Mercy Hospital Watonga, Inc

Summary Statement of Deficiencies D0000 The recertification survey was performed on 10/,22,23,24/2024. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the manager, laboratory manager, testing person #2, and testing person #3 at the conclusion of the survey. 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 a review of records, nursing policy, and interview with the manager, the facility failed to ensure written policies were followed for documenting vital signs for one of five units of packed red blood cells. Findings include: (1) On 10/23/2024 at 1: 00 pm, the manager stated that blood transfusions were performed by nursing staff; (2) A review of the hospital policy titled, "WTG MW NUR Administration Transfusion of Blood or Blood Products Policy" defined vitals as temperature, blood pressure, pulse and respirations and stated: (a) "Obtain vital signs within 30 minutes before transfusion begins"; (b) "Obtain vital signs within 10-15 minutes after start of the transfusion"; (c) "Obtain vital signs at the end of the transfusion, but not more than 60 minutes after the transfusion has been discontinued". (3) A review of transfusion records for five units identified the policy had not been followed for one of five units as follows; (a) Unit #W091024106559 - The unit was started at 08:23 am and vital signs were not taken between 8:23 am and 10:11 am; (4) The records were reviewed with the manager who stated on 10/23/2024 at 01:00 pm, the vital signs had not been documented according to policy. 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 -- D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) 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 interview with the technical consultant, the laboratory failed to provide written instructions to clients collecting and referring specimens for testing performed in the laboratory. Findings include: (1) On 10/22/2024 at 11:15 am, the laboratory manager stated the following testing were performed and specimens were transported to the laboratory from nursing homes and home health care agencies: (a) CBC (complete blood count) testing using the Sysmex XS 1000i analyzer; (b) Routine Chemistry testing using the Roche Cobas c 311 analyzer. (2) Interview with the technical consultant on 10/22/2024 at 02:15 pm confirmed the laboratory did not provide written instructions (i.e., client service manual) to the clients to explain the laboratory's specimen collection and transportation policies. 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 observation, a review of policies and procedures, and interview with the manager, the laboratory failed to follow their written protocol for centrifuging urine samples for microscopic exam during the review period of June 2022 through the current date. Finding include: (1) On 10/23/2024 at 10:00 am, the manager stated the following: (a) Urine sediment examinations were performed by the laboratory; (b) The specimens were processed in a Hettich EBA 270 centrifuge at a speed of 2000 rpm (revolutions per minute) for 5 minutes. (2) A review of the procedure titled, "WTG LABCO Urinalysis-Microscopic and Culture", stated "Place 12 milliliters (ml) of a well mixed urine into a labeled urine tube. Cap the tube and place it in the centrifuge at 400 RCF (Relative Centrifugal Force) for 5 minutes"; (3) A calculation of the RCF for the Hettich Centrifuge at 2000 RPM revealed that the laboratory was centrifuging at 563 RCF, rather than 400 RCF as stated in the policy; (4) The records were reviewed with the manager, who stated on 10/23/2024 at 10:00 am, the laboratory had not followed their policy. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a review of records, observation, and interview with the laboratory director, the laboratory failed to ensure expired supplies were not available for use. Findings include: (1) Observation of the laboratory on 10/22/2024 at 11:00 am, identified the following expired supplies were available for use: (a) One bottle of NERL reagent grade water, lot #597839, expired 07/31/2024 and put into use by the laboratory on 10 /02/2024. (2) Interview with the manager on 10/22/2024 at 11:00 am confirmed the reagent grade NERL water was currently in use. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 01/19,20/2023. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the hospital administrator, senior quality improvement specialist, director of nursing, laboratory director, operational manager, lead technologist, testing person #2, testing person #3, and testing person #5 during an exit conference performed at the conclusion of the survey. 