The Medical Laboratory at a glance

The Medical Laboratory at a glance.

Background

A Medical Laboratory is an institution where diagnostic testing is done on clinical and biological samples in order to obtain information about the health of patients as pertaining to the diagnosis, treatment and prevention of maladies.

In Jamaica, Medical Laboratory Services are divided into different tiers and are categorized as Independent reference laboratories, Research laboratories and Physician- office laboratories. The Jamaican public and private sector furnishes laboratory support to all social strata both in urban and rural areas.

Seventy percent of medical decisions made in terms of the diagnosis and treatment of pathologies are due to Medical laboratory results, which play a vital import and sometimes singular role in the decisions made by Physicians in diagnosing patients. The amalgamation of the history, physical examination, x-ray studies and other diagnostic procedures with laboratory diagnoses always lead to sound medical diagnostic judgment.

Individually and communally, medical laboratories should ascertain the functions, scope and the capacity of the services offered as well as have the appropriate infrastructure with necessary measures in place in terms of biosafety. Also, the personnel hired in the medical lab should be qualified and trained staff who are employed with periodic upgrading of their skills. Total Quality Management(TQM) is significant in the overall function of health care laboratories having a worldwide recognized importance. Without the implementation of TQM in the medical lab, misdiagnosis, erroneous therapeutic assessment, wastage and litigation, amongst others, are the long-term negative consequences affecting the integrity of the medical lab.

In order to harmonize the standards of all medical laboratories globally, the international organization for standardization announced ISO15189. This is the standard used by the Jamaica National Agency for Accreditation (JANAAC) to accredit labs in Jamaica. The requirements and guidelines set by JANAAC documented in ISO15189 are very comprehensive and very tasking to achieve. The first Medical laboratory in Jamaica to achieve accreditation status from JANAAC is Biomedical Caledonia Medical Laboratory. However, very few medical labs in Jamaica conform to these standards because of inadequate knowledge of implementation.

This guideline is thus compiled to guide health professionals, especially Doctors, to understand the requirements for setting up a medical laboratory in Jamaica.   

Categories of Medical Laboratories in Jamaica.

The different categories of medical laboratories in Jamaica has three tiers namely, Primary laboratory, Secondary laboratory, and Tertiary laboratory. Primary laboratories perform simple waived laboratory tests and can be managed by a registered Medical Laboratory Scientist or a Medical Laboratory Technician. These labs include primary healthcare laboratories, side laboratories within clinics or in medical centres. Some Point-of-Care testing that these primary medical laboratories perform include Haemoglobin, Packed Cell Volume, Urinalysis, pregnancy screening test.

Secondary laboratories are those medical labs that can carry out diagnostic services which may be required by the community and may be a research laboratory centre which must be managed by a Medical Laboratory Scientist.

Tertiary laboratories are medical labs that can carry out diagnostic services as well as training and research at sophisticated level, and could also be an independent reference laboratory. It can have all or specialized disciplines or departments such as Haematology, Clinical Chemistry, Microbiology, Blood Banking, Cytology, Histotechnology, Molecular Diagnostics, Immunology and Serology.

Quality Management in the medical laboratory

The medical laboratory in Jamaica has evolved from just a mere service unit to a business entity. Hence adequate and quality space must be provided to enhance quality management of lab services. Medical laboratories should be situated more than two-hundred-meter radius of another medical lab, market or an environment where wastes from the lab can pose any form of health hazard to the Jamaican public. The space of the medical laboratory should have enough working space and appropriate conditions to ensure quality services. The medical laboratory space should be such that the contaminated area is well defined, drafted and separated from the clean area. The Medical laboratory shall monitor control and document all environmental conditions which may affect the quality of its services. The medical lab in Jamaica should design appropriate room/space for collection of samples which should not affect the quality of its services. There should also be a clear procedure for waste management and environmental protection. The lab should develop and implement a quality management system that satisfies the requirement under the following twelve clauses:

·         Organization and management

·         Personnel

·         Equipment

·         Purchasing and Inventory

·         Process Control

·         Documents and Record

·         Occurrence Management

·         Assessment

·         Process Improvement

·         Client Management

·         Information Management

·         Facility and Safety

The organization of the medical laboratories should be legally identifiable and all services of the medical labs should meet relevant requirements, and the scope of service should be defined.

