Introduction

Laboratory services in medicine can be broadly divided into two categories:

1. Clinical laboratories, meant for diagnosis, prognosis and response to treatment, and
2. Public health laboratory; which is concerned with origin, spread and control of the diseases. The practice of medicine is becoming more and more important, as the clinicians are becoming more dependent upon the laboratory report for diagnosis and progress of the diseases. For most of the hospitals the laboratory is the revenue generating unit.

 

Characteristics of Clinical Laboratories

1. Service levels: Medical needs, legal or professional requirements, technical and personnel capabilities, and administrative convenience.
2. Organization: Pathologist, laboratory scientists, technologists, technicians, clerks and aides.
3. Physical plant and equipment
4. Strategic planning: Entering into joint ventures with other regional laboratories, sharing resources, marketing excess capacity.
5. Information system: Requisitioning, specimen procurement, specimen processing, analysis, reporting, financial data, management reporting.

 

Objectives

1. To perform tests on physicians’ requisitions.
2. To undertake research for medical science advancement.
3. To perform post-mortem examinations.
4. To collect, process, store, and distribute blood and blood products.

 

Policies

1. To perform tests such as biochemistry, haematology, anatomic pathology and serology.
2. To perform complicated tests at hospital or at a regional or other laboratory.
3. To make available services to ambulatory patients, public health services, and community physicians.
4. To select and use blood donors.
5. To report promptly the results of tests.

 

 

Functions

Histopathology

The histopathology section prepares and examine tissues to provide data on cause and progress of disease; makes microscopic examinations of tissue pathology; engages in research to develop new histopathological methods and new stains to produce greater clarity during examination of special tissue structures or chemical components; performs autopsies and interprets gross and microscopic autopsy findings in conference with medical staff and technologists for future diagnoses and treatment of patients.

 

Biochemistry

The biochemistry section performs chemical tests of body fluids and exudates to provide information for diagnosis and treatment of disease; investigates chemical processes involved in functioning and malfunctioning of the human body; and studies effects of chemical compounds upon physiological and biochemical functions of the body to provide information on optimum methods of treating pathological conditions.

 

Haematology

The haematology section analyses and test blood specimens and interprets test results to provide a basis d for treatment of diseases; and engages in research related to haematological methods and diagnosis. The blood bank in a hospital having these special units, are usually a part of Hematology. The bank provides for storage and preservation of blood plasma. Blood may be procured either directly from donors or from other blood banks. When obtained from donors, this unit extracts blood and makes necessary laboratory tests to certify its fitness for transfusion.

 

Microbiology

The microbiology section cultivates, classifies and identifies micro-organisms found in body fluids, exudates, skin scrapings, or autopsy and surgical specimens to provide data on cause, cure, and prevention of disease; engages in research to develop new or improved methods for discovering and identifying pathogenic organisms; and investigates biology, distribution and mode of transmission of bacteria and nature and efficiency of chemotherapeutic treatment. Bacteriology also comes under microbiology.

 

Serology

The serology section prepares serums used to treat and diagnose infectious diseases and immunize against these diseases, and identifies diseases based on characteristic reactions of various serums; investigates safety of new commercial antibiotic products and accuracy of therapeutic claims; direct immunology tests and injections; investigates problems of allergy; and conducts tests to determine therapeutic and toxic dosages and most effective methods of administering serums, vaccines, antibiotics, antitoxins, antigens and related drugs. Air-conditioning of this laboratory is necessary.

 

Virology

Virology is the study of various viruses, which produce pathogenic conditions in the human body. Tests like Western Blot to confirm AIDS infection, study of hepatitis, rabies virus infections, etc. are done in virology laboratory. Air-conditioning is required.

 

Cytology

The cytology section examines human cells to detect evidence of cancer in its early stages and other diseased conditions; engages in research to develop new cytological methods and new stains to produce greater clarity during examination of cell structures. The clinical laboratories may be responsible for a number of other functions, such as bawl metabolism tests; activities of clinical photo chromic laboratory, medical illustration unit and mortuary and care and treatment of animals used in research Teaching programs for student nurses, interns, residents, and medical technologists and other laboratory personnel may also be a function of the department.