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: Based on a review of records, manufacturer's instructions and interview with the lead technologist and testing person #3, the laboratory failed to follow the manufacturer's instructions for implementing one of three coagulation reagents. Findings include: (1) On 01/19/2023 at 09:45 am, the lead technologist stated the Stago STA Satellite analyzer was used to perform PT/INR (Prothrombin Time/International Normalized Ratio) testing; (2) On 01/20/2023 at at 11:00 am, testing person #3 stated the current PT reagent, STA Neoplastine CI Plus lot #260019, was put into use on 04/02/2022; (3) A review of the manufacturer's instructions titled, "Protocol Quick User Guide", contained instructions for implementing new reagents and in Section 4 "Total Precisions (for each analyte reported)" it stated, "Total precision studies should be performed with the new lot of reagents" and provided the following instructions: (a) "Use control material that will be used for the assay"; (b) Run each level six (6) times per day over five (5) days"; (c) Data will be used to create 'site specific' quality control range". (4) A review of the implementation records for the PT reagent 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 -- identified the laboratory did not use control materials to perform the total precisions as stated in the manufacturer's instructions; (5) The records were reviewed with testing person #3 who stated on 01/20/2023 at 11:35 am the total precision studies had not been performed with the PT reagent lot change. 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 a review of records and interview with the lead technologist and testing person #2, the laboratory failed to utilize the demonstrated reportable range for one of one new analyte added to the Roche Cobas c311 analyzer. Findings include: (1) On 01 /19/2023 at 09:35 am, the lead technologist stated the laboratory added the analyte CRP (C-Reactive Protein) to the test menu for the Roche Cobas c300 analyzer on 11 /17/2021; (2) On 01/20/2023 a review of the performance specification records identified the laboratory had demonstrated a reportable range of 3.0-334.4 mg/L for CRP: (3) A review of the reportable range programmed into the LIS (Laboratory Information System) and interview with the lead technologist and testing person #2 on 01/20/2023 at 01:50 pm, confirmed the laboratory was using a reportable range of 3.0- 350 mg/L instead of the reportable range that had been demonstrated by the laboratory. 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: Based on a review of records, manufacturer's instructions, and interview with the lead technologist, testing person #2, and testing person #3, the laboratory failed to ensure the manufacturer's instructions were followed for performing maintenance procedures for three of four instruments reviewed from 06/01/2021 through 12/31/2022. Findings include: QUICKSLIDE HEMA PRO SLIDE STAINER (1) On 01/19/2023 at 09:30 am, the lead technologist stated the Hardy Diagnostics Quick Slide Hemapro slide stainer was used to stain patient blood smears to perform manual differentials; (2) A review of the Hemapro "Users Operation Manual" on page 22 under the title, "Tubing Kit Replacement" stated, "The orange pump tubes and the clear lines with color coded cannulas must be replaced every six (6) months to ensure the Hemapro is operating under normal operating conditions"; (3) A review of records from 06/01/2021 through 12/31/2022 identified no documentation to prove the tubing kit replacement procedure had been performed before or after 04/29/2022; (4) The records were reviewed with -- 2 of 3 -- the lead technologist and testing person #2. Both stated on 01/19/2023 at 02:40 pm the maintenance procedure had not been performed as stated above. SYSMEX XS-1000i (1) On 01/19/2023 at 09:35 am, the lead technologist stated CBC (Complete Blood Count) testing was performed using the Sysmex XS 1000i analyzer; (2) On 01/20 /2022, a review of the manufacturer's maintenance log showed the following required weekly maintenance procedure: (a) "Power Down IPU" (3) A review of maintenance logs from 06/01/2021 through 12/31/2022 identified weekly maintenance had not been documented as performed between: (a) 07/23/2021 and 08/02/2021 (b) 10/24 /2022 and 11/07/2022 (4) The records were reviewed with the lead technologist and testing person #3. Both stated on 01/20/2023 at 10:00 am, the weekly maintenance had not been documented as performed as shown above. STAGO STA SATELLITE (1) On 01/19/2023 at 09:45 am, the lead technologist stated PT/INR (Prothrombin Time/International Normalized Ratio) and D-dimer testing were performed using the Stago STA Satellite analyzer; (2) On 01/20/2022, a review of the manufacturer's maintenance log showed the following required weekly maintenance procedures: (a) Decontaminate needle and washing well (b) Clean Shield (Soak 0.37% fresh decontamination solution 10 min) (c) Clean Carousels (warm water) (d) Clean sample and product compartments (warm water) (e) Clean rail (warm water) (f) Clean rail glass (STA leaner solution) (g) Clean rail, sample and product covers with 0.37% fresh decontamination solution (h) Clean optical sensor (STA Cleaner solution) (i) Clean the cover and monitor (with 20%ethanol) (j) Save Test configurations to Disk /Saveall Disc (k) Decontaminate stir bars as per package insert (3) A review of maintenance logs from 06/01/2021 through 12/31/2022 identified weekly maintenance had not been documented as performed between: (a) 08/25/2021 and 09/08/2021 (b) 12/22/2021 and 01/06/2022 (c) 06/21/2022 and 07/06/2022 (4) The records were reviewed with testing person #3 who stated on 01/20/2023 at 11:00 am, the weekly maintenance had not been documented as performed as shown above. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on a review of a patient report and interview with the lead technologist and testing person #3, the laboratory failed to make appropriate reference ranges available for one of one coagulation reagent lot number change. Findings include: (1) On 01/19 /2023 at 09:45 am, the lead technologist stated the Stago STA Satellite analyzer was used to perform PT/INR (Prothrombin Time/International Normalized Ratio) testing; (2) On 01/20/2023 at at 11:00 am, testing person #3 stated the current PT reagent, STA Neoplastine CI Plus lot #260019, was put into use on 04/02/2022; (3) A review of PT reagent implementation records identified the PT normal reference interval had been verified as 11.7-13.6; (4) A review of one random PT patient report identified the testing had been performed on 01/18/2023 at 07:33 pm with a normal reference range of 12.2-14.0; (5) The reports and implementation records were reviewed with the lead technologist who stated on 01/20/2023 at 01:40 pm, the laboratory had not updated the normal reference range into the laboratory's computer information system. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and from the proficiency testing provider. 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 desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluations obtained from the proficiency testing program, the laboratory failed to successfully participate in a proficiency testing program for the subspecialty of Compatibility Testing. Findings include: (1) The laboratory failed to achieve satisfactory performance for two consecutive proficiency testing events for Compatibility Testing. Refer to D2179 and D2181. 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 -- D2179 COMPATIBILITY TESTING CFR(s): 493.863(d) (1) For any unsatisfactory testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unsatisfactory testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluations obtained from the proficiency testing program, the laboratory failed to achieve successful performance for Compatibility Testing. Findings include: (1) The laboratory failed to achieve satisfactory performance on the Second 2021 Event and the Third 2021 Event. Refer to D2181. NOTE: The only acceptable

Summary Statement of Deficiencies D0000 The recertification survey was performed on 05/10,11/2021 The findings were reviewed with the laboratory director, general supervisor, testing person #3, testing person #4, hospital administrator, manager of operations, and senior quality improvement services during an exit conference performed at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with the general supervisor, the laboratory failed to following the manufacturer's instructions for specimen transport and storage for five of five patient specimens. Findings include: (1) On 05/10/2021 at 09:45 am, the laboratory manager stated the following to the surveyor: (a) The laboratory performed COVID-19 testing using the following instrument (i) Sofia SARS Antigen FIA - qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal swab specimens. (2) The