Biosafety and Biosecurity Principles PDF

1\. Historical Context and Key Figures: U.S. Biological Weapons Program (1943): Initiated by President Franklin D. Roosevelt, aimed at developing defensive biological capabilities during World War II. Ira L. Baldwin: First scientific director of Camp Detrick (later Fort Detrick), tasked with estab...

1\. Historical Context and Key Figures: U.S. Biological Weapons Program (1943): Initiated by President Franklin D. Roosevelt, aimed at developing defensive biological capabilities during World War II. Ira L. Baldwin: First scientific director of Camp Detrick (later Fort Detrick), tasked with establishing the biological weapons program. Newell A. Johnson: Played a pivotal role in developing containment equipment like Class III safety cabinets and laminar flow hoods at Camp Detrick. Arnold Wedum (1907-1908): Credited for introducing mechanical pipettors to prevent laboratory-acquired infections. Pharmaceutical Company in Pennsylvania (1909): Developed a ventilated cabinet to protect workers from Mycobacterium tuberculosis. WHO's Smallpox Eradication Program (1967): A major public health initiative to combat the increasing mortality and morbidity rates from smallpox. Richard Nixon (1969): U.S. President who terminated the biological weapons program, leading to the focus on biosafety. American Biological Safety Association (ABSA) (1984): Formed to promote the advancement of biological safety practices. Centers for Disease Control and Prevention (CDC) (1974): Introduced the Classification of Etiological Agents on the Basis of Hazard, defining containment levels based on pathogen risks. Select Agent Regulations (1996, revised in 2012): Implemented by the U.S. government to regulate handling of select biological agents. 2\. International Legislation on Biosafety: Singapore: Biological Agents and Toxins Act aligns with U.S. Select Agent Regulations but enforces more severe penalties for non-compliance. South Korea: Amended the Act on Prevention of Infectious Diseases in 2005 to require biosafety and biosecurity measures for handling dangerous pathogens. Canada: Canadian Containment Levels 3 and 4 require certification for facilities handling high-risk pathogens. Denmark: Parliament passed a law in 2008 empowering the Minister of Health to regulate biological agents. Comité Européen de Normalisation (CEN) (2008): Published the CEN Workshop Agreement 15793 to standardize biorisk management across Europe. National Committee on Biosafety of the Philippines (NCBP): Formed under Executive Order 430 (1990). Philippines: Established the National Biosafety Framework (NBF) through Executive Order 514 (2006), mandating biosafety protocols in laboratories. 3\. Biosafety and Biosecurity Principles: Biosafety: Involves containment principles, technologies, and practices to prevent accidental exposure to or unintentional release of pathogens and toxins. "Protecting People from Dangerous Pathogens" Includes engineering controls (biosafety cabinets, directional airflow), good laboratory practices (hand washing, spill cleanup), and the use of personal protective equipment (PPE). Biosecurity: Refers to protection, control, and accountability for biological materials to prevent unauthorized access, theft, or intentional release. "Protecting Pathogens from Dangerous People" Includes security controls like locked doors, access cards, biometrics, surveillance cameras, and security personnel. 4\. Risk Groups: Organisms are classified based on the risk they pose to individuals and the community: Risk Group 1: Low individual and community risk; unlikely to cause disease. Risk Group 2: Moderate individual risk, low community risk; can cause disease but treatable and preventable. Risk Group 3: High individual risk, low community risk; causes serious disease but is not easily spread. Risk Group 4: High individual and community risk; causes life-threatening diseases with no available treatments or vaccines (e.g., Ebola, Marburg viruses). 5\. Biosafety Levels: Laboratories are categorized into four levels based on the pathogens they handle and the required containment measures: Biosafety Level 1 (BSL-1): Deals with well-classified organisms that pose minimal risks. Example agents: Bacillus subtilis, Escherichia coli. No biosafety cabinet required, but PPE and limited access are enforced. Biosafety Level 2 (BSL-2): Handles moderate-risk agents that may cause infections. Example agents: HIV, Hepatitis B Virus, Salmonella spp.. Requires immunizations, biosafety cabinets, and autoclaving for waste disposal. Biosafety Level 3 (BSL-3): Used for agents that can be transmitted via aerosols and pose severe health risks. Example agents: Mycobacterium tuberculosis, Brucella spp.. Requires biosafety cabinets, ante rooms, and directional airflow systems. Biosafety Level 4 (BSL-4): Reserved for the most dangerous and lethal pathogens, often without available treatments. Example agents: Marburg virus, Smallpox virus, Crimean-Congo hemorrhagic fever virus. Requires full isolation, positive pressure suits, and non-recirculating air systems. 