POST ANALYTICAL PROCESSES
5. TECHNICAL REQUIREMENTS GENERAL
a) Factors that determine the correctness and reliability of the tests performed are:- i) Human factors
ii) Accommodation and environmental conditions iii) Test, method and method validation
iv) Equipment
v) Measurement traceability vi) Sampling
vii) The handling of test and calibration items
b) The laboratory shall ensure that the factors that contribute to the total uncertainty of measurement are also considered.
i) When developing test procedures
ii) In the training and qualification of personnel and iii) In the selection and calibration of equipment
Prepared by Approved by
Assoc Prof Dr Hasnan Jaafar Dato’ Dr Zaidun Kamari
Page 50 of 70
LABORATORY QUALITY MANUAL
(HUSM/LCD/LQM)
Title: PERSONNEL Version 2
5.1. Personnel
a) The laboratory management shall have an organizational plan, personnel policies and job descriptions that define qualifications and duties for all personnel.
b) The laboratory shall ensure personnel performing the tests or providing the services are competent. Their level of competency is regularly monitored. Staffs undergoing training are appropriately supervised.
c) The laboratory shall have procedure on identifying training needs and providing training of personnel
d) The laboratory shall ensure contract staffs are competent and duly supervised.
e) All staff shall have their job descriptions which define:
i) Responsibilities with respect to planning & performing tests, evaluating & reporting results, reporting opinion & interpretation. ii) Responsibilities with respect to validation of new methods
iii) Expertise and experienced required iv) Qualification and training programs and v) Managerial duties
Prepared by Approved by
Assoc Prof Dr Hasnan Jaafar Dato’ Dr Zaidun Kamari
Page 51 of 70
LABORATORY QUALITY MANUAL
(HUSM/LCD/LQM)
Title: PERSONNEL Version 2
5.1
f) The management shall authorize specific personnel to perform test, to issue report and to provide interpretations. The laboratory shall also maintain records of the relevant educational and professional qualifications, training and experience, immunization status and competence of all personnel.
g) There shall be staff resources adequate to undertake work required and carry out other functions of the QMS
h) Personnel shall have training specific to quality assurance and quality management for services offered
i) The management shall establish policies which define who may use the computer system, who may access patient data and who is authorized to enter and change patient results, correct billing or modify computer programs
j) The management shall ensure that employees are trained to prevent or contain the effects of adverse incidents
k) The personnel making professional judgements with reference to examinations shall have the applicable theoretical and practical background as well as recent experience. Professional judgements can be expressed as opinions, interpretations, predictions, simulations and models, and value and should be in accordance with national, regional and local regulations
l) Personnel shall take part in regular professional development or other professional liaison
Related Procedures/Records:
i) HUSM/LCD/QP-12: Orientation for New Staff ii) HUSM/LCD/QP-13: Pengurusan Latihan Staf Makmal iii) Staff credential and training record of each laboratory iv) Staff Job Description & File of each laboratory
v) Department policy of each laboratory/department Prepared by
Approved by
Assoc Prof Dr Hasnan Jaafar Dato’ Dr Zaidun Kamari
Page 52 of 70
LABORATORY QUALITY MANUAL
(HUSM/LCD/LQM)
Title: ACCOMODATION AND ENVIRONMENTAL CONDITIONS
Version 2
5.2. Accommodation and environmental conditions
a) The laboratory shall have space allocated so that its workload can be performed without compromising the quality of work, quality control procedures and safety of personnel or patient care services.
b) Patients, employees and visitors shall be protected from recognized hazards. c) When primary sample collection facilities are provided, consideration shall be
given to the accommodation of patient disabilities, comfort and privacy, in addition to the optimization of collection conditions
d) The laboratory shall monitor, control and record environmental conditions, as required by relevant specifications or where they may influence the quality of the results.
e) There shall be effective separation between adjacent laboratory sections in which there are incompatible activities. Measures shall be taken to prevent cross-contamination.
f) Access to, and use of, areas affecting the quality of the examinations shall be controlled. Appropriate measures shall be taken to safeguard samples and resources from unauthorized access.
g) Communication systems within the laboratory shall be those appropriate to the size and complexity of the facility and the efficient transfer of messages.
h) Work areas shall be clean and well maintained. Storage and disposal of dangerous materials shall be those specified by relevant regulations.
i) Good housekeeping shall be instituted. Each individual is responsible for the housekeeping of his/her work area.