surveyor reviewed the manufacturer's product insert titled, "Sofia SARS Antigen FIA" under the section, "USING SOFIA AND SOFIA 2" stated, "Critically important: Allow the test to develop for a FULL 15 minutes BEFORE placing it into Sofia or Sofia 2."; (3) The surveyor reviewed five test reports for patients tested on 11/23/2020, 12/14/2020, 02/01/2021, 03/08/2021, and 03/30/2021 and identified the following: (a) Patient Report #1 - Specimen collection date and time (11/23/2020 at 01:56 pm) and the result date and time (11/23 /2020 at 02:21 pm); (b) Patient Report #2 - Specimen collection date and time (11/23 /2020 at 01:56 pm) and the result date and time (11/23/2020 at 02:21 pm); (c) Patient 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 -- Report #3 - Specimen collection date and time (02/01/2021 at 08:13 am) and the result date and time (02/01/2021 at 08:28 am); (d) Patient Report #4 - Specimen collection date and time (03/08/2021 at 11:48 am) and the result date and time (03/08 /2021 at 12:06 pm); (e) Patient Report #5 - Specimen collection date and time (03/30 /2021 at 02:52 pm) and the result date and time (03/30/2021 at 03:12 pm). (4) The surveyor was not able to determine if the test had developed for a full 15 minutes before placing it into the analyzer since the time between the specimen collection date and recieved time were identical; (5) The surveyor reviewed the records with the general supervisor. The general supervisor stated on 05/10/2021 at 04:45 pm the laboratory could not prove the test had developed for a full 15 minutes before placing it into the analyzer. 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 a review of records, written policy, and interview with the general supervisor, the laboratory failed to have a written general supervisor and technical consultant competency policy based on the position responsibilities as listed in Subpart M. Findings include: (1) On 05/10/2021, the surveyor reviewed the competency assessment policy. It did not include guidance for assessing the competency of the general supervisor and technical consultant; (2) The surveyor then reviewed personnel records for competency assessments performed during 2019, 2020, and 2021. There was no evidence of competencies performed for the general supervisor and technical consultant based on their job responsibilities; (3) The surveyor asked the general supervisor if a written policy to evaluate the general supervisor and technical consultant based on job responsibilities was available. The general supervisor stated on 05/10/2021 at 02:21 pm a policy had not been written and competencies had not been performed. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with the general supervisor, the laboratory failed to review and evaluate proficiency testing results for one of 34 events. Findings include: (1) On 05/10/2021, the surveyor reviewed 2019, 2020, and 2021 proficiency testing records. The following biases were identified (biases were identified using the SDI (Standard Deviation Index) values assigned by the proficiency program): (a) First 2019 Chemistry Core Event (i) Cholesterol HDL (High Density Lipoprotein) - 3 of 5 results exhibited a positive bias (aa) Sample CH-02 - SDI of 3.1 (bb) Sample CH-04 - SDI of 2.2 (cc) Sample CH-05 - SDI of 2.0 (2) The surveyor could not locate evidence -- 2 of 7 -- in the records proving the biases had been identified and addressed; (3) The records were reviewed with the general supervisor. The general supervisor stated on 05/10 /2021 at 01:30 pm the biases had not been addressed. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of records and interview with the general supervisor, the laboratory failed to evaluate the accuracy of testing when proficiency testing results had not been graded by the proficiency program for two of 34 events reviewed. Findings include: (1) On 05/10/2021, the surveyor reviewed 2019, 2020, and 2021 proficiency testing records and identified the following for two of 34 events: (a) First 2020 Hematology Event: (i) For two of two results, the following was identified: (aa) EC1-01- Under "Expected Results" it stated, "See Commentary". There was no evidence the laboratory reviewed the commentary contained in the "Participant Summary Report" to evaluate their result; (bb) EC1-02 - Under "Expected Results" it stated, "See Commentary". There was no evidence the laboratory reviewed the commentary contained in the "Participant Summary Report" to evaluate their result. (b) Third 2020 Hematology Event for Urine Sediment: (i) For one of one result, the following was identified: (aa) US-06 - Under "Expected Results" it stated, "See Data Summary". There was no evidence the laboratory reviewed the commentary contained in the "Participant Summary Report" to evaluate their result. (2) The surveyor reviewed the records with the general supervisor who stated on 05/10/2021 at 01:40 pm, the laboratory had not evaluated the results that were not graded by the proficiency testing program. 