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Clinical Laboratory Policy and Procedure Manual

Clinical Laboratory Policy and Procedure Manual is a manual containing many of our policy and procedure templates for the medical office, hospital, and other healthcare organizations. The policies cover: Joint Commission (JCAHO or TJC) • CMS • HIPAA • CDC • AAAHC and more.

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Changes Table of Contents - TJC, CLIA standards Copyright Disclaimer

SECTION I - LEADERSHIP

Mission Vision Statement Scope of Services Objectives Compliance Plan for Clinical Laboratory Patient Rights and Responsibilities Patient Identification for Clinical Care and Treatment Patient Confidentiality Data Protection and Confidentiality Guidelines for Departments Clinical Laboratory Policy and Procedure Manual Suspected Child, Adult, Disabled Person or Elderly Abuse/Neglect Requisitions Laboratory Reporting Laboratory Test Panels Routine AM Collection of Specimens Transporting of Lab Specimens Daily Review of Patient Results Problem Log Errors in Patient Test Orders or Results - Problem Log Processing of Specimens for Reference Labs STAT Laboratory Tests and Results Waived and Point-of-Care Testing Waived Testing - Personnel One Touch II Blood Glucose Monitoring Blood Glucose Monitoring Competency Checklist Routine Duties Product Ordering Manufacturers and Suppliers Addresses for Primary Standards Quality Control Records

SECTION II

Surveillance, Prevention and Control of Infection

Standard Precautions Hand Hygiene Exposure Control Plan Sharps Injury Protection Plan - Addendum to Exposure Control Plan Sharps Injury Log Exposure of Personnel to Mycobacterium Tuberculosis and Pathogenic Fungi Bloodborne Pathogens/Infectious Diseases and the Laboratory Worker HIV Infected Healthcare Workers

SECTION III - HUMAN RESOURCES

Position Description/Performance Evaluation - Clinical Laboratory Director Performance Evaluation - Age-Related Competency - Clinical Laboratory Director Annual Competency Clinical Skills Assessment - Clinical Laboratory Director Position Description/Performance Evaluation - Chief Medical Technologist Performance Evaluation - Age-Related Competency - Chief Medical Technologist Annual Competency Clinical Skills Assessment - Chief Medical Technologist Position Description/Performance Evaluation - Medical Technologist Supervisor Performance Evaluation - Age-Related Competency - Medical Technologist Supervisor Annual Competency Clinical Skills Assessment - Medical Technologist Supervisor Position Description/Performance Evaluation - Medical Technologist - Blood Bank Performance Evaluation - Age-Related Competency - Medical Technologist - Blood Bank Annual Competency Clinical Skills Assessment - Medical Technologist - Blood Bank Position Description/Performance Evaluation - Medical Technologist - Chemistry Performance Evaluation - Age-Related Competency - Medical Technologist - Chemistry Annual Competency Clinical Skills Assessment - Medical Technologist - Chemistry Position Description/Performance Evaluation - Medical Technologist - Hematology Performance Evaluation - Age-Related Competency - Medical Technologist - Hematology Annual Competency Clinical Skills Assessment - Medical Technologist - Hematology Position Description/Performance Evaluation - Medical Technologist - Microbiology Performance Evaluation - Age-Related Competency - Medical Technologist - Microbiology Annual Competency Clinical Skills Assessment - Medical Technologist - Microbiology Position Description/Performance Evaluation - Medical Technologist - Serology/Immunology Performance Evaluation - Age-Related Competency - Medical Technologist - Serology/Immunology Annual Competency Clinical Skills Assessment - Medical Technologist - Serology/Immunology Position Description/Performance Evaluation - Phlebotomist Performance Evaluation - Age-Related Competency - Phlebotomist Annual Competency Skills Assessment - Phlebotomist Position Description/Performance Evaluation - Clinical Laboratory Secretary/Clerk Performance Evaluation - Age-Related Competency - Clinical Laboratory Secretary/Clerk Annual Competency Skills Assessment - Clinical Laboratory Secretary/Clerk Position Description/Performance Evaluation - Clinical Laboratory Assistant Performance Evaluation - Age-Related Competency - Clinical Laboratory Assistant Annual Competency Skills Assessment - Clinical Laboratory Assistant Proficiency Testing for Non-Waived Testing Laboratory Personnel Competency Competency Record - Coagulation Competency Record - Hematology Hematology Competency Test Blood Bank/Serology Competency Test Hazardous Chemicals and Safety Competency Test Documentation of Annual Personnel Review of Clinical Laboratory Manuals Clinitek 200 Form New Employee Orientation and Training Training for New Personnel Inservice Education and Continuing Education Inservice Training Form - Clinical Laboratory

