PMLS Midterms - Nature of the Clinical Laboratory PDF

PMLS - MIDTERMS 2. Anatomic Pathology UNIT 4 - focuses on the areas of NATURE OF THE CLINICAL LABORATORY histopathology,...

PMLS - MIDTERMS 2. Anatomic Pathology UNIT 4 - focuses on the areas of NATURE OF THE CLINICAL LABORATORY histopathology, immunohistopathology, cytology, autopsy, and forensic pathology THE CLINICAL LABORATORY among others. Its main task is to provide accurate and - concerned with the diagnosis of reliable information to medical doctors, for diseases through microscopic the diagnosis, prognosis, treatment, and examination of tissues and organs. management of diseases. Seventy percent (70%) of all decisions B. ACCORDING TO INSTITUTIONAL performed by medical doctors are based on CHARACTERISTICS laboratory test results. 1. Institution-based The clinical laboratory is also actively involved in research, community outreach - operates within the premises or part programs, surveillance, infection control in of an institution such as a hospital, the hospital and community settings, school, medical clinic, medical facility information dissemination, and evaluation of for overseas workers and seafarers, applicability of current and innovative birthing home, psychiatric facility, diagnostic technologies. drug rehabilitation center, and others. It is the place where the specimens (eg., ex: hospital-based blood and other body fluids, tissues, feces, laboratories hair, nails) collected from individuals are processed, analyzed, preserved, and 2. Free-standing properly disposed. - not part of an established institution. CLASSIFICATIONS OF CLINICAL LABORATORIES ex: free standing out-patient A. ACCORDING TO FUNCTION laboratory 1. Clinical Pathology C. ACCORDING TO OWNERSHIP - focuses on the areas of clinical chemistry, immunohematology and 1. Government-owned - owned, wholly or blood banking, medical microbiology, partially, by national or local government immunology and serology, units. hematology, parasitology, clinical microscopy, toxicology, therapeutic ex: San Lazaro Hospital drug monitoring, and endocrinology, among others. 2. Privately-owned - owned, established, and operated by an individual, corporation, - concerned with the diagnosis and institution, association, or organization. treatment of diseases performed through laboratory testing of blood ex: St. Luke’s Medical Center and other body fluids. D. ACCORDING TO SERVICE CAPABILITY PMLS - MIDTERMS 1  immunohematology and blood 1. PRIMARY banking - licensed to perform basic, routine - has a minimum floor area laboratory testing, namely, routine requirement of at least 60 square urinalysis, routine stool examination, meters routine hematology or complete blood count that includes - equipment requirements include hemoglobin, hematocrit, WBC and those seen in 2° category RBC count, WBC differential count laboratories along with automated and qualitative platelet count, blood chemistry analyzer, biosafety cabinet typing, and Gram staining (if hospital- class II, serofuge, among others. based) 4. NATIONAL REFERENCE LABORATORY - equipment requirements are, but not limited to, microscopes, centrifuge, - laboratory in a government hospital hematocrit centrifuge designated by the DOH to provide special diagnostic functions and - space requirement is at least 10 services for certain diseases square meters. - functions include: referral services, 2. SECONDARY provision of confirmatory testing, assistance for research activities, - (hospital and non-hospital-based) implementation of External Quality Assurance Programs (EQAP) of the - licensed to perform laboratory test government, resolution of conflicts being done by the primary category regarding tests results of different clinical laboratories along with routine laboratories, and training of medical clinical chemistry tests like blood technologists on certain specialized glucose concentration, BUN, BUA, procedures that require blood creatinine, cholesterol standardization determination, qualitative platelet count, and if hospital-based, Gram LAWS ON THE OPERATION, MAINTENANCE AND stain, KOH mount, and REGISTRATION OF CLINICAL LABORATORIES IN THE crossmatching PHILIPPINES - a minimum requirement of 20 square REPUBLIC ACT NO. 4688 meters is needed for the floor area of this type of laboratory “An act regulating the operation and maintenance of clinical laboratories and requiring the registration of - minimum equipment requirements the same with the department of health, providing are microscopes, centrifuge, penalty for the violation thereof, and for other hematocrit centrifuge, semi- purposes.” automated chemistry analyzers, autoclave, incubator, and oven SECTION 1 3. TERTIARY Any person, firm or corporation, operating - (hospital and non-hospital-based) and maintaining a clinical laboratory shall register and secure a license annually at - licensed to perform all the laboratory the office of the Secretary of Health tests performed in the 2° category laboratory plus (1) immunology and serology; (2) microbiology, Government hospital laboratories doing bacteriology, and mycology; (3) routine or minimum laboratory examinations special clinical chemistry; (4) special shall be exempt from the provisions of this hematology and; (5) PMLS - MIDTERMS 2  section if their services are extensions of government regional or central laboratories All Acts or parts of Acts which are inconsistent with the provisions of this Act SECTION 2 are hereby repealed. Person professionally in-charge of a SECTION 8 registered clinical laboratory must be a licensed physician duly qualified in laboratory medicine and authorized by the This act shall take effect upon its approval. Secretary of Health, such authorization to be Approved, June 18, 1966. renewed annually ADMINISTRATIVE ORDER NO. 59 S. 2001 SECTION 3 SECTION 1: TITLE The Secretary of Health, through the Bureau of Research and Laboratories shall be charged with the responsibility of This Administrative Order shall be known as strictly enforcing the provisions of this Act the “Rules and Regulation Governing the and shall be authorized to issue such rules Establishment, Operation and and regulations as may be necessary to Maintenance of Clinical Laboratories in carry out its provisions the Philippines.” SECTION 2: AUTHORITY SECTION 4 Any person, firm or corporation who violates These rules and regulations are issued to any provisions of this Act or the rules and implement R.A. 4688: Clinical Laboratory regulations issued thereunder by the Law consistent with E.O. 102 series 1999: Secretary of Health shall be punished with Redirecting the Functions and imprisonment for not less than one month Operations of the Department of Health. but not more than one year, or by a fine of The Department of Health (DOH), through not less than one thousand pesos nor the Bureau of Health Facilities and Services more than five thousand pesos, or both (BHFS) in the Health Regulation Cluster, such fine and imprisonment, at the shall exercise the regulatory functions under discretion of the court these rules and regulations. SECTION 5 SECTION 3: PURPOSE If