SC 26 Annex : Checklist on compliance with HOKLAS requirements– Chemical PathologySC 26 Annex – Page 1 of 10
Issue No. 3
HOKLAS Requirement / Clause / * / Y / N / NA / QM Clause / RemarksEXAMINATION BY REFERRAL LABORATORIES
/ 4.5Has each referral laboratory to which the specimens are sent been approved by the person-in-charge? / 4.5.1
When referral is required, are the referred laboratories accredited to perform the test(s) being referred? / 4.5.H
IDENTIFICATION AND CONTROL OF NONCONFORMITIES / 4.9
Are there instructions for acceptance and rejection of test results when QC results indicate problems or deficiencies? / 4.9.3
QUALITY AND TECHNICAL RECORDS
/ 4.13Are there documented policies and operating procedures to guide the proper storage and handling of records, (such as retrieval and disposal) to ensure the integrity and confidentiality of these records? / 4.13.1
Are filed recordsreadily accessible and retrievable? / 4.13.2
Are all quality control results maintained? / 4.13.3
Is it possible to identify from the laboratory records the person(s) performing a test and/or checking a set of results? / 4.13.H
If computer systems are used, are there procedures for checking transcription, calculation, or data entry errors? / 4.13.H / ●
Are laboratory request forms (electronic and/or hardcopy format) retained for at least 3 years as required by HOKLAS? / 4.13.3
Are laboratory reports (electronic and/or hardcopy format) retained for the length of time pursuant to the local requirements? / 4.13.H, 5.8.6
PERSONNEL
/ 5.1Is the number of staff appropriateand adequate for the work undertaken? / 5.1.5 / ●
Is the competency of staff reassessed periodically? / 5.1.11 / ●
ACCOMMODATION AND ENVIRONMENTAL CONDITIONS
/ 5.2Does the laboratory have adequate, conveniently located and uncluttered space for:
(i)workbench? / 5.2.1 / ●
(ii)equipment? / 5.2.2 / ●
(iii)storage (including refrigerated storage)? / 5.2.9 / ●
Are first-aid facilities readily available? / 5.2.2 / ●
Are there emergency overhead shower facilities located in appropriate areas if corrosive solutions are used? / 5.2.2 / ●
Are there emergency eye wash facilities located in appropriate areas? / 5.2.2 / ●
Is protective clothing provided for and worn by staff members? / 5.2.2 / ●
Are the utilities provided in the work areas adequate? / 5.2.4 / ●
Does the laboratory have:
(i)adequate lighting? / 5.2.4 / ●
(ii)adequate ventilation? / 5.2.4 / ●
(iii)adequate water supplies (tap, deionized, distilled)? / 5.2.4 / ●
(iv)adequate fume hoods or fume cupboards? / 5.2.4 / ●
(v)adequate ambient temperature and humidity control(particularly where sensitive instruments are in use)? / 5.2.5 / ●
(vi)adequate drainage/sewerage for solvent and biological waste disposal which are conformed to relevant local authorities’ requirements? / 5.2.10 / ●
Electrical
(i)are there sufficient power points (it is undesirable to use double adapters and long extension cords)? / 5.2.5 / ●
(ii)are the electricity voltage, polarity and ground integrity of the power points monitored or checked periodically? / 5.2.5 / ●
(iii)are voltage regulators / stabilizers / UPS used on instruments requiring them? / 5.2.5 / ●
(iv)do automated instruments which have special electrical criteria have a dedicated and/or adequate electricitysupply ? / 5.2.5 / ●
If radioactive substances are handled in the laboratory :
(i)does the laboratorycarry a valid license? / 5.2.H / ●
(ii)is background radiation checked? / 5.2.5 / ●
(iii)are monitoring badgesin use, and the exposure records kept? / 5.2.2, 5.2.H / ●
(iv)are radioactive substances properly disposed of to ensure that they pose no hazard to laboratory workers or to the community? / 5.3.6 / ●
(v)are guidelines for safe handling of radioactive substancesavailable? / 5.2.H / ●
Are there adequate cold storage space and facilities for specimens and reagents, including refrigerators and freezers? / 5.2.9, 5.2.H / ●
Are all reagents stored properly in good condition according to the special storage requirements by manufacturers or local regulation (refrigeration, flammable or dark storage)? / 5.2.9 / ●
LABORATORY EQUIPMENT
/ 5.3Are there adequate equipment installed compatible with the requirements for service provision, including the volume and scope of tests being performed? / 5.3.1 / ●
Are there established protocols for verifying the performance of pipeting devices, water baths, incubators, freezers, refrigerators and analytical balances? / 5.3.2 / ●
Are operation manual and records on calibration, performance verification and maintenance of all equipments available and ready for inspection? / 5.3.2, 5.3.4 / ●
