Medical Laboratory Application Form

8/3/2019 Medical Laboratory Application Form

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LAFM03-MED/Oct 05 Page 1 of 38

CONFIDENTIAL

SINGAPORE ACCREDITATION COUNCILSINGAPORE LABORATORY ACCREDITATION SCHEME (SAC-SINGLAS)

Medical Laboratory Assessment Checklist

(ISO 15189)

Type of Assessment : Preliminary / Initial / Renewal / Surveillance / Non-Routine / Verification

Laboratory :

Address :

Tel / Fax :

Names of personsseen

:

Field / Disciplines :

Date of visit :

Technical Assessor(s) :

Staff Officer :

Name & Signature Date

File Ref: LAS / /


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ClauseNo.

Description Yes No N/A Remarks

4 Management requirements

4.1 Organisation

4.1.1 Is the laboratory or the organisation:- legally responsible?

- ROC available?

4.1.2 Does the medical laboratory services,including appropriate interpretation andadvisory services meet :- the needs of patients and all personnel

responsible for patient care?

4.1.3 Does the laboratory managementsystem cover & meet the requirementof the standard for work carried out in:- permanent facilities?- sites away from its permanent facilities?- associated temporary facilities?

- mobile facilities?

4.1.4 If the laboratory is part of an organisationperforming other than testing:- are responsibilities of key personnel

defined in order to identify potentialconflicts of interest?

4.1.5 Is the management responsible for thedesign, implementation, maintenance andimprovement of the quality system withregards to the following:-

a) Management support to all personnel byproviding the appropriate authority andresources to carry out their duties?

b) Have arrangements to ensure that itsmanagement and personnel are free from:- any undue internal and external

commercial pressure?- financial pressure?- other pressures and influences that may

adversely affect the quality of work?

c) Policies and procedures to ensureconfidentiality of information?

d) Have policies and procedures to avoidinvolvement in any activities that woulddiminish confidence in its competence,impartiality, judgment or operational integrity?

e) Define the organisation and managementstructure of the laboratory:- its place in any parent organisation?

- relationships between qualitymanagement, technical operations andsupport services?


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ClauseNo.


- its relationships to other associatedorganisations (if any)?

f) Specify the:- responsibility?- authority?

- Interrelationships?of all personnel

g) Provide adequate supervision of all testingstaff by competent persons familiar with- methods and procedures?- purpose of each test and /or calibration?- assessment of the test results of the

relevant examination procedures?

h) Is technical management available?

i) Is a quality manager appointed?- with defined responsibility and authority?

- direct access to the highest level ofmanagement?

j) Appoint deputies for key managerialpersonnel?(In smaller laboratories, staff may have morethan one function and it may be impractical toappoint deputies for every function.)

4.2 Quality management system

4.2.1 Are policies and procedures including therequirements of the methods to be used:- defined?- documented?- implemented?- understood?

4.2.2 Does the quality system include, but notlimited to- internal quality control?- participation in inter-laboratory

comparisons?- external proficiency programmes?

4.2.3 Is quality policy statement- defined under the authority of laboratory

director?- documented in quality manual?- concise & readily available to all

personnel?- and include the following:

a) the scope of service the laboratory intends toprovide?

b) the managements statement of thelaboratorys standard of service?

c) objectives of the quality system?


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ClauseNo.


d) a requirement that all staff within thelaboratory familiarize themselves with thequality documentation and implement thepolicies and procedures in their work?

e) the laboratorys commitment to good

professional practice, the quality of itsexaminations, and compliance with the qualitymanagement system?

f) laboratory managements commitment tocompliance with ISO 15189?

4.2.4 Does the laboratory outline the structure ofthe documentation used in the qualitysystem?

Does it define the roles and responsibilities ofthe technical management and qualitymanager?

Are personnel instructed on the use andapplication of the quality manual references,supporting procedures including technicalprocedures?

Is the quality manual maintained currentunder the authority and responsibility of thequality manager?

4.2.5 Does the laboratory establish and implementprogrammes that regularly monitors anddemonstrates proper calibration and functionof- instruments?- reagents?- analytical systems?

Are documentation of programme forpreventive maintenance and calibrationavailable?

Does the calibration interval followmanufacturers recommendations?

4.3 Document Control

4.3.1 Does the laboratory establish and maintainprocedures to control all documents that formpart of its quality system?

Is a copy of these controlled documents- archived for later reference?- retention period defined?

(Document refers to any information includingpolicy statements, text books, procedures,specifications, calibration tables, biologicalreference intervals and their origins, charts,posters, notices, memoranda,


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ClauseNo.


software, drawings, plans, documents ofexternal origin such as regulations, standards,and examination procedures. These may bemaintained on any appropriate medium, whichmay or may not include paper.)

4.3.2 Are procedures adopted to ensure that:

a) documents issued to personnel reviewed andapproved for use prior to issue?

b) a master list or an equivalent documentcontrol procedure available to identify thecurrent revision status and distribution ofdocuments?

c) current authorised versions of appropriatedocuments are available at all appropriatelocations?

d) documents periodically reviewed, revisedwhere necessary and approved by authorisedpersonnel?

e) invalid or obsolete documents are promptlyremoved from all points of issue or use?

f) obsolete documents appropriately identified toprevent unintended use?

g) If the laboratorys documentation controlsystem allows for the amendment ofdocuments by hand pending the re-issue ofthe documents:

- are the procedures for such amendmentsdefined?- are the authorities for such amendments

defined?

