Nature) off tlie, Clini¢allationatony, @ INTENDED LEARNING OUTCOMES at the end of the lesson, the students should be able to: . discuss the different sections of the laboratory and the tests done in each; 2. compare and contrast the different types of clinical laboratories; 3. identify the salient points of the laws overning the establishment, ; operation, and maintenance of clinical laboratories in the Philippines, and 4, discuss the importance of quality assurance in the clinical laboratory.Nat ture of the Clinical Laboratory TNT 0 PRE-TEST Namie: section! —— Date: Score: structions: Transcrib i a e the following acronyms: 1. RITM », DOH 3, BHFS 4, CHD 5. EQAS 6. NRL 8. PCR 9. QC 1o. TAT‘Nature of the Clinical Laborato os y The Clinical Laboratory The clinical laboratory is an essentiz to provide accurate and reliable information to medi rreatment, and management of diseases, ce medical doctors are based on laboratory test results, al co; mponent of health institutions, Its main task is cal doctors for the diagnosis, prognosis, iat of all decisions performed by » thus the need for accurate and reliable test results. The clinical laboratory is also actively involved in . in the hospital Tesearch, community outreach rograms, surveillance infestion control Se 3 dissemination, and Le of the applicability of Suet settings, information technologies. Thus, ae technologist/clinical abate and innovative diagnostic partner of medical doctors and is an imp, Ty scientist serves as the integral ortant member of th n athe clinical laboratory itt Reno of the health care delivery system. f e Te speci f tissues, feces, hair, nails) collected from indgiahs pee aoe and other body fluids, properly disposed. Clinical laboratories vary accor aera pa } analyzed, preserved, and tests performed. » function, and the complexity of medical technologist/clini ity aaa of Ae ie Scientist plays ‘a very significant role in the Pt . A ry testing and ensuring the reliability of test results, Ass undertaken in the clinical laboratory in the past were described as aah tier labor-intensive, and time-consuming, Currently, with the advent of an a ae Jess laborious, with shortened turnaround time (TAT). Also, test ee ree ea d to produce more reliable results. In the near future, there will be more changes in the clinical laboratory. Changes may be due to shifting demographics, emergence ees re-emergence of infectious and non-infectious diseases, demand for a more efficient and effective workflow, and new government institutional policies. These factors can usher in change in the activities done in the laboratory. Classifications of Clinical Laboratories According to Function 1. Clinical Pathology is a clinical laboratory that focuses on the areas of clinical chemistry, immunohematology and. blood banking, medical microbiology, immunology and serology, hematology, parasitology, clinical microscopy, toxicology, therapeutic drug monitoring, and endocrinology, among others. It is concerned with the diagnosis and treatment of diseases performed through laboratory testing of blood and other body fluids. 2. Anatomic Pathology is a clinical laboratory that focuses on the areas of histopathology, immunohistopathology, eytology, autopsy, and forensic pathology among others. Tt is concerned with the diagnosis of diseases through microscopic examination of tissues and organs. 19120 According to Service Capability Principles of Medical Laboratory Science 1 According to Institutional Characteristics s 1. An institution-based is a clinical laboratory that operates within the premises gy Gf an institution such as a hospital, school, medical clinic, medical facility for oyer™ vorkers and seafarers, birthing: home, psychiatric facility, drug rehabilitation centey others. Hospital-based clinical laboratories are the most common example of, institution based laboratories. 2. A free-standing clinical laboratory is not part of an established institution. The ‘common example is a free-standing out-patient clinical laboratory. Mgt According to Ownership 1, Government-owned clinical laboratories are owned, wholly or partially, by national , local government units. Examples are the clinical and anatomical laboratories of Dow. run government hospitals like the San Lazaro Hospital, Jose R. Reyes Memorial Medica} Center, University of the Philippines-Philippine General Hospital and local mall run hospital-based clinical laboratories of the Ospital ng Maynila Medical Cente, Sta. Ana Hospital, and Bulacan Medical Center. bing 2. Privately-owned clinical laboratories are owned, established, and operated by an 4 individual, corporation, institution, association, or organization. Examples are St. Luke Medical Center, Makati Medical Center, and MCU-FDTMF Hospital. fs 1. Clinical laboratories under the primary category are licensed to perform basic, routine laboratory testing, namely, routine urinalysis, routine stool examination, routine hematology or complete blood count that includes hemoglobin, hematocrit, WBC RBC count, WBC differential count and qualitative platelet count, blood typing, a Gram staining (if hospital-based). Equipment requirements are, but not limited microscopes, centrifuge, hematocrit centrifuge. Space requirement is at least 10 sq a meters. a 2. Clinical laboratories secondary category (Hospital and non-hospital-based) are licensed to perform laboratory tests being done by the primary category clinical laboratories along with routine clinical chemistry tests like blood glucose concentration, blood urea nitrogen, blood uric acid, blood creatinine, cholesterol determination, qualitative platelet count, and if hospital-based, Gram stain, KOH mount, and crossmatching. A minimum requirement of 20 square meters is needed for the floor area of this type of laboratory. Personnel requirement depends on the workload. Minimum equipment requirements are microscopes, centrifuge, Hematocrit centrifuge, semi automated chemistry analyzers, autoclave, incubator, and oven. ;+ Nature of the Clini rate Clinical laboratories under the ae 3 " jpased) are licensed to perform alt tile (Hospital and non-hospital- secondary ae laboratory’ plas (1) immunolog 7, {88 Performed in the dengnes bas plasma reagin, ‘BY and serology (eg., NSI-Ag for Q) feist pre, and mycolo, pues agglutination tests); culture na eee of bacteria s erential staining techniques, susceptibility testing); (8) special clinical chem ‘om ‘specimens, antimicrobial drug aap me for certain naan, “ace pe poe marrow st oe a Staining for abnormal blood cells, est fe sate wha Oi TCE ate net MER Ccewbooditeaas ee sereening and identification, Preparation of blood eae ion program, antibody = um floor i along with automated chemistry analyzer, tcaniary category laboratories sig) iosafety cabinet class II, serofuge, among 7 ‘ ratory in a i i by the DOH to provide special diagnostic fas ee eee These functions include referral Services, provision of confirmato: testi i ee for research activities, implementation of External Quality ieee ee of the government, resolution of conflicts regarding test results of different laboratories and training of medical technologists on certain specialized procedures that require standardization. Laws on the Operation, Maintenance, and Registration of Clinical Laboratories in the Philippines Republic Act No. 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 alicense 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. 21122 Principles of Medical Laboratory Science 1 SECTION 2. It shall be unlawful for any person to be professionally in-charge of a re clinical laboratory unless he is a licensed physician duly qualified in laboratory medicine ang authorized by the Secretary of Health, such authorization to be renewed annually, No j shall be granted or renewed by the Secretary of Health for the operation and main of a clinical laboratory unless such laboratory is under the administration, direction anq 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 shay be charged with the responsibility of strictly enforcing the provisions of this Act and shall pe 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 thereunder 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 no less than one thousand pesos nor more than five thousand pesos, or both such fine ang imprisonment, at the discretion of the court. ! f 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 much 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. wi Approved, June 18, 1966. fray 4. Administrative Order No. 59 s. 2001 eae Rules and Regulation Governing the Establishment, Operation and Maintenance of Clinical Laboratories in the Philippines ie 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. atNature of the Clinical Laboratory hall apply to all entiti spese regulations SI ply entities performi, 1 Toe ial laboratories which shall include the exon, th actin and fonctions 3 ‘These regulations do not include government laboratories doin, * jimited to acid fast bacilli microscopy, provided their services are declared laboratory. ‘on 5: Classification of Laboratories 1 g laboratory examinations malaria screening and cervical cancer screening, as extension of a licensed government clinical Secti 1, Classification by Function a, Clinical Pathology - includes Hematology, Clinical Chemistry, Microbiology, Parasitology, Mycology, Clinical Microscopy, Immunology. and_ Serology, Immunohematology, Toxicology and Therapeutic Drug Monitoring and other similar disciplines. b, Anatomic Pathology - includes Surgical Pathology, Immunohistopathology, Cytology, Autopsy and Forensic Pathology. 