 

Components of Laboratory

The pathology laboratory is a very big set up in the large hospital especially if, it is associated with a teaching institution. The components of the laboratory can be enumerated as follows:

1. Morphological pathology:

a. Morbid anatomy (autopsy)

b. Histopathology

c. Exfoliate cytology.

 

2. Clinical pathology:

a. Determination of blood sugar

b. Lipids, proteins, electrolytes

c. Examination of urine and other body fluids

d. Determination of hormones and enzymes.

 

3. Microbiology:

a. Bacteriology

b. Parasitology

c. Mycology

d. Virology

 

4. Haematology:

a. Study of blood

b. Study of bone marrow

c. Study of reticuloendothelial system

d. Laboratory procedures associated with blood transfusion.

 

5. In some places additional fields are being developed like:

a. Medical biophysics

b. Clinical physiology

 

Procedures

Procedures include preparing standard solutions, cross-matching blood donors and recipients, and preservation and storage of specimens. Respective procedures include test purpose, equipment and materials, method, specimen’s collection (time and container type), specimen size and retention period, patients’ preparation (food and drink restrictions), location for obtaining specimens (in laboratory or at bedside), and normal range for test results. The routine procedures are as follows:

1. Requests for investigations should be in writing.
2. The physician, nurse or laboratory technician may be responsible for obtaining specimens.
3. Instituting time schedule for accepting certain types of specimens will facilitate the operations of the laboratory.
4. Emergency requests are normally accepted at all times, and shall have priority over all other requests, the hospital should, however, ensure that this facility is not misused. Misuse of laboratory’s facilities occur when physicians order tests as emergency even though they are not emergency tests. Sometimes tests are ordered as emergency when they should have been requested on the previous day.
5. Specimens should be sent to the laboratory in properly labeled containers. Nurses should be familiar with proper time for
6. Taking specimens minimum volume necessary and the proper container. A list of commonly requested investigations with all these details should be posted and readily available at the nurses’ station.
7. All requests should be in well-designed request forms and uniform in size.
8. Different colours may be used for different types of forms for easy identification.
9. No specimen or request should be left in the laboratory. It should be handed over to the laboratory staff, will receive and enter it in a daily record ledger. A laboratory numbering system should be followed to identify specimens.
10. Results of the tests are entered in both copies of the request form; the original is then returned to the nursing unit to be attached to the patients’ records. The results are also entered in the daily record om register.
11. The laboratory results should be given only to authorized hospital personnel or sent to the medical records department to get mounted I the patient’s records. They are never given t patients.

 

Environment

Adequate fresh air and removal of noxious and toxic fumes is essential for workers’ health. Lighting should be adequate for matching of colours and accurate reading of fine gradations. Danger can occur from careless handling of infected specimens and cuts from equipment. Errors in test results can occur if patients do not report, for example, their use of proprietary pain relievers.

 

Records

1. Requisition-Identifies patient and attending physician, states date, test required and time specimen received in clinical laboratory.
2. Test report-Identifies person making test. One copy is placed in medical record and one retained in laboratory. Report may be part of requisition.
3. Register of specimens received.
4. Blood donors’ register.
5. Blood transfusion register.
6. Calibration checks on equipment.
7. Equipment and material inventory.
8. Administration department records common to other departments.

 

Organization of Pathology Laboratory

The factors which determine the type, size and organization of a laboratory are as:

1. Existing hospital laboratory: An assessment of the availability of existing laboratories in the area is a must. The availability of the services at a primary care level intermediate or secondary care level and regional laboratories or laboratories at the tertiary level is to be evaluated; accordingly, the further establishment or extension of the laboratory service can be prioritized.
2. Local health condition: Assessment of the health situation of the community is made, the data in respect of morbidity rate of the various diseases, mortality rates, availability of health institution, doctors and also the age and sex wise distribution of the population in nutshell the epidemiological and demographic data are collected and analysed.
3. Extent of the public health services: The availability of the public health services and kind of services being provided by these laboratories are assessed; to prevent any chance of over lapping of the services.
4. Economic support: The cost effectiveness and cost benefit analysis must be done before establishing or extending the services and also for prioritization of the services to be delivered.

