Although the actual or projected workload and equipment alone can determine the size of various functional accommodations within the laboratory, general estimates can be made based on the experience of existing hospitals.
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Certain recommendations can be found in the recommendations for an area laboratory of the NHS of England, the report on General Hospitals of the Committee of Plan Projects, Government of India, New Delhi (1966), and the Scales of Accommodation for Armed Forces Hospitals for planning of hospital laboratories.
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An outline description for the accommodation for a general hospital (approximately 300 beds). This is based taking into considerations some of the recommendations mentioned above, coupled with empirical studies and experiences at the operational level.
Layout:
Departmentation of laboratory work into the four basic divisions may become less rigid due to increasing mechanisation and automation of many techniques.
Continual developments in electronic equipment and techniques call for a structure that is sufficiently adaptable to accommodate these changes.
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A simple, basic layout of spaces and equipment which can be supplemented or modified to suit different requirements is likely to be more efficient. Laboratories of the future are going to require different type of space rather than more space.
The structure, equipment and finishes should permit the original space allocation and the layout to be changed while the building is in use, with minimum disturbance. Flexibility for use is needed so that areas can be converted from secondary to primary space and vice versa.
In the interest of rearrangement for expansion or change in an atmosphere of rapid technical change, structural flexibility can be achieved by use of movable or adjustable benching systems in association with an installation of service mains that has been designed to permit the repositioning of outlets.
For instance, a few large sinks which are capable of being shifted without undue inconvenience are both more economical and more convenient than a larger number of small fixed sinks.
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On the other hand, a fixed layout of services and equipment can be designed to be conveniently used in a number of alternative ways providing that working methods can be adapted or modified to fit the layout.
Such variations in working methods will in some cases be preferable to the provision of structural flexibility because of the administrative and physical inconvenience of making the alterations required. Open planning with a suitable arrangement of bays permits a higher ratio of usable bench length to floor area.
Administrative and Auxiliary Areas:
The administrative area is separated from the technical work areas that the no laboratory personnel need not enter the technical areas administrative area is the central collection point for receiving specimens and is the reception and interaction area for the patients and the hospital staff
Reception and Sample Collection:
This is the area where the patient and his relatives will be coming. It should have a good pleasing atmosphere. It should be well-ventilated and well-lighted.
It should have a chair where the patient can sit in comfort and his arm could be stretched for the phlebotomy.
A bed where the patient can lie down for paediatric collection or aspiration cytology (FNAC)) is also desirable. The area should also have a needle destroyer where used syringes and needles can be discarded.
Bar-coding System for Samples:
Many big labs now use bars coding system to trace the samples. As soon as the sample is received in the lab it is bar coded and then sent to the processing area.
This protects the patient identity. It also avoids confusion over similar names. Retrieving of archival data is also easy.
Specimen Toilet:
A specimen toilet is provided for the collection of urine and stool specimens.
Pathologists Office:
Pathologist’s office is so placed that he can have easy access to the technical areas, particularly the histopathology unit. The office can be separated by a glass partition which permits the pathologist to observe technical work areas.
Glass Washing and Sterilizing Unit:
Very few things are reused in labs these days. Most of the things that are used are disposables.
Syringes, needles vacutainers are not reused. Small labs collect blood in bottles that are washed and reused. However, washing area is needed for all glasswares.
The unit is partitioned into the washing and the sterilisation area. Within the unit are located a water still, pressure steriliser, sterilising oven, and pipette washer, and a large sink with drain board.
Storage cabinets and shelves are provided for glassware and other items. An exhaust removes the heat generated by the water still and steriliser.
Report Issue:
This should be a separate area from the work area. A separate person well-versed in typing is desirable.
The reports should be issued in printed format. Many electronic software are available that make the report typing fast.
These automatically include the normal reference range of various lab parameters and the relevance of many specialised tests.
The hospital lab software can also be made as per the requirement of the hospital. Some hospitals have a software where once the reports are fed to the computer they can be accessed from anywhere in the hospital. These are specifically useful in large hospitals.
Laboratory software:
There are numerous computer software’s that help on reporting. Many types of software can be tailor – made for the specific requirement of a laboratory.
These help in better and fast reporting. The old data is also stored in the computer. This helps in better archiving of data with better data management for statistical analysis and publication.
Staff Locker Room and Toilet:
Locker and toilet facilities should be provided separately for the technical staff.
