Freestone Medical Center

Summary Statement of Deficiencies D0000 An onsite survey conducted February 21st and 22nd of 2023 found the laboratory in compliance with 42 CFR Part 493, Requirements for Laboratories. 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 review of manufacturers' instructions, laboratory maintenance records, and confirmed in interview, the laboratory failed to perform one of four quarterly maintenance tasks required in 2022 for the CA-660 coagulation analyzer. The findings include: 1. Review of the Sysmex Quick Reference Guide had the following maintenance to be performed quarterly: "- LED Calibration Refer to the LED page to perform an LED Calibration." 2. Review of the laboratory "Sysmex CA-600 Operator's Maintenance Checklist" for 2022 had documentation of quarterly maintenance being performed as follows: Perform LED Calibration: 3/25/2022 10/1 /2022 12/30/2022 3. In an interview on 2/21/2023 at 16:40, in the conference room, the technical consultant confirmed that the fourth quarterly maintenance had not been documented elsewhere for the LED calibration for 2022. II. Based on review of manufacturers' instructions, laboratory maintenance records, and confirmed in interview, the laboratory failed to perform three of four quarterly maintenance tasks required in 2022 for the CA-660 coagulation analyzer. The findings include: 1. Review of the Sysmex Quick Reference Guide had the following maintenance to be performed quarterly: "- Cleaning the rinse container 1. Turn OFF the instrument power. 2. Turn the cap of the rinse bottle counterclockwise to release the pressure from the bottle. Place cap on a clean paper towel. 3. Discard any remaining liquid in 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 -- the rinse bottle. 4. Add 250-300 mL of 70% isopropyl alcohol to the rinse bottle. 5. Replace the cap on the rinse bottle to make sure it comes in contact with all surfaces, including the float switch. 7. Discard the alcohol and rinse the bottle well with distilled water." 2. Review of the laboratory "Sysmex CA-600 Operator's Maintenance Checklist" for 2022 had documentation of quarterly maintenance being performed as follows: Clean DI Water Rinse Bottle with Alcohol: 3/31/2022 3. In an interview on 2 /21/2023 at 16:40, in the conference room, the technical consultant confirmed that the remaining three quarterly maintenance had not been documented elsewhere for the DI Water Rinse Bottle for 2022. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of laboratory policy, laboratory quality control (QC) records, and confirmed in interview, the laboratory failed to have documentation in place to monitor accuracy and precision over time for Prothrombin Time (PT) for five to five months from March to July 2022 on the Sysmex CA-660 coagulation analyzer use in patient coagulation testing. The findings include: 1. Review of the laboratory policy titled "C-003 Prothrombin time/INR", section "Quality Control" had the following statement: "Control results are entered into the RealTime QC software program for monthly analysis." 2. Surveyor queried the technical consultant (TC) for documentation of monthly quality control for PT, to monitor for accuracy and precision over time, from March to July 2022, and none was provided. The TC stated that the software program had deleted the documentation for the previous lot number of QC in use and that they had not printed hard copies since all review was performed in the software system. 3. In an interview on 2/21/2023 at 14:55 hours, the TC confirmed that the laboratory did not have documentation that accuracy and precision had been monitored for prothrombin time QC on the Sysmex CA-660 coagulation analyzer from March to July 2022. 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. -- 2 of 5 -- This STANDARD is not met as evidenced by: Based on review of quality control records, patient testing records, and interview with facility personnel, the laboratory failed to perform two levels of quality control each day of patient testing for 14 of 17 days of testing in September 2022 for the D-dimer assay performed on the Triage analyzer. The findings included: 1. Based on review of quality control records, the laboratory performed two levels of quality control for D- dimer on 9/6/2022. The "Triage QC & Maintenance Log" contained the following documentation: "Installed/Qc'd D-Dimer Lot#T13193N on Triage #1 L1-536, L-2 2,240 Triage #2 L1-508 L2-2130 9/6/2022" 2. Based on review of patient records, 19 patients were tested on 14 days in September that did not have documentation of two levels of quality control for the D-Dimer assay. Patient ID Date of Testing 1134751 09 /01/2022 1135030 09/05/2022 1135040 09/05/2022 1135413 09/08/2022 1135566 09 /10/2022 1135669 09/12/2022 1135704 09/12/2022 1135752 09/13/2022 1135862 09 /13/2022 1136172 09/17/2022 1136251 09/19/2022 1136624 09/22/2022 1136776 09 /24/2022 1136843 09/26/2022 1136883 09/26/2022 1136932 09/27/2022 1137166 09 /29/2022 1137313 09/30/2022 1137359 09/30/2022 3. In an interview at 15:00 hours on 2/21/2022 in the conference room, the Laboratory Manager confirmed two levels of quality control had not been performed each day of patient testing for the D-Dimer analyte on the Triage chemistry analyzers during September 2022. 