Afc Urgent Care Lyndhurst

Summary Statement of Deficiencies D0000 The survey conducted on October 14, 2021 found the laboratory in compliance with 42 CFR part 493 Requirements for Laboratories. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Office Manage (OM), the laboratory failed to verify the accuracy of Hematology test results obtained from the American Proficiency Institute (API) for the 3rd event in 2020. The findings include: 1) The laboratory received a zero score on all Hematology anayltes for nonparticipation in API event 3, 2020. 2) There was no documented evidence the laboratory verified the zero score. 3) The OM confirmed on 10/14/21 at 11:30 am that the laboratory failed to verify the accuracy of Hematology test results. 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 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 -- 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 surveyor review of Calibration Verification (CV) records and interview with the Technical Consultant (TC), the laboratory failed to perform and document CV procedures at least once every six months for Hematology Testing on the Medonic M- series analyzer from 7/7/20 to the date of survey. The finding includes: 1. There was no documented evidence CV was performed after 7/7/20. 2. The TC confirmed on 10 /13/21 at 11:a0 pm CV was not performed every six months. -- 2 of 2 --

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: a) Based on surveyor review of the Procedure Manual (PM) and interview with the Technical Consultant (TC), the laboratory failed to follow the procedure for Quality Assurance in the calendar year 2018. The findings include: 1. The PM stated Levy Jennings (LJ) charts are to be reviewed monthly but the laboratory reviewed LJ charts as follows: a. February & March LJ were reviewed in June 2018. b. April, May, June, & July LJ were reviewed in October 2018. 2. The TC confirmed on 12/11/18 at 11:50 am that the PM was not followed. b) Based on surveyor review of the PM and interview with the TC, the laboratory failed to follow the procedure for verification of controls used on the Medonic M series analyzer in the calendar year 2018. The findings include: 1. The PM stated to run controls five times before using but the laboratory ran controls two or three times before using. 2. Control verification was not performed on controls received in March and June 2018. 3. The TC confirmed on 12 /14/18 at 12:00 pm that the PM was not followed. 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. 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 -- This STANDARD is not met as evidenced by: Based on surveyor review of the Maintenance Records (MR) and interview with the Technical Consultant (TC), the laboratory failed to perform and document maintenance as specified by the manufacturer on the Medonic M series analyzer in the calendar year 2018. The findings include: 1. There was no documented evidence that monthly maintenance was performed in February, March, April, May, July, September, October and November. 2. The TC confirmed on 12/11/18 at 10:15 am that monthly maintenance as specified by the manufacturer was not performed. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on surveyor review of the Personnel Files and interview with the Technical Consultant (TC), the Laboratory Director failed to have training documented for four out of ten Testing Personnel (TP) from 7/11/17 to the date of the survey. The TC confirmed on 12/11/18 at 9:20 am that all TP did not have training records. -- 2 of 2 --