The WHO has recommended following criteria for organizational structure of the laboratories:

1. Providing best service in a most economical way
2. Maintenance of quality.
3. Direct advantage of close liaison between the physician and the laboratory personnel.

The WHO has suggested grouping of laboratories in three categories, i.e.:

1. Regional laboratories (tertiary care level)
2. Intermediate level (secondary level)
3. Local hospital level (primary care level).

 

Rules

Rules Include

1. Persons authorized to requisition tests and obtain specimens;
2. Specimens submitted in prescribed undamaged containers, adequately labelled, and with completed requisition.
3. Requisitions and specimens identified by patients’ registration/hospital number;
4. Duplicate report on all tests retained in laboratory; checking and calibrating equipment’s and instruments.
5. Release of body from the mortuary; and disposal of human tissue.

 

Standards

Standards such as adequate equipment, materials, space for technicians derive from regulatory agency constraints. Reagents and stains should be of recognized standard. The standard times for performing tests, without hurrying which can cause errors and necessitate re-testing, individually or in batches, manually or electronically, need determining. A standard format for procedures conserves time and other resources.

 

Duty Hours

All workers are on duty five days a week during the day with professional workers ‘on-call’ to provide a twenty-four-hour service everyday. Immediate examination of surgical department tissues may be needed. Pre-admission tests may be performed during evenings. All technicians in specialist divisions should be able to perform routine tests in other divisions.

 

 

Staffing

Sufficient staffing is provided in early mornings to collect antecibum (AC) and corresponding post cibum (PC) blood specimen from large number of patients. Split duties are arranged to cover busy and nonbusy hours.

 

Information System

The laboratory’s product is information. The objective of any laboratory information system is to present data in the most orderly, legible, and timely manner. Clinical laboratory information systems are rapidly becoming highly automated.

In modern hospitals, results of various examinations with reference to the identification number and name of the patient fed into the local area network computer system are made accessible to clinicians through terminals provided in clinics and wards. This provides quick transfer of information to speedup treatment procedures.

 

Workflow: Manual vs Automatic System

Manual System	Automatic System
Requisitioning	Requisitioning
·         Physician orders laboratory test on physician order sheet.	·         No change
·         Nursing personnel prepares requisition.	·         Order via hospital information system
·         Requisition transported to lab	·         Activity eliminated
Specimen procurement	Specimen procurement
·         Requisition time stamped when received	·         Activity automated
·         Label tube	·         Same (using computer labels)
·         Stamp or write time of collection	·         Function automated, improved quality by forcing user response
Specimen preparation	Specimen preparation
·         Label pour-off tubes & sample cups	·         Use printed labels
·         Log in specimen	·         Actively automated
·         Enter Requests on worksheets	·         Actively automated
Analysis & Data Handling	Analysis & Data Handling
·         Perform analysis	·         No change
·         Record results on worksheets	·         No change for manual test, automated tests are run online
·         Record results on log	·         Actively automated
·         Data review by supervisor	·         Process made easier due to online delta checks
Reporting	Reporting
·         Separate forms	·         Actively eliminated
·         Sort by nursing station	·         Actively automated
·         File/distribution	·         Actively eliminated
·         Write or tape results on summary sheets	·         Actively eliminated
·         Chart multiple documents	·         Process simplified by handling only one document
Financial Data	Financial Data
·         Sort charge tickets	·         Actively eliminated
·         Keypunch charges into hospital information system	·         Actively eliminated
Management reporting	Management reporting
·         Compile monthly statistics	·         Actively eliminated

 

Blood Bank

Perfect administration of blood and blood products should be maintained by following procedures very strictly and avoiding administering contaminated or improperly collected blood. The hospital should have a committee with pathologist as a member to establish written procedures for the use of blood and blood derivatives, including identification and compatibility testing of blood, criteria for use and review of all transfusion reactions occurring in the hospital. An alarm system must be instituted to notify personnel of the power failure and abnormal temperature conditions, which may spoil bloodstock. For AIDS test, the hospital can have its own testing facilities with approved equipment and reagents. Positives on ELISA must be confirmed by Western Blot test and authenticated by the pathologist. Only blood in perfect condition should be allowed for either donation or for transfusion.

