South Lincoln Hospital District

Summary Statement of Deficiencies D0000 The following deficiencies were 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 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] 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 Centers for Medicare and Medicaid Services Casper Report 155, review of the American Proficiency Institute evaluation reports, and staff 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 -- interview, the laboratory failed to achieve a satisfactory performance score for the analyte of creatine kinase on 2 consecutive testing events (2025 event #2, 2025 event #3). Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services (CMS) Casper Report 155, review of the API (American Proficiency Institute) evaluation reports, and staff interview, the laboratory failed to achieve a satisfactory performance score for creatine kinase on two consecutive testing events (2025 event #2, 2025 event #3). The findings were: 1. Review of the CMS 155 report showed the laboratory failed to successfully obtain a passing score for the analyte of creatine kinase on the following API proficiency testing events: a. 2025 event #2 showed the laboratory scored a 0%. b. 2025 event #3 showed the laboratory scored a 40%. 2. Review of the API proficiency testing evaluations confirmed the proficiency testing scores from the CMS Casper 155 were accurate. 3. Telephone interview with the laboratory manager on 11 /26/25 at 10:39 AM confirmed the laboratory had failed the proficiency testing events for creatine kinase. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The following deficiencies were 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 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] 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 Centers for Medicare and Medicaid Services Casper Report 155 and review of the American Proficiency Institute evaluation reports the laboratory Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- failed to achieve a satisfactory performance score for compatibility testing on 2 out of 3 testing events (2024 event #3, 2025 event #2). Refer to D2173. D2173 COMPATIBILITY TESTING CFR(s): 493.863(a) (a) Failure to attain an overall testing event score of at least 100 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services (CMS) Casper Report 155 and review of the API (American Proficiency Institute) evaluation reports, the laboratory failed to achieve a satisfactory performance score for compatibility testing on 2 out of 3 testing events. The findings were: 1. Review of the CMS Casper 155 report showed the laboratory failed to successfully obtain a passing score for compatibility testing on the following API proficiency testing events: a. 2024 event #3 showed the laboratory scored 0%. b. 2025 event #2 showed the laboratory scored an 80%. 2. Review of the API proficiency testing evaluations confirmed the laboratory had scored 0% for compatibility testing on the 2024 event #3 and the 2025 event #2 testing events. 3. Telephone interview with the laboratory manager on 10/28/25 at 12: 17 PM confirmed the laboratory had failed 2 out of 3 compatibility proficiency testing events. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The following deficiencies were 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 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] . 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 Centers for Medicare and Medicaid Services Casper Report 155 and review of the American Proficiency Institute evaluation reports the laboratory Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- failed to achieve a satisfactory performance score for the analyte of potassium on 2 consecutive testing events (2025 event #1, 2025 event #2). In addition, the laboratory failed to achieve a satisfactory performance score for the analyte of total protein on 2 out of 3 testing events (2024 event #3, 2025 event #2). Refer to D2096. . D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services (CMS) Casper Report 155, review of the API (American Proficiency Institute) evaluation reports, and staff interview, the laboratory failed to achieve a satisfactory performance score for potassium on two consecutive testing events (2025 event #1, 2025 event #2) and failed to achieve a satisfactory performance score for total protein on 2 out of 3 testing events (2024 event #3, 2025 event #2). The findings were: 1. Review of the CMS Casper 155 report showed the laboratory failed to successfully obtain a passing score for the analyte of potassium on the following API proficiency testing events: a. 2025 event #1 showed the laboratory scored a 40%. b.2025 event #2 showed the laboratory scored 0%. 2. Review of the CMS Casper 155 report showed the laboratory failed to successfully obtain a passing score for the analyte of total protein on the following API proficiency testing events: a. 2024 event #3 showed the laboratory scored a 20%. b. 2025 event #2 showed the laboratory scored 0%. 3. Review of the API proficiency testing evaluations confirmed the proficiency testing scores from the CMS Casper 155 report were accurate. 4. Telephone interview with the laboratory manager on 7/22/25 at 10:44 AM confirmed the laboratory had failed the proficiency testing events for potassium and total protein. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was completed on 6/17/24. Immediate Jeopardy existed for the following condition-level deficiencies: 42 C.F.R. 493.1100 Condition: Facility Administration 42 C.F.R. 493.1217 Condition: Immunohematology D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on observation, staff interview, and policy and procedure review, the laboratory failed to ensure appropriate equipment was available (D3007) to ensure safe and timely thawing of fresh frozen plasma (FFP) for patient use in the event of an emergency in 1 of 1 blood bank. This failure resulted in a determination of immediate jeopardy. D3007 FACILITIES CFR(s): 493.1101(b) The laboratory must have appropriate and sufficient equipment, instruments, reagents, materials, and supplies for the type and volume of testing it performs. 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 -- This STANDARD is not met as evidenced by: Based on observation, staff interview, and policy and procedure review, the laboratory failed to ensure appropriate equipment was available to ensure safe and timely thawing of fresh frozen plasma (FFP) for patient use in the event of an emergency in 1 of 1 blood bank. This failure resulted in a determination of immediate jeopardy. The findings were: 1. Observation on 6/12/24 at 8:30 AM and again on 6/13/24 at 2:20 PM showed 3 units of fresh frozen plasma were stored in the Jewett PRF series blood bank freezer. 2. Interview with the technical supervisor (TS) on 6/12/24 at 8:30 AM revealed the hospital's physicians requested FFP be available in the event of an emergency; however, the laboratory did not have the appropriate equipment to ensure safe and timely thawing of the FFP. In an additional interview with the TS on 6/13/24 at 10:13 AM revealed she would not feel comfortable releasing the FFP for patient use and would contact the laboratory's contracted blood and blood product supplier or surrounding hospitals to obtain the blood product. There was no evidence the laboratory had developed an alternative policy and procedure. 3. Review of the "Blood Bank General" policy and procedure, approved on 10/2/23, showed "2. The following blood products are routinely available...Fresh Frozen Plasma (5) 3. All other blood products and blood groups and types are not routinely stocked. The Blood Bank department can obtain these products from American Red Cross in SLC through their online portal. There may be a significant delay in obtaining these products." 4. Review of the "ER Department Clinical Protocol/Procedure Rapid Transfusion Protocol" policy, approved on 10/2/23, showed after the provider had ordered the rapid transfusion protocol the lab would release packed red blood cells as per protocol and immediately begin to thaw two units of FFP. Once the FFP was thawed nursing staff would immediately begin to transfuse the blood product. D5026 IMMUNOHEMATOLOGY CFR(s): 493.1217 If the laboratory provides services in the specialty of Immunohematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1271, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on observation, review of immunohematology patient records, the blood and blood product storage unit temperature logs, lack of documentation, staff interview, and policy and procedure review, the laboratory failed to ensure a system was in place to monitor proper blood and blood product storage temperatures over a 24-hour period for 6 of 20 months reviewed from October 2022 through June 2024 (October 2023, February 2024, March 2024, April 2024, May 2024, June 2024). In addition, the laboratory failed to ensure the audible alarm was inspected and functioning from October 2022 through June 2024 (D5555) for 3 consecutive survey cycles 9/11/20, 5 /25/22, and 6/17/24. This failure resulted in a determination of immediate jeopardy. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the -- 2 of 9 -- overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of the CMS (Centers for Medicare and Medicaid Services 209 form, review of personnel records, lack of documentation, staff interview, and policy and procedure review, the technical consultant failed to complete an annual competency assessment (D5209) for two consecutive survey cycles conducted on 5/25/22 and 6/17 /24. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the CMS (Centers for Medicare and Medicaid Services) 209 Laboratory Personnel Report, lack of documentation, review of policy and procedure, and staff interview, the technical supervisor failed to complete an annual competency assessment for 2 of 2 respiratory therapists for 1 of 2 years reviewed (2023). The findings were: 1. Review of the personnel files for respiratory therapist #1 and of respiratory therapist #2 showed no evidence an annual competency assessment had been completed in 2023. 2. Interview with respiratory therapist #1 on 6/13/24 at 11:30 AM revealed he thought a competency assessment had been completed in 2023; however, he was unable to locate the document. 3. Interview with the technical supervisor on 6/13/24 at 2:21 PM revealed she was unaware she was responsible for completing the competency assessments on the respiratory therapists. 4. Review of the 10/13/23 Employee Competency policy and procedure showed competency assessment should be performed upon initial hire, at 6 months, and then annually. Further review showed "...The Technical Supervisor is responsible for: (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 IS A REPEAT DEFICIENCY, last cited on 5/25/22. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of proficiency testing records, lack of documentation, staff interview, and review of policy and procedure, the laboratory failed to review proficiency test results that received an artificial score of 100% due to lack of peer group consensus for 2 of 26 American Proficiency Institute (API) proficiency testing events reviewed -- 3 of 9 -- from June 2022 through May 2024. The findings were: 1. Review of the 2023 Immunology/Immunohematology Event #3 comparative evaluation showed the laboratory received an artificial score of 100% for the blood bank compatibility challenge due to lack of peer consensus. There was no documentation the laboratory had performed a self-evaluation. 2. Review of the 2024 Chemistry Core Event #1 comparative evaluation showed the laboratory received an artificial score of 100% for the analyte of total bilirubin due to an increased variance of results. There was no documentation the laboratory had performed a self-evaluation. 3. Interview with the technical supervisor on 6/12/24 at 11:38 AM confirmed an investigation of the ungraded specimens had not been completed. 4. Review of the 7/31/22 API Proficiency Test Procedure showed "PT Survey Summary Report...5...Results that were not graded are compared to the results on the Summary Report. This investigation and comparison are signed by the director and filed with along with the Summary Report..." D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of patient test reports, the VITROS XT 7600 analyzer manufacturer's instructions for use, and staff interview, the laboratory failed to follow the manufacturer's instructions to include the prostate specific antigen (PSA) test assay method on 3 of 3 PSA patient test reports (patient #1, patient #2, patient #3) reviewed. The laboratory performed approximately 69 PSA tests per year. The findings were: 1. Review of the VITROS XT 7600 analyzer manufacturer's instructions stated "Different test methods cannot be used interchangeably. PSA results in a given patient sample determined with different tests and from different manufacturers can vary due to differences in test methods and reagent specificity. A change to a different method during serial monitoring of a patient should be accompanied by additional sequential testing to confirm baseline values. The results reported by the laboratory to the physician must include the identity of the PSA test used." Review of the VITROS XT 7600 new instrument verification study showed it was approved by the laboratory director on 8/8/22. The following concerns were identified: a. Review of the PSA test report for patient #1, dated 1/15/24; patient #2, dated 3/8/24; and patient # 3, dated 6/5 /24, showed "This Total PSA was obtained using a One Step Enzyme Immunoassay principle performed on the Vitros 5600 platform. 2. Interview on 6/12/24 at 3 PM with the director of quality and compliance confirmed the test report had not been updated to reflect the change in instrumentation. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. -- 4 of 9 -- (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of the laboratory's environmental records, review of manufacturer's instructions, and staff interview, the laboratory failed to monitor the room temperature and the ambient relative humidity in 2 of 2 reagent and storage areas (main lab, immunohematology room). The findings were: 1. Review of the laboratory's environmental records showed no evidence the room temperature and the ambient relative humidity were monitored and documented. 2. Review of the manufacturer's instructions for the Ortho Workstation, used for performing immunohematology assays, showed the room temperature must be maintained between 15 and 30 degrees Celsius and the relative humidity must be between 15% and 85% (non-condensing). 3. Review of the manufacturer's instructions for the VITROS XT 7600 chemistry analyzer showed the operating temperature must be maintained between 15 and 30 degrees Celsius and the ambient relative humidity must be between 15% and 75%. 4. Interview with the technical supervisor on 6/13/24 at 2:21 PM revealed the laboratory staff would check the temperature of the laboratory; however, nothing was documented. 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 new instrument and new test method verification study review, lack of documentation, staff interview, and policy and procedure review, the laboratory failed to confirm the reference values were appropriate for the patient population for 1 of 1 new instrument verification study reviewed (Vitros XT 7600). The laboratory performed approximately 32,127 patients tests annually using the Vitros XT 7600 analyzer. The findings were: 1. Review of the Vitros XT 7600 verification study showed the laboratory director approved the precision, accuracy, and analytical range studies on 8/8/22. There was no evidence the laboratory director had verified the reference intervals were appropriate for the laboratory's population. 2. Interview with the technical supervisor on 6/12/24 at 1:50 PM revealed she was unable to locate the documentation. 3. Review of the Quantitative Test Method Validation policy and procedure showed "...Reference Values...Reference values are evaluated with new analytes, new methodology, or new information from an instrument company..." 