any section or part of this Act shall be adjudged by any court of competent These rules and regulations are promulgated jurisdiction to be invalid, the judgement shall to protect and promote the health of the not affect, impair, or invalidate the remainder people by ensuring availability of clinical thereof. laboratories that are properly managed with adequate resources, with effective and SECTION 6 efficient performance through compliance with quality standards. The sum of fifty thousand pesos, or so much SECTION 4: SCOPE thereof as may be necessary, is hereby authorized to be appropriated, out of any funds in the National Treasury not otherwise 1. These regulations shall apply to all entities appropriated, to carry into effect the performing the activities and functions of provisions of this Act. clinical laboratories which shall include the examination and analysis of any or all samples of SECTION 7 human and other related tissues, fluids, secretions, radioactive, or other materials from the human body PMLS - MIDTERMS 3 for the determination of the existence of pathogenic b. Secondary – provides the minimum service organisms, pathologic processes or conditions in the capabilities of a primary category and the following: person from whom such samples are obtained. (1) Routine Clinical Chemistry – includes Blood 2. These regulations do not include government Glucose Substance Concentration, Blood Urea laboratories doing laboratory examinations Nitrogen Concentration, Blood Uric Acid Substance limited to acid fast bacilli microscopy, malaria Concentration, Blood Creatinine Concentration, screening and cervical cancer screening, Blood Total Cholesterol Concentration provided their services are declared as extension of (2) Cross matching a licensed government clinical laboratory. c. Tertiary – provides the secondary service capabilities and the following: SECTION 5: CLASSIFICATION OF LABORATORIES (1) Special Chemistry (2) Special Hematology 1. CLASSIFICATION BY FUNCTION (3) Immunology/Serology (4) Microbiology a. Clinical Pathology – includes Hematology, SECTION 6: POLICIES Clinical Chemistry, Microbiology, Parasitology, Mycology, Clinical Microscopy, Immunology and Serology, Immunohematology, Toxicology and An approved permit to construct and Therapeutic Drug Monitoring and other similar design lay–out of a clinical laboratory disciplines. shall be secured form the BHFS prior to submission of an application for a Petition to b. Anatomic pathology – includes Surgical Operate. Pathology, Immunohistopathology, Cytology, Autopsy and Forensic Pathology. No clinical laboratory shall be constructed unless plans have been approved and 2. CLASSIFICATION BY INSTITUTIONAL CHARACTER construction permit issued by the BHFS. A clinical laboratory shall operate with a a. Hospital–based laboratory – a laboratory that valid license issued by BHFS/CHD, based operates within a hospital. on compliance with the minimum licensing requirements (Annex A). b. Non–hospital–based laboratory – a laboratory that operates on its own. SECTION 7: REQUIREMENTS AND PROCEDURES FOR APPLICATION OF PERMIT TO CONSTRUCT AND LICENSE TO OPERATE 3. CLASSIFICATION BY SERVICE CAPABILITY 1. APPLICATION FOR PERMIT TO CONSTRUCT a. Primary – provides the minimum service capabilities such as: The following are the documents required: (1) Routine Hematology (Complete Blood Count or a. Letter of Application to the Director of BHFS CBC) – includes Hemoglobin Mass Concentration, b. Four (4) sets of Sited Developmental Plans and Erythrocyte Volume Fraction (Hematocrit), Floor Plans approved by an architect and/or Leucocyte Number Concentration (WBC count) and Engineer. Leucocyte Type Number Fraction (Differential c. DTI/SEC Registration (for private clinical Count), Qualitative Platelet Determination laboratory) (2) Routine Urinalysis (3) Routine Fecalysis 2. APPLICATION FOR NEW LICENSE (4) Blood typing – hospital based (5) Quantitative platelet determination – hospital based A duly notarized application form “Petition to Establish, Operate and Maintain a Clinical PMLS - MIDTERMS 4 Laboratory”, shall be filed by the owner or his duly a. A penalty of one thousand pesos (P1,000.00) for authorized representative at the BHFS. 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. 3. APPLICATION FOR RENEWAL OF LICENSE b. An application received more than two (2) A duly notarized application form “Application for months after expiry date shall be fined one Renewal of License to Establish, Operate and hundred pesos (P100.00 for each month Maintain a Clinical Laboratory” shall be filed by the thereafter in addition to the P1,000.00 penalty. owner or his duly authorized representative at the respective CHD. 6. INSPECTION a. Renewal of License: Application for renewal of license shall be filed within a. Each license shall make available to the Director 90 days before the expiry date of the license of the BHFS/CHD or his duly authorized described as follows: representative(s) at any reasonable time, the premises and facilities where the laboratory examinations are being performed for inspection. SCHEDULE OF REGION APPLICATION FOR b. Each license shall make available to the Director RENEWAL OF of the BHFS/CHD or his duly authorized LICENSE representative(s) all pertinent records. NCR JAN - MARCH c. Clinical laboratories shall be inspected every two 1, 2, 3 & CAR FEB - APRIL (2) years or as necessary. 4, 5 & 6 MARCH - MAY 7. MONITORING 7, 8 & 9 APRIL - JUNE The Director of the BHFS/CHD or his authorized 10, 11, 12 CARAGA & MAY - JULY representative(s) shall be allowed to monitor the ARMM clinical laboratory at any given time. All clinical laboratories shall make available to the 4. PERMIT AND LICENSE FEES Director of the BHFS or his duly authorized representative(s) records for monitoring. a. A non–refundable license fee shall be charged 8. ISSUANCE OF LICENSE for application for permit to construct, and for license to operate a government and private clinical laboratory. The license shall be issued by the Director of the CHD or his authorized representative, if the b. A non–refundable fee shall be charged for application is found to be meritorious application for renewal of license to operate. c. All fees shall be paid to the Cashier of the 9. TERMS AND CONDITIONS OF LICENSE BHFS/CHD. d. All fees shall follow the current prescribed a. The license is granted upon compliance with the schedule of fees of the DOH. licensing requirements. b. The license is non–transferable. 5. PENALTIES c. 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. PMLS - MIDTERMS 5 d. The laboratory in its new location shall be subject 1. If upon investigation, any person is found to re–inspection and shall comply with the licensing violating the provision of R.A. 4688, or any of requirements. these rules and regulations, the BHFS/CHD or his e. An extension laboratory shall have a separate duly authorized representative(s) shall suspend, license. 