 

Non-eligible Blood Donors

1. Low haemoglobin level.
2. Pregnant women.
3. Infected by any virus or tuberculosis.
4. Chronic disease (diabetic, hypertensive, cardiac. Etc.).
5. Less than 3 months from the previous date of blood donation.
6. Trading blood donations.

 

Controlling

The main measure of quality control is the number of tests performed. It may be analysed by test type, clinical service, inpatients and outpatients, and treating physician. Other measures include post mortems performed, pints of transfusion blood prepared, medical photographs and illustrations produced, and materials used.

Controlling includes extent of specimens brought to department between scheduled collections, and whether technicians are offering a diagnosis when telephoning test results to wards. Other controlling includes reasons for increase in number of tests performed (for example, increased admissions, research needs, and community increasingly law suit conscious). An increase in number of tests for each patient stay is related to a decreasing average length of patient stay.

 

Coordinating

Coordination is needed with the surgical department to know what tissue to expect. It is needed with the public relations department for informing community of need for blood donors.

 

Quality Control

Wrong results may prove fatal and liable for severe consequences. The laboratory must receive special attention to ensure efficiency and accuracy. Tests should be performed according to established procedures on the basis of several factors such as the number and types of tests ordered, the time they are ordered, etc. Some factors relating to quality maintenance:

1. Strict adherence to procedures.
2. Right usage of reagents.
3. Checks and counterchecks on accuracy of results
4. Periodic review of results with central laboratory quality control unit
5. Periodic calibration of equipment and instruments
6. Coordination with biomedical technical services unit
7. Immediate reporting of unsafe conditions
8. Time bound delivery of results
9. Keeping confidentiality of patient information round the clock service.

 

Regional Laboratory

It is usually associated to a teaching hospital and situated in big cities. This laboratory will consist of almost all the possible units and it works as a referral laboratory. Research work is an important component in such laboratories.

 

Location and Space

It should be situated centrally for easy access of the clinicians. The requirement of the space is dependent upon the types of facilities available.

 

Staffing

The staff of regional laboratories will consist of medical professionals, non-medical professional, technical and non-technical both. The staff strength will again depend upon the type of the facilities and work load.

 

 Intermediate Hospital Laboratory

1. Location: It should be easily accessible to the out patients, relatives, inpatients and emergency department. It is preferably be located in the ground floor.
2. Rooms and space requirement: For a 100 to 300 bed hospital following areas are considered:

SI. No.	Name of Facility	No of Room	Size	Area in sq. feet
1	Administrative area	1	12*10	120 sq. feet
	Toilet facility	1	8*5	40 sq. feet
	Clerk/ secretary/ record room	1	12*10	120 sq. feet
2	Laboratory area	1	10*20	200 sq. feet
	Clinical pathology	1	10*20	200 sq. feet
	Biochemistry, Bacteriology & Serology	1	10*20	200 sq. feet
3	Service area	1	10*10	200 sq. feet
	Washing & sterilization Storage	1	10*10
4	Patient area	1	10*10
	Reception area & waiting	1
	Specimen collection		10*10	200 sq. feet

 

 