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: Based on review of the Dimension chemistry analyzer operator's manual, quality control instructions for use, review of quality control records, and interview with facility personnel, the laboratory failed to accurately enter quality control acceptability criteria for three of three levels of quality control material used to assure the accuracy of twenty-six chemistry assays in February 2023. The findings included: 1. Based on review of the Dimension chemistry analyzer operator's manual (Dimension EXL with LM/EXL 200 System Operator's Guide), on page 4-27, the operator's manual stated the following: "Enter QC Ranges 1. Select FS: PROCESS CTRL > F4: QC RANGES. 2. Select the test key for the assay that will be edited. 3. Select the Lytes test key, then select F1: NEXT METHOD to see the K and Cl assays. 4. For each QC level, enter the QC range (low and high), expected mean, or expected SD as appropriate. The number of QC levels used determines how many days of QC data can be stored in the software for an assay." 2. Based on review of the BioRad Liquid Assayed Multiqual Premium quality control instructions for use (English * 2021-10 * 5871-00), under ASSIGNMENT OF VALUES, the instructions stated the -- 3 of 5 -- following: "The mean values and corresponding plus/minus 3 SD ranges in the Assignment of Values Data charts (available separately) were derived from replicate analyses and are specific for this lot of product." 3. Based on review of the laboratory's quality control policy "POLICY NUMBER: CH-007 CONTROL RULES FOR REPORTING PATIENT DATA", under Purpose, the policy stated: "Quality control (QC) results are used to validate whether the instrument is operating within pre-defined specifications, inferring that patient test results are reliable. Once the test system is validated, patient results can then be used for diagnosis, prognosis, or treatment planning. Westgard Rules are multi-rule control procedures used to monitor clinical chemistry control values. The purpose of Westgard Rules are: 1. To detect errors 2. Monitor sensitivity to both random and systematic errors The Westgard Rules applied to control runs in the chemistry department are: 1. 1-2S - This is a warning rule only. If one control measurement exceeds the mean +/- 2 standard deviations, other controls in the run (within the run) and in previous runs should be evaluated before accepting the run and reporting the results. 2. 1-3.5s- rule indicates random error and may also indicate systematic error. The run is considered out of control when one control value exceeds the mean 3.5SD. This rule is applied within the run only. 3. R4s - reject when 1 control measurement in a group exceeds the mean plus 2s and another exceeds the mean minus 2s." 4. Based on a review of from February 1, 2023, the laboratory had set the Bio-Rad three standard deviation ranges in place of the acceptability criteria in the instrument software. Based on a random review of quality control records, the following Bio-Rad 3SD ranges had been entered into the laboratory's instrument acceptability criteria: Level 1 Analyte Lab Range Bio- Rad 3SD Sodium 114-124 114-124 Total Protein 3.9- 4.4 3.86-4.42 Phosphorus 1.8- 2.3 1.78-2.32 Glucose 54-66 54.3-65.6 Urea Nitrogen 13-18 12.7-18 Level 2 Analyte Lab Range Bio-Rad 3SD Sodium 138-149 138-149 ALP 131-175 131-175 Glucose 115-133 115-133 Level 3 Analyte Lab Range Bio-Rad 3SD Sodium 154-166 154-166 Cholesterol 234-283 234-283 Chloride 116-129 116-129 AST 235-272 235-272 The outcome of using the Bio-Rad 3SD ranges as acceptability criteria for the assays would be the laboratory would not be able to apply quality control rules from the policy that were related to 2SD such as the 1-2S or R4 rules. 5. In an interview at 09: 59 hours on 2/22/2023 in the laboratory, the Laboratory Manager stated the night shift was responsible for updating the quality control ranges and they likely did not calculate the expected standard deviation based on the Bio-Rad assignment of values. Key: SD - Standard deviation QC - quality control K - potassium Cl- Chloride ALP - Alkaline Phosphatase AST - Aspartate Aminotransferase D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on review of laboratory instruments, assay instructions for use, and interview with facility personnel, the laboratory failed to evaluate and define the relationship between test results using different instruments or methodologies for the analyte CK- MB performed on both the Triage analyzer and the Dimension analyzer for two of two events in 2022. The findings included: 1. Based on review of laboratory -- 4 of 5 -- instrumentation test menu documentation, the laboratory performed the same test using different methodolgies or instrumentation for the following: Complete Blood Counts - Sysmex XN-450 and XN-550 Siemens Dimension EXL 200 - two instruments performing routine chemistry tests including sodium, potassium, chloride Alere Triage - two instruments performing Cardiac Panels including Troponin I, Myoglobin, CK-MB CK-MB is performed on both the Dimension EXL platforms and the Alere Triage analyzers. 