Medcare Express-North Charleston Llc

Summary Statement of Deficiencies D0000 A Recertification Survey was initiated on 11/09/2023 and concluded on 11/09/2023. The facility was found not to be in compliance with the laboratory requirements of 42 CFR Part 493 with deficiencies cited. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on electronic document review and staff interview, the laboratory failed to ensure the current Laboratory Director (LD) approved, signed, and dated 2 (i-STAT chemistry testing and complete blood count [CBC] testing) of 2 non-waived testing procedures. Findings included: An electronic laboratory procedure manual, last revised on 09/13/2023, was reviewed by the surveyor in the presence of a technical consultant (TC) on 11/09/2023. There was no evidence of a date or signature by the LD to denote review of the electronic procedure manual. During an interview on 11/09 /2023 at 11:25 AM, the TC stated the electronic laboratory procedures were reviewed during monthly leadership meetings with the LD. Per the TC, the LD was aware of all procedures and changes, but confirmed there were no signatures or dates to signify the LD's review. The TC reiterated the information during a second review at 12:45 PM on 11/09/2023. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the 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 -- manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on observation, document review, and interview, the laboratory failed to perform and verify accuracy, precision, and reportable range of test results for 1 (blood analyzer) of 1 new test instrument used. Findings included: During a laboratory tour on 11/09/2023 at 10:40 AM, an Abbott i-STAT blood analyzer was observed. A Technical Consultant (TC) stated the instrument was installed in January of 2023. Per the TC, staff used the Abbott i-STAT to perform Chemistry 8 (Chem 8) panels. During an interview on 11/09/2023 at 11:30 AM, the TC stated the i-STAT instrument was previously used at another clinic in another state. On 11/09/2023 at 11: 30 AM, the TC presented calibration records dated 01/12/2023. The TC stated a calibration was performed when the instrument was received. The TC further stated that an Abbott i-STAT representative was contacted on an unspecified date and reportedly told the TC that only a calibration was needed. -- 2 of 2 --

Summary Statement of Deficiencies 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 American Academy of Family Practitioners (AAFP) proficiency testing record review, and testing personnel interview, the laboratory failed to review and evaluate proficiency testing results for 4 of 7 proficiency testing events reviewed from 2017 through 2018 (2017, Events A, B, and C; 2018, Events A). Findings include: 1. Review of proficiency testing results revealed the following scores: a. 2017, Event A; 60% for hematocrit a. 2017, Event B; 60% for thyroid stimulating hormone, 0% for testosterone a. 2017, Event C; 60% for red blood cell count, 0% for hematocrit a. 2018, Event A; 20% for white blood cell count, 40% for lymphocyte, 40% for granulocyte, 20% for red blood cell count, 20% for hemoglobin, 20% for hematocrit, 60% mean corpascular volume, 40% platelet There was no documentation of director review and evaluation or

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 analytes white blood cell differential (WBC Diff), red blood cell (RBC), and hematocrit (HCT) for two consecutive proficiency testing events reviewed (2017, Event C and 2018, Event 1). 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 WBC Diff, RBC, and HCT in two consecutive testing events (2017, Event C and 2018, Event A). Findings include: 1. Review of the CASPER report 155D revealed of the following proficiency testing scores: a. 2017, Event C WBC Diff: 76% RBC: 60% HCT: 0% b. 2018, Event A WBC Diff: 28% RBC: 20% HCT: 20% 2. The scores were confirmed upon review of the graded report from AAFP. -- 2 of 2 --