Engineering Specification

1. Floors: It is desirable to have a resilient floor. Moisture resistant floor are preferable.
2. Walls: Wall should be permanent durable; finish of the wall should be hard, impermeable, chemically resistant and washable.
3. Ceiling: It should be made of material which can be easily cleaned and disinfected. The desirable height is 2.55 to 2.80 meter.
4. Doors: Width of the door should not be less than 1 meter wide to allow easy movement of the equipment’s.
5. Lighting: The provision of the design should be such that there is access for day and natural light, particularly in developing countries where there is power cut. The intensity of light should be 250-500 lux.
6. Work benches: The top of the benches should be about 80 cm above the floor level. In case of microbiology lab and biochemistry lab the height of the benches, preferably 90 cm above the floor level.
7. Refrigeration: There should be provision of adequate number of refrigerators with appropriate capacity depending upon the type of s laboratory.
8. Communication system: Facilities of two-way communication for within and outside the department.
9. Sanitary fitting: Wash basins with elbow type taps are preferable. Adequate provision of sinks should be in the laboratory.
10. Ventilation: 10 to 15 air changes per hour are recommended.
11. Air-conditioning: Most of the laboratories at the intermediate level laboratory and regional level laboratory have sophisticated equipment’s like auto analyser. At least the rooms which are occupied by sophisticated equipment must be provided with window type or split AC. In regional laboratory central air conditioning may be preferred.
12. Noise control: Noise level should not exceed 40-50 dB.
13. Colourings: It should be soothing colour and the technician and pathologist have to work with light microscopes, so white paint should be preferred to get good quality of reflected light.
14. Firefighting: Arrangement for fire detection and prevention and firefighting equipment should be installed.
15. Water supply: Normal requirement is 500 litre/ bed/day. In addition to that, provision for storage of water in the form of overhead tanks for emergency be made.
16. Electricity: Normal requirement is 3 kV/bed/ day. In addition to that emergency light, inverter, UPS and also a stand by generator be installed.
17. Space requirement: It varies from laboratory to laboratory depending upon the type and level of laboratory. The committee on plan project (COPP) has recommended 5.0 to 7.5 sq. feet/ bed. WHO has recommended space requirement at the rate of 6 square meters of net floor space for each member of staff of laboratory, technical and administrative both excluding corridors, toilets and stores or wall spaces.

 

 

Staffing

The requirement of the staff is calculated on the basis of number of investigations performed. Ideally the staff requirement can be evaluated on the basis of activity sampling and work studies. The formula is used to determine the investigation/day/ technical staff.

Standard time = Total basic time x time allowance

Total basic time = Total average basic time of job element.

Basic time = average observed time x rating

Time allowance = contingency allowance (5 % of total basic time) x Relaxation time (12 % of basic time)

 

Criteria

1. Elements/ job description steps
2. Observation 5-10 times
3. Total observed time in each step
4. Average observed time of one test.

Rating of person at 100% by an average working day functioning technical staff = 6½ hours of duty (36 hours per week). Observed work/day/technical staff when both automation/conventional techniques are shared in mixed type of spectrum of investigation = 60-70 investigation/day.

 

Equipment’s and Reagents

Basic equipment’s/instruments must be provided in all the laboratories. Following are some of the equipment’s/instruments and reagents of the common use:

1. Calorimeter
2. Centrifuging machine
3. Water bath
4. Hot air oven
5. Microscope: Preferably binocular with electric lamp as a source of light
6. Autoclave
7. Incubator
8. Refrigerator
9. meter PH
10. Auto analyser
11. ELISMA reader
12. ELISHA washer
13. Microtome
14. Wax melting box
15. Hot plates.

 

Layout of Laboratory

 

 

The requirement of various types of laboratory equipments depends upon the type and facilities of E laboratory and also work load. Some of the factors are enumerated as follows:

1. Types of hospital laboratory
2. Facilities available
3. Work load
4. Spectrum of investigation
5. Automation and extent of automation
6. Availability of technical manpower
7. Training and experience of technical man power
8. Research work
9. Referral work load
10. Availability of reagents, kits, electricity, water supply xi. Inventory control system.

 

QUALITY ASSURANCE PROGRAM IN THE LABORATORY

 

Quality Control

Quality control is a process for assessing the accuracy and reliability of test system. In a clinical laboratory, this is usually accomplished by running chemistry against a specimen with known value (standard, calibrator or control), along with patient’s unknown samples to determine whether the analytical system is functioning within prescribed limits.

Quality control in a clinical laboratory has been defined as the study of errors and the procedures used to recognize and minimize them It is surveillance process in which action of people and performance of equipment and materials are observed in a systematic and periodic way so that it provides a record of consistency of performance and action taken when performance does not conform to standards established in the laboratory. In other words quality control focuses mainly on technical, procedural and process issues.