2. Based on review of the Triage Cardiac Panel instructions for use, under Principles of the Procedure, the instructions stated: "The Alere Triage Cardiac Panel is a single use fluorescence immunoassay device designed to determine the concentration of CK-MB, myoglobin and troponin I in EDTA anticoagulated whole blood or plasma specimens. The test procedure involves the addition of several drops of an EDTA anticoagulated whole blood or plasma specimen to the sample port on the Test Device. After addition of the specimen, the whole blood cells are separated from the plasma using a filter contained in the Test Device. The specimen reacts with fluorescent antibody conjugates and flows through the Test Device by capillary action. Complexes of each fluorescent antibody conjugate are captured on discrete zones specific for each analyte. The Test Device is inserted into the Alere Triage Meter (hereafter referred to as Meter). The Meter is programmed to perform the analysis after the specimen has reacted with the reagents within the Test Device. The analysis is based on the amount of fluorescence the Meter detects within a measurement zone on the Test Device. The concentration of the analyte(s) in the specimen is directly proportional to the fluorescence detected. The results are displayed on the Meter screen in approximately 20 minutes from the addition of specimen. All results are stored in the Meter memory to display or print when needed. If connected, the Meter can transmit results to the lab or hospital information system." Based on review of the Dimension EXL 200 LMMB (CK-MB) instructions for use, the instructions stated: Principles of Procedure: The LMMB method Is a one-step enzyme immunoassay based on the 'sandwich" principle. The sample Is incubated with chromium dioxide particles coated with monoclonal antibodies' specific for CKB subunit, and conjugate reagent (B-galactosidase labeled monoclonal antibodies' specific for CKMB isoenzyme).' A particle/CKMB/conjugate sandwich forms during the incubation period. Unbound conjugate is removed by magnetic separation and washing. The sandwich bound B-galactosidase is combined with a chromogenic substrate chlorophenol red B-d-galactopyranoside (CPRG). Hydrolysis of CPRG releases a chromophore (CPR). The concentration of CKMB present in the patient sample is directly proportional to the rate of color change due to formation of CPR measured at 577 nm. The amount of CKMB protein is measured immunologically, and the results are reported In mass units (ng/ml or ug/L). The Triage and Dimension platforms use different methodologies to measure the analyte CK-MB. Based on review of documentation and policy, the laboratory did not have a means to evaluate the relationship between multiple instruments performing the same test or across multiple methodologies. 3. In an interview at 09:30 hours on 2/22/2023 in the conference room, the Laboratory Manager stated that the laboratory would use proficiency samples to compare between analzyers but did not have a formal policy or evaluation of bias between methodologies such as CKMB performed on the Triage versus CKMB performed on the Dimension EXL 200 platforms. -- 5 of 5 --

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on March 1, 2022, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation D6076 - 42 C.F.R. 493.1441 Condition: Laboratories performing high 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: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute comparative evaluation records, the laboratory failed to achieve successful 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 -- performance in two of two consecutive testing events for the specialty Immunohematology for the analyte Compatibility Testing, resulting in unsuccessful performance. Refer to D2181. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory for 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 the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and the American Proficiency Institute (API) Comparative Evaluations, the laboratory failed to attain a score of at least 80 percent for the analyte Compatibility Testing in two of two consecutive testing events in 2021. The findings included: 1. Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and the American Proficiency Institute (API) Comparative Evaluations, the laboratory received the following unsatisfactory scores (satisfactory is 100%) for the analyte Compatibility Testing in the specialty of Immunohematology in two of two consecutive events: 2021 API 2nd event 60% 2021 API 3rd event 60% D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing records, the Laboratory Director failed to ensure successful participation in a HHS approved proficiency testing program for analyte Compatibility Testing in Immunohematology. Refer to D6016. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute (API) Comparative Evaluations, the Laboratory Director failed to ensure successful participation in a HHS approved proficiency testing program for analyte Compatibility Testing in the specialty of Immunohematology for two of two events in 2021. Refer to D2181. -- 2 of 2 --

