Associated Medical Specialists, Pa Dba

Summary Statement of Deficiencies D0000 An announced onsite CLIA recertification survey was conducted on May 21, 2025, at the laboratory of Coastal Cancer Center of Myrtle Beach by the South Carolina Department of Public Health (SC DPH) Bureau of Nursing Homes and Medical Services. The laboratory was found to be out of compliance with Medicare condition 42 CFR Part 493, CLIA Requirements for Laboratories. The following is a list of Standard Level deficiencies cited as a result of the May 21, 2025 recertification survey: D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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 records review, CMS 209 form, and staff interview, the laboratory failed to rotate chemistry proficiency testing (PT) among testing personnel (TP). Findings included: 1. Review of the CMS 209 form for the survey conducted on May 21, 2025 lists 19 TP. 2. Review of American Proficiency Institute (API) Attestation statement documentation reveals: TP1 is listed as testing personnel for the following PT events: 2024 Chemistry 1st event 1/24/24 2024 Chemistry 2nd event 5/30/24 2024 Chemistry 3rd event 9/10/2024 2025 Chemistry 1st event 1/21/2025 2024 Immunology 1st event 3/28/2024 2024 Immunology 2nd event 8/1/2024 2025 Immunology 1st eevent 4/1 /2025 2024 Hematology 1st event 3/8/2024 2024 Hematology 2nd event 7/22/2024 2024 Hematology 3rd event 11/8/2024 2025 Hematology 1st event 3/14/2025 3. The above documentation reveals the laboratory's failure to rotate PT testing to TP that routinely perform testing. 4. In an interview with TP1 on May 21, 2025 at 1:00pm in the laboratory, the findings were confirmed. 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 -- D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on records review, lack of documentation, and staff interview, the laboratory failed to follow its policy and procedure for an ongoing process to monitor , assess, and when indicated, correct problems identified by quality assessments. Findings included: 1. Review of laboratory documentation reveals a lack of quality assessment activities. 2. Review of the laboratory's "QA Statement and Additional QA Measures" indicates QA audits are to be performed "quarterly". No quarterly documentation was available for review. 3. In an interview on May 21, 2025 at 1:00pm in the laboratory conference room with the Techincal Supervisor (TS), the findings were confirmed. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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 instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 records review, manufacturer's instructions, observation, and staff interview, the laboratory failed to ensure materials used in patient testing were being stored as required. Findings included: 1. Review of temperature and humidity logs reveals a lack of documentation for the blood drawing room and storage room. 2. Vacutrainer collection tubes were observed in the storage room with manufacturer's storage temperature of 4-25 degrees C. The tubes included: a. 36 flats of lavender top collection tubes 4ml K3EDTA, lot # 24103M, expiration date 01/31/2026. b. 1 flat of green top collection tubes sodium heparin, lot #B240936K, expiration date 01/31 /2026. 3. Surveyor observed that there was no temperature monitoring device in the storage room or the blood drawing room. 4. In a staff interview on May 21, 2025, at 2: 51pm in the storage room with TP1, the findings were confirmed. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: -- 2 of 3 -- Based on records review, manufacturer's instruction, and staff interview, the laboratory failed to perform maintenance procedures as required by the manufacturer. Findings included: 1. Review of the Vitros 5600 maitainence log reveals the following: a. Lack of documentation for monthly maintainence for January 2023, June 2023, and December 2023. b. Lack of documentation for quarterly maintainece for April 2023, August 2023, and December 2023. 2. In an interview with TP1 on May 21, 2025 at 1:40pm in the laboratory, the findings were confirmed. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Recertification Survey was initiated on 06/07/2023 and concluded on 06/07/2023. The facility was found not to be in compliance with the laboratory requirements of 42 CFR Part 493 with deficiencies cited. 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 a review of the policy/procedure manual and interview, the laboratory failed to establish a written policy/procedure to specify how employee competency would be assessed. Findings included: A review of the laboratory policy/procedure manual, reviewed and approved by the Laboratory Director on 09/26/2022, revealed there was not a written policy/procedure to indicate how employee competency would be evaluated. In an interview on 06/07/2023 at 1:30 PM, the Technical Consultant /Testing Personnel #1 said the laboratory did not have a policy to indicate how employee competency would be evaluated. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. 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 observation, laboratory policy review, and interview, the laboratory failed to evaluate the relationship between test results gathered from 2 of 2 hematology analyzers operated at the laboratory to ensure each analyzer produced consistent results. Findings included: A review of a laboratory policy titled, "Hematology Analyzer Procedure," reviewed and signed by the Laboratory Director (LD) on 09/26 /2022, revealed there was not a written procedure for the required twice-yearly evaluation of test results between the two hematology analyzers. During a tour of the laboratory on 06/07/2023 at 12:15 PM, the surveyor observed two complete blood count (CBC) analyzers in use. In an interview on 06/07/2023 at 1:20 PM, the Technical Consultant/Testing Personnel #1 stated the two hematology (CBC) analyzers were not evaluated to ensure consistent results. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) 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)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on document review, policy review, and interviews, the Laboratory Director failed to establish policies and procedures to indicate how testing personnel competency assessments would be monitored. Findings included: A review of laboratory policy/procedure manual, reviewed and approved by the Laboratory Director on 09/26/2022, revealed there was not a policy/procedure to indicate how the competency of testing personnel would be monitored. A review of the Technical Consultant/Testing Personnel #1's personnel file, revealed there was no competency assessment. In an interview on 06/07/2023 at 1:30 PM, the Technical Consultant /Testing Personnel #1 stated the laboratory did not have a policy that addressed the competency assessment of testing personnel. In a follow-up interview on 06/07/2023 at 2:30 PM, the Technical Consultant/Testing Personnel #1 stated they had not had a competency assessment since hire. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on interview and document reviews, the Technical Consultant failed to evaluate -- 2 of 3 -- the performance of testing personnel (TP) semiannually during their first year of employment for 5 of 18 TPs reviewed. Findings included: A review of the "Laboratory Personnel Report (CLIA) [Clinical Laboratory Improvement Amendments]," signed by the Laboratory Director and dated 06/07/2023, indicated the laboratory had a total of 18 testing personnel qualified to perform moderate complexity testing. A review of TP #5's "New Employee Criteria," revealed TP #5's hire date as 10/18/2021. Per the document, TP #5 had one competency evaluation during their first year of employment on 12/04/2021. A review of TP #6's "New Employee Criteria," revealed TP #6's hire date as 10/27/2021. Per the document, TP #6 had one competency evaluation during their first year of employment on 12/08 /2021. A review of TP #7's "New Employee Criteria," revealed TP #7's hire date as 04 /26/2021. Per the document, TP #7 had one competency evaluation during their first year of employment on 06/15/2021. A review of TP #8's "New Employee Criteria," revealed TP #8's hire date as 02/02/2022. Per the document, TP #8 had one competency evaluation during their first year of employment on 03/14/2022. A review of TP #13s "New Employee Criteria," revealed TP #13's hire date as 08/10/2021. Per the document, TP #13 had one competency evaluation during their first year of employment on10/05/2021. In an interview on 06/07/2023 at 2:30 PM, the Technical Consultant/TP #1 stated there were multiple TPs who missed one or both of their semiannual competency assessments. Per the TC, staff were provided a training worksheet when first hired, but competency was not evaluated twice during their first year of employment. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on interview and document reviews, the Technical Consultant failed to annually evaluate the performance of 2 of 18 testing personnel (TP) qualified to perform moderate complexity testing. Findings included: A review of the "Laboratory Personnel Report (CLIA) [Clinical Laboratory Improvement Amendments]," signed by the Laboratory Director and dated 06/07/2023, indicated the laboratory had a total of 18 testing personnel qualified to perform moderate complexity testing. A review of TP #3's "Annual Employee Competency Assessment," revealed their last competency assessment was completed on 03/19/2021. A review of TP #4's "Annual Employee Competency Assessment," revealed their last competency assessment was completed on 04/01/2021. In an interview on 06/07/2023 at 2:30 PM, the Technical Consultant /TP #1 stated there were multiple TPs who missed their annual competency assessment. -- 3 of 3 --