2. Classification by Institutional Character a. Hospital-based laboratory ~ a laboratory that operates within a hospital b. Non-hospital-based laboratory — a laboratory that operates on its own. 3. Classification by Service Capability a. Primary — provides the minimum service capabiliti (2) 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 (3) Routine Fecalysis (4) Blood Typing - hospital-based (5) Quantitative Platelet Determination - hospital-based s such as: 123- 124 Principles of Medical Laboratory Science 1 b. Secondary ~ provides the minimum service capabilities ofa primary category following: a (4) Routine Clinical Chemistry ~ includes Blood Glucose Substance Conceng, Blood Urea Nitrogen Concentration, Blood Uric Acid Substance Con Blood Creatinine Concentration, Blood Total Cholesterol Concentration (2) Crossmatching c. Tertiary - provides the secondary st (1) Special Chemistry (2) Special Hematology (3) Immunology/Serology (4) Microbiology : Section 6: Policies 1. An approved permit to construct and design layout of a clinical laboratory secured form the BHES prior to submission of an application for a Petition to O 2. No clinical laboratory shall be constructed unless plans have been appro construction permit issued by the BHFS. ie 3. A clinical laboratory shall operate with a valid license issued by Bee c . compliance with the minimum licensing requirements (Annex A). 4. The clinical laboratory shall be organized and managed to provide effective e ef laboratory services. q 5. The clinical laboratory shall provide adequate and appropriate safety practices 1 personnel and clientele. Section 7: Requirements and Procedures for Application of Permit to Construct and License to Operate ’ ervice capabilities and the following: 1. 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 Site Development Plans and Floor Plans approved by and/or engineer. f c. DTI/SEC Registration (for private clinical laboratory) 2. Application for New License A duly notarized application form “Petition to Establish, Operate and Maintain a Cli Laboratory’, shall be filed by the owner or his duly authorized representative BHFS. eyNi oi cation for renewal of license MtUr8 Of the Clinical Laboratory 125 BS tarized application fi 4 P tapi dug and Maintain a Clinical Lap eeaton for . orat norized representative at the respecte Gee shall a rnewal of License: eam aA Of License to Establish, CHD, by the owner or his duly a Re} ication for renewal of ki Application i ot license shall sth ofthe license described as follows: Within 90 days before the axplty date 40, 11, 12, CARAGA & ARMM May to July permit and License Fees ,, Anon-refundable license fee shall be ch, and for license to operate a government larged for application for permit to construct, and private clinical laboratory. non-refundable fee shall bi rah b. aa e charged for application for renewal of license to c. Allfees shall be paid to the Cashier of the BHFS/CHD, d. All fees shall follow the current prescribed schedule of fees of ‘the DOH. 5, Penalties a. A penalty of one thousand pesos (1,000.00) 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. b. 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. 6. Inspection a. 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. b. Each license shall make available to the Director of the BHFS/CHD or his duly authorized representative(s) all pertinent records. . Clinical laboratories shalll be inspected every two (2) years or as necessary.— T2G Principles of Medical Laboratory Science 1 7. Monitoring a. All clinical laboratories shall be monitored regularly and records shall be made available to determine compliance with these rules and regulations. b. The Director of the BHFS/CHD or his authorized representative(s) shall be allowed to monitor the clinical laboratory at any given time. clinical laboratories shall make available to the Director of the BHFS or his duly c All authorized representative(s) records for monitoring. 8, 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. g. Terms and Conditions of License a. The license is granted upon compliance with the licensing requirements. b. 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. An extension laboratory shall have a separate license. ‘Any change affecting the substantial conditions of the license to operate a laboratory shall be reported within 15 days in writing by the person(s) concerned, to the BHFS/ CHD for notation and approval. Failure to do so will cause the revocation of the license of the clinical laboratory. ‘The clinical laboratory license must be placed in a conspicuous location/area within eS the laboratory. 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. * The following acts committed by the Owner, President, Managers, Board of Trustees/ Director, Pathologist or its personnel are considered violations. a. Operation of a clinical laboratory without a certified pathologist or without 2 registered medical technologist b. Change of ownership, location, head of laborato} i i i J » ry or personnel without informing the BHFS and/or the CHD : ie gyNature of the Clinical Laboratory Refusal to allow inspection of the clinical labo ‘ * the BHES during reasonable hours ratory by the person(s) authorized by 4. Gross negligence e. Any act or omission detrimental to the public ‘he provincial, City and Municipal Health 3 CHD and BHFS the existence of unlicensed clinical laboratories or any rivate ‘erforming laboratory examinations without at ane ene Proper license and/or violations to these rules and ref 4 section 9: Investigation of Charges or Complaints 5 ‘the BHES, /CHD or his duly authorized representative verify fthe laboratory concerned or any of its personnel 1. Ifupon 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, (s) shall investigate the complaint and 1 is guilty of the charges. 