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: Based on a review of records, manufacturer's instructions, and interview with the general supervisor, the laboratory failed to follow the manufacturer's instructions for detecting the presence or absence of the expected ABO blood group antibodies anti-A and/or anti-B; Findings include: (1) On 05/10/2021 at 11:45 am, the general supervisor stated to the surveyor Crossmatch testing was performed in the laboratory which included ABO Typing using the tube method; (2) On 05/10/2021 at 11:55 am, the general supervisor stated the Ortho Affirmagen A1 cells and B Cells were used in reverse grouping to check for the presence or absence of the expected ABO blood group antibodies anti-A and/or anti-B; (3) The surveyor reviewed the manufacturer's -- 3 of 7 -- instructions which stated, "3. Mix well and centrifuge. Suggested centrifugation: approximately 15 seconds at 3400 rpm (900-1000 rcf) or 1 minute at 1000 rpm (100- 125 rcf)."; (4) The surveyor reviewed the blood bank centrifuge records and identified the Hettich EBA 280 centrifuge (serial number 0000709-02) used to processed blood bank specimens had been checked as follows: (a) 07/01/2020 at a speed of 5000 rpms and time of 30 seconds; (b) 06/16/2019 at a speed of 5000 rpms and time of 30 seconds. (5) On 05/11/2021, the surveyor reviewed the findings with the general supervisor. On 05/11/2021 at 09:35 am, the general supervisor stated to the surveyor the laboratory had not followed the manufacturer's instructions as indicated above. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on a review of records and interview with the general supervisor, the laboratory failed to ensure reagents had not exceeded their expiration date for six of six days. Findings include: (1) On 05/10/2021 at 11:45 am, the general supervisor stated to the surveyor Crossmatch testing was performed in the laboratory which included ABO Typing using the tube method; (2) On 05/10/2021 at 11:50 am, the surveyor observed the following in the blood bank refrigerator: (a) Ortho Affirmagen A1 cells and B Cells lot #A437, expiration date 05/04/2021. (3) The surveyor asked the general supervisor what the materials were used for in the laboratory. On 05/10/2021 at 11:55 am, the general supervisor stated the Affirmagen A1 cells and B Cells were used in reverse grouping to check for the presence or absence of the expected ABO blood group antibodies anti-A and/or anti-B; (4) The surveyor showed the general supervisor the expired materials. On 05/10/2021 at 12:05 pm, the general supervisor stated the expired materials were available for use. 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: Based on a review of records, manufacturer's instructions, and interview with the general supervisor, the laboratory failed to follow the manufacturer's instructions for performing maintenance procedures for two of three months. Findings include: (1) On 05/10/2021 at 11:35 am, the general supervisor stated to the surveyor that Arterial Blood Gas and Venous Blood Gas testing were performed on the Opti CCA-TS analyzer; (2) On 05/11/2021, the surveyor reviewed the manufacturer's maintenance requirements as stated on the manufacturer's maintenance logs. The requirement for weekly maintenance was as follows: (a) Clean Sample Measurement Chamber (3) The surveyor reviewed maintenance records for three months (February 2019, October 2019, and April 2020). There was no evidence the weekly maintenance had been performed: (a) Between 10/11/2019 and 10/25/2019 (b) Between 04/10/2020 and 04 -- 4 of 7 -- /24/2020 (4) The surveyor reviewed the records with the general supervisor, who stated on 05/11/2021 at 09:50 am the weekly maintenance had been performed as required but not documented. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (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. (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 a review of records, policies and procedures, and interview with the general supervisor, the laboratory failed to follow their written protocol for ensuring the pipettes were functioning properly for four of four function checks. Findings include: (1) On 05/10/2021 at 01:00 pm, the general supervisor stated to the surveyor, coagulation testing was performed in the laboratory. The reagent preparation was processed using pipettes; (2) On 05/10/2021 at 10:45 am the surveyor observed the following pipettes in the laboratory: (a) MLA 1000 l serial number 951126; (b) Thermofisher Scientific Finnipipette adjustable 100-1000 l serial number 0624281. (3) The surveyor reviewed the pipette calibration policy titled, "WTG LABQ PIPETTE CALIBRATION". Under the section titled, "INTENDED USE" it stated, "Pipette calibration will be performed every 6 months."; (4) The surveyor ask the general supervisor for the 2019 and 2020 pipette maintenance records. The general supervisor stated on 05/10/2021 at 01:45 pm, the pipettes had not been checked in 2019 and 2020. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on a review of records and interview with the general supervisor, the laboratory failed to make appropriate reference ranges available for one of one reagent lot number change. Findings include: (1) On 05/10/2021 at 11:25 am, the general supervisor stated to the surveyor the laboratory performed PT/INR (Prothrombin Time /International Normalized Ration) testing on the STA Stago analyzer. In addition the following reagent was put into use on 10/15/2019: (a) Neoplastine PT reagent lot #257258 (2) On 05/10/2021, the surveyor reviewed the PT reagent implementation records and identified the laboratory had verified a PT normal reference interval of 11.8 - 14.3 seconds; (3) The surveyor then reviewed a patient PT report dated 12/09 /2019 at 10:49 am with a normal reference range of 12.2 -14.0 seconds; (4) On 05/11 /2021, the surveyor surveyor reviewed the findings with the general supervisor. On 05 -- 5 of 7 -- /11/2021 at 01:40 pm, the general supervisor stated that although the laboratory had established a PT normal reference interval with the PT reagent lot change, the laboratory had not implemented the change into the laboratory's computer information system. 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 a review of records and interview with the general supervisor, the laboratory director failed to attest that, at the time of testing, proficiency testing samples were tested in the same manner as patient specimens as required under Subpart H for 11 of 34 events. Findings include: (1) On 05/10/2021, the surveyor reviewed 2019, 2020, and 2021 proficiency testing events. For 11 of 34 events, the attestation statements had been signed approximately two to three months after the samples had been tested (not within a timeframe for the director to attest that, at the time of testing, the proficiency samples had been tested as required) as follows: (a) First 2019 Hematology/Coagulation Event - The sample testing had been completed on 04/01 /2019, and the attestation statement had not been signed by the laboratory director /designee until 07/23/2019; (b) Second 2019 Hematology/Coagulation Event - The sample testing had been completed on 07/26/2019, and the attestation statement had not been signed by the laboratory director/designee until 09/17/2019; (c) Second 2019 Microbiology Event - The sample testing had been completed on 06/28/2019, and the attestation statement had not been signed by the laboratory director/designee until 09 /17/2019; (d) First 2019 Immunohematology Event - The sample testing had been completed on 04/24/2019, and the attestation statement had not been signed by the laboratory director/designee until 07/23/2019; (e) First 2019 Chemistry Miscellaneous Event - The sample testing had been completed on 05/14/2019, and the attestation statement had not been signed by the laboratory director/designee until 07/23/2019; (f) First 2020 Hematology/Coagulation Event - The sample testing had been completed on 03/25/2020, and the attestation statement had not been signed by the laboratory director/designee until 06/23/2020; (g) Second 2020 Hematology /Coagulation Event - The sample testing had been completed on 07/27/2020, and the attestation statement had not been signed by the laboratory director/designee until 09 /22/2020; (h) First 2020 Microbiology Event - The sample testing had been completed on 03/02/2020, and the attestation statement had not been signed by the laboratory director/designee until 06/23/2020; (i) Second 2020 Microbiology Event - The sample testing had been completed