Utility Services:
Utility services include, water, gas and compressed air systems. The need for uninterrupted functioning of these systems and the probability of future expansion, calls for careful study in designing them for safety and efficiency.
Piping systems should be located where they will be easily accessible for maintenance and repairs with minimum disruption of work.
A sufficient number of valves, traps and cleanout openings should be installed, and should be located so as to permit maximum use of the facilities during repairs.
Arrangement of laboratory benches at right angles to outside walls simplifies the arrangement of piping systems by installing vertical line in the outside wall and mounting the horizontal piping on this wall.
Removable panels between the bench islands on the outside wall provide easy access to the main piping system for repairs.
Branch lines may be carried from the horizontal wall piping through the centre of the island to serve the benches on both sides
For safety purposes and to facilitate repairs, each individual piping system should be identified by colour, coding or labelling.
All waste piping from the laboratory should be of a noncorrosive material and should be carried to a point in the piping system where the discharge will be diluted by waste water from other areas.
Internal Design and Fitments Work Benches:
Technicians work while seated on revolving stools with or without back rests. The height of the work bench may vary from 75 to 90 cm depending upon the height of the workers.
However, the optimum height for work benches is considered to be 75 cm. Work benches could be in the form of a ‘wall unit’ (along a wall) or an ‘island unit’ (at right angle to the outer wall)
An optimum width of a laboratory work bench is 60 cm. This is sufficient to accommodate most of the commonly used equipment and permit the technician to lean over to work, adjust equipment or manipulate controls.
The length of work bench per individual technician or for particular processes or test procedure is generally optimized at 2.0 m.
A continuous bench length of 6.0 m provides sufficient flexibility to accommodate 3 or even 4 technicians with associated equipment.
The haematology and bacteriology sections also require sinks for staining of slides. Separate staining sinks should be built into the work bench units at convenient points to avoid the necessity of using the large laboratory sink.
Lighting:
A high level of natural lighting is desirable in laboratory. Natural light should be used to the fullest extent. The best arrangement of work benches from this point of view will be parallel with the windows.
But if the preferred bench layout is not along the window, suitable lighting can produce required viewing conditions. Each work bench should be provided with adequate electric points.
Fluorescent fixtures are preferred as they give uniform illumination and minimise heat.
Service Spine:
The service spine is one of the important aspects of laboratory benching in very large public hospitals and consists of the plumbing, electrical and gas lines carried within the spine.
To allow for appropriate working positions and under bench storage, the service spine runs behind the benches but completely independent of the benches themselves.
Storage:
Each laboratory bench length should have storage space for reagents, chemicals, glassware and other items. This is provided in the form of double tiered over bench shelving, under bench drawers and cupboards, or trolley storage, the trolleys being capable of being pushed under the benches. Instead of open over bench shelving, wooden cupboards with sliding doors provide additional space for storage.
Partitions:
Partitions may be required between some laboratory spaces. Such partitions should be capable of being demounted with a minimum of disturbance to services and benching.
Dust:
Laboratories should have a dust-free atmosphere. Some authorities suggest windows without shutters on the ground floor and suitable measures to prevent ingress of dust (e.g. rubber lining) through the gaps between window frame and shutters on upper floors. Requirement of a forced exhaust should be given due consideration.
Air-conditioning/Exhaust:
Formalin vapours accumulate in the histopathology laboratory. Although it would be preferable that the whole of the laboratory be air-conditioned, at least this section should be considered for air-conditioning.
Otherwise a powerful exhaust system should be installed to remove formalin vapours on the histopathology laboratory. Air-conditioning obviates the necessity for opening windows in bacteriology section where air-borne bacteria are a source of contamination.
Air conditioning increases the lifespan of instruments and the staff efficiency is increased.
Working Surface:
The surface of work benches should be resistant to heat and chemicals stain proof, and easy to clean and decontaminate.
High density vinyl, industrial grade laminated sheets and stainless steel serves this purpose suitably. Polished granite is also a suitable alternative.
Flooring:
Flooring materials in the laboratory should be tested with acids, strong alkalies, solvents and histological stains. They should be easy to clean, and not slippery.
Flexible vinyl flooring is preferred for laboratory floor covering, because it is greatly impervious, resistant to acids and many chemicals. However, it is not resistant to all solvents. Vinyl floor coverings also help to reduce noise level in laboratory corridors.
Staffing:
The hospital laboratory service should be under the control and direction of a doctor with qualifications in pathology or a PG degree in the new discipline of ‘Laboratory Medicine’.
