New Horizons Medical Pc

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the New Horizons Medical, PC laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. Please refer to Conditions of Participation for Clinical Laboratories 42 CFR Part 493. . D2116 TOXICOLOGY CFR(s): 493.845(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on the College of American Pathologist (CAP) proficiency testing record review and interview, the laboratory failed to undertake appropriate remedial action in response to unsatisfactory proficiency testing results as evidenced by the following: a) A review of proficiency testing results for calendar years 2021 and 2022 (6 testing events) revealed that the laboratory obtained unacceptable scores. The following test event modules and specimens include but do not cover all unacceptable specimens noted: Drug Monitoring for Pain Management (DMPM) 1. 2021 modules: DMPM A specimens: DMPM-02 75% DMPM-03 75% DMPM B specimens: DMPM-05 33% DMPM-06 0% DMPM-07 33% 2. 2022 modules DMPM-A specimens DMPM-01 66% DMPM-02 66% Ethanol Biomarkers (ETB) 1. 2022 ETB-A 50% (2 specimen module) Urine Drug Adulterants (DAI) 1. DAI-A specimen DAI-06 50% for creatinine and pH. b) A review for each of the proficiency testing reports was completed by the technical supervisor. The reviews indicated that the problem with 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 -- the unsatisfactory proficiency testing results was either data entry error into the CPA proficiency testing reporting system or mistranscription of the results into the same system. The reports included no documentation of any remedial action or retraining taken in response to the unsatisfactory results. c) The laboratory technical supervisor confirmed in an interview on 2/2/23 at 9:15 AM that no remedial action or retraining to correct the problem of data entry and mistranscription errors in response to unsatisfactory proficiency testing results had been undertaken. . D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on policy review and interview the laboratory failed to have and follow written policies and procedures to evaluate the competency of the technical supervisor as evidenced by the following: a) A review of employee competency records on 2/2/23 for four (4) laboratory personnel revealed that there was no competency assessment performed for technical supervisor #1. b) The technical supervisor confirmed in an interview on 2/2/23 at 9:00 AM that a competency assessment had not been completed on him. c) Review of competency policies and procedures on 2/3/24 revealed that there was no provision for evaluating the technical supervisor position. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the New Horizons Medical, PC laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on interview and procedural review, the laboratory failed to have a written procedure describing the system that twice a year evaluates and defines the relationship between test results using two Liquid chromatography/mass spectrometry (LC/MS) analyzers as evidenced by the following: a) The laboratory performs twice annual comparisons for drug of abuse analytes on the two LC/MS analyzers. A procedure describing the steps for performing and evaluating the comparison could not be found during a review of the laboratory's procedure manual. b) The technical supervisor confirmed in an interview on 3/30/21 at 12:34 PM that a written procedure for twice annual comparisons of the two LC/MS analyzers was not 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 --