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 -- 5 of 9 -- 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 the Ortho Workstation for ID-MTS manufacturer's instructions, staff interview, and review of immunohematology quality control records, the laboratory failed to follow the manufacturer's instructions to perform day of use function checks on the Ortho Workstation for 4 of 19 months reviewed (February 2024, March 2024, April 2024, May 2024). The laboratory performed approximately 145 immunohematology patient tests annually. The findings were: 1. Review of the blood bank quality control sheets from October 2022 through January 2024 showed a section which documented the incubator temperature and the centrifuge revolutions per minute (RPM) of the Ortho Workstation. Review of the February 2024, March 2024, April 2024 and May 2024 quality control sheets showed no acceptable documentation of acceptable incubator temperature and centrifuge RPMS. 2. Interview with the TS on 6/12/24 at 3:48 PM revealed the laboratory had stopped using the quality control forms with the section to document the function checks in February. Further, the TS stated testing personnel would check the Ortho Workstation to ensure it was working properly; however, the data was not documented. 3. Review of the Ortho Workstation for ID-MTS manufacturer's instructions showed "Daily Procedures Centrifuge Display-Speed Check Since the speed of the centrifuge is displayed during operation, Ortho recommends a daily check of the displayed speed. This will ensure the centrifuge speed LED display matches the correct speed of 1032 rpm plus or minus 10 rpm. Incubator Temperature Status Display Check the incubator temperature status display and verify that it is green. This will indicate it is with the correct range." D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on review of the Ortho Workstation for ID-MTS manufacturer's instructions, lack of documentation, and staff interview, the laboratory failed to define a function check protocol to ensure system performance which was necessary for accurate and reliable test results for the immunohematology Ortho Workstation. The laboratory performed approximately 145 blood banking procedures per year. The findings were: 1. Review of the Ortho Workstation for ID-MTS showed "As Needed Procedures Speed Verification The centrifuge is fully calibrated at the factory. Additional calibration is not necessary. However, an additional speed verification may be performed with an optical or electronic device...as needed. Refer to your local laboratory practices for frequency of speed verification. Ortho recommends that calibration checks be performed with 10 cards. Centrifuge Timing Verification A -- 6 of 9 -- calibrated stopwatch or equivalent is acceptable to check the timer. Verify accuracy of the centrifuge timer according to your organization's standard operating procedures. The manufacturer's instructions also included a procedure for verifying the incubator temperature and timer. 2. Review of the laboratory's documentation showed no evidence the function checks had been performed or a protocol developed. 3. Interview with the technical supervisor on 6/12/24 at 3:48 PM confirmed there was no evidence periodic function checks had been performed and a protocol had not been developed. 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 observation, review of immunohematology patient records, the blood and blood product storage unit temperature logs, lack of documentation, staff interview, and policy and procedure review, the laboratory failed to ensure a system was in place to monitor proper blood and blood product storage temperatures over a 24-hour period for 6 of 20 months reviewed from October 2022 through June 2024 (October 2023, February 2024, March 2024, April 2024, May 2024, June 2024). In addition, the laboratory failed to ensure the audible alarm was inspected and functioning from October 2022 through June 2024. This failure affected 4 patients who received a total of 11 packed red blood cells from February 2024 through May 2024 and resulted in a determination of immediate jeopardy. The findings were: 1. Observation on 6/12/24 at 8:30 AM and again on 6/13/24 at 2:20 PM showed the Jewett blood bank freezer contained 3 units of fresh frozen plasma (FFP) and the blood bank refrigerator contained 12 units of packed red blood cells (PRBC). The storage units were monitored by a SensoScientific monitoring system. The following concerns were identified: a. Interview with the technical supervisor (TS) on 6/12/24 at 8:30 AM revealed the 24-hour monitoring system was currently operational for the blood bank refrigerator; however, the probe in the blood bank freezer was not functioning. Further, the technical supervisor stated the failure of the monitoring unit was discovered the end of March and the laboratory started a daily check of the blood bank refrigerator temperature on 4/1/24. In addition, the TS stated the hospital physicians requested FFP be available for patient use and the units currently in the freezer had arrived from the Red Cross on 6/11/24. b. Review of the October 2023 blood bank refrigerator log sheet showed no temperatures were recorded from 10/11 /23 until 10/24/23. Review of the blood bank freezer log showed the average temperature was minus 19.6 degrees Celsius (C) with the highest temperature documented at 3.7 degrees C on 10/11/24. There was no comment or

