Liberty Doctors Dba South Strand Urgent Care

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), it was determined that the laboratory failed to successfully participate in proficiency testing for the specialty of hematology, the analytes white blood cell diff (WBC Diff), red blood cell (RBC), hemoglobin (Hgb), hematocrit (Hct), white blood cell count (WBC) and platelets (Plt) for two consecutive proficiency testing events reviewed (2018, Events 2 and 3). See D2121 and D2130. D2121 HEMATOLOGY 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): 493.851(a) 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 report from American Proficiency Institute), 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 white blood cell diff (WBC Diff), red blood cell (RBC), hemoglobin (Hgb), hematocrit (Hct), white blood cell count (WBC) and platelets (Plt) for two consecutive proficiency testing events (2018, Events 1 and 2). The findings include: 1. Review of CASPER report 155D revealed the following proficiency scores for your laboratory: a. 2018, Event 1: white blood cell diff (WBC Diff)- 0%, red blood cell (RBC)- 0%, hemoglobin (Hgb)- 0%, hematocrit (Hct)- 0%, white blood cell count (WBC)- 0% and platelets (Plt)- 0%. b. 2018, Event 2: white blood cell diff (WBC Diff)- 0%, red blood cell (RBC)- 0%, hemoglobin (Hgb)- 0%, hematocrit (Hct)- 0%, white blood cell count (WBC)- 0% and platelets (Plt)- 0%. 2. The scores were confirmed upon review of the graded API reports. 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 American Proficiency Institute results, it was determined that the laboratory failed to achieve satisfactory performance for the analytes white blood cell diff (WBC Diff), red blood cell (RBC), hemoglobin (Hgb), hematocrit (Hct), white blood cell count (WBC) and platelets (Plt) for two consecutive proficiency testing events reviewed (2018, Events 2 and 3). See D2121 -- 2 of 2 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: During an onsite recertification certification survey on 02/22/2018, based on the Drew 3 hematology analyzer operator's guide, laboratory temperature records, and testing personnel interview, the laboratory failed to document an acceptable room temperature for 81 out of 730 days reviewed in 2016 and 2017. Findings include: 1. The Drew 3 hematology analyzer operator's guide stated that the instrument should be operated in an ambient room temperature of 64.4 to 89.6 degrees fahrenheit. 2. Review of the laboratory's temperature records revealed 81 out of 730 days in 2016 and 2017 during which room temperature was recorded below 64.4 degrees Fahrenheit. There was no