AppHealthCare Appalachian District Health Department Policy and Procedure Policy Name: Section 1100 Approved Date: Laboratory Procedure 3‐6‐2015 Policy Topic: Chapter 1130 Revision Date: Scope of Services MISSION The laboratory of the Appalachian District Heath Department (ADHD) , located in Sparta, Jefferson, and Boone North Carolina, provides medical laboratory testing in support of the clinics health programs. All functions of the laboratories are regulated by the Clinical Laboratory Improvement Amendments of 1993, which set federal standards designed to improve the quality of clinical laboratory services. II. PURPOSE The purpose of this manual is to set forth the general, personnel and procedural policies of the ADHA laboratory. A copy of this manual will be in each the laboratories. This manual is reviewed and approved annually. It is updated to reflect current practices. All laboratory personnel are oriented to the manual upon employment and required to review its contents annually. III. ORGANIZATION A. ADHD laboratory is classified as “moderate ” and operates under its the umbrella CLIA certificate of Area B of t he North Carolina State Laboratory of Public Health in Raleigh, North Carolina. B. The current ADHD Medical Director serves as the Clinical Consultant and the Director of the NCSLPH serves as the Laboratory Director. C.
Technical consultation is provided through the Technical Consultant.The Technical Consultant provides assistance with laboratory policy and procedure manuals, laboratory QA and safety, and other laboratory functions.
D.
On‐site laboratory supervision and administration is provided by the Nursing Section Supervisor who serves as the Laboratory Manager’s supervisor.
E.
Laboratory testing is primarily performed by one full time laboratory Technician/technologist, who functions as the laboratory manager. Laboratory testing is also performed by qualified nursing staff, and qualified MOA.
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F. Staff members are assigned laboratory responsibilities by the Nursing Supervisor. During temporary absences of the laboratory technician, the Nursing Supervisor assigns laboratory duties to other qualified staff members, who are approved testing personnel. All laboratory testing personnel must be approved by the Laboratory Director and Laboratory Manager.
IV.
G.
Laboratory budgetary needs are primarily determined by the laboratory technician and the Nursing Supervisor. Requests and justifications are submitted to the Health Director through the Nursing Director.
H. The current test menu for the ADHA Laboratory is attached. GENERAL INFORMATION The ADHD operates three clinic sites with in‐house laboratories located at:
1.
Alleghany County Health Department 157 Health Center Drive Sparta, NC 28675
2.
Ashe County Health Department 213 McConnell Street Jefferson, NC 28640
3.
Watauga County Health Department 126 Poplar Grove Connector Road Boone, NC 28607
A.
Official business hours are 8:00 am‐5:00 pm, Monday through Friday. Work hours of individuals vary due to the use of flex time and clinic patient load.
B.
The laboratory observes official county government holidays.
C.
Courier numbers:
D.
Fax numbers:
Alleghany County Health Department Ashe County Health Department Watauga County Health Department
15‐97‐05 15‐67‐01 15‐90‐01
Alleghany County Health Department Ashe County Health Department Watauga County Health Department 2 Occult Blood
336‐372‐7793 336‐246‐3278 or 336‐246‐8163 828‐264‐4497 or 828‐265‐3101
E.
The ADHD is listed under the North Carolina County Health Department Area B CLIA certificate #34D0865330
F.
The state county codes:
Alleghany Ashe Watauga
003 005 095
G. All forms used for laboratory services are facility specific. V.
STANDING ORDERS A.
B.
C.
Standing orders for laboratory testing are specified in program protocols which are approved and signed by the Medical Director who serves as the Laboratory Clinical Consultant. Protocols with standing orders are found in program manuals located in the Nursing Supervisor’s office.
All laboratory tests requested by standing orders are listed on the Laboratory Requisition Form.(ie: hgb,)
VI.
A.
The ADHD uses the approved laboratory requisition form to order laboratory tests.
B.
No verbal orders are accepted.
C.
All staff who order laboratory tests must sign the laboratory requisition form.
D.
The laboratory requisition accompanies specimens and/or clients to the lab.
E.
Laboratory requisitions include patient identification information, clinic, date of service, and the time of laboratory testing.
F.
Laboratory testing personnel perform tests as ordered, record results obtained and sign the requisition. No results are given to the patient by laboratory technicians.
USE OF THE LABORATORY SERVICES REQUISITION FORM
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G.
Completed laboratory requisitions are promptly routed back to the provider for review.
H.
Laboratory errors are followed up promptly. The correct lab data will be reported to the requesting provider and the nursing supervisor. The correct data is to be entered on the original and lab copy of the requisition. The correction will be initialed and dated by the person making the correction. Laboratory testing personnel will ensure all lab log sheets are updated with the correct data.