·         Design implementation, improvement of the quality management system and maintenance are necessary responsibilities of the medical laboratory management.

·         Quality policies, procedures and manual shall be documented and communicated to all relevant personnel. The management should ensure that the documents are understood and implemented.

·         Reviewal of internal audit reports, surveillance reports, quality index results, laboratories services evaluation reports, and complaint records are important to management of medical labs and the management reviews should be documented.

·         The quality index for quality monitoring shall be specified.

Employing sufficient, qualified and trained staff are important to the success of medical laboratories in Jamaica. The laboratory should have sufficient number of registered medical laboratory scientists proportional to the amount of work as well as being available at all times. The manager of the medical laboratory is responsible for the duties related to advising, instructing, managing, budgeting, training, etc. and should be an experienced professional medical laboratory scientist. Personnel qualification shall be specific to the job description:

·         There shall be staff development and appropriate continuing education program available at all levels of the medical lab organization in order to upgrade the knowledge of the staff in the lab.

·         There should be regular monitoring of work performance evaluation for designing the training plan.

·         Curriculum vitae, training records and relevant records of laboratory personnel should be maintained.

·         Annual medical check-up and vaccinations should be supported.

·         Personnel privileged to access to the confidential laboratory data stored in computers or in files should be well defined.

Medical laboratory equipment, reference materials, reagents and test kits should be selected and verified appropriately. The analytical and logistic technology has to be available on a level which fulfils the minimum requirements for quality diagnostic services. Only authorized personnel should operate medical lab equipment, and it is important to stress that the most recent sophisticated equipment should have easy access to reagents. This can be a negative critical success factor and will not make the recommended equipment list. Prudent procurement management is pivotal to medical laboratories which should define and document its policy and procedure for selection of suppliers in its supply chain. There should be inventory control system for suppliers of critical reagents and services that affect the quality of test results. There should be maintenance of records documenting the approved suppliers by the manager of the medical lab.

Every clinical laboratory should ensure the definition and documentation of procedure for selection of the referral laboratories and advisory matters.

Procedures should be established to ensure that the reports received from external medical labs are correct. A copy should be maintained for an appropriate period of time. Implementation of internal quality control for monitoring the quality system and recording all factors affecting the quality of lab services are important. The procedures for testing should be calibrated using reference material and each medical laboratory should participate in External Quality Assessment Scheme (EQAS). The medical lab should formulate a specimen collection manual which among others should include procedure for collection, transporting, storage, handling, acceptance or rejection of specimens. The Laboratory should use only the validated methods which are standardized for specimen testing. The procedures for all test should be maintained and documented. There should be lucid organization of reporting procedures including the use of computer networks for reporting and critical results reporting. There should be an appropriate format stating:

·         The name of the medical laboratory and logo

·         Name and age of the patient

·         The hospital registration number of the patient

·         The laboratory number of the patient

·         Test request

·         Nature of the specimen

·         Specimen receiving date

·         Reporting date

·         Test result and SI units

·         Name and signature of Medical laboratory scientist reporting the result

·         Name and signature of Medical laboratory scientist authorizing release of the result

·         Biological reference when applicable

The medical laboratory should maintain a copy of report for an appropriate period of time. A list of all documents should be maintained and should be reviewed and approved by authorized persons, whist discontinued documents should be archived or removed. Only the authorized personnel should have access to the laboratory records and data. The criteria for the control of non-conformance should be defined and root cause analysis should be undertaken to forestall future occurrence. Testing may be stopped and results held until the non-conformance is resolved, depending on nature and seriousness of the non-conformance. Results reported during the non-conformance should be recalled when the non-conformance is of a critical nature to patient care. The quality system of the medical laboratory must undergo internal audits, at least once per year, to facilitate verification that the medical laboratory is in compliance with the quality system. The management of the medical laboratory should systematically review all operational procedures at regular intervals or other opportunities for improvement in the quality management system or technical practices. Action plans for improvement should be documented, developed and implemented. Medical laboratory management should ensure that the lab participates in continual improvement activities that encompass relevant area and outcomes of patient care. There should also be the development of a process for monitoring client’s satisfaction and complaint. Procedures should be developed for receiving client feedback, opinion analysis, reporting to laboratory personnel and top management. An implementation plan should be developed to address all complaints.