2. Any person who operates 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 or both at the discretion of the court, Provided, however, that if the offender isa 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 = 1. Alicense maybe revoked, suspended or modified in full or in part for any material false statement by the applicant, or as shown by the record of inspéction or for a violation of, or failure to comply with 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.- T28 _Principies of Medical Laboratory Science 1 Section 11; Repealing Clause ‘These rules and regulations shall supersede all other pr Section 12: Publication and List of Licensed Clinical Laboratories ‘A list of licensed clinical laboratories shall be published annually in a newspaper of genera) circulation. Section 13: Effectivity ‘These rules and regulations shall take effect 15 days after its publication in the Official Gaxette, or ina newspaper of general circulation. -evious official issuances hereof, ANNEX A Techniéal Standards and Minimum Requirements The clinical laboratory shall be organized to provide effective and efficient laboratory services. I. STAFFING 4. The clinical laboratory shall be managed by a licensed physician certified by the Philippine Board of Pathology. In areas where pathologists 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 laboratory. The BHES shall certify such training. 2, The clinical laboratory shall employ qualified and adequately train personnel. Work assignment shall be consistent with the qualification of the concerned personnel. a. A clinical laboratory shall have sufficient number of registered medical technologists proportional to the workload and shall be available at all times during hours of laboratory operations, For hospital-based clinical laboratory, there chall be at least one registered medical technologist per shift to cover the laboratory operation. 3, There shall be staff development and appropriate continuing education program available at all levels of the organization to upgrade the knowledge, attitudes and skills of staff. Il. PHYSICAL FACILITIES 1. The clinical laboratory shall be well-ventilated, adequately lighted, clean and safe. 2. The working space shall be sufficient to accommodate its activities and allow for smooth and coordinated work flow. 3. There shall be an adequate water supply.ul. Vi. , WASTE MANAGEMENT 4, The working space for al] Nature of the Clinical Laboratory 129 non-hospital-based) shall havea est laboratoig (both hospital and Caeeee space in sq.m, llowing measurements: Primary 10 Secondary 20 Tertiary 60 EQUIPMENT/INSTRUMENTS 1. There shall be provisions 1 Li for suffici equipment/instruments in order to ee Say and types of appropriate examinations. This equipment shall comply Sak all the activities and laboratory safety requirements. ions being performed, the i i the appropriate equipment Procedures shall be made available. 2. For other laboratory examinati necessary for performing such , GLASSWARES/REAGENTS/SUPPLIES All categories of clinical laboratories shi i ‘ glassware, reagents and supplies necesary to une (eee usted appropriate ‘sary to undertake the required services. There shall be provisions for adequate and efficient di : i icient dis] guidelines of the Department of Health and the local gover oe waste following (copies of which are available at respective CHDs and DOH-BHFS and local government offices) QUALITY CONTROL PROGRAM All clinical laboratories shall have a functional Quality Assurance Program 1. Internal Quality Control Program a. There shall be a documented, continuous competency assessment program for all laboratory personnel. b. The program shall provide appropriate and standard laboratory methods, reagents and supplies and equipment. c. There shall be a program for the proper maintenance and monitoring of all equipment. d. ‘The program shall provide for the use of quality control reference materials. 2. External Quality Control Program a. All clinical laboratories shall participate in an External Quality Assurance Program given by designated National Reference Laboratories and/or other recognized reference laboratories. b. A satisfactory performance rating given by a National Reference Laboratory — shall be one of the criteria for the renewal of license.130 Principtes of Medical Laboratory Science 1 ¢. Any refusal to participate in an External Quality Assurance Program giver, ¥ the designated National Reference Laboratories shall be one OF the bases suspension/revocation of the license of the laboratory. VII. REPORTING Laboratory requests shall be construed as consultation between the requ physician and the Pathologist of the laboratory and as such laboratory results shallig released accordingly. 