In many countries, there are two main types of labs that process the majority of medical specimens. Hospital laboratories are attached to ahospital, and perform tests on patients. Private (or community) laboratories receive samples from general practitioners, insurance companies, and other health clinics for analysis. These can also be called reference laboratories where more unusual and obscure tests are performed. For extremely specialised tests, samples may go to a research laboratory. A lot of samples are sent between different labs for uncommon tests. It is more cost effective if a particular laboratory specializes in a rare test, receiving specimens (and money) from other labs, while sending away tests it cannot do.
In many countries there are mainly three types of Medical Laboratories as per the types of investigations carried out. 1. Clinical Pathology 2. Clinical Microbiology & 3. Clinical Biochemistry laboratories. 1. Clinical Pathology: Haematology, Histopathology, Cytology, Routine Pathology2. Clinical Microbiology: Bacteriology, Mycobacteriology, Virology, Mycology, Parasitology, Immunology, Serology.3. Clinical Biochemistry: Biochemical analysis, Hormonal assays etc.Blood Banks:- Blood bank is a separate body. Its laboratory need Microbiological analysis for infectious diseases that may be found in blood. Pathology to observe Blood grouping, Haematology & cross matching reactions. It also involves PRO department for the communication & contact for blood donations etc..
Specimen processing and work flow
Sample processing will usually start with a set of samples and a request form.
Typically a set of vacutainer tubes containing blood, or any other specimen, will arrive to the laboratory in a small plastic bag, along with the form.
The form and the specimens are given a laboratory number. The specimens will usually all receive the same number, often as a sticker that can be placed on the tubes and form. This label has a barcode that can be scanned by automated analyzers and test requests uploaded from the LIS. Entry of requests onto a laboratory management system involves typing, or scanning (where barcodes are used) in the laboratory number, and entering the patient identification, as well as any tests requested. This allows laboratory machines, computers and staff to know what tests are pending, and also gives a place (such as a hospital department, doctor or other customer) for results to go.
For biochemistry samples, blood is usually centrifuged and serum is separated. If the serum needs to go on more than one machine, it can be divided into separate tubes.
Many specimens end up in one or more sophisticated automated analysers, that process a fraction of the sample and return one or more "results". Some laboratories use robotic sample handlers (Laboratory automation) to optimize the workflow and reduce contamination risk and sample handling of the staff.
The work flow in a lab is usually heavy from 2:00 am to 10:00 am. Nurses and doctors generally have their patients tested at least once a day with general complete blood counts and chemistry profiles. These orders are then drawn during a morning run by phlebotomists for results to be available in the patient's charts for the attending physicians to consult during their morning rounds. Another busy time for the lab is after 3:00 pm when private practice physician offices are closing. Couriers will pick up specimens that have been drawn throughout the day and deliver them to the lab. Also, couriers will stop at outpatient drawing centers and pick up specimens. These specimens will be processed in the evening and overnight to ensure results will be available the following day.
Laboratories today are held together by a system of software programs and computers that exchange data about patients, test requests, and test results known as a Laboratory information system or LIS. The LIS is interfaced with the hospital information system.
This system enables hospitals and labs to order the correct test requests for each patient, keep track of individual patient or specimen histories, and help guarantee a better quality of results as well as printing hard copies of the results for patient charts and doctors to check.
Result analysis, validation and interpretation
According to ISO 15189 norm, all pathological results must be verified by a competent professional. In some countries staff like clinical scientists do the majority of this work inside the laboratory with abnormal results referred to the relevant pathologist. In others, only medical staff (pathologist or clinical biologist) is concerned by this phase. It can be assisted by some software in order to validate normal or non modified results. Medical staff are sometimes also required in order to explain pathology results to physicians. For a simple result given by phone or for a technical problem it's a medical technologist explaining it to a registered nurse.
Departments in some countries are exclusively directed by a specialized Pathologist, in others a consultant, medical or non-medical, may be the Head of Department. Clinical Scientists have the right to interpret and discuss pathology results in their discipline in many countries, in Europe they are qualified to at least Masters level, may have a PhD and can have an exit qualification equivalent to medical staff e.g. FRCPath in the UK. In France only medical staff (Pharm.D. and M.D. specialized in Anatomical pathology or Clinical biology) can discuss pathological results, clinical scientists are not considered as a part of medical staff.