 

Quality Assurance

Quality assurance has been used to represent the techniques available to ensure with a specified degree of confidence that the results reported by the laboratory are correct.

 

Quality Control Policy

For any clinical laboratory there should be a well written quality control policy, which should include a description of:

1. The control material to be used with each assay.
2. Frequency at which the calibration is required to be checked.
3. Criteria for acceptability and remedial actions in case of unacceptable QC.
4. Required documentation.

 

Quality Control for Qualitative Tests

Me rule for accepting or rejecting a run should be early stated in the quality control policy. For qualitative tests, the quality control rules are simple. He positive control must be positive and negative Control must be negative for the patient’s result to e valid.

 

Quality Control for Quantitative Tests

The use of sample obtained from the pool of serum with known values for analysts for the verification of laboratory analysis was introduced in 1970’s and s still the most direct and widely applied quality control technique.

 

QUALITY CONTROL TECHNIQUES

Types of Quality Control Procedures

Quality control can be divided into two major types:

1. Internal QC (intra laboratory quality control)
2. External QC (Inter laboratory quality control).
3. Internal Quality Control
4. Performed by individual laboratory at their own level.
5. Forms the basis of day-to-day work of quality assurance.
6. Should be considered as a system for assuring the quality of total laboratory processes.
7. The purpose of a quality control program is to assess realistically the laboratory’s performance.
8. To identify significant problems, its documentation and resolution.
9. Ideally the quality control coordination is the responsibility of one person who has been assigned the responsibility of maintaining and reviewing the laboratory’s Q.C records.
10. A coordinated system of Q.C. provides an opportunity for developing uniform standards of performance throughout the laboratory.
11. Professionally managed quality control laboratory prepares a monthly report for discussion, and Improvement between laboratory supervisors and laboratory directors.
12. Statistical Quality Control (SQC) Techniques
13. Statistical control techniques are also known as cumulative sum technique.
14. Systematic errors can be observed qualitatively by noticing whether the control point scatter randomly about the expected mean.

 

Mean and Range (Standard Deviation) Techniques

In clinical laboratories the use of Mean and Range charts have good performance characteristics.

Arithmetic Mean

The mean of a set of observation is defined as sum of all the observations divided by the total number of observations, i.e.

Mean = sum of observations/ no of observations

If x_1, x_2, x_3,……….x_N are N observations

The mean’s given as

              x̄ = x₁ + x₂ +x₃₊……….+x_N /N

x̄ = Σx_i /N

i= 1, 2, 3, 4………N

It is applied in the clinical laboratory as the Target value for particular analysis of study.

1. The mean is a fundamental statistic used in the calculation of other QC related statistics.
2. The NCCLS (National Committee for Clinical Laboratory Standard’s) recommends that 20 individual data points should be collected before patient result is released from the laboratory.

 

Standard Deviation (SD)

Standard Deviation: It is also called Root Mean Square Deviation It is denoted by Greek letter sigma or simply SD. It is derived by the following formula:

Steps in calculation of

1. Calculate the mean, i.e., X
2. Take deviation from mean for each value, i.e. (x- x̅)
3. Then calculate square of (x- x̅) ²
4. Summation, i.e., Σ (x – x) ²
5. Divide the results by (n-1) in case the sample size is less than 30.
6. Calculate the square root which gives SD.

 

Coefficient of Variance

It is the percentage of variance observed in a set of values.

CV (%) = (SD/Mean) x 100

The coefficient of variance (CV) measures the precision of the test (replicates) performed.

Low CV = Increased assay precision

High CV = Reduced assay precision

 

External Quality Control

1. Performed by many laboratories at the same time monitored by one.
2. Periodic monitoring for the performance of the laboratories.

External quality assessment refers to a system in which laboratory results are scrutinized objectively by an outside agency in order to get a general impression of the standard of laboratory practice and to achieve inter-laboratory comparability. There are two types of programs in which a laboratory can compare their analytical results.