Prepared by Approved by
Assoc Prof Dr Hasnan Jaafar Dato’ Dr Zaidun Kamari
Page 53 of 70
LABORATORY QUALITY MANUAL
(HUSM/LCD/LQM)
Title: ACCOMODATION AND ENVIRONMENTAL CONDITIONS
Version 2
j) Relevant storage space and conditions shall be provided to ensure the continuing integrity of samples, slides, histology blocks, retained micro-organisms, documents, files, manuals, equipment, reagents, laboratory supplies, records and results
Related Procedures:
i) HUSM/LCD/QP-18: Management of Consumable and Reagent ii) HUSM/LCD/QP-19: Pengurusan Sisa Hospital
iii) Guidelines on retention of Pathology Records and Materials (version 1/2005) College of Pathologist Malaysia
iv) Guidelines on laboratory construction and design (version 1/2004) College of Pathologist Malaysia
Prepared by Approved by
Assoc Prof Dr Hasnan Jaafar Dato’ Dr Zaidun Kamari
Page 54 of 70
LABORATORY QUALITY MANUAL
(HUSM/LCD/LQM)
Title: LABORATORY EQUIPMENT Version 2
5.3. Laboratory equipment
a) The Technical Manager shall identify and ensure that the laboratory be furnished with equipments that fit for purpose, ie.
i) meet the required accuracy ii) comply to specification
iii) be calibrated before being put into service/ before use iv) being calibrated as scheduled and
v) handled by authorized/trained personnel
b) In those cases where the laboratory needs to use equipment outside its permanent control, it shall ensure that the requirements of this international standard are met.
c) Each item of equipment and its software shall be uniquely identified.
d) Records of each items of equipment and its software shall be maintained. The record shall include:
i) identify of the equipment
ii) manufacturer’s name, type identification and serial number or other unique identification
iii) manufacturer’s contact person and telephone number, as appropriate iv) date of receiving and date of putting into service
v) current location, where appropriate
Prepared by Approved by
Assoc Prof Dr Hasnan Jaafar Dato’ Dr Zaidun Kamari
Page 55 of 70
LABORATORY QUALITY MANUAL
(HUSM/LCD/LQM)
Title: LABORATORY EQUIPMENT Version 2
vi) condition when received (e.g. new, used or reconditioned) vii) manufacturer’s instruction if available
viii) equipment performance records that confirm the equipment’s suitability for use
ix) maintenance carried out and that planned for the future
x) dates, result and copies of reports and certificate of all calibrations, adjustment, acceptance criteria and the due date of next calibration xi) maintenance plan, and maintenance carried out to date and
xii) damage to, or malfunction, modification or repair of the equipment e) Procedures on handling, transport, storage, use and planned maintenance of
measuring equipment to ensure proper functioning and in order to prevent contamination or deterioration.
f) Equipment that is subjected to overload or mishandling shall not be used until its defect has been corrected and certified to be so by authorized personnel.
g) All equipments under the control of laboratory are identified with respect to its calibration status, where applicable, by means of a calibration record tag attached to the equipment.
h) All equipment leaving the direct control of the laboratory shall be ascertained to be satisfactory by the authorized personnel before being returned to service.
i) Where applicable, the laboratory maintains a record of all current correction factors arising from calibration and ensures that these are appropriately communicated to the relevant personnel and used.
Prepared by Approved by
Assoc Prof Dr Hasnan Jaafar Dato’ Dr Zaidun Kamari
Page 56 of 70
LABORATORY QUALITY MANUAL
(HUSM/LCD/LQM)
Title: LABORATORY EQUIPMENT Version 2
j) Only authorized personnel is allowed to make adjustments to the equipment, including hardware and software, so as to safeguard from any adjustments which would invalidate the test results.
k) For the computers and automated testing equipments which are used for processing of test specimen, recording, reporting, storage or retrieval of test results, the authorized personnel shall ensure that:
i) Procedures are establish and implemented for protecting the integrity of the results at all times and
ii) The computers and automated equipment are maintained to ensure proper functioning and provided with environmental and operating conditions necessary to maintain the integrity of data.
Related Procedures/Records:
i) HUSM/LCD/QP-15: Receiving and Commissioning New Equipment ii) HUSM/LCD/QP-16: Calibration and Maintenance of Equipment iii) HUSM/LCD/QP-17: Pelupusan Aset dan Barang atau Harta Benda
Prepared by Approved by
Assoc Prof Dr Hasnan Jaafar Dato’ Dr Zaidun Kamari
Page 57 of 70
LABORATORY QUALITY MANUAL
(HUSM/LCD/LQM)
Title: PRE-EXAMINATION PROCEDURES Version 2
5.4. Pre-examination procedures
5.4.1 The request form shall contain information sufficient to identify the patient and the authorized requester, as well as providing pertinent date, according to local requirement.