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 the Centers for Medicare and Medicaid Casper 155 report, review of the American Proficiency Institute (API) evaluation reports, and staff interview, the laboratory failed to successfully participate in two out of three consecutive API chemistry core proficiency testing events for partial pressure of oxygen (2022 event #1, 2022 event #3) Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- 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 the review of the Centers for Medicare and Medicaid (CMS) Casper 155 report, review of the American Proficiency Institute (API) chemistry core evaluations reports, and staff interview, the laboratory failed to successfully participate in two out of three consecutive API chemistry core proficiency testing (PT) events (2022 event #1, 2022 event #3) for pO2 (partial pressure of oxygen). The findings were: 1. Review of the CMS Casper 155 report and the API chemistry core PT evaluations showed the laboratory failed to successfully obtain a passing score for the analyte of pO2 on the following API testing events: a. 2022 event #1 showed the laboratory scored a 0%. b. 2022 event #3 showed the laboratory scored a 60%. 2. Telephone interview on 12/16 /22 at 11:22 AM with the laboratory manager revealed he was unaware the laboratory had failed to achieve a passing score on the 2022 API chemistry core event #1 and event #3. 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 review of the Centers for Medicare and Medicaid Casper 155 report, review of the American Proficiency Institute (API) evaluation reports, and staff interview, the laboratory director failed to ensure an effective

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: . Based on review of proficiency testing records, lack of documentation, and staff interview, the individual testing the proficiency testing samples and/or the laboratory director failed to attest to the routine integration of the American Proficiency Institute (API) proficiency tests into the patient workload for 3 of 18 proficiency testing events reviewed from September 2020 through May 2022. The findings were: 1. Review of the proficiency testing records showed attestation statements with the following concerns: a. 2021 API Immunohematology Event #1 was not signed by the laboratory director. b. 2021 API Immunohematology Event #2 was not signed by the testing personnel performing the tests. c. 2022 API Hematology Event #1 was not signed by the laboratory director. 2. Interview with the laboratory manager on 5/24/22 at 11:44 AM revealed she was not the laboratory manager at the time of the 2021 proficiency testing events. In addition, the laboratory manager confirmed the 2022 API Hematology Event #1 attestation statement was incomplete. . D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: . Based on review of proficiency testing records and staff interview, the laboratory failed to maintain a copy of the testing results and the attestation statements for the API (American Proficiency Institute) proficiency testing samples for 4 of 18 proficiency testing events reviewed from September 2020 through May 2022. The findings were: 1. Review of the proficiency testing records showed no evidence of the following documentation: a. 2021 API Miscellaneous Chemistry Event #1 was missing the attestation statement and documentation of the testing results. b. 2021 API Immunohematology Event #2 was missing the attestation statement. d. 2021 API Hematology Event #1 was missing documentation of the testing results. e. 2021 API Hematology Event #3 was missing documentation of the testing results. 2. Interview with the laboratory manager on 5/24/22 at 11:44 AM revealed she was not the laboratory manager at the time of the 2021 proficiency testing events; however was able to confirm the documentation was unavailable. . 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 Centers for Medicare and Medicaid Casper 155 report, review of the American Proficiency Institute (API) evaluation reports, and staff interview, the laboratory failed to successfully participate in two consecutive API Hematology proficiency testing events for the white blood cell differential (2021 Event #3, 2022 Event #1). Refer to D2130. . D2130 HEMATOLOGY CFR(s): 493.851(f) -- 2 of 12 -- 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 the review of the Centers for Medicare and Medicaid Services (CMS) Casper 155 report, review of the American Proficiency Institute (API) evaluation reports, and staff interview, the laboratory failed to successfully participate in two consecutive API Hematology proficiency testing (PT) events for the white blood cell differential which included basophils, eosinophils, lymphocytes, monocytes, and neutrophils (2021 Event #3, 2022 Event #1). The findings were: 1. Review of the CMS Casper 155 report and the API Hematology PT evaluations showed the laboratory failed to successfully obtain a passing score for the white blood cell differential on the following API testing events: a. 2021 Event #3 showed the laboratory scored a 0% b. 2022 Event #1 showed the laboratory scored a 0%. 2. Interview with the laboratory manager on 5/24/22 at 11:44 AM revealed she was not the laboratory manager at the time the 2021 API Hematology Event #3 was tested and was unaware of the failure. In addition, the laboratory manager confirmed the 2022 Event #1 had failed and the cause of the failure had not been investigated. . 