Facility Registration - Medical Laboratory Services

Requirements for Registration of Health Facilities

Medical Laboratory Services

A Medical Laboratory is a centre for investigation of medical disorders. All medical laboratories are classified according to the scope of services provided.

Primary Medical Laboratory:

These laboratories perform simple laboratory tests and can be managed by a registered Medical Laboratory Scientist. They include primary healthcare laboratories, side Laboratories within clinics and Point of Care Testing (POCT).

Secondary Medical Laboratory:

These laboratories carry out diagnostic services as required by the community and may serve as research centres. A secondary laboratory shall be headed by a Medical Laboratory Scientist.

Tertiary Medical Laboratory:

These are laboratories that can carry out diagnostic services as well as training and research at a sophisticated level. They can also act as reference laboratories. A tertiary laboratory shall be headed by a Medical Laboratory Scientist.

SCOPE OF SERVICE

Depending on the classification of the laboratory, the scope of services rendered will include at least two of the following disciplines:

  1. Medical Microbiology,
  2. Clinical Chemistry,
  3. Haematology,
  4. Blood Transfusion Science,
  5. Virology,
  6. Histopathology,
  7. Histochemistry,
  8. Immunology,
  9. Cytogenetic,
  10. Exfoliative Cytology,
  11. Parasitology,
  12. Forensic Science,
  13. Molecular Biology,
  14. Laboratory Management;
  15. And other area as approved by the MLSCN

MINIMUM REQUIREMENTS

In addition to meeting the standards described below, all medical laboratories shall possess a Corporate Affairs Commission (CAC) certificate. The practitioner in charge shall be a fully registered Medical Laboratory Scientist with at least 5 years of post NYSC work experience. He/she shall have a current license from the appropriate regulatory body; The Medical Laboratory Science Council of Nigeria (MLSCN).

Physical/Work Environment

The physical structure of the medical laboratory as well as the work environment should take into consideration patient safety, patient privacy and accessibility for people living with disabilities and protocol for possible emergencies.

Location and Accessibility

  1. The medical laboratory shall be located in a structurally safe and clean area.
  2. Whether attached to a clinic/hospital (as in primary laboratories) or operating independently, the facility shall put in place adequate biosafety measures and be at least 100 meters from residential buildings and restaurants. Laboratories should also maintain a minimum distance of at least 200 meters from one another.
  3. The medical laboratory shall not be located in a residential building with a common entrance and shared space for all residents.
  4. Appropriate signage showing all services provided and directional signs shall be available as needed.
  5. The name of the medical laboratory shall be displayed at the entrance of the premises where the building is located. In a situation where the medical laboratory is located in a premises with other similar businesses, the name shall also be displayed at the entrance to the laboratory.
  6. The appropriate current certificate and/or evidence of renewal obtained from MLSCN and EDSMOH shall be displayed at the reception area of the Laboratory.

Size of the Facility

  1. The size of the medical laboratory will be determined by the classification of the laboratory (i.e. primary, secondary or tertiary), the scope of services rendered, the number of professional and complement staff and the variety of equipment required.
  2. The size of the facility shall conveniently cater for the number of people to be present at peak periods in all sections of the facility.
  3. The laboratory space irrespective of whether it is attached to a clinic or hospital (even PHCs) should consist of:
    • A reception
    • A laboratory working area not less than 16x20ft
    • A Medical Laboratory Scientist’s office
    • A laboratory specimen collection area
    • A convenience
    • Media preparatory Room (Applicable to bacteriology/ microbiology Laboratory)
    • Wash up Room

Security and Privacy

  1. Security and privacy are essential components of the patient’s experience. Adequate security shall be ensured for life and property in all sections of the medical laboratory.
  2. The medical laboratory shall have lockable doors and have security mechanism in place.
  3. Sensitive areas of the laboratory (such as the phlebotomy room) shall provide privacy for patients undergoing procedures.

Structure and Layout

  1. The physical structure shall be planned and constructed in such a way that   allows for ease of patient and workflow.
  2. The medical laboratory shall be planned such that there is a clear demarcation between clean and dirty areas.
  3. Directional and safety signs are especially important and shall be used as appropriate.
  4. Parking spaces for vehicles should be adequate.

