Copper Queen Community Hospital

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on September 30, 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 D6076 - 42 C.F.R. 493.1441 Condition: Laboratory Director, high 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 American Proficiency Institute's (API) proficiency testing records, the laboratory failed to successfully participate in two of three consecutive testing events 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 -- in the subspecialty of Immunohematology for the regulated test, Compatibility Testing in 2024 resulting in an initial unsuccessful performance. Refer to D2181. 1. The laboratory's PT performance was unsatisfactory for the first event of 2024 as indicated below: - Compatibility Testing - 80% 2. The laboratory's PT performance was unsatisfactory for the second event of 2024 as indicated below: - Compatibility Testing - 80% D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the CASPER 155 report and American Proficiency Institute (API), PT records from 2024, the laboratory failed to achieve satisfactory performance (100%) for two of three testing events in the subspecialty of Immunohematology for the test, Compatibility Testing. Findings include: 1. A review of the CASPER 155 report revealed the following unsatisfactory scores: 2024 event 1, Compatibility Testing 80% 2024 event 2, Compatibility Testing 80% 2. A review of the proficient testing scores from API (2024) confirmed the above findings. 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 a proficiency testing desk review of the CASPER-0155 Individual Laboratory Report and American Proficiency Institute (API), and 2024 records, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER-0155 and American Proficiency Testing (API) 2024-1 and 2024-2, evaluation reports, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2181. -- 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 the manual Cerebrospinal fluid (CSF) cell counts performed by the laboratory and interview with the Technical Supervisor (TS-2), the laboratory failed to retain the manufacturer's package insert for at least 2 years for each lot of Quality Control (QC) used. Findings include: 1. During the survey conducted on 7/31/2024, 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 for the manual CSF cell counts performed by the laboratory. 2. The TS-2 interviewed on 7/31/2024 at 10:40 AM confirmed the laboratory failed to retain the manufacturer's assay information sheets for at least 2 years for each lot of QC for the testing indicated above. 3. The laboratory performs approximately five CSF counts on patients per year under the specialty of Hematology. 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 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 laboratory's patient population. This STANDARD is not met as evidenced by: Based on lack of performance specification documentation for the Minicube analyzer and interview with the technical supervisor l (TS-2), the laboratory failed to verify the manufacturer range and reportable range for the Minicube analyzer prior to reporting patient test results. Findings include: 1. The laboratory began using the Minicube analyzer to perform Erythrocyte Sedimentation Rate (ESR) testing on patients in May 2022. 2. The laboratory failed to demonstrate that it can obtain the manufacturer range and reportable range comparable to that established by the manufacturer for the Minicube analyzer prior to reporting patient test results. 3. The TS-2 interviewed on 7 /31/24 at 8:50 AM confirmed the laboratory failed to verify the manufacturer range and reportable range for the Minicube analyzer prior to reporting patient test results. 4. The laboratory performs approximately 35 ESR tests on patients per month. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on lack of Quality Control (QC) documentation and interview with the Technical Supervisor (TS-2), the laboratory failed to perform and document control procedures using the number and frequency as required for testing performed in the specialty of Hematology. Findings include: 1. The laboratory began using the Minicube analyzer to perform Erythrocyte Sedimentation Rate (ESR) on patients under the specialty of Hematology in May 2022. 2. The laboratory failed to perform two levels of external quality control on the Minicube analyzer on 5/6/2022. 3. On 5/6 /2022, ESR testing was performed on five patients. 4. The TS-2 interviewed on 07/31 /2024 at 1:15 PM confirmed the laboratory failed to perform and document two levels of external control material on the Minicube analyzer on 5/6/2022. -- 2 of 2 --

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of Proficiency Testing (PT) records from 2020 and interview with the facility personnel, the laboratory failed to document

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 2018 sent to the State Agency by the PT provider, the laboratory failed to successfully participate in a PT program for the (A) subspecialty, ABO Group and Rh Group, and for the (B) regulated test, ABO, under the specialty of Immunohematology. Findings include: A1. The laboratory's PT performance was unsatisfactory for the 2nd event of 2018 for the subspecialty, ABO Group and Rh Group, with a score of 90%. A2. The laboratory's PT performance was unsatisfactory for the 3rd event of 2018 for the subspecialty, ABO Group and Rh Group, with a score of 0%. B1. The laboratory's PT performance was unsatisfactory for the 2nd event of 2018 for the regulated test, ABO, with a score 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 80%. B2. The laboratory's PT performance was unsatisfactory for the 3rd event of 2018 for the regulated test, ABO, with a score of 0%. D2160 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(e) (1) For any unsatisfactory testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or unsatisfactory testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on information the Proficiency Testing (PT) provider furnishes to the State Agency for 2018, 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 regulated test, ABO, and for the subspecialty, ABO Group and Rh Group. See D2016 for findings. D2162 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(f) Failure to achieve satisfactory performance for the same analyte 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 Proficiency Testing (PT) reports for 2018 sent to the State Agency by the PT provider, the laboratory failed to successfully participate in a PT program for the regulated test, ABO, resulting in unsuccessful PT performance. See D2016 for findings. D2163 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(g) Failure to achieve an overall testing event score of satisfactory for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on 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 ABO Group and Rh Group for the 2nd and 3rd event of 2018, resulting in unsuccessful PT performance. See D2016 for findings. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. -- 2 of 3 -- 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: The Condition of Laboratory Director was found to be not met based on the failure to provide overall management and direction as evidenced by D6089 - ensuring that proficiency testing samples are tested as required under Subpart H. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on information furnished to the State Agency by the Proficiency Testing (PT) provider, it was determined that the laboratory director failed to ensure that PT samples are tested in a manner that results in successful participation in a proficiency testing program for the regulated test, ABO, and for the subspecialty, ABO Group and Rh Group. See D2016 for findings. -- 3 of 3 --

