12:09 pm o15) Acct# 1021904 performed on December 28, 2020 at 13:17 pm p15) Acct# 1021913 performed on December 28, 2020 at 14:04 pm q15) Acct# 1021914 performed on December 28, 2020 at 14:26 pm r15) Acct# 1021917 performed on December 28, 2020 at 15:06 pm s15) Acct# 1021919 performed on December 28, 2020 at 16:15 pm t15) Acct# 1021923 performed on December 29, 2020 at 08:43 am u15) Acct# 1021816 performed on December 29, 2020 at 09:06 am v15) Acct# 1021925 performed on December 29, 2020 at 09:43 am w15) Acct# 1021928 performed on December 29, 2020 at 10:30 am x15) Acct# 1021934 performed on December 29, 2020 at 11:25 am y15) Acct# 1021936 performed on December 29, 2020 at 11:13 am z15) Acct# 1021938 performed on December 29, 2020 at 11:31 am a16) Acct# 1021943 performed on December 29, 2020 at 08:52 am b16) Acct# 1021949 performed on December 29, 2020 at 11:40 am c16) Acct# 1021958 performed on December 31, 2020 at 09:14 am d16) Acct# 1021959 performed on December 31, 2020 at 09:13 am e16) Acct# 6000094 performed on January 2, 2021 at 12:58 pm f16) LAB 59617 performed on January 4, 2021 at 09:00 am g16) Acct# 1021964 performed on January 4, 2021 at 08:51 am h16) Acct# 1021965 performed on January 4, 2021 at 08:51 am i16) Acct# 1021969 performed on January 4, 2021 at 09:45 am j16) Acct# 1021970 performed on January 4, 2021 at 09:48 am k16) Acct# 1021972 performed on January 4, 2021 at 11:00 am l16) Acct# 1021971 performed on January 4, 2021 at 11:07 am m16) Acct# 1021974 performed on January 4, 2021 at 11:24 am n16) Acct# 1021975 performed on January 4, 2021 at 11:36 am o16) Acct# 1021982 performed on January 4, 2021 at 1555 pm p16) Acct# 1021983 performed on January 4, 2021 at 16:15 pm q16) Acct# 1021984 performed on January 4, 2021 at 16:45 pm r16) Acct# 1021995 performed on January 4, 2021 at 10:11 am s16) Acct# 1022002 performed on January 5, 2021 at 10:49 am t16) Acct# 1022017 performed on January 5, 2021 at 15:47 pm u16) Acct# 1022025 performed on Januray 6, 2021 at 09:50 am v16) Acct# 1022026 performed on January 6, 2021 at 09:40 am w16) Acct# 1022027 performed on January 6, 2021 at 09:43 am x16) Acct# 1022028 performed on January 6, 2021 at 09:47 am y16) Acct# 1022048 performed on January 6, 2021 at 11:26 am z16) Acct# 1022058 performed on January 6, 2021 at 13:53 pm a17) Acct# 1022059 performed on January 6, 2021 at 14:20 pm b17) Acct# 1022063 performed on January 7, 2021 at 04:45 am c17) Acct# 1022081 performed on January 7, 2021 at 12:14 pm d17) Acct# 1022084 performed on January 7, 2021 at 14:18 pm e17) Acct# 1022090 performed on January 8, 2021 at 09:13 am f17) Acct# 1022103 performed on January 12, 2021 at 08:30 am g17) Acct# (no identifier only patient name recorded) performed on January 12, 2021 at 11:19 am h17) Acct# 1022117 performed on January 12, 2021 at 13:03 pm i17) Acct# 1022137 -- 8 of 9 -- performed on January 13, 2021 at 10:41 am j17) Acct# 1022140 performed on January 13, 2021 at 10:41 am k17) Acct# 1022145 performed on January 13, 2021 at 12:24 pm 6. In interview on January 14, 2021 at 4:50 pm, the Laboratory Director confirmed external QC was not performed for each of the above cited patients. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to provide overall management and direction for the laboratory. Findings: 1. The Laboratory Director failed to ensure that complete verification procedures were performed. Refer to D6013. 2. The Laboratory Director failed to ensure that a quality control program was maintained to assure quality laboratory services were provided. Refer to D6020. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on observation, record review, and interview with personnel, the Laboratory Director failed to ensure that complete verification procedures were performed. Refer to D5421. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with personnel, the Laboratory Director failed to ensure that a quality control program was maintained to assure quality laboratory services were provided. Refer to D5449. -- 9 of 9 --

Summary Statement of Deficiencies D0000 A PT Desk Review was performed on June 18, 2020. Caldwell Memorial Hospital, INC, CLIA ID 19D1082041, was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.803 CONDITION: Successful Participation 42 CFR 493.807 CONDITION: Reinstatement of laboratories performing nonwaived testing 42 CFR 493.1403 CONDITION: Laboratories Performing Moderate Complexity Testing; Laboratory Director D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Based on review of proficiency testing (PT) results from the CASPER 155D report, the laboratory failed to successfully participate in proficiency testing for Chloride. Refer to D2096. D2017 REINSTATEMENT OF NONWAIVED LABORATORIES CFR(s): 493.807(a)(b) (a) If a laboratory's certificate is suspended or