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
Patient Instructions for Semen Collection and Transport of Semen (3 of 4)
* 7. Collection
* 8. Following collection
Patient Instructions for Semen Collection and Transport of Semen (4 of 4)
* 9. Complete your patient information form. Deliver the semen specimen and the patient information form to the laboratory technologist. The technologist will review the information provided, and may ask for additional information.

What else should I include regarding the specimen?
* Specimen type
* Semen specimen collected per Patient Instructions for Semen Collection and Transport of Semen. Handling conditions
o Special timing considerations
+ Semen should be used within 3 hours of collecting. ImmunoSpheres Detection of Sperm Reactive Antibodies
o Special equipment

Specimen Type
* Preferred type and acceptable sources
o Semen specimen collected per Patient Instructions for Semen Collection and Transport of Semen. Liquefied semen samples are required. It is recommended that the test begin no more than three hours after sample collection. The performance of the test with frozen samples has not been established. Testing can also be performed on serum or bromelain-solubilized cervical mucus.
* ImmunoSpheres Detection of Sperm Reactive Antibodies

Specimen Type
* Optimum and minimum amount
* Acceptable collection containers
o Specimen Collection:
o Semen should be collected in clean cup. The semen sample should be stored at room temperature until use. Semen should be used within 3 hours of collecting.
o ImmunoSpheres Detection of Sperm Reactive Antibodies
* Stability of specimen and storage requirements.
* It is recommended that the test begin no more than three hours after sample collection. The performance of the test with frozen samples has not been established. ImmunoSpheres Detection of Sperm Reactive Antibodies
* Criteria for unacceptable specimen and action to be taken
* Semen collected in a condom or by coitus interruptus is not acceptable for evaluation. If you are unable to collect by masturbation, contact your physician to discuss an alternative collection method.
* Physical characteristics that can compromise the test results
* Drugs that can interfere with test results

What about calibration?
* List when needed
* Include standard preparation
o Name and chemical formula when possible
o Acceptable grade; usual source
o Directions for prep including special cleaning or quality of glassware and volumetric equipment
o Degree of accuracy required
o Storage requirements
* Include calibration procedure
o Detailed instructions in tabular form
o Frequency to be performed
o Photometric specifications
o Type of calibration graph, point of origin, type of graph paper
o Acceptable tolerances

How do I assess the quality of my results?
* Quality control
* No standard controls are used, but you may use photos or video to become familiar with normal and abnormal values.
What do I need to do the test?
* Equipment
* Materials
* Preparation and storage of reagents
* Performance parameters
* Procedural notes

Hazardous Materials
* Specify any protective clothing and safety equipment required
* Specify type of spill kit or disposal method
* Set health and safety instruction
Finally…What do we include in the procedures?
* Quality control
* List equipment and reagents
* List storage requirement
* Include step-by-step instructions

Now, what about my results?
* Include reference ranges with reporting format and any necessary calculations
* State procedure for abnormal results
o Repeat procedure if chamber counts do not agree within ±5%.
* List any limitations of the procedure
o Semen odor is an individual interpretation, and description of the odor will vary among technologists. Analysis of Semen Odor

Where did I get my information?
* Manufacturer Product Literature
* Textbooks
* Standards Publications (NCCLS)
* Written Personal communications

What if we change procedures?
* Establish a system of authority to conduct procedure reviews and system for noting changes
* Review each procedure at least annually
* Minor changes
* Major changes
* Interim changes
* Document review and any changes

References
Using NCCLS Standards to Create Procedure Manuals.ppt

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