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 f. Any change affecting the substantial conditions of judicial authority for criminal action. the license to operate a laboratory shall be reported within 15 days in writing by the person(s) concerned, 2. Any person who operated a clinical laboratory to the BHFS/CHD for notation and approval. Failure without the proper license from the Department to do so will cause the revocation of the license of of Health shall upon conviction be subject to the clinical laboratory. imprisonment for not less than 1 month but not g. The clinical laboratory license must be placed in more 1 year or a fine of not less than P1,000.00 a conspicuous location/area within the laboratory. and not more than P5,000.00 and not more than P5,000.00 or both at the discretion of the court. SECTION 8: VIOLATIONS 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. 1. The license to operate a clinical laboratory shall be suspended or revoked by the Secretary of 3. Any Clinical Laboratory operating without a Health upon violation of R.A. 4688 or the Rules valid license or whose license has been and Regulations issued in pursuance thereto. revoked/cancelled shall be summarily closed upon order issued by the BHFS/CHD or his duly 2. The following acts committed by the Owner, authorized representative. The BHFS/CHD may President, Managers, Board of Trustees/Director, seek the assistance of the law enforcement agency Pathologist or its personnel are considered to enforce the closure of any clinical laboratory. violations. 4. The closure order issued by the DOH shall not be a. Operation of a clinical laboratory without a rendered ineffective by any restraining order and certified pathologist or without a registered medical injunction order issued by any court, tribunal or technologist. agency or instrumentalities. b. Change of ownership, location, head of laboratory or personnel without informing the BHFS and/or the SECTION 10: MODIFICATION AND REVOCATION OF CHD. LICENSE c. Refusal to allow inspection of the clinical laboratory by the person(s) authorized by the BHFS 1. A license maybe revoked, suspended or modified during reasonable hours. in full or in part for any material false statement by d. Gross negligence. the applicant, or as shown by the record of e. Any act or omission detrimental to the public. inspection or for a violation of, or failure to comply any of the terms and conditions and provisions of 3. The Provincial, City and Municipal Health these rules and regulations. Officers are authorized to report to the CHD and BHFS the existence of unlicensed clinical 2. No license shall be modified, suspended or laboratories or any private party performing revoked unless prior notice has been made and laboratory examinations without proper license the corresponding investigation conducted except in and/or violations to these rules and regulations. cases of willful, or repeated violations hereof, or where public health interest or safety requires SECTION 9: INVESTIGATION OF CHARGES AND otherwise. COMPALINTS SECTION 11: REPEALING CLAUSE The BHFS/CHD or his duly authorized representative(s) shall investigate the complaint and verify if the laboratory concerned or any of its These rules and regulations shall supersede all personnel is guilty of the charges. other previous official issuances hereof. PMLS - MIDTERMS 6  SECTION 12: PUBLICATION AND LIST OF LICENSED 2. The working space shall be sufficient to CLINICAL LABORATORIES accommodate its activities and allow for smooth and coordinated work flow. 3. There shall be an adequate water supply. A list of licensed clinical laboratories shall be published annually in a newspaper of general 4. The working space for all categories of clinical circulation. laboratories (both hospital and non–hospital based) shall have at least the following measurements: SECTION 13: EFFECTIVITY CATEGORY Space in sq. m. These rules and regulations shall take effect 15 days Primary 10 after its publication in the Official Gazette, or in a newspaper of general circulation. Secondary 20 ANNEX A TECHNICAL STANDARDS AND MINIMUM Tertiary 30 REQUIREMENTS III. EQUIPMENT/ INSTRUMENTS I. STAFFING 1. There shall be provisions for sufficient number 1. The Clinical Laboratory shall be managed by a and types of appropriate equipment/instruments in licensed physician certified by the Philippine Board order to undertake all the activities and laboratory of Pathology. examinations. This equipment shall comply with safety requirements. ★ In areas where Pathologist are not available, a physician with three (3) months training on 2. For other laboratory examinations being clinical laboratory medicine, quality control performed, the appropriate equipment necessary for and laboratory management, may manage a performing such procedures shall be made primary/secondary category clinical available. laboratories. The BHFS shall certify such training. IV. GLASSWARES/ REAGENTS/ SUPPLIES 2. The clinical laboratory shall employ qualified and adequately train personnel. Work assignment shall All categories of clinical laboratories shall provide be consistent with the qualification of the concerned adequate and appropriate glassware, reagents and personnel. supplies necessary to undertake the required services. ★ A clinical laboratory shall have sufficient number of registered medical technologists V. WASTE MANAGEMENT proportional to the workload and shall available at all times during hours of laboratory operations. For hospital–based There shall be provisions for adequate and efficient clinical laboratory, there shall be at least one disposal of waste following guidelines of the registered medical technologist per shift to Department of Health and the local government. cover the laboratory operation. (copies of which are available at respective CHDs and DOH – BHFS and local government offices) 3. There shall be staff development and appropriate continuing education program available at all levels of organization to upgrade the knowledge, attitudes VI. QUALITY CONTROL PROGRAM and skills of staff. 1. INTERNAL QUALITY CONTROL II. PHYSICAL FACILITIES PROGRAM 1. The clinical laboratory shall be well–ventilated, adequately lighted, clean and safe. PMLS - MIDTERMS 7 a. There shall be a documented, continuous IX. LABORATORY FEES competency assessment program for all laboratory personnel. b. The program shall provide appropriate and 1. The rates shall be within the range of the usual standard laboratory methods, reagents & supplies fees prevailing at the time and the particular and equipment. place, taking into consideration the cost of testing c. There shall be a program for the proper and quality control of various laboratory procedures. maintenance and monitoring of all equipment. 