Medcare Express-North Charleston Llc

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 03/11/2021, based on review of CASPER report 155D and graded reports from American Academy of Family Physicians Proficiency Testing (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 consecutive proficiency testing events reviewed (2019 Event 3 and 2020 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 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 (2019 Event 3 and 2020 Event 1). The findings include: 1. Review of CASPER report 155D revealed the following HCT proficiency scores for your laboratory: a. 2019, Event 3: 60% b. 2020, Event 1: 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 (2019 Event 3 and 2020 Event 1) resulting in unsuccessful proficiency testing performance. See D2121. -- 2 of 2 --

Summary Statement of Deficiencies 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: During an onsite recertification survey on 11/2/2018, based on hematology data log review and testing personnel interview, the laboratory failed to perform and document at least two levels of acceptable hematology quality control (QC) before patient testing on 8 random test days reviewed from February 2018 through March 2018. Findings include: 1. Review of the hematology data log revealed that patient complete blood count (CBC) testing was performed on the following days before having two levels of acceptable controls: a. 2/6/2018--mean corpuscular value (MCV) out of range on low, normal, and high controls; 3 patients tested b.2/7/2018--MCV out of range on low, normal, and high controls; 6 patientes tested c. 2/19/2018--MCV out of range on low, normal, and high controls; 5 patientes tested d. 2/22/2018--MCV out of range on low, normal, and high controls; 6 patientes tested e. 2/23/2018--MCV out of range on low, normal, and high controls; 7 patients tested f. 2/26/2018--MCV out of range on low, normal, and high controls; 4 patients tested g. 2/28/2018--MCV out of range on low, normal, and high controls; 7 patients tested h. 3/1/2018--MCV out of range on low, normal, and high controls; 2 patients tested 2. Testing personnel confirmed during an interview on 11/2/2018 at 2:30 pm that the laboratory failed to perform and document at least two levels of acceptable hematology QC on these dates. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT 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 -- CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: During an onsite recertification survey on 11/2/2018, based on quality control review and lack of documentation, the laboratory failed to establish and follow written policies and procedures to monitor, assess, and correct problems associated with unacceptable hematology quality control testing (see D5447). -- 2 of 2 --