Laboratory Policies Policy #1/ version #04 Effective Date: 11/1/13 Laboratory Policies Assigned Duties Duties are assigned by the Laboratory Supervisor. However, they are subject to change during the day since staffing is limited and flexibility is needed at times to get the daily work accomplished. Laboratory Test Performed at CCHD (In-House Tests) Culture, Presumptive for Gonorrhea Glucose (HemoCue® 201) Glucose (HemoCue® 201) Gram Stain (Male Urethral Smears for Gonorrhea) Hemoglobin (HemoCue® 201) Urine Chemical Analysis (Clinitek 50) Urine Pregnancy Test Wet Mount (Vaginal) Amine Test Urine (Microscopic) Ordering of Test Specimen Handling Collections No oral request will for testing will be accepted at CCHD Laboratory. Standing orders for clinics (see appendix). Outside Doctors orders for lab test will be accepted at CCHD Laboratory with the proper documentation. Refer to collections procedures in the CCHD Laboratory Procedure Manual. CCHD Laboratory does not accept outside collected specimens for in-house testing. Outside specimens collected by home health nurses are accepted. These specimens are prepared by CCHD Laboratory personnel and picked up by the LabCorp courier daily. All Laboratory specimens will be transported to and from the CCHD Laboratory in Biohazard transport bags. Specimens transported to the CCHD Laboratory will be dropped off in designated areas marked within the Laboratory. Reference Specimens Specimens for referred tests must be labeled with patient’s legal name, date of birth, test to be performed, and date of specimen collection. All information on specimen must match the accompanying requisition. Columbus County Health Department Laboratory, Whiteville NC 28472 Laboratory Policies Policy #1/ version #04 Recording of Results Effective Date: 11/1/13 Report Handling All results of in-house tests (including repeats) are recorded on the lab form and entered into the EMR. The lab forms are retained in the lab for five years. The lab will keep a log of the gonorrhea cultures on file for two years. Red ink will be used to record on the patient log the date results of specimens sent to reference laboratories were received back in CCHD Laboratory. If the time of performing an in-house test is more than 15 minutes from the time of specimen collection, the time of testing must be indicated on the lab form. The initials of the person collecting and/or testing a specimen must be recorded on the lab form. Results of in-house tests are communicated to Nursing Staff via CureMD. Laboratory personnel, using red ink as directed above in “Recording of Results”, will write the dates results for referred test are received on the Laboratory Log. All reports of referred tests will be stamped with the date received and scanned into the patient record. Errors in Documentation When there is an error made on a lab document, draw a single line through the incorrect information and initial. Do not erase, use white-out or pencil over the error. Panic values Normal Values Listed in test procedures and appendix. Panic levels are repeated, circled on the requisition, and initialed by the person performing the test. Upon completion of the panic value repeat, report orally to the clinic nurse or clinician. Document in comments the date, time, and clinic nurse or clinician that took the oral panic value report. In-house o Listed in CureMD. o Listed in the appendix. Reference Lab o Listed on test report. Columbus County Health Department Laboratory, Whiteville NC 28472 Laboratory Policies Policy #1/ version #04 Effective Date: 11/1/13 Proficiency Testing Columbus County Health Department participates in the North Carolina County Health Department Area C CLIA certificate. Proficiency Testing is rotated amount the participating counties. If Columbus is chosen, instructions in the proficiency testing policy will be followed. Competency Assessment The Columbus County Health Department Laboratory personnel participate in the Competency Assessment program offered by the NCSLPH. Continuing Education For Testing Personnel Inservice Training: See Columbus County Health Department Personnel Policies. Other: Required to attend 6 hours of lab-related continuing education per year (APPLIES TO PERSONNEL PERFORMING MODERATE COMPLEXITY LABORATORY TESTS). Personnel of Columbus County Health Department performing waived-only testing need only 3 hours of lab-related continuing education per year. Quality Control Supplies Levels and Frequency (See appendix) The CCHD Laboratory will follow the manufacture’s instructions when running control specimens. Only assayed control material meeting the manufacture’s specifications will be used for moderate complexity test. Tolerance levels for assayed controls are verified before new lot numbers of controls are used. Control specimens will be treated the same as patient specimens. All control values must be within range before any patient results are released. Control values are documented on appropriate logs and kept on record for two years. CCHD Laboratory will use +/- 2SD from mean for tolerance levels of controls. All out of range controls will undergo troubleshooting (see appendix). All corrective action taken while troubleshooting will be documented and retained on record for two years. All supplies must be labeled with a received date. All supplies will be stored according to manufacture instructions. Columbus County Health Department Laboratory, Whiteville NC 28472 Laboratory Policies Policy #1/ version #04 Effective Date: 11/1/13 Any unusual conditions must be noted on the item upon receipt and, where applicable, noted on the Quality Control sheet for that product. Each time a kit or bottle of reagent is opened, that date and initials of the person opening it must be written on the container. If the expiration date after opening the container is different from the manufacture’s expiration date, the new expiration date must also be written on the container. All manufacture’s procedural instructions will be followed. A correlation study will be completed prior to the implementation of a new instrumentation or test kit. See CCHD Laboratory Correlation Policy located in the Correlation Study book in the main laboratory. Free Standing Clinics See CCHD Laboratory Policy For Freestanding Clinics located in the CCHD Laboratory Off Site Policy & Procedure Manual in the main Laboratory. Reference Laboratories AFP Screening Laboratory 216 MacNider Bldg. CB# 7570 Department of Obstetrics & Gynecology University of North Carolina Chapel Hill, N.C. 27599-7570 CLIA # 34D0655124 Routine test sent: MSAFP (Maternal Serum Alpha-Feto Protein) North Carolina State Laboratory of Public Health 4312 District Drive Raleigh, NC 27607 Postal Address: P.O. Box 28047 Raleigh, NC 27611-8047 Routine tests sent: CLIA# 34DO692393 Gonorrhea Confirmation Hemoglobin Electrophoresis (Sickle Cell Screen) Hepatitis Status HIV Lead Screening Newborn Screening Parasitology Thin Prep Rubella Immune Status Stool Cultures Syphilis Serology (TRUST) Thyroid Profile Tuberculosis (TB) Cultures and Acid Fast Staining Columbus County Health Department Laboratory, Whiteville NC 28472 Laboratory Policies Policy #1/ version #04 Effective Date: 11/1/13 Viral Cultures – Herpes Chlamydia Antigen Consult the NCSLPH website if other tests are needed. LabCorp 1447 York Court Burlington, NC 27215 Routine Test sent: CLIA # 34D0655059 ABO Blood Typing and Antibody Screening Complete Metabolic Panel (CMP) Lipid Panel CBC GC cultures (Thursday, Friday, and Holidays) Urine Cultures Group B Strep Cultures Beta hCG Quantitive Culture, Throat, Comprehensive T3 T4 Consult LabCorp Directory of Services Reference Guide on non-routine test. Columbus County Health Department Laboratory, Whiteville NC 28472