Community Healthcare Consultants Llc Dba Community

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 document review and interview, the laboratory failed to successfully participate in the American Proficiency Institute (API) proficiency testing (PT) program for the analyte sodium during PT testing event 3 in 2020 and testing event 1 in 2021. (Refer to D2096). D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on document review and interview (email confirmation), the laboratory failed to achieve a proficiency test (PT) score of 80% or higher for sodium during two consecutive PT events (Events 3, 2020 and Event 1, 2021), resulting in unsatisfactory performance. Findings include: 1. Review of "CASPER Report 0155D" indicated the laboratory received unsatisfactory scores for sodium: 1) Event 3, 2020 = 20% 2) Event 1, 2021 = 0% 2. Review of proficiency testing scores from American Proficiency Institute (API), indicated the above failing scores for event three in 2020 and event one in 2021. 3. In interview on 5/03/21 at 3:20 pm, SP-1 (Laboratory Technician), confirmed (via email), the unsatisfactory scores from API (Proficiency Testing Provider) for the above listed analyte, sodium. -- 2 of 2 --

Summary Statement of Deficiencies D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on document review and interview, the laboratory failed to follow their policy to document weekly spore checks for its autoclave. Finding(s) include: 1. The policy, "Community Medical Center, Autoclave", no date or number listed, read: "Weekly spore testing will be performed and results documented on the weekly log". 2. In interview on 11/02/20 at 10:45 a.m., E#1 (Medical Assistant) acknowledged that there was no documentation the facility's autoclave had been tested for weekly spore testing and results entered into the weekly log. 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 D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on record reviews and interview, the laboratory failed to perform calibration verification every six months for three (cholesterol, glucose, and triglycerides) of three tests in the specialty of Routine Chemistry. Finding(s) include: 1. The policy, Calibration/Calibration Verification, approved 12/07/17, in the SOP (Standard Operating Procedures) manual read: "Calibration verification is necessary to verify 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 -- that an analyte's calibration has remained valid, and confirms that patient testing provides continued accurate results throughout the previously established reportable range. Calibration verification is performed every six months..." 2. Review of calibration verification documents indicated the last calibration verification performed for cholesterol, glucose, and triglycerides was on 12/17. 3. The laboratory reported the following patients volumes during July (107), August (131), and September (103) in 2018. The following patients had been reported without calibration verification: ID # Date Test Value (2018) Cholesterol mg/dL 11 9/05 157 14 7/26 169 17 8/16 136 Glucose 10 9/25 97 13 7/12 171 ID # Date Test Value Glucose 16 8/09 117 Triglycerides 12 8/27 344 15 7/13 96 18 8/21 154 4. On 10/01/18 at 9:50 a.m., staff member #1 confirmed the last calibration verification for cholesterol, glucose, and triglycerides was documented on 12/17. The next calibration verification was due on 6 /18, but was not performed. -- 2 of 2 --