on 07/03/2020, and the attestation statement had not been signed by the laboratory director/designee until 09/22/2020; (j) First 2020 Immunohematology Event - The sample testing had been completed on 04/10/2020, and the attestation statement had not been signed by the laboratory director/designee until 06/23/2020; (k) Second 2020 Chemistry Miscellaneous Event - The sample testing had been completed on 10/30/2020, and the attestation statement had not been signed by the laboratory director/designee until 01/08/2021. (2) The surveyor reviewed the findings with the general supervisor who stated on 05/10/2021 at 01:40 -- 6 of 7 -- pm the attestations had been signed approximately two to three months after the proficiency samples had been tested. The surveyor explained that attestation statements must be signed within a timeframe to definitively attest to the fact that proficiency samples were tested in the same manner as patient specimens. -- 7 of 7 --

Summary Statement of Deficiencies D0000 The recertification survey was performed 10/2/18 - 10/4/18. The laboratory was found out of compliance with the following CLIA regulation: 493.1409: D6033: Condition: Technical Consultant, Moderate Complexity The findings were reviewed with the laboratory manager and the director of nursing services at the conclusion of the survey. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory failed to thoroughly review and evaluate proficiency testing results. Findings include: (1) On the first day of the survey, the surveyor reviewed the 2017 and 2018 proficiency testing records. The following biases (the biases were identified using the SDI (Standard Deviation Index) values assigned by the proficiency testing program) were identified: (a) Second 2017 Chemistry Core Event (i) Alcohol: 5 of 5 results exhibited a Negative bias (aa) ALC-06: SDI -2.3 (bb) ALC-07: SDI -3.0 (cc) ALC-08: SDI -3.2 (dd) ALC-09: SDI -4.4 (ee) ALC-10: SDI -2.4 (ii) Digoxin: 4 of 5 results exhibited a Negative bias (aa) CH-06: SDI -4.0 (bb) CH-08: SDI -0.1 (cc) CH- 09: SDI -3.7 (dd) CH-10: SDI -3.5 (iii) Dilantin: 4 of 5 results exhibited a Negative bias (aa) CH-06: SDI -3.5 (bb) CH-08: SDI -0.7 (cc) CH-09: SDI -3.7 (dd) CH-10: SDI -3.6 (iv) Total Cholesterol: 5 of 5 results exhibited a Negative bias (aa) CH-06: SDI -2.5 (bb) CH-07: SDI -4.6 (cc) CH-08: SDI -4.7 (dd) CH-09: SDI -3.0 (ee) CH- 10: SDI -1.9 (b) Second 2017 Hematology Event (i) Red Blood Cell: 4 of 5 results exhibited a Positive bias (aa) XE-07: SDI 3.7 (bb) XE-08: SDI 3.6 (cc) XE-09: SDI 0.7 (dd) XE-10: SDI 3.5 (2) Documentation showed that although the biases had been identified, they had not been thoroughly investigated to determine the cause or if a Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- systematic failure had occurred; (3) The surveyor reviewed the findings with the laboratory manager who stated to the surveyor the biases had not been thoroughly investigated to determine the cause and to ensure a systematic failure had not occurred. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory failed to evaluate the accuracy of testing when a proficiency testing result had not been graded by the proficiency program. Findings include: (1) On the first day of the survey, the surveyor reviewed the 2017 and 2018 proficiency testing records and identified the laboratory did not address a result not graded by the proficiency testing program for Urobilinogen testing: (a) Second 2017 Event (i) Sample UA-03 had not been evaluated by the proficiency testing program due to non-consensus among the peers. The laboratory reported, "2.0/3.0 mg/ml." Under "Expected Result" it stated, "See Data Summary." There was no evidence the laboratory reviewed the data summary to evaluate their result. (2) The surveyor reviewed the records with the laboratory manager, who stated to the surveyor the non-graded proficiency testing result had not been evaluated. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on a review of records, and interview with the laboratory manager, individuals performing the duties of a technical consultant failed to meet the qualification requirement of a technical consultant as defined in 493.1411. Findings include: (1) The technical consultant failed to ensure individuals who performed the duties and responsibilities of the technical consultant, met the qualifications. Refer to D6035. D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of -- 2 of 4 -- Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (b)(2)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i) Hold an earned doctoral or master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (b)(3)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. Note: The technical consultant requirements for "laboratory training or experience, or both" in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service, excluding waived tests. For example, an individual who has a bachelor's degree in biology and additionally has documentation of 2 years of work experience performing tests of moderate complexity in all specialties and subspecialties of service, would be qualified as a technical consultant in a laboratory performing moderate complexity testing in all specialties and subspecialties of service. This STANDARD is not met as evidenced by: Based on a review of records, and interview with the laboratory manager, the technical consultant failed to ensure individuals who performed the duties of a technical consultant met the educational qualifications as defined in 493.1411. Findings include: (1) On the first day of the survey, the laboratory manager stated to the surveyor the laboratory performed moderate complexity testing, which included the following: (a) CBC (Complete Blood Count) testing (e.g., WBC-White Blood Count, RBC-Red Blood Count, Hemoglobin, Hematocrit, Platelet Count, etc.) using the Sysmex XS-1000i analyzer (b) Chemistry (e.g., Alcohol, Digoxin, Glucose, Potassium, Triglycerides, Uric Acid, etc.) using the Roche Cobas c311 analyzer (c) Microscopic urinalysis (d) Wet prep examinations (e) PT/INR (Prothrombin Time /International Normalized Ratio) testing using the Stago STA Satellite analyzer (f) Arterial Blood Gas (pH, pO2, pCO2) testing using the OPTI CCA-TS analyzer (2) The surveyor reviewed the Laboratory Personnel Report (Form CMS-209) completed by the laboratory prior to the survey. The form indicated the laboratory director was designated as the technical consultant for the moderate complexity testing performed by the laboratory; (3) The surveyor then reviewed personnel records and identified individuals who did not meet the required educational requirements of a technical consultant performed testing person competency assessments. The findings follow: (a) Laboratory Manager - Obtained an Associates of Applied Science degree in Medical Laboratory Technology: (i) Performed the 2017 annual competency assessment (on 06 /07/17) for Testing Person #1 (ii) Performed the 2017 annual competency assessment (on 08/15/17) and the 2018 annual competency assessment (on 04/16/18) for Testing Person #2 (iii) Performed the 2017 annual competency assessment (on 06/20/17) and the 2018 annual competency assessment (on 08/16/18) for Testing Person #3 (b) Testing person #1 - Obtained an Associates of Applied Science degree in Medical -- 3 of 4 -- Laboratory Technology: (i) Performed the semi-annual competency assessment (on 08 /17/18) for Testing Person #4 (ii) Performed the semi-annual competency assessment (on 12/27/17) for Testing Person #5 (c) Testing person #2 - Obtained an Associates of Applied Science degree in Medical Laboratory Technology: (i) Performed the 2017 annual competency assessment (on 06/01/17) and the 2018 annual competency assessment (on 06/04/18) for the laboratory manager (d) Testing person #5 - Obtained an Associates of Applied Science degree in Medical Laboratory Technology: (i) Performed the 2018 annual competency assessment (on 06/01/18) for Testing Person #1 (4) The surveyor reviewed the findings with the laboratory manager who stated to the surveyor, the laboratory failed to ensure individuals who performed competency assessments, met the educational requirements of a technical consultant. -- 4 of 4 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database. 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 desk review of proficiency testing scores, the laboratory failed to successfully participate in a proficiency testing program for the subspecialty of Routine Chemistry. Findings include: (1) The laboratory failed to achieve satisfactory performance for two of three consecutive testing events for the analyte Total Bilirubin. Refer to D2094 and D2096; 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 -- D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores, the laboratory failed to achieve a successful performance for the analyte Total Bilirubin. Findings include: (1) The laboratory failed to achieve satisfactory performance on the third event of 2017 and second event of 2018. NOTE: The only acceptable