Cobre Valley Regional Medical Center

Summary Statement of Deficiencies D5801 TEST REPORT CFR(s): 493.1291(a) (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 patient test reports maintained in the LIS (Laboratory Information System), review of instrument results generated from the GEM 5000 blood gas analyzer and interview with the facility personnel, the laboratory failed to have an adequate system in place to ensure the accuracy of patient-specific information that is electronically interfaced from the instrument to the LIS for three out of three patient records reviewed. Findings include: 1. The laboratory performs blood gas testing in the specialty of Chemistry with a reported annual test volume of 12,646. The laboratory began using the GEM 5000 analyzer for blood gas testing in October 2024. 2. The test results generated from the analyzer are electronically interfaced to the LIS, Meditech. 3. Review of the instrument printout for ID# 116613 from 11/25/24 indicated the specimen collection time as 13:17:00. The test report maintained in the LIS indicated the specimen collection time as 1417. 4. Review of the test report maintained in the LIS for ID# 148226 from 2/13/25 indicated the specimen collection time as 1330. The instrument printout indicated the specimen analyzed time as 13:27: 43. 5. Review of the instrument printout for ID# 116613 indicated a critical test result for PCO2 was reported to the ordering physician on 11/25/24 at 13:24. The final test report maintained in the LIS indicated the critical test result for PCO2 was reported to 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 -- the ordering physician at 1433. 6. The laboratory failed to have a system in place to ensure patient-specific data is accurately and reliably sent from the GEM 5000 analyzer to the LIS. 7. The facility personnel interviewed on 4/14/25 at 1:20 PM confirmed that the laboratory failed to have a system in place to ensure the accuracy of patient-specific data that is electronically transmitted from the GEM 5000 analyzer to the LIS (Meditech), including the time of specimen collection, time of specimen analysis and time of critical result reporting. -- 2 of 2 --

Summary Statement of Deficiencies 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 manufacturer's package inserts presented for review for testing performed on the Radiometer ABL80 and interview with the technical consultant (TC- 2), the laboratory failed to retain the manufacturer's package inserts for at least 2 years for each lot of Quality Control (QC) used on the analyzer. Findings include: 1. The laboratory utilizes the Radiometer ABL80 to perform Blood Gas testing under the specialties of Chemistry and Hematology with an annual test volume of 13.340. 2. During the survey conducted on 10/8/24, no evidence 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 used on the Radiometer ABL80. 3. The TC-2 interviewed on 10/8/2024 at 11:45 AM confirmed the laboratory failed to retain the manufacturer's assay information sheets for at least 2 years for each lot of QC used on the analyzer indicated above. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value 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 -- of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's quality control (QC) records, lack of QC lot correlation documentation and interview with the technical consultant (TC-2), the laboratory failed to verify the criteria for acceptability of quality control materials. Findings include: 1. The laboratory performs Blood Gas testing under the specialties of Chemistry and Hematology utilizing the Radiometer ABL80 analyzer with an annual test volume of 13,340. 2. No documentation was presented for review to indicate the laboratory verified the criteria for acceptability of each lot of control material used on the analyzer indicated above from 2022 through the date of the survey on 10/8/2024. 3. The TC-2 interviewed on 10/8/2024 at 11:45 AM confirmed the laboratory failed to document the criteria for acceptability of control lots used on the Radiometer ABL80. 4. The number of QC lots used on the analyzer from 2022 through the date of the survey could not be determined at the time of the survey. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(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 a record review of competency assessments from 2023-2024, and interview with the technical consultant (TC-2), the technical consultant failed to evaluate the competency of testing personnel. Findings include: 1. The laboratory failed to provide evidence that indicated a qualified technical consultant performed and evaluated the semiannual competencies for one of one testing personnel. 2. The laboratory failed to provide evidence that indicated a qualified technical consultant performed and evaluated the 2023 annual competencies for two of eight testing personnel. 3. The laboratory failed to provide evidence that indicated a qualified technical consultant performed and evaluated the 2024 annual competencies for four of seven testing personnel. 4. The TC-2 interviewed on 10/8/24 at 09:30 AM confirmed the technical consultant failed to evaluate the competency of the above personnel. 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 competency evaluation documentation for review and interview with -- 2 of 3 -- the technical consultant (TC-2), the technical consultant failed to evaluate and document the performance of one individual responsible for moderate complexity testing at least annually. Findings include: 1. No annual competency evaluation documentation from 2023 was presented for review for six of eight testing personnel who perform testing on the Radiometer ABL80. 2. No annual competency evaluation documentation from 2024 was presented for review for three of seven testing personnel who perform testing on the Radiometer ABL80. 2. The facility personnel interviewed on 10/8/24 at 9:30 AM confirmed the technical consultant failed to evaluate and document the performance of the testing personnel indicated above. -- 3 of 3 --