As medical technology advanced doctors were able to get more and more tests done in shorter and shorter amounts of time. Where in the past a doctor might order a potassium and glucose and it would take hours for the results, now a doctor can order a full chemistry panel of 20 or more different analytes and get the results in under an hour. The results are also much more accurate and reliable now than in the past. Thus, into the 1970s and 1980s the lab became a source of profit within the hospital structure.
Some commercial labs began taking illegal and nefarious actions to increase their income. These practices included medicare and medicaid fraud by performing and billing for tests that the ordering physician never ordered, paying kickbacks to private doctor offices for sending their specimens to these reference labs, and other complicated criminal activity. These kickbacks included donuts, free computers, fax machines, and more. These events culminated mostly in the mid-1990s with the SmithKline Beecham Clinical Laboratory (SBCL) scandal. It is believed SBCL paid at least $325 million in penalties and the industry as a whole paid over $1 billion to insurance and government agencies that were defrauded. Ever since this time, the lab has become a source of expense and loss in the hospital budget (commercial labs have nothing to do with hospitals) and lab medicine's reputation was given a black eye. Now many labs have a compliance officer with mandatory annual meetings about compliance for all employees.
Medical laboratory accreditation
Credibility of medical laboratories is paramount to the health and safety of the patients relying on the testing services provided by these labs. The international standard in use today for the accreditation of medical laboratories is ISO 15189 - Medical laboratories - particular requirements for quality and competence.
Accreditation is done by the Joint Commission, AABB, and other state and federal agencies. CLIA 88 or the Clinical Laboratory Improvement Amendments also dictate testing and personnel.
The accrediting body in Australia is NATA, all laboratories must be NATA accredited to receive payment from Medicare.
In France, where accrediting body is COFRAC, in 2010, modification of legislation established ISO 15189 accreditation as an obligation for all clinical laboratories.
1.Explain the food laws and regulations in detail.
To meet a country’s sanitary and phytosanitary requirements, food must comply with the local laws and regulations to gain market access. These laws ensure the safety and suitability of food for consumers, in some countries; also govern food quality and composition standards.
The requirement of food regulation may be based on several factors such as whether a country adopts international norms developed by the Codex Alimentarius Commission of the Food and Agriculture Organization of the United Nations and the World Health Organization; good agricultural and manufacturing practices; or a country may also has its own suite of food regulations. Each country regulates food differently and has its own food regulatory framework. Usually more than one agency is involved in food regulations e.g. health and agriculture, they may have centralized or regionally controlled food regulations, and different agencies may be involved in enforcement activities.
Types of food safety and quality standards that apply in most countries:
The Act establishes a new national regulatory body, the Food Safety and Standards Authority of India, to develop science based standards for food and to regulate and monitor the manufacture, processing, storage, distribution, sale and import of food so as to ensure the availability of safe and wholesome food for human consumption. All food imports will therefore be subject to the provisions of the Act and any rules and regulations made under the Act.
As a temporary measure, the standards, safety requirements and other provisions of the repealed Acts and Orders and any rules and regulations made under them will continue to be in force until new rules and regulations are put in place under the Food Safety and Standards Act, 2006. For that reason, importers will for some time have to continue to take into account the provisions of those repealed Acts and Orders.
Prevention of Food Adulteration Act
A basic statute (Prevention of Food Adulteration Act (PFA) of 1954 and the PFA Rules of 1955, as amended) protects India against impure, unsafe, and fraudulently labelled foods. The PFA standards and regulations apply equally to domestic and imported products and cover various aspects of food processing and distribution. These include food colour, preservatives, pesticide residues, packaging and labelling, and regulation of sales. Further details are available from the Ministry of Health and Family Welfare. All imported products must adhere to the rules specified in the Act and its regulations, including those covering labelling and marketing requirements. The PFA focuses primarily on the establishment of regulatory standards for primary food products, which constitute the bulk of the Indian diet.
PFA rules sometimes appear to be drafted in a manner that goes beyond the mere establishment of minimum product quality specifications, by prescribing recipes for how food products are to be manufactured.
There is an appeals process for amending rules, although this is time-consuming. The Central Committee for Food Standards, chaired by the Director General of Health Services, is the decision-making entity Syrups.
Weights and measures
Standards for weights and measures are administered by the Ministry of Consumer Affairs, Food and Public Distribution under the Standards of Weights and Measures Act, 1976and related rules and notifications. All weights or measures must be recorded in metric units and certain commodities can only be packed in specified quantities (weight, measure or number). These include baby and weaning food, biscuits, bread, butter, coffee, tea, vegetable oils, milk powder, and wheat and rice flour.