Work stations

The height of Medical laboratory work benches should be between 28-35inches above the floor and should have adequate leg and knee clearance under the workbench.  The workbenches should be 4-6 inches below elbow height while practitioner is seated on the stool. Laboratory stool, chairs should not height between 20-25 inches and should not have rollers. The top materials for workbenches should be made of epoxy resin, silica, and chemically resistant plastic laminate. Stainless steel is good for glass wash rooms and cold rooms. However, workbench top materials must have chemical impact, moisture, and bacteria resistance. Floor tiles and Kitchen granite work tops are not recommended. The windows must be glass (opaque translucent/tinted) but lacking window blind drabs. The position of the window should be in a way that good cross ventilation is achieved. The windows must be secured and netted and no fans should be in the medical lab which should be well lit at all times. Multiple white energy saving or fluorescent tubes are recommended and the plumbing for water and gas must be conduit wiring devoid of crisscrossing to avoid accidents. The water tap must be sink and elbow enamel, whilst the drainage must be connected to soak-away, sited away from the laboratory and domestic water source. There must be constant running water available and no carpeting should be in the medical laboratory. The floor can be tiled with vinyl composition tiles, sheath vinyl, rubber floors, or monolithic flooring. Floors must be mopped not swept and acoustic type ceiling is recommended for high sound absorbance. Ceiling must be solid, no liquid penetration, no access panels and open ceiling is acceptable if there are no exposed ducts/ tapes. It should be free from decorations and high enough for free movement. Electrical sockets should be placed on the laboratory benches or walls proximal to the workbench depending on the bench design. Crisscrossing of wires should be avoided, while conduit wiring or surface trunking is recommended. If the local electricity supply is intermittent or inadequate, a generator of adequate capacity should be provided. Medical laboratory wastes should be separated appropriately into hazardous, non-hazardous and sharps. Liquid waste should be either heat-treated or chemically treated before being discarded into the drainage system. A pivotal element in waste management is that there must be incinerator, needle destroyer or pit. All microbial wastes must be sterilized before incineration.

The medical laboratory in Jamaica should be managed by a licensed Medical Technologist, and in situations where a Medical Technologist is not available, a certified Medical Laboratory Technician with three years training on Clinical Laboratory Sciences quality control and lab management, may manage a primary category clinical laboratories with supervision by a licensed Medical Laboratory Scientist. The lab should employ qualified and adequately trained personnel for the level of service. Work assignment should be consistent with the qualification of the concerned personnel. There should be sufficient number of registered medical lab scientist proportional to the work load and shall be available at all times during the medical laboratory operation hours. There should be at least one registered Medical Technologist per call duty to cover laboratory operation at the hospital based clinical laboratory. There should be sufficient number and types of appropriate medical lab equipment to undertake all laboratory examinations and procedures for each test menu. All equipment should comply with safety measures and the manager of the medical lab should be responsible for overseeing the management of all equipment including Point-of-Care testing devices irrespective of where they are located and there should be an establishment and maintenance of a quality and safety manual in the medical laboratory.

The List of Equipment for each Medical Laboratory level.

Primary laboratory:

·         Binocular microscope with (×100) objective

·         Centrifuge

·         Haematocrit centrifuge; reader

·         Refrigerator

·         ESR tubes & stand

·         Stop watch

·         Ambient room thermometer

·         Refrigerator thermometer

·         Glasswares

·         Automatic pipettes

·         Consumable & reagent/kits

·         Electronic weighing balance

Secondary laboratory (The following equipment are needed minimum depending on discipline/ department):

Clinical Chemistry:

·         Colorimeter

·         Spectrophotometer

·         Flame photometer or ISE

·         Refrigerator

·         Chemical balance

·         Automatic pipette

·         Water bath

·         Water distiller

·         Stopwatch

Clinical Haematology:

·         Haematocrit centrifuge & reader

·         Binocular microscope

·         Electric Centrifuge

·         Colorimeter

·         ESR stand & tubes

·         Electrophoretic machine and tank

·         WBC counter

·         Automatic pipettes

·         Neubaeur Counting chamber

·         Water bath

·         Glassware and Reagents

·         Staining Racks

·         Refrigerator, Freezer

Clinical Parasitology:

·         Binocular microscope

·         Centrifuge

·         Hot air oven

·         Reagent & Consumable

·         Glasswares

·         Standing rack

·         Automatic pipettes

·         Refrigerator

·         Stopwatch

·         Micro-ELISA system

Clinical Bacteriology:

·         Microscope

·         Autoclave

·         Hot air oven

·         Anaerobic Jar

·         Facility for CO2 incubation

·         Centrifuge

·         Incubator

·         Refrigerator

·         Freezer

·         Reagent & Consumables

·         Glassware

·         Weighing balance

·         Automatic pipettes

·         Thermometer

·         70° Celsius freezer

·         Facility for Tuberculosis culture

Blood Banking:

·         Bleeding Couch

·         Blood Bank

·         Centrifuge

·         Microscope

·         Water bath

·         Chemical balance

·         Refrigerator

·         Freezer

·         Plasma Extractor

·         Weighing Balance

·         Blood pressure monitor

·         Bath Weighing Scale

Tertiary Laboratory:

In addition to the equipment in the secondary laboratory, the tertiary laboratory must have the following:

Virology:

Virology reagent and Facility for viral culture; ELISA system

Histotechnology:

·         Microtome

·         Tissue Incubator

·         Cryotome (refrigerator microtome)

·         Slide staining rack (assorter)

·         Binocular Microscope

·         Cytocentrifuge

·         Automatic slide staining machine

·         Consumables

Medical Microbiology:

·         Anaerobic Station

·         Blood culture system

·         ELISA machine and reader

·         Florescent Microscope

·         Carbon Dioxide Incubator

·         Laminar Flow Cabinet

·         Sperm Quality Analyzer

·         API Systems

Clinical Chemistry:

·         Chromatography

·         Atomic Absorption

·         Spectrophotometer

·         Photometer

·         Electrophoretic system

·         High Pressure Liquid Chromatography

·         ELISA System

·         Densitometric Scanner

·         Turbidimeter

·         Autoanalyses

·         Ion Specific Electrodes

·         pH meter

·         Mass Spectrometer

·         Fluorimeter

·         Chemiluminometer

·         Biosafety cabinet

·         Anodic Strip Voltammeter

·         Lead Analysers

·         Vortex mixer

·         Microplate Reader

·         Osmometer

·         70 degrees Celsius Freezer

·         Chemistry Analyzer

·         Immunology Analyzer

·         Deionizer

Mycology:

·         Microscope

·         Incubator

·         Mycology reagents: e.g. Lactophenol cotton blue,

Molecular lab:

Three rooms with unidirectional workflow for a manual PCR lab.

·         Biosafety hood/ cabinet

·         Standard work benches

·         Thermocycler

·         Automatic Pipettes designated for each room

·         Area Specific Laboratory Coat

·         UV Transilluminator

·         DNA sequencer

·         Ultracentrifuge

·         Gel Documentation System

·         Gel Turing device

·         Gel Electrophoretic system

·         Fraction Collector

LIST OF TESTS FOR EACH LABORATORY LEVEL

PRIMARY LABORATORY

1. HIV Serology: Rapid Test

2. Haemoglobin/Packed Cell Volume

3. Urine Test for Pregnancy

4. Urinalysis

5. Direct Microscopy

6. Rapid Syphilis Test (RST)

7. Other Rapid Point-of-Care Tests

SECONDARY LABORATORY

All the tests listed in primary level and the following:

1. Complete blood count (CBC)

2. CSF analysis

3. CD4

4. Blood Chemistry

5. Bacteriology

6. Parasitology

7. Blood transfusion service

TERTIARY LABORATORY

All the tests listed in secondary level and the following:

1. Histopathology

2. Mycology

3. Viral Load

4. DNA PCR

5. Drug resistance monitoring (DRM)

6. Immunology

7. Any other specialized assay