Are fume cupboards and biological safety cabinets : / 5.3.2
(i)available? / ●
(ii)functioning properly? / ●
(iii)checked regularly? / ●
Are there records maintained for all major equipment, including: / 5.3.4
(i)identity of the instrument; / ●
(ii)type, model, serial number or other unique identification; / ●
(iii)manufacturer's information and contact; / ●
(iv)historical data; / ●
(v)current location; / ●
(vi)corrective services carried out and preventive maintenance scheduled; / ●
(vii)expected service life span, if possible? / ●
Is Grade Iwater used in reconstitution of all standards, reagents, and sample dilution, where appropriate? / 5.3.2 / ●
Are all reagents used within their expiry date? / 5.3.2 / ●
Are all reagents fully labeled and well-dated? / 5.3.3 / ●
Are all equipment maintained under adequate and stable electrical supply? / 5.3.6 / ●
Are special area or specially designed container available for storage of volatile chemicals and flammable solvents? / 5.3.6 / ●
Are safety guidelines available for handling hazardous, toxic and caustic chemicals? / 5.3.6 / ●
Are compressed gas cylinders: / 5.3.6
(i)kept away from flame or heat sources? / ●
(ii)secured in position and prevented from falling? / ●
(iii)transported on specially designed trolleys? / ●
PRE-EXAMINATION PROCEDURES
/ 5.4Are specific primary sample collection guidelines provided to those responsible for specimen collection?
/ 5.4.2 / ●Are there documentations on the scope of service available to all users? / 5.4.3 / ●
Are written instructions provided to patients for primary sample collection? For example: / 5.4.3
(i)Proper collection of random / timed urine specimens and information on the content in the container for special tests; and / ●
(ii)the need for fasting or other special requirements such as dietary and drugs restriction. / ●
Does the sample collection guidelines include / 5.4.3
(i)procedures for preparation of patients, e.g. need for fasting, postures? / ●
(ii)type of primary sample containers and preservatives required? / ●
(iii)type and amount of primary sample to be collected? / ●
(iv)special timing of collection? / ●
(v)special sample handling requirement between time of collection and time received by the laboratory, e.g. need for protection from light, transportation in low temperature, immediate delivery etc.? / ●
(vi)labeling and unique identification of primary specimen? / ●
(vii)drug history? / ●
Does the laboratory inspect the integrity of specimens upon receipt and reject those requests which fail to meet predefined criteria, e.g. delayed delivery, inappropriate containers / preservation and leaking containers? / 5.4.6 / ●
Are there records indicating the daily accession of specimens? / 5.4.7 / ●
Is there a record of specimens received by the laboratory, including information on: / 5.4.7
(i)the name and other identification of the patient; / ●
(ii)the laboratory number or other form of identification; / ●
(iii)the identity of the referring practitioner; / ●
(iv)the date and time of specimen collection; and / ●
(v)the date and time of specimen received? / ●
Are all patient samples in the laboratory traceable to the original primary specimen, including aliquots and portions? / 5.4.5, 5.4.12 / ●
Are there written policies for handling non-compliant specimens, including poorly labeled samples and unauthorized requests? / 5.4.8 / ●
Is there a documented procedure for accelerated handling of urgently requested specimens? / 5.4.11 / ●
Are specimens stored properly in the laboratory at all time? / 5.4.14 / ●
EXAMINATION PROCEDURES / 5.5
Are SOPs revised and validated at least once a year? / 5.5.2 / ●
Is there a written procedure for all tests performed? / 5.5.3 / ●
Are all procedures in the work place readily accessible? / 5.5.3 / ●
Does the procedure manual :
(i)quote the source of references for the methods? / 5.5.1 / ●
(ii)state the principle and clinical purpose of the method? / 5.5.3 / ●
(iii)include the linearity of method and instructionsfor appropriate dilution protocols? / 5.5.3 / ●
(iv)state the type of specimens appropriate for the method used? / 5.5.3 / ●
(v)state the type of containers and additives used? / 5.5.3 / ●
(vi)include the preparation of reagents, standards and controls (methods, source of supplies, catalogue numbers)? / 5.5.3 / ●
(vii)include calibration procedures, if applicable? / 5.5.3 / ●
(viii)have step by step procedures written clearly? / 5.5.3 / ●
(ix)include methods for calculations, if any? / 5.5.3 / ●
(x)include requirements for quality control and criteria for unacceptable results?
