Community Hospital Association Inc Dba

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records from 2025 for Triiodothyronine (T3) testing and interview with the General Supervisor (GS-1), the laboratory failed to follow established policies to document

Summary Statement of Deficiencies D2089 ROUTINE CHEMISTRY CFR(s): 493.841(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3)The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on a review of Proficiency Testing (PT) records from 2022 and interview with the general supervisor (GS-1), the laboratory failed to participate in the second testing event of 2022 for Arterial Blood Gases (ABG) resulting in unsatisfactory performance and a score of 0% for the testing event, and the laboratory failed to suspend patient testing during that time period. Findings include: 1. The laboratory performs ABG testing on patients under the subspecialty of Routine Chemistry. 2. The laboratory reported a PT sample issue to the PT provider, College of American Pathologists (CAP), for ABG samples received by the laboratory for the second testing event of 2022. 3. The laboratory failed to participate in the second testing event of 2022 for ABG testing, resulting in unsatisfactory performance and a score of 0% for that testing event. 4. The laboratory failed to suspend patient testing during the time frame allotted for testing and reporting proficiency testing results during the second testing event of 2022 for ABG testing. 5. The GS-1 interviewed on 1/18/24 at 11:30 AM confirmed the laboratory failed to participate in the second testing event of 2022 for Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- ABG testing resulting in unsatisfactory performance and a score of 0 for that testing event, and failed to suspend patient testing during that timeframe. 6. The laboratory's annual test volume under the specialty of Chemistry is 230,976. 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 review of the proficiency testing (PT) scores from 2023, review of the performance review documented by the laboratory, and interview with the general supervisor (GS-1), the laboratory failed to undertake appropriate training and employ the technical assistance necessary to correct problems associated with the unsatisfactory results received for the regulated analyte, PO2. Findings include: 1. The laboratory performs Arterial Blood Gas (ABG) testing utilizing the Siemens RapidPoint 500 analyzer under the subspecialty of Routine Chemistry. 2. PT records provided by the College of American Pathologists (CAP) and reviewed during the survey show an unsatisfactory score of 60% for the regulated analyte, PO2, for the second ABG event of 2023. 3. No evidence was provided to indicate the laboratory had undertaken appropriate training and employ the technical assistance necessary to correct problems associated with the unsatisfactory results indicated above. 4. The GS- 1 interviewed on 1/18/24 at 12:15 PM acknowledged that the laboratory failed to undertake appropriate training and employ the technical assistance necessary to correct problems associated with the unsatisfactory results indicated above. 5. The laboratory's annual test volume under the specialty of Chemistry is 230,976. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on lack of analytic records for review and interview with the general supervisor (GS-1), (A) the laboratory failed to retain patient test records for hematology testing for at least two years; (B) failed to retain the manufacturer's package inserts for reagents, quality control (QC), and test kits used for Chemistry testing for at least two years. Findings include: A1. The laboratory performs Complete Blood Count (CBC) testing on the Sysmex XN-2000 analyzer under the specialty of Hematology with an approximate annual test volume of 77,033. A2. During the survey conducted on January 18, 2024, no documentation was presented for review to indicate the laboratory retained instrument printouts showing patient test results for at least two years from the Sysmex XN-2000 analyzer prior to 7/10/22. A3. The GS-1 interviewed -- 2 of 9 -- on 1/18/24 at 2:40 PM confirmed the laboratory failed to retain instrument printouts from the Sysmex XN-2000 analyzer showing patient test results for at least 2 years. B1. The laboratory utilizes the Abbott Architect ci4100 and the Medline HCG Combo Pregnancy kit to perform patient testing under the specialty of Chemistry, with a reported annual test volume of 230,976. B2. No documentation was presented for review to indicate the laboratory retained the manufacturer's assay information sheets for at least 2 years for each lot of QC material and test reagent material used on the Abbott Architect ci4100 chemistry analyzer. B3. No documentation was presented for review to indicate the laboratory retained the manufacturer's package inserts for at least 2 years for each lot number of the Medline hCG Combo Pregnancy test kits used by the laboratory during 2022, 2023, and 2024 through the date of the survey. B4. The GS-1 interviewed on 1/18/24 at 3:56 PM confirmed the laboratory failed to retain the manufacturer's assay information sheets and package inserts for at least 2 years for each lot of QC and test reagent material used on the analyzer and test kit indicated above. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on direct observation of collected specimens, review of establish policies and procedures for specimen collection and handling and interviews with the testing personnel (TP) and general supervisor (GS-1), the laboratory failed to follow established policies and procedures to ensure optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results as evidenced by: (A) the laboratory's failure to record the collection date on one of one specimen label and (B) the laboratory's failure to test a patient sample within the sample's stability time frame. Findings include: A1. The laboratory performs patient testing in the specialties of Microbiology, Diagnostic Immunology, Chemistry, Hematology and Immunohematology with a reported annual test volume of 314,052. A2. The laboratory's established 'Specimen Collection and Handling' procedure reviewed states: "All specimens must be labeled with patient name (first and last), patient's ID number, date and time of collection, and method of collection (clean-catch, cath, deep-suctioned, etc.)." A3. Direct observation of the specimen label for one out of one specimen's collected by the laboratory showed the laboratory failed to document the collection date on the specimen label (MR# 615386 collected on 1/18/24) to ensure acceptability of specimen integrity prior to testing. A4. The TP and GS-1 interviewed during the survey on 1/18/24 at 1:45 PM stated the collection date is not documented on the label of the specimens collected by the laboratory. B1. The laboratory utilizes the Siemens RapidPoint 500 analyzer to perform Arterial Blood Gas (ABG) testing on patient samples under the subspecialty of Routine Chemistry. B2. The RapidPoint 500 policy and procedure reviewed during the survey states: "Samples in plastic syringes or capillaries should be kept at room temp, as long as analysis is performed within 30 minutes." B3. One out of two ABG patient reports reviewed during the survey (MR#1058666 from 3/12/22 collected at 1: 30 PM; resulted at 2:10 PM) showed the ABG result was tested outside of the established 30 minute time frame. B4. The GS-1 interviewed on 1/18/24 at 4:00 PM -- 3 of 9 -- confirmed the laboratory failed to ensure optimum integrity of a patient's specimen from the time of collection of the specimen through completion of testing and reporting of results, as evidenced by testing the patient specimen indicated above which was outside of the sample stability time frame established in the laboratory's policy and procedure. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on lack of employee competency policies and procedures for review and interview with the general supervisor (GS-1), the laboratory failed to establish policies and procedures to assess the competency of the Technical Consultant (TC), Technical Supervisor (TS) and General Supervisor (GS). Findings include: 1. The CMS-209, Laboratory Personnel form submitted for review during the survey conducted on 1/18 /24 listed four TC's, three TS's and two GS's who provide technical oversight for testing performed in the specialties of Microbiology, Diagnostic Immunology, Chemistry, Hematology and Immunohematology. 2. No documentation was presented for review to indicate the laboratory established policies and procedures to assess the competency of the TC's, TS's and GS's. 3. The GS-1 interviewed on 1/18/24 at 1:00 PM confirmed the laboratory failed to have policies and procedures established to assess the competency of the laboratory personnel indicated above. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of Quality Assessment (QA) policies and procedures, analytic test records, and interview with the general supervisor(GS-1), the laboratory's established QA policies and procedures failed to monitor, assess and, when indicated, correct problems identified in the general laboratory systems specified in 493.1231 through 493.1236. Findings include: 1. No QA documentation was presented for review during the survey to indicate the laboratory monitored, assessed and, when indicated, corrected problems identified with Proficiency Testing (PT). See D2089 and D2094 for findings. 2. No QA documentation was presented for review during the survey to indicate the laboratory monitored, assessed and, when indicated, corrected problems identified with a lack of personnel competency assessments. See D5209 for findings. 3. No QA documentation was presented for review during the survey to indicate the laboratory monitored, assessed and, when indicated, corrected problems identified with the lack of record retention under the specialities of Hematology and Chemistry. See D3031 for findings. 4. No QA documentation was presented for review during the survey to indicate the laboratory monitored, assessed and, when indicated, corrected -- 4 of 9 -- problems identified with sample labeling and sample integrity. See D5203 for findings. 5. The GS-1 interviewed on 1/19/24 at 11:45 AM confirmed the laboratory's QA processes were not effective at monitoring, identifying and correcting problems associated with the general laboratory systems. 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 lack of performance specification documentation for the Medline HCG Combo Pregnancy test kit and interview with the general supervisor (GS-1), the laboratory failed to verify the manufacturer's performance specifications for the serum HCG test system, including accuracy, precision, reportable range and reference range, prior to reporting patient test results. Findings include: 1. The laboratory uses the Medline HCG Combo Pregnancy kit to perform HCG testing on serum samples under the subspecialty of Endocrinology. Patient testing began in February 2020. 