He becomes the overall in charge of the laboratory with responsibilities of quality control, standardisation and administration.
He should be a part of the regular medical staff of the hospital, and this would actually be the case in respect of large hospitals. The amount of work in smaller hospitals may not justify full-time services of a pathologist.
The other personnel that are needed are technicians, phlebotomists and attendants.
The number of medical laboratory technicians (MLTs) will depend upon: (i) the number of samples per day, (ii) the range of tests to be performed under various sections, viz. clinical chemistry, hematology, microbiology and histopathology (or other specialist laboratories), (iii) emergency service, and (iv) leave reserve.
MLTs perform all technical procedures in various sections, prepare reports of completed investigations, check and maintain equipment, and requisition necessary supplies and materials.
MLTs are responsible for most of the routine technical the endeavour should be to ensure optimum utilisation of work of the laboratory.
The selection, training and technicians’ time on the workbench in a efficiently experience of MLTs should instill confidence in the medical functioning laboratory, with general duty personnel employed staff as regards the standard of their output.
A committed on nontechnical and administrative work, person with basic qualification and experience can successfully handle various technical functions under the Scheduling and Turnover supervision of the pathologist even under adverse working.
For the day-to-day working, staff scheduling should ensure conditions. MLTs in a section work under a technical that all technical staff is turned over between different supervisor who has special expertise and experience in that sections from time-to-time.
This ensures that all staff section. For large laboratories a supervisory/administrative sharpen their skills on different analytical procedures, besides person is needed who can take care of indents, records, overcoming the monotony of carrying out similar tests all stocks, technicians rotation, etc. throughout. Adequate provision must be made for leave entitlements.
Nonproductive activities:
Studies have shown that a considerable amount of technician’s time is spent on a variety of nontechnical activities like documentation, errands, and other administrative work, giving a ratio of technical to other work at 63:37. This adds to underutilization of an already short technical manpower.
Equipment:
The tendency towards more and more automation is leading hospitals to acquire sophisticated automated electronic, laboratory instruments with a high level of investment.
However, good equipment pays for itself over a reasonable period of time if the volume of work is appropriate to the capacity of the equipment.
Instruments:
Some of the core instruments that are needed are listed below. Additional instruments that are needed will depend on the tests that are performed.
Colorimeters/Spectrophotometers: These were used a lot in the old days. They were particularly useful for end-point biochemistry tests.
In kinetic tests that are faster they were not of much use. These have been replaced by the new autoanalysers these days. However, smaller laboratories still use them.
Colorimeters are based on filters. There are different colour filters that allow only light of certain wavelength to pass through. The wavelengths that are commonly used are 340, 505, 546, 578 and 620nm.
Spectrophotometers on the other hand are based on the principle of prism that detracts light into various wavelengths.
In this a specific wavelength from 340 to 640 can be obtained. The light of a-specified wavelength passes through a cuvette that holds the solution. The absorbance is then detected by a photodiode.
Autoanalysers:
This is the core of any laboratory. This is the instrument that is used maximum for all the biochemistry work. Biochemistry is the major chunk of pathology work. There are autoanalysers of many makes. They include semiautoanalysers and batch autoanalysers.
Semiauto- analysers require some manual pipetting before the reagents are fed to the machine. These instruments are based on colorimetric or spectrophotometer principle.
The advantage they have over colorimeter or spectrophotometer is that they can take the light absorbance reading over a continuous period of time. This is essential in kinetic based biochemistry.
There are some analysers that use dry biochemistry for analysers that do not use liquids as reagents. They are based on strips impregnated with reagents.
A major advantage of autoanalysers is the speed with which they can handle large workload. The chances of manual error are also reduced.
Cell-counter:
Labs now prefer cell counter to manual blood cell analysis procedures.
This gives a more complete blood picture. The principle of the instrument is that the cells are made to pass through a thin capillary. A laser beam passes through the capillary and scatters the light.
The scatter is based on the type of blood cell that passes. The light scatter is than detected. The RBC, WBC and platelet counts are more accurately measured in a cell counter.
The RBC indices (MCV, MCH and MCHC) are also better calculated. The limitations are in case of leukaemia where the morphology on peripheral smear needs evaluation by an expert eye.
The following is a list of the important items of equipments and instruments in a general hospital laboratory.