1. Survey programs: In which a large number of laboratories analyse the same specimen several times each year and compare their results. The most commonly observed program is of college of American Pathology (CAP).
2. Regional QC programs: Where a group of laboratories in a geographical region use the same lot of QC specimen on a daily basis for their internal QC. Major manufacturers of QC sera mostly run this program. In this program the QC sera for 1 year is distributed to the participating laboratory. The laboratory does the analysis and sends weekly or monthly results to the supplier for compiling and analysis of data. The analysis report is then shared with the laboratory.

 

Techniques Used for External QC

1. Standard deviation Index (SDI).
2. Coefficient of Variation Index (CVI).

Most well established big branded laboratories participate in various different external quality control program which include:

1. EQAS (External Quality Assurance Services) from BIORAD USA.
2. RIQAS (Randox international quality assurance scheme) immunoassay tests from Randox, UK.
3. EHPT (External Haematology Proficiency Testing), AIIMs, India.

 

Accreditation

Accreditation is the process by which an organization is formally recognized and certified by an authoritative body as meeting standards established by experts. It involves a laboratory’s overall quality system and its technical capability. Accreditation agencies review and organizational setup for the quality of its services and certify that the organization meets a set of standards. By asking for accreditation, an organization agrees to be measured against standards set by professionals. Setup for the quality of its services and certify that the organization meets a set of standards. By asking for accreditation, an organization agrees to be measured against standards set by professionals.

 

Why Accreditation?

• Increases and strengthens consumer and supplier confidence in services.
• Offers an objective evaluation of the organization’s performance.
• Stimulates the organization’s quality improvement efforts.
• Improved documentation of records.
• Motivates the staff to perform better.

 

What are the Processes Involved?

Accreditation is a series of good team work done right from the management to the all-laboratory staff to maintain the quality standards at the best expected.

 

Document review:

1. Document can be said to be the foundation of a quality management system. It describes the processes and procedures followed by the organization to meet its goals.
2. Assesses whether the organization has addressed all the requirements of the agency on paper.
3. Streamlined documentation procedure ensures that half the battle is won.
4. Accreditation agencies go by the dictum “If you have not documented it, you have not done it. So, you have to basically prove whatever one claim.

 

Onsite audit:

1. Determines the implementation of the above-mentioned policy.
2. This is to ensure that the laboratory actually practices what it preaches.
3. The laboratory should work as per predefined internal policies as well as meet industry standards.

 

Annual surveillance:

1. Ensures that the system is effectively maintained.
2. Laboratories have to undergo an internal audit by trained auditors within the organization. Internal audit should be planned, performed and documented.
3. Checklists need to be made based on the procedures followed, SOP’s and work instructions.

 

Significance of Accreditation

1. If a laboratory can demonstrate to its clients that it has a quality management system in place and that is designed to improve performance and satisfy customers then customers will react positively.
2. Grading by external agencies may bring about competition and also entry of newer and better players in the market as it gives the recipients a competitive edge over the competitors.

 

Benefits of Accreditation

Formal recognition of competence of a laboratory by an accreditation body in accordance with international criteria has many advantages:

1. Potential increase in business due to enhanced customer confidence and satisfaction.
2. Savings in terms of time and money due to reduction or elimination of the need for re-testing of products.
3. Better control of laboratory operations and feedback to laboratories as to whether they have sound Quality Assurance System and are technically competent.
4. Increase of confidence in Testing/Calibration data and personnel performing work.
5. Customers can search and identify the laboratories accredited by NABL for their specific requirements from the Directory of Accredited Laboratories.
6. Users of accredited laboratories will enjoy greater access for their products, in both domestic and international markets, when tested by accredited laboratories.

 

Certifications Granted to Laboratories

For diagnostic setups in India, Government of India. Has authorized National Accreditation Board for Testing and Calibration Laboratories (NABL) as the sole accreditation body for Testing and Calibration laboratories.

 

National Accreditation Board for Laboratories (NABL)

NABL is an autonomous body under the Dept. of Science and Technology, Government of India. It provides laboratory accreditation services to laboratories that are performing tests calibrations in accordance with NABL criteria, which is based on internationally accepted standards and guidelines. NABL promotes, coordinates, implements and maintains an accreditation system in the country comparable to relevant national and international standards in order to ensure accuracy, reliability and reproducibility of test results.

