Medcare Express-North Charleston Llc

Summary Statement of Deficiencies D0000 An announced onsite CLIA recertification survey was conducted on January 5, 2026, at the laboratory of MEDcare Express of Mt. Pleasant by the South Carolina Department of Public Health (SC DPH) Bureau of Nursing Homes and Medical Services. The laboratory was found to be out of compliance with Medicare condition 42 CFR Part 493, Requirements for Laboratories. The following is a list of deficiencies cited as a result of the January 5, 2026 survey: D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on records review, lack of documentation, and staff interview, the laboratory failed to have a written policy and procedure for quality assessments. Findings included: 1. Procedure manual review reveals a lack of written procedure for at least twice annual quality assessments. 2. Laboratory documentation reveals quality assessments such as patient chart reviews are being conducted. 3. In an interview with the practice manager in the laboratory on January 5, 2026 at 12:10pm, the findings were confirmed. 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 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: This STANDARD is not met as evidenced by: During an onsite recertification survey on 2/14/20, based on proficiency testing review, lack of documentation, and staff interview, it was determined that the staff failed to sign attestation statements from 3 of 3 events of 2018 proficiency testing (2018, Events 1, 2, and 3). Findings include: 1. Review of 2018 proficiency testing records revealed that the attestation statements for the 1st, 2nd, and 3rd events of 2018 were not signed by testing personnel or by the lab director. There was no

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 PT desk review performed on 12/27/2018, based on review of CASPER report 155D and graded reports from American Academy of Family Physicians (AAFP), the laboratory failed to successfully participate in proficiency testing for the regulated analyte hematocrit (HCT) for two consecutive proficiency testing events reviewed (2018, Events A and B). See D2130. D2130 HEMATOLOGY CFR(s): 493.851(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 -- 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 a PT desk review performed on 12/27/2018, based on review of CASPER report 155D and graded reports from AAFP, the laboratory failed to achieve satisfactory performance for HCT in two consecutive testing events (2018, Events A and B). Findings include: 1. Review of the CASPER report 155D revealed of the following proficiency testing scores for HCT: a. 2018, Event A: 60% b. 2018, Event B: 60% 2. The scores were confirmed upon review of the graded report from AAFP. -- 2 of 2 --

Summary Statement of Deficiencies No Tags No deficiency details available. 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 --