Summary:
Summary Statement of Deficiencies D3001 FACILITIES CFR(s): 493.1101(a)(1) The laboratory must be constructed, arranged, and maintained to ensure the space, ventilation, and utilities necessary for conducting all phases of the testing process. This STANDARD is not met as evidenced by: Based on observation and the interview with the laboratory consultant, the laboratory failed to provide the safety and sanitary conditions to personnel. Findings included: Observation on March 8, 2018 at 12:30 PM revealed that the main laboratory did not have nearby sink for hand washing. During a phone interview on March 9 at 1:30PM, laboratory consultant confirmed that nearby sink was next to microscope, across the main laboratory. D5305 TEST REQUEST CFR(s): 493.1241(c) The laboratory must ensure the test requisition solicits the following information: (1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. (2) The patient's name or unique patient identifier. (3) The sex and age or date of birth of the patient. (4) The test(s) to be performed. (5) The source of the specimen, when appropriate. (6) The date and, if appropriate, time of specimen collection. (7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. 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 record review and interview with the laboratory consultant, the laboratory failed to have contact information besides address of the laboratory and the ordering provider. Findings included: Requisition slips and test report review on March 8, 2018 at 12:30 PM revealed that the requisition slips and the final laboratory test result report for; 1 Urinalysis Complete, 2 Comprehensive Metabolic Panel, 3 Bilirubin Direct, 4 Lipid Panel, 5 Urine Creatinine, 6 Urine protein, 7 Total Iron Binding capacity w/Iron 8 PTH (parathyroid hormone) Intact 9 Ferritin 10 Free T4 (Thyroxine) 11 TSH (thyroid stimulating hormone) 12 Vitamin D, did not have the phone number, e-mail address or fax number for the ordering provider or the laboratory to enable the reporting of imminently life threatening test results or panic or alert values. During an interview on March 8 at 12:30PM, laboratory consultant confirmed that requisition slips and the final test report did not have the phone number, e-mail address or fax number for the following tests and/or test panels. 1 Urinalysis Complete, 2 Comprehensive Metabolic Panel, 3 Bilirubin Direct, 4 Lipid Panel, 5 Urine Creatinine, 6 Urine protein, 7 Total Iron Binding capacity w/Iron 8 PTH (parathyroid hormone) Intact 9 Ferritin 10 Free T4 (Thyroxine) 11 TSH (thyroid stimulating hormone) 12 Vitamin D. -- 2 of 2 --