Are these amendments clearly:- marked?- initialed?- dated?

h) Changes in documents maintained incomputerised systems are made andcontrolled?

4.3.3 Is the quality system documents generated bythe laboratory uniquely identified? And dosuch identification include:- title?- date of issue?- revision identification/revision number?- page numbering?/the total number of

pages or a mark to signify the end of thedocument?

- the issuing authority(ies)?- source identification?


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ClauseNo.


4.4 Review of Contracts

4.4.1 Are procedures established and maintainedfor review of contracts?

Are policies and procedures for these reviewsensure that:a) The requirements, including the methods to

be used are:- defined?- documented?- understood?

b) Capability and resources meet therequirements?- physical?- personnel?- information resources?

c) Appropriate method is selected and capableof meeting the contract requirements andclinical needs?

4.4.2 Are records of these reviews and anysignificant changes maintained?

4.4.3 Does the review cover any work referred bythe laboratory?

4.4.4 Is the client (eg clinicians, health care bodies,health insurance companies, pharmaceuticalcompanies) informed of any deviation fromthe contract work?

4.4.5 If the contract needs to be amended after thework commerce:- is the same contract review process

repeated?- are any amendments communicated to all

affected parties?

4.5 Examination by referral laboratories

4.5.1 Are documented procedures available toevaluate and select- referral laboratories?- consultants who provide second opinions

for histopathology, cytology, and relateddisciplines?

When referral laboratories or consultants areused,- are the users consulted, where

appropriate?- Is laboratory management responsible for

selecting and monitoring the quality ofreferral laboratories and consultants?


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ClauseNo.


Does the laboratory ensure that the referrallaboratory or consultant is competent toperform the requested examinations?

4.5.2 Are arrangements with referral laboratoriesand consultants periodically reviewed to

ensure that:

a) The requirements, including the pre-examination and post-examination proceduresare adequately- defined?- documented?- understood?

b) The referral laboratorys capability to meet therequirements and there are no conflicts ofinterest?

c) Selection of examination procedures is

appropriate for the intended use?

(records of such reviews shall be maintainedto local, national or regional requirements)

d) The responsibilities for the interpretation ofexamination results clearly defined?

4.5.3 Does the laboratory maintain- a register of all referral laboratories?- a register of all samples that have been

referred to another lab?

Are the names and address of the referrallaboratory given to the user?

Is a duplicate laboratory report retained inboth the patient record and permanent file ofthe lab?

4.5.4 Is the referring laboratory, and not the referrallaboratory, responsible to ensure thatexamination results and findings are providedto the clinician making the request?

Does the report have all the essentialelements of the results if it is reported by thereferral laboratory, without alterations thatcould affect any clinical interpretations?

(The referring laboratory director may elect toprovide additional interpretative remarks tothose, if any, of the referral laboratory, in thecontext of the patient and the local medicalenvironment. The author of such addedremarks should be clearly identified.)


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ClauseNo.


4.6 External services and supplies

4.6.1 Are policy and procedure(s) available for:

- selection?- purchasing of services, equipment, and

consumable supplies it uses?

that affect the quality of the tests and/orcalibrations.

Do the purchased items consistently meet thelaboratorys quality requirements?

Do procedures exist for the:- inspection?- acceptance/rejection?- storage?

4.6.2 Are purchased equipment/supplies/ reagents/

consumable materials inspected forcompliance with standard specificationsbefore use?

(This may be accomplished by examiningquality control samples and verifying thatresults are acceptable. Documentation of thesuppliers conformance to its quality systemmay also be used for verification.)

4.6.3 Is there an inventory control system for allsupplies?

Are records maintained for

- external services?- supplies?- purchased products established and

maintained for a period of time?

Are these quality records reviewed during themanagement review?

4.6.4 Does the laboratory evaluate:- suppliers of critical consumables?- Supplies and services which affect the

quality of testing?- Maintain approved list and records of

evaluation?

4.7 Advisory services

Are laboratory professional staffappropriate to provide advice on- choice of examination?- use of services?- repeat frequency?- required sample?- interpretation of test results, where

appropriate?


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(There should be regular documentedmeetings of professional staff with the clinicalstaff regarding the use of laboratory services,and for the purpose of consultation onscientific matters. The professional staffshould participate in clinical rounds, enabling

advice on effectiveness in general as well asin individual cases.)

4.8 Resolution of complaints

Are policy and procedures available forresolution of complaints or other feedbackfrom clinicians, patients or other parties?

Are records of complaints, investigations andcorrective actions taken maintained by thelaboratory?

(Laboratories are encouraged to obtain

feedback from their users, preferably in asystematic way (e.g. surveys). Both positiveand negative feedback should be included).

4.9 Identification and control of non-conformities

4.9.1 Ensure policy and procedures areimplemented when the results do not conformto its own procedures or the agreedrequirements of the requested tests of theclinician?

These shall ensure that :

a) Personnel responsible for corrective actionsare defined?

b) Actions to be taken are defined?

c) The medical significance of the non-conforming tests is considered and requestingclinician informed where appropriate?

d) The examinations are halted and reportswithheld as necessary?

e) Corrective actions and decisions takenimmediately?

f) Non-conforming test results and examinationsalready released are recalled?

g) The responsibility for authorisation of theresumption of work is defined?

h) Details of the non-conformity is documentedand recorded and reviewed at regularspecified intervals to detect trends and initiatepreventive actions?