At the time of importation food products are required to have a valid shelf life, or residual shelf life, of not less than 60 per cent of their original shelf life. For more information, see the relevant notification at the Government of India Ministry of Commerce and Industry website.
The fruit and vegetable processing sector is regulated by the Fruit Products Order, (FPO), which is administered by the Department of Food Processing Industries.
The FPO contains specifications and quality control requirements regarding the production and marketing of processed fruits and vegetables, sweetened aerated water, vinegar, and synthetic syrups.
All such processing units are required to obtain a license under the FPO, and periodic inspections are carried out. Processed fruit and vegetable products imported into the country must meet the FPO standards.
Meat Food Products Order
Regulations for the production of meat products are covered by the Meat Food Products Order, .
Specifies sanitation and hygiene requirements for slaughterhouses and manufacturers of meat products.
Contains packing, marking and labeling provisions for containers of meat products.
Defines the permissible quantity of heavy metals, preservatives, and insecticide residues in meat products.
The Directorate of Marketing and Inspection at the Ministry of Agriculture is the regulatory authority for the order, which is equally applicable to domestic processors and importers of meat products.
Livestock Importation Act
India has established procedures for the importation of livestock and associated products under the Livestock Importation Act, 1898.
Under the regulations, the import of meat products, eggs and egg powder and milk products require a sanitary import permit from the Department of Animal Husbandry, Dairying and Fisheries at the Ministry of Agriculture.
A detailed import risk analysis is carried out, taking into account the disease situation prevailing in the exporting country compared with the disease situation in India.
Milk and Milk Products Order
The production, distribution and supply of milk products is controlled by the Milk and Milk Products Order, 1992. The order sets sanitary requirements for dairies, machinery, and premises, and includes quality control, certification, packing, marking and labeling standards for milk and milk products.
Standards specified in the order also apply to imported products. The Department of Animal Husbandry, Dairying and Fisheries at the Ministry of Agriculture is the regulatory authority.
Essential Commodities Act, 1955: The main objective of the Act is to regulate the manufacture, commerce, and distribution of essential commodities, including food. A number of Control Orders have been promulgated under the provisions of this Act. These are:
Standards of Weights and Measures Act, 1976 and the Standards of Weights and Measures (Packaged Commodities) Rules, 1977: The Act governs sale of packaged commodities and provides for mandatory registration of all packaged products in the country.
Consumer Protection Act, 1986: The Act provides for constitution of District Forum/State/National Commission for settlement of disputes between the seller/service provider and the consumer.
The Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Act, 1992 and Rules 1993: This Act aims at promoting breast feeding and ensuring proper use of infant milk substitutes and infant food.
The Insecticide Act, 1968: The Act envisages safe use of insecticides so as to ensure that the leftover chemical residues do not pose any health hazard.
Export (Quality Control and Inspection) Act, 1963: The Act aims at facilitating export trade through quality control and inspection before the products are sold to international buyers.
Environment Protection Act, 1986: This Act incorporates rules for the manufacture, use, import and storage of hazardous microorganisms / substances / cells used as foodstuff.
Pollution Control (Ministry of Environment and Forests): A no-objection certificate from the respective State Pollution Control Board is essential for all dairy plants.
(i) Industrial Licences: No licence is required for setting up a dairy plant in India. Only a memorandum has to be submitted to the Secretariat for Industrial Approvals (SIA) and an acknowledgement obtained. However, a certificate of registration is required under the Milk and Milk Products Order (MMPO), 1992.
There are two organizations that deal with voluntary standardization and certification systems in the food sector. The Bureau of Indian Standards looks after standardization of processed foods and standardization of raw agricultural produce is under the purview of the Directorate of Marketing and Inspection.
Bureau of Indian Standards (BIS)
The activities of BIS are two fold the formulation of Indian standards in the processed foods sector and the implementation of standards through promotion and through voluntary and third party certification systems. BIS has on record, standards for most of processed foods. In general, these standards cover raw materials permitted and their quality parameters; hygienic conditions under which products are manufactured and packaging and labelling requirements. Manufacturers complying with standards laid down by the BIS can obtain and "ISI" mark that can be exhibited on product packages. BIS has identified certain items like food colours/additives, vanaspati, and containers for packing, milk powder and condensed milk, for compulsory certification.