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 documentation and staff interview, the laboratory failed to retain the instrument printouts for blood gas testing on the Abbott i-STAT analyzer for 2 of 2 years of testing reviewed (2021, 2022). The laboratory performed approximately 60 blood gas tests per year. The findings were: 1. Review of the laboratory's records showed no evidence the Abbott i-STAT instrument printouts had been retained. 2. Interview with the laboratory manager on 5/25/22 at 11:17 AM revealed the respiratory therapists performed the blood gas testing and manually entered the results into the patient's medical record. Further, the laboratory manager stated the instrument printouts for the blood gases had not been saved. . D5016 ROUTINE CHEMISTRY CFR(s): 493.1210 If the laboratory provides services in the subspecialty of Routine Chemistry, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1267, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: . Based on observation, review of the Abbott i-STAT operator's manual, lack of documentation, review of the Abbott i-STAT patient testing log sheets, review of quality control (QC) records, review of the laboratory's individualized quality control plan (IQCP), and staff interview, the laboratory failed to ensure manufacturer's instructions were followed to perform function checks as required on the Abbott i- -- 3 of 12 -- STAT instrument (D5431); failed to ensure calibration verification was performed on the Abbott i-STAT instrument every 6 months (D5439); and failed to ensure QC was performed as outlined in the IQCP for blood gas analysis (D5445). . D5026 IMMUNOHEMATOLOGY CFR(s): 493.1217 If the laboratory provides services in the specialty of Immunohematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1271, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: . Based on observation, review of patient test reports, lack of documentation, policy and procedure review, and staff interview, the laboratory failed to ensure the emergency release of uncrossmatched blood was signed by the ordering physician (D5551) and failed to ensure the audible alarm system on the blood and blood product storage units were functioning properly (D5555) for two consecutive surveys conducted on 9/11/20 and 5/25/22. . D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: . Based on review of the Centers for Medicare and Medicaid Services (CMS) 209 Laboratory Personnel Report, review of policy and procedures, lack of documentation, review of proficiency testing records, review of the laboratory's test menu, and staff interview, the laboratory failed to complete an initial competency assessment (D5209), failed to review and evaluate proficiency testing results (D5211), failed to at least twice annually verify the accuracy of test results (D5217), and failed to monitor, assess, and correct problems in the general laboratory system (D5291). . D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: . Based on review of the CMS (Centers for Medicare and Medicaid Services) 209 Laboratory Personnel Report, lack of documentation, review of policy and procedure, and staff interview, the technical supervisor failed to complete an initial competency assessment for 1 of 1 testing personnel prior to independently testing patient samples -- 4 of 12 -- (TP #1). 1. There was no evidence the technical supervisor had completed an initial competency assessment prior to TP #1 independently testing patient samples. 2. Interview with TP #1 revealed she was hired on 11/14/21 and confirmed a competency assessment had not been completed prior to her independently testing patient samples. 3. Review of the policy titled "Employee Competency" showed "(b) The Technical Supervisor is responsible for: (8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report tests results promptly, accurately and proficiently..." . D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: . Based on review of API (American Proficiency Institute) proficiency testing records, lack of documentation, and staff interview, the laboratory failed to review and evaluate proficiency testing results for 9 of 18 testing events reviewed from November 2020 to May 2022. The findings were: 1. Review of the API proficiency testing (PT) reports failed to include documentation the laboratory had evaluated test scores of less than 100%. The following concerns were identified: a. Review of the 2020 API Chemistry Core Event #3 showed the laboratory scored an 80% on sodium, an 80% on lactic acid, and a 40% on lipase. There was no documentation the laboratory had evaluated the proficiency testing results. b. Review of the 2021 API Chemistry Core Event #1 showed the laboratory scored an 80% on chloride and an 80% on free triiodothyroxine (FT3). There was no documentation the laboratory had evaluated the proficiency testing results. c. Review of the 2021 API Chemistry Core Event #2 showed the laboratory scored an 80% on triglyceride and an 80% on FT3. There was no documentation the laboratory had evaluated the proficiency testing results. d. Review of the 2021 API Hematology Event #1 showed the laboratory scored a 60% on monocytes. There was no documentation the laboratory had evaluated the proficiency testing results. e. Review of the 2021 API Hematology Event #2 showed the laboratory scored a 60% on lymphocytes. There was no documentation the laboratory had evaluated the proficiency testing