QUALITY PLAN FOR COMPETENCY AND INTEGRITY OF DRUG

TESTING
 PERSONNEL REQUIREMENTS
o The Owners shall provide both the technical and administrative personnel the
necessary training and skills for the tasks assigned to them.
o It would be the policy of the section to ensure that the only qualified staff will
handle the process.
o The laboratory staff will continually attend any training available to update the
competency of staff.
o The number of personnel handling the specimen must be minimized.
 DOCUMENTATIONS
o The laboratory must have standard operating procedures (SOP) manual that
describe all laboratory operations. It ensures that all specimen are tested using the
same procedure and in a consistent manner.
o Documents the date and the purpose on the CCF. Identify each person who
handled the specimen
o Records and reports any apparent tampering with the container or specimen, any
discrepancy in the specimen and the CCF
 HANDLING COMPLAINTS AND LABORATORY ACCIDENTS
o Any complaints on the sample must be properly documented and reported to the
Head of the Laboratory.
o A memorandum for record must be properly filled up if the error pertains to those
that can be cancelled.
o Patients personal complain will be handled by the immediate supervisor. The
nature of the complaint must be documented and personnel involved in the
incident shall make a written incident report for her/him to explain his/her side.
Any negligence on the part of the personnel shall be dealt by reprimand or
suspension depending on the gravity of the offense.
o Any Laboratory accidents must be reported immediately to the OIC for immediate
action.
 QUALITY MONITORING
 To minimize the risk of adulterations, substitution or dilution of urine specimen:
a. Use of toilet water coloring agents (bluing agent) placed in the toilet bowl to
prevent dilution of specimen.
b. Inspection of garments and body search to check for any adulterants.
c. Donors must wash their hand prior to collection.
d. ASC must remain with the donor during the entire collection process
e. ASC shall allow the donor to choose the specimen container for use from the
supplies.
 f. Donors are instructed not to flush the toilet until the specimen is handed to the
ASC.
 Documentation
 Handling Complaints
 Quality Indicators:
a. Number of rejected specimen due to improper collection.
b. Number of complaints with regards to results
c. Proficiency Testing