Accomodation

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Accomodation environmental conditions
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Design

• Adequate workspace
• A functional reliable condition for
• lab resources
• with defined separations

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Design

• For
• efficient operation
• Optimized comfort of the occupants
• and patients
• Minimized risk of injury occupational illness
  for employees and patients

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Accommodation

• Sample collection facilities for disable patients
• Keeping the privacy and comfort of patients

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what should be considered

• Energy sources
• Lighting
• Ventilation
• Water
• Waste disposal
• Environmental conditions

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Environmental conditions

• Sterility
• Dust
• Electromagnetic interference
• Radiation
• Humidity
• Electrical supply
• Temperature
• Sound vibration levels

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• Access to the laboratory should be
• determined and controlled
• The communication systems
• ( efficient to the size complexity of
• the facility )

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Storage

• Documented procedure for storage
• Adequate storage space
• Following specific regulations for dangerous
  materials

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• Good housekeeping and keeping the laboratory
  space clean and well maintained ( including
  required training programmes for staff )

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Laboratory equipment
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Laboratory equipment

• Instruments , reference materials,
• consumables , reagents and
• analytical systems are included
• as laboratory equipment

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Main types of equipment

• Expendable
• ( consumable or recurrent )
• Nonexpendable
• ( capital or non-recurrent )

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Equipment records in the technical
department

• Shall include at least the following
• - Identification of the equipment
• - Manufacturer,s name , type
  identification ,
• serial
• number or other unique identification
• - Manufacturer,s contact person and
  telephone
• number ( as appropriate )
• - Date of receiving and date of putting
  into
• service

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Equipment records in the technical
department

• - Current location
• -Condition when received ( e.g. new , used
  or
• reconditioned )
• - Manufacturer,s instructions or reference
  to
• their location
• - Equipment performance records that
  confirm
• the equipment,s suitability for use

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Equipment records in the technical
department

• - maintenance carried out and that planned
• for the future
• - Damage to or malfunction , modification
• or repair of the equipment
• - predicted replacement date ( if possible
  )

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Performance records

• Reports / certificates of all calibrations
  and / or
• verifications including
• - dates
• - times , results and adjustments
• - the acceptance criteria
• -date of the next calibration and /or
  verification
• - frequency of checks carried out between
  
• calibration and verification

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Performance records

• Details of any maintenance contract and
  maintenance contractor
• Maintenance history

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Equipment records

• These records shall be maintained and shall be
  readily available for the life span of the
  equipment or for any time period required by law
  or regulation

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Equipment listing

• For all the expendable equipments
• For some nonexpendable equipments
• ( based on defined criteria )

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Equipment coding

• Using a conventional system to identify any
  item and separate all its procedures
• The chosen system is optional but should be
  defined in the quality documents
• - basic sequence number
• - speaking number
• - barcode

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Equipment labeling

• All the equipments must be labeled showing
• at least the following characteristics
• 1- name
• 2-eq.code
• 3- last date of calibration
• 4-operators
• 5-condition (if applicable )

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Control of laboratory equipment

• In order to ensure that the equipments have the
  capability of achieving the required performance
  , a program that regularly monitors and
  demonstrates proper calibration and function of
  them should be established

1Preventive maintenance program
2-Scheduled
calibration / verification program

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Equipment shall be

• Operated by authorized personnel only
• Maintained in a safe working condition
• ( examination of electrical safety , emergency
  stop devices and the safe handling and disposal
  of chemical , radioactive and biological
  materials by authorized persons )
• Put out of service if it is found to be defective

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Preventive maintenance program

• Purpose
• keeping equipment in a good order ,
• cleaned and inspected based on
• - manufacturer,s instruction
• - reference standards

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Preventive maintenance program

• A special form for checking different parameters
  of equipment based on its technical instruction
  shall be designed and being kept under control
• All the records must be kept for a defined period
  of time

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Calibration

• Definition
• The procedure of calibration of measuring
  systems and verification of their accuracy should
  be done to ensure that results are traceable to
  SI units or by reference to a natural constant or
  other stated reference

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Calibration

• Preparing a list of equipment that need
  calibration
• Establish a program for regular calibration of
  equipment according to
• - manufacturer,s recommendations
• - expected accuracy precision of eq.
• - reference standards
• - Degree of usage of equipment

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External calibrator contractors

• Should use standards and references traceable to
  international standards
• Should be certified or licensed by the equipment
  manufacturer
• These contractors are considered as
• other suppliers of system and must be
  reevaluated periodically

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Repair

• Whenever equipment is found to be defective
• - it shall be taken out of service
• - clearly labelled
• - properly decontaminated
• - appropriately stored
• ( before repair )
• Shall meet specified acceptance criteria , shown
• by calibration , verification or testing
• ( after repair )

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Repair

• All the records of any service or repair of the
  equipment and the test results performed after
  repair must be kept appropriately

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Pre-examination procedures
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Request form

• Sufficient information to
• - identify the patient
• - identify authorized requester
• - provides pertinent clinical data