results. f. Review of the 2021 API Immunohematology Event #3 showed the laboratory scored a 40% on antibody detection and a 40% on compatibility testing. There was no documentation the laboratory had evaluated the proficiency testing results. g. Review of the 2021 API Chemistry Core Event #3 showed the laboratory scored an 80% on pH, pCO2, and chloride. There was no documentation the laboratory had evaluated the proficiency testing results. h. Review of the 2021 API Miscellaneous Chemistry Event #1 showed the laboratory scored 0% on microalbumin. There was no documentation the laboratory had evaluated the proficiency testing results. i. Review of the 2021 API Miscellaneous Chemistry Event #2 showed the laboratory scored 0% due to lack of participation. There was no documentation the laboratory had evaluated the proficiency testing results. 2. Interview with the laboratory manager on 5/24/22 at 11: 44 AM revealed she was new to the position and was unaware of the results of the PT events. . D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) -- 5 of 12 -- At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: . Based on review of the laboratory's test menu and staff interview, the laboratory failed to at least twice annually verify the accuracy of the C-reactive protein (CRP) analyte for 2 of 2 years reviewed (2020, 2021). The laboratory performed approximately 800 CRP patient tests annually. The findings were: 1. Review of the laboratory test menu showed the laboratory performed CRP testing. 2. Interview with the laboratory manager on 5/24/22 at 11:44 AM revealed she was new to the position and had assumed CRP was included in the proficiency testing program. . 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 policy and procedure review, lack of documentation, and staff interview, the laboratory failed to follow written procedures to monitor, assess, and correct problems in the general laboratory system for 2 of 2 years reviewed (2021, 2022). The findings were: 1. Review of the last quality assessment documentation was dated 12/31 /2020. 2. Interview with the laboratory manager on 5/25/22 at 11:30 AM revealed she was new to the position and was unaware of any quality assessment documentation. 3. Review of the policy and procedure titled "Quality Assessment Program" last reviewed by the laboratory director on 10/28/21 showed "Purpose The laboratory has an ongoing Quality Assessment Program that is designed to monitor, evaluate and improve the quality of laboratory performance and ensures the reliability of test data, and to evaluate the competency of the laboratory staff. The lab will identify and resolve any problems that may affect lab performance and thus patient care...The following Quality Assurance monitors are actively evaluated to maintain an established standard of laboratory performance and compliance. Data from each monitored area is collected, recorded and analyzed...When required, appropriate

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 the Centers for Medicare and Medicaid Casper 155 report, review of the American Proficiency Institute (API) evaluation reports, and staff interview, the laboratory failed to successfully participate in two consecutive API chemistry core proficiency testing events for total protein (2021 event #3, 2022 event #1). Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- 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 the review of the Centers for Medicare and Medicaid (CMS) Casper 155 report, review of the American Proficiency Institute (API) evaluation reports, and staff interview, the laboratory failed to successfully participate in two consecutive API chemistry core proficiency testing (PT) events for total protein (2021 event #3, 2022 event #1). The findings were: 1. Review of the CMS Casper 155 report and the API chemistry core PT evaluations showed the laboratory failed to successfully obtain a passing score for the analyte of total protein on the following API testing events: a. 2021 event #3 showed the laboratory scored a 60%. b. 2022 event #1 showed the laboratory failed to participate and scored 0%. 2. Telephone interview on 4/15/22 at 9 AM with the laboratory manager revealed she was unaware the laboratory had failed to achieve a passing score on the API chemistry core 2021 event #3 and had failed to participate in the API 2022 chemistry core #1 testing event. In addition, the laboratory manager stated the laboratory was having difficulty obtaining reagents and had discontinued routine testing, however the laboratory continued to perform testing in emergency situations. The laboratory manager confirmed the laboratory had not developed a

