Colonial Family Practice

Summary Statement of Deficiencies D0000 An onsite CLIA recertification survey was conducted at the clinical laboratory of Colonial Family Practice on January 8, 2025, by the South Carolina Department of Public Health's Bureau of Nursing Homes and Medical Services. The laboratory was found to be out of compliance with 42 CFR Part 493, CLIA Requirements for Laboratories. 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 Supply Storage Room lacked a mechanism to monitor the temperature in the room. Findings included: 1) During a tour of the laboratory on January 8, 2025 at 1:00pm with the office manager, the surveyor reccognized the lack of mechanism to monitor the temperature and humidity in the supply storage room. 2) The following is a list of temperature sensitve reagents observed in the supply storage room: a. CTNG 16 kits, lot # B403420, expiration date (exp) 03/31/2026, storage temp (st) 2- 25 C b. Bechman wash solution 10 bottles, lot # M2055441, exp 03/31/2026, st 2-25 C c. Bechman ISE Reference Solution 9 bottles, lot# M402446, exp 06/30/2025, st 2-25 C d.Bechman Mid Standard Solution 12 bottles, lot # M410475, exp 2/28/2026, st 2-25 C. e.Bechman Ethylene Glycol 4 bottles, lot # M402446, exp 2/29/2028 st 2-25 C. f. 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 -- Cepheid 5 Kits COV 2FLU/RSV plus, lot # 100144604, exp 8/31/2026, st 15-30 C. g. Bechman Coulter Unicel DXI Diluent 21boxes, lot # 331613 exp 11/26/2025, st 2-40 C. 3) In an interview with the office manager on January 8, 2025 at 1:00pm in the laboratory, the findings were confirmed. -- 2 of 2 --

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: During a proficiency testing desk review performed on 03/03/2022, based on review of CASPER report 155D and graded reports from American Proficiency Institute (API), it was determined that the laboratory failed to successfully participate in proficiency testing for the specialty of chemistry, the analyte total bilirubin for two of three consecutive proficiency testing events reviewed (2021, Events 2 and 3). See D2087 and D2096. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(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 -- Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: During a PT desk review performed on 03/03/2022, based on review of CASPER report 155D and graded reports from API, the laboratory failed to successfully participate in proficiency testing for the specialty of chemistry, the analyte total bilirubin for two of three consecutive proficiency testing events reviewed (2021, Events 2 and 3).Findings include: 1. Review of the CASPER report 155D revealed the following total bilirubin event scores: a. 2021, Event 2: 20% b. 2021, Event 3: 40% 2. The above event scores were confirmed upon review of the graded report from API. Scores less than 80% for this analyte indicates unsatisfactory performance. A failure of this analyte for two consecutive or two out of three consecutive testing events is scored as unsuccessful. 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: During a proficiency testing desk review performed on 03/03/2022, based on review of the CASPER 155D report and graded report from API, it was determined that the laboratory failed to achieve satisfactory performance for total bilirubin in two consecutive testing events (2021, Events 2 and 3). See D2087. -- 2 of 2 --

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: During an onsite recertification survey performed on 11/02/2021, based on review of CASPER report 155D and graded reports from American Acadamey of Family Physicians (AAFP), it was determined that the laboratory failed to successfully participate in proficiency testing for the specialty of chemistry, the analyte ALT (alanine transaminase) for two consecutive proficiency testing events reviewed (2020, Events 2 and 3). See D2087, D2096 D2087 ROUTINE CHEMISTRY CFR(s): 493.841(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 -- Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: During the onsite recertification survey performed on 11/02/2021, based on review of CASPER report 155D and graded proficiency reports from AAFP, it was determined that the laboratory failed to attain a satisfactory score of at least 80% for ALT (alanine transaminase) on two consecutive proficiency testing events. Findings include: 1. The CASPER 155D report revealed the following scores for your laboratory's ALT: a. 2020, Event 2: 0% b. 2020, Event 3: 0% 2. The scores were confirmed by review of the graded AAFP results. Scores less than 80% for these analytes indicate failure or unsatisfactory performance. A failure of the analytes for two consecutive or two out of three testing events is scored as unsuccessful. A failure of the analyte for three consecutive or three out of four/five events is scored as a repeat unsuccessful. 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: During an onsite recertification survey performed on 11/02/2021, based on review of the CASPER 155D report and graded report from AAFP, it was determined that the laboratory failed to achieve satisfactory performance for ALT in two consecutive testing events (2020, Events 2 and 3). See D2087. -- 2 of 2 --

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: During a proficiency testing desk review performed on 08/20/2021, based on review of CASPER report 155D and graded reports from American Acadamey of Family Physicians (AAFP), it was determined that the laboratory failed to successfully participate in proficiency testing for the specialty of chemistry, the analyte albumin and chloride for three consecutive proficiency testing events reviewed (2020, Events 1,2 and 3) (See D2087, D2096). D2087 ROUTINE CHEMISTRY CFR(s): 493.841(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 3 -- Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: During the proficiency testing desk review performed on 08/20//2021, based on review of CASPER report 155D and graded proficiency reports from AAFP, it was determined that the laboratory failed to attain a satisfactory score of at least 80% for albumin and chloride on three consecutive proficiency testing events reviewed (2020, Events 1, 2, and 3) . Findings include: 1. The CASPER 155D report revealed the following scores for your laboratory's albumin: a. 2020, Event 1: 40% b. 2020, Event 2: 0% c. 2020, Event 3: 0% The CASPER 155D report revealed the following scores for your laboratory's chloride: a. 2020, Event 1: 0% b. 2020, Event 2: 0% c. 2020, Event 3: 0% 2. The scores were confirmed by review of the graded AAFP results. Scores less than 80% for these analytes indicate failure or unsatisfactory performance. A failure of the analytes for two consecutive or two out of three testing events is scored as unsuccessful. A failure of the analyte for three consecutive or three out of four/five events is scored as a repeat unsuccessful. 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: During a proficiency testing desk review performed on 08/20/2021, based on review of the CASPER 155D report and graded report from AAFP, it was determined that the laboratory failed to achieve satisfactory performance for albumin and chloride in three consecutive testing events (2020, Events 1,2 and 3). See D2087. 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: During the proficiency testing desk review performed on 08/20/2021, based on review of CASPER report 155D and graded AAFP reports, it was determined that the laboratory director failed to ensure proficiency testing for albumin, chloride was performed as required by 42 CFR, Part 493.801(see 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 -- 2 of 3 -- 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: During the desk review on 08/20/2021, based on CASPER report 155D review and AAFP graded report review, it was determined that the laboratory director failed to ensure the laboratory attained a result of 80% for albumin, chloride, and ALT, specialty of routine chemistry. The laboratory failed three consecutive proficiency testing events for albumin and chloride (2020, Events 1,2 and 3). -- 3 of 3 --

