SC 23 Annex : Checklist on compliance with HOKLAS requirements– Hospital Autopsy SC 23 Annex - Page 1 of 5

Issue No. 3

HOKLAS Requirement / Clause / * / Y / N / NA / QM Clause / Remarks / Questions to be asked at laboratory

Technical requirements

Personnel

/ 5.1
Are staff qualifications appropriate? / SC23 2.1, 2.2, 2.3 / ●

Accommodation and environmental conditions

/ 5.2
Is overall space adequate? / 5.2.1 / ●
Is there adequate space allotted to:
-refrigerated storage of bodies?
/ 5.2.1 / ●
-lockers, changing area and shower facilities?
/ 5.2.1 / ●
-facilities for authorized viewing?
/ 5.2.1 / ●
Is ventilation adequate to eliminate noxious fumes and biological odors? / 5.2.2 / ●
Are utilities (water, sink, electrical) sufficient? / 5.2.4 / ●
Is the autopsy room clean and well-maintained? / 5.2.10 / ●
Is waste segregated, bagged and disposed of according to relevant regulations? / 5.2.10 / ●
Are autopsy tables, dissection areas, instruments and aprons adequately disinfected after use? / SC23 3.1 / ●
Is the administrative area separate from the autopsy rooms and body receiving area? / SC23 3.2 / ●
Equipment
/ 5.3
Are instruments clean and well maintained? / 5.3.6 / ●
Is there a written procedure for the safe and proper operation of the equipment? / 5.3.5 / ●
Is there a written procedure for decontaminating or routine cleansing? / 5.3.8 / ●
Balance
Are they clean, regularly serviced and documented? / 5.3.2 / ●
Are recognized standard weights available? / 5.3.4(h) / ●
Are the weights clean? / 5.3.4(h) / ●
Are results of periodic accuracy checks recorded? / 5.3.4(h) / ●
Are analytic balances mounted on vibration-free benches in areas free from draught? / 5.3.6 / ●
Bone saw
Are the safety measures checked according to the manufacturer’s recommendations and documented? / 5.3.2 / ●
Refrigerators & Freezers
Are they free of improper items (i.e. food, open bottles, etc.)? / 5.2.10 / ●
Are temperatures monitored regularly and recorded? / 5.3.2 / ●
Are temperature tolerance limits defined? / 5.3.2 / ●
Is there documented evidence of corrective action when temperature tolerance limits are exceeded? / 5.3.4 (j) / ●
Are temperature sensitive reagents only placed in non-defrosting refrigerators? / 5.3.2 / ●
Are there documented procedures to ensure that temperature sensitive reagents are not affected if defrosting refrigerators are used? / 5.3.2 / ●
Are refrigerator and freezer doors free from temperature sensitive reagents? / 5.3.2 / ●
Are only non-temperature sensitive reagents stored in refrigerators/freezers without temperature monitoring? / 5.3.2 / ●
Are protective mitts available for use when loading and unloading the freezers? / 5.3.12 / ●
Pre-examination procedures / 5.4
Does the request form include: / 5.4.1
-Unique identification of the patient/body? / ●
-A second identifier? / ●
-Date and approximate time of death? / ●
-Name of requesting doctor? / ●
-Test requested (Limited or full autopsy)? / ●
-Pertinent clinical information? / ●
Are available clinical records reviewed and/or clinical information discussed with the attending doctor before conducting the autopsy? / 5.4.1 / ●
Are there written instructions covering such items as receipt, storage and release of bodies? / 5.4.7 / ●
Examination procedures / 5.5
Is there a manual for handling and examination of highly infectious cases? / SC23 4.1 / ●
Are the autopsies performed by a qualified pathologist? / SC23 4.2 / ●
When autopsies are performed by a pathology trainee, is he/she under the supervision of a qualified pathologist? / SC23 4.2 / ●
Post-examination procedures / 5.7
Are minimum retention periods of the following met:
-request forms – 3 years? / SC23 5.1 / ●
-slides – 20 years? / SC23 5.1 / ●
-blocks – 20 years? / SC23 5.1 / ●
-copies of reports – 20 years (permanent if possible)? / SC23 5.1 / ●
- wet tissue / SC23 5.1 / ●
Reporting of results / 5.8
Are all autopsies reported by a qualified anatomical pathologist (or qualified pathologist as advised by the HKCPath) or pathology trainee under the direct supervision of a qualified pathologist? / SC23 6.1 / ●
Does the final autopsy report contain sufficient information in an appropriate format to ascertain the patient’s major disease processes and probable cause of death? / SC23 6.2 / ●
Are photos taken for documentation, where appropriate? / SC23 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.