6\. Biorisk Management (BRM): Biorisk management ensures the safe handling and storage of biological materials through a three-part system: Assessment, Mitigation, and Performance Evaluation (AMP Model). Assessment: Identifying hazards, assessing risks, and determining risk acceptability. Steps include defining the situation, defining and characterizing risks, and evaluating risk acceptability. Mitigation: Implementing control measures to reduce risks, focusing on five areas: Elimination: Deciding not to work with certain pathogens. Substitution: Replacing a hazardous agent or procedure with a safer alternative. Engineering Controls: Physical modifications to equipment or workstations (e.g., biosafety cabinets). Administrative Controls: Policies and protocols to manage risk (e.g., lab access control, staff training). Personal Protective Equipment (PPE): Protective gear like gloves, masks, and goggles. Performance Evaluation: Continuous monitoring and reevaluation of the effectiveness of the mitigation strategies. Ensures that organizational goals are met through regular reviews and assessments. 7\. Hazard, Threat, and Risk: Hazard: An object that has the potential to cause harm (e.g., a biological agent). Threat: A person who intends or is capable of causing harm (e.g., an individual with malicious intent). Risk: The likelihood of harm occurring based on hazards or threats. There shall be provisions for filing, storage and accession of all reports. All laboratory records shall be kept on file for at least one (1) year. Records of anatomic and forensic pathology shall be kept permanently in the laboratory. Nature of Clinical Laboratory The Clinical Laboratory An essential component of health institutions Main Task: to provide accurate and reliable information to medical doctors for the diagnosis, prognosis, treatment and management of diseases It is a place where specimens collected from individuals are processed, analyzed, preserved and properly disposed. Classification of Clinical Laboratory According to Function According to Institutional Characteristics According to Ownership According to Service Capability According to Function Clinical Pathology Focuses on the areas of clinical chemistry, immunohematology and bloodbanking, medical microbiology, immunology and serology, hematology, clinical microscopy and others. Concerned with diagnosis and treatment of diseases performed through laboratory testing of blood and other body fluids Anatomic Pathology Focuses on areas of histopathology, immunohistopathology, cytology, autopsy and forensic pathology Concerned with the diagnosis of diseases through microscopic examination of tissues and organs According to Institutional Characteristics Institutional-based Clinical laboratory that operates within the premises part of an institution Free-standing Clinical laboratory that is not a part of an established institution According to Ownership Government-owned Clinical laboratories are owned, wholly or partially, by national or local government units Privately-owned Clinical laboratories are owned, established and operated by an individual, corporation, institution, association or organization According to Service Capability Primary Category Services rendered include routine hematology, urinalysis, fecalysis, and Gram staining. Secondary Category Services rendered include those of the Primary Category plus routine chemistry, blood typing, and crossmatching. Tertiary Category Services rendered include those of the Primary and Secondary Categories plus donor selection and blood collection, special chemistry, and special hematology procedures. National Reference Laboratory Government hospital designated by the DOH to provide certain special diagnostic functions and services for certain diseases Laws on the Operation, Maintenance and Registration of Clinical Laboratories in the Philippines Republic Act 4688: "An Act Regulating the Operation and Maintenance of Clinical Laboratories and Requiring the Registration of the Same with the Department of Health, Providing Penalty for the Violation Thereof, and for Other Purposes" SECTION 1: Any person, firm or corporation, operating and maintaining a clinical laboratory in which body fluids, tissues, secretions, excretions and radioactivity from beings or animals are analyzed for the determination of the presence of pathologic organisms, processes and/or conditions in the persons or animals from which they were obtained, shall register and secure a license annually at the office of the Secretary of Health: provided, that government hospital laboratories doing routine or minimum laboratory examinations shall be exempt from the provisions of this section if their services are extensions of government regional or central laboratories. SECTION 2: It shall be unlawful for any person to be professionally in-charge of a registered clinical laboratory unless he is a licensed physician duly qualified in laboratory medicine and authorized by the Secretary of Health, such authorization to be renewed annually. No license shall be granted or renewed by the Secretary of Health for the operation and maintenance of a clinical laboratory unless such laboratory is under the administration, direction and supervision of an authorized physician, as provided for in the preceding paragraph. SECTION 3: The Secretary of Health, through the Bureau of Research and Laboratories shall be charged with the responsibility of strictly enforcing the provisions of this Act and shall be authorized to issue such rules and regulations as may be necessary to carry out its provisions. SECTION 4: Any person, firm or corporation who violates any provisions of this Act or the rules and regulations issued there under by the Secretary of Health shall be punished with imprisonment for not less than one month but not more than one year, or