Precise Diagnostics, Llc

Summary Statement of Deficiencies D0000 Laboratory representatives were present at the entrance conference. The survey process was discussed. An opportunity for questions and comments was given. The exit conference was held with the laboratory representatives. The laboratory was found to be in substantial compliance for the specialties/subspecialties for which it was surveyed. The standard level deficiencies cited were discussed. The process for submitting the corrections was explained. CMS form 2567 will be emailed from the Texas Health and Human Services Commission, Health Facility Compliance Arlington Group. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D0000 An entrance conference was held with the laboratory representative. The survey process was discussed and survey forms were provided. An opportunity for questions and comments was given. Noted deficiencies and plans of correction were discussed with the laboratory representatives at the exit conference. The laboratory representatives were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in COMPLIANCE with applicable Conditions of Participation in the CLIA program, and recertification is recommended. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the preanalytic systems and correct identified problems as specified in 493. 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Revisit 09/06/2018 New condition. Based on review of the laboratory's policy, patient test requisitions, and patient test reports, the laboratory failed to meet the requirements of the preanalytical systems, as evidenced by: 1. The laboratory failed to ensure the test requisitions solicited the tests to be performed for 5 of 13 patients in 07/2018. Refer to D5305. 2. The laboratory's policies were not consistent for preservation of specimen type received and processed. Refer to D5311. 3. The written policy provided to clients for specimen handling did not include all required components. Refer to D5317. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- This STANDARD is not met as evidenced by: Revisit 09/06/2018 New deficiency. Based on review of the laboratory's policy and client services manual, the laboratory's policy were not consistent for preservation of specimen type received and processed. Findings included: 1. Review of the laboratory's "Specimen Receiving" stated, "PROCEDURE: 1. Each specimen has been placed inside a biopsy bottle that is label with patient name, date of birth, name of specimen site that contains 10% formalin fixative, the top replaced tightly and the bottle place inside a biohazard specimen bag with the universal symbol for biohazard on it with the requisition by Lab." 2. Review of the "REQUIREMENT FOR SPECIMEN COLLECTION" provided to clients stated, "2. Place patient biopsy inside specimen-envelopes or specimen-bottles (with no fixative enclosed) and write the patient's name, date, and anatomic site the clipping was taken from." The policies were not consistent with one another for toenail specimen preservation for fixative versus no fixative. 3. A total of 13 patient toenail specimens were processed in 07 /2018, the disposition of the specimens was unknown. Note: The laboratory had not not recieved specimens at the time of the revisit. The last date of service for receiving and processing specimens from outside clients was 07/07/2018, 07/09/2018 and 07/10 /2018. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies No Tags No deficiency details 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 --