1. Alllaboratory reports on various examinations of specimens shall bear the p, of the registered medical technologist and the Pathologist and duly signeq by both. 2. No person in the clinical laboratory shall issue a report, orally or in writin whole or portions thereof without a directive from the Pathologist or his authorized associate to the requesting physician or his authorized representative except in emergency cases when the results may be released as authorized by the Pathologist. VIII. RECORDING There shall be a system of accurate recording to ensure quality results. 1. There shalll be an adequate and effective system of recording requests and reports of all specimens submitted and examined. 2. There shall be provisions for filing, storage and accession of all reports. 3. All laboratory records shall be kept on file for at least one (1) year. a. Records of anatomic and forensic pathology shall be kept permanently in the laboratory. IX. LABORATORY FEES The laboratory and professional fees to be charged for laboratory examination shall be at the prevailing rates. 1. 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. 2. 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. A clinical laboratory is made up of different sections cohesively and comprehensively performing different activities and procedures for each specimen collected from patients to produce reliable test results. At the forefront of theses activities are the clinical laboratory‘Nature of the Clinical Laboratory ely the pathologists, medical techn 1, 2 i ologists/cli ancl ©. jans, phlebotomists, and othe (clinical laboratory. scienti ti mj wecnnicians Pi other laboratory personnel, ry. scientists, # chemistry « cection is intended for the testing of blood an iy 1 emia including waste products useful potter Pesca ein essential ol, and urine are the two most common body fluids subjected for ih aad diseases. er ales of tests performed in this section are fasting blood sugar Cis) ads ‘a shidied ssa “pin (HATE) for the diagnosis of diabetes; total cholesterol including hi ERTS sa ts CHDL ad LDL ihre CAG a cet a i priovasculat diseases; blood urie acid (BUA); blood urea nitrogen (BUN); creatinine for diagnosis of diseases involving the Kidney; total protein (TP); albumin; electrolytes ‘Ssodiom, Potassium, Chloride); clinical enzymology (e.g, aminotransferase, creatine iinioal ase, etc.) In terms of the number of tests performed, this section is considered to be one of the pusiest. In majority of tertiary-evel clinical laboratories, this section is characterized as a cate-of-the-art, fully automated facility. In some laboratories, hormone in the blood and wrne are also measured under endocrinology. Thyroid hormones tests include thyroid- imulating hormone (TSH), T3 and T4 (triodothyronine and thyroxine, respectively); other tests involving estrogen, prolactin, and testosterone. Other laboratories also have Toxicology ind Drug Testing sections where therapeutic drug monitoring tests for prohibited drugs are performed. Internal Quality Assurance (IQA), Continuous Quality Improvement (CQA), and participation in National External Quality Assurance Program (NEQAP) are important activities that medical technologists perform and are responsible for. i collecting blood Glinical Chemistry, Figure 8.1 Vacutainer tubes used for for Hematology, Coagulation Studies, Immunohematology, and Serology 131132 Principles of Medical Laboratory Science 1 Microbiology This section is subdivided into four sections: bacteriology, mycobacteriology, mycology and virology. At present, the work in this section is more focused on the identification op bacteria and fungi on specimens received. Specimens usually submitted are blood and other body fluids, stool, tissues, and swabs from different sites in the body. Tests include the microscopic visualization of microorganisms after staining, isolation, and identification of bacteria (aerobes and anaerobes) and fungi using varied culture medig and different biochemical tests, and at times, antigen typing, and antibacterial susceptibilit testing. Other activities performed in this section include the preparation of culture media and stains, quality assurance and control, infection control, and biosafety and proper waste disposal. Mycobacteriology looks into the identification of mycobacterium (eg, ‘Mycobacterium tuberculosis) from the specimens submitted. Although not as automated as clinical chemistry, automated instruments are available such as those used for blood culture and antimicrobial susceptibility testing. Clamp with clamp screw Lid with Palladium, O-ring gasket catalyst pellets ‘Anaerobic: earabee indicator onic (methylene sodium blue) bicarbonate and sodium bet borohydride Figure 8.2 Culture media used for Figure 8.3 Anaerobic glass jar used isolation of bacteria in Bacteriology _for the isolation of anaerobic bacteria section (e.g., Clostridium tetan’) ar Figure 8.4 Biosafety Cabinet 2 in Microbiology section-_— Nature of the Clinical Laboratory 133 logy and Coagulation Studies to ema jon deals with the enumeration of cells j the blo i qhis sete etc.). The pe done in this seton acne er? ne bee of prt jobin, hematocrit, ea differential count, ted cell morphology and cell indices, (60 eat platelet count, total cell count and diff smear preparation, _nttatve