SECTION IV - PERFORMANCE IMPROVEMENT

Clinical Laboratory Performance Improvement Plan Performance Improvement Monitoring and Evaluation Plan - Clinical Laboratory Organizational Performance Improvement - Volume Measures/Statistics - Clinical Laboratory Organizational Performance Improvement - Performance Measures/Outcomes - Clinical Laboratory Clinical Laboratory - Blood Usage Organizational Performance Improvement - Performance Measures/Outcomes - Clinical Laboratory - Blood Usage Criteria for Transfusion Review Service Specific Blood Usage Summary - General Staff Report Request for Investigation of Transfusion Reaction Form Sentinel Event Conducting Root Cause Analysis Incident Reporting Staff Questionnaire

SECTION V - DIRECTED DONOR/AUTOLOGOUS PROGRAM

Autologous Blood Donor Program Protocol, Phlebotomy, Patient Care Autologous Blood Donation Form Autologous Blood Donor Record Form Facts about Autologous Blood Transfusion Autologous Blood Bank Discharge Instructions Informed Consent: Blood/Blood Component Transfusion Blood/Blood Component Transfusion Consent Form Refusal of Blood/Blood Component Transfusion Refusal to Permit Blood/Blood Component Transfusion Form Labeling of Autologous Units Autologous Units - Clinical Laboratory Processing Autologous Units - Storage Charges for Autologous Donor Procedure Transfer of Autologous Blood Autologous Units That Are Shipped Blood Shaker/Weight Monitor

SECTION VI - CHEMISTRY

Manual Requisitions Glucose Tolerance - Manual Requisition Form (Sample)Urine Chemistry - Manual Requisition Form (Sample)Chemistry I, Chemistry II - Manual Requisition Form (Sample)Specimen Requirements Criteria for Rejection of Specimens for Chemistry Reference Values Insert Facility Reference Ranges Panic Values Insert Facility Panic Values Method Linearity Supporting Information - Linearity Testing on Du Pont Systems Coronary Risk Profile Authorization for CKMB on Normal CK Troponin Levels LDH Isoenzymes Gentamicin Discrepancies Digoxin Levels Iron Studies Serum Acetone Swallowed Blood Syndrome (APT Test)Oliguria Profile Creatinine Clearance Calculations 24-Hour Urine Calculations Glucose Tolerance Preparation Glucose Tolerance Test (Oral)Drugs of Abuse Screen for Urine Test Instrumentation and Back-Up Insert Clinical Chemistry System Equipment Test Test Specifications Form (Example)Calibration Frequency Quality Control - Out-of-Control Quality Control Updating Quality Control Monthly Reports Control Product Inserts Maintenance Log Daily ISE and System Check Log Na+ K+ Analyzer Log Daily Maintenance Log - Discrete Clinical Analyzer Weekly and Monthly Maintenance Log - Clinical Analyzer Shift Log

SECTION VII - HEMATOLOGY

Criteria for Rejection of Specimens for Hematology Workups Hematology Quality Control Guidelines Hematology Panic Values Abnormal Presurgical Results Correction of RBCs and RBC Parameters for Over Range WBCs Pre-Op CBC Guidelines for Manual Differential Blood Cell Differential Pathologist Smear Review Criteria Hematology Slides and Reports to be Reviewed by Pathologist Average Normal Blood Values at Different Ages - Chart Mean Hematologic Values Infant through Adult - Chart Thalassemia Trait Versus Iron Deficiency Bone Marrow Procedure Eosinophil Count Hemacytometer Microhematocrit Centrifuge Quality Control Hematocrit Mucin Clot Test Nasal Smear for Eosinophilia Red Blood Cell Indices Reticulocyte Count Sugar Water Screening for Paroxysmal Nocturnal Hemoglobinuria Erythrocyte Sedimentation Rate (Modified Westergren)Wintrobe Sedimentation Rate Platelet Clumping Cold Agglutinin Procedure Lipemic CBC - HGB Correction Morphologic Characteristics of the Myeloid and Non-Myeloid Cells (Wright's Stain) Chart Correction of White Count for Nucleated RBCs Automated Differential Check Sample Analysis Manufacturers and Suppliers List