2. Professional services rendered to the patient in d. The program shall provide for the use of quality the performance of special procedures or control reference materials. examinations shall be charged separately and not included in the laboratory fee/s. 2. EXTERNAL QUALITY CONTROL SECTIONS OF THE CLINICAL LABORATORY PROGRAM a. All clinical laboratories shall participate in an External Quality Assurance Program given by A. CLINICAL CHEMISTRY designated National Reference Laboratories and/or other recognized reference laboratories. b. A satisfactory performance rating given by a intended for testing of blood and other body National Reference Laboratory shall be one of the fluids to quantify essential soluble chemicals criteria for the renewal of license. including waste products useful for diagnosis c. Any refusal to participate in an External Quality of certain diseases. Assurance Program given by the designated blood and urine - two most common body National Reference Laboratories shall be one of the fluids subjected for analyses in this section bases for suspension/revocation of the license of the one of the busiest in terms of number of tests laboratory. performed VII. REPORTING Examples: FBS, HbA1c, Total Cholesterol (HDL & LDL), TAG, BUA, BUN, Total Protein, Albumin, Electrolytes, Clinical Enzymology 1. All laboratory reports on various examinations of specimens shall bear the name of the registered B. MICROBIOLOGY medical technologists and the Pathologist and duly signed by both. subdivided into four sections: (1) 2. No person in the clinical laboratory shall issue bacteriology; (2) mycobacteriology; (3) a report, orally or in writing, whole or portions, mycology and; (4) virology thereof without a directive from the Pathologist or his work is more focused on the identification of authorized associate to the requesting physician or bacteria and fungi his authorized representative except in emergency specimens usually submitted are blood and cases when the results may be released as other body fluids, stool, tissues, and swabs authorized by the Pathologist. from different sites of the body VIII. RECORDING Examples: Gram staining, Antibiotic Susceptibility Testing, KOH mount 1. There shall be an adequate and effective system C. HEMATOLOGY AND COAGULATION STUDIES of recording requests and reports of all specimens submitted and examined. 2. There shall be provisions for filing, storage and deals with the enumeration of cells in the accession of all reports. blood and other body fluids 3. All laboratory records shall be kept on file for at coagulation studies focus on blood testing least one (1) year. for determination of various coagulation ★ Records of anatomic and forensic pathology factors shall be kept permanently in the laboratory. Examples: CBC, Hemoglobin, Hematocrit, WBC differential count, Red cell morphology and PMLS - MIDTERMS 8 indices, Qualitative Platelet count, Blood Smear ★ combines anatomical, clinical, and Preparation, Staining for other body fluids biochemical techniques where antibodies (monoclonal and polyclonal) bounded to D. CLINICAL MICROSCOPY enzymes and fluorescent dyes are used to detect presence of antigens in tissue Two Major Areas: ★ useful in the diagnosis of some types of 1. First area – allotted to routine and special cancers by detecting the presence of tumor examinations of urine specific antigens, oncogenes, and tumor ex: Physical and Chemical Examination, suppressor genes Macroscopic and Microscopic Examination ★ used to assess response of patient to 2. Second area – assigned to the examination of therapy stool or routine fecalysis, detection and identification of parasitic worms and ova B. MOLECULAR BIOLOGY AND BIOTECHNOLOGY E. BLOOD BANK / IMMUNOHEMATOLOGY ★ DNA and RNA are identified and sequenced to detect pathologic conditions/disease screening for all antibodies and detection of processes by primarily using different antibodies as well as the blood components enzymes and reagents used for transfusion are all conducted in this ★ Polymerase Chain Reaction (PCR) is the section most common technique currently in use in hospital-based clinical laboratories, blood donation activities prompt other activities such as donor recruitment and screening, LABORATORY TESTING CYCLE bleeding of donor, and post-donation care Encompasses all activities starting from a Examples: Blood typing, Compatibility testing medical doctor writing a laboratory request up to the time the results are generated and F. IMMUNOLOGY AND SEROLOGY become useful information for the treatment and management of patients analyses of serum antibodies in certain Three phases: infectious agents (primarily viral agents are performed in this section 1) Pre-analytic Laboratory test requisition/order Examples: Hepatitis B profile tests, Serological test Order Reception for Syphilis, Test for Hepatitis C and Dengue Fever Patient preparation Specimen collection Specimen Transport and Processing ANATOMIC PATHOLOGY G. HISTOPATHOLOGY / CYTOLOGY 2) Analytic Actual Testing activities performed in this section include 3) Post-analytic tissue (removed surgically as in biopsy and Data transmission autopsy) processing, cutting into sections, Results application staining and preparation for microscopic TAT examination by a pathologist SPECIALIZED SECTIONS OF THE LABORATORY A. IMMUNOHISTOCHEMISTRY PMLS - MIDTERMS 9  4. East Avenue Medical Center – Drugs of abuse (methamphetamine and cannabinoids) 5. San Lazaro Hospital STD-AIDS Cooperative Center Laboratory – HBsAg, HIV, HCV) PMLS - MIDTERMS UNIT 5 PROFESSIONAL ETHICS AND VALUES: MORAL IMPLICATIONS Bioethics: A branch of science that deals with the study of the morality of human QUALITY ASSURANCE IN THE CLINICAL LABORATORY conduct concerning human life in all its aspects from the moment of conception to its natural end. QUALITY ASSURANCE Ethics: A philosophical and practical science that deals with the study of the morality of Encompasses all activities performed by laboratory human acts or human conduct. personnel to ensure reliability of test results. Malpractice: An intentional act of professional negligence by a healthcare 2 MAJOR COMPONENTS provider, in which care provided deviates from accepted standards of practice in the medical community and may cause injury or 1. Internal Quality Assurance System (IQAS) – death to the patient. includes day-to-day activities that are undertaken in order to control factors or variables that may affect Medical data breach: The intentional and test results. unintentional disclosure of medical records without the consent of the patient. 