P other body fluids. Coagulation studies focus on bl S ’ a of various coagulation factors, ee a sai developments and innovations that contribute to the automation of this section. Automated hematology anal ee marrow examination using automated ‘Yers are currently available in the analyzers is also conducted in this mi While maintaining contact with Maintain firm Piace a small drop of whole rina ee Hold a second slide at ‘back to contact the drop, which the top slide in one motio si Fe eer aecm acd push the angle shown. Figure 8.6 Cellular components of blood134 Principtes of Medical Laboratory Science 1 Clinical Microscopy There are two major areas in this section of the laboratory. The first area is al} to routine and other special examinations of urine such as macroscopic examinations determine color, transparency, specific gravity, and pH level, and microscopic examinations 4. detect presence of abnormal cells and/or parasites as well as to quantify red cells and We and other chemicals found in urine. Examination of other body fluids is also performed in thig area. The second area is assigned to the examination of stool or routine fecalysis. Detection and identification of parasitic worms and ova are the primary activities in this area. 4 Physical observation of volume and color yirsoscopic exami of cells, microorganisms and crystals Biochemical determinations for pH, osmolarity, protein, Urea, creatine, glucose Figure 8.7 Routine analysis of urine Figure 8.8 Parasitic ova identified in routine fecalysisee Nature of the Clinical Laboratory glood Bank/Immunohematology ‘i ee g main activi cree sion. Sereening for all antibodies and identification of antibaige no sen tes ents used for transfusion are also conducted in th still axithe blood ital-based clinical laboratories, bl i vit In hospital-base » blood donation activiti iviti donor recruitment and screening, bleeding of donor, activities prompt other activities such and post-donation care. Figure 8.9 Blood bank refrigerator used for storage of blood collected from donors used for blood transfusion Figure 8.11. Sample result in ABO and Ah Figure 8.10 Reagents in y !mmunohematology for ABO and RA typing typing 135136 Principles of Medical Laboratory Science 1 Immunology and Serology Analyses of serum antibodies in certain infectious agents (primarily viral agents) arg performed in this section. Hepatitis B profile tests, serological tests for syphilis, and tests fop hepatitis C and dengue fever are some examples of antibody screening tests. Similar to Clinjeay Chemistry and Hematology sections, automated analyzers are commonly used in this section when performing different serological tests. Anatomic Pathology Section of Histopathology/Cytology Activities performed in this section include tissue (removed surgically as in biopsy and autopsy) processing, cutting into sections, staining, and preparation for microscopic examination by a pathologist. Specialized Sections of the Laboratory Immunohistochemistry It is a specialized section of the laboratory that combines anatomical, clinical, and biochemical techniques where antibodies (monoclonal and polyclonal) bounded to enzymes and fluorescent dyes are used to detect presence of antigens in tissue. This is useful in the diagnosis of some types of cancers by detecting the presence of tumor-specific antigens, oncogenes, and tumor suppressor genes. It can also be used to assess the responses of patients to cancer therapy as well as diagnosis of certain neurodegenerative disorders. Molecular Biology and Biotechnology One of the exciting developments in medical technology is molecular biology and biotechnology diagnostics. Primarily using different enzymes and other reagents, DNA and RNA are identified and sequenced to detect any pathologic conditions/disease processes. The most common technique currently in use is the polymerase chain reaction (PCR). This technique has contributed to scientific advancements in laboratory research and is useful for number of clinical techniques such as screening genetic indicators of disease and diagnosis of cancer and infectious diseases. Laboratory Testing Cycle The laboratory testing cycle encompasses all activities starting from a medical docto® writing a laboratory request up to the time (called the turnaround time [TAT]) the results are generated and become useful information for the treatment and management of patien's: This cycle has three phases, namely, pre-analytic, analytic, and post-analytic. The pre-analy®Judi des the receiptof the laboratory request, rs Actual testing Analytic phase Figure 8.12 Laboratory Testing Cycle Medical technologists/clinical laboratory scientists should have a clear understanding of this testing cycle in order to prevent erroneous test results. In the pre-analytic phase, variables that may affect the test results are present in the preparation of the request slip for the patient until the sample is transported to and processed in the clinical laboratory. Some of the variables that may cause errors are physiologic factors, diet, medications, alcohol and caffeine