SECTION VIII - BLOOD BANK

Blood Bank Policies and Procedures Patient's Guide to Blood/Blood Component Transfusion Informed Consent: Blood/Blood Component Transfusion Blood/Blood Component Transfusion Consent Form Refusal of Blood/Blood Component Transfusion Refusal to Permit Blood/Blood Component Transfusion Form Blood Bank Requisitions Collection and Labeling of Blood Specimens Identification of Blood Samples in the Blood Bank Criteria for Rejection of Specimens for Blood Bank and Serologies Sign-Out Protocol for Blood/Blood Components Cross Agglutination Report Form Platelet Concentrate Form Blood Bank Panic Values Transfusion Reaction Procedure Request for Investigation of Transfusion Reaction Form Patient Blood Samples Comparison of Past Blood Bank Records Pretransfusion Protocol Type/Screen Protocol Selection of Donor ABO/Rh Release of Blood in Emergency Situations Blood Bank Emergency Release Form Hemolytic Disease of the Newborn Antibody Screening and Crossmatch Results/Interpretation Reset-Up of Previously Crossmatched and Released Blood Donor Inspection and Criteria for Rejection of Stored Blood Massive Transfusion Multiple Transfusions Releasing Directed Donors for General Use Retention of Blood Bank Specimen and Donor Samples Retesting of Donor Units Return and Reissue of Blood for Transfusion Filtration Protocol ABO Group Testing of Red Cells and Serum - Test Tube Resolving ABO Discrepancies Agglutination Interpretation of Tube Antibody/Antigen Reactions Antibody Screen/Indirect Antiglobulin Test (IAT)Antibody Identification Auto Control Cold Reactive Autoantibodies Prewarming Technique Direct Antiglobulin Test (DAT)Immediate Spin Compatibility Testing and Saline IAT (Crossmatch)Fresh Frozen Plasma (FFP)Thawing Fresh Frozen Plasma Cryoprecipitate AHF Frozen Red Blood Cells, Thawed, Deglycerolized Granulocytes Packed Red Blood Cells (PRBCs)Platelets - Single Unit Plateletpheresis Rh Immune Globulin (RhoGAM)Rh Testing of Red Cells for "D" and "Weak D" Test Tube Method Rouleaux vs. Agglutination Determinations Whole Blood Blood Bank Refrigerator Maintenance Procedures Quality Control: Blood Bank Refrigerator and Freezer Quality Control Testing - Reagents, Equipment Functional Calibration of Blood Bank Serologic Centrifuges Centrifuge Calibration Form Storage of Blood Components in the Event of the Loss of Monitored Refrigeration Blood Warmers Blood Bank Reagent Quality Control Out-of-Control Plan Disposition of Expired Blood Look-Back Creutzfeldt-Jacob Disease Suppliers of Blood Bank Products/Services

SECTION IX - PHLEBOTOMY

Identification of Patients Labeling of Specimen Tubes Transport of Specimens to the Clinical Laboratory Skin Puncture Blood Collection Venous Blood Collection The Blood Smears Multiple Specimen Collections IV Care Blood Sampling, Groshong, Hickman/Quinton Catheters Blood Drawing - Outpatient Surgery

SECTION X - COAGULATION/SEROLOGY

Specimen Collection List Patient Preparation List Panic Values - Coagulation Coagulation Panel Cold Agglutination Test Lee and White Clotting Time Tests for Circulating Anti-Coagulants Thrombin Time RPR - Syphilis Screening Test Coagulation Quality Control Guidelines Coagulation Out-of-Control Form Out-of-Control Plan (Reagents)Parallel Testing - Serology Kits HIV Antibody Test Consent and Results Consent for the HIV Test (Sample Form)Authorization for Disclosure of the Results of the HIV Test Form Marriage Health Certificates