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on July 1, 2024, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful Participation D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the Certification and Survey Enhanced Reporting (CASPER) 155 report and Accutest Inc., the laboratory failed to successfully participate in three of three consecutive testing events in the subspecialty of Routine Chemistry for 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 -- regulated analyte pH Blood Gas in 2023 and 2024, resulting in non-initial unsuccessful performance. Refer to D2096. 1. The laboratory's PT performance was unsatisfactory for the second event of 2023 as indicated below: - pH Blood Gas - 60% 2. The laboratory's PT performance was unsatisfactory for the third event of 2023 as indicated below: - pH Blood Gas - 60% 3. The laboratory's PT performance was unsatisfactory for the first event of 2024 as indicated below: - pH Blood Gas - 60% D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the CASPER 155 report and Accutest Inc. PT records from 2023 and 2024, the laboratory failed to achieve satisfactory performance (80% or greater) for three of three consecutive testing events in the subspecialty of Routine Chemistry for the analyte pH Blood gas. Findings include: 1. A review of the CASPER 155 report revealed the following unsatisfactory scores: 2023 event 2, pH Blood gas 60% 2023 event 3, pH Blood gas 60% 2024 event 1, pH Blood gas 60% 2. A review of the proficient testing scores from Accutest Inc. (2023 and 2024) confirmed the above 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: Based on a proficiency testing desk review of the CASPER-0155 Individual Laboratory Report and Accutest Inc. 2023 and 2024 records, the laboratory director failed to provide overall management and direction of the laboratory services. Refer D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER-0155 and Accutest Inc. 2023-2, 2023-3, and 2024-1 evaluation reports, the laboratory director failed to ensure -- 2 of 3 -- successful participation in an HHS approved proficiency testing program. Refer to D2096. -- 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 2022 and 2023 sent to the State Agency by the PT provider, the laboratory failed to successfully participate in a PT program for the subspecialty of Routine Chemistry and for the following regulated analytes: PCO2 Blood Gas, and pH Blood Gas. Findings include: 1. The laboratory's PT performance was unsatisfactory for the second event of 2022 as indicated below: - Subspecialty of Routine Chemistry - 73% - PCO2 Blood Gas - 60% 2. The laboratory's PT performance was unsatisfactory for the first event of 2023 as indicated below: - Subspecialty of Routine Chemistry - 73% - PCO2 Blood Gas - 60% 3. The laboratory's PT performance was unsatisfactory for the second event of 2023 as 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 -- indicated below: - pH Blood Gas - 60% 4. The laboratory's PT performance was unsatisfactory for the third event of 2023 as indicated below: - pH Blood Gas - 60% 5. Unsatisfactory participation in the second and third events of 2023 (two consecutive testing events) for the regulated analyte, pH Blood Gas, constitutes unsuccessful PT performance. 6. Unsatisfactory participation in the second event of 2022 and the first event of 2023 (two out of three testing events) for the regulated analyte, PCO2 Blood Gas, constitutes unsuccessful PT performance. 7. Unsatisfactory participation in the second event of 2022 and the first event of 2023 (two out of three testing events) for the subspecialty of Routine Chemistry constitutes unsuccessful PT performance. 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 failures for the subspecialty of Routine Chemistry and the regulated analyte, PCO2 Blood Gas, during the 2nd event of 2022 and 1st event of 2023, and for the regulated analyte, pH Blood Gas, during the second and third events of 2023. 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 analytes, PCO2 Blood Gas (second event of 2022 and for the 1st event of 2023) and pH Blood Gas (second and third events of 2023) resulting in unsuccessful performance. See D2016 for findings. D2097 ROUTINE CHEMISTRY CFR(s): 493.841(g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. -- 2 of 3 -- 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 an overall testing event score of satisfactory performance for the subspecialty of Routine Chemistry for the second event of 2022 and for the first event of 2023, resulting in unsuccessful 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 subspecialty of Routine Chemistry (second event of 2022 and the first event of 2023) and for the regulated analytes, pH Blood Gas (second and third events of 2023), and PCO2 Blood Gas (second event of 2022 and 1st event of 2023). See D6000 for findings. -- 3 of 3 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on lack of Proficiency Testing (PT) records presented for review for 2019 and interview with the facility personnel, the laboratory failed to enroll in an HHS approved PT program for regulated analytes including pO2, pCO2 and pH for blood gas testing under the specialty of Chemistry and hemoglobin under the specialty of Hematology, which are included in subpart I. Findings include: 1. There was no documentation provided for review for the the first two PT events of 2019 for the analytes indicated above. 2. An invoice from the PT program dated September 16, 2019 was presented for review confirming enrollment for the third event of 2019. 3. Testing of patient specimens for the analytes noted above was not suspended during the first two PT events of 2019. 4. The laboratory tests approximately 3976 patients per year under the specialty of Chemistry and 1704 patients per year under the specialty of Hematology . D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- 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 proficiency testing (PT) scores received by the State, PT submission forms provided by the laboratory and interview with the laboratory personnel, the laboratory failed to submit PT results for blood gas testing within the timeframe indicated by the PT provider for the third event of 2018. Findings include: 1. The laboratory received unsatisfactory scores of zero for the regulated analytes pH, pCO2, and pO2 respectively for the third event of 2018. 2. The PT provider's results confirmation sheet indicated that the laboratory submitted the results on October 25, 2018, while the results submission deadline was October 24, 2018, attributing to the zeros received by the laboratory. 3. The laboratory provided no documentation of