Summary Statement of Deficiencies D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: During an onsite recertification survey on 10/17/2019, based on based on the Gene expert analyzer operator's guide, lack of documetnation, and testing personnel interview, the laboratory failed to ensure that a routine calibration was performed on the analyzer at least every year or at 2,000 tests as required by the manufacturer for 2 of 2 years reviewed (2017 and 2018). Findings include: 1. The Gene expert analyzer operator's guide stated that a calibration and calibration verification should be performed at least every year or at 2,000 tests 2. Documentation of a calibration and calibration verfication for the analyzer was unavailable for review on the day of the survey for the years 2017 and 2018. 3. Testing personnel confirmed during an onsite interview on 10/17/2019 at 2:00pm that the laboratory had failed to ensure that a routine calibration and calibration verification was performed on the analyzer at least every year or at 2,000 tests . D6055 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) 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 technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing whenever test methodology or instrumentation changes. The individual's performance must be reevaluated to include the use of the new test methodology or instrumentation prior to reporting patient test results. This STANDARD is not met as evidenced by: During an onsite recertification survey on 10/17/2019, based on CMS 209 review, Hitachi CLA User Manual review, personnel record review and testing personnel interview, it was determined that the laboratory director/technical consultant failed to document initial and annual competency evaluation for the Hitachi CLA analyzer for 11 of 11 testing personnel performing testing for 2 of 2 years reviewed (2017 and 2018). Findings include: 1. The laboratory listed 11 testing personnel on the CMS 209 on the day of the survey. 2. Review of the Hitachi CLA User manual revealed that documentation of training personnel appropriate for testing prior to analysis of patient specimens is required for instrument use. 3. On the day of the survey, initial and annual competency evaluations for the years 2017 and 2018 for the Hitachi CLA analyzer were unavailable for review for testing personnel 1 through 11 on the CMS 209. 4. During an interview at 1:00 pm on 10/17/2019, testing personnel confirmed that the Hitachi CLA analyzer had been put into use in 2017 and that the laboratory director/technical consultant failed to document initial and annual competency evaluation for the Hitachi CLA analyzer for 11 of 11 testing personnel. -- 2 of 2 --

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: During the desk review performed on 05/30/2019, based on review of CASPER report 155D and graded reports from American Academy of Family Physicians (AAFP), it was determined that the laboratory failed to successfully participate in proficiency testing for the specialty of hematology, the analyte white blood cell differential (WBC Diff) for three out of four consecutive proficiency testing events reviewed (2018, Events 1 and 3, 2019 Event 1). See D2121 and D2130. D2121 HEMATOLOGY CFR(s): 493.851(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 3 -- Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: During a proficiency testing desk review performed on 05/30/2019, based on review of the CASPER report 155D and laboratory proficiency testing records (graded copies from AAFP), it was determined that the laboratory failed to attain a score of at least 80 percent in proficiency testing for the specialty of hematology, the analyte white blood cell differential (WBC Diff) for three out of four consecutive proficiency testing events (2018, Events 1 and 3, and 2019, Event 1). The findings include: 1. Review of CASPER report 155D revealed the following WBC Diff proficiency scores for your laboratory: a. 2018, Event 1: 76% b. 2018, Event 3: 64% c. 2019, Event 1: 72% 2. The scores were confirmed upon review of the graded AAFP results. Scores less than 80% for these analytes indicate failure or unsatisfactory performance. A failure of the analytes for two consecutive or two out of three testing events is scored as unsuccessful. A failure of the analyte for three consecutive or three out of four/five events is scored as a repeat unsuccessful. 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: During the proficiency test desk review performed on 05/30/2019, based on review of CASPER report 155D and graded American Academy of Family Physicians (AAFP) results, it was determined that the laboratory failed to achieve satisfactory performance for the analyte white blood cell differential in three out of four consecutive testing events (2018, Events 1 and 3, and 2019, Event 1) resulting in unsuccessful proficiency testing performance. See D2121. 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: During the proficiency testing desk review performed on 05/30/2019, based on review of CASPER report 155D and graded reports from American Academy of Family Physicians (AAFP), the laboratory director failed to ensure proficiency testing for WBC Differential was performed as required by 42 CFR, Part 493.801 (see D2016, D2130, and D6016). D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) -- 2 of 3 -- 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: During the proficiency testing desk review on 05/30/2019, based on CASPER report 155D review and American Academy of Family Physicians (AAFP) graded report review, the laboratory director failed to ensure the laboratory attained a result of 80% for white blood cell differential, specialty of hematology. The laboratory failed three out of four consecutive proficiency testing events(2018, Events 1 and 3, and 2019, Event 1). -- 3 of 3 --