Summary Statement of Deficiencies 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: Review of manufacturer's instructions, patient final reports, personnel records and interview of facility personnel found the laboratory failed to follow the manufacturer's instructions when using the Sofia SARS Antigen FIA , Sofia Flu+SARS Antigen FIA and the the GeneXpert Xpert Xpress SARS-COV-2/Flu/RSV test kits for testing patients as defined by the manufacturer under the Emergency Use Authorization (EUA). The findings included: 1. Review of the manufacturer's instructions for the Sofia SARS Antigen FIA found on page 19 under the heading CONDITIONS OF AUTHORIZATION FOR LABORATORY " Authorized laboratories must include with the test result reports, all authorized Fact Sheets." Further review found: " All operators using your product must be appropriately trained in performing and interpreting the results of your product, use appropriate personal protective equipment when handling this kit, and use your product in accordance with authorized labeling." 2. Review of patient test records found the laboratory had tested 9081 patient specimens for SARS Covid providing no fact sheets with the final reports between December 2020 and the date of the inspection. 3. Review of personnel records found no documentation of training for eight of eight testing personnel. Interview of the General Supervisor conducted October 12, 2021 at 12:58 PM confirmed that the authorized Fact Sheets were not included with the patient test results for SARS COV- 2 testing, and the laboratory failed to document training for eight of eight testing personnel. D3031 RETENTION REQUIREMENTS 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 -- CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Review of quality control records and interview of facility personnel found the laboratory failed to retain instrument printouts for Prothrombin time (Protime) and Activated Partial Thromboplastin time (APTT) tested on the ACL Elite coagulation analyzer between January 1, 2021 and July 29, 2021. The findings included: 1. Review of quality control records found the laboratory had printed and retained the monthly summary reports for Protime and APTT but did not retain individual printouts between January 1, 2021 and July 29, 2021. 2. Interview of the General Supervisor conducted on October 14, 2021 at 9:22 AM confirmed that the laboratory did not retain instrument printouts. She stated the printer was broken and results were transmitted directly into the Laboratory Information system (LIS) during this time. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on observations, review of media quality control records, and verified in staff interview, it was revealed the laboratory failed to perform quality control procedures to ensure that each batch of blood culture media used for patient testing was able to support growth of organisms. The findings included : 1. Observations made during the tour of the facility found the laboratory was currently using blood culture media lots as follows: a. BacT Alert (anaerobic) FN Plus Lot # 0004100216 Expiration Date: 2022-03-17 3045727 12-09-2016 b. BacT Alert (pediatric) PF Plus Lot # 0004057068 Expiration Date: 2022-02-26 3045837 12-29-2016 c. BacT Alert (aerobic) FA Plus Lot #0004100216 Expiration Date: 2022-04-16 3045847 12-27-2016 2. The laboratory was asked to provide documentation of performing quality control testing for ability to support growth for each lot number of commercially prepared media it received or an IQCP study to modify the required frequency of controls. No documentation was provided. 3. Review of patient test records found the laboratory had tested 285 patients in 2021 for blood cultures without performing quality control procedures to ensure the media supports growth of microorganisms. 4. Interview with testing personnel conducted on October 13, 2021 at 9:45 AM confirmed the above findings. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) -- 2 of 5 -- (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Review of policies and procedures, refrigerator and freezer temperature records, observations and interview of facility personnel found the laboratory failed to to store fresh frozen plasma ( for transfusion purposes) in a freezer with an audible alarm system that continuously monitors the product storage temperature. The findings included: 1. Review of policy BB-028 Quality Control of Refrigerator/Freezer Units ( revised November 19, 2018) found on page 1: "Blood components, blood samples from patients and reagents for blood bank must be maintained with strict range of temperature, in order to ensure efficacy and avoid some potentially severe complications. For refrigerated storage, refrigerators must have a fan or be of the capacity and design to ensure stable, designated temperature is maintained throughout. The temperature of all areas of the Blood Bank refrigerator must be between 1 and 6C. The temperature of the Blood Bank plasma freezer must be at -18C or colder. There must be a system to continuously monitor the temperature of the Blood Bank refrigerator and freezer. There must be continuous surveillance of temperature. Standard recorders provide a continuous written record (temperature Chart). For circumstances when these recording devices fail to function, temperatures must be recorded at least every 4 hours. Temperature fluctuations that exceed the regulatory requirements must be explained in writing on the written record (i.e. door ajar, or alarm check). At the end of each 7 day cycle, the recording chart from the mechanical recording device should be changed, dated, and initialed by the individual changing the chart. The blood bank refrigerator and freezer is equipped with an alarm system. The alarm alerts personnel to take appropriate action before stored blood components reach undesirable temperatures. The alarm signals at the nursing station that has adequate personnel coverage 24 hours per day. The sound on this audible alarm can be heard by any personnel in adjacent hallways." 2. Review of refrigerator and freezer temperature recording charts for 2020 and 2021 found no documentation of continuous temperature monitoring (using temperature recording graphs) of the freezer used to store fresh frozen plasma after June 2, 2021. Temperature recording graphs were requested and a temperature log with daily recording of freezer temperatures was provided. 3. Observations made during the tour of the facility found the laboratory did not have a means to continuously monitor and record the temperature of the Jewett freezer (SN 1132819601210628 Model JPL 430A21) used to store fresh frozen plasma. Current Inventory of plasma stored in the freezer included: one unit O negative plasma one unit B positive plasma one unit B negative plasma two units A positive plasma one unit AB negative plasma three units O positive plasma. 4. Interview of the General Supervisor conducted October 12, 2021 at 4:23 PM confirmed the laboratory did not have a means to continuously monitor and record the temperature of the blood bank freezer used to store fresh frozen plasma. She stated that the previous freezer died June 2, 2021 and was replaced with the Jewett freezer on July 29, 2021. She states that she bought the temperature monitoring device for the freezer but the maintenance department said they can't attach it". She went on to say the laboratory measures the freezer temperature once each day and records it on the blood bank temperature and humidity logs. -- 3 of 5 -- D6040 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(2) The technical consultant is responsible for-- (b)(2) Verification of the test procedures performed and the establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system. This STANDARD is not met as evidenced by: Review of the verification records provided for the Sysmex XN 450 and 550 hematology analyzers found that the technical consultant failed to ensure that the reference range study met the manufacturer's specifications. The verification study had no documentation of review. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of policies and procedures, testing personnel files, and interview of facility personnel, the Technical Supervisor failed to evaluate and document personnel competency at least semiannually during the first year the individual tests patient specimens for three of eight testing personnel performing high complexity procedures. The findings included: 1. Review of the policy GL-021 LABORATORY PERSONNEL COMPETENCY ASSESSMENT POLICY (approved 10May19) found on page one under the heading POLICY: "1. Competency is the ability of personnel to apply their skill, knowledge, and experience to perform their laboratory duties correctly. 2. Competency must be assessed a minimum of twice in the first year of employment for testing personnel and annually thereafter. Competence must also be assessed, prior to reporting results, whenever there are test methodology or instrumentation changes. Competency assessment can be done throughout the year the entire year coordinating it with routine practices and procedures to minimize impact on workload. 3. Competency will be documented in writing with additional supporting documentation when indicated. These records may be retained electronically or on paper. An annual Competency Assessment Summary Form must be completed for each person indicating the dates of assessment, procedure, method of assessment, identity of person assessing the competency, and dates of review. 