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Sample collection manual

• Documented instructions for the proper
  collection and handling of primary samples
• ( should be in the document control
• system )

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Sample collection manual

• List of offered laboratory examinations
• Consent forms
• Information instructions provided to patients
  in relations to their own preparation before
  primary sample collection
• Information for users on the medical indications
  appropriate selection of available procedures

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Sample collection manual

• Procedures for
• - preparation of patient
• - identification of primary sample
• - primary sample collection
• ( with descriptions of the primary
• sample containers necessary
• additives

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Sample collection manual

• Instructions for
• - type amount of the primary sample to be
  collected
• - special timing of collection
• - any special handling needs between time of
  collection and time received by the laboratory

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Sample collection manual

• Instructions for
• - labeling of primary samples
• - clinical information
• - identity of the person who take the
• sample
• - safe disposal of collecting materials

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Sample collection manual

• Instructions for
• - storage of examined samples
• - time limits for requesting additional
• examinations
• - allowed additional examinations
• - repeating examination due to analytical
• failure or further examinations of same
• primary sample

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• Traceability of primary samples to
• the identified patient by a request form

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• Rejection criteria

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monitoring how the samples are
transported to the lab

• Within an appropriate time
• In an appropriate temperature
• With the proper preservative
• In a safe manner ( carrier , general
• public and the lab )

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• Recording all the primary samples
• - in an accession book , worksheet ,
• computer
• - with date time of receipt
• - with the identity of receiving officer

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• Systematic review of requests samples by the
  authorized
• personnel

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• Urgent requests

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• Verbal requests

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• Sample storage

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Examination procedures
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• Standards of procedures
• ( SOP )

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Standard of procedure

• Should meet the needs of lab services
• Should be appropriate for
• examinations
• Should be selected from valid
• references

In-house methods
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Standard of procedure

• Is based in whole or in part on the
• instructions for use written by the
  manufacturer
• - any changes in examination kits
• should be checked for performance
• suitability
• - any procedural changes should be
• dated authorized as for other
• procedures

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Standard of procedure

• Includes
• - purpose of the examination
• - principle of the procedure used for
• examinations
• - performance specifications
• - primary sample system (plasma ,urine)
• - type of container additive

Linearity Precision Accuracy Detection
limit Measuring interval Sensitivity specificity
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Standard of procedure

• Includes
• - required equipment reagents
• - calibration procedures
• - procedural steps
• - quality control procedures
• - interferences cross reactions
• - principle of procedure for calculating
• results

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Standard of procedure

• Includes
• - biological reference intervals
• - critical values
• - lab interpretation
• - safety precautions
• - potential sources of variability

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Assuring quality of examination procedures
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• Designing internal quality control systems that
  verify the attainment of the intended quality of
  results
• ( with clear and easily understood
• information )

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• Determining the uncertainty of results ( if
  possible )
• Take account to all uncertainty components

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• Calibrating the measuring systems
• and verify their trueness

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Participating in Interlaboratory comparisons
Use of Suitable reference materials
Documentation of claimed traceability By provider
Confidence in the results can be achieved
by alternative procedures
Examination Or calibration by another procedure
Using mutual Consent standards
Ratio or Reciprocity type measurements
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• Participating in interlaboratory
• comparisons
• ( such as those organized by external
• quality assessment schemes )

• Monitoring the results
• Implementing the corrective
• actions

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• When there is no external quality control program

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• Documentation recording

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Post examination process
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• Systematic review of results
• Sample storage
• Safe disposal

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Reporting of results
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Report form

• The format of the report form should
• be determined in discussion with
• the lab users

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Report form

• The laboratory manager should be
• ensured that the legible report is received by
  the appropriate individual within the agreed
  upon time interval

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Report form

• The description of examinations
• performed and their results should
• follow internationally approved nomenclature
  and vocabulary

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Report form

• Should include but not limited to
• - clear unambiguous identification
• of the examination
• - identification of the lab that
• issued the report
• - identification of the patient
• - name address of requester

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Report form

• Should include but not limited to
• - time of sample collection
• receipt
• release of report
• - primary sample type
• - results of examination ( traceable
• to SI units )
• - biological reference intervals

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Report form

• Should include but not limited to
• -interpretation of results
• - other comments
• - detection limit uncertainty of
• measurement ( upon request )
• - identification of the authorized
• person checking or releasing the
• report

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Report form

• If the quality of primary sample is unsuitable
  for examination or could have compromised the
  result , it should be included in the report
• Retaining the copies or files of reported results
  for a defined time

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Critical intervals

• Should be determined
• Procedures for immediate notification of
  clinician ( including the samples that have been
  sent to
• referral labs )
• Forwarding the original report ( after
• notification )

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Critical intervals

• The records of actions taken in response to
  results
• - should be maintained
• - should include
• date time
• responsible lab staff member
• person notified
• examination results
• any difficulty

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Turnaround times

• Should be
• - monitored
• - recorded
• - reviewed

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Alteration of report

• Should have a written procedure and policy
• Altered report should include
• - time date
• - name of person responsible for
• the change
• Original altered report should be
• retained

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