Golden Corner Family Practice

Summary Statement of Deficiencies D0000 An onsite Recertification survey was conducted at Golden Corner Family Practice on April 30, 2025, by South Carolina Department of Public Health (SC DPH) Bureau of Nursing Homes and Medical Services. The facility was found to be out of compliance with the Medicare Condition at 42 CFR 493 CLIA Laboratory Requirements. The following is a list of Standard Level deficiencies cited as a result of the CLIA survey on April 30, 2025. 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 record review and staff interview the laboratory failed to examine proficiency testing (PT) samples by personnel who routinely perform the testing in the laboratory for 3 years reviewed (2023, 2024 and 2025). Findings included: 1. Review of CMS 209 personnel report form reveals 10 testing personnel (TP). 2. Review of PT records reveals 2 out of 10 testing personnel performed proficiency testing for 2 out of 3 years examined (2023, 2024 and 2025). a. 2023 Hematology/Coagulation-3rd Event reveal TP5 and TP7 performed PT test. b. 2025 Hematology/Coagulation-1st Event reveal TP5 & TP7 performed PT test. 3. In an interview on April 30, 2025, at 2:25 pm in the office with testing personnel the above findings were confirmed. 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, 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 -- consultant competency. This STANDARD is not met as evidenced by: Based on records review, lack of documentation, and staff interview the laboratory failed to establish and follow written policies and procedures to assess for 1 of 1 technical consultant (TC) as specified 493.1413. Findings include: 1. Review of CMS 209 list one technical consultant (TC). 2. Review of policies and procedures reveal lack of documentation for established written policies and procedures to assess the TC. 3. In an interview on April 30, 2025, at 2:25 pm with TC and TP7 in the office the above findings were confirmed. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on policies and procedures reviewed and staff interview, the laboratory director failed to sign and date the hematology procedure before use for three years reviewed (2023, 2024, and 2025). Findings included: 1. A review of hematology procedures for hematology analyzer installed and validated March 31, 2023, revealed a lack of the laboratory director's approval by signature and date as specified 493.1251(d). 2. In an interview on April 30, 2025, at 4:00 pm in the office with TP7 and TC confirmed the user manual is used as a procedure manual and is not signed by the laboratory director confirming the above findings. 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 direct observation, lack of documentation and staff interview the laboratory failed to ensure accurate and reliable test system for the monitoring of temperature and humidity for the laboratory for 17 months (Augus 2023 thru December 2024) reviewed. Findings included: 1. During an onsite survey on April 30, 2025, a tour of the laboratory at 4:30 pm, the surveyor directly observed the room thermometer and humidity embeded in a clock on the wall was used to monitor the laboratory's temperature. 2. A review of environmental records reveals the laboratory lack documentation of temperature and humidity verification of clock's device. 3. In an interview on April 30, 2025, at 4:30 pm in the laboratory with TC and TP7 the above findings were confirmed. -- 2 of 5 -- D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on direct observation, review of package inserts for quality control of moderately complex hematology analyzer and staff interview the laboratory failed to ensure controls were labeled for open and expiration dates to retain the stability for 15 days as required by Sysmex for 3 of 3 vials viewed. Findings included: 1. During a tour of the laboratory on April 30, 2025, at 4:30 pm, the surveyor directly observed 3 vials of XN-L controls. a. Sysmex XN L CHECK L1, Lot# 5066 b. Sysmex XN L CHECK L2, Lot# 5066 c. Sysmex XN L CHECK L3 , Lot# 5066 3 of 3 vials were not labeled for open and/or expiration dates on day of survey. 2. Review of package insert for Sysmex XN-L CHECK reveals storage and shelf life after first opening vials will retain stability for 15 days if stored at 2-8 Celsius after being re-capped. 