5.4.2 The request form should allow space for the inclusion of the following: a) unique identification of the patient
b) name or other unique identifier of the physician or other person legally authorized to request examinations and their address
c) type of primary sample and the anatomic site of origin, where appropriate
d) examinations requested
e) clinical information relevant to the patient, which should include gender and date of birth as a minimum, for interpretation purposes f) date of time of primary sample collection
g) date and time of receipt of samples by the laboratory
5.4.3 The laboratory shall develop a manual for the proper collection and handling of primary samples and made available to those responsible for primary sample collection.
Prepared by Approved by
Assoc Prof Dr Hasnan Jaafar Dato’ Dr Zaidun Kamari
Page 58 of 70
LABORATORY QUALITY MANUAL
(HUSM/LCD/LQM)
Title: PRE-EXAMINATION PROCEDURES Version 2
5.4.4 The primary sample collection manual shall include the following: a) copies or reference to
i) lists of available laboratory examinations offered
ii) information and instructions provided to patients in relation to their own preparation before sample collection, and
iii) information for users of laboratory services on medical indications and appropriate selection of available procedures b) procedures for:
i) preparation of the patient
ii) identification of the primary sample and
iii) primary sample collection (e.g. phlebotomy, skin puncture, blood, urine and other body fluids), with descriptions of the primary sample containers and any necessary additives c) instructions for:
i) completion of request form
ii) type and amount of the primary sample to be collected special timing of collection, if required
iii) any special handling needed between the time of collection and time received by the laboratory (transport requirements, refrigeration, immediate delivery, etc)
iv) labeling of primary sample
v) clinical information (e.g. history of administration of drug) vi) positive identification, in detail, of the patient from whom a
primary sample is collected and
d) The primary sample collection shall be distributed according to the distribution list, maintained by the laboratory.
Prepared by Approved by
Assoc Prof Dr Hasnan Jaafar Dato’ Dr Zaidun Kamari
Page 59 of 70
LABORATORY QUALITY MANUAL
(HUSM/LCD/LQM)
Title: PRE-EXAMINATION PROCEDURES Version 2
5.4.5 The laboratory shall monitor the transportation of samples to the laboratory such that they are transported.
a) within a time frame appropriate to the nature of the requested examinations and the laboratory discipline concerned
b) within a specified transportation requirement and with the designated preservatives to ensure the integrity of the sample and c) in a manner that ensures safety for the carrier, the general public
and the receiving laboratory, in compliance with hospital requirement. 5.4.6 All primary samples received shall be recorded in the dispatch book from the
clinics and wards in HUSM, worksheet and computers. The date and time of receipt of samples, as well as identity of the receiving officer shall be recorded.
5.4.7 Criteria shall be developed and documented for acceptance or rejection of primary samples. If compromised primary samples are accepted, the final report shall indicate the nature of the problem and if applicable, that caution is required when interpreting the result.
5.4.8 The laboratory shall periodically review its sample volume requirements for phlebotomy and other sample such as cerebrospinal fluid to ensure that neither insufficient nor excessive amounts of samples collected.
5.4.9 Authorized personnel shall systematically review requests and samples and decide which examinations are to be performed and the methods to be used in performing them.
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Assoc Prof Dr Hasnan Jaafar Dato’ Dr Zaidun Kamari
Page 60 of 70
LABORATORY QUALITY MANUAL
(HUSM/LCD/LQM)
Title: PRE-EXAMINATION PROCEDURES Version 2
5.4.10 The laboratory shall have a documented procedure for the receipt, labeling, processing and reporting of those primary samples received by the laboratory and specifically marked as urgent. The procedure shall include details of any special labeling of the request form and primary sample, the mechanism of transfer of the primary sample to the examination area of the laboratory, any rapid processing made to be used and any special reporting criteria to be followed.
5.4.11 Sample portion shall also be traceable to the original primary sample.
5.4.12 The laboratory shall have a written policy concerning verbal request for sample examinations.
5.4.13 Samples shall be stored, if appropriate for a specified time, under conditions ensuring stability of samples proportion to enable repetition of the examination after reporting of the result or for additional examinations. Related Procedures/Document:
i) Department’s policy and information of each laboratory ii) Procedure for Receipt of Specimens of each laboratory iii) Procedure for Subcontracting of tests of each laboratory
Prepared by Approved by
Assoc Prof Dr Hasnan Jaafar Dato’ Dr Zaidun Kamari