Flooring

Generally, floors should be fit for purpose and shall be made of appropriate materials. The following considerations should be made:

  1. Safety – Floors shall necessarily be non-slip to prevent trips and falls. The required slip resistance shall not be compromised for any real or perceived ease of cleaning.
  2. Acoustics – Sound absorbing or non-sound reflecting materials are ideal to     reduce impact generated noise.
  3. Hygiene and Infection Control - Smooth surfaces are the most ideal for areas with a likelihood of fluid or body fluid spills. Textile/ floor (carpet, rugs etc.) coverings shall not be used in these areas.
  4. Ease of Cleaning – Materials used should be resistant to corrosion   from disinfectant use.

Work Sections

The medical laboratory should have at least the following sections:

Waiting/Reception Area

  1. The reception area should be located as close to the entrance as possible.
  2. It shall be well lit, well ventilated, kept at a comfortable temperature and be free from unwelcome smells.
  3. The size of the reception area shall cater for the peak number of users expected at the facility per time.
  4. Hand washing and toilet facilities should also be located reasonably close to the reception area.
  5. It should be conducive for staff and patients and have at least the following:
    • A receptionist’s desk / station that provides a clear, unobstructed view of the entrance and waiting area
    • Adequate, comfortable, non-absorbent, and wipeable seats for patients and their relatives
    • Record keeping facilities such as a secure storage cabinet and/or computers for electronic records.
    • Appropriately placed cooling and ventilation systems (fans are not acceptable)
    • Appropriate telecommunication systems for internal and external use
    • Appropriate number of waste disposal bins with appropriate colour coded bin liners.
    • Portable water

Testing Laboratory

  1. The medical laboratory shall be completely separated from outside areas.
  2. The recommended dimension is a minimum of 16ft x 20ft.
  3. Windows should be fitted to ensure cross ventilation. Fans are not allowed and should not be used in the medical laboratory. Air Conditioner should be provided in the Laboratory.
  4. Flooring should be made with impervious materials such as vinyl or epoxy coated concrete slab.
  5. Each laboratory should have:
    • Laboratory workbenches 28-35 inches above the floor and 4-6 inches below elbow height with top materials made of epoxy resin, silica or chemically resistant laminate. There shall be separate workbenches for each discipline offered within the facility, and appropriately labeled/designated
    • Wipeable ergonomic Laboratory stools shall be in place
    • Equipment as appropriate
    • Adequate personal protective equipment such as laboratory coats, gloves, face masks, safety goggles and covered non-fabric shoes should be readily available.
    • Refrigerator (sample and reagent) Sample refrigerator different from reagent refrigerator
    • Hand washing station with running water, liquid antibacterial soap, disposable hand towels/ paper towels and alcohol-based hand sanitizer.
    • Appropriate medical waste segregation (swing or pedal dustbins with black, yellow and red bin liners)
    • An emergency eye washing station

Phlebotomy Room

  1. The Phlebotomy room shall be well lit, uncluttered, and kept clean at all times.
  2. The room location and design should be oriented to provide patient privacy.
  3. Cubicle curtains or partial walls may be used to accomplish privacy when more than one service station is present.
  4. The recommended minimum size of the room is 6 square meters. It should have:
    • Comfortable phlebotomy chair(s)
    • Work counter(s)
    • Rolling stool(s), Revolving chairs/stool
    • Cabinets for storage of supplies (e.g. Hand gloves, tourniquets, needles, syringes, sample bottles, alcohol swabs etc.)
    • A reclining chair or gurney for patients who become unsteady
    • Adequate personal protective equipment such as gloves, protective coats/gowns and face masks
    • Hand washing station with running water, liquid antibacterial soap, disposable hand towels/ paper towels and alcohol-based hand sanitizer.
    • Appropriate medical waste segregation (safety box, swing or pedal dustbins with black, yellow and red bin liners)
    • Refrigerator for storing specimen and another for reagents

Media preparatory Room

Wash- up room

Storage room

Should be fitted with well labeled shelves and pallets for the storage of utilities and consumables

Offices/Staff common room

  1. Staff spaces such as offices, changing rooms, break rooms, common rooms, shall be provided as required and equipped with tables, chairs, cupboards, stationery, etc. as applicable.
  2. Offices shall be located close enough to service areas in case of emergency requests.
  3. The staff common room should be located away from the laboratory working area and will be suited for food storage/consumption and personal hygiene.
  4. Dedicated office for the Laboratory manager

Equipment

Basic Requirement

Equipment should be provided as relevant to the discipline(s) being covered by the medical laboratory. The basic equipment required for a medical laboratory include but are not limited to:

  1. Laboratory Incubator
  2.  Bench Centrifuge
  3. Micro-Haematocrit Centrifuge/
  4. Micro- Heamatocrit Reader (not laminated paper)
  5.  Electrophoresis Machine
  6. Laboratory Autoclave
  7. Binocular Microscope
  8. Laboratory Weighing Scale
  9. Refrigerator and external thermometer
  10. Room Thermometer
  11. Erythrocyte Sedimentation Rate (ESR) tubes and stand
  12. Automatic pipettes
  13. Stopwatch
  14. Water Bath
  15.  Consumables & Reagents
  16.  Weighing Balance (preferably digital)

Safety and Management

  1. Posters, labels, and signs shall be displayed in visible places with instructions about the use of equipment and warnings of potential hazards and dangers.
  2. All equipment shall be in good working condition at all times and be regularly serviced as indicated by the manufacturer.
  3. Laboratories should have documented back-up plans in case of equipment down time.
  4. Maintain an equipment logbook for all major equipment

Document and Records

It is essential that medical laboratories have written documents that guide their processes. These should be readily available and well known to staff. Basic document requirements include:

  1. Quality Manual
  2. Safety manual
  3. Laboratory handbook
  4. Guidelines for conducting common diagnostic tests (Bench reference)
  5. Guidelines for sample referral, transfer and transportation
  6. Standard Operating Procedures for all tests and for relevant processes in the laboratory, including quality control processes.
  7. Protocols and procedures for infection prevention and control
  8. Document master list

Infection Prevention and Control

 It is required that measures to ensure infection prevention and control within the medical laboratory and its resident community are put in place. Measures shall align with the Edo State Infection Prevention and Control Guidelines.

Hand Hygiene

All medical laboratories shall have:

  1. Clean running water in all sections. Storage of water in buckets and drums is    not acceptable.
  2. Liquid antibacterial soap (in dispensing bottle with plunger) and not bar soaps
  3. Disposable hand towels / Paper towels
  4. Alcohol based hand sanitizer
  5. Hand washing poster reminding staff and patients of how to wash their hand.

Personal Protective Equipment (PPE)

All medical laboratories shall have adequate PPE, at least the following should be available:

  1. Hand gloves
  2. Face Masks
  3. Safety Goggles
  4. Overalls / Scrubs
  5. Laboratory coats
  6. Non-fabric, non-absorbent shoes
  7. Hair covers

Medical Waste Management

The medical laboratory shall ensure compliance with standard healthcare waste management guidelines and adopt practices that do so such as:

  1. Availability of safety boxes in all relevant areas
  2. Use of safety boxes for all sharps e.g. needles/syringes, scalpels, blades, broken glasses, and lancets
  3. Availability of appropriate waste bins in all areas of the medical laboratory i.e. pedal and or swing dustbins. All bins shall be covered. Perforated and non-covered bins are not allowed.
  4. Use of appropriate colour coded bin liners/bags for all waste collection and disposal as highlighted below:
    • Black: non-infectious waste e.g. paper, packaging materials, food, plastic
    • Yellow: infectious waste e.g. used gloves, swabs
    • Red: highly infectious waste e.g. heavily blood-stained cotton wool
  5. Safe management and disposal of general and medical waste by ensuring the following:
    • Availability of relevant PPE (utility gloves, boots, aprons) for all waste handlers
    • Availability of an appropriate final waste collection point that takes into cognizance separation of medical waste from general waste
    • Keeping waste storage points out of the reach of patients and their relative
    • Registration with the Edo Waste Management Board for final waste disposal.
    • Provision of incinerators in bigger laboratories especially secondary and tertiary laboratories.

Other Precautions

  1. Sanitation and hygiene of toilet facilities
  2. Regular wiping of surfaces and equipment with disinfectant
  3. Storage of sterile/decontaminated materials and consumables in a manner that prevents contamination
  4. Appropriate pest control procedures (spraying, weeding, fumigating, etc.)

Facility and Safety

Environment

  1. The surroundings of the medical laboratory shall be kept clean at all times, free of bushes and other environmental safety hazards.
  2. Adequate illumination shall be ensured within and outside of the medical laboratory
  3. Proper ventilation shall be maintained in all rooms within the medical laboratory

Water

  1. There shall be adequate supply of clean running water supply at all times throughout the medical laboratory
  2. A back up source shall also be available in case of scarcity

Sanitation

  1. The drainage system of the medical laboratory shall be connected to the septic tank, sited away from the medical laboratory’s source of water supply.
  2. Toilet facilities shall be exclusive to the medical laboratory and shall be adequate for patients, their relatives, and staff.
  3. Toilets suitable for people with disabilities shall be available.