by a fine of not less than one thousand pesos nor more than five thousand pesos, or both such fine and imprisonment, at the discretion of the court. SECTION 5: If any section or part of this Act shall be adjudged by any court of competent jurisdiction to be invalid, the judgment shall not affect, impair, or invalidate the remainder thereof. SECTION 6: The sum of fifty thousand pesos, or so mush thereof as may be necessary, Is hereby authorized to be appropriated, out of any funds in the National Treasury not otherwise appropriated, to carry into effect the provisions of this Act. SECTION 7: All Acts or parts of Acts which are inconsistent with the provisions of this Act are hereby repealed. SECTION 8: This Act shall take effect upon its approval. ✔Approved: June 18, 1966 Administrative Order No. 59 s. 2001: "Rules and Regulations Governing the Establishment, Operation and Maintenance of Clinical Laboratories in the Philippines." Section 1: Title This Administrative Order shall be known as the "Rules and Regulations Governing the Establishment, Operation and Maintenance of Clinical Laboratories in the Philippines." Section 2: Authority These rules and regulations are issued to implement R.A. 4688: Clinical Laboratory Law consistent with E.O. 102 series 1999: Redirecting the Functions and Operations of the Department of Health. The Department of Health (DOH), through the Bureau of Health Facilities and Services (BHFS) in the Health Regulation Cluster, shall exercise the regulatory functions under these rules and regulations. Section 3: Purpose These rules and regulations are promulgated to protect and promote the health of the people by ensuring availability of clinical laboratories that are properly managed with adequate resources, with effective and efficient performance through compliance with quality standards. Section 4: Scope 1\. These regulations shall apply to all entities performing the activities and functions of clinical laboratories which shall include the examination and analysis of any or all samples of human and other related tissues, fluids, secretions, radioactive, or other materials from the human body for the determination of the existence of pathogenic organisms, pathologic processes or conditions in the person from whom such samples are obtained. 2\. These regulations do not include government laboratories doing laboratory examinations limited to acid fast bacilli microscopy, malaria screening and cervical cancer screening, provided their services are declared as extension of a licensed government clinical laboratory. Section 5: Classification of Laboratories 1. Classification by Function Clinical Pathology -- includes Hematology, Clinical Chemistry, Microbiology, Parasitology, Mycology, Clinical Microscopy, Immunology and Serology, Immunohematology, Toxicology and Therapeutic Drug Monitoring and other similar disciplines. Anatomic pathology -- includes Surgical Pathology, Immunohistopathology, Cytology, Autopsy and Forensic Pathology. 2. Classification by Institutional Character Hospital-based laboratory -- a laboratory that operates within a hospital. Non-hospital-based laboratory -- a laboratory that operates on its own. 3\. Classification by Service Capability a\. Primary -- provides the minimum service capabilities such as: Routine Hematology (Complete Blood Count or CBC) -- includes Hemoglobin Mass Concentration, Erythrocyte Volume Fraction (Hematocrit), Leucocyte Number Concentration (WBC count) and Leucocyte Type Number Fraction (Differential Count), Qualitative Platelet Determination Routine Urinalysis Routine Fecalysis Blood typing -- hospital based Quantitative platelet determination -- hospital based b\. Secondary-provides the minimum service capabilities of a primary category and the following: Routine Clinical Chemistry -- includes Blood Glucose Substance Concentration, Blood Urea Nitrogen Concentration, Blood Uric Acid Substance Concentration, Blood Creatinine Concentration, Blood Total Cholesterol Concentration Cross matching c\. Tertiary -- provides the secondary service capabilities and the following: Special Chemistry Special Hematology Immunology/Serology Microbiology Section 6: Policies An approved permit to construct and design lay-out of a clinical laboratory shall be secured form the BHFS prior to submission of an application for a Petition to Operate. No clinical laboratory shall be constructed unless plans have been approved and construction permit issued by the BHFS. A clinical laboratory shall operate with a valid license issued by BHFS/CHD, based on compliance with the minimum licensing requirements (Annex A). The clinical laboratory shall be organized and managed to provide effective and efficient laboratory services. The clinical laboratory shall provide adequate and appropriate safety practices for its personnel and clientele. Section 7: Requirements and Procedures for application of Permit to Construct and License to Operate Application for Permit to Construct The following are the documents required: a. Letter of Application to the Director of BHFS b. Four (4) sets of Sited Developmental Plans and Floor Plans approved by an architect and/or Engineer. C. DTI/SEC Registration (for private clinical laboratory) Application for new license A duly notarized application form "Petition to Establish, Operate and Maintain a Clinical Laboratory", shall be filed by the owner or his duly authorized representative at the BHFS. Application for renewal of license