2. The laboratory failed to demonstrate that it can obtain performance specifications for the serum HCG test system comparable to those established by the manufacturer prior to reporting patient test results, including accuracy, precision, reportable range and reference range. 3. The GS-1 interviewed on 1/18/24 at 4:30 PM confirmed that no evidence was provided for review to indicate the laboratory verified the manufacturer's performance specifications for the serum HCG test system prior to testing patients. 4. The laboratory performs approximately 188 serum HCG tests annually. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on review of hematology test records and interview with the general supervisor (GS-1) the laboratory failed to document the background count performed each day prior to patient testing on the hematology analyzer. Findings include: 1. The laboratory performs patient testing on the Sysmex XN-2000 hematology analyzer, with an approximate annual test volume of 77,033. 2. No documentation was presented for review to indicate the laboratory performed and retained background count doucumention prior to 7/10/22. 3. The GS-1 interviewed on 1/18/24 at 2:40 PM confirmed that the laboratory failed to have documention of the background count performed each day prior to testing patients prior to 7/10/22. -- 5 of 9 -- D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on lack of Quality Control (QC) documentation and interview with the general supervisor (GS-1), (A) the laboratory failed to perform and document control procedures using the frequency indicated in the laboratory's Individualized Quality Control Plan (IQCP) for testing performed in the subspecialty of Bacteriology; and (B) the laboratory's established IQCP for 3 out of 3 test systems failed to include the Quality Assessment (QA) component. Findings include: A1. The laboratory performs Clostridium difficile (C. Diff) testing on patient specimens using the GeneXpert Cepheid analyzer under the subspecialty of Bacteriology. A2. The laboratory's Individualized Quality Control Plan (IQCP) for the C. Diff test system reviewed during the survey on 1/19/24 stated, "External QC (1 positive and 1 negative) performed per lot/shipment; External QC (1 positive and 1 negative) performed monthly. A3. The laboratory failed to perform and document external QC using positive and negative control materials in February 2022 and April 2022, for C. Diff testing performed on the Cepheid analyzer. QC records reviewed from that timeframe indicated the laboratory performed positive and negative controls on 01/24/22, 3/17 /22, 3/25/22 and 5/26/22. A4. The number of patients affected could not be determined at the time of the survey. The laboratory performs 5,181 tests annually under the specialty of Microbiology. A5. The GS-1 interviewed on 1/19/24 at 9:35 AM confirmed the laboratory failed to perform and document positive and negative quality control for C. Diff testing in February and April 2022. B1. The laboratory's established IQCP's reviewed during the survey for 3 out of 3 test systems failed to include the QA component. The test systems include: Medline Serum hCG test kit, Medtox Drug Screen analyzer, and the GeneXpert Cepheid analyzer which tests for the C. Diff toxin, CT/NG, MRSA, and Strep A. B2. The GS-1 interviewed on 1/19/24 at 9:30 AM confirmed the IQCP's for the test systems above failed to include the QA component. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on review of Quality Assessment (QA) policies and procedures, analytic test records, and interview with the general supervisor (GS-1), the laboratory's established -- 6 of 9 -- QA policies and procedures failed to monitor, assess and, when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. Findings include: 1. No QA documentation was presented for review during the survey to indicate the laboratory monitored, assessed and, when indicated, corrected problems identified with a lack of quality control (QC) records for testing performed in the subspecialty of Bacteriology. See D5545 for findings. 2. No QA documentation was presented for review during the survey to indicate the laboratory monitored, assessed and, when indicated, corrected problems identified with a lack of background count records for testing performed in the specialty of Hematology. See D5431 for findings. 3. No QA documentation was presented for review during the survey to indicate the laboratory monitored, assessed and, when indicated, corrected problems identified with the lack of performance specification documention for testing performed under the subspecialty of Endocrinology. See D5421 for findings. 4. The GS-1 interviewed on 1/19/24 at 11:45 AM confirmed the laboratory's QA processes were not effective at monitoring, identifying and correcting problems associated with the analytic systems. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on review of laboratory policies and interview with the general supervisor (GS- 1), the laboratory failed to follow their established policy to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. Findings include: 1. The laboratory performs patient testing on the following interfaced analyzers: Siemens RAPIDPoint 500, Werfen ACL Top 350, Arkray AU 4050, Sysmex XN-2000, Abbott Architect ci4100 and MEDTOXScan analyzers. Test results and patient-specific data are electronically interfaced from the analyzers to CPSI Evident Thrive, the Laboratory Information System (LIS). 