1. The International organization for Standardization (ISO).
2. Credit Rating Information Services of India Ltd. (CRISIL).
3. College of American Pathologists (CAP).

 

Total Quality Management:

This is again a quality control method, in which we lay emphasis on total organization wide change in the concept of quality. It is dependent upon the following parameters:

1. Performance superiority; that you have to be leader in performance in industry, a bench mark.
2. Doing right the first time, every time, on time.
3. There should be customer’s delight.
4. There should be value for money.
5. The quantum of work done should be optimum.

 

Six-Sigma

It is a disciplined, data-driven approach and methodology for eliminating defects (driving towards six standard deviations between the mean and the nearest specification limit) in any process-from manufacturing to transactional and from product to service) The Six Sigma describes quantitatively how a process is performing. To achieve Six Sigma, a process must not produce more than 3.4 defects per million opportunities. A Six Sigma defect is defined as anything outside of customer specifications. Six Sigma has two key methodologies. DMAIC and DMADV. DMAIC is used to improve an existing business process. DMADV is used to create new product designs or process designs in such a way that it results in a more predictable, mature and defect free performance. Sometimes, a DMAIC project may turn into a DFSS project because the process in question requires complete redesign to bring about the desired degree of improvement. When we use statistical methods like standard deviation, six sigma techniques or other statistical tools for quality assurance it is called statistical quality control. The standard deviation is one such tool for statistical Quality Control (SQC).

Autopsy Room and Mortuary

The autopsy room is related to the laboratory as it functions under the control of the pathologist. When the hospital performs a post-mortem examination. It generally faces difficulty in securing the permission of a deceased person’s next of kin or guardian before the actual post-mortem is performed. It is advisable to obtain a written permission for legal protection. This can be in a standard form. A committee of the medical staff should review all deaths in the hospital. The following facilities are required for autopsy room and mortuary:

1. Autopsy table with a sink at the foot end and a shadow less lamp fitted over the table
2. Work counter with sink, X-ray viewing box, writing table, instrument cabinet and sterilizers
3. Storage room for equipment, supplies and specimens
4. Changing rooms, toilet and lockers Refrigerated facilities for storing bodies
5. Embalming facility for bodies transported to far away places.

 

Safety

Laboratory personnel are more exposed to infections as they handle pathogenic specimens. They should use all safety provisions to avoid cross-infections. They should:

1. Use hand gloves and face masks.
2. Wash hands after procedures with disinfectants.
3. Undergo relevant immunizations.
4. Take Needle Prick Precautions.
5. Dispose used syringes, needles and other disposables properly through earmarked containers.

 

Possible Problems and Suggested Solutions

Specimen without Request

Authorized persons should collect specimens after verifying request and clinical data.

 

Specimen without Identification Data

All specimens should be collected in the clinic itself with identification details in the presence of nursing staff.

 

Lack of Clinical Data

Written instructions should be given to all clinicians and nursing staff regarding this. Patients Handling Urine and Faeces Specimen. The receiver should confirm all required information before receiving the specimen (ID of the patient, request, to confirm when early morning or midstream urine, etc.).

 

Improper Specimen Collection

Orient staff repeatedly and supervise closely in the cases of arterial blood/venous blood, minimum quantity of specimen required for various tests.

 

Punctuality in Collecting Specimen

Give clear instruction to patient in local language in an emphasizing manner. Hemolyzation of blood due to delay in handling specimen. Use specified containers and reagents and store them in specified places.

 

Damage and Transit loss of Specimen

Ensure proper packing and handling and caution notes.

 

Transporting Specimen to Higher Centres at Long Distances

Plan duration of transit time, pack in appropriate containers to withstand transit duration and ensure delivery at the right time to the right person with required caution notes.

 

Conclusion

Skill mix, workstation configuration, workload, and workflow determine the operational characteristics of clinical laboratories. Service levels determine workload and skill mix. Workload and skill mix affect organizational structure, manpower needs, information systems design, physical plant, and equipment needs. All of these operational characteristics provide the basis for determining what goals and objectives the planning process must develop and implement to keep the hospital laboratory a viable, state-of-the-art operation.