Wildwood Family Clinic Sc

Summary Statement of Deficiencies 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 surveyor review of proficiency testing (PT) records and interview with Testing Personnel (Staff A), the laboratory did not document the duplicate testing and reporting of five of five chloride tests during the second chemistry event in 2023. Findings include: 1. Review of PT records showed two sets of chloride results for the five samples in the 2023 second chemistry event. The records showed personnel performed all chemistry tests, including chloride tests, on May 30, 2023, and showed personnel repeated chloride testing of the five samples on June 5, 2023. The laboratory reported the June 5, 2023, chloride results to the proficiency testing provider. The records showed no documented reason for the repeated chloride testing on June 5, 2023. 2. Interview with Staff A on March 11, 2024, at 11:15 AM confirmed there was no documentation of the need for repeat testing of the chloride results or the reason for reporting the results from June 5, 2023, instead of the results from May 30, 2023. D3031 RETENTION REQUIREMENTS 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 -- CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor review of pediatric bilirubin control records and manufacturer's instructions and interview with Testing Personnel (Staff A), the laboratory did not document and retain the lot number of control material in use for two of two pediatric bilirubin control levels in 2022 or 2023. Findings include: 1. Review of the control logs, 'Neonatal Bilirubin Control Data', showed the forms included a space to record the lot numbers of control level 1 and 2. Personnel had not entered the lot numbers on the forms during 2022 or 2023. 2. Review of the manufacturer's instructions provided by Staff A for the Quantimetrix Bilirubin Control Pediatric / Level 1 & 2 showed the instructions were specific for lot numbers 22571 & 22572. The insert showed no indication of when the laboratory started using lot numbers 22571 and 22572. 3. Interview with Staff A on March 11, 2024, at 12:45 PM confirmed personnel had not documented the lot number of control material used on the log and confirmed the laboratory had not retained documentation showing the lot number of the pediatric bilirubin controls in use for at least two years. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies 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 surveyor review of proficiency testing (PT) reports from the American Proficiency Institute (API) and interview with the administrative laboratory supervisor, the laboratory did not have documentation of the evaluation of "Not Graded" results for the Chemistry-Core events for 2019 and 2020. Findings include: 1. Review of the API PT records shows no documented evaluation of "Not Graded" Neonatal Direct Bilirubin results for five of five Chemistry-Core events in 2019 and 2020. 2. Interview with the administrative laboratory supervisor, Staff A, on September 16, 2020 at 10:15 AM confirmed the laboratory did not document evaluation of the "Not Graded" proficiency testing results for for Neonatal Direct Bilirubin. 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 D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(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 surveyor review of proficiency testing (PT) records and interview with the Technical Consultant who is also the Lab Director, the laboratory failed to include all testing personnel who routinely perform non-waived testing in 2016 and 2017. Findings include: 1. Review of PT records for non-waived testing show that one of four Testing Personnel (TP), TP A, has not participated in PT in 2016 and 2017. TP A performed testing in the laboratory in 2016 and 2017. 2. Interview with the Technical Consultant/Lab Director on April 24, 2018 at 11:00 AM confirmed that TP A has not participated in PT in 2016 and 2017. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory quality control records and interview with the laboratory Technical Consultant who is also the Lab Director, the laboratory does not 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 -- use an elevated serum total bilirubin control for monitoring the abnormal range of neonatal bilirubin testing. Findings include: 1. Review of laboratory quality control (QC) records for the total bilirubin assay show that two levels of QC are performed on a daily basis. The QC records for the total bilirubin assay show that an elevated serum based total bilirubin control for monitoring the abnormal range of neonatal bilirubin is not assayed when performing neonatal bilirubin testing. 2. Interview with the Technical Consultant/Lab Director on April 24, 2018 at 12:30 PM confirms that an elevated serum based total bilirubin control is not used to monitor the abnormal range when performing neonatal bilirubin testing. D6047 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b(8)(i) The procedures for evaluation of the competency of the staff must include, but are not limited to direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. This STANDARD is not met as evidenced by: Based on surveyor review of competency assessment records and interview with the Technical Consultant, the Technical Consultant has not documented the direct observations of routine patient testing for four of four Testing Personnel in 2017. Findings include: 1. Review of competency assessment records show no evidence of direct observation of routine patient testing for four of four Testing Personnel in 2017. 2. Interview with the Technical Consultant on April 24, 2018 at 10:30 AM confirms direct observation of routine patient testing was not documented as part of the competency evaluation procedures. -- 2 of 2 --