2. The laboratory's Quality Assessment policy states: "Accuracy of interfaced laboratory results is verified periodically by comparing the analyzer printout with results printed from the LIS." 3. The laboratory failed to produce documentation from 2022, 2023 and 2024 (through the date of the survey) to demonstrate the laboratory followed the policy referenced above to ensure patient test results and patient-specific data are accurately and reliably electronically interfaced from the the laboratory analyzers indicated above to the LIS. 4. The GS-1 interviewed on 1/19/24 at 11:30 AM confirmed the laboratory failed to follow their established policy to verify the accuracy of patient test results and patient-specific data which are electronically interfaced from the laboratory analyzers indicated above to the LIS. 5. The laboratory performs approximately 308,009 tests annually under the specialties of Chemistry and Hematology. -- 7 of 9 -- D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on lack of performance evaluation documentation and interview with the general supervisor (GS-1), the technical consultant failed to evaluate and document the performance of one out of four testing personnel, at least semiannually during the first year the individual tested patient specimens. Findings include: 1. No semiannual competency evaluation documentation was presented for review for one out of four testing personnel (TP-8) who was hired in February 2022. 2. The GS-1 interviewed on 1/18/24 at 1:00 PM confirmed the technical consultant failed to perform and document a semiannual competency evaluation for the testing personnel indicated above. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on lack of performance evaluation documentation and interview with the general supervisor (GS-1), the technical consultant failed to evaluate and document the performance of one out of four testing personnel, at least semiannually during the first year the individual tested patient specimens. Findings include: 1. No semiannual competency evaluation documentation was presented for review for one out of four testing personnel (TP-8) who was hired in February 2022. 2. The GS-1 interviewed on 1/18/24 at 1:00 PM confirmed the technical consultant failed to perform and document a semiannual competency evaluation for the testing personnel indicated above 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 annual competency evaluation documentation from 2023 for one out of one testing personnel (TP-11) and interview with the general supervisor (GS-1), the technical supervisor failed to perform the evaluation of competency for testing -- 8 of 9 -- performed in the specialties of Immunohematology and Microbiology. Findings include: 1. The annual competency evaluation reviewed during the survey for TP-11 from 2023 revealed that TP-1 evaluated the competency for high complexity testing performed in the specialties of Immunohematology and Microbiology. 2. TP-1 was not listed as a Technical Supervisor (TS) on the CMS-209, Laboratory Personnel Form submitted by the laboratory during the survey. 3. The GS-1 interviewed on 1/18 /24 at 1:30 PM confirmed that TP-1 performed the competency evaluation for TP-11, and TP-1 is not listed as a TS. 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 lack of performance evaluation documentation and interview with the general supervisor (GS-1), the technical supervisor failed to evaluate and document the performance of one out of four testing personnel, at least semiannually during the first year the individual tested patient specimens. Findings include: 1. No semiannual competency evaluation documentation was presented for review for one out of four testing personnel (TP-8) who was hired in February 2022. 2. The GS-1 interviewed on 1/18/24 at 1:00 PM confirmed the technical superviosr failed to perform and document a semiannual competency evaluation for the testing personnel indicated above. 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 lack of performance evaluation documentation and interview with the general supervisor (GS-1), the technical supervisor (TS) failed to evaluate and document the performance of individuals responsible for high complexity testing at least annually. Findings include: 1. No documentation of an annual competency evaluation from 2022 was presented for review for four out of five testing personnel (TP). 2. No documentation of an annual competency evaluation from 2023 was presented for review for five out of nine testing personnel. 3. The GS-1 interviewed on 1/18/24 at 1:00 PM confirmed the TS failed to evaluate and document the performance of the testing personnel indicated above at least annually during 2022 and 2023. -- 9 of 9 --

