Florida Physician Specialists Llc

Summary Statement of Deficiencies D0000 At the time of the announced, onsite recertification survey, Florida Physician Specialists was found to not be in compliance with the CLIA laboratory requirements of 42 CFR 493. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of proficiency testing records and interview with staff, the Laboratory Director or designee failed to sign proficiency test attestation statements for 9 of 9 testing events reviewed. The findings include: Review of American Proficiency Institute (API) records showed the Laboratory Director or designee failed to sign API's attestation statements attesting to the routine integration of the proficiency samples into the patient workload using the laboratory's routine methods for the following testing events: a. 2024 - Chemistry Event 1, Event 2, and Event 3 b. 2024 - Microbiology Event 1, Event 2, and Event 3 c. 2025 - Chemistry Event 1, Event 2 d. 2025 - Microbiology Event 1 During interview on 7/10/2025 at 11:40 AM, testing person #1 confirmed the attestation statements listed above were not signed by the Laboratory Director or designee. . 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 D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, observation and interview the laboratory failed to follow written policies and procedures to ensure positive patient identification during nongynecologic specimen processing. Findings include: 1. The laboratory failed to follow the procedure PROCEDURE FOR ACCESSIONING & LABELING SPECIMENS which stated: "-Specimens are entered into the LIS System and assigned a unique Accession Number (e.g.C99-1234 for cytology specimens). - Label the container in which the specimen is received with the accession number on the side of the container. -Throughout the specimen accessioning, processing, labelling procedures of testing, staff are to ensure that specimen name and numbers match and correspond." 2. The laboratory failed to follow the procedure CENTRIFUGE PROCEDURE which stated: "Label a 50 ml conical centrifuge tube with the cytology case number, the patient's last name." 3. During an observation of nongynecologic specimen processing on February 6, 2024 at 12:10 PM the Cytology Processor failed to label the specimen centrifuge tubes with a patient identifier. a. The Cytology Processor wrote a partial accession number on the specimen centrifuge tube cap. The Cytology Processor failed to write the "C24" portion of the accession number on the specimen centrifuge tube cap. b. The Cytology Processor failed to label the specimen centrifuge tubes with the cytology case number and the patient's last name. When the centrifuge tube cap was removed, the specimen centrifuge tube was unlabeled and did not have a patient identifier. c. The laboratory failed to ensure 10 of 10 patient specimens were labeled with a positive patient identifier during Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- nongynecologic specimen processing on February 6, 2024. Specimens include: -C24- 125 -C24-126 -C24-127 -C24-128 -C24-129 -C24-130 -C24-131 -C24-132 -C24-133 - C24-134 4. During an interview on February 6, 2024 at 12:27 PM these findings were confirmed with the Laboratory Manager and the Cytology Processor. 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 laboratory policies and procedures, lack of competency assessment records and interviews with the Laboratory Manager the laboratory failed to establish and follow written policies and procedures to assess the competency of the Technical Supervisors. The laboratory failed to assess the competency of two of two Technical Supervisors in 2023 and January 1, 2024 to the date of the survey in 2024. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to describe the process for assessing the competency of the Technical Supervisors who performed cytology testing on patient specimens. 2. The Survey Team requested and the laboratory failed to provide documentation of competency assessments for the cytology duties performed by two of two Technical Supervisors in 2023 and January 1, 2024 to the date of the survey in 2024. Technical Supervisors include: -Technical Supervisor A -Technical Supervisor B 3. During interviews on February 5, 2024 at 11:40 AM and February 6, 2024 at 8: 10 AM these findings were confirmed with the Laboratory Manager. D5309 TEST REQUEST CFR(s): 493.1241(e) If the laboratory transcribes or enters test requisition or authorization information into a record system or a laboratory information system, the laboratory must ensure the information is transcribed or entered accurately. This STANDARD is not met as evidenced by: Based on review of final cytology test reports and corresponding laboratory requisitions and interview with the Laboratory Manager the laboratory failed to ensure that cytology specimen information was transcribed accurately into the laboratory information system (LIS) for six of twenty cytology specimens sampled from December 2023. Findings include: 1. The Survey Team compared 20 final cytology test reports from December 2023 with corresponding laboratory requisitions. Six of 20 final cytology test reports failed to have accurate specimen information transcribed into the LIS. Specimen information includes: -Case #: C24-1345 Lab Requisition: ICD codes 1233.9; C67.4; R31.0; R39.89 Cytology Test Report: ICD codes 1233.9 and C67.4 not entered -Case #: C24-1367 Lab Requisition: collection date 12/20/21 Cytology Test Report: collection date 12/19/2023 -Case #: C24-1372 Lab Requisition: ICD code N39.0 Cytology Test Report: ICD code not entered -Case #: C24-1377 Lab Requisition: voided urine Cytology Test Report: bladder wash -Case #: C24-1390 Lab Requisition: bladder wash catheter urine Cytology Test Report: catheter urine -Case #: C24-1393 Lab Requisition: clinical hematuria Cytology Test Report: hematuria not -- 2 of 5 -- entered 2. During an interview on February 6, 2024 at 12:30 PM these findings were confirmed with the Laboratory Manager. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(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 preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records and interviews with the Laboratory Manager the laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and correct problems identified in the preanalytic cytology systems. The laboratory failed to document preanalytic quality assessment activities for cytology during 2023 and January 1, 2024 to the date of the survey in 2024. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures for an ongoing program to monitor, assess and correct problems identified in the preanalytic cytology systems. 2. The Survey Team requested and the laboratory failed to provide documentation of preanalytic quality assessment activities during 2023 and January 1, 2024 to the date of the survey in 2024. a. The laboratory failed to document a system for monitoring and evaluating the accuracy of transcription of patient specimen information into the final test report. (See D5309) 3. During an interview on February 6, 2024 at 9:50 AM these findings were confirmed with the Laboratory Manager. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the lack of quality control records and interview with the Laboratory Manager the laboratory failed to test staining materials for intended reactivity of the Papanicolaou stain used for nongynecologic cytology specimen slides for each day of use in 2023 and January 1, 2024 to the date of the survey in 2024. Findings include: 1. The Survey Team requested and the laboratory failed to provide laboratory records documenting that the characteristics of the Papanicolaou stain used for nongynecologic cytology slide preparations were assessed each day of use in 2023 and January 1, 2024 to the date of the survey in 2024. 2. During an interview on February 5, 2024 at 1:50 PM these findings were confirmed with the Laboratory Manager. D5637 CYTOLOGY CFR(s): 493.1274(d)(1)(ii) -- 3 of 5 -- (d) Workload limits. The laboratory must establish and follow written policies and procedures that ensure the following: (d)(1)(ii) Each individual's workload limit is reassessed at least every 6 months and adjusted when necessary. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, lack of workload limit reassessment records and interview with the Laboratory Manager the laboratory failed to establish and follow written policies and procedures to reassess and adjust when necessary, a maximum workload limit at least every six months for the Technical Supervisors who performed primary screening of cytology specimens. The Technical Supervisor failed to reassess a maximum workload limit for two of two Technical Supervisors in 2023 and January 1, 2024 to the date of the survey in 2024. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to detail how the Technical Supervisor would reassess a maximum workload limit for the Technical Supervisors at least every six months and adjust when necessary. The laboratory failed to provide written policies and procedures to detail what performance criteria would be reviewed as part of a workload reassessment. 2. The Survey Team requested and the laboratory failed to provide documentation the Technical Supervisor reassessed a maximum workload limit for two of two Technical Supervisors in 2023 and January 1, 2024 to the date of the survey in 2024. Technical Supervisors include: -Laboratory Director/Technical Supervisor A -Technical Supervisor B 3. During an interview on February 6, 2024 at these findings were confirmed with the Laboratory Manager. D5659 CYTOLOGY CFR(s): 493.1274(e)(6) (e) The laboratory must establish and follow written policies and procedures that ensure the following: (e)(6) Corrected reports issued by the laboratory indicate the basis for correction. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures and interview with the Laboratory Manager the laboratory failed to establish written policies and procedures to ensure corrected test reports indicated the basis for correction on the corrected test report. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to ensure corrected test reports indicated the basis for correction on the corrected test report. 2. During an interview on February 6, 2024 at 10:00 AM these findings were confirmed with the Laboratory Manager. 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 laboratory policies and procedures, lack of quality control records and interview with the Laboratory Manager the Laboratory Director failed to ensure -- 4 of 5 -- written quality control policies and procedures for cytology were followed. Findings include: 1. The Laboratory Director failed to ensure the written policy and procedure titled CYTOLOGY STAINING-QUALITY CONTROL was followed. The policy stated: "A Pathologist or designee, will check the Cytology staining quality on a daily basis." Refer to D5473 2. During an interview on February 5, 2024 at 1:50 PM these findings were confirmed with the Laboratory Manager. -- 5 of 5 --