3. In an interview on April 30, 2025, at 4:30 pm in the laboratory with TC and TP7 the above findings were confirmed. D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; AND (b)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i)(A) Hold an earned doctoral or master's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (b)(3)(i)(B) Meet either requirements in 493.1405(b)(3)(i)(B) or (b)(4)(i)(B) or (C); AND (b)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i)(A) Have earned a bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (b)(4)(i)(B) Meet 493.1405(b)(5)(i)(B); and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(5)(i) Have earned an associate degree in medical laboratory technology, medical laboratory science, or clinical laboratory science; and -- 3 of 5 -- (b)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. (b)(6) For blood gas analysis, the individual must- (b)(6)(i) Be qualified under paragraph (b)(1), (2), (3) or (4) of this section; or (b)(6)(ii)(A) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; and (b)(6)(ii)(B) Have at least 2 years of laboratory training or experience, or both, in blood gas analysis; or (b) (7) Notwithstanding any other provision of this section, an individual is considered qualified as a technical consultant under this section if they were qualified and serving as a technical consultant for moderate complexity testing in a CLIA-certified laboratory as of December 28, 2024, and have done so continuously since December 28, 2024. This STANDARD is not met as evidenced by: Based on records review and staff interview, the laboratory failed to have a qualified technical consultant for moderate complexity testing for 21 of 21 months. Findings included: 1. Review of CMS 209 personnel report form reveals 1 TC for moderate complex testing. 2. Review of CMS 116 application reveals specialty of Hematology non-waived moderate complex testing being performed. 3. On April 30, 2025, day of survey, the laboratory lacked documentation to qualify technical consultant as required for moderate complex testing according to 493.1411. 4. In an interview on April 30, 2025, at 4:30 pm in the office with TP7 and TC the surveyor requested but the laboratory failed to provide documentation qualifying technical consultant on day of survey. 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 (b)(2) Have earned a doctoral, master's, or bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology, or nursing from an accredited institution; or (b)(3) Meet the requirements in 493.1405(b)(3)(i)(B), (b)(4)(i)(B), (b)(4)(i)(C) or (b)(5)(i)(B); or (b)(4) Have earned an associate degree in a chemical, biological, clinical or medical laboratory science, or medical laboratory technology or nursing from an accredited institution; or (b)(5) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least a duration of 50 weeks and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(6)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on records review, lack of policies and procedures and staff interview, the laboratory failed to ensure 1 out of 10 testing personnel had documentation of their highest diploma (high school, GED, 50 weeks military training, Associates Degree, Bachelor's Degree, Master's Degree, or Doctorate in Biological, Chemical or Physical Science) as listed under 42 CFR Section 493.1423 to qualify as moderate complexity testing personnel. Findings include: 1. The laboratory listed 10 testing personnel on the CMS 209 personnel form on the day of survey. 2. No education records were present for review on the day of the survey for 1 out 10 testing personnel (TP4). 3. -- 4 of 5 -- Testing personnel confirmed during an onsite interview on April 30, 2025, at 2:25 pm in the office with TP6 and TP 7 the above findings were confirmed. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) (e)(15) Specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on records review, lack of policies and procedures and staff interview, the laboratory failed to specify in writing the responsibilities and duties of the technical consultant as well as each person engaged in the performance of preanalytical, analytic, and postanalytical phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required 493.1413 (b) (7) (8) prior to reporting test results. Findings included: 1. Review of CMS 209 personnel report form reveal one laboratory director (LD), one technical consultant (TC), and ten testing personnel (TP). 2. Review of policies and procedures for moderately complex testing laboratory reveal a lack of written duties/responsibilities for each person involved in all phases of the testing process on the day of survey. 