2. External Quality Assurance System (EQAS) – a system for checking performance among clinical Medical ethics: A field of applied ethics that laboratories and is facilitated by designated external studies moral values and judgments as they agencies. The National Reference Laboratories is apply to medicine. the DOH-designated EQAS. Morality: A system of ideas and/or beliefs on At present, the designated NRL-EQAS are the following: good (right) or evil (wrong). Negligence: A general term denoting 1. National Kidney and Transplant Institute – conduct lacking in due care. Hematology and Coagulation Professional ethics: A branch of moral 2. Research Institute for Tropical Medicine – science that deals with the obligations that a Microbiology ( identification and antibiotic member of a profession owes to the public, susceptibility testing) and Parasitology (Identification the profession, and his/her clients. of ova and quantitation of malaria) Values: The beliefs that guide peoples' 3. Lung Center of the Philippines – Clinical thoughts and Value development: It is a Chemistry (for testing 10 analytes, namely glucose, product of human interaction with the cultural creatinine, total protein, albumin, BUN, uric acid, environment. cholesterol, sodium, potassium, chloride) TYPES OF ETHICS PMLS - MIDTERMS 10  associated professionals in making decisions in 1. GENERAL ETHICS clinical settings. Moral values are based on various sources such as religion, philosophy, professional This type of ethics presents truths about human acts, codes, professional associations, family, culture, from which the general principle of morality is community, colleagues, and personal experience. deduced. MORAL PRINCIPLES IN MEDICAL TECHNOLOGY 2. SPECIAL ETHICS ETHICS This involves the application of the principles of Autonomy. This principle dictates that the general ethics in different departments of human patient has the right to refuse or choose their activity both at the individual and social levels. treatment. Special ethics can be further divided into individual ethics, which are concerned with God, self, and Beneficence. This principle indicates that a fellow human beings; and social ethics, which are practitioner should act in the best interest of concerned with family, the state, and the world. the patient. 3. PROFESSIONAL ETHICS Nonmaleficence. This principle provides that evil or harm should not be inflicted either Professional ethics is a branch of moral science that on oneself or on others. deals with how and what a professional should or should not do in the workplace. It addresses the Justice. This principle is concerned with the question, "What should I do in this situation?" distribution of scarce health resources and Professional ethics are intended to bind professions the decision on who gets what treatment in more tightly together around a shared standard of terms of fairness and equality. values. Respect for Dignity. This principle provides CODE OF PROFESSIONAL ETHICS for all the necessary means of care, high regard for the person or the patient, and The objectives of professional ethics: needed information to make a relevant decision. Perform duties and responsibilities objectively in accordance with relevant Truthfulness and Honesty. This is simply standards and guidelines. the dedication of a person to his job and is Serve in a lawful and honest manner, while reflective of being honest and concerned. maintaining high standards of conduct and character and not engage in acts Stewardship. This principle refers to the discreditable to the profession. expression of one's responsibility to nurture Maintain the privacy and confidentiality of and cultivate what has been entrusted to information obtained in the course of duty him. unless disclosure is required by a legal authority. Such information should not be used for VALUES OF A MEDICAL TECHNOLOGIST personal benefit or released to inappropriate parties. A person's beliefs are influenced by one's Perform tasks with full confidence, absolute family, community, society, culture, religion, reliability, and accuracy. and colleagues. These factors shape one's Be dedicated to the use of clinical laboratory values and behavior science to promote life and for the benefit of Personal values are developed from life mankind. experiences. The values of an employee are important to 4. MEDICAL ETHICS keep order within the workplace. A code of conduct, which defines the expected behavior of an employee, is set within the are a set of norms, values, and principles that serve workplace. In a professional setting, values as guidelines for medical practitioners-such as and ethics serve as the foundation of an physicians, nurses, medical technologists and other organization. PMLS - MIDTERMS 11  The practice of medical technology Medical technologist should keep themselves consists of engaging in activities to informed of the developments and changes in conduct analysis and tests in the field of biomedical and political healthcare legislations. medical biology on the human body or on a They should also ensure that all biological materials specimen, and to ensure the technical be disposed in an ethical and environmentally safe validity of the results for diagnostic or manner. therapeutic follow-up purposes. A medical technologist is accountable to PROBLEMS AND CONCERNS IN MEDICAL the patient, to the attending physician and to TECHNOLOGY PRACTICE the community in general. This means that the medical technologist takes on the Negligence - failure to act and use responsibility of providing accurate and reasonable care. Anyone, including reliable test results. nonmedical persons, Negligence involves The medical technologist works carelessness and deviation from the collaboratively with the medical expected standard of care in a particular set practitioner in providing patient care of circumstances. through accurate diagnosis and treatment. The commitment to provide prompt and Malpractice - care provided deviates from professional service is important in efficient accepted standards of practice in the healthcare delivery. medical community and may result in injury The medical technologist review records or death of the patient. Malpractice is a more in compliance with clinical guidelines in specific term that pertains to both the specimen diagnostic assay, and data standard of care and professional status of collection. The obligation, the confidentiality the healthcare provider. of all laboratory test results and information is a sign of respect to the right of patient for privacy PMLS - MIDTERMS UNIT 6 MEDICAL TECHNOLOGISTS AND PATIENTS MEDICAL TECHNOLOGIES AND ABBREVIATIONS Patients' rights include the right to be treated with dignity, the right to self-determination and the right Three basic part of a Medical Terms: to not be harmed or hurt. 1. ROOT WORD - the main part of the medical MEDICAL TECHNOLOGISTS AND THEIR term that denotes the meaning of the word COLLEAGUES ❖ Examples: colo - colon Medical technologists should respect the work of hemat - blood their colleagues and support them professionally. phlebo - vein They must exhibit tolerance toward other aero - air professionals work methods and circumstances. 2. PREFIX - found at the beginning of the term MEDICAL TECHNOLOGISTS AND THEIR and it shows how meaning is assigned to the WORKPLACE word ❖ Examples: a- or an - without, absence Medical technologists are expected to make their hyper - increased, above knowledge available to other medical technologists, poly - many biomedical students, and other members of the pre - before healthcare team. They should be respectful of their responsibility and other professional disciplines and 3. SUFFIX - found at the terminal portion or at work toward establishing and building cooperation the end of the term. It also denotes the with other professionals. meaning to the root word. ❖ Examples: MEDICAL TECHNOLOGISTS AND THE SOCIETY -megaly - enlargement -emia - blood PMLS - MIDTERMS 12  -uria - urine -ostomy - to make an opening, mouth RULE 1. If the suffix starts with a consonant, a combining vowel needs to be used (usually the letter O). ◦ The combining vowel does not change the meaning of the root word and is added in order to make the pronunciation of the word easier. 