Heartland Family Medical

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of Cell Dyn Emerald hematology analyzer records from 2/7/19 until 8 /4/21 and interview with the clinic owner and Technical Consultant (TC) group owner at 3:30 p.m. on the day of survey, the laboratory failed to document as performed the monthly maintenance on the Cell Dyn Emerald analyzer as required by the manufacturer. Findings include: 1. Review of the Cell Dyn Emerald records revealed no maintenance records available for the period from 2/7/19 through 8/4/21. 2. The following Cell Dyn Emerald hematology maintenance is required by the manufacturer: a. Monthly - Bleach cleaning b. Semi-annually - Lubricate the pistons c. Unscheduled - Bleach Cleaning d. As needed. B. Interview at 3:30 p.m. on 8/4/21 with the laboratory owner and TC Group owner confirmed maintenance was not documented as performed on the Cell Dyn Emerald maintenance log provided by the manufacturer and /or no maintenance records were 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 --

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: Based on Surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 9/14/2018, the laboratory has not successfully participated in proficiency testing for WHITE BLOOD CELL (WBC) DIFFERENTIAL. Findings include: Our records indicate the following proficiency testing scores for your laboratory for WHITE BLOOD CELL (WBC) DIFFERENTIAL . PROFICIENCY TESTING PROVIDER: American Proficiency Institute WHITE BLOOD CELL (WBC) DIFFERENTIAL: Year 2018 1st Event 0% Year 2018 2nd Event 0% Scores less than 80% for this analyte or parameter indicate 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 for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. 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: Based on Surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 9/14/2018, the laboratory has not successfully participated in proficiency testing for WHITE BLOOD CELL (WBC) DIFFERENTIAL. Findings include: Our records indicate the following proficiency testing scores for your laboratory for WHITE BLOOD CELL (WBC) DIFFERENTIAL . PROFICIENCY TESTING PROVIDER: American Proficiency Institute WHITE BLOOD CELL (WBC) DIFFERENTIAL: Year 2018 1st Event 0% Year 2018 2nd Event 0% Scores less than 80% for this analyte or parameter indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. -- 2 of 2 --