3. In an interview on April 30, 2025, at 4:30 pm with TP7 and TC the above findings were confirmed. -- 5 of 5 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director 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 a proficiency testing desk review of Centers for Medicare and Medicaid 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 -- Services (CMS) form 0155 and American Proficiency Institute (API) 2021 and 2022 records, the laboratory had not successfully participated in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the specialty of Hematology and for the Red Blood Cell (RBC), Hematocrit (HCT), Hemoglobin (HGB), White Blood Cell (WBC), Platelet (PLT), and WBC Diff analytes. Refer to D2130 and D2131. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of CMS form 0155 and American Proficiency Institute (API) 2021 and 2022 records, revealed that the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in three of three consecutive testing events in the specialty of Hematology for the Red Blood Cell (RBC), Hematocrit (HCT), Hemoglobin (HGB), White Blood Cell (WBC), Platelet (PLT) analytes and four of four consecutive testing events WBC Diff analyte. Findings included: 1. Review of the CMS 0155 report revealed the following results: Hematology 2021 - 3rd Event the laboratory received an unsatisfactory score of 33% for the WBC Diff. Hematology 2022 - 1st Event the laboratory received an unsatisfactory score of 0% for the WBC Diff. Hematology 2022 - 1st Event the laboratory received an unsatisfactory score of 0% for RBC. Hematology 2022 - 1st Event the laboratory received an unsatisfactory score of 0% for HCT. Hematology 2022 - 1st Event the laboratory received an unsatisfactory score of 0% for HGB Hematology 2022 - 1st Event the laboratory received an unsatisfactory score of 0% for WBC Hematology 2022 - 1st Event the laboratory received an unsatisfactory score of 0% for PLT. Hematology 2022 - 2nd Event the laboratory received an unsatisfactory score of 0% for the WBC Diff. Hematology 2022 - 2nd Event the laboratory received an unsatisfactory score of 0% for RBC. Hematology 2022 - 2nd Event the laboratory received an unsatisfactory score of 0% for HCT. Hematology 2022 - 2nd Event the laboratory received an unsatisfactory score of 0% for HGB Hematology 2022 - 2nd Event the laboratory received an unsatisfactory score of 0% for WBC Hematology 2022 - 2nd Event the laboratory received an unsatisfactory score of 0% for PLT. Hematology 2022 - 3rd Event the laboratory received an unsatisfactory score of 0% for the WBC Diff. Hematology 2022 - 3rd Event the laboratory received an unsatisfactory score of 0% for RBC. Hematology 2022 - 3rd Event the laboratory received an unsatisfactory score of 0% for HCT. Hematology 2022 - 3rd Event the laboratory received an unsatisfactory score of 0% for HGB Hematology 2022 - 3rd Event the laboratory received an unsatisfactory score of 0% for WBC Hematology 2022 - 3rd Event the laboratory received an unsatisfactory score of 0% for PLT. 2. A review of the American Proficiency Institute (API) 2021 and 2022 proficiency testing records confirmed the laboratory received the above results. Word Key: WBC Diff=White Blood Cell Differential D2131 HEMATOLOGY CFR(s): 493.851(g) Failure to achieve an overall testing event score of satisfactory performance for two -- 2 of 3 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of CMS form 0155 and American Proficiency Institute (API) 2021 and 2022 records, revealed that the laboratory failed to achieve satisfactory performance (80% or greater) for the overall specialty of Hematology in three of three consecutive testing events. Findings included: 1. Review of the CMS 0155 report revealed the following results: Hematology 2022 - 1st Event the laboratory received an unsatisfactory score of 0% for Hematology. Hematology 2022 - 2nd Event the laboratory received an unsatisfactory score of 0% for Hematology. Hematology 2022 - 3rd Event the laboratory received an unsatisfactory score of 0% for Hematology. 2. A review of American Proficiency Institute (API) 2021 and 2022 proficiency testing records confirmed the laboratory received the above results. 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 a proficiency testing desk review of CMS form 0155 and American Proficiency Institute (API) 2021 and 2022 records, revealed that the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. 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 a proficiency testing desk review of CMS form 0155 and American Proficiency Institute (API) 2021 and 2022 records, revealed that the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2130 and D2131. -- 3 of 3 --