Elm Tree Clinic Llc

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Elm Tree Clinic LLC laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: . Based on proficiency testing (PT) record review and an interview with the Laboratory Director (LD) on 9/2/21, the laboratory failed to enroll and participate in a HHS approved proficiency testing (PT) program commensurate with the services offered as evidenced by the following: The surveyor requested to review PT records on 9/2/21 for calendar years 2019, 2020, and 2021. The review revealed that the laboratory enrolled late in a HHS approved PT testing program for 2020 for the subspecialty performed. The laboratory failed to participate in CAP-UT-A 2020 Urine Toxicology Event #1. The LD confirmed in an interview on 9/2/21 at 10:47A.M. that the Technical Supervisor enrolled the laboratory late in a HHS approved PT program for 2020 and therefore the laboratory failed to participate in CAP-UT-A 2020 Urine Toxicology Event #1. The laboratory performs approximately 561,600 Toxicology tests annually. (Refer to D6116) . 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 -- D6116 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(3) The technical supervisor is responsible for enrollment and participation in an HHS approved proficiency testing program commensurate with the services offered. This STANDARD is not met as evidenced by: . Based on proficiency testing (PT) record review and an interview with the Laboratory Director (LD) on 9/2/21, the Technical Supervisor (TS) failed to enroll and participate in a HHS approved PT program commensurate with the services offered as evidenced by the following: The surveyor requested to review PT records on 9/2/21 for calendar years 2019, 2020, and 2021. The review revealed that the TS enrolled the laboratory late in a HHS approved PT testing program for 2020 for the subspecialty performed. The laboratory failed to participate in CAP-UT-A 2020 Urine Toxicology Event #1. The LD confirmed in an interview on 9/2/21 at 10:47A.M. that the TS enrolled the laboratory late in a HHS approved PT program for 2020 and therefore did not participate in the CAP-UT-A 2020 Urine Toxicology Event #1. The laboratory performs approximately 561,600 Toxicology tests annually. (Refer to D2000) -- 2 of 2 --

Summary Statement of Deficiencies D0000 An initial CLIA certification survey was conducted for Elm Tree Clinic LLC laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to demonstrate that it could obtain performance specifications comparable to comparable to those established by the manufacturer for the following performance characteristic: reportable range as evidenced by the following: The surveyor reviewed the validation study for the Beckman Coulter AU480. The review revealed that reportable range validation was not performed prior to implementing the test system for patient testing and reporting. The laboratory director interviewed on 7/17/19 at 10:36 A.M. confirmed that the reportable range validation for the above system had not been completed. The laboratory performs 182,000 toxicology tests annually. 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 --