limited or its Medicare or Medicaid approval is cancelled or its Medicare or Medicaid payments are suspended because it fails to participate successfully in proficiency testing for one or more specialties, subspecialties, analyte or test, or voluntarily withdraws its certification under CLIA for the failed specialty, subspecialty, or analyte, the laboratory must then demonstrate sustained satisfactory performance on two consecutive proficiency testing events, one of which may be on site, before CMS will consider it for reinstatement for certification and Medicare or Medicaid approval in that specialty, subspecialty, analyte or test. (b) The cancellation period for Medicare and Medicaid approval or period for suspension of Medicare or Medicaid payments or suspension or limitation of certification under CLIA for the failed specialty, subspecialty, or analyte or test is for a period of not less than six months from the date of cancellation, limitation or suspension of the CLIA certificate. This CONDITION is not met as evidenced by: Based on review of proficiency testing (PT) results from the CASPER 155D report, the laboratory failed to achieve satisfactory performance for Chloride (Cl) in five (5) of eight (8) consecutive events resulting in non-initial unsuccessful participation. Findings: 1. 1. Review of the CASPER 155D report for proficiency testing results revealed the laboratory received the following scores of less than 80% for five (5) of eight (8) consecutive testing events resulting in non initial unsuccessful performance for CL: a) 2018 Event 1: 20% b) 2018 Event 3: 40% c) 2019 Event 2: 40% d) 2020 Event 1: 60% e) 2020 Event 2: 60% D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) results from the CASPER 155D report, the laboratory failed to achieve a score of at least 80% for Chloride (CL) in five (5) of eight (8) consecutive testing events. Findings: 1. Review of the CASPER 155D report for proficiency testing results revealed the laboratory received the following scores of less than 80% for five (5) of eight (8) consecutive testing events resulting in non initial unsuccessful performance for CL: a) 2018 Event 1: 20% b) 2018 Event 3: 40% c) 2019 Event 2: 40% d) 2020 Event 1: 60% e) 2020 Event 2: 60% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. -- 2 of 3 -- 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on record review, the Laboratory Director failed to provide overall management and direction for the laboratory. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on record review, the Laboratory Director failed to ensure that proficiency testing results are satisfactory as required. Refer to D2096. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A PT DESK REVIEW was performed for Caldwell Memorial Hospital - CLIA # 19D1082041 on November 14, 2018. Caldwell Memorial Hospital was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.803 CONDITION: Successful Participation 42 CFR 493.1407 CONDITION: Laboratory Director, Moderate Complexity 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 record review of CMS Casper Reports 0153D and 0155D, the laboratory 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 -- failed to successfully participate in Proficiency Testing as follows: 1. The laboratory failed to achieve satisfactory performance for Chloride in two of three consecutive events resulting in initial unsuccessful participation. Refer to D2096 D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of proficiency testing results, the laboratory failed to achieve satisfactory performance for Chloride in two of three consecutive events resulting in initial unsuccessful participation. Findings are: 1. Review of American Proficiency Institute (API) proficiency testing results and CMS Report 0153D and 0155D revealed the laboratory received unsatisfactory performance for the following two events resulting in the first unsuccessful participation for Chloride: Event 1 of 2018 received a score of 20% Event 3 of 2018 received a score of 40% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to provide overall management and direction for the laboratory. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: The laboratory director failed to ensure that proficiency testing samples are satisfactory as required. Refer to D2096 -- 2 of 2 --