A duly notarized application form "Application for Renewal of License to Establish, Operate and Maintain a Clinical Laboratory" shall be filed by the owner or his duly authorized representative at the respective CHD. Renewal of License: Application for renewal of license shall be filed within 90 days before the expiry date of the license described as follows: 3. Permit and License Fees: A non-refundable license fee shall be charged for application for permit to construct, and for license to operate a government and private clinical laboratory. A non-refundable fee shall be charged for application for renewal of license to operate. All fees shall be paid to the Cashier of the BHFS/CHD. All fees shall follow the current prescribed schedule of fees of the DOH. 4. Penalties A penalty of one thousand pesos (P1,000.00) for late renewal shall be charged in addition to the renewal fee for all categories if the application is filed during the next two (2) months after expiry date. An application received more than two (2) months after expiry date shall be fined one hundred pesos (P100.00 for each month thereafter in addition to the P1,000.00 penalty. 5. Inspection Each license shall make available to the Director of the BHFS/CHD or his duly authorized representative(s) at any reasonable time, the premises and facilities where the laboratory examinations are being performed for inspection. Each license shall make available to the Director of the BHFS/CHD or his duly authorized representative(s) all pertinent records. Clinical laboratories shall be inspected every two (2) years or as necessary. 6. Monitoring All clinical laboratories shall be monitored regularly and records shall be made available to determine compliance with these rules and regulations. The Director of the BHFS/CHD or his authorized representative(s) shall be allowed to monitor the clinical laboratory at any given time. All clinical laboratories shall make available to the Director of the BHFS or his duly authorized representative(s) records for monitoring. 7. Issuance of License The license shall be issued by the Director of the CHD or his authorized representative, if the application is found to be meritorious. 8. Terms and conditions of License The license is granted upon compliance with the licensing requirements. The license is non-transferable. The owner or authorized representative of any clinical laboratory desiring to transfer a licensed clinical laboratory to another location shall inform the CHD in writing at least 15 days before actual transfer. The laboratory in its new location shall be subject to re-inspection and shall comply with the licensing requirements. Section 8: Violations 1\. The license to operate a clinical laboratory shall be suspended or revoked by the Secretary of Health upon violation of R.A. 4688 or the Rules and Regulations issued in pursuance thereto. 2\. The following acts committed by the Owner, President, Managers, Board of Trustees/Director, Pathologist or its personnel are considered violations. Operation of a clinical laboratory without a certified pathologist or without a registered medical technologist. Change of ownership, location, head of laboratory or personnel without informing the BHFS and/or the CHD. Section 9: Investigation of Charges or Complaints The BHFS/CHD or his duly authorized representative(s) shall investigate the complaint and verify if the laboratory concerned or any of its personnel is guilty of the charges. If upon investigation, any person is found violating the provision of R.A. 4688, or any of these rules and regulations, the BHFS/CHD or his duly authorized representative(s) shall suspend, cancel or revoke for a determined period of time the license, as well as the authority of the offending person(s), without prejudice to taking the case to judicial authority for criminal action. The BHFS/CHD or his duly authorized representative(s) shall investigate the complaint and verify if the laboratory concerned or any of its personnel is guilty of the charges. Any person who operated a clinical laboratory without the proper license from the Department of Health shall upon conviction be subject to imprisonment for not less than 1 month but not more 1 year or a fine of not less than P1,000.00 and not more than P5,000.00 and not more than P5,000.00 or both at the discretion of the court. Provided, however, that if the offender is a firm or corporation, the Managing Head and/or owner/s thereof shall be liable to the penalty imposed herein. Any Clinical Laboratory operating without a valid license or whose license has been revoked/cancelled shall be summarily closed upon order issued by the BHFS/CHD or his duly authorized representative. The BHFS/CHD may seek the assistance of the law enforcement agency to enforce the closure of any clinical laboratory. The closure order issued by the DOH shall not be rendered ineffective by any restraining order and injunction order issued by any court, tribunal or agency or instrumentalities. Section 10: Modification and Revocation of License A license maybe revoked, suspended or modified in full or in part for any materials false statement by the applicant, or as shown by the record of inspection or for a violation of, or failure to comply any of the terms and conditions and provisions of these rules and regulations. No license shall be modified, suspended or revoked unless prior notice has been made and the corresponding investigation conducted except in