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ClauseNo.


(Non-conforming examinations or activitiesoccur in many different areas and can beidentified in many different ways. Theseinclude clinician complaints, quality controlindications, instrument calibrations, checking

of consumable material, staff comments,reporting and certificate checking, laboratorymanagement reviews, and internal andexternal audits.)

4.9.2 If evaluation of the non-conformity determinerecurrence, then are procedures establishedand implemented to- identify?- document?- eliminate the root cause(s)?These should lead to preventive actions.

4.9.3 Are procedures defined and implemented for

the release of results in the case of non-conformities, including review of such resultsand are these documented?

4.10 Corrective Action

4.10.1 Do the procedures for corrective actionsinclude an investigation process to determineunderlying causes of the problem?

The findings, where appropriate, shall lead topreventive actions.

(Corrective actions shall be appropriate to themagnitude and the risk of the problem.)

4.10.2 Does the management document andimplement any changes required to itsoperational procedures resulting fromcorrective action investigations?

410.3 Are the results of corrective actionsmonitoredto ensure the effectiveness in overcoming theproblem?

4.10.4 Are the appropriate areas of activity audited inaccordance with 4.14 when there is a doubt(s)on the laboratorys compliance?

Are the results for corrective actionssubmitted for laboratory management review?

4.11 Preventive Action

4.11.1 Are the needed improvements and potentialsources of nonconformances identified?


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ClauseNo.


If preventive action is required, are actionplans:- developed?- implemented?- monitored for effectiveness?

to take advantage of the opportunities forimprovement.

4.11.2 Are procedures for preventive actionseffective?

Preventive actions might involve:- analysis of data, including trend- and risk-

analyses, andexternal quality assurance

4.12 Continual Improvement

4.12.1 Are potential sources of non-conformances or

other opportunities for improvement in thequality management system or technicalpractices identified through review at regularintervals, as defined by the management?

If improvement is required, are action plans:- developed?- documented?- implemented?to take advantage of the opportunities forimprovement.

4.12.2 Is the effectiveness of the actions evaluatedthrough a review or audit of the areaconcerned?

4.12.3 Are the results of actions resulting from thereview submitted to management for reviewand implementation of any needed changes?

4.12.4 Are quality indicators implemented- to systematically monitor and evaluate the

labs contribution to patient care?- when improvements are identified, are

these issues addressed regardless ofwhere they occur?

- participation in quality improvementactivities that deal with relevant areas andoutcomes of patient care

4.12.5 Are suitable training opportunities for all labpersonnel and relevant users of the laboratoryprovided?


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4.13 Quality and technical records

4.13.1 Does the laboratory establish and maintainprocedures for:- identification

- collection- indexing- access- filing- storage- maintenance- safe disposal of quality and technical

records?

4.13.2 Are all records:- legible?- stored and easily retrievable?- to prevent damage or deterioration?- to prevent loss?

- to prevent unauthorized access?(Records may be stored on any appropriatemedium subject to local, national, or regionallegal requirements.)

4.13.3

a)

b)

c)

d)

e)

f)

g)

h)

i)

Is retention time of all records established? Isthe retention time for test results defined bythe nature of test and some records inaccordance with statutory authority?

Does the laboratory for the defined periodretain records of but not limited to thefollowing:

request forms (including the patient chart ormedical record only if used as the requestform),

examination results and reports,

instrument printouts,

examination procedures,

laboratory work-books or sheets,

accession records,

calibration functions and conversion factors,

quality control records,

complaints and action taken,

j)

k)

records of internal and external audits,

external quality assessmentrecords/interlaboratory comparisons,


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ClauseNo.


l)

m)

n)

lot documentation, certificates of supplies,package inserts,

incident/accident records and action taken,

staff training and competency records.

4.14 Internal audits

4.14.1 Are internal audits conducted periodically andin accordance with a predeterminedschedule?

Are all elements of the quality system, testingand/or calibration activities addressedespecially, areas of critical importance topatient care?

4.14.2 Are such audits carried out by trained and

qualified personnel who are, howeverresources permit, independent of the activityto be audited?

Do the procedures for internal audit define thetype of audits, frequencies, methodologiesand other necessary information?

When audit findings cast doubts, does thelaboratory take timely corrective action?

4.14.3 Are the results of internal audit submitted tothe laboratory management for review?

4.15 Management review

4.15.1 Does the management review cover thefollowing:- laboratorys quality system?- all medical services including examination

and advisory activities?- continuing suitability and effectiveness in

patient care?- introduce any necessary changes or

improvements?

Are management reviews conductedperiodically and in accordance with a

predetermined schedule?

(A typical period for conducting amanagement review is once every twelvemonths.)

Is the review incorporated into a plan toinclude goal, objectives, and action plans forthe coming year?


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ClauseNo.


4.15.2

a)

b)

c)

d)

Does the review take account of:

follow-up of previous management reviews?

status of corrective actions taken and required

preventive action?

reports from managerial and supervisorypersonnel?

the outcome of recent internal audits?

e)

f)

g)

h)

i)

j)

k)

l)

m)

assessment by external bodies?

the outcome of external quality assessmentand other forms of inter-laboratorycomparison?

any changes in the volume and type of work

undertaken?

feedback, including complaints and otherrelevant factors, from clinicians, patients andother parties?

quality indicators for monitoring thelaboratorys contribution to patient care?

non-conformities?

monitoring of turnaround time?

