Kendall & Kemmerlin Pa (Drs)

Summary Statement of Deficiencies D0000 An onsite announced CLIA recertification survey was conducted on November 18, 2024, at the clinical laboratory in the office of Kendall and Kemmerlin, PA 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. The following ia a list of standard level deficiencies found during the survey at the cite: 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 the review of the College of American Pathologist (CAP) survey evaluation forms and staff interview, the laboratory failed to document the laboratory director (LD) and testing personnel (TP) review and approval of attestation forms for proficiency testing (PT) performed for 2 years reviewed. (2023and 2024). Findings included: 1. Review of the PT documentation reveals a lack of signed attestation forms for events listed below: a. CAP CM-A 2023 b. CAP HE-A 2023 c. CAP FH1-B 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 -- 2023 d. CAP FH1-C 2023 e. CAP CM-B 2023 f. CAP CM-A 2024 g. CAP FH1-A 2024 2. In an interview on November 18, 2024, in the laboratory office at 1:30 pm with the office manager (OM) and TP1, the 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, consultant competency. This STANDARD is not met as evidenced by: Based on the review of the laboratory's policy and procedures and staff interview, the laboratory failed to produce a written policy for the assessment personnel competency. Findings included: 1. Review of the laboratory's policy and procedure manual reveals a lack of a written policy and procedure for establiehing competency assessment of testing personnel. 2. In an interview on November 18, 2024, in the laboratory office at 1:30 pm with the OM and TP1, the findings were confirmed. 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 the review of CAP PT documentation and staff interview, the laboratory failed to provide evidence of review and evaluation of the laboratory's PT performance. Findings included: 1. Review of CAP PT documentation reveals a lack of evidence of performance review and evaluation for each of the following PT events: a. CAP CM-A 2023 b. CAP HE-A 2023 c. CAP FH1-B 2023 d. CAP FH1-C 2023 e. CAP CM-B 2023 f. CAP CM-A 2024 g. CAP FH1-A 2024 2. The events listed above lack the signatures of the LD or TP1 to verify review and evaluation. 3. In an interview on November 18, 2024, in the laboratory office at 1:30 pm with the OM and TP1, the findings were confirmed. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on the review of CAP PT documentation review and staff interview, the laboratory failed to review and document

Summary Statement of Deficiencies D1002 REPORTING OF SARS-CoV-2 TEST RESULTS During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Findings: During an onsite recertification survey performed on 12/16/2021, based on testing personnel interview and lack of documentation, the laboratory failed to report SARS-CoV-2 test results to the South Carolina Department of Health (SCDHEC) in such form and manner, and at such timing and frequency, as defined in 400.200 CFR for 2 of 2 years reviewed (2020 and 2021). Findings include: Documentation regarding the submission of positive and negative SARS-CoV2 results to SCDHEC was unavailable for review on the day of the survey for 2 of 2 years reviewed (2020 and 2021). Testing personnel confirmed during an onsite survey on 12/16/2021 that the laboratory did not report positive or negative SARS-CoV-2 test results back to SCDHEC as required by federal law. 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 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 03/11/2021, 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 hematocrit (HCT) for two of three consecutive proficiency testing events reviewed (2020, Events 1 and 3). 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 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 proficiency testing desk review performed on 03/11/2021, 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 hematocrit (HCT) for two of three consecutive proficiency testing events (2020, Events 1 and 3). The findings include: 1. Review of CASPER report 155D revealed the following HCT proficiency scores for your laboratory: a. 2020, Event 1: 40% b. 2020, Event 3: 60% 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 desk review performed on 03/11/2021, based on review of CASPER report 155D and graded AAFP results, it was determined that the laboratory failed to achieve satisfactory performance for the analyte HCT in two of three consecutive testing events (2020, Events 1 and 3) resulting in unsuccessful proficiency testing performance. See D2121. -- 2 of 2 --

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: During an onsite recertification survey on 10/10/2019, based on direct observation and testing personnel interview, it was determined that the laboratory failed to ensure that potassium hydroxide (KOH) solution was not used past the expiration date. Findings include: 1. During the laboratory walkthrough at 11:45 am, a bottle of KOH was observed near the microscope. The bottle was printed with a note to "discard after 2013". 2. During the exit interview at 12:00 pm, testing personnel confirmed that the KOH on site had expired and was actively being utilized for patient testing.. 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 --