2. The combining vowel is added between the root word and the suffix. ❖ Examples: hemat + logy = hematology - study of blood phlebo + tomy = phlebotomy - the process of cutting into the vein using a needle. 3. The plural form of medical terms is made by changing the end of the word and not by simply adding S, which follows the rule for irregular nouns. ❖ Examples: bacterium bacteria nucleus nuclei PREFIXES thrombus thrombi bacillus bacilli ROOT WORDS iso- sam cryo- cold intra- inside/ macro- large within cardio heart anaero- without pseudo- false myo muscle oxygen heap / hepato liver homo- same, like mono- one pyro fever micro- small neo- new arterio arteries nano- billionth hypo- decreased arthro joint pyo pus SUFFIXES osteo bone cyto cell -itis inflammati -meter measure on of cranio skull -cidal killing of -tome cutting nephro kidney instrument -pathy disease -blast young -emia blood -penia deficiency condition PMLS - MIDTERMS 13  to NPO Nothing Per Orem -megaly enlargeme -oma tumor BAP Blood Agar Plate nt -poiesis formation -ectomy surgical removal PMLS - MIDTERMS UNIT 7 BASIC CONCEPTS ON LABORATORY BIOSAFETY AND ABBREVIATIONS BIOSECURITY BRIEF HISTORY OF LABORATORY BIOSAFETY DOH Department of Health CHED Commission on Higher Laboratory biosafety and biosecurity traces Education its history in North America and Western Europe. VDRL Veneral Disease Research Laboratories The origins of biosafety is rooted in the US biological weapons program which AIDS Acquired began in 1943, as ordered by then US Immunodeficiency President Franklin Roosevelt and was Syndrome active during the cold war. AIDs Autoimmune disorders/ diseases It was eventually terminated by US President Richard Nixon in 1969. AMI Acute Myocardial Infarction In 1943, Ira L. Baldwin became the first scientific director of Camp Detrick (which BUN Blood Urea Nitrogen eventually became Fort Detrick), and was tasked with establishing the biological 2PPBS 2 hours Postprandial weapons program for defensive purposes to Blood Sugar enable the United States to respond if attacked by such weapons. AFS Acid Fast Stain After the Second World War, Camp PCQACL Philippine Council for Detrick was designated a permanent Quality Assurance in installation for biological research and the Clinical development. Laboratories FBS Fasting Blood Sugar Later on, Newell A. Johnson, designed modifications for biosafety at Camp Detrick. IV Intravenous He engaged some of Camp Detrick’s leading HIV Human scientists about the nature of their work, and Immunodeficiency developed specific technical solutions such Virus as Class III safety cabinets and laminar flow hoods to address specific risks. IU International Unit Consequent meetings led to the formation of ICU Intensive Care Unit the American Biological Safety Association (ABSA) in 1984. The K Potassium association held annual meetings that soon became the ABSA annual conferences. Na Sodium PMLS - MIDTERMS 14  Other contributors outside the United States marked the development of the practice of included Arnold Wedum who described the laboratory biosafety. use of mechanical pipettors to prevent laboratory-acquired infections in 1907 and These documents established the model of 1908. biosafety containment levels with certain agents which increased the biosafety levels Ventilated cabinets, early progenitors to the for biological agents that pose risks to human nearly ubiquitous engineered control now health. known as the biological safety cabinet, were also first documented outside the US Biosafety levels are the technical means of biological weapons program. mitigating the risk of accidental infection from or release of agents in the laboratory setting In 1909, a pharmaceutical company in as well as the community and environment it Pennsylvania developed a ventilated is situated in. cabinet to prevent infection from Mycobacterium tuberculosis. Although biosafety levels are concentrated in a combination of engineered controls, At the height of the increasing mortality and administrative controls, and practices, the morbidity due to small pox in 1967, WHO emphasis is clearly on the equipment and aggressively pursued the eradication of the facility controls, with little attention given to virus. risk assessment. It was also during this time that serious Progress in biosafety practice continued until concerns about biosafety practices the emergence of a community of “biosafety worldwide were raised, contributing directly officers” who adopted the administrative to the decision of the World Health Assembly role of ensuring that the proper to consolidate the remaining virus stocks into equipment and facility controls are in two locations: the Center for Disease place based on the specified biosafety level Control and Prevention (CDC) in the of the laboratory. United States and the State Research Center for Virology and Biotechnology Arnold Wedum, director of Industrial Health VECTOR (SRCVB VECTOR) in Russia. and Safety at the US Army Biological In 1974, the CDC published the Research Laboratories in 1944, was Classification of Etiological Agents on the recognized as one of the pioneers of Basis of Hazard, that introduced the concept biosafety. of establishing ascending levels of In 1966, Wedum and microbiologist containment associated with risks in Morton Reitman, colleagues at Fort Detrick, handling groups of infectious analyzed multiple epidemiological studies of microorganisms that present similar laboratory-based outbreaks. characteristics. In 1966, the US government enacted the Two years later, the National Institutes of Select Agent Regulations to monitor the Health (NIH) of the United States published transfer of a select list of biological agents the NIH Guidelines for Research Involving from one facility to another. Recombinant DNA Molecules. It explained in detail the microbiological practices, Slightly after the terrorist attacks and equipment, and facility necessarily anthrax attacks of 2001, also known as corresponding to four ascending levels of Amerithrax, the US government changed its physical containment. perspective. The revised Select Agent Regulations then required specific security These guidelines laid the foundation for the measures for any facility in the United States introduction of a code of biosafety practice. that used or stored one or more agents on This code, along with WHO’s first edition of the new, longer list of agents. Laboratory Biosafety Manual (1983) and the CDC and NIH’s jointly-published first The revision of the Select Agent edition of the Biosafety in Microbiological Regulations in 2012 sought to address the and Biomedical Laboratories (1984), creation of two tiers of select agents. Tier 1 PMLS - MIDTERMS 15  agents are materials that pose the greatest the National Biosafety Framework (NBF), risk of deliberate misuse, and the remaining which prescribes the guidelines for its select agents. implementation, strengthening the National Committee on Biosafety of the