Results of continuous improvementprocesses, and

Evaluation of suppliers?

(It is recommended that more frequentintervals be adopted when a qualitymanagement system is being established.This will allow early action to be taken inresponse to areas identified as requiringamendment of the quality system or otherpractices.)

4.15.3 Are the quality system and theappropriateness of the laboratoryscontribution to patient care monitored andevaluated?

4.15.4 Are findings and actions from managementreviews recorded and carried out within anappropriate and agreed timescale?


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5 Technical requirements

5.1 Personnel

5.1.1 Does the laboratory management have an

organisational plan, personnel policies and jobdescriptions for all personnel?

5.1.2 Does the management maintain records ofrelevant educational and professionalqualifications, training, experience andcompetence of all personnel?

a)

b)

c)

d)

e)

f)

Information may include:

Certification or licence, if required,

References from previous employment,

Job descriptions,

Records of continuing education andachievements,

Competency evaluations, and

Provision for untoward incident or accidentreports.

(Other personnel records should includerecords of exposure to occupational hazardsand records of immunization status.)

5.1.3 Does competent person with medical,scientific and technical background direct thelaboratory?

(Competence is understood as the product ofbasic academic, postgraduate and continuingeducation, as well as training and experienceof several years in a medical laboratory.)

5.1.4

a)

Do the responsibilities of the laboratorydirector or designees include professional,scientific, consultative, advisory,organisational, administrative, andeducational matters?

The laboratory director or designees for eachtask should have the appropriate training andbackground to be able to discharge thefollowing responsibilities:

Provide advice to those requestinginformation about the choice of tests, the useof the laboratory service and the interpretationof laboratory data,


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o) Ensure good staff morale?

5.1.5

(The laboratory director need not perform allresponsibilities personally. However, it is thelaboratory directors responsibility for theoverall operation and administration of the

laboratory, for ensuring that quality servicesare provided for patients.)

Are staff resources adequate to carry out allthe functions of the quality system?

5.1.6 Are personnel trained specifically in qualityassurance and management for servicesoffered?

5.1.7 Does the management authorise personnel toperform particular tasks such as- sampling?- examination?

- operating particular types of equipment,including use of computers in the labinformation system?

5.1.8 Are policies and procedures established todefine who- operate the computer system?- may access patient data only?- is authorised to enter patient results?- change results?- correct billing?- modify computer programs?

5.1.9 Is continuing education program available forall levels of staff?

5.1.10 Are employees trained to prevent or containthe effects of adverse incidents?

5.1.11 Is the competency of the staff undergoingtraining assessed? Is it done periodicallythereafter?

5.1.12 Do the personnel making professionaljudgment with reference to test examinationhave theoretical and practical knowledge andrecent experience?

Note: The professional judgment can beexpressed as opinions, interpretation,predictions, simulations & models and values.

Do they take part in regular professionaldevelopment or other professional liaison?

5.1.13 Do all personnel maintain confidentiality ofpatient information?


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5.2 Accommodation and environmentalconditions

5.2.1 Is the laboratory workspace adequate to carryout quality work, quality control procedures,and safety of personnel and patient care

services?

Is there evidence that the laboratory directordetermined the adequacy of the laboratorysspace?

Are laboratory resources maintained in afunctional and reliable condition?

Are provisions made for appropriate primarysample collection and examinations sites,which are different from permanent laboratoryfacility?

5.2.2 Is the laboratory designed for- efficiency of its operation?- to optimise the comfort of its occupants?- to minimise the risk of injury and

occupational illness?

Are patients, employees and visitors protectedfrom recognised hazards?

5.2.3 Are considerations made for accommodatingpatient disabilities, comfort, and privacy whenprimary sample collection facilities areprovided?

5.2.4 Is the laboratory design and environmentsuitable for the tasks carried out?

Is the environment in which the primarysample collection and/or examinationsundertaken is suitable and monitored so that itdoes not invalidate the results or adverselyaffect the required quality of anymeasurements?

(Laboratory facilities for examination shouldfacilitate correct performance of examinations.These include but are not limited to energysources, lighting, ventilation, water, and wasteand refuse disposal and environmentconditions. The laboratory should haveprocedures for checking that the environmentdoes not adversely affect the performance ofspecimen collection and equipment.)

5.2.5 Does the laboratory monitor, control andrecord environment conditions as required byrelevant specification or where they mayinfluence the quality of results?


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(Due attention should be paid to sterility, dust,electromagnetic interference, radiation,humidity, electrical supply, temperature, andsound and vibration levels, as appropriate, tothe technical activities concerned.)

5.2.6 Is there effective separation betweenneighbouring areas where incompatibleactivities are performed?Are appropriate measures taken to preventcross-contamination?

Examples where separation is neededinclude: where examination procedures pose a

hazard (e.g. mycobacteriology,radionuclides)

where the work may be affected orinfluenced by not being separated (e.g.nucleic acid amplifications)

where an environment conducive to quietand uninterrupted work is required (e.g.cytopathology screening) and

where work requires a controlledenvironment (e.g. large computersystems).

5.2.7 Is access to laboratory controlled?

Is the control of access determined?

5.2.8 Are the communication systems within thelaboratory efficient to the size and complexityof the facility and the efficient transfer of

messages?

5.2.9 Are relevant storage space and conditionsprovided to ensure the following:-- continuing integrity of samples- slides- histology blocks- retained micro-organisms- documents- files- manuals- equipment- reagents- laboratory supplies- records and results?