Directorate of Marketing and Inspection (DMI)
The DMI enforces the Agricultural Products (Grading and Marketing) Act, 1937. Under this Act, Grade Standards are prescribed for agricultural and allied commodities. These are known as "Agmark" Standards. Grading under the provisions of this Act is voluntary. Manufacturers who comply with standard laid down by DMI are allowed to use "Agmark" labels on their products.
Management Systems for Quality and Food Safety
ISO 9000 Quality Management Systems
The ISO 9000 system is looked at as a system with minimum quality requirements. It builds a baseline system for managing quality. The focus, therefore, is on designing a total quality management system, one that complies with external standards, but includes the specific requirement of industry and integrates elements of competitiveness.The millennium standard (ISO 9000:2000) has changed the focus from procedure to process. The main features of the ISO 9000:2000 standards are:
Refinement in the presentation to make reading easy and elimination of general inauditable statements such as "consideration shall be given”
The present standard gave an impression that it was applicable to manufacturing situation though it was applied in organizations of different types and sizes, including the service sector. The new standard is a broad-based standard applicable to all sectors.
In the new standards, approach has changed from continuous improvement to continual improvement. Continuous improvement remained an implied approach to quality improvement in ISO 9000.
Plant Quarantine Order
India introduced the Plant Quarantine (Regulation of Import intoIndia) Orderin 2003 to prohibit and regulate the import of agricultural articles. Orders include:
A ban on the import of certain plants and planting materials from designated countries (eg sugarcane from Australia)
A restriction on the import of other plants and plant materials to authorized institutions, with additional declarations and special conditions attached.
A requirement for additional declarations (such as a phytosanitary certificate issued by the exporting country) and special conditions for a further positive list of plants and plant materials. The Order, with amendments, is available at the Department of Agriculture and Cooperation and Plant Quarantine Organization of India websites. The implementing agency is the Directorate of Plant Protection, Quarantine, and Storage, under the Department of Agriculture and Cooperation, Ministry of Agriculture.
Export (Quality Control and Inspection) Act, 1963
The Export Inspection Council is responsible for the operation of this Act. Under the Act, a large number of exportable commodities have been notified for compulsory pre-shipment inspection. The quality control and inspection of various export products is administered through a network of more than fifty offices located around major production centres and ports of shipment. In addition, organizations may be recognized as agencies for inspection and /or quality control. Recently, the government has exempted agriculture and food products, fruit products and fish and fishery products from compulsory pre-shipment inspections; provided that the exporter has a firm letter from the overseas buyer stating that the overseas buyer does not require pre-shipment inspection from official Indian inspection agencies.
Other Government Regulations
No licence is required for setting up a Dairy Project in India. Only a Memorandum has to be submitted to the Secretariat for Industrial Approvals (SIA) and an acknowledgment is to be obtained.
However Certificate of Registration is required under the Milk and Milk Products Control Order (MMPO) 1992.
Foreign Investment in dairying requires prior approval from the Secretariat of Industrial Approvals, Ministry of Industry, as dairying has not been included in the list of High Priority Industries.
Automatic approval will be given upto 51% Foreign Investment in High Priority Industries.
In case of other Industries, proposals will be cleared on case to case basis. Government may allow 51% without enforcing the old limit of 40% applicable under Foreign Exchange Regulations Act at its discretion.
Foreign Technology Agreements:
Foreign Technology Agreements are freely allowed in high priority industries under the following terms:Lump sum payment of Rs 10 million
Royalty payment of 5% on domestic sales and 8% as exports subject to total payment of 8% on sales turnover, over a 10 year period from the date of agreement or 7 years from commencement of production.
Foreign Technology Agreements in dairying also need prior approval. Foreign Exchange required for payment of Royalty will have to be purchased at market rates.
Foreign Technicians can be freely hired.
Import of Capital Goods
Import of capital goods is automatically allowed if it is financed through Foreign Equity. Alternatively, approval is needed from the Secretariat of Industrial Approvals. The approval depends on the availability of Foreign Exchange Resources.
Import of Second Hand Capital Goods
Import of Second hand goods is allowed subject to the following conditions:
Minimum Residual life of 5 years
The equipment should not be more than 7 years old
A certificate from the Chartered Engineers of the country of origin certifying the age and the Residual life is to be produced.
Import will be allowed only for actual users.
Remittances of dividend should be covered by earnings from exports recorded in the years prior to the payment of dividend or in the years of the payment of the dividend.
2.Explain the Prevention of Food Adulteration Programme