Summary Statement of Deficiencies D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on lack of calibration verification documentation for the Abbott Architect chemistry analyzer and interview with the facility personnel, the laboratory failed to perform and document calibration verification procedures as required during 2019 and 2020. Findings include: 1. The laboratory began using two Abbott Architect chemistry analyzers (serial# C402511 and #C402512) in January 2019 to conduct patient testing in the specialty of Routine Chemistry, with an approximate annual test volume of Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- 277,364. 2. No documentation was presented for review to indicate the laboratory performed calibration verification procedures at least once every six months from January 2019 through the date of the survey conducted on July 28, 2021, including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results. 3. The facility personnel confirmed that the laboratory failed to perform calibration verification procedures every six months as required for testing performed on the analyzers indicated above. D5543 HEMATOLOGY CFR(s): 493.1269(a)(d) (a) For manual cell counts performed using a hemocytometer-- (a)(1) One control material must be tested each 8 hours of operation; and (a)(2) Patient specimens and control materials must be tested in duplicate. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of patient test records and interview with the testing personnel it was determined that the laboratory failed to document duplicate cell counts using a hemacytometer. Findings include: 1. The laboratory performs body fluid counts using a hemacytometer. It is the practice of the laboratory to perform each patient cell count and each control cell count in duplicate. 2. No documentation was presented for review to indicate the patient specimens and quality control material are counted in duplicate by testing personnel. 3. The laboratory performs approximately 20 body fluid cell counts annually. 4. The testing personnel confirmed that patient specimens and control material are tested in duplicate but the laboratory failed to document both counts. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on review of patient test worksheets, review of patient test reports in the Laboratory Information System (LIS) and interview with the facility personnel, the laboratory failed to include the gram stain result for testing performed in the specialty of Microbiology. Findings include: 1. The laboratory performs blood culture testing, including a gram stain on any blood culture bottle flagged as positive. It is the practice of the laboratory to utilize a 'Blood Culture Card' (worksheet) to record the gram stain test result. The test information is then manually transcribed from the worksheet to the LIS. 2. Review of the blood culture test report in the LIS for patient# 1022815 performed on 04/16/2021 revealed the gram stain test result was not entered into the LIS. 3. Review of the Blood Culture Card for the patient referenced above indicated the Gram Stain test result as "Gram Positive Cocci (GPC)", performed on 04/16/21. 4. -- 2 of 3 -- The facility personnel confirmed that the testing personnel failed to document the gram stain test result in the LIS for the patient indicated above. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on lack of Quality Assessment (QA) documentation, review of patient test reports and interview with the General Supervisor, the laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems. Findings include: 1. It is the practice of the laboratory to electronically transmit patient test results from the instruments to the Laboratory Information System (LIS) for the following test systems: Abbott Architect chemistry analyzers, Sysmex XN-2000 hematology analyzers, Medtox toxicology analyzer, Stago Satellite coagulation analyzers, Rapid Point 500 blood gas analyzer, Aution Hybrid Arkray Urine analyzer and Cepheid Microbiology analyzer. 2. It is the practice of the laboratory to manually input test results into the LIS for the following tests: Serum hCG, Bactec, Blood bank, manual cell counts, and urine microscopic testing. 3. No documentation was presented for review during the survey conducted on 07/28/2021 to indicate the laboratory established a policy or procedure regarding the laboratory's audit process for checking the accuracy and timeliness of electronically transmitted test results and manually entered test results into the LIS. 4. The general supervisor indicated that the laboratory performs an audit to check the accuracy and timeliness of test results interfaced or manually entered into the LIS as part of the laboratory's QA processes but failed to establish a policy or procedure describing the audit process. 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 personnel competency records and interview with the facility personnel, the laboratory failed to document the competency evaluation of five testing personnel in 2020. Findings include: 1. No 2020 annual competency evaluation was presented for review for five out of five testing personnel. 2. The facility personnel confirmed the testing personnel indicated above were missing annual competency evaluations for 2020. -- 3 of 3 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of Proficiency Testing (PT) reports for 2019 sent to the State Agency by the PT provider, the laboratory failed to successfully participate in a PT program for the regulated analytes, (A) CK- Iso, under the sub-specialty of Routine Chemistry and (B) Theophylline, under the sub-specialty of Toxicology. Findings include: A1. The laboratory's PT performance was unsatisfactory for the 1st event of 2019 for the regulated analyte, CK- Iso, with a score of 0%. A2. The laboratory's PT performance was unsatisfactory for the 2nd event of 2019 for the regulated analyte, CK - Iso, with a score of 0%. B1. The laboratory's PT performance was unsatisfactory for the 1st event of 2019 for the regulated analyte, Theophylline, with a score of 0%. B2. 