I.
The Laboratory Copy of the requisition will be kept on file in the laboratory section for 2 years. After 2 years the lab copy will be destroyed.
VII.
PANIC VALUES A.
Panic or critical values, and normal patient ranges, if applicable, are specified in the laboratory procedure manual for that test.
B.
For panic values, the result is circled with red ink, on the laboratory requisition form by the laboratory testing personnel and the patient’s nurse is immediately notified. If nurse is not readily available, the Nursing Supervisor is immediately notified.
C.
Panic values and normal ranges are approved by the Clinical Consultant and reviewed annually. A statement of approval is attached to this policy manual.
VIII. SPECIMEN ACCEPTABILITY CRITERIA A. All specimens sent to the laboratory must be properly labeled with patient identification data. (Last name, First name, and last 4 ss an or birth date) B. A properly completed laboratory requisition accompanies all specimens sent to the laboratory. C. An unlabeled container or one labeled improperly will not be accepted by the laboratory. D. If the patient identification on the specimen label is illegible, the specimen is unacceptable for laboratory testing. E. If the specimen container identification does not exactly match the identification on the requisition form for that patient specimen, the laboratory can not accept the specimen. F. All specimen containers must be properly labeled immediately after collection by the person who performed the specimen collection. 4 Occult Blood
G.
Laboratory testing personnel will notify the appropriate clinic nurse when unacceptable specimens are brought to the laboratory. The clinic nurse will resolve the problem, i.e. recollect, reschedule.
H.
The Clinic Nurse is notified if a patient refuses collection or is unmanageable.
IX.
X.
REFERENCE LABS: The ADHD laboratories utilize the following reference laboratories for testing services beyond in house testing capabilities: 1. LabCorp (Burlington, NC) #34D0655059 2. NC State Laboratory of Public Health #34D0692393 3. WFUHS Pediatric Genetics Lab #34D0685331 4. Alleghany Memorial Hospital #34D0019034 5. Ashe Memorial Hospital #34D0018976 6. Watauga Medical Center #34D0667863 (Boone Pathology)
REFERENCE LOGS A.
Specimens sent to reference labs are documented on lab log sheets in order to track the disposition of the specimen and verify the receipt of test results.
B.
Laboratory Testing Personnel will monitor reference lab log entries periodically to monitor receipt of results. When a patient test result(s) has not been received in the routine turn around time, the reference lab will be contacted to obtain the status of the patient results. The internet can be used to access ADHD patient results from the NCSLPH.
C.
Completed logs are maintained in a file for two years.
XI.
LABORATORY TESTING PERSONNEL A.
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Laboratory technicians and other full or part time testing personnel must successfully complete orientation and on the job training, demonstrate competency performing the assigned test procedures and administrative tasks, and have written approval from the Laboratory Manager.
B.
Laboratory testing personnel are required to comply with all policies and procedures.
C.
Minimum Testing Requirements (CLIA Contract)
1. 2.
Testing personnel are required to maintain their level of proficiency by ensuring they perform minimum testing on each laboratory test assigned. Each employee must perform each approved test a minimum of once per quarter in order to continue being authorized to perform that particular test. a. If a person performs each test once a month or less, they are required to perform quality control testing each day they do the test. An employee who does not comply with this requirement will lose approval to provide laboratory testing.
D. E.
F. G.
Venipuncture Proficiency: Specified nursing and testing personnel are required to maintain and demonstrate venipuncture proficiency. The Technical Consultant is notified within ten working days of any changes in testing personnel duties and the hiring or termination of testing personnel. The Technical Consultant reviews the qualifications of perspective new testing personnel prior to hire. The Technical Consultant is notified within ten working days of a change in Clinical Consultant. Testing personnel who are authorized to perform moderate complexity testing will have, at a minimum, six contact hours per year of continuing education. Staff performing waived testing will have three contact hours per year of continuing education.
H. Documentation of laboratory related continuing education activities for laboratory testing staff is documented on the continuing education log sheet.
I.
XII.
Testing personnel who perform moderate complexity testing must successfully participate and in competency assessment as provided by the NCSLPH Laboratory Competency Assessment Program.
OFF‐SITE SCREENING A. Lab personnel and/or nurses occasionally conduct off‐site screening using the HemoPoint H2 analyzer in Ashe County and collect blood for lead testing on children for kindergarten physicals. B. The established Laboratory Procedure Manual will be followed by these personnel and is reviewed and signed annually.
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THIS POLICY HAS BEEN REVIEWED AND APPROVED: _______________________________________ _________________ Health Director Date _______________________________________ _________________ Nursing Director Date _______________________________________ _________________ Laboratory Manager Date
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