Palm Beach County Health Department-Laboratory

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Palm Beach County Health Department Laboratory on June 6, 2025 to July 16, 2025. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Condition was cited: D6168 - 493.1487 Condition: Testing Personnel D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) (b)The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on interview, review of American Proficiency Institute Proficiency Testing (PT) records and the procedure manual, the laboratory failed to run proficiency testing samples for hematology in the same manner as it runs patients for two (2024 2nd, 2025 1st) of five (2024 1st, 2nd, 3rd; 2025 1st, 2nd) events. Findings: 1. Review of the Proficiency Testing (PT) Procedure noted "PT Survey samples are to be handled same as a patient sample." 2. Review of the PT documents contained two sets of instrument printouts with test results for each PT sample (five per event) for the 2024 2nd and 2025 1st events. 3. During an interview on 06/05/2025 at 3:15 PM, Technical Supervisor B acknowledged the PT samples were run twice and patients are not normally run twice. D3031 RETENTION 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 6 -- 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. In addition, retain the following: This STANDARD is not met as evidenced by: Based on observation, record review and interview, the Laboratory failed to pull chemistry quality control Architect instrument printouts for October 2023 and June 2024. Findings: 1. Tour of the Laboratory on 06/05/2025 at 12:00 PM, revealed an Architect in use for Chemistry testing. The Architect did not have any stored Chemistry quality control results for the months of October in 2023 and June in 2024. 2. Review of record retention policy revealed there was no procedure for record retention. 3. On 06/05/2025 at 12:08 PM, the Technical Supervisor stated the quality control results could not be pulled from the Architect for October 2023 and June 2024. 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 competency evaluations and interview, the laboratory failed to to perform competency assessment for three of three Technical Supervisors (A, B, C) and two of two General Supervisors (A, B) for 2023 and 2024; and the Laboratory Director failed to sign off on the competency assessment for Testing Personnel D for two of two competency assessments in 2023 and 2024. Findings: Review of the Laboratory Personnel Report signed by the Laboratory Director on 06/02/2025 showed there were three Technical Supervisors and 13 Testing Personnel (A - L) listed on the form. A 1. Review of the employee competency assessment binders revealed there were no evaluations performed on the three Technical Supervisors and two General Supervisors for the duties they performed as supervisors. 2. During an interview on 06/06/2025 at 5:17 PM, Technical Supervisor A stated there were no competency evaluations for the Supervisors. B 1. Review of the competency assessment for Testing Personnel D, who was also Technical Supervisor B, revealed the competency assessments for Testing Personnel D were signed by a Testing Personnel. The Hematology/Coagulation Competency Checklist was signed by Testing Personnel J on 07/23/24 and 07/24/23. The Immunology Department Competency Checklist and Molecular Department Competency Checklists were signed by Testing Personnel K on 07/23/2024, and 07/24/2023. 2. During an interview on 06/06/2025 at 5:17 PM, Technical Supervisor B acknowledged her competency assessments as Testing Personnel were signed by another Testing Personnel. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test -- 2 of 6 -- procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies D0000 An announced recertification survey was conducted on 1/31/23 at Palm Beach County Health Department, a clinical laboratory in West Palm Beach, Florida. Palm Beach County Health Department was found not in compliance with Code of Federal Regulations (CFR) 42, Part 493, Laboratory Requirements. 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 CAP (College of American Pathologists) proficiency testing results and interview with Technical Supervisor D, the laboratory failed to document evaluation of proficiency testing (PT) results that were ungraded for the 3rd HIV (Human immunodeficiency virus) Viral Load testing event of 2022 and the 2nd Human Papilloma virus (HPV) testing event of 2022. Findings Include: Review of CAP proficiency testing events CHPV-B 2022 and HIV-C 2022 showed an Exception Reason Code of 33 as the grade given to the laboratory. The CAP uses "Exception Reason Codes" to signify the PT for an analyte that has not been graded. The description for Code 33 states: "Document that the laboratory has contacted CAP and no replacement specimens were available. Perform and document alternative assessment (i.e., split sample) for the period that commercial PT was not tested to the same level and extent that would have been tested". During an interview on 1/31/23 at 12:10 p.m., Technical Supervisor D confirmed that the laboratory did not perform an alternative assessment for HPV or HIV testing. 