4. Competency assessments will be performed by the Laboratory Director or Laboratory Supervisor/Manager who have documented competency and are proficient in the area assessed. Personnel performing the assessment must at a minimum meet the CLIA requirements of general supervisor, but need not be in a supervisory position." 2. Review of personnel files found: Testing person 4 (hired 03/04/2019) had no record of semiannual competency evaluations during 2021. Testing person 5 (hired 09/03/2019) had no record of semiannual competency evaluations during 2021. Testing person 7 (hired 07/29/2019) had no record of semiannual competency evaluations during 2021. 3. Interview of the general supervisor conducted October 12, 2021 at 10:38 AM confirmed that competency assessments would have to be retrieved from the Human Resources department if they were not in the laboratory files. Interview of personnel in the Human resources department conducted October 12, 2021 at 11:32 AM -- 4 of 5 -- confirmed no additional competency assessment records were available for review for testing persons four, five and seven. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on review of policies and procedures, testing personnel files, and interview of facility personnel, the Technical Supervisor failed to evaluate and document personnel competency at least annually for three of eight testing personnel performing high complexity procedures in 2020 and 2021. The findings included: 1. Review of the policy GL-021 LABORATORY PERSONNEL COMPETENCY ASSESSMENT POLICY (approved 10May19) found on page one under the heading POLICY: "1. Competency is the ability of personnel to apply their skill, knowledge, and experience to perform their laboratory duties correctly. 2. Competency must be assessed a minimum of twice in the first year of employment for testing personnel and annually thereafter. Competence must also be assessed, prior to reporting results, whenever there are test methodology or instrumentation changes. Competency assessment can be done throughout the year the entire year coordinating it with routine practices and procedures to minimize impact on workload. 3. Competency will be documented in writing with additional supporting documentation when indicated. These records may be retained electronically or on paper. An annual Competency Assessment Summary Form must be completed for each person indicating the dates of assessment, procedure, method of assessment, identity of person assessing the competency, and dates of review. 4. Competency assessments will be performed by the Laboratory Director or Laboratory Supervisor/Manager who have documented competency and are proficient in the area assessed. Personnel performing the assessment must at a minimum meet the CLIA requirements of general supervisor, but need not be in a supervisory position." 2. Review of personnel files found: Testing person 1 (hire date September 26, 2018) had no documentation of competency assessment for 2020 or 2021. Testing person 3 (hire date December 10, 2018 ) had no documentation of competency assessment for 2020 or 2021. Testing person 6 (hire date 08/30/2015) had no documentation of competency assessment for 2020 or 2021. 3. Interview of the general supervisor conducted October 12, 2021 at 10:38 AM confirmed that competency assessments would have to be retrieved from the Human Resources department if they were not in the laboratory files. Interview of personnel in the Human resources department conducted October 12, 2021 at 11:32 AM confirmed no additional competency assessment records were available for review for testing persons one three and six. -- 5 of 5 --

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 verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of participation of the CLIA program The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 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: Based on a review of the CMS (Center for Medicare Services) national database and 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 3 -- proficiency desk review of the American Proficiency Institute (API) proficiency testing (PT) records from 2020, it was determined the laboratory has not successfully participated in a proficiency testing program, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the specialty of hematology for the analyte partial thromboplastin time (PTT) in 2 of 3 PT events in 2020. Refer to D2130 D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a review of the CMS (Center for Medicare Services) national database and a proficiency desk review of the American Proficiency Institute (API) proficiency testing records from 2020, it was determined the laboratory failed to achieve satisfactory performance (at least 80%) in the specialty of hematology for the analyte PTT, for 2 of 3 consecutive testing events in 2020. Findings were: 1. A review of the CMS national proficiency testing database revealed the following scores for the analyte PTT for 2 of 3 consecutive testing events in 2020: 2020 API 2nd event PTT - 60 % 2020 API 3rd event PTT - 60% 2. A proficiency desk review of the API proficiency testing records from 2020 confirmed that the laboratory received the following scores for the analyte PTT for 2 of 3 testing events in 2020. 