5.2.10 Is the work areas kept clean and wellmaintained?

Are the dangerous materials stored anddisposed as specified by relevant regulations?


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Are measures taken to ensure goodhousekeeping in the laboratory?

Are special procedures and training forpersonnel provided when necessary?

5.3 Laboratory Equipment

Note: Instruments, reference materials,consumables, reagents, and analyticalsystems are included as laboratoryequipment, as applicable.

5.3.1 Is the laboratory furnished with all the items ofequipment required for its services (includingprimary sample collection, sample preparationand processing, examination and storage)?

Where the laboratory needs to use equipment

outside its permanent control, does thelaboratory management ensure that therequirements of ISO 15189 are met?

(When selecting equipment, account shouldbe taken of the use of energy and futuredisposal (care of environment).)

5.3.2 Is equipment shown to be capable ofachieving the performance required andcomplies with specifications relevant to theexaminations concerned?

Is a programme established to regularlymonitor and demonstrates proper calibrationand function of instruments, reagents andanalytical systems?

Is there documentation of preventivemaintenance, at a minimum, following therecommendation from the manufacturer?

Note: Manufacturers instructions, operatorsmanual or other documentation may be usedto establish requirements, for compliance withrelevant standards or to specify requirementsfor periodic calibration.

5.3.3 Is each equipment uniquely labeled, markedor otherwise identified?


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ClauseNo


5.3.4

a)

b)

c)

d)

Are the following records of each item ofequipment contributing to the performance ofexaminations maintained:

identity of the equipment,

manufacturers name, type identity, and serial

number or other unique identification,manufacturers contact person and telephonenumber as appropriate,

date received and date placed in service,

e)

f)

g)

h)

current location, where appropriate,

condition when received (e.g. new, used orreconditioned),

manufacturers instructions, if available, orreference to their retention,

equipment performance records that confirmequipments suitability for use,(The performance records referred aboveshould include copies of reports andcertificates of all calibrations and/orverifications including dates, time and results,adjustments, acceptance criteria and due dateof next calibration and/or verification, togetherwith the frequency of checks carried outbetween maintenance/calibration, asappropriate, to fulfill part or all of thisrequirement. Manufacturers instructions maybe used to establish acceptance criteria,procedures and frequency of verification for

maintenance or calibration or both, asappropriate, to fulfill part or all of thisrequirement.)

i)

j)

k)

maintenance carried out and that planned forthe future,

damage to, or malfunction, modification orrepair, of the equipment,

predicted replacement date, if possible

Are the above records maintained and readilyavailable for the life span of the equipment or

for any time period required by law orregulation?

5.3.5 Are the equipment operated by authorisedpersonnel only?

Are up-to-date instructions on the use andmaintenance of equipment (including anyrelevant manuals and directions for useprovided by the manufacturer of theequipment) readily available?


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5.3.6 Are equipment maintained in safe workingcondition?

Are procedures in place to ensureexamination of electrical safety, emergencystop devices, and safe handling and disposal

of chemical, radioactive and biologicalmaterials by authorized persons?

Manufacturers specifications or instructionsor both shall be used, as appropriate.

5.3.7 Is defective equipment taken out of service,clearly labeled and appropriately stored until ithas been repaired and shown by calibration,verification or testing to meet specifiedacceptance criteria?

Is the effect of this defect on previous

examinations examined and institute theprocedure given in 4.9?

Are reasonable measures taken todecontaminate equipment prior to service,repair or decommissioning?

5.3.8 Is a list of the measures taken to reducecontamination given to the person working onthe equipment?

Does the laboratory provide suitable space forrepairs and appropriate personal protectiveequipment?

5.3.9 Are the equipment labeled or otherwise codedto indicate the status of calibration orverification and the date when recalibration orreverification is due?

5.3.10 When equipment goes outside the directcontrol of the laboratory, does the laboratoryensure that the function and calibration statusof the equipment are checked and shown tobe satisfactory before the equipment isreturned to service?

5.3.11

a)

b)

Does the laboratory ensure the following

when computers or automated examinationequipment are used for collection, processing,recording, reporting, storage or retrieval ofexamination data?

computer software (including that built intoequipment) is documented and suitablyvalidated as adequate for the use in thefacility?

procedures are established and implementedfor protecting the integrity of data at all times?


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ClauseNo


c)

d)

computers and automated equipment aremaintained to ensure proper functioning andprovided with environmental and operatingconditions necessary to maintain the integrityof data?

computer programmes and routines areadequately protected to prevent access,alteration or destruction by casual orunauthorised persons?

5.3.12 Are procedures available for safe handling,transport, storage, and use of equipment toprevent its contamination or deterioration?

5.3.13 Where calibrations give rise to a set ofcorrection factors, does the laboratory haveprocedures to ensure that copies of priorcorrection factors are correctly updated?

5.3.13 Are equipment including both hardware andsoftware, reference materials, consumables,reagents and analytical systems safeguardedfromadjustments or tampering that might invalidateexamination results?

5.4 Pre-examination Process

5.4.1

a)

b)

c)

d)

e)

Does the request form contain sufficientinformation to identify- the patient?- authorised requester?- provides pertinent clinical data?