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 3 -- laboratory's PT performance was unsatisfactory for the 2nd event of 2019 for the regulated analyte, Theophylline, with a score of 0%. 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 the information furnished to the State Agency by the Proficiency Testing (PT) provider, it could not be determined if the laboratory underwent training and technical assistance and if remedial action was taken to correct the PT failure for the analyte, CK-Iso, for the 1st and 2nd testing event of 2019. See D2016 for findings. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on information furnished to the State Agency by the Proficiency Testing (PT) provider, the laboratory failed to achieve satisfactory performance for the regulated analyte, CK-Iso, for the 1st and 2nd event of 2019 resulting in unsuccessful PT performance. See D2016 for findings. D2116 TOXICOLOGY CFR(s): 493.845(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 information the Proficiency Testing (PT) provider furnishes to the State Agency for 2019, it could not be determined if the laboratory underwent training and technical assistance and if remedial action was taken to correct the PT failures for the analyte, Theophylline. See D2016 for findings. -- 2 of 3 -- D2118 TOXICOLOGY CFR(s): 493.845(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on information furnished to the State Agency by the Proficiency Testing (PT) provider, the laboratory failed to achieve satisfactory performance for the regulated analyte, Theophylline, for the 1st and 2nd events of 2019 resulting in unsuccessful PT performance. See D2016 for findings. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: The Condition of Laboratory Director was found to be not met based on the failure to provide overall management and direction as evidenced by D6016 - ensuring that the proficiency testing samples are tested as required under Subpart H. 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 information furnished to the State Agency by the Proficiency Testing (PT) provider, it was determined that the laboratory director failed to ensure that PT samples are tested in a manner that results in successful participation in a proficiency testing program for the regulated analytes, CK-Iso and Theophylline. See D2016 and D6000 for findings. -- 3 of 3 --

Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on lack of quality control (QC) documentation and interview with the facility personnel, the laboratory failed to perform and document control procedures using the number and frequency as required for the following test systems: (A) Gene Expert Cepheid, (B) Cardinal Serum hCG, (C) Acceava Mono test and (D) Medtox Drug Screen. Findings include: A1. The laboratory performs the following tests on the Gene Expert Cepheid test system under the specialty of Microbiology: C. Diff, MRSA, and CT/NG (Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG). On the date of the survey, December 28, 2018, the laboratory's quality control procedure consisted of performing two levels of external control material, once per month, with each new lot and/or each shipment. A2. No QC documentation was provided for review during the survey to indicate the laboratory performed two levels of control material of different concentrations, each day of patient testing as required since January 1, 2016. B1. The laboratory performs serum hCG testing using the Cardinal Serum pregnancy test kit under the sub-specialty of Endocrinology. On the date of the survey, December 28, 2018, the laboratory's quality control procedure consisted of performing two levels of external control material, with each new QC shipment or each new lot of test kit. B2. No QC documentation was provided for review during the survey to indicate 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 6 -- laboratory performed two levels of control material of different concentrations, each day of patient testing as required since January 1, 2016. C1. The laboratory performs Mono testing using the Acceava Mono test kit under the sub-specialty of General Immunology. On the date of the survey, December 28, 2018, the laboratory's quality control procedure consisted of performing two levels of external control material, monthly and/or with each new shipment or each new lot of test kit. C2. No QC documentation was provided for review during the survey to indicate the laboratory performed two levels of control material of different concentrations, each day of patient testing as required since January 1, 2016. D1. The laboratory performs urine drug screen testing using the Medtox test system under the sub-specialty of Toxicology. On the date of the survey, December 28, 2018, the laboratory's quality control procedure consisted of performing two levels of external control material, weekly and/or with each new shipment or each new lot of test kit. D2. No QC documentation was provided for review during the survey to indicate the laboratory performed two levels of control material of different concentrations, each day of patient testing as required since January 1, 2016. 3. During the survey, review of QC records from January 1, 2016 through December 28, 2018 indicated the laboratory performed and documented QC with the number and frequency as described in their policy above for each test system, and as of January 1, 2016, the laboratory had not implemented an Individualized Quality Control Plan (IQCP) for any test systems listed above. 