POLICY & PROCEDURE

MANUALS
By: Kimberly A. Barro, RMT
 DEFINITION OF TERMS
POLICY: a statement or a memo that outlines the institution’s position on an
administrative or operational issue

PROCEDURE: an instructional document that provide explanations and step-by-step

directions on how to perform a task, test or a process

POLICY MANUALS: collections of statements and memos that outline the position of
the institution on a wide range of administrative and operational issues

PROCEDURE MANUALS: provide detailed information about subjects only alluded to

memos, performance evaluations, training sessions, and day-to-day verbal and
written interchange between laboratory workers and their clients
Policy and procedure manuals
should be dynamic documents
with up-to-date, pertinent, and
accurate information.
OBJECTIVES OF PPMs
- Primary objective: ensure effective communication
between members of the organization
- attempt to remove any ambiguities
- allow uniform and consistent application of the
laboratory’s policies and procedures
- living documents that are continually adjusting to the
rapid changes of social, technological and legal
environment within the laboratory
SAMPLES OF CONTENTS IN A PPM
- responsibility and control
- performance appraisals
- completion of tasks and duties
- quality standards and monitoring indexes
- job descriptions
- work flow and job analysis
- productivity measurement
- financial accountability
POLICY MANUALS
Policy manuals may be:

- a simple statement about the intent and philosophy of a

company to a detailed plan of implementation
- an extensive document listing strategies on how minorities
will be recruited as potential employees
- contains only a few paragraphs, with sufficient explanation
to establish the intent
GENERAL HOSPITAL POLICY MANUAL
Relevant to the whole institution as well as the departmental policies

Topics include:
- administrative organization
- employment and personnel policies
- safety and health procedures
- disaster plans
- confidentiality of patient information
- facility security
- solicitation on premises
LABORATORY POLICY MANUAL
Specific to the laboratory departmental policies

Topics include:
- dress code
- food and smoking rules
- telephone/mobile phone use
- safety rules
- laboratory organization
- absences and tardiness notification
- vacation and holiday leave
- supply requisition
- reporting and releasing results
 Confidentiality of patient
results is both under the
hospital and laboratory policy.
TYPES OF POLICY & PROCEDURE
MANUAL

1.EXTERNAL MANUALS
2.INTERNAL MANUALS
EXTERNAL MANUALS

- directed to the users of the laboratory services such

as: nurses, doctors, and patients
- Laboratory service manual for NURSES
- Instructional booklets about preparation for testing
for PATIENTS
EXTERNAL MANUALS
SPECIMEN COLLECTION MANUAL
- required by inspection agencies
- distributed to all areas in which specimens are
collected for submission to the laboratory
1. Nursing units
2. Physician’s offices
3. Satellite collection sites
EXTERNAL MANUALS
LABORATORY SERVICE MANUAL
An all-encompassing document designed to meet a wide
range of user needs
- laboratory operation hours
- collection and courier pick up scheduling
- insurance
- billing
- lab telephone number
- location of facility
INTERNAL MANUALS
- intended for the members of the laboratory department
ADMINISTRATIVE MANUALS
Policies that apply to the whole laboratory:
- work schedules
- vacation and holiday staffing
- dress codes
- changes in schedules/swapping
- supervisory delegation
INTERNAL MANUALS
TECHNICAL MANUALS
- step-by-step instructions for operating instruments
- performing individual tests, tasks and duties
- instructions should be COMPREHENSIVE
- include: calibration, specimen collection, QC, safety,
actual test performance, troubleshooting, and
reporting results
- EACH LABORATORY SECTIONS HAVE THEIR OWN
TECHNICAL MANUALS
INTERNAL MANUALS
SAFETY MANUALS
- universal precaution
- general safety rules and regulations
- instructions for handling dangerous substances and
biological samples
INTERNAL MANUALS
QUALITY MANAGEMENT MANUALS
- overall policies, procedures and rules for ensuring
quality laboratory services
- issues of specimen acceptability
- administrative and technical review of quality data
- coordination and integration with the institutional
quality plan
- assignment of authority and responsibility
 WRITING POLICY AND
PROCEDURE MANUALS
CHARACTERISTICS OF A WELL WRITTEN PPM

- easy consultation and retrieval of information

- consistency of design
- emphasis should be on the USER of the manual
- format and style of manual should be considered
FORMAT AND STYLE FACTORS
- Skill and technical ability of the users, especially the use of
layman’s terms for easier understanding of users
- Ready resource for checking performance criteria
- Performance expectation of laboratory
- Behavior expectation of laboratory
POLICY MANUAL FORMAT
- may be a one-sentence statement to a more extensive discussion
of a topic
- too much detail on the topic, makes it a procedure not a policy
- organized with topic and subject headings
- not as specific and detailed as the procedure manual
- composed according to standard writing styles
POLICY MANUAL sample
QUALITY POLICY MANUAL. (2010). https://www.slulabservices.com/wp-
content/uploads/2010/11/GN-MP-QualMan.pdf
PROCEDURE MANUAL FORMAT
- detailed and comprehensive
- specific guidelines by regulatory agencies are imposed
- laboratory must maintain specific procedures relating to the work
done
- PHOTOCOPIES from reference books, package inserts or MSDS are
NOT ACCEPTABLE if they do not actually describe the work being
done
- procedures are tailored to the specific methodology being
performed in the laboratory
PROCEDURE MANUAL FORMAT
- laboratory must adhere to the standard rules and guidelines by
the governing agencies
- Governing agencies:
1. Department of Health (DOH)
2. Joint Commission on Accreditation of Healthcare Organizations
(JCAHO)
3. College of American Pathologists (CAP)
4. AABB (American Association of Blood Banks)
5. CLIA (Clinical Laboratory Improvement Amendments)
6. OSHA (Occupational Safety and Health Administration)
PROCEDURE MANUAL FORMAT
NATIONAL COMMITTEE FOR CLINICAL LABORATORY STANDARDS
(NCCLS)
- provides the general format for the PPM
- the format is published in its approved guideline, “CLINICAL
LABORATORY PROCEDURE MANUALS”
PROCEDURE MANUAL SAMPLE
Yumpu.com. (n.d.). Laboratory procedure Manual - Centers for Disease Control and ... yumpu.com.
https://www.yumpu.com/en/document/view/9825623/laboratory-procedure-manual-centers-for-disease-control-and-
END OF DISCUSSION. THANK YOU.