Lee Health Coconut Point Clinical Laboratory

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Lee Health Coconut Point on 04/21/2025 - 04/24/2025. The Laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Conditions were cited: D5200 493.1230 Condition: General Laboratory Systems D6076 493.1441 Condition: Laboratory Director 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 document review and interview, the laboratory failed to have competency evaluations to assess Pathologists performing Histopathology and Cytology for two years (4/2023-4/2025). See D5209. 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: 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 -- Based on document review and interview, the laboratory failed to have competency evaluations to assess Pathologists performing Histopathology and Cytology for two years (4/2023-4/2025). This is a repeat citation from the 03/21/2023 Recertification survey. Findings included: 1. The accepted

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Lee Health Coconut Point Clinical Laboratory on 03/20/2023 - 03/21/2023. The laboratory was surveyed under 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: 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 interview with the Histology Manager and review of the Laboratory Personnel Report (Form CMS-209), Pathologist competency evaluations, and policy and procedures, the laboratory failed to have competency evaluations for 2 out of 2 years (2021-2023) reviewed. Findings Included: Review of the CMS-209 signed by the Lab Director on 03/17/2023 revealed there were 2 Pathologists. Pathologist #A was the Laboratory Director and Pathologist #B provided coverage in the Laboratory Director's absence. Review of employee competency evaluation revealed no competency evaluations for Pathologist #B. Pathologist #B had been providing coverage since 07/2021. Review of the policy and procedure titled "Professional Competency of Pathologists" revealed "Pathologist will have their professional competency assessed and reviewed by the Medical Director(s) monthly and/or quarterly via the Quality Management and Quality Improvement program." During an interview on 03/21/2023 at 10:00 AM, the Histology Manager confirmed the laboratory was using peer review as the only form of competency evaluation. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) 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 -- (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on interview with the Laboratory Manager and review of "Microbiology Supply Request" the laboratory failed to document the lot number and expiration of the media for the visual check and sterility for 10 (March 2023, February 2023, October 2022, September 2022, August 2022, May 2022, March 2022, January 2022, October 2021, and June 2021) out of 20 months (March 2023, February 2023, December 2022, November 2022, October 2022, September 2022, August 2022, July 2022, June 2022, May 2022, March 2022, February 2022, January 2022, December 2021, October 2021, September 2021, July 2021, June 2021, May 2021, and March 2021 ) reviewed. Findings Included: Review of "Microbiology Supply Request" logs revealed the lot number and expiration of the media was not recorded for March 2023, February 2023, October 2022, September 2022, August 2022, May 2022, March 2022, January 2022, October 2021, and June 2021). The Laboratory Manager confirmed on 03/21/2023 at 2:30 PM the logs did not always capture the lot numbers and expirations. D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on interviews with the General Supervisor and Histology Manager and review of H & E (Hematoxylin & Eosin) stain logs, the laboratory failed to document H & E stain quality for frozen specimens and failed to document a negative control for Cytokeratin (AE1/AE3) Antibody (IHC stain) for 4 (September 2021, April 2022, October 2022, and January 2023) out of 4 months reviewed. Findings Included: Review of H & E stain quality logs revealed the Pathologist who reviewed the stain quality did not document if it was acceptable or not in September 2021, April 2022, October 2022, and January 2023. The Histology General Supervisor confirmed during an interview on 03/20/2023 at 5:15 PM, the Histology Tech documents H & E stain quality for frozen sections and not the Pathologist. Review of the policy "Cytokeratin (AE1/AE3) Antibody," last reviewed by the Lab Director on 01/03/2023, showed "Positive tissue (with negative element) controls are utilized." The Histology Manager confirmed on 03/21/2023 at 10:30 AM, they do not run a separate negative quality control tissue in some IHC stains. -- 2 of 3 -- D5633 CYTOLOGY CFR(s): 493.1274(d)(1) (d) Workload limits. The laboratory must establish and follow written policies and procedures that ensure the following: (d)(1) The technical supervisor establishes a maximum workload limit for each individual who performs primary screening. This STANDARD is not met as evidenced by: Based on interview with the Histology Manager, lack of workload limits, and lack of workload limit policy, the laboratory failed to establish and follow written policies for the Technical Supervisor to establish maximum workload limits for each Pathologist who performed primary screening for 2 (2021-2023) out of 2 years reviewed. Findings Included: Review of policies and procedures revealed no policy for the Technical Supervisor to establish maximum workload limits for each Pathologist performing primary screening of cytology slides. Interview with the Histology Manager on 03/21/2023 at 11:00 AM confirmed no policy was established and no maximum workload limits were set for performing primary screening. 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 interview with the Histology Manager and review of Histology final reports, the laboratory failed to have the correct address of the laboratory location where testing was performed for 3 (7H, 8H, and 9H) out of 9 (1H, 2H, 3H, 4H, 5H, 6H, 7H, 8H, and 9H) Histology reports reviewed. Findings Included: Review of 3 (7H, 8H, and 9H) Histology final reports showed the slides were read at the laboratory. When the "Case Assignments" were pulled for these 3 reports, it was revealed they were read at a different location than the final report stated. During an interview on 03/21 /2023 at 12:00 PM the Histology Manager confirmed the location on the report of where the slides were read was incorrect. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A desk review survey of the laboratory's proficiency test results was performed on August 11, 2021 for Lee Health Coconut Point Clinical Laboratory. The Lee Health Coconut Point Clinical Laboratory is not in compliance with Code of Federal Regulations (CFR), Part 493, Laboratory Requirements. 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 laboratory's proficiency testing records for 2020 and 2021, the laboratory did not have successful performance in proficiency testing in the subspecialty of routine chemistry. Refer to D2096. Findings include: Review of the College of American Pathologists (CAP) proficiency testing records and the review of Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports, on August 11, 2021 on or about 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the analyte, lactate dehydrogenase for two out of three testing events in 2020 and 2021. 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 the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports and the laboratory's proficiency testing records, the laboratory did not have successful performance in proficiency testing in the specialty of routine chemistry. Findings include: On August 11, 2021 on or about 10:00 AM the College of American Pathologists (CAP) proficiency testing records and the CMS 153 and 155 reports were reviewed. The review showed that the laboratory failed to achieve satisfactory performance for the analyte, lactate dehydrogenase, as shown below. Event #1, 2021 lactate dehydrogenase-0% Event #2, 2021 lactate dehydrogenase-0% 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 the review of the laboratory's proficiency testing records, the laboratory director failed to ensure that the laboratory maintained a satisfactory score for proficiency testing in the subspecialty of routine chemistry. Findings include: On August 11, 2021 on or about 10:00 AM, the College of American Pathologists (CAP) proficiency records and the Centers for Medicare & Medicaid Service (CMS) 153 and 155 reports were reviewed. The review showed that the laboratory had unsatisfactory testing scores for two out of three testing events for the analyte, lactate dehydrogenase, in the subspecialty of routine chemistry. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2096 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 the review of the laboratory's proficiency testing scores, the laboratory director failed to ensure that the laboratory performed proficiency testing in such a -- 2 of 3 -- manner as to achieve and maintain successful participation in proficiency testing in the subspecialty of routine chemistry. Findings Include: The review of the College of American Pathologists (CAP) proficiency testing records and the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports on August 11, 2021 on or about 10:00 AM showed that the laboratory received unsatisfactory proficiency testing scores for two out of three testing events as shown below. Event #1, 2021 lactate dehydrogenase-0% Event #2, 2021 lactate dehydrogenase-0% -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced recertification survey was conducted from 03/2/21 through 03/03/21 at Lee Health Coconut Point Clinical Laboratory, a clinical laboratory in Estero, Florida. Lee Health Coconut Point Clinical Laboratory is not in compliance with Code of Federal Regulations (CFR) 42, Part 493, Laboratory Requirements. The following is a description of the noncompliance. 42 CFR 493.1101 Standard: Facilities 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 with the Laboratory Compliance Officer, the laboratory failed to follow the State of Florida Statute 483 regarding independent clinical laboratories and requirements for persons performing testing in the independent clinical laboratory since 07/18/2019. (See D3009) 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 2 -- This STANDARD is not met as evidenced by: Based on record review and interview with the Laboratory Compliance Officer, the laboratory failed to be in compliance with Florida Statute 483 regarding independent clinical laboratories and requirements for persons performing testing in the independent clinical laboratory since 7/18/19. The finding included: Review of CMS 209 Laboratory Personnel Report dated 3/2/21 and signed by the Laboratory Director revealed that 28 testing personnel (#TP M - NN) out of 41 testing personnel (#TP A - NN) were performing moderately complexity testing (iStat testing). Review of personnel files for 7/28/19 - 3/2/21 for Testing Personnel (#M - NN) revealed that the Testing Personnel did not have a Florida Clinical Laboratory Technologist or Technician license. Review of the State of Florida Hospital license 9/29/19 - 9/28/21 revealed the facility was licensed as an Off-Site Emergency Department. Review of the "Point of Care Testing Program" showed that Point of Care Testing was performed at "Alternate Site Testing" (which is an exception for hospital lab testing) and the personnel requirements were "Personnel performing moderate complexity testing, including non - laboratory personnel, must have a minimum of one of the following: 1. Associate degree in chemical, physical, or biological science or medical laboratory technology from an accredited institution: or 2. High School graduate or equivalent and have successfully completed an official military medical laboratory procedures course and have held the military enlisted occupational specialty of Medical Laboratory Specialists; or 3. High School diploma or equivalent and have a record of training defined in the CLIA regulation 42 CFR493.1423". Review of the "Test Orders and Requisitions" revealed "Laboratory tests must be ordered by the physician or a non - physician provider (not a Lee Health organization provider)". Interview on 3/3/21 at 5:00 p.m., with the Laboratory Compliance Officer, she stated she did not know the laboratory should have been certified as an independent lab according to CLIA regulations due to acceptance of non-physician client specimens. The iStat testing personnel must be Florida licensed clinical laboratory personnel under Florida Statutes Chapter 483. -- 2 of 2 --