4. The facility personnel confirmed that the laboratory did not perform and document controls as required since January 1, 2016 and confirmed that the laboratory had not implemented an Individualized Quality Control Plan (IQCP) for the test systems referenced above. 5. The number of patients tested on each test system during the time period indicated above could not be determined at the time of the survey. 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 lack of Quality Control (QC) documentation, review of the laboratory's QC procedures and interview with the facility personnel, the laboratory failed to check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response. Findings include: 1. The laboratory performs patient testing in the sub-specialty of Bacteriology, with an annual approximate test volume of 1,890. 2. The laboratory utilizes BD Bactec Lytic /10 Anaerobic and BD Bactec Aerobic media for blood culture testing performed on the Bactec FX40 test system. 3. No QC documentation was presented for review on the day of the survey, December 28, 2018, to indicate the laboratory checked each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms prior to using the media for patient testing. 4. The facility personnel confirmed that the laboratory was not checking each batch of media used in the Bactec test system for its ability to support and/or inhibit growth. -- 2 of 6 -- D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of blood bank temperature documentation and interview with the facility personnel, the laboratory failed to perform and document inspection of the audible alarm system used to monitor proper blood and blood product storage. Findings include: 1. The laboratory performs patient testing in the specialty of Immunohematology with an approximate annual test volume of 786. 2. It is the policy of the laboratory to perform quarterly audible alarm checks on the refrigerator and freezer used to store blood and blood products. 3. No documentation was presented for review during 2018 to indicate the alarm checks were performed and documented on a quarterly basis. The laboratory's records indicated an alarm check was documented on 12/12/17, 7/13/18 and 12/26/18. 4. The facility personnel confirmed the laboratory failed to perform and document the audible alarm check during 2 quarters of 2018. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on lack of test comparison results and interview with the facility personnel, the laboratory failed to have a system in place that twice a year evaluates and defines the relationship of test results using two separate Bactec FX40 instruments. Findings include: 1. The laboratory utilizes two separate Bactec FX40 instruments to perform blood culture testing on patient specimens. The two instruments are used interchangeably. 2. No documentation was presented for review to indicate the laboratory had a system in place to evaluate and define the relationship between the test results from each Bactec FX40 instrument 3. The facility personnel confirmed that the laboratory did not document a test result comparison between the two Bactec FX40 instruments. D5781

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of Proficiency Testing (PT) reports for 2017 sent to the State Agency by the PT provider, the laboratory failed to successfully participate in a PT program for the regulated analyte, PO2 Blood Gas, under the specialty of Chemistry. Findings include: 1. The laboratory's PT performance was unsatisfactory for the 1st event of 2017 for the regulated analyte, PO2 Blood Gas, with a score of 60%. 2. The laboratory's PT performance was unsatisfactory for the 3rd event of 2017 for the regulated analyte, PO2 Blood Gas, with a score of 60%. D2094 ROUTINE CHEMISTRY 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 -- 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 the information furnished to the State Agency by the Proficiency Testing (PT) provider, it could not be determined if the laboratory underwent training and technical assistance and if remedial action was taken to correct the PT failure for the analyte, PO2 Blood Gas, for the 1st and 3rd testing event of 2017. See D2016 for findings. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on information furnished to the State Agency by the Proficiency Testing (PT) provider, the laboratory failed to achieve satisfactory performance for the regulated analyte, PO2 Blood Gas, for the 1st and 3rd event of 2017 resulting in unsuccessful PT performance. See D2016 for findings. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: The Condition of Laboratory Director was found to be not met based on the failure to provide overall management and direction as evidenced by D6016 - ensuring that the proficiency testing samples are tested as required under Subpart H. 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 -- 2 of 3 -- required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on information furnished to the State Agency by the Proficiency Testing (PT) provider, it was determined that the laboratory director failed to ensure that the PT samples are tested in a manner that results in successful participation in a proficiency testing program for the regulated analyte, PO2 Blood Gas. See D2016 for findings. -- 3 of 3 --