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on direct inspection of the current in use quality control (QC) material for CBC's, and interview with the laboratory personnel, the laboratory failed to include the new expiration date of the QC material based on the opened date that the laboratory personnel indicated on each QC tube. Findings include: 1. Each CBC QC tube indicated the open date with no new expiration date which according to the manufacturer's package insert is 7 days from the open date. 2. The laboratory personnel stated that the QC material was always used up prior to the new expiration date. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- This STANDARD is not met as evidenced by: Based on lack of quality control (QC) documentation and interview with the facility personnel, the laboratory failed to perform and document control procedures using the number and frequency as required for testing performed on the Medtox analyzer. Findings include: 1. The laboratory began testing under the sub-specialty of Toxicology using the Medtox analyzer in March 2017. On the date of the survey, November 6, 2018, the laboratory's quality control procedure consisted of performing two levels of external control material, once each week and/or each new shipment or lot of test reagents. 2. No QC documentation was provided for review during the survey to indicate the laboratory performed two levels of external quality control material of different concentrations each day of patient testing as required since January 1, 2016. The laboratory had not implemented an Individualized Quality Control Plan (IQCP) for this test system. 3. The facility personnel confirmed that the laboratory did not perform and document controls as required and confirmed that the laboratory had not implemented an Individualized Quality Control Plan (IQCP) for testing performed on the Medtox analyzer. 4. The laboratory tests approximately 140 patients annually using the Medtox test system. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of one patient report (MRN #356458) from 07/28/2017, the laboratory's Alere Clostridium Difficile (C. Diff) quality control log and interview with laboratory personnel, the laboratory failed to perform a positive and negative control on 07/28/2017, the day that the patient was tested. Findings include: 1. The Alere C. Diff quality control log for the month of July 2017 did not have an entry for both the positive control and negative control for 07/28/2017, the day that the patient specimen was collected, tested and reported out. 2. The laboratory personnel could not explain why there was no QC entry for 07/28/2017. 3. It was not determined at the time of the survey if any other patients were tested for C. Diff on 07/28/2017. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on review of test comparison results from 2017 and 2018 and interview with -- 2 of 4 -- the facility personnel, the laboratory failed to perform an instrument to instrument comparison at least twice a year for testing performed on two of the same instruments. Findings include: 1. The laboratory utilizes two separate Beckman Coulter AU480 chemistry analyzers to perform testing. The laboratory's approximate annual test volume in the sub-specialty of Routine Chemistry is 263,936. 2. During the survey conducted on November 6, 2018, no documentation was presented for review to indicate the laboratory performed a comparison of the test results from the two instruments at least twice a year. The laboratory performed a test result comparison on March 3, 2017 and October 17, 2018. 3. The facility personnel confirmed that the laboratory failed to perform a test result comparison at least twice annually for testing that is performed on the AU480 analyzers. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on review of patient test reports and interview with the facility personnel, the laboratory failed to have a system in place to ensure the accuracy of test results that are manually entered into the laboratory's information system (LIS). Findings include: 1. The laboratory performs patient testing in the specialties of Microbiology, Diagnostic Immunology, Chemistry, Hematology and Immnuohematology, with an approximate annual test volume of 376,628. It is the practice of the laboratory to manually enter test results into the LIS for the following tests: KOH, Wet Mount, Gram Stain, C. Difficile, Shiga A/B stool, Manual Differentials, Urine Microscopic, RF (Rhuematoid Factor), Serum hCG and Blood Gas testing performed on the I-stat analyzer. 2. No documentation was presented for review during the survey to indicate the laboratory has a system in place to ensure the accuracy of patient test results that are manually entered into the LIS. 3. The facility personnel confirmed that the laboratory did not have a system in place to verify the accuracy of the patient test results that are manually entered by the testing personnel into the LIS. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of quality control records and control procedures, the laboratory -- 3 of 4 -- director failed to ensure that quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. See D5445 for findings. -- 4 of 4 --