The request form or electronic equivalentshould allow space for the inclusion of, but notlimited to:

unique identification of the patient;

name or other unique identifier of physician orother person legally authorised to orderexaminations or use medical informationtogether with the destination for the report. Ifthe requesting clinicians address is differentfrom that of the receiving laboratory, thataddress should be provided as part of therequest form information;

type of primary sample and the anatomic siteof origin, where appropriate;

examinations requested;

clinical information relevant to the patient,which should include gender and date of birth,as a minimum, for interpretation purposes;


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f)

g)

date and time of primary sample collection;and

date and time of receipt of samples by thelaboratory.

The format of the request form (e.g. electronicor paper) and the manner in which requestsare to be communicated to the laboratoryshould be determined in discussion with theuser of laboratory services.

5.4.2. Are specific instructions for the propercollection and handling of primary samples- documented?- implemented?- made available to those responsible for

primary sample collection

Are these instructions contained in a primarysample collection manual?

5.4.3

a)

Does the primary sample collection manualinclude

copies of or references to:

1) list of laboratory examinations offered?

2) consent forms, where applicable?

3) information and instructions provided topatients in relations to their ownpreparation before primary sample

collection?

4) information for users on the medicalindications and appropriate selection ofavailable procedures?

b) procedures for

1) preparation of the patient (e.g.instructions to caregivers andphlebotomists)?

2) identifications of primary sample?

3) primary sample collection (e.g.,phlebotomy, skin puncture, blood, urineand other body fluids) with descriptionsof the primary sample containers andany necessary additives?

c) instructions for:

1) completion of request form or electronicrequest?


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2) type and amount of the primary sampleto be collected?

3) special timing of collection, if required?

4) any special handling needs between

time of collection and time received bythe laboratory (e.g., transportrequirements, refrigeration, warming,immediate delivery, etc.)?

5) labeling or primary samples?

6) clinical information (e.g. history ofadministration of drugs)?

7) positive identification in detail of thepatient from whom a primary sample iscollected?

8) recording the identity of the personcollecting the primary sample?

9) safe disposal of materials used in thecollection?

d) instructions for :

1) storage of examined samples?

2) time limits for requesting additionalexaminations?

3) allowed additional examinations?

4) repeat examination due to analyticalfailure or further examinations of sameprimary sample?

5.4.4 Is the primary sample collection manual partof the document control system?

5.4.5 Are primary samples traceable to an identifiedindividual normally by a request form?

Are primary samples lacking properidentification rejected by the laboratory?

Where there is uncertainty in the identificationof the primary sample, or instability of theanalytes in the primary sample (cerebro-spinalfluid, fluid, biopsy, etc), and the primarysample is irreplaceable critical, the laboratorymay choose initially to process the sample butnot release the results until the requestingphysician or person responsible for theprimary sample collection takes responsibilityfor identifying and accepting the sample, orproviding proper information. In such instance,


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5.4.11 Is there a documented procedure for thereceipt, labeling, processing and reporting ofthose primary samples received by thelaboratory and specifically marked as urgent?

Does the procedure include:

- details of special handling of the requestform and the primary sample?- mechanism of transfer of the primary

sample to be examination area of thelaboratory?

- any rapid processing mode to be used?- any special reporting criteria to be

followed?

5.4.12 Are the sample portions traceable to originalprimary sample?

5.4.13 Are written polices available concerningverbal requests for sample examinations?

5.4.14 Are samples stored for a specified time underconditions- ensuring the stability of sample

preparations?- to enable repetition of the examinations

after reporting of the result?- or for additional examinations?

5.5 Examination procedures

(Some of the following may not apply to alldisciplines in the scope of laboratorymedicine.)

5.5.1 Is the laboratory using appropriateexamination procedures for:- selecting or taking sample portions,- meet the needs of the users of the

laboratory services?- appropriate for the examinations?

Is the laboratory selecting appropriatemethods published from:- established/authorative textbooks,- peer-reviewed texts,- journals,- international, regional, national

guidelines?

If in-house procedures are used, are they- appropriately validated for their intended

use?- fully documented?


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5.5.2 Are validated procedures used for confirmingthat the examination procedures are suitablefor the intended use?

The validations shall be as extensive asnecessary to meet the needs in the given

application or field of application.

Are results obtained and the procedure usedfor validation recorded?

Are the methods and procedures evaluatedfor satisfactory results before implementation?

Does the laboratory director or designatereview these procedures initially and atdefined intervals (normally annual review)?

Are these reviews documented?

5.5.3 Are all documented test procedures availableat the workstation? Is it available in acommonly understood language?

Card files or similar systems that summarisekey information are acceptable for use as aquick reference at the workbench, providedthat a complete manual is available forreference. The card file or similar systemsshall correspond to the complete manual. Anysuch abridged procedures shall be part of thedocument control system.

- Is the procedure based on whole or inpart on the instructions for use (e.g.package insert) written by themanufacturer, provided that they are inaccordance with 5.5.1 and 5.5.2 and thatthey describe the procedure as it isperformed in the laboratory and arewritten in the language commonlyunderstood by the staff?

- Are deviations reviewed anddocumented?

- Is each new version of the examination

kits with major changes in reagents orprocedure checked for performance andsuitability for intended use?

- Are procedural changes dated andauthorised as for other procedures?