cases of willful, or repeated violations hereof, or where public health interest or safety requires otherwise. Section 11: Repealing Clause These rules and regulations shall supersede all other previous official issuances hereof. Section 12: Publication and List of Licensed Clinical Laboratories A list of licensed clinical laboratories shall be published annually in a newspaper of general circulation. Section 13: Effectivity These rules and regulations shall take effect 15 days after its publication in the Official Gazette, or in a newspaper of general circulation. ANNEX A: TECHNICAL STANDARDS AND MINIMUM REQUIREMENTS The Clinical Laboratory shall be organized to provide effective and efficient laboratory services. I. STAFFING The Clinical Laboratory shall be managed by a licensed physician certified by the Philippine Board of Pathology. In areas where Pathologist are not available, a physician with three (3) months training on clinical laboratory medicine, quality control and laboratory management, may manage a primary/secondary category clinical laboratories. The BHFS shall certify such training. The clinical laboratory shall employ qualified and adequately train personnel. Work assignment shall be consistent with the qualification of the concerned personnel. A clinical laboratory shall have sufficient number of registered medical technologists proportional to the workload and shall available at all times during hours of laboratory operations. For hospital- based clinical laboratory, there shall be at least one registered medical technologist per shift to cover the laboratory operation. There shall be staff development and appropriate continuing education program available at all levels of organization to upgrade the knowledge, attitudes and skills of staff. II. PHYSICAL FACILITIES The clinical laboratory shall be well-ventilated, adequately lighted, clean and safe. The working space shall be sufficient to accommodate its activities and allow for smooth and coordinated work flow. There shall be an adequate water supply. The working space for all categories of clinical laboratories (both hospital and non- hospital based) shall have at least the following measurements: III. EQUIPMENT/INSTRUMENTS There shall be provisions for sufficient number and types of appropriate equipment/instruments in order to undertake all the activities and laboratory examinations. This equipment shall comply with safety requirements. For other laboratory examinations being performed, the appropriate equipment necessary for performing such procedures shall be made available. IV. GLASSWARES/ REAGENTS/SUPPLIES All categories of clinical laboratories shall provide adequate and appropriate glassware, reagents and supplies necessary to undertake the required services. V. WASTE MANAGEMENT There shall be provisions for adequate and efficient disposal of waste following guidelines of the Department of Health and the local government. (copies of which are available at respective CHDS and DOH -- BHFS and local government offices) VI. QUALITY CONTROL PROGRAM All clinical laboratories shall have a functional Quality Assurance Program Internal Quality Control Program There shall be a documented, continuous competency assessment program for all laboratory personnel. The program shall provide appropriate and standard laboratory methods, reagents & supplies and equipment. There shall be a program for the proper maintenance and monitoring of all equipment. The program shall provide for the use of quality control reference materials. External Quality Control Program All clinical laboratories shall participate in an External Quality Assurance Program given by designated National Reference Laboratories and/or other recognized reference laboratories. A satisfactory performance rating given by a National Reference Laboratory shall be one of the criteria for the renewal of license. Any refusal to participate in an External Quality Assurance Program given by the designated National Reference Laboratories shall be one of the bases for suspension/revocation of the license of the laboratory. VII. REPORTING Laboratory requests shall be construed as consultation between the requesting physician and the Pathologist of the laboratory and as such laboratory results shall be released accordingly. All laboratory reports on various examinations of specimens shall bear the name of the registered medical technologists and the Pathologist and duly signed by both. No person in the clinical laboratory shall issue a report, orally or in writing, whole or portions, thereof without a directive from the Pathologist or his aut IX\. LABORATORY FEES The laboratory and professional fees to be charged for laboratory examination shall be at the prevailing rates. The rates shall be within the range of the usual fees prevailing at the time and the particular place, taking into consideration the cost of testing and quality control of various laboratory procedures. Professional services rendered to the patient in the performance of special procedures or examinations shall be charged separately and not included in the laboratory fee/s. Pre-analytical Phase The pre-analytic phase is a crucial part of laboratory testing and is as equally important as the subsequent phases. Laboratory professionals have no direct involvement in this process. Preanalytical factors that can affect the results of a test include: Sample type Sample timing Sample handling Sample identification