Palmetto Pediatric & Adolescent Clinic, Pa

Summary Statement of Deficiencies 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 laboratory's, the laboratory's testing personnel competency records, the laboratory's Policy and Procedures, and an interview with the laboratory compliance officer (CCO) on September 18, 2024, the laboratory failed to perform testing personnel competency assessments for the six elements listed in the Subpart M for five of five testing personnel. The findings include: 1. The laboratory Quality Assessment plan item #5 "...The personnel will be able to perform all procedures, including performance and reporting of quality control, maintenance procedures, troubleshooting procedures, problem-solving, and patient tests performing and reporting..... The employee will not be allowed to continue performing the procedure until appropriate training has taken place and the employee is deemed competent by the lab director." 2. A review of five testing personnel's competency records revealed that five of the five testing personnel had incomplete competency records, with missing competency review elements or were not reviewed and deemed competent by the lab director (LD) for complete blood counts (CBC) and Neonatal Bilirubin (NBili) for testing personnel as listed on the submitted CMS-209 form: a. TP#1: start date (SD) 2/5/18- 2022, 2023 missing elements: 2022 NBili missing two of six elements reviewed 2022 CBC missing one of six elements reviewed 2023 NBili, CBC missing two of six elements, no LD signature. 2024 Competency due on 8/29/2024, no record at time of survey b. TP#2: SD 1/9/23- 2022, 2023 missing elements: 2023 six-month competency missing five of six elements, no LD signature. 2024 annual Competency NBili/CBC- Missing Assessment of PT/Blind Samples, LD signature. c. TP#3: SD 4/6 /15- Annual Competency: 2022 NBili is missing two of six elements. 2022 CBC 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 -- missing one of six elements 2023 CBC, NBili competency, no record at time of survey. 2024 NBili, five of six elements missing, CBC four of six elements missing, no LD signature d. TP#4: SD 11/29/21 2022 six-month competency: NBili is missing three of six elements, and CBC is missing two of six elements. 2022 annual competency, no record at time of survey. 2023 annual competency NBili, CBC is missing four of six elements, no LD signature. e. TP#5: SD 7/2/18 2022 annual competency NBili and CBC are missing one of six elements. 2023 annual competency, no record at time of survey. 3. The CCO confirmed, by interview on September 18, 2024, at 3:00 p.m., that the laboratory's policy and procedures for performing testing personnel competency assessments were not being followed. 4. The laboratory reports performing 164 NBili and 1285 CBC patient tests annually. 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 a record review of the laboratory's Proficiency testing (PT) policy and procedures, American Proficiency Institute (API) proficiency testing (PT) records, and an interview with the laboratory compliance officer (CCO) on September 18, 2024, the laboratory failed to review and documentation PT results. The findings include: 1. A review of the laboratory's policy and procedure manual identified that the laboratory's Quality Assessment policy #3, Proficiency Testing Assessment and Comparison of Results, states, "The lab Director will review and sign all proficiency testing reports along with all Proficiency Testing failure/corrective Acton forms. 2. A review of the laboratory's PT API records for 2024, 2nd event Hematology /Coagulation, revealed the laboratory received a score of 80% for Hematology (Unacceptable Sample# 6, (Hemoglobin, MCH, MCHC)). The LD failed to sign and date their review on the review and

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 05/30/2019, based on review of CASPER report 155D and graded reports from American Proficiency Institute (API) and Accutest, it was determined that the laboratory failed to successfully participate in proficiency testing for the specialty of hematology, the analytes red blood cell (RBC) and hematocrit (Hct) for two consecutive proficiency testing events reviewed (2017, Event 3 and 2018, 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 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 05/30/2019, based on review of the CASPER report 155D and laboratory proficiency testing records (graded copies from American Proficiency Institute and Accutest), 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 analytes red blood cell (RBC) and hematocrit (Hct) for two consecutive proficiency testing events reviewed (2017, Event 3 and 2018, Event 1). The findings include: 1. Review of CASPER report 155D revealed the following proficiency scores for your laboratory: a. 2017, Event 3: red blood cell 40%; hematocrit 40% b. 2018, Event 1: red blood cell 60%; hematocrit 60% 2. The scores were confirmed upon review of the graded API and Accutest 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 API and Accutest results, it was determined that the laboratory failed to achieve satisfactory performance for the analytes red blood cell (RBC) and hematocrit (Hct) for two consecutive proficiency testing events reviewed (2017, Event 3 and 2018, Event 1) resulting in unsuccessful proficiency testing performance. See D2121. -- 2 of 2 --