Fire Safety

  1. Safety hazard and caution signs (e.g. electrical shock, inflammable, radiation, etc.) shall be displayed at appropriate places
  2. Signage for “No Smoking” shall be displayed in prominent places
  3. Firefighting equipment such as fire extinguishers, fire balls, and / or sand buckets shall be conspicuously placed and readily accessible. Fire hose reel and fire hydrants are optional. Fire extinguishers shall be serviced when due. Fire balls are not serviceable and thus should be replaced once expired.
  4. Firefighting equipment shall be located close to exits and along hallways/corridors
  5. Emergency exits shall be well defined and free from obstruction
  6. An appropriate muster point shall be easily accessible with appropriate signage and located at a safe distance as prescribed by the Federal or State Fire Service. The size of the muster point depends on the average number of people occupying the medical laboratory at peak periods.
  7. Emergency evacuation diagrams shall be clearly displayed in all areas.

Power Supply

  1. Constant electricity supply to the medical laboratory is compulsory and shall be available from a main source
  2. Alternative power source(s) in case of power cuts is required and mandatory.

Staff Complement

  1. A Laboratory Manager who must be a qualified and licensed Medical Laboratory Scientist
  2. Other qualified and licensed Medical Laboratory Scientist to handle other key offices like the quality officer, safety officer, inventory control officer, (Number would vary based on the workload of the laboratory)
  3. Medical Laboratory Technicians (To handle areas of the laboratory like front desk, phlebotomy, minor tests etc.)
  4. Cleaners (Trained and dedicated for the laboratory in case of a healthcare facility with other areas)
  5. Other support staff like Business Development Officers, security guards, drivers etc. as required.

Minimum Staff Requirement

All professional staff shall be qualified, licensed and shall operate within the jurisdiction of their licensure and job descriptions. Staff roles and job descriptions shall be clearly defined and documented. The minimum staffing requirements is as follows:     

  1. One Medical Laboratory Scientist registered with the Medical Laboratory Science Council of Nigeria (MLSCN) with a minimum of 5 years post NYSC experience who serves as the Practitioner-In-Charge. He/she shall be a full-time staff and be responsible for:
    • The day to day running of the laboratory
    • Ensuring hiring of qualified complement staff as need
    • Providing oversight for all clinical processes
    • Ensuring that best practices are upheld in all sections of the laboratory
  2. One Medical Laboratory Technician/Assistant registered with the Medical Laboratory Science Council of Nigeria (MLSCN) with current work permit
  3. One Clerk/Receptionist
  4. Other domestic and secretarial staff as needed by the facility.

Administration

  1. Copies of staff credentials (certificates, licenses or work permit as applicable) and job descriptions shall be available at the medical laboratory.
  2. Personnel files shall include evidence of medical surveillance reports and mandated immunizations.

Continuous Staff Training/ professional development

  1. Core staff members shall take part in relevant programs for continuous learning and annual license renewal.
  2. There shall be regular in-house training for all staff on laboratory quality management systems and biosafety.

Record Keeping and Advertising

Record Keeping

  1. Record keeping should be in line with Nigeria Data Protection Regulation (NDPR).
  2. There shall be a system (preferably digital) for secure storage of laboratory records against loss, damage or use by unauthorized persons
  3. Systems should be put in place to keep records for 10 years since the patient was last seen. (Result Retention Period).
  4. Archived records should be accessible within 24 hours
  5. Bookkeeping and financial records shall be maintained
  6. Staff records containing personal and professional information shall be kept and regularly updated.
  7. Incident registers shall be available and in use.
  8. Appropriate records shall be taken and kept.

Advertising

A sign board that clearly displays the name of the laboratory and business hours shall be located at the entrance of the medical laboratory for public information.

Quality Management System Requirements

The Laboratory shall develop and implement a quality management system that satisfies the requirement under the following twelve (12) clauses in accordance with ISO 15189 -2012/2022

  • Organization and Management
  • Personnel
  • Equipment
  • Purchasing and Inventory
  • Process Management
  • Information Management
  • Documents and Record
  • Non-Conforming Events Management
  • Assessment
  • Continual Improvement
  • Client Management/Customer Focus
  • Facility and Safety

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