2020 API 2nd event PTT - 60 % 2020 API 3rd event PTT - 60% D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the CMS (Center for Medicare Services) national database and a proficiency desk review of the American Proficiency Institute (API) proficiency testing records from 2020, it was determined the laboratory failed to achieve satisfactory performance (at least 80%) in the specialty of hematology for the analyte PTT for 2 of 3 consecutive testing events in 2020, resulting in an unsuccessful PT performance for PTT. Findings were: 1. A review of the CMS national proficiency testing database revealed the following scores for the analyte PTT for 2 of 3 consecutive testing events in 2020: 2020 API 2nd event PTT- 60 % 2020 API 3rd event PTT - 60% 2. A proficiency desk review of the API proficiency testing records from 2020 confirmed that the laboratory received the following scores for the analyte PTT for 2 of 3 testing events in 2020. 2020 API 2nd event PTT - 60 % 2020 API 3rd event PTT - 60% 3. Two out of three unsatisfactory scores of the same analyte result in unsuccessful PT performance. 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 a desk review of laboratory proficiency testing performance it was revealed that the laboratory director failed to provide overall management and direction of the laboratory services. Findings were: 1. A review of the laboratory proficiency testing results revealed that the laboratory director failed to ensure that the laboratory participated successfully. (refer to D6016) By not providing overall management and direction of the laboratory, the laboratory director could not ensure the accuracy or reliability of all laboratory services provided by the facility. 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 desk review of proficiency testing results it was revealed that the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an approved proficiency testing program. (refer to D2130) -- 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 Center of Medicare Services CMS) national database and verified with the American Proficiency Institute (API). The facility was found to be out of compliance with the conditions of participation for the CLIA program. The following Conditions of Participation were found to be out of compliance: 493.803 Successful participation (proficiency testing) . 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 review of an Individual Laboratory Profile (CASPER Report 0155D) dated 10-27-2020, online access to proficiency testing (PT) results provided 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 2 -- American Proficiency Institute (API),verified by telephone on 12-01-2020, the laboratory failed to successfully participate in an approved PT program for the specialty of immunohematology in the third testing event of 2019 and the first testing event of 2020. Refer to D 2163. . D2153 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(a) Failure to attain a score of at least 100 percent of acceptable responses for each analyte or test in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: . Based on review of an Individual Laboratory Profile dated 10-27-2020, confirmed by API PT results, the laboratory failed to achieve acceptable performance in ABO Group and D (Rho) testing in 2019 and 2020 in the specialty of immunohematology. Findings: 1. Review of API testing records showed the following overall scores for the third testing event of 2019 and the first testing event of 2020: Testing event: 2019 3rd Analyte: D (Rho) Sample Reported Expected Score RED-11 Rh neg Rh neg Acceptable RED-12 Rh pos Rh pos Acceptable RED-13 Rh neg Rh neg Acceptable RED-14 Rh pos Rh pos Acceptable RED-15 Rh neg Rh pos Unacceptable Testing event: 2020 1st Analyte: ABO Group Sample Reported Expected Score RED-01 Grp AB Grp AB Acceptable RED-02 Grp B Grp B Acceptable RED-03 Grp A Grp A Acceptable RED-04 Grp AB Grp O Unacceptable RED-05 Grp B Grp B Acceptable Analyte: D (Rho) Sample Reported Expected Score RED-01 Rh neg Rh neg Acceptable RED-02 Rh pos Rh pos Acceptable RED-03 Rh neg Rh neg Acceptable RED-04 Rh pos Rh neg Unacceptable RED-05 Rh pos Rh pos Acceptable 2. API PT results were confirmed with API tech support via telephone on 12-01-2020. . D2163 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(g) Failure to achieve an overall testing event score of satisfactory for 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 an Individual Laboratory Profile dated 10-27-2020, confirmed by API PT results, the laboratory failed to achieve