Summary Statement of Deficiencies D0000 A CERTIFICATION SURVEY was performed at Caldwell Memorial Hospital - CLIA # 19D1082041 on March 22, 2018. Caldwell Memorial Hospital was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1250 CONDITION: Analytic Systems 42 CFR 493.1403 CONDITION: Laboratories performing Moderate Complexity Testing, LABORATORY DIRECTOR 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, record review, and interview with personnel, the laboratory failed to ensure the quality of testing within the analytic systems. Findings: 1. The laboratory failed to have a complete policy and procedure manual. Refer to D5401. 2. The laboratory failed to ensure that patient samples for Prothrombin Time (PT)/ International Normalized Ratio (INR) testing are analyzed within three (3) minutes of collection according to the manufacturer for fifteen (15) of twenty two (22) patients reviewed. Refer to D5411 I. 3. The laboratory failed to ensure patient samples for Lactate are analyzed within three (3) minutes according to the manufacturer for fourteen (14) of twenty six (26) patients reviewed. Refer to D5411 II. 4. The laboratory failed to have complete performance specification studies for the Horiba ABX Pentra 400 analyzer. Refer to D5421. 5. The laboratory failed to include in- house quality control (QC) data and pertinent literature to support reduction of 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 8 -- frequency of QC in their Individualized Quality Control Plan (IQCP). Refer to D5445. 6. The laboratory failed to perform two (2) levels of quality control material each day of patient testing for Chloride. Refer to D5447. 7. The laboratory failed to follow established policies to monitor, assess, and correct quality issues in Analytic Systems. Refer to D5791. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to have a complete policy and procedure manual. Findings: 1. Review of the laboratory's policy and procedure manual revealed the laboratory did not have written detailed policies for the following: a) Performance specification to include accuracy, precision, reportable range and reference range as well as detailed instructions for how these studies are to be performed and acceptable criteria for each. b) Individualized Quality Control Plan (IQCP) c) Proficiency Testing: How to address unacceptable results as well as failed analytes or events. 2. Interview with Personnel 1 on March 22, 2018 confirmed the procedure manual did not contain the above policies. 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. This STANDARD is not met as evidenced by: I. Based on observation, record review and interview with personnel, the laboratory failed to ensure that patient samples for Prothrombin Time (PT)/ International Normalized Ratio (INR) testing are analyzed within three (3) minutes of collection according to the manufacturer for fifteen (15) of twenty two (22) patients reviewed. Findings: 1. Observation by the surveyor on March 22, 2018 revealed the laboratory was performing PT/INR testing on the Abbott iSTAT Clinical Analyzers. 2. Review of the Abbott iSTAT PT/INR package insert revealed that samples for PT/INR are to be tested within three (3) minutes of collection. 3. Review of patient records from January 2018 revealed the laboratory did not document testing of patient samples for PT/INR within three (3) minutes of collection for the following fifteen (15) patients: Patient 142 - Collected January 3, 2018 at 11:37 am then Resulted January 3, 2018 at 11:43 am - three (3) minutes over the manufacturer's requirement of three (3) minutes Patient 143 - Collected January 3, 2018 at 16:02 pm then Resulted January 3, 2018 at 16:28 pm - twenty three (23) minutes over the manufacturer's requirement of three (3) minutes Patient 144 - Collected January 4, 2018 at 05:30 am then Resulted January 4, 2018 at 05:44 am - eleven (11) minutes over the manufacturer's requirement of three (3) minutes Patient 145 - Collected January 5, 2018 at 05:38 am then Resulted -- 2 of 8 -- January 5, 2018 at 06:19 am - thirty eight (38) minutes over the manufacturer's requirement of three (3) minutes Patient 146 - Collected January 5, 2018 at 08:23 am then Resulted January 5, 2018 at 08:33 am - seven (7) minutes over the manufacturer's requirement of three (3) minutes Patient 147 - Collected January 10, 2018 at 13:58 pm then Resulted January 10, 2018 at 14:03 pm - two (2) minutes over the manufacturer's requirement of three (3) minutes Patient 148 - Collected January 14, 2018 at 06:21 am then Resulted January 14, 2018 at 07:27 am - sixty three (63) minutes over the manufacturer's requirement of three (3) minutes Patient 150 - Collected January 18, 2018 at 12:38 pm then Resulted January 18, 2018 at 13:24 pm - forty three (43) minutes over the manufacturer's requirement of three (3) minutes Patient 154 - Collected January 22, 2018 at 06:18 am then Resulted January 22, 2018 at 06:45 am - twenty four (24) minutes over the manufacturer's requirement of three (3) minutes Patient 155 - Collected January 22, 2018 at 10:38 am then Resulted January 22, 2018 at 15:07 pm - four hours sixteen minutes (4 hr 16min) minutes over the manufacturer's requirement of three (3) minutes Patient 156 - Collected January 23, 2018 at 