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ClauseNo


a)

b)

c)

d)

e)

f)

In addition to document control identifiers,does documentation include, when applicable,the following:

purpose of the examination

principle of the procedures used forexaminations

performance specifications (e.g., linearity,precision, accuracy as expressed asuncertainty of measurement, detection limits,measuring interval, trueness of measurement,sensitivity, and specificity)

primary sample system (e.g. plasma, serum,urine)

type of container and additive

required equipment and reagents

g)

h)

calibration procedures

procedural steps

i) quality control procedures

j) interferences (e.g., lipaemia, haemolysis,bilirubinemia) and cross reaction

k)

l)

m)

n)

principle of procedure for calculating resultsincluding measurement uncertainty

biological reference intervals

reportable interval of patient examinationresults

alert/critical values, where appropriate

o)

p)

q)

laboratory interpretations

safety precautions and

potential sources of variability

(Electronic manuals are acceptable provided

that the information described above isincluded. The same requirements fordocument control should also apply toelectronic manuals.

The laboratory director is responsible forensuring that the contents of examinationprocedures are complete, current, and hasbeen thoroughly reviewed.)


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5.5.4 Does the performance specifications for eachprocedure used in an examination relate tothe intended use of that procedure?

5.5.5 Are the biological reference intervalsperiodically reviewed?

Does the laboratory undertake investigationsif the laboratory has reason to believe that aparticular interval is no longer appropriate forthe reference population? Are necessaryfollow-ups made as corrective action?

Are biological reference intervals alsoreviewed, if appropriate, when the laboratorychanges an examination procedure or pre-examination procedure?

5.5.6 Does the laboratory make list of its currentexamination procedures, including primary

sample requirements and relevantperformance specification and requirements,available to laboratory users upon request?

5.5.7 When the laboratory changes an examinationprocedure so that results or theirinterpretations may be significantly different,are:

the implications explained to users in writingprior to the introduction of the change?

This requirement can be accomplished in anyof several different ways, depending on localcircumstances. Some methods includedirected mailings, laboratory newsletters, orpart of the examination report itself.

5.6 Assuring the quality of examinationprocedures

5.6.1 Does the laboratory design internal qualitycontrol systems that verify the attainment ofthe intended quality of results is achieved?

It is important that the control system providesstaff members with clear and easilyunderstood information on which to basetechnical and medical decisions. Specialattention should be paid to the elimination ofmistakes in the process of handling samples,requests, examinations, reports, etc.

5.6.2 Does the laboratory determine the uncertaintyof its measurements, where relevant andpossible?

Are the uncertainty components which are ofimportance taken into account?


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Sources that may contribute to the uncertaintymay include- sample preparation,- sample portion selection,- calibrators,- reference materials,

- input quantities,- equipment used,- the environmental conditions,- the conditions of the sample and- changes in the operator, etc.

5.6.3 Is a programme designed for calibration ofmeasuring systems and verification oftrueness designed and performed so as toensure that results are traceable to SI units orby reference to a natural constant or otherstated reference?

Where the laboratory is using external

calibration services, is traceability ofmeasurement assured by these externalcalibration laboratories?(refer to SAC-SINGLAS 006)

Where none of these are possible or relevant,other means for providing confidence in theresults shall be applied including but notlimited to the following:-

a)

b)

c)

d)

participation in a suitable programme of inter-laboratory comparisons,

the use of suitable reference materials,certified to indicate the characterisation of thematerial,

examination or calibration by anotherprocedure

ratio or reciprocity-type measurements,

e)

f)

mutual consent standards or methods whichare clearly established, specified,characterised, and mutually agreed upon byall parties concerned,

documentation of statements regardingreagents, procedures or examination systemwhen traceability is provided by the supplier ormanufacturer.

5.6.4 Does the laboratory participate in inter-laboratory comparisons such as thoseorganised by external quality assessmentschemes?


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Does the laboratory- monitor the results of external quality

assessment?- participate in the implementation of

corrective actions when control criteriaare not fulfilled?

Note: external quality assessmentprogrammes should, as far as possible,provide clinically relevant challenges thatmimic patient samples and have the effect ofchecking the entire examination processincluding pre- and post-examinationprocedures.

5.6.5 When proficiency or inter-laboratorycomparison programmes are not available,does the laboratory develop mechanism fordeciding the acceptability of procedures nototherwise evaluated?

Wherever possible, this mechanism shallutilise externally derived challenge materialssuch as exchange of samples with otherlaboratories.

Does the laboratory monitor the results in theabove programmes and participate in theimplementation and recording of correctiveactions?

5.6.6 For tests and examinations performed using- different procedures,- different equipment, or- different sites

Is a defined mechanism for verifying thecomparability of results throughout theclinically appropriate intervals?

Are such verifications performed at definedperiods of time appropriate to thecharacteristics of the procedure orinstrument?

5.6.7 Does the laboratory document, record theresults appropriately?

Does the laboratory expeditiously act uponresults from the above comparisons?

Are the problems or deficiencies identified andrectified and records of actions retained?

5.7 Post-examination process

5.7.1 Do authorised personnel systematicallyreview the results of examinations andevaluate them in conformity of the clinical


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ClauseNo


information available regarding the patientand authorise the release of the results?

5.7.2 Are primary samples and other laboratorysamples stored in accordance with approvedpolicy?

5.7.3 Are samples that are no longer required forexamination disposed safely and inaccordance with regulations orrecommendations for waste management?

5.8 Reporting of results

5.8.1 Is the laboratory responsible for formattingreports?

Note: The format of the report form (e.g.,electronic or paper) and how it is to becommunicated from the laboratory should be

determined in discussion with the laboratoryusers.

5.8.2 Does the laboratory management shareresponsibility with the requester to ensure thatthe reports are received by the appropriateindividual within the agreed-upon timeinterval?