satisfactory performance for two consecutive testing events in 2019 and 2020 in the specialty of immunohematology. Findings: 1. Review of the Individual Laboratory Profile report showed the following overall scores for the third testing event of 2019 and the first testing event of 2020: Specialty: Immunohematology Testing Event 2019 3rd ABO Group 100% D (Rho) Type 80% Overall score: 90% (Unsatisfactory) Specialty: Immunohematology Testing Event 2020 1st ABO Group 80% D (Rho) Type 80% Overall score: 80% (Unsatisfactory) -- 2 of 2 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: . Based on review of competency assessment documentation and staff interview, the laboratory failed to establish and follow policies and procedures to assess competency for the laboratory technical consultant, clinical consultant, technical supervisor and general supervisor. Findings: 1. Competency assessment materials for consultants and supervisory personnel were requested. None were available or could be offered. The CMS form 209 for the facility lists, separate from the laboratory director, a clinical consultant, two technical supervisors, a technical consultant and two general supervisors. 2. In an interview at the site on 04-16-2019, technical supervisor 2 (CMS form 209) stated she was unaware of the requirement for documented competency assessment for consultants and supervisory personnel. . D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: . Based on review of laboratory procedure for coagulation testing using the ACL Elite 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 -- Pro analyzer, laboratory study testing records for 2019 and staff interview, the laboratory failed to follow its own procedure for establishment of a patient normal mean for prothrombin time (PT) prior to introducing Hemosil Recombiplastin lot NO789332. Findings: 1. Laboratory procedure states: Reference Intervals (Patient Normal Range) will be established whenever there is a change in the following: - Instrumentation -Lot numbers of reagents -Sample collection procedures -At least once a year 2. Laboratory procedure further states: Donors will be screened carefully utilizing the following guidelines: 1. Healthy with no known pathological conditions. 2. Not on medication, including oral contraceptives, estrogen therapy drugs, thyroid meds, aspirin or vitamin K. 3. Exclude donors that drink alcohol or have a diet that includes greens. 4. Will span the adult age range. 5. The study will include a fairly even number of males and females. 6. A minimum of 20 donors should be used. (Freestone Medical Center Policy and Procedure, policy number C-005, Patient Normal Range Determination, effective January 1 2017-excerpts) 3. Study materials were reviewed and found to include instrument printouts identified by patient name; some by last and first names, some by last name only, some by specimen ID only. Also included were 25 questionnaires identified by patient name and speciment ID with answer options for: -Age -Sex -Aspirin Y/N -Alcohol Y/N -Oral Contraceptives Y/N -Vitamin K Y/N -Greens in diet Y/N -Thyroid meds Y/N Space for patient signature 4. The questionnaires were found to be in various stages of completion as follows: Filled out and signed, with all disqualifiers marked "N"--5 Filled out and signed, with some disqualifiers marked "Y"--6 Filled out, not signed--4 Not filled out, not signed--9 No questionnaire--1 5. In an interview at the site on 04-16-2019, the laboratory technical consultant (CMS form 209) was unable to verify whether samples from some or all of the patients reviewed were used in the study. . D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of laboratory personnel competency verification documents for 2017, 2018 and 2019, confirmed by staff interview, laboratory technical supervisor 2 (CMS form 209) failed to evaluate the competency of testing personnel as required. Findings: 1. Laboratory personnel competency verification documents were reviewed. For 2017, verification documentation was found for 4 testing personnel; materials for testing persons 6, 7 and 9 included an 8-page form covering lab duties evaluated using the required methods as applicable, signed by the technical supervisor at that time, who has since left the facility. Also included in this number was general supervisor 2, also listed as a testing person. 2. For 2018, no competency verification documentation was found or could be offered for any laboratory testing personnel. 3. For 2019, forms identical to those used in 2017 were found for testing persons 2, 3, 4 and 6. None of the forms were signed by the laboratory director or technical supervisor, and most bore initials indicating that the testing personnel had been evaluated by each other. -- 2 of 3 -- This was confirmed in an interview with technical supervisor 2 at the site on 04-16- 2019. 4. No competency verification materials were found or could be offered for the remaining 7 testing personnel listed on CMS form 209. -- 3 of 3 --