SECTION XI - URINALYSIS

Criteria for Rejection of Specimens for Urinalysis Urine Collection by Patients Routine Urinalysis Preoperative Patient Macro Urines Microscopic Urinalysis Urinalysis - Ranges of Values and Definition of Ranges Twenty-Four (24) Hour Urine Collection 24-Hour Urine Collection Guide Specific Gravity of Urine Daily Urine Quality Control Guidelines Action Log Collection and Processing of Employment Drug Tests Checklist Procedure for Pre-Employment Drug Testing

SECTION XII - MICROBIOLOGY

Quality Control - Laboratory Equipment Quality Control - Autoclave Autoclave Autoclave Quality Control Log Equipment Quality Control Log Thermometers Record Form Constant Temperature Form Quality Control - Calibrated Loops Calibrated Loop Quality Control Log Calibration of the Ocular Micrometer Calibration of the Ocular Micrometer Diagram Quality Control - Media Control Organisms to be Used for Media Performance Testing Quality Control - Reagents Reagent Information Log Reagent Quality Control Log Microbiology Reagent Quality Control Log Quality Control Organisms - Stock Organisms Maintenance and Use CTA Medium (For Maintenance of Stock Organisms)Stock Cultures - Methods of Maintenance Working Stock Cultures - Maintenance Bacteriology Hazards Disposal of Contaminated Materials Microbiology Specimen - Collection, Ordering and Reporting Receiving Laboratory Specimens Criteria for Rejection of Specimens - Microbiology Criteria for Rejection of Stool for Ova and Parasites Out-of-Control Plan Panic Values in Microbiology Department of Health Services: Submitting and Reporting Cultures Aerobic Bacteria Identification - General Culture Procedure Aerobic Identification - Enteric Gram Negative Bacilli Aerobic Identification - Gram Positive Bacilli Aerobic Identification - Gram Positive Cocci Aerobic Identification - Gram Negative and Gram Variable Cocci and Coccobacilli Gram Positive Rods Gram Positive Rods Diagram AFB Cultures and Fungus - Reference Lab Request Form (Sample)Anaerobic Cultures - Ordering and Collection Anaerobic Cultures - Identifying and Reporting Infections Commonly Involving Anaerobes - Chart Beta Strep GC Cultures Identification of Neisseria (From the Urogenital Tract, Eye and Body Fluids)Blood Cultures - Ordering and Collection Blood Cultures - Processing and Reporting Campylobacter Cultures Catheter Tip Cultures (CVPs)Body Fluid Cultures - Ordering and Collection Body Fluid Cultures - Identifying and Reporting Fungus Cultures and Direct Examination of Specimens for Fungus Respiratory Cultures - Ordering and Collection Respiratory Cultures - Identifying and Reporting Spinal Fluid Cultures - Ordering and Collection Spinal Fluid Cultures - Processing and Reporting Sputum Cultures - Ordering and Collection Sputum Cultures - Processing and Reporting Stool Cultures Urine Cultures - Ordering and Collection Urine Cultures (Colony Count) - Identifying and Reporting Urogenital Tract Cultures - Ordering and Collection Urogenital Tract Cultures - Identifying and Reporting Viral Specimens - Collection, Transport, Storage - Chart OF Basal Medium with Dextrose Bile Esculin Agar Slants Ornithine Motility Indole Medium (OMI)Salt Tolerance Test Simmons Citrate Agar Slants Cytology Preparation Catalase Test Floxin (Ofloxacin) Procedure Germ Tube Test Gram Stain Haemophilus Identification Test Hippurate Hydrolysis Test India Ink Method for Cryptococcus Detection in CSF Wet Mounts Plating Protocol for Clinical Microbiology Specimens Media Used for Plating Microbiology Specimens Streak Plate Technique (For Plating Culture Specimens)Multiple-Resistant Organisms Antibiotic Susceptibility Susceptibility with Streptococcus Pneumoniae Recommendations for Sensitivity Panels Sensitivity Testing - Kirby-Bauer Method Quality Control of Antimicrobial Susceptibility Disks (Kirby-Bauer Method)CSF and Body Fluid Counts Cellophane Tape Preparation for Enterobius Vermicularis (Pin Worm)Semen Analysis Stool - Wright's Stain for Polys Synovial Fluid Crystal Analysis Distributors and Suppliers List