intake, exercise, underlying disease conditions, identification of patients and labeling of specimens, anticoagulant used, and volume of specimen collected vis-a-vis volume of ‘nticoagulant. The major sources of variables under the ahalytic phase are equipment and ‘struments, quality of reagents used, and internal quality control program. The post-analytic Phase looks into the control of the variables of TAT and transcription errors (e.g., wrong value ‘sed, results given to the wrong patient). {ality Assurance in the Clinical Laboratory Quality assurance (QA) encompasses all activities performed by laboratory eae ic eliability of test results, It is organized, systematic, well-planned, an regulad ‘he esults properly documented and consistently reviewed. eng Nature of the Clinical Laboratory 137138 Principies of Medical Laboratory Science 1 Quality assurance in the clinical laboratory has two major components: Internal Quay Assurance System (IQAS) and External Quality Assurance System (EQAS). TQAS ingly, ity day-to-day activities that are undertaken in order to control factors or variables that. affect test results. Regular review and audit of results are done in order to identify weaknen and consequently perform corrective actions. EQAS, on the other hand, is a system checking performance among clinical laboratories and is facilitated by designated extern, agencies. The National Reference Laboratories (NRL) is the DOH-designated EQas, unknown sample with known test results is regularly sent to a clinical laboratory for testin, Results are then returned to the external facility and are compared with the known result, This procedure determines the performance of the laboratory. A certificate of performance ig given to the participating clinical laboratory. At present, the designated NRL-EQAS are the following: + National Kidney and Transplant Institute (NKTI) - Hematology and Coagulation + Research Institute of Tropical Medicine (RITM) - Microbiology (identification and antibiotic susceptibility testing) and Parasitology (identification of ova ang quantitation of malaria) + Lung Center of the Philippines (LCP) ~ Clinical Chemistry (for testing 10 analytes, namely glucose, creatinine, total protein, albumin, blood urea nitrogen, uric acid, cholesterol, sodium, potassium, and chloride) + East Avenue Medical Center (EAMC) - Drugs of abuse (methamphetamine and cannabinoids) + San Lazaro Hospital STD-AIDS Cooperative Center Laboratory (SACCL) - Infectious immunology hepatitis B surface antigen (HBsAg), human immunodeficiency virus (HIV), hepatitis C virus (HCV)Nature of the Clinical Laboratory | key POINTS js, and treatment of diseases. gnosis, cal laboratory is made up of different s mi ae ing different activities and procedures ties reliable results. top! ections cohesively and comprehensively ‘imen collected from patients assurance (QA) encompasses all activiti a ies performed by laboratory personnel to » Ot ny cree ea ensure rel 139Nature of the Clinical Laboratory T41 0 posT-TEST Name: — Score: ecto” —— a Date: instructions: Read the following statements and for your answer, please use the following options. A- if option A is correct C - if options A and B are correct B - if option B is correct D - if neither options A nor B is correct ____1. Complete blood count and routine urinalysis are performed in: a. Primary laboratory b. Tertiary Laboratory 2 The government agency responsible for the licensing and monitoring of clinical laboratories in the Philippines is: a. DOH b. CHED 3. The law that governs the operation, registration, and maintenance of clinical laboratories in the Philippines a. A.0.59s.2001 b. R.A. 4688 4, Implementing Rules and Regulations of R.A. 4688 a. A.O. 2007-0027 b. A.O. 201s. 1973 5. Clinical Chemistry, Medical Microbiology, Hematology and Coagulation Studies are the sections that comprise: a. Anatomic Pathology b. Clinical Pathology 6. Which of the following is laboratory testing performed in a non-hospital-based secondary clinical laboratory? a. Gram stain b, ABO and Rh blood typingJ42__Principies of Medical Laboratory Science 1 ke's Medical Center, MCU-FDTMF Hosp fedical Center, St. Luke's Eat ownership, oft b. Tertiary level Which ofthe following are activities performed in Anatomic Pathology? a. Tissue processing for microscopic examination b. Tissue processing for isolation of pathogenic bacteria 7. Makati M examples, according to a. Institution-based 9. The primary responsibilities of a medical technologist in a clinical to: a. Ensure reliability of test results b. Control variables/factors during the laboratory testing cycle that may a test results 10. Variables or possible sources of errors in the analytic phase of laboratory tes cycle include: a. Working conditions of equipment and instruments b. Quality of test reagents, controls and standards used during the testing proper II. Instructions: Answer the following questions briefly. 1. Explain why medical technologists are significant members of the health care deli system. 2. Elaborate on the importance of quality assurance in the clinical laboratory.