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 A desk review survey of the laboratory's proficiency test results was performed on 12 /17/2021 for Palm Beach County Health Department. The Palm Beach County Health Department 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 had subsequent unsuccessful performance in proficiency testing for the subspecialty of routine chemistry. Refer to D2097. 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 December 17, 2021 at 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the analyte, blood urea nitrogen, BUN, for three out three out of four testing events in 2020 and 2021. 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. 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 had subsequent unsuccessful participation in proficiency testing for the subspecialty of routine chemistry. Findings include: On December 17, 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 had unsuccessful proficiency testing scores for three out of four testing events for the analyte, blood urea nitrogen, BUN, as shown below. Event #3, 2020 BUN-40% Event #1, 2021 BUN-60% Event #3, 2021 BUN-20% 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 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 December 17, 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 subsequent unsatisfactory proficiency testing score for the analyte, blood urea nitrogen, BUN, in the sub specialty of routine chemistry. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2097. 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; -- 2 of 3 -- 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 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 December 17, 2021 on or about 10:00 AM showed that the laboratory received unsatisfactory proficiency testing scores for three out of four testing events as shown below. Event #3, 2020 Blood urea nitrogen-40% Event #1, 2021 Blood urea nitrogen-60% Event #3, 2021 Blood urea nitrogen-20% -- 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 palm Beach County Health Department-Laboratory. The Palm Beach County Health Department-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, blood urea nitrogen, 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 subspecialty 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, blood urea nitrogen, BUN, as shown below. Event #3, 2020 blood urea nitrogen-40% Event #2, 2021 blood urea nitrogen-60% 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 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 American Association of Bioanalysts (AAB) 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, blood urea nitrogen, 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. 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; -- 2 of 3 -- 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 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 #3, 2020 blood urea nitrogen-40% Event #2, 2021 blood urea nitrogen-60% -- 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 the laboratory's proficiency testing records for 2018 and 2019, the laboratory did not have successful performance in proficiency testing for the analyte of albumin 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 the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports, on May 15, 2019, on or about 1:00 PM, showed that the laboratory had unsatisfactory testing scores for the analyte, albumin for two out of three testing events in 2018 and 2019. 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 -- 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 participation in proficiency testing in the sub-specialty of routine chemistry. Findings include: On May 15, 2019 on or about 1:00 PM 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, albumin, as shown below. Event #3, 2018 albumin-0% Event #1, 2019 albumin-0% 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 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 for the analyte, albumin, in the subspecialty of routine chemistry. Findings include: On May 15, 2019, on or about 1:00 PM, the College 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, albumin, in the sub-specialty of routine chemistry. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2096. 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 the review of the laboratory's proficiency testing scores, the laboratory director failed to ensure that the laboratory performed proficiency testing in such a manner as to achieve and maintain successful participation in proficiency testing for -- 2 of 3 -- the analyte, albumin, 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 May 15, 2019 on or about 1:00 PM showed that the laboratory received unsatisfactory proficiency testing scores as shown below. Event #3, 2018 albumin-0 % Event #1, 2019 albumin-0%. -- 3 of 3 --

Summary Statement of Deficiencies D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel, the technical supervisor did not document a six month competency evaluation for one of two testing personnel hired since the last survey, Findings include: Review of personnel records on 11/28/18 revealed that one of the two technologists hired over the past year did not have any documentation to indicate that a competency evaluation had been done since she was hired 02/05/18. During an interview with her supervisor who was also one of the technical supervisors, he did not recall documenting an evaluation of her. 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 --