Policy and Procedure Manual

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Avatar for Michael18
3 years ago

Policy

● Statement or memo

○ Outline the institution’s position on an administrative or operational issue

Procedure

● Instructional document

○ Provides explanations and step-by step directions on how to perform a task, test,

or process

● Also referred to as SOP - Standard Operating Procedure

Manual

● Handbook

○ Contains information and instructions about the operation or how to do something

Types of Manuals

● Policy Manual

○ Contains policies that apply to the general and overall operations of the institution

■ Administrative organization

■ Employment and personnel process

■ Adherence and enforcement of safety and health procedures

■ Disaster plans

■ Confidentiality and release of patient information

■ Security and access to facilities

■ Dress codes

■ Food and smoking rules

■ Telephone use

■ Safety rules

■ Absences and late arrival notifications

■ Vacation and holiday requests

■ Supply requisition

● Procedure Manual

○ Standardize the way tasks and tests are performed

○ Ensure that all work is performed according to criteria set

○ Assist in problems which require troubleshooting

○ Contains procedures that apply to specific work tasks and duties

■ Technical manuals - contains procedures for performing test, operating

instruments, or processing quality control information.

● Objective of these manuals

○ To ensure effective communication between the members of the organization

○ To remove any ambiguities

○ To allow uniform and consistent application of the laboratory’s policies and

procedures

● Issues of these manuals

○ Responsibility and control

○ Performance appraisals

○ Completion of tasks and duties

○ Quality standards and monitoring indexes

○ Job descriptions

○ Workflow and job analysis

○ Financial accountability

Types of Policy and Procedure Manuals

● External manuals - Directed for the users of laboratory services

○ Specimen Collection Manual

■ Contains detailed instruction for patients and health care providers for

collecting, labeling, storing, rejecting, transporting, and delivering

specimens to the laboratory

○ Laboratory Service Manual

■ Covers policies and procedures concerning operational factors:

● Business hours

● Services provided

● Specimen submission requirements

● Billing practices

● Internal manuals - Designed for workers of the laboratory

○ Administrative manuals

■ Addresses policies that apply to the entire laboratory

● Work schedules

● Vacation and holiday staffing

● Dress codes

● Telephone use

● Changes in schedule

● Delegation

● Disaster plans

● Procedures for supply requisitions

○ Technical manuals (organized according to discipline)

■ Contains information and step-by-step instructions:

● Operating instruments

● Performing individual tests

● Tasks and duties

● Procedures for calibration

● Quality Control

● Safety

● Troubleshooting

● Releasing of results

○ Safety manuals

■ Dedicated to specific safety concerns present in facility

■ Covers physical, chemical, fure, natural disaster, and blood borne

dangers

■ Contains the chemical and exposure control plan as dictated by OSHA

● OSHA - Occupational Safety and Health Administration

○ Quality management manuals

■ Contains overall policies, procedures, and rules for ensuring the quality of

laboratory services

■ Deals with…

● Specimen acceptability

● Administrative and technical review of quality data

● Ensuring the quality standards and goals are achieved

Writing Policy and Procedure Manuals

● Ensures

○ CONSISTENCY - serves as a checklist

○ ACCURACY - Accurate results > relying on memory

○ QUALITY - consistent and reliable results is primary goal of the laboratory

● Policy Manual Format

○ Organized BY TOPIC, present using an OUTLINE MODEL with subject

headings

○ Policy can range from a one-sentence statement to more extensive discussion

■ “Example: All staff will present a professional appearance at all times”