11:49 am then Resulted January 23, 2018 at 11:58 am - six (6) minutes over the manufacturer's requirement of three (3) minutes Patient 157 - Collected January 24, 2018 at 11:23 am then Resulted January 24, 2018 at 11:29 am - three (3) minutes over the manufacturer's requirement of three (3) minutes Patient 158 - Collected January 29, 2018 at 10:50 am then Resulted January 29, 2018 at 11:06 am - thirteen (13) minutes over the manufacturer's requirement of three (3) minutes Patient 159 - Collected January 29, 2018 at 12:15 pm then Resulted January 29, 2018 at 13:03 pm - forty five (45) minutes over the manufacturer's requirement of three (3) minutes Patient 160 - Collected January 30, 2018 at 12:06 pm then Resulted January 30, 2018 at 12:16 pm - seven (7) minutes over the manufacturer's requirement of three (3) minutes 4. In interview on March 22, 2018, Personnel 1 confirmed the above patients were not analyzed within three (3) minutes according to the manufacturer's requirements. 5. Review of the Task 1 & 3 form provided to surveyors revealed the laboratory performs five hundred (500) PT/INR tests annually. II. Based on observation, record review and interview with personnel, the laboratory failed to ensure patient samples for Lactate are analyzed within three (3) minutes according to the manufacturer for fourteen (14) of twenty six (26) patients reviewed. Findings: 1. Observation by the surveyors on March 22, 2018 revealed the laboratory was performing Lactate testing on the Abbott iSTAT Clincal Analyzer. 2. Review of the Abbott iSTAT Lactate package insert revealed that patient samples are to be tested within three (3) minutes of collection. 3. Review of patient records from September 1, 2017 through March 21, 2018 revealed the laboratory did not document testing of patient samples for Lactate within three (3) minutes of collection for the following fourteen (14) patients: Patient 165 - Collected November 26, 2017 at 10:58 am then resulted November 26, 2017 at 13:07 pm - six (6) minutes over the manufacturer's requirement of three (3) minutes Patient 166 - Collected February 9, 2018 at 12:17 pm then resulted February 9, 2018 at 12:28 pm - eight (8) minutes over the manufacturer's requirement of three (3) minutes Patient 167 - Collected September 28, 2017 at 09:26 am then resulted September 28, 2017 at 09:33 am - four (4) minutes over the manufacturer's requirement of three (3) minutes Patient 168 - Collected November 16, 2017 at 11:52 am then resulted November 16, 2017 at 12:03 pm - eight (8) minutes over the manufacturer's requirement of three (3) minutes Patient 169 - Collected December 5, 2017 at 11:23 am then resulted December 5, 2017 at 11:32 am - six (6) minutes over the manufacturer's requirement of three (3) minutes Patient 170 - Collected December 14, 2017 at 11:30 am then resulted December 14, 2017 at 11:34 pm - one (1) minutes over the manufacturer's requirement of three (3) minutes Patient 171 - Collected December 26, 2017 at 15:18 pm then resulted December 26, 2017 at 15:23 pm - two (2) minutes over the manufacturer's requirement of three (3) minutes Patient 172 - -- 3 of 8 -- Collected December 27, 2017 at 09:04 am then resulted December 27, 2017 at 09:08 am - one (1) minutes over the manufacturer's requirement of three (3) minutes Patient 173 - Collected January 3, 2018 at 10:02 am then resulted January 3, 2018 at 10:09 am - four (4) minutes over the manufacturer's requirement of three (3) minutes Patient 174 - Collected January 24, 2018 at 16:09 pm then resulted January 24, 2018 at 16:18 pm - six (6) minutes over the manufacturer's requirement of three (3) minutes Patient 175 - Collected January 29, 2018 at 11:20 am then resulted January 29, 2018 at 11:25 am - two (2) minutes over the manufacturer's requirement of three (3) minutes Patient 174 - Collected February 20, 2018 at 11:08 am then resulted February 20, 2018 at 11: 12 am - one (1) minutes over the manufacturer's requirement of three (3) minutes Patient 177 - Collected February 26, 2018 at 08:28 am then resulted February 26, 2018 at 08:36 am - five (5) minutes over the manufacturer's requirement of three (3) minutes Patient 178 - Collected March 5, 2018 at 12:20 pm then resulted March 5, 2018 at 12:30 pm - seven (7) minutes over the manufacturer's requirement of three (3) minutes 4. In interview on March 22, 2018, Personnel 1 confirmed the above patients were not analyzed within three (3) minutes according to the manufacturer's requirements. 5. Review of the Task 1 & 3 form provided to surveyors revealed the laboratory performs fifty (50) Lactate tests annually. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on observation, record review and interview with personnel, the laboratory failed to have complete performance specification studies for the Horiba ABX Pentra 400 analyzer. Findings: 1. Observation by surveyors during laboratory tour on March 22, 2018 revealed the laboratory utilizes a Horiba ABX Pentra 400 analyzer for chemistry testing to include the following tests: *Complete Metabolic Panel (CMP) - Albumin (ALB), Alkaline Phosphatase (ALP), Alanine Transaminase (ALT), Aspartate Aminotransferase (AST), Blood Urea Nitrogen (BUN), Calcium, Chloride, Carbon Dioxide (CO2), Creatinine, Glucose, Sodium, Potassium, Total Bilirubin, Total Protein *Lipid Panel - Cholesterol (CHOL), Triglyceride (TRIG), High Density Lipoprotein (HDL) *Amylase, Lipase, C-Reactive Protein (CRP), Magnesium, Uric Acid 2. Review of the laboratory's data revealed the following studies performed: a) Accuracy b) Simple Precision c) Linearities for Reportable Range 3. Review of the laboratory's data revealed the following information was not included: a) Complete Precision: day to day and operator variance b) Reference Range: data to support reference ranges in use 4. In interview on March 22, 2018 at 1030 am, Personnel 1 confirmed the above findings. 5. Review of the Task 1 & 3 form provided to surveyors revealed the laboratory performs thirteen thousand (13,000) tests annually on the Horiba ABX Pentra 400. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) -- 4 of 8 -- 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 observation, record review, and interview with personnel, the laboratory failed to include in-house quality control (QC) data and pertinent literature to support reduction of the frequency of QC in their Individualized Quality Control Plan (IQCP). Findings: 1. Observation by surveyors during the laboratory tour on March 22, 2018 revealed the laboratory utilizes the Abbott i-STAT 1 for testing of the following analytes: pH, pCO2, pO2, Lactate, Troponin (cTNL), Prothrombin Time/International Normalized Ratio (PT/INR), and Brain Natriuretic Peptide (BNP). 2. Review of the IQCP Risk Assessment revealed the laboratory did not include the in-house quality control data and pertinent literature to support the reduction of performing QC to that of the manufacturer. 3. In interview on March 22, 2018, Personnel 1 confirmed the laboratory did not include the in-house data and literature supporting the QC reduction in the IQCP. 4. Review of the Task 1 & 3 form provided to suveyors revealed the laboratory performs the following test volumes annually: a) pH - fifty (50) b) pCO2 - fifty (50) c) pO2 - fifty (50) d) Lactate - fifty (50) e) cTNL - six hundred (600) f) PT /INR - five hundred (500) g) BNP - five hundred (500) D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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 quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with personnel, the laboratory failed to perform two (2) levels of quality control material each day of patient testing for Chloride. Findings: 1. Observation by surveyors during laboratory tour on March 22, 2018 revealed the laboratory utilizes the Horiba ABX Pentra 400 analyzer with ABX Pentra Clinical Chemistry controls for Chloride testing. 2. Review of the laboratory's Policy and Procedure Manual revealed a policy that stated the laboratory is to run two (2) levels of Quality Controls (QC) daily. 3. Review of QC records from January 1, 2017 through March 22, 2018 revealed the laboratory did not perform two (2) levels of QC prior to patient testing on February 19, 2018. QC was documented on February 18, 2018 at 06:31 am and then on February 19, 2018 at 18:07 pm. 4. Review of the patient records revealed the laboratory performed Chloride testing on the following twenty seven (27) of forty eight (48) patients reviewed: Patient 28 - resulted February 19, 2018 at 06:44 am Patient 29 - resulted February 19, 2018 at 06:48 am Patient 30 - resulted February 19, 2018 at 06:50 am Patient 31 - resulted February 19, -- 5 of 8 -- 2018 at 06:52 am Patient 32 - resulted February 19, 2018 at 06:54 am Patient 33 - resulted February 19, 2018 at 08:40 am Patient 34 - resulted February 19, 2018 at 09: 01 am Patient 35 - resulted February 19, 2018 at 10:12 am Patient 36 - resulted February 19, 2018 at 10:24 am Patient 37 - resulted February 19, 2018 at 10:33 am Patient 38 - resulted February 19, 2018 at 10:37 am Patient 39 - resulted February 19, 2018 at 10:40 am Patient 40 - resulted February 19, 2018 at 11:07 am Patient 41 - resulted February 19, 2018 at 11:09 am Patient 42 - resulted February 19, 2018 at 11: 14 am Patient 43 - resulted February 19, 2018 at 11:17 am Patient 44 - resulted February 19, 2018 at 11:46 am Patient 45 - resulted February 19, 2018 at 11:51 am Patient 46 - resulted February 19, 2018 at 11:59 am Patient 47 - resulted February 19, 2018 at 12:10 pm Patient 48 - resulted February 19, 2018 at 12:18 pm Patient 49 - resulted February 19, 2018 at 12:21 pm Patient 50 - resulted February 19, 2018 at 12: 29 pm Patient 51 - resulted February 19, 2018 at 12:42 pm Patient 52 - resulted February 19, 2018 at 12:45 pm Patient 53 - resulted February 19, 2018 at 13:26 pm 5. In interview on March 22, 2018 at 3:32 pm, Personnel 1 stated that she was unaware two (2) levels of QC was not performed. Personnel 1 confirmed the above patients were resulted without QC performed. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with personnel, the laboratory failed to follow established policies to monitor, assess, and correct quality issues in Analytic Systems. Findings: 1. The laboratory failed to have a complete policy and procedure manual. Refer to D5401. 2. The laboratory failed to ensure that patient samples for Prothrombin Time (PT)/ International Normalized Ratio (INR) testing are analyzed within three (3) minutes of collection according to the manufacturer for fifteen (15) of twenty two (22) patients reviewed. Refer to D5411 I. 3. The laboratory failed to ensure patient samples for Lactate are analyzed within three (3) minutes according to the manufacturer for fourteen (14) of twenty six (26) patients reviewed. Refer to D5411 II. 4. The laboratory failed to have complete performance specification studies for the Horiba ABX Pentra 400 analyzer. Refer to D5421. 5. The laboratory failed to include in-house quality control (QC) data and pertinent literature to support reduction of the frequency of QC in their Individualized Quality Control Plan (IQCP). Refer to D5445. 6. The laboratory failed to perform two (2) levels of quality control material each day of patient testing for Chloride. Refer to D5447. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: -- 6 of 8 -- Based on observation, record review, and interview with personnel, the Laboratory Director failed to provide overall management and direction for the laboratory. Findings: 1. The Laboratory Director failed to ensure that complete verification procedures were performed. Refer to D6013. 2. The Laboratory Director failed to ensure laboratory personnel performed testing as required. Refer to D6014. 3. The Laboratory Director failed to ensure that the quality control was maintained to assure quality laboratory services were provided. Refer to D6020. 4. The Laboratory Director failed to ensure that a quality assessment (QA) program was established and maintained to assure the quality of laboratory services provided. Refer to D6021. 5. The Laboratory Director failed to ensure that an approved procedure manual was available to all personnel responsible for any aspect of the testing process. Refer to D6031. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on observation, record review, and interview with laboratory personnel, the Laboratory Director failed to ensure that complete verification procedures were performed. Refer to D5421. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(3) Ensure that-- (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with personnel, the Laboratory Director failed to ensure laboratory personnel performed testing as required. Findings: 1. The laboratory failed to ensure that patient samples for Prothrombin Time (PT)/ International Normalized Ratio (INR) testing are analyzed within three (3) minutes of collection according to the manufacturer for fifteen (15) of twenty two (22) patients reviewed. Refer to D5411 I. 2. The laboratory failed to ensure patient samples for Lactate are analyzed within three (3) minutes according to the manufacturer for fourteen (14) of twenty six (26) patients reviewed. Refer to D5411 II. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) -- 7 of 8 -- The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with personnel, the Laboratory Director failed to ensure that the quality control was maintained to assure quality laboratory services were provided. Findings: 1. The laboratory failed to include in- house quality control (QC) data and pertinent literature to support reduction of the frequency of QC in their Individualized Quality Control Plan (IQCP). Refer to D5445. 2. The laboratory failed to perform two (2) levels of quality control material each day of patient testing for Chloride. Refer to D5447. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on observation, record review and interview with laboratory personnel, the Laboratory Director failed to ensure that a quality assessment (QA) program was established and maintained to assure the quality of laboratory services provided. Refer to D5791. D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel, the Laboratory Director failed to ensure that an approved procedure manual was available to all personnel responsible for any aspect of the testing process. Refer to D5401. -- 8 of 8 --