1. Centrifuge
2. Microhaematocrit centrifuge
3. Refrigerators
4. Water still
5. Pressure sterilisers
6. Pipette washer
7. Flame photometer
8. Spectrophotometer
9. Colorimeter
10. Analytical balance
11. Incubator
12. Semiautoanalyser
13. Random access autoanalyser
14. Haematology cell counter
15. Sodium, potassium, calcium analyser
16. ELISA reader
17. Blood gas analyser
18. PCR equipment
19. Flow cytometer.
The above equipments are common to most hospital laboratories. As the level of technological sophistications increases, new equipments get introduced.
The advantage with the modern technologically sophisticated equipment is that they are fully automated and programmed for all stages of test procedures, so much so that except for placing the sample on the machine no human element is involved, thus eliminating all human errors.
Automation ensures speed, accuracy, and less use of consumables and lesser manpower. Autoanalysers can take on a large number and vast array of tests at a very rapid rate.
If the number of tests to be carried out is much smaller than this capacity, procurement of such equipment should be reconsidered.
The cost-per-test on automated versus manual or less sophisticated mechanical method is generally the criterion which clinches the decision apart from other advantages of sophisticated equipment or instruments.
A judicious use of semi automated equipment may well serve the purpose of a small hospital with limited workload whereas in case of large hospital, fully automated equipments and the possibility of interfacing with laboratory computer should be considered.
Calibration and testing of automated equipment is a matter of high technology. Instructions of the manufacturers should be meticulously followed in the daily upkeep and maintenance of such equipment.
For prompt attention to breakdowns or malfunctioning, there is no other way but to enter into annual maintenance contract with the manufacturers.
For other simple mechanical equipment or instruments, periodic preventive maintenance should be carried out by the hospital’s own trained technicians.
Policies and procedures:
laboratory samples:
Sample to be examined by the laboratory fall into two groups, viz. (i) samples collected by nursing staff in nursing units or OPD and sent to the laboratory, and (ii) samples obtained by laboratory personnel from patients sent to the laboratory. All requests for laboratory examinations must be in writing.
Sample receiving:
In the reception area, all samples of blood, faeces, urine, pus, body fluids, swabs, etc. should be received at the reception window counter. Sufficient racks/shelves and a hand washing facility must be available in this area. Under no circumstances, samples should be collected from any patient in any room used as laboratory work area.
Specimen collection for fine-needle aspiration cytology (FNAC) requires a separate cubicle in the patient reception area or in the pathologist’s office laboratory.
Request forms:
All request forms should be uniform in size and contain only pertinent information. A laboratory request form has two basic components, viz. (i) the patient’s particulars including brief clinical details, and (ii) the laboratory test results. Unplanned laboratory forms have resulted in a waste of paper and effort. Very few hospitals have standardised forms. Use of structured request forms, with appropriate colour coding, standard size and appropriate design leads to time saving all around and a definite aid in quality control.
Time for accepting specimens:
Establishment of a time schedule for accepting certain types of specimen will facilitate the operations of the laboratory, although emergency requests are accepted at all times and have priority over all other requests.
Medical staff and nursing personnel at times develop a tendency to assign such priority when in reality they should have requested the examination much before. Laboratory personnel tend to lose respect for such emergency classifications.
Containers:
All specimens sent to the laboratory should be in proper containers. Instructions on the time of taking specimens, minimum volume necessary, type of container, preservatives, etc. should be posted at the nurses’ station in wards, together with the list of commonly requested examinations and the time schedule for sending specimens to the laboratory.
Identification of Specimens:
The laboratory personnel are responsible for the proper disposition of all specimens and requests within the laboratory. No specimen or request should be permitted to be left in the laboratory unless a laboratory representative is present.
In order to properly identify specimens received, a numbering system should be devised whereby the specimen and the request form are given the same number, and this number is also entered in the request register.
This number becomes the sole means of identification of the patient’s name with the specimen. Therefore, the patient’s particulars should be double checked with the specimen label and request form.
Bar coding system for samples this modern system of identification of samples has been discussed earlier.
Reports:
Laboratory personnel should give reports only to authorised ward/OPD personnel and never directly to patients.
Records:
A daily record register should be kept of all examinations performed in the laboratory in order to maintain a monthly and yearly account of the work done. Sufficient space is allowed against the name of the patient for noting the results.
The system of preparing two copies of request form and entering examination results on both copies can be obviated if the register is meticulously maintained.
This becomes the permanent master record for reference at any time in future. The task of this register is now being taken over by computer.
Blood Bank Service:
This vital service should be carefully controlled by the officer in charge and the technical supervisor.