Philippines. Other countries also relatively implemented and prescribed biosecurity regulations for The NBF is a combination of policy, legal, bioscience facilities. administrative, and technical instruments developed to attain the objective of the LOCAL AND INTERNATIONAL GUIDELINES ON Cartagena Protocol on Biosafety which the LABORATORY BIOSAFETY AND BIOSECURITY Philippines signed on May 24, 2000. In February 2008, the Comité Européen de The Department of Agriculture (DA) also Normalisation (CEN), a European issued Administrative Order No. 8 to set in Committee for Standardization published place policies on the importation and release CEN Workshop Agreement 15793 (CWA of plants and plant products derived from 15793) which focuses on laboratory biorisk modern biotechnology. management. The Department of Health (DOH), To address concerns on biosafety guidance together with NCBP, formulated guidelines for research and health laboratories, issues in the assessment of the impacts on health on risk assessment and guidance to posed by modern biotechnology and its commission and certify laboratories, the Who applications. in 1983 published its 3rd edition of the Laboratory Biosafety Manual. DOH Administrative Order No. 20017- 0027 requires clinical laboratories to ensure The 3rd edition of the Laboratory Biosafety policy guidelines on laboratory biosafety and Manual includes information on the different biosecurity. levels of containment laboratories (Biosafety levels 1-4), different types of biological safety cabinets, good microbiological techniques, DIFFERENT ORGANIZATIONS IN THE FIELD OF BIOSAFETY and how to disinfect and sterilize equipment. The Cartagena Protocol on Biosafety 1. AMERICAN BIOLOGICAL SAFETY (CPB), made effective in 2003 which applies ASSOCIATION (ABSA) to the 168 member-countries provides an international regulatory framework to ensure a regional professional society for biosafety and “an adequate level of protection in the field of biosecurity founded in 1984. It promotes biosafety safe transfer, handling, and use of living as a scientific discipline and provides guidance to its modified organisms (LMOs) resulting from members on the regulatory regime present in North modern biotechnology”. America. The new National Committee on Biosafety 2. ASIA-PACIFIC BIOSAFETY ASSOCIATION (A- of the Philippines (NCBP) established PBA) under E.O. 430 series of 1990 was formed on the advocacy efforts of scientists. The a group founded in 2005 that acts as a professional Mandate of NCBP focuses on the society for biosafety professionals in the Asia-Pacific organizational structure for biosafety: region. procedures for evaluation of proposals with biosafety concerns; procedures and 3. EUROPEAN BIOLOGICAL SAFETY guidelines on the introduction, movement, ASSOCIATION (EBSA) and field release of regulated materials; and procedures on physico-chemical and biological containment. a non-profit organization founded in June 1996, On March 17, 2006, the Office of the that aims to provide a forum for discussions and President promulgated E.O 514 establishing debates on issues of concern and to represent those working in the field of biosafety. PMLS - MIDTERMS 16  includes microorganisms that are unlikely to be a 4. PHILIPPINE BIOSAFETY AND BIOSECURITY significant risk to laboratory workers and the ASSOCIATION (PhBBA) community, livestock, or the environment. Laboratory exposure may cause infection, however, effective treatment and preventive measures are assist the DA and DOH in their efforts to create a available while the risk pf spread is limited. This risk national policy and implement plan for laboratory group bring about moderate individual risk and biosafety and biosecurity. limited community risk. 5. BIOLOGICAL RISK ASSOCIATION PHILIPPINES (BRAP) RISK GROUP 3 includes microorganisms that are known to cause a non-government and non-profit association serious disease to humans or animals and may that works to serve the emergent concerns of present a significant risk to laboratory workers. It biological risk management in various professional could present a limited to moderate risk if this fields such as in the health, agriculture, and microorganisms spread in the community or the technology sectors throughout the country. BRAP environment, but there are usually effective goes by the tagline “assess, mitigate, monitor” preventive measures or treatment available. They bring about high individual risk and limited to FUNDAMENTAL CONCEPTS OF LABORATORY moderate community risk. BIOSAFETY AND BIOSECURITY RISK GROUP 4 By simple definition, “biosafety protects people from germs” while “biosecurity protects germs from people” includes microorganisms that are known to produce life-threatening diseases to humans or animals. It In 1996, Charles Baldwin, an environmental represents a significant risk to laboratory workers health engineer working for the Dow and may be readily transmissible from one individual Chemical Company containment system to another while effective treatment and preventive products, created the biohazard symbol measures are not usually available. In effect, they used in labeling biological materials carrying bring about high individual and community risk. significant health risks. CATEGORIES OF LABORATORY BIOSAFETY ACCORDING TO LEVELS CLASSIFICATIONS OF MICROORGANISMS ACCORDING TO RISK GROUPS In order to facilitate precautionary measures, CDC categorized laboratories into biosafety Risk group classification for humans and animals is levels – Biosafety Level 1, Biosafety Level 2, based on the agent’s pathogenicity, mode of Biosafety Level 3, and Biosafety Level 4. transmission, host range, and the availability of preventive measures and effective treatment. Biosafety level designations are based on a Through the classification, infective microorganisms composite of the design features, are classified as: construction, containment facilities, equipment, practices, and operational RISK GROUP 1 procedures required for working with agents from the various risk groups. includes microorganisms that are unlikely to cause They are designed in ascending order, by human or animal disease. These microorganism degree of protection provided to the bring about low individual and community risk. personnel, the environment, and the community. RISK GROUP 2 1. BIOSAFETY LEVEL 1 (BSL 1) PMLS - MIDTERMS 17 - suitable for work involving viable microorganisms via aerosol route, for which there are no that are defined and with well-characterized available vaccines or treatment. strains known not to cause disease in - generally a separate building or completely isolated humans. zone with specialized ventilation requirements - this level is the most appropriate among the and waste management systems. undergraduate and secondary educational training and teaching laboratories that require ex: Marburg virus, Crimean-Congo basic laboratory safety practices, safety equipment, hemorrhagic fever virus and facility design that requires basic level of containment. ex: Bacillus subtilis, Naegleria gruberi, infectious canine hepatitis virus, exempt