Emerald Coast Oncology And Hematology

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Emerald Coast Oncology and Hematology Associates PA on 5/22/2024. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Conditions were cited: D6000-Laboratory Director-493.1403 D6063-Testing Personnel -493.1421 D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of review of Proficiency Testing (PT) records, interview, the Laboratory Director failed to sign Proficiency Evaluation forms for PT for the speciality of Hematology for six of six ( 2022-2nd, 3rd, 2023-1st, 2nd, 3rd, and 2024- 1st) events reviewed. Findings: Review of American Academy of Family Physicians (AAFP) records for 2022 and Wisconsin State Laboratory of Hygiene (WSLH) records for 2023-2024 showed there was no Proficiency Evaluation signed by the Laboratory Director. On 05/22/2024 at 11:30 AM, Testing Personnel C confirmed there were no Proficiency Evaluations reviewed by the Laboratory Director . 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: 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 -- Based on record review and inteview, the Laboratory Director failed to provide overall management and direction of the laboratory for two of two years reviewed (2022-2024). Findings: The Laboratory Director failed to provide effective direction over the laboratory for two of two years reviewed (2022-2024). (See D6004) The Laboratory Director failed ensure Proficiency Evaluations were reviewed by him for PT for the speciality of Hematology for six of six ( 2022-2nd, 3rd, 2023-1st, 2nd, 3rd, and 2024-1st) events. (See D5211) The Laboratory Director (Technical Consultant ) failed to ensure evaluation of competency for testing personnel listed on the Laboratory Personnel Report for 6 of 7 testing personnel (B, C, D, E, F, and G) for two of two years reviewed (2022-2024). (See D6046) The Laboratory Director failed to ensure education qualifications were verified for 2 Testing Personnel (TP E and TP F) out of 7 Testing Personnel (TP A-TP-G). (See D6063) D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on record review and interview, the Laboratory Director failed to provide effective direction over the laboratory for two of two years reviewed (2022-2024). Findings: The Laboratory Director failed ensure Proficiency Evaluations were reviewed by him for PT for the speciality of Hematology for six of six ( 2022-2nd, 3rd, 2023-1st, 2nd, 3rd, and 2024-1st) events. (See D5211) The Laboratory Director (Technical Consultant ) failed to ensure evaluate competency of testing personnel listed on the Laboratory Personnel Report for 6 of 7 testing personnel (B, C, D, E, F, and G) for two of two years reviewed (2022-2024). (See D6046) The Laboratory Director failed to ensure education qualifications were verified for 2 Testing Personnel (TP E and TP F) out of 7 Testing Personnel (TP A-TP-G). (See D6063) D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: -- 2 of 4 -- Based on record review and interview, the Laboratory Director failed to ensure Testing Personnel (TP) had education verified prior to reporting patient results for 2 (TP E and TP F) out of 7 Testing Personnel (A-G). Findings: See D6065. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of competency evaluations, and interview, the Technical Consultant (Laboratory Director) failed to evaluate competency of testing personnel listed on the Laboratory Personnel Report for 6 of 7 testing personnel (B, C, D, E, F, and G) for two of two years reviewed (2022-2024). Findings: Review of the Laboratory Personnel Report signed by the Laboratory Director on 05/22/2024 showed there were 6 testing personnel other than himself. The Laboratory Director was also listed as Clinical Consultant and Technical Consultant. Review of initial, semi-annual, and annual competency evaluations for Testing Personnel B to G performed from 6/2022 to 5/2024 showed they were signed by Testing Personnel B or Testing Personnel C. On 05/22/2024 at 10:30 AM Testing Personnel B and C stated they performed and signed all competency evaluations from 6/2022 to 5/2024. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on review of the Laboratory Personnel Report, personal records, and interview, the laboratory failed to verify the education qualifications for 2 Testing Personnel (TP E and TP F) out of 7 Testing Personnel (TP A-TP-G). (See 6065) D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and -- 3 of 4 -- This STANDARD is not met as evidenced by: Based on review of the Laboratory Personnel Report, personnel records and interview, the laboratory failed to verify the educational qualifications for 2 Testing Personnel (TP E and TP F) of 7 Testing Personnel (TP A-TP G). Findings: Review of the Laboratory Personnel Report, signed by the Laboratory Director 05/22/2024 showed there were 7 laboratory staff listed as moderate complexity testing personnel. Review of the laboratory personnel records showed there was no documentation of education for TP E and TP F available for review. On 05/22/2024 at 10:30 AM TP C confirmed there was no education available for review for TP E and TP F. On 05/22/2024 at l:30 PM the Laboratory Director/Technical Consultant confirmed the lack of educational documentation for TP E and TP F. -- 4 of 4 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on March 8, 2022 and continued through April 1, 2022 to gather additional documentation. Emerald Coast Oncology and Hematology, a clinical laboratory, was not in compliance with 42 CFR 493, Requirements for Laboratories. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on record review and interview with Testing Personnel (TP) #A, the laboratory failed to have the proficiency testing attestation sheet signed by the laboratory director and testing personnel for the first testing event of 2020. Findings included: Record review of attestation sheets revealed the form for the first testing event in 2020 had not been signed by the laboratory director or the testing personnel. Interview on 3/08 /2022 at 1530 with TP #A confirmed the attestation sheet had not been signed by the laboratory director or the testing personnel. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) 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 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 record review and interview with Testing Personnel (TP) #A, the laboratory failed to establish and follow a written quality assessment policy. Findings included: Review of laboratory records revealed there was no quality assessment policy. Interview with TP #A on 3/08/2022 at 1530 confirmed the laboratory did not have a quality assessment policy in place. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Emerald Coast Oncology And Hematology Associates PA on April 3, 2020. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of CMS 209- Laboratory Personnel Report, review of American Academy of Family Physicians (AAFP) proficiency testing, and interview with the Laboratory Staff, the laboratory failed to have all testing people to rotate through the testing of proficiency testing for 1 of 1 year (2019) reviewed. Findings Included: Review of the CMS 209 (signed and dated by the Laboratory Director 03/30/20) had 8 testing people listed ( #2 - #9 ). Review of AAFP proficiency testing found that Testing Person #2 was the only person who performed the proficiency testing in 2019. Interview with the Laboratory Manager on 04/03/20 at 11:00 AM confirmed that Testing Person #2 was the only person performing proficiency testing even though Testing Person #2 - #9 all performed patient testing. 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 interview with the laboratory staff, the laboratory failed to monitor the room temperature and humidity of the laboratory for 2 of 2 years ( 2018-2020 ) reviewed. Findings included: Review of the maintenance logs showed no room temperature and humidity were recorded from 2018 through 2020. Review of the instrument manual of the Complete Blood Count (CBC) Analyzer, Coulter Act Diff revealed that the environmental conditions of the equipment needed a maintenance of a room temperature between 16 degrees Celsius to 35 degrees Celsius and a humidity no higher than 85 %. Interview with Laboratory Manager at 1:00 PM confirmed that the room temperature and humidity of the laboratory were not documented. D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) 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)(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; This STANDARD is not met as evidenced by: Based on record review and interview with the laboratory staff, the laboratory director failed to approve and sign the Policies and Procedures of the laboratory for 2 of 2 years ( 2018-2020 ) reviewed. Findings included: Review of the Policies and Procedures of the laboratory showed that signature and approval of the laboratory director were missing from 2018 through 2020. Interview with Laboratory Manager at 11:30 AM confirmed that the laboratory director did not approve and sign the Policies and Procedures of the laboratory. -- 2 of 2 --

Summary Statement of Deficiencies D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to perform yearly preventive maintenance on LW Scientific ( M Series Labscope) microscope being used for manual cell identification in hematology for 2 years ( 2016-2018). Findings included: Review of the equipment maintenance records for March 2016 - March 2018 showed that no documentation for annual preventive maintenance done on the microscope. Interview on 3/14/18 at 11:00 AM , personnel # E confirmed that the lab did not have records to show annual preventive maintenance performed on the microscope. 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 --