The control should ensure that all are aware of the establishment of written procedures for identification of blood samples, compatibility testing, HIV and HBs Ag testing, storage facility, etc.
If the laboratory obtains blood for transfusion from other sources, only the storage facility for blood will be required. However, clear understanding with the supplying blood bank on the above factors should be established.
Outpatient Samples:
Provision of sample collection centre in the outpatient department will be a necessity in larger hospitals where the volume of workload from outpatient department is considerable.
A technician receives urine and stool sample and draws blood for haematology and clinical chemistry. The samples are then sent to the main laboratory for processing.
HIV:
Necessary safety precaution should be understood clearly by all concerned while drawing blood samples from suspected HIV and hepatitis patients, with disposable syringes and needles.
Liaison with Clinicians:
Differences between laboratory reports as compared to the patient’s clinical status may arise from time-to-time. These should be discussed in the medical audit committee.
Additionally, meetings can be held by the officer in charge of the laboratory with the clinicians to pinpoint short-comings if any.
Such meetings should be utilised for assisting the clinicians to understand the scope of available laboratory facilities and newer methodologies.
Technician’s Motivation:
At the technician’s level, the officer in charge of the laboratory should discuss professional, technical and administrative matters concerning the laboratory during periodical meetings with technical staff.
Such meetings need not be at a formal level because formal meetings generally do not encourage discussion.
Cross-training of Technicians:
Laboratory policy must lie down that all technical staff is cross-trained to work in all the different sections of the laboratory.
Training programmes should be organised if necessary so that the staff can handle any situation in case of exigencies of the situation.
Laboratory Waste Disposal:
Histopathology and microbiology laboratory waste should be considered as hazardous waste and should be disposed accordingly.
In fact, all waste material from all the sections of the laboratory can be treated as hazardous waste and should be disposed of by burning in the hospital incinerator.
Optimal Utilisation of Laboratory Service:
Comparison of working hours to actual number of tests performed gives an indication of the productivity of technicians’ and of the laboratory as a whole.
Quality control is achieving a degree of excellence with effectiveness of communication. A high utilisation of technicians’ time giving a sense of high productivity may miss the possible adverse effect on the quality of output.
Because appropriate utilisation of the laboratory service depends primarily on the clinicians, a constant emphasis is needed on ordering only the appropriate tests required for diagnosis or prognosis based on clinical judgement and filling the required forms completely.
Quality control:
Quality control is the sheet anchor for accuracy of tests carried out in the hospital laboratory. Quality control in hospital laboratory starts from the person who sweeps and cleans the premises through laboratory technicians and terminates at the level of the pathologist.
As a part of quality control function, standard operating procedures (SOPs) should be laid down by the in charge pathologist for each function and each functionary in the laboratory.
Calibration forms a part of quality control for each equipment.
For automated equipment, equipment suppliers have arrangement for periodical checking and calibration of each equipment at specified intervals. Calibrators are also supplied with some equipment like auto- analysers.
There is an internal and an external quality control that is recommended. The internal quality control is done in the lab itself. Standards are run at regular intervals.
The national external quality control for biochemistry and haematology is run by CMC, Vellore. Some private companies also run the external quality control programme.
If the lab is enrolled in this programme, a sample is sent to the lab and the various biochemistry/haematology parameters performed.
Results are then mailed to the managing organisations where they are studied, evaluated and corrective action taken.
Medico legal Issues and Insurance:
All medical reports are documentary evidence in the Court of Law. The treatment that was given during the illness is based on the lab reports.
Histopathology, Cytology reports that give a diagnosis of malignancy carry great importance. There are documented litigations even for simple things like pregnancy test on urine.
It is hence important that all records be properly maintained and reports issued after due verification. Pathologists sign all the reports and hence the authenticity of the reports is his prime responsibility.
Some insurance companies also offer insurance for Pathology Labs which cover the liabilities upto a certain limit.
This is more popular in the West than in India. Pathologists working in a big hospital set-up are covered by the hospital and may not be individually liable.
Pathologists working in small labs may need to take a separate insurance on their own.
Accreditation:
Getting accreditation with Pathology Boards is not a must in India. However, a National Board of Laboratories (NABL) consists and getting an accreditation is useful.
The process is stringent and it requires external and internal quality control records to be maintained. The Board has also to certify the control records maintained.
There are very few labs that are accredited at present ISO certification involves quality control checks and also staff behaviour. Getting an ISO certification is relatively easy as compared to National Laboratory Board accreditation.