Policy and Procedure Manual

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