Summary:
Summary Statement of Deficiencies D0000 The Technical Consultants #1 and #2 (TC-1, TC-2) were at the entrance conference conducted 09/28/2018. The survey process was discussed. An opportunity for questions and comments was given. Exit conference was held with TC-1 and TC-2 on 09/28/2018. 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 Health and Human Services Commission, Health Facility Compliance Arlington Group. 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: Based on review of the laboratory's procedure manual, patient test report, and in interview with staff, the laboratory failed to follow their own written policy for documenting notification of the attending physician of a patient panic value on 08/04 /2018. Findings included: 1. Review of the laboratory's procedure manual stated, "Panic/Alert Value Procedures: When certain test results are much higher or lower than normal, the patient may need immediate attention by a physician. If a 'Medical Alert Value' is obtained: 1. Repeat the test to confirm the result. 2. Notify a physician if the result is confirmed. 3. If a 'Medical Alert Value' is called to the lab from the reference laboratory immediately notify a physician of the report. 4. Date, time and initial that the result was given to physician." Medical Alert Values included: "Hemoglobin: Low Value: 8.0 g/dL and High Value: 20.0 g/dL." 2. Review of Patient #3364350 instrument printout (Coulter AcT Diff 2 analyzer) test results from 08/04 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- /2018 revealed a Hemoglobin result of 7.6 g/dL. The instrument printout included a section to document that the attending physician was notified of the panic value: "Provider notified of panic value: Date: Time:." The instrument printout for Patient #3364350 did not include documentation that the attending physician was notified of the Hemoglobin panic value of 7.6 g/dL. The laboratory did not follow their own written policy for documenting notification of the attending physician. 3. During an interview on 09/28/2018 at 11:30 am, Technical Consultants #1 and #2 reviewed and confirmed the above findings. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure manual, manufacturer's instructions, quality control (QC) data,