Using NCCLS Standards to Create Procedure Manuals
Using NCCLS Standards to Create Procedure Manuals
by:Mary E. Gray
What is NCCLS?
* A nonprofit, educational organization that provides a communication forum for the development, promotion and use of national and international standards.
* Founded in 1968 and accredited by the American National Standards Institute.
Why NCCLS?
* Based on the principle that voluntary consensus standards are essential for performing clinical laboratory testing at the high level necessary for quality patient care
* Describes laboratory procedures, bench and reference methods, and evaluation protocols applicable within all the major laboratory disciplines
What are the different types of publications?
* Standard: clearly identifies specific, essential requirements for materials, methods, or practices for use in an unmodified form. May contain discretionary elements.
* Guideline: describes criteria for a general operating practice, procedure, or material for the clinical community. May be modified by the user.
* Report: document that has not been subjected to consensus review
What is the consensus process?
* A voluntary process is a protocol establishing formal criteria for:
o The authorization of a standards project
o The development and open review of documents
o The revision of documents in response to comments by laboratory users
o The acceptance of a document as a clinical laboratory standard
How is consensus reached?
* Consists of formal procedures describing the development of an NCCLS document and criteria for its acceptance as a clinical laboratory standard
* Most NCCLS documents are subject to 2 levels of consensus
o Proposed
o Approved
What are the levels of consensus?
* Proposed: document undergoes the first stage of review.
* Tentative: a tentative standard or guideline made available for review and comment
* Approved: has achieved consensus within the clinical laboratory testing community
How does one design a NCCLS clinical laboratory technical procedure manual?
* Determined by the laboratory’s needs
* Start each procedure on a new page
* Consider using tabs and a table of contents
* Use a numbering system
* Provide supplementary materials where necessary
* Use electronic word-processing equipment
What sources can I use?
* Manufacturer product literature
* Scientific journals
* Textbooks
* Standards publications
* Research and validation data
* Written personal communications
What style must be used in a technical procedure?
* Uniform style
* Month and year adopted
* Page number and total number of pages
* The author and initials of approving authority
* Dated, noted, and signed corrections
* Does it replace a previous procedure
How should I title my procedures?
* Should be concise and descriptive
* Considerations
o The type of specimen
+ Semen Agglutination
o The specific method or instrumentation
+ Mycotrim GM Triphasic Culture System for Identification of Mycoplasma hominis and Ureaplasma urealyticum
o The particular property for which the test procedure is designed
+ Fructose in Seminal Plasma
What is in the principle?
* Includes type of reaction(s), specimen(s), or organism(s) involved
* Clinical reason for performing the test
* Written in paragraph form
* Example:
* Principle: Examine semen specimen for presence of sperm, dead or alive, to evaluate effectiveness of patient vasectomy.
What should be included in specimen collection?
* Specific instructions, such as fasting and special diets, written instructions to the patient that are given for their preparation, and drug regimes that should be noted on the requisition form
* An outline of the steps involved in complicated specimen-collection procedures
Patient Preparation: Patient given written instructions (see Patient Instructions for Semen Collection and Transport of Semen form. (1 of 4)
* Patient Instructions for Collection and Transport of Semen for Laboratory Analysis
* In order to avoid delays and the increased cost of repeat testing, please follow these instruction for preparing for the semen analysis and for properly collecting the semen specimen.
* 1. You must have an appointment in order to have your semen specimen evaluated.
* 2. You must have abstained from (no ejaculation) for a period of 3-5 days (ideally 3 days) before you collect the sample unless otherwise advised by your physician.
* 3. If collected at the laboratory, you will collect in a private room adjacent to the testing area. You may bring your own magazines or videotapes. Check with lab personnel regarding the availability of a VCR.
* 4. If you collect your specimen outside the laboratory collection room, you must
+ keep the sample near body temperature (25°-40°C or 77°-104° F)
+ deliver your sample to the laboratory within 45 minutes of collection
Patient Instructions for Semen Collection and Transport of Semen (2 of 4)
* 5. Collection method
* 6. Preparation for collection
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