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on proficiency testing records review, lack of documentation, and interview with staff, the laboratory director and testing personnel failed to attest to the routine integration of proficiency tests into the patient workload using the laboratory's routine methods for 5 of 18 American Proficiency Institute (API) proficiency testing events reviewed from September 2018 to September 2020. Findings include: 1. Proficiency testing records review failed to include the signed attestation statement for 2nd Bacteriology event of 2020 and the 3rd event of 2019; the 3rd hematology event of 2018 and 2019; and the first immunohematology event of 2020. 2. In an interview conducted on 09/11/2020 at approximately 5:30 P.M., staff confirmed the attestation statements were missing from the proficiency testing records. 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 documentation and interview with staff, the laboratory failed to retain hematology quality control records for at least two years. The laboratory Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 13 -- performed hematology Complete Blood Count testing daily totaling approximately 2788 tests per year. Findings include: 1. The laboratory failed to retain quality control records prior to February 2020 when the previous hematology cell counter was replaced. 2. In an interview conducted on 09/11/2020 at approximately 3:00 P.M. staff stated the laboratory failed to have a system to back up the qualify control records stored on the instrument and stated when the prior instrument failed, the laboratory was unable or failed to recover quality control performance records stored on the instrument from September 2018 to February 2020. D5026 IMMUNOHEMATOLOGY CFR(s): 493.1217 If the laboratory provides services in the specialty of Immunohematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1271, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on compatibility testing records review, immunohematology reagent and blood product storage records review, lack of documentation and interview with staff, the laboratory failed to follow Ortho MTS test system current instructions, and failed to perform alarm checks on the blood storage refrigerator to ensure the product is stored within the acceptable range over a 24 hour period. (See D5551 and D5555) D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on proficiency testing records review, lack of documentation, and interview with staff, the laboratory failed to ensure the lab recorded

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 American Proficiency Institute (API) report review, e-mail confirmation of test results, and CASPER 153 and 155 reports review, the laboratory failed to successfully participate in 2 of 3 proficiency testing events for the Digoxin analyte (API event 3 of 2018 and API event 2 of 2019). (See D2118.) D2118 TOXICOLOGY CFR(s): 493.845(f) Failure to achieve satisfactory performance for the same analyte or test in two Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on American Proficiency Institute (API) report review, CASPER 153 and 155 reports review, and e-mail confirmation of test results, the laboratory failed to successfully participate in 2 consecutive proficiency testing events for the Digoxin analyte (API event 3 of 2018 and API event 2 of 2019). Findings include: 1. API summary evaluation reports review for the second chemistry proficiency testing event of 2019 included a summary score of 0% for Digoxin analyte tests and 60% score for Digoxin analyte testing performed for the 3rd event of 2018. 2. Casper reports for 2 out of 3 events reviewed included Digoxin scores of 0% for the 2nd event of 2019 and 60% for the 3rd event of 2018. 3. In an e-mail interview conducted on 08/12/2019 the laboratory staff confirmed the laboratory scores of 60% and 0% for Digoxin proficiency tests scores in the 3rd event of 2018 and the 2nd event of 2019 respectively. -- 2 of 2 --

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on proficiency testing records review, lack of documentation, lack of written delegation of director's duties to the qualified technical consultant, and interview with staff, the director failed to attest to the routine integration and testing of proficiency samples for 8 of 26 American Proficiency Institute (API) proficiency testing events reviewed from May 2016 to May 2018. Findings include: 1. API proficiency testing records review failed to include the director's signature and date attesting Chemistry, Hematology, Microbiology, and Immunohematology proficiency tests were performed in the same manner and number of times patient tests were routinely performed for: Chemistry events - 1 of 2016 and 3 of 2017; Hematology events 1 of 2017 and 1 of 2018; Immunohematology events 1 and 3 of 2016 and events 1 and 3 of 2017. 2. The laboratory lacked a written delegation of duty by the director to authorize a qualified technical consultant or technical supervisor to sign the attestation in lieu of the director. 3. In an interview conducted on 05/07/2018 at approximately 7:00 P.M. staff confirmed the laboratory director had not signed the attestation statements listed and that the laboratory did not have a written delegation by the director for qualified 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 -- technical supervisors of Chemistry, Hematology, and Microbiology to sign the attestation statement in the director's absence (only the director qualifies to sign Immunohematology attestation statements). 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 quality control records review, lack of documentation, and interview with staff, the laboratory failed to monitor quality control records over time for test accuracy and precision for approximately 30 tests performed on the Vitros 5600, 3 of 3 tests performed on the Stago satellite coagulation instrument, and 6 of 6 tests performed on the Ruby 5 complete blood count instrument. Findings include: 1. Quality control records review failed to include documentation for evaluations of quality control performance overtime to detect shifts or trends controls may demonstrate and may need