Pre-analytical errors are those which arise before the samples are measured by laboratory professionals. Although most pre-analytical errors are discovered before the samples reach the lab, if they are not spotted, they can cause serious problems further down the line. Here is a rundown of some of the most common pre-analytical errors: Quality Assurance in the Clinical Laboratory Encompasses all activities performed by a laboratory personnel to ensure reliability of test results It is organized, systematic, well-planned and regularly done with the results properly documented and consistently reviewed Major components: Internal Quality Assurance System (IQAS) and External Quality Assurance System (EQAS) Patient Identification Patient identification errors are common during the pre-analytical phase and can cause medical laboratories serious issues with patient safety. This type of error includes missing or wrong patient information and may arise when a patient is not conscious at the time the sample is taken, or because the sample is needed very quickly. Patient identification errors may also be caused by improper or illegible specimen labeling. Specimen Collection Sometimes errors can occur during specimen collection. Specimen collection errors might arise from patient conditions during collection---such as fragile veins. They can also occur if samples are taken at different points during the day, or when the patient is receiving laboratory medicines. Quality Control To reduce pre-analytical error rates, all procedures should be standardized and automated whenever possible. By establishing a standardized system to recognize pre-analytical errors, many of these said errors can be prevented. Implementing an automated system for identifying, storing, and tracking samples can eliminate errors at the front end. Doing this also cuts down the labor intensiveness of manual implementation. In this way, once an error has been detected, the system can be used to reject related samples. Analytical Phase The analytical phase begins when the lab prepares a patient specimen for testing, and culminates in the verification and interpretation of the test results. Advances in lab automation tools have helped to improve analytical techniques within the lab, provide superior instrumentation, and decrease error rates. Laboratory Testing Human and instrumental errors may be encountered during the analytical phase. Occasionally random errors may also occur. Errors that skew sample measurement due to human mistakes or instrumental malfunctions are more common. The following errors may arise during laboratory testing in the analytical phase: Issues with verification and quality control of performance specs Collaboration errors Reagent mistakes Errors stemming from manual pipetting Interference from unidentified antibodies Mathematical errors Clinician errors in preparation and processing Mistakes caused by staff fatigue Quality Assurance Even with automation in place, analytical quality remains a significant issue. For example, issues can arise due to inadequate sample preparation or the accidental presence of substances that can interfere with the accuracy, sensitivity, and precision of results. To avoid these problems between test ordering and reporting test results, laboratories should commit to the following protocols: Implementation of manuals defining policy, process, and procedure Provision of clinician training and competency evaluation Implementation of a testing program for clinician test menu Automation of instrument calibration and tracking Upkeep of records relating to the lab environment Post-analytical Phase The post-analytical phase is the final stage of the testing process, in which the test results are reviewed by clinicians. During this phase, the results should also be promptly released. This is particularly important for critical results and those which are needed to help medical professionals to make critical health decisions for their patients. Test Results Even at the post-analytics phase, errors can still occur. Data entry errors can arise when results are recorded and stored manually. Post-analytical errors can also occur during data transmission. In some instances, verbal information may be passed on incorrectly or misheard. Other common errors with post-analytical test results include: Incorrect calculations Delayed turnaround time for results Results returned to the wrong individual Results are not reported Quality Assurance To improve and maintain high levels of quality assurance at the post-analytic phase, clinicians can implement the following preventive measures: Implement a bar code ID system: This not only prevents specimen misidentification and inaccurate labeling, but it also prevents the results from going to the wrong doctor or patient. Utilize automated transmission of reports: Digital transmission of reports ensures that results are being shared in a timely manner and that they are being sent to the person who needs them. Develop a troubleshooting plan: Take note of previous errors or close calls. Even more importantly, identify the source of the error, whether human or equipment. Once you have determined what happened, you can prevent a recurrence. Establish a standard for result reporting: If you set out clear protocols for your team of clinicians and it is in line with the healthcare facilities you are working with, you can reduce errors significantly throughout the total testing process.