● Procedure Manual Format

○ Regulatory agencies have specific guidelines governing the information provided

in procedure manual format

○ Regulatory agencies require that the laboratory maintain specific procedures

relating to the work done in its facility

○ Examples of REGULATORY AGENCIES *REMEMBER THESE*

■ JCAHO - Joint Commission on Accreditation of Healthcare Organizations

■ CAP - College of American Pathologists

■ AABB - American Association of Blood Banks

■ CLIA ‘88 - Clinical Laboratory Improvement Amendment of 1988

■ OSHA - Occupational Safety and Health Administration

■ NCCLS - National Committee for Clinical Laboratory Standards

● Factors in selecting Format and Style

○ Skill and technical ability of the user

○ Manual’s use as a ready resource for checking performance criteria

○ Performance and behavior expectations of the laboratory

Items found in Technical Procedure Manual

● Name of test, procedure, task or duty

● Effective date and any changes

● Short summary of the main elements of the procedure

● Principle of the test

● Specimen requirements

● Instrumentation, equipment needed

● Reagent preparation

● Calibration

● QC procedures

● Interferences

● Step-by-step instructions

● Calculations and interpretations of results

● Reference ranges

● Troubleshooting suggestions

● References

● Authorization and schedule for review

Document Control

● Ensures that the more current version of any documents is the one that is in use

● Ensure availability and ease of use when a document is needed

● Provide for the appropriate archiving of documents when they need to be replaced

Elements of Document Control

● Uniform format

○ Includes a numbering system and method for identifying the version (date)

document

● Process for formal approval for each new document and procedure for updating and

revising laboratory documents

● Master log or inventory of all documents of the laboratory

● Process to ensure that the documents are available

● Method for archiving documents that get outdated but used for future reference

Controlled Documents

● SOPs

● Texts, articles, and books

● Documents of external origin

Developing the Document Control System

● Create a system for standardizing the format and/or numbering

○ Indicates document version

● All pages of the documents must contain an appropriate number

● Approval, distribution, and revision process

● Master log

● Accessibility

● System for archiving

Implementing Document Control

● Collect, review and update all existing documents and records

● Determine the additional needs

○ New process or procedure descriptions

● Develop or obtain example of documents

● Involves stakeholders

Common issues for Document Control

● Outdated documents in circulation

● Distribution Problems

● Failure to account for documents of external origin

Importance of Records

● Continuous monitoring

● Tracking of samples

● Evaluating problems

● Management

Examples of Laboratory Records

● Sample logbook, registers

● Laboratory workbooks or worksheets

● Instrument printouts—maintenance records

● Quality control data

● External quality assessment or proficiency testing records

● Patient test reports

● Personnel records

● Results of internal and external audits

● Continuous improvement projects

● Incident reports

● User surveys and customer feedback

● Critical communications

Records that are Easily Forgotten

● Information on the management and handling of rejected samples

● Data needed on any sample referred to another laboratory; to include when the sample

was transported, where it was sent and when the report was issued.

○ The sample should be able to be tracked throughout the referral process

● Information about adverse occurrences or problems

● Include all information that is pertinent, such as the results of any investigation of the

problem

● Inventory and storage records. These helps keep track of reagents and supplies

● Equipment records

Test Report Content

● Identification of test

● Identification of laboratory

● Unique identification and location of patient, where possible, and destination of the

report

● Name and address of requestor

● Date and time of collection, and time of receipt in laboratory

● Date and time of release of report

● Primary sample type

● Results reported in SI units or units traceable to SI units, where applicable

● Biological reference intervals, where applicable

● Interpretation of results, where appropriate

● Applicable comments relating to quality or adequacy of sample, methodology limitations

or other issues that affect interpretation

● Identification and signature of the person authorizing release of the report

● If relevant, notation of original and corrected results

Storing of Records - PAST

● Permanence - how long records last

● Accessibility - how easily available the information is

● Security - maintains patient confidentiality

● Traceability - record of all the processes

Electronic System - PST

● Permanence - backup systems

● Security - access codes

● Traceability - input and availability of record

Record Retention

● Length of time the laboratory will need to have access to its records

● Government requirements or standards that dictate record retention times

● Whether laboratory is engaged in ongoing research requiring many years of data

● Time interval between the laboratory’s assessments

KEY POINTS

● INFORMATION is the product of laboratory

● DOCUMENTS are essential for assuring accuracy and consistency in the laboratory

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