/ 5.5.3 / ●(xi)include clear instructions for reporting results, with reference intervals whereappropriate? / 5.5.3 / ●
(xii)include reference notes (e.g. special requirements, drug/other interference, safety precautions, etc.)? / 5.5.3 / ●
(xiii)document history of authorized changes for each method? / 5.5.3 / ●
(xiv)include criteria for identifying and dealing with seriously abnormal results? / 5.5.3 / ●
(xv)state how the reference ranges are set up? / 5.5.5 / ●
(xvi)state the appropriate units to be used e.g. SI and/or Conventional? / 5.8.3 / ●
Is there a list of procedures broadly categorized, for example, by methodology? / 5.5.6 / ●
ASSURING QUALITY OF EXAMINATION PROCEDURES
/ 5.6Does the laboratory have a clearly defined internal control programme? / 5.6.1 / ●
Is each batch of quality control results evaluated before the relevant test results are released? / 5.6.1 / ●
Are quality control records reviewed to identify potential problem(s)? / 5.6.1 / ●
Are there any records to show participation of external QA program(s)? / 5.6.3, 5.6.4 / ●
Are correlation checks implemented for different methods and protocols of the same test? / 5.6.6 / ●
Is there any documented record for corrective measures in response to problems or deficiencies identified from QC results? / 5.6.7 / ●
Does the laboratory have guidelines for the estimation of uncertainty of measurement? / SC26 4.2 / ●
Has the laboratory made an effort to estimate the Uncertainty of Measurement and document the uncertainty components for all the quantitative tests? / SC26 4.2 / ●
POST EXAMINATION PROCEDURES / 5.7
Are results routinely reviewed by authorized personnel with supervisory responsibility for clerical errors, absurd results or results requiring special notification before they are released? / 5.7.1 / ●
REPORTING OF RESULTS
/ 5.8Are reports dispatched without undue delay so that the appropriate individuals received them within an agreed-upon time interval?
/ 5.8.2 / ●Are results legible and without mistakes in transcription? / 5.8.3 / ●
Do reports include the appropriate reference intervals? / 5.8.3, 5.8.H / ●
Is there a documented procedure in place for accelerated handling of seriously abnormal results? / 5.8.7 / ●
Are all test reports of tests that require direct input of pathologists reviewed and signed by a qualified chemical pathologist (or qualified pathologist as advised by the HKCPath)? / SC 26 6.1 / ●
For computer auto-validated reports, does the laboratory define and document the person(s) authorising the use of the particular algorithm for the automatic release of the results? Is the authorization for release of auto-validated reports traceable? / SC 26 6.3 / ●
Are the requesters informed on the reports that the results are auto-validated by computer system? / SC 26 6.3 / ●
Note: 1. * The assessor should concentrate on items marked with a ●; other items will be checked by the team leader.
2. QM Clause stands for the clause number of the laboratory’s quality documentation that describes the laboratory’s procedures for the areas concerned.