Carestream Medical Ltd

Summary Statement of Deficiencies D0000 A Recertification survey was conducted on February 13, 2023. Carestream Medical Ltd clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to provide documentation that showed the Laboratory Director approved, signed, and dated the procedure manual from 7/19/2021 to 2/13/2023. Findings: According to the laboratory's response to the Statement of Deficiencies for the survey on 07/16/2021, "A new CMS116 form with a qualified laboratory director has been submitted and communication has been established with the state of Florida, of this forms receipt." The completion date for the deficiency was 07/19/2021. Review of the procedure manuals titled "General Safety Policies and Procedures", "Quality Assurance Program Policies and Procedures", "Analytical (Pre/Post} Procedures", and "General Lab Standard Operating Procedures" revealed that the current Laboratory Director failed to sign the procedure manuals. On 02/13/2023 at 12:11 PM, the Technical Supervisor acknowledged the Laboratory Director had not signed the procedure manuals. Word Key CMS - Centers for Medicare and Medicaid Services 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 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 -- 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 observation, record review and interview the laboratory failed to follow manufacturer's instructions by storing the Hyaluronidase reagent at -20 degrees Celsius (C) on 02/13/2023 Findings: During a tour of the laboratory on 02/13/2023 at 9:34 AM, two bottles of Hyaluronidase lyophilized powder (lot #SLCH0779 and #SLBW4154) were found in the refrigerator with a temperature range of 2-8 degrees C. The label on the bottles indicated the storage temperature is -20 degrees C. Review of the Sigma-Aldrich (manufacturer's) Product Specification sheet lists the "Storage Temperature: -20 degrees C." On 02/13/21 at 9:40 AM, the Technical Supervisor acknowledged the Hyaluronidase was stored at the wrong temperature. D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: Based on record review and interview, the Laboratory Assistant performed the proficiency testing (PT) for the Fibronectin-Aggrecan Complex Test on 10/01/2021, 05/31/2022, and 10/11/2022, and failed to have a State of Florida Clinical Laboratory Personnel license. (Refer to D6170). D6170 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(a) Each individual performing high complexity testing must possess a current license issued by the State in which the laboratory is located, if such licensing is required. This STANDARD is not met as evidenced by: Based on record review and interview, the Laboratory Assistant performed the proficiency testing (PT) for the Fibronectin-Aggrecan Complex Test on 10/01/2021, 05/31/2022, and 10/11/2022, and failed to have a State of Florida Clinical Laboratory Personnel license. Findings: According to Florida Administrative Code (FAC) Rule: 64B3-5.003, Laboratory Testing Personnel who work in an Independent Laboratory must be licensed in the specialty that testing is being performed (Chemistry). The Clinical Laboratory Improvement Amendments (CLIA) Application for Certification signed by the Laboratory Director on 02/13/2023 reflects that the laboratory is an independent lab, and the test they are performing is the Fibronectin-Aggrecan Complex Test which is listed as high complexity testing. Review of the PT records showed the laboratory performed split testing on 10/01/2021, 05/31/2022, and 10/11 /2022. The PT records for each date included one sets of test results initialed by the Technical Supervisor and another set initialed by the Laboratory Assistant. Review of Laboratory Assistant's personnel records revealed there was no record of a Florida Laboratory personnel license. Review of the Personnel File Checklist for the Laboratory Assistant showed that the box for "Certificate/license/registry number and -- 2 of 3 -- state registration (as required by position)" was not checked. On 02/13/2023 at 9:30 AM, the Technical Supervisor stated the Laboratory Assistant was performing the PT and that he knew that she was not licensed. -- 3 of 3 --

Summary Statement of Deficiencies D5800 POSTANALYTIC SYSTEMS CFR(s): 493.1290 Each laboratory that performs nonwaived testing must meet the applicable postanalytic systems requirements in 493.1291 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 postanalytic systems and correct identified problems as specified in 493. 1299 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review and interview, the laboratory's quality assessment program failed to correct identified problems in the postanalytic system. Findings: Cross Reference D5805: Based on record review and interview, the patient test reports failed to provide all required information for laboratory test reports for 3 of 3 patients, (#1, #2, #3). This is a repeat deficiency from the initial survey on 07/16/2021. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D0000 An initial certification survey was conducted on June 28 to July 16, 2021. Carestream Medical Ltd clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. 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 record review and interview, the Laboratory Director failed to meet the qualification requirements to function as laboratory director according to Florida state law Findings: Cross Reference D3009. Based on record review and interview, the Laboratory Director failed to meet the qualification requirements to function as laboratory director according to Florida state law. D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This STANDARD is not met as evidenced by: Based on record review and interview, the Laboratory Director failed to meet the qualification requirements to function as laboratory director according to Florida state law from 08/05/2020 to 07/16/2021. Findings: Review of Florida state law 64B3- 5.007 Director; Limitations and Qualifications read "at least one of the following requirements must be met for specific areas of licensure. In some cases, there are multiple options for meeting the requirements." The following are the options available : 1. Certification in Clinical Pathology by the ABP (American Board of Pathology) or AOBP (American Osteopathic Board of Pathology). 2. Certification in the pertinent laboratory specialty by ABIM (American Board of Internal Medicine), AOBIM (American Osteopathic Board of Internal Medicine), ABMM (American Board of Medical Microbiology), ABCC (American Board of Clinical Chemistry), ABNM (American Board of Nuclear Medicine), AOBNM (American Osteopathic Board of Nuclear Medicine), ABMG (American Board of Medical Genetics and Genomics), ABB (American Board of Bioanalysis), ABMLI (American Board of Medical Laboratory Immunology), or ABHI (American Board of Histocompatibility and Immunogenetics). 3. Four years of pertinent clinical laboratory experience (post- graduate), with two years experience in the specialty to be directed Review of the Laboratory Director's CV (Curriculum Vitae) showed the Laboratory Director, listed on the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification signed on 06/28/2021, was not a pathologist or certified by one of the above mentioned organizations. The CV did not include any evidence of four years of pertinent clinical laboratory experience. According to CLIA Application for Certification signed and dated by the Laboratory Director on 06/28/20, the laboratory had an estimated annual test volume of 600 tests per year. On 06/30/2021 at 3:10 PM, the Technical Supervisor stated the CV provided was the current CV for the Laboratory Director and he did not believe the Laboratory Director had four years of pertinent laboratory experience. D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to provide complete documentation of performance specifications for the Fibronectin Aggrecan Complex (FAC) laboratory developed test from 08/05/2020 to 07/16/2021. Findings: Review of the validation plan for the FAC test showed the plan did not include analytic sensitivity, analytic specificity including interfering substances, and information on -- 2 of 3 -- how the laboratory determined what was considered a positive and a negative test result. On 07/16/2021 at 5:33 PM, the Technical Supervisor stated the above mentioned performance specifications were not included in the validation. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on record review and interview, the patient test reports failed to provide all required information for laboratory test reports for 3 of 3 patients, (#1, #2, #3). Findings: Review of the patients #1, #2, and #3 test reports showed the name and address of the laboratory was not listed on the reports. According to the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification, signed and dated by the acting Laboratory Director on 06/28/2021, the laboratory annual estimated hematology test volume was 600 tests. During an interview on 07/07/21 at 9: 37 AM, Technical Supervisor stated the patient test reports did not have the name or address of the laboratory. -- 3 of 3 --