Summary Statement of Deficiencies D0000 At the time of the announced, onsite recertification survey, Florida Physician Specialists was found to not be in compliance with the CLIA laboratory requirements of 42 CFR 493. 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 record review and staff interview, the facility failed to have personnel competency assessment performed by a qualified Technical Consultant or Technical Supervisor for 1 of 4 testing personnel reviewed (Testing person D). Findings include: The form titled "Competency Checklist" states "Evaluator: Document by dating and initialing each item at the time of evaluation that employee has shown competency and complete the method of review to include information on specific tests and records reviewed." Review of Personnel Competency assessment records for Testing person D showed annual competency was performed on 2/16/21 by Testing Person C. Testing Person C does not qualify as a Technical Consultant or Technical Supervisor. The interview with Testing Person C on 10/11/21 at 2:30PM confirmed they did not have the requirements to perform Competency Assessment. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's 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 -- instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to document daily laboratory room temperature and humidity for one of three months reviewed (July 2020). The findings include: Review of the document titled "Humidity & Ambient Temperature Chart Accessioning Area" dated July 2020 showed daily temperature and humidty was documented on July 1, 2, 3, 6, 7, 13, 20, 27, 28, 29, 30, and 31. The remaining days (July 8, 9, 10, 14, 15, 16, 17, 21, 22, 23, and 24) had a line drawn down through the column with an arrow at the end. During an interview on 10/11/21 at 12:00PM with Testing Person B, it was confirmed that room temperature was not recorded daily and a line was drawn from the start of the week until weeks end. D5645 CYTOLOGY CFR(s): 493.1274(d)(3) (d) Workload limits. The laboratory must establish and follow written policies and procedures that ensure the following: (d)(3) The laboratory must maintain records of the total number of slides examined by each individual during each 24-hour period and the number of hours spent examining slides in the 24-hour period irrespective of the site or laboratory. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to document and maintain records number of hours spent examining cytology slides during each 24 hour period for two of two years reviewed (2019-2021). Findings include: Review of the laboratory's cytology logs showed that the laboratory failed to have records showing the amount to time spent examining cytology slides during each 24 hour period from August 2019 - September 2021. During an interview on 10/11/14 at 12:20 PM, Testing Person B acknowledged that the laboratory did not have records showing the amount to time spent examining cytology slides. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on 7/9/19-7/11/19. Florida Physician Specialists Llc was found not in compliance with 42 CFR 493, requirements for clinical laboratories. Twelve CLIA Conditions were not met, all at the Immediate Jeopardy level: 42 CFR 493.801 Enrollment and testing of samples, 42 CFR 493.1201 Bacteriology, 42 CFR 493.1210 Chemistry, 42 CFR 493.1230 General Laboratory Systems, 42 CFR 493.1250 Analytic Systems, 42 CFR 493.1403 Laboratories Performing Moderate Complexity Testing; Laboratory Director, 42 CFR 493.1409 Laboratories Performing Moderate Complexity Testing; Technical Consultant, 42 CFR 493.1415 Laboratories Performing Moderate Complexity Testing; Clinical Consultant, 42 CFR 493.1441 Laboratories Performing High Complexity Testing; Laboratory Director, 42 CFR 1447 Laboratories Performing High Complexity Testing; Technical Supervisor, 42 CFR 493.1453 Laboratories Performing High Complexity Testing; Clinical Consultant, and 42 CFR 493.1459 Laboratories Performing High Complexity Testing; General Supervisor. Immediate Jeopardy was identified as beginning on 7/11/19 and is presently ongoing. . 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 record review and interview with laboratory personnel, the laboratory was Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 18 -- not enrolled in proficiency testing (PT) for bacteriology in 2018 or 2019. Findings include: Review of PT records and interview with Testing Person A at 2:50 p.m. on July 10, 2019 revealed that the laboratory did not have documentation to indicate that PT had been performed for the speciality of bacteriology in 2018 and 2019. Testing performed under this specialty includes Urine Culture and Sensitivity. Testing Person A confirmed the laboratory had not performed any PT testing for Urine Culture and Sensitivity since testing began in 2018. . D5002 BACTERIOLOGY CFR(s): 493.1201 If the laboratory provides services in the subspecialty of Bacteriology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1261, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of Bacteriology records and staff interviews, the laboratory failed to ensure quality control was performed each day of patient testing (refer to D5445); failed to check each batch of media for its ability to support growth (refer to D5477); and failed to document