organisms under NIH guidelines 2. BIOSAFETY LEVEL 2 (BSL 2) - designed for laboratories that deal with indigenous moderate-risk agents present in the community. - observes practices, equipment, and facility design that are applicable to clinical, diagnostic, and teaching laboratories. - appropriate when work is done with human blood, body fluids, tissues or primary human cell lines where there is uncertain presence of infectious agents ex: Hepatitis B virus, HIV, Salmonellae, Toxoplasma spp. 3. BIOSAFETY LEVEL 3 (BSL 3) PMLS - MIDTERMS - work with indigenous or exotic agents with a UNIT 8 potential for respiratory transmission, and that may cause serious and potentially lethal infection BIORISK MANAGEMENT are being conducted here. - activities are required to be performed in a biosafety cabinet or other containment equipment BIORISK MANAGEMENT AND THE AMP MODEL like gas-tight aerosol generation chamber. (Assessment, Mitigation, Performance) - personnel must be supervised by scientists competent in handling infectious agents and Biorisk – is the risk associated to biological associated procedures in a BSL-3 laboratory. toxins or infectious agents. ex: Mycobacterium tuberculosis, St. Louis Biorisk management – is the integration of encephalitis virus, Coxiella biosafety and biosecurity to manage risks when working with biological toxins and infectious agents. 4. BIOSAFETY LEVEL 4 (BSL 4) According to the CEN Workshop Agreement (CWA) 15793:2011, Biorisk Management - required for work with dangerous and exotic agents (BRM) is “a system or process to control that pose high individual risks of life- safety or security risks associated with threatening diseases that may be transmitted the handling or storage and disposal of PMLS - MIDTERMS 18  biological agents and toxins in ➔ Risk is the likelihood that an adverse event laboratories and facilities”. involving a specific hazard or threat will occur followed by the consequences of the BRM encompasses the identification, occurrence. understanding and management aspects of a system in interrelated processes. It is STEPS IN RISK ASSESSMENT divided into three primary components: ❖ Assessment (A) In performing risk assessment, a structured and ❖ Mitigation (M) repeatable process is followed. It consists of the ❖ Performance (P) following steps: This components are collectively captured 1. DEFINE THE SITUATION by what is called the AMP model (WHO, 2010). the risk assessment team must identify the following: ❖ Hazards and risks of the biological agents The model requires that control measures be ❖ At-risk hosts (humans or animals) based on a robust risk assessment, and a ❖ Work activities and laboratory continuous evaluation of effectiveness and environment (location, procedures, suitability of the control measures. equipment) Like a three-legged stool, a biorisk system 2. DEFINE THE RISKS fails if one of the components or legs, is overlooked or is not addressed. include a review of how individuals inside and outside the laboratory may be exposed to the In contrast to other risk management hazards. models, which typically focus heavily on ❖ Inhalation mitigation measures, AMP focuses on all ❖ Droplets components with equal attention. ❖ Ingestion ❖ Inoculation 3. CHARACTERIZE THE RISK the risk assessment team needs to compare the KEY COMPONENTS OF BIORISK MANAGEMENT likelihood and the consequences of infection – either qualitatively or quantitatively 4. DETERMINE IF THE RISK ARE RISK ASSESSMENT ACCEPTABLE OR NOT ➔ Initial step in implementing biorisk this process of evaluating the biorisk arising from a management biohazard takes into account the adequacy ➔ Includes identification of hazards and of any existing controls, and deciding whether or not characterization of risks that are possibly the biorisk is acceptable. present in the laboratory ➔ HAZARD refers to anything in the environment that has the potential to cause MITIGATION PROCEDURES harm while RISK is generally defined as the possibility that something bad or unpleasant (such as injury or loss) will happen. The second fundamental component of ➔ In order for a risk to occur, there must be a the biorisk management model situation for the hazard to cause harm. Biorisk mitigation measures are actions ➔ For example, a sharp needle is a hazard, but and control measures that are put into place if no one is using it, the needle will not pose to reduce or eliminate the risks associated any risks. with biological agents and toxins. PMLS - MIDTERMS 19  There are five major areas of control or environment that can reduce or prevent measures that can be employed in mitigating exposure to hazards the risks. ➔ Examples are installation of biosafety cabinets, safety equipment, facility design enabling proper airflow, ventilation system, air treatment systems, controlled access zones, airlocks, separate buildings or modules to isolate the laboratory 4. ADMINISTRATIVE CONTROLS ➔ Policies, standards, and guidelines used to control risks ➔ Proficiency and competency training for laboratory staff is considered an administrative control ➔ Examples are displaying of biohazard or warning signages, markings, and labels, controlling visitor and working access, and 5 COMPONENTS OF MITIGATION documenting written standard operating PROCEDURES procedures 1. ELIMINATION 5. PERSONAL PROTECTIVE EQUIPMENT (PPE) ➔ MOST DIFFICULT AND MOST EFFECTIVE CONTROL MEASURE ➔ Last mitigation control measure ➔ Involves the total decision not to work with a ➔ These are devices worn by workers to specific biological agent or even not doing protect them against chemicals, toxins, and the intended work pathogenic hazards in the laboratory ➔ Provides the highest degree of risk reduction ➔ Examples are: Gloves, Gown, Respirators ➔ LEAST EFFECTIVE MEASURE because it only protects the person wearing it, and only when it is used correctly 2. SUBSTITUTION The concept or hierarchy of controls describes the order of effectiveness (from most effective to least effective) of mitigation ➔ Second control measure measures and implies that this order should ➔ Replacement of procedures or biological be taken into account when selecting and agent with a similar entity in order to implementing controls to reduce risks. reduce the risks ➔ For example: A lab conducting research with PERFORMANCE EVALUATION the pathogen Bacillus anthracis is substituted by a less dangerous experimental surrogate such as the Bacillus thuringiensis The last pillar of the biorisk management model 3. ENGINEERING CONTROLS Involves a systematic process intended to achieve organizational objectives and goals Ensures that the implemented mitigation ➔ Includes physical changes in work measures are indeed reducing or eliminating stations, equipment, production facilities, risks or any other relevant aspect of work Also helps to highlight biorisk strategies that are not working effectively and measures PMLS - MIDTERMS 20  that are ineffective or unnecessary. These can be eliminated or replaced Performance management is simply a reevaluation of the overall mitigation strategy. PERFORMANCE EVALUATION PROCEDURES PMLS - MIDTERMS 21