5.8.3 Are the test results- legible?- without mistakes in transcription?- reported to persons authorised to receive

and use medical information?

The report should include but not limited to:

a) clear unambiguous identification of theexamination including, where appropriate, themeasurement procedure?

b) the identification of the laboratory that issuedthe report?

c) unique identification and location of thepatient, where possible, and destination of thereport?

d) name or other unique identifier of therequester and the requesters address?

e) date and time of primary sample collection,where available and relevant to patient care,and the time of receipt by the laboratory?

f) date and time of release of report, if not on thereport, shall be readily accessible whenneeded?


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ClauseNo


g) source and system (or primary sample type),

h) results of the examination including SI units orunits traceable to SI units, where applicable?

i) biological reference intervals, where

applicable?

(Under some circumstances, it may beappropriate to distribute lists or tables ofbiological reference intervals to all users andsites where reports are received.)

j) interpretations of results, where appropriate?

k) other comments (e.g., quality or adequacy ofprimary sample, which may havecompromised the result, results/interpretationsfrom referral laboratories, use ofdevelopmental procedure)?

(the report should identify examinationsundertaken as part of a developmentprogramme and for which no specific claimson measurement performance are made.

Where applicable, information on detectionlimit and uncertainty of measurement shouldbe provided upon request.)

l) identification of the person authorising therelease of the report?

m) if relevant, original and corrected results?

n) signature or authorisation of the personchecking or releasing the report, wherepossible?

5.8.4 As appropriate, the description ofexaminations performed and their resultsshould follow the vocabulary and syntaxrecommended by one or more of the followingorganisations:- International Council for Standardisation

in Haematology (ICSH),- International Society of Haematology,- International Federation of Clinical

Chemistry and Laboratory Medicine(IFCC),

- International Union of Pure and AppliedChemistry (IUPAC),

- International Society of Thrombosis andHaemostasis (ISTH)

- European Committee for Standardisation(CEN)


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ClauseNo


Do these records include- date?- time?- responsible laboratory staff member?- person notified?- examination results?

- any difficulty encountered in meeting thisrequirement?Are such records reviewed during the audits?

5.8.11 Does the laboratory in consultation with therequesters, establish turnaround times foreach of its examinations?

Does the turnaround time reflect the clinicalneeds?

Is there a policy available for notifyingrequester when an examination is delayed?

Are the turnaround times as well as anyfeedback from clinicians regarding turnaroundtimes- monitored?- recorded?- reviewed?- where necessary, identify corrective

actions to address any problems?

(This does not mean that the clinicalpersonnel are to be notified of all delays inexamination, but only in those situationswhere the delay may compromise patientcare. This procedure should be developed incollaboration between clinical and laboratorypersonnel.)

5.8.12 When examination results from referrallaboratory need to be transcribed by thereferring laboratory, are there proceduresavailable to verify the correctness of alltranscriptions?

5.8.13 Does the laboratory have clearly documentedprocedures for release of examination resultsincluding details of who may release resultsand to whom?

Do the procedures also include guidelines for

the release of results directly to patients?

5.8.14 Does the laboratory establish policies andpractices to ensure that the results distributedby telephone or other electronic means onlyreach authorised receivers?

Are results provided verbally followed by aproperly recorded report?


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ClauseNo


5.8.15 Does the laboratory have written policies andprocedures regarding the alteration ofreports?

Does altered reports indicate the

time? date? and name of person responsible for the

change?

Are original entries legible when alterationsare made?

Are original electronic records retained andalterations added to the record throughappropriate editing procedures so that reportsclearly indicate the alteration?

5.8.16 Are results used for clinical decision-makingrevised and retained in subsequent

cumulative reports and clearly identified ashaving been revised?

If the reporting system cannot captureamendments, changes, or alterations, is anaudit log used?

SAC-SINGLAS Requirements

A.1.

Key Personnel

Do the key personnel still occupy appropriatepositions in the staff structure to beresponsible for the adequacy of test results?

2. Do the key personnel still retain sufficientcontact time with testing procedures tomaintain the ability for critical evaluation ofresults?

3. For key personnel, are the requirementsstated in Clause 7 of SAC-SINGLAS 001-MEDbeing met?

B.

1.

SAC-SINGLAS Endorsed Reports and Useof MarkDoes the laboratory comply with the termsand conditions for SAC-SINGLAS endorsedreport as stipulated in SAC-SINGLAS 001-

MED, Clause 10?

C.

1.

10.1(c)(i)

10.1(c)(ii)

Obligations of the accredited laboratory(SAC-SINGLAS 001-MED)Immediately notify on:

Any change in its legal, commercial ororganisational status;

Any change in policies and procedures, whereappropriate;


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ClauseNo


10.1(c)(iii)

10.1(c)(iv)

10.1(c)(v)

10.1(c)(vi)

10.1(c)(vii)

Any change in organisation and managementeg. key personnel, authorised representative;

Changes of duties of key personnel;

Significant changes in laboratory environment,equipment, facilities and/or other resource;

Change of premises, where the laboratory willbe subjected to a re-assessment which willcover the full scope of accreditation and thelaboratory has the responsibility to informSAC-SINGLASat least 3 months in advance;

Any lawsuit or criminal investigation of thelaboratory or its staff;

D. Follow up on last year findings

E. Other Observation and Comments

Safety (SAC-SINGLAS 001-MED

, Clause 9.1)

Documents

Medical Laboratory Application Form