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1 Clause 6.3
2 Facilities and environmental conditions
3
4
5
6
7
8 Dennis Mok CQP FCQI
9 Naira Eloyan BSc MSc CQP MCQI
10 Rana Nabulsi BSc MSc GEMBA PhD FACHE CPHQ
11
12
13 Definitions
14
15 Facility — Collection of assets which is built, installed or established to serve an entity’s
16
17
needs.
18 Standards Australia. Facility management — Mangement systems — Requirement with guidance for use.
19 AS ISO 41001:2019. Sydney (AU): Standards Australia; 2019 Jun. Prepared by the Standards Australia Technical
20 Committee on Facilities Management (MB-022). Clause 3.2.3.2, Facility; p. 3.
21
22
23 The facilities and environmental conditions of the medical laboratory
24
25
26 Table 1. Organisations providing relevant guidance documents in support of the
27 Clause 6.3 (Facilities and environmental conditions) of ISO 15189:2022
28 implementation. International organisations that were accepted by the
29 Union of International Associations Type 1 typology classification are indicated in the
30
31
second column.
Classification
Organisations References
(Type A to Type F)

Australasian Health Infrastructure Alliance

International Labour Organization A1
International Organization for Standardization A2
National Association of Testing Authorities, Australia
Safe Work Australia
Standards Australia
Standards New Zealand
World Health Organization A3 4

32
33
34 Australasian Health Infrastructure Alliance (AHIA)
35 International Labour Organization (ILO)
36 International Organization for Standardization (ISO)
37 National Association of Testing Authorities, Australia (NATA)
38 Safe Work Australia (SWA)
39 Standards Australia
40 Standards New Zealand (SNZ)
41 World Health Organization (WHO)
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42
43
44 Clause 6.3 (Facilities and environmental conditions) of AS ISO 15189:2023
45 Clause 6.3 of AS ISO 15189:2023 contains ?/1 501 (?%) conformance requirements
46 (CReqs).
47
48
49 Clause 6.3.1 (General) of AS ISO 15189:2023
50 Clause 6.3.1 of AS ISO 15189:2023
51
52
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53 Clause 6.3.2 (Facility controls) of AS ISO 15189:2023
54 Clause 6.3.2 of AS ISO 15189:2023
55
56
57
58
59
60 Clause 6.3.2 a) of AS ISO 15189:2023 specifies that the medical laboratory must provide
61 accessibility control to medical information and patient samples. The safety,
62 confidentiality, quality and safeguard aspects must taken into consideration. The
63 medical laboratory access control must be applied to all categories of laboratory
64 personnel, including patients, and visitors5.
65
66 Control of access —
67
68
69
70 First, medical information must be stored in a secure location that has controlled access.
71 Access of medical information should be supported by a documented procedure for
72 handling with requests for information6.
73
74 A controlled area —
75
76 A limited area —
77
78 An exclusion area —
79
80
81
82
83 The medical laboratory must control the regulation of medical information and patient
84 samples into, out of, and within a facility.
85
86
87
88
89
90 Australasian Health Infrastructure Alliance. Australasian health facility guidelines: part C - Design for access, mobility,
91 safety and security. Revision 6.0. St. Leonards (AU): Australasian Health Infrastructure Alliance; 2021 Nov.
92 Section 6.8, Access control; p. 81.
93 Standards Australia. Security for health care facilities: part 1: general requirements. AS 4485.1:2021. 2nd ed. Sydney
94 (AU): Standards Australia; 2021 May. Prepared by the Standards Australia Technical Committee on Security for
95 Health Care Facilities (HT-008).
96 Standards Australia. Base-building physical security handbook — Terrorism and extreme violence. SA HB 188:2021.
97 Sydney (AU): Standards Australia; 2021 Dec. Prepared by the Standards Australia Technical Committee
98 (HB-188).
99
100 Clause 6.3.2 b) of AS ISO 15189:2023 specifies that the medical laboratory
101
102
103
104 Clause 6.3.2 c) of AS ISO 15189:2023 specifies that the medical laboratory
105
106
107
108
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109 Clause 6.3.2 d) of AS ISO 15189:2023 specifies that the medical laboratory must provide
110 relevant maintained safety devices and facilities according to laboratory activities.
111 Clause 6.3.2 d) of AS ISO 15189:2023 has not specified for safety devices and facilities7
112 that the medical laboratory are required to provide [Clause 6.3.2 d) of
113 AS ISO 15189:2023]; it can be open to interpretation. However, the medical laboratory
114 is required to provide relevant emergency devices and facilities that are reasonably
115 practicable to minimise risks to health and safety. Clause 6.3.2 d) of AS ISO 15189:2023
116 has listed examples, as follows: emergency release, intercom, and alarm systems for
117 walk-in coolers and freezers8; emergency shower9-11; emergency eyewash12,13,11,14; and
118 resuscitation equipment.
119
120 The medical laboratory must provide the following facilities in accordance with
121 Standards Australia: at least seven (≥ 7) facilities:
122
123 Safety showers — Safety showers are for laboratory personnel to use for emergency
124 decontamination15-17,11. The provision of safety showers is justified by relevant
125 specifications [Clause 6.2 (Safety showers and eyewashers) of AS/NZS 2982:2010].
126 Safety showers must be supplied with potable water [Clause 3.9.4 (Safety shower and
127 eyewash) of AS/NZS 2982:2010]. The medical laboratory must ensure safety showers
128 are maintained in accordance with relevant maintenance specifications [Clause 6.8
129 (Maintenance and training) of AS 4775―2007; Subclause 10.4
130 (Emergency/drench showers) of ISO 15190:2020]. The medical laboratory can seek
131 further information from the AHIA relating to safety showers for specified floor areas
132 (≥ 1.00 m2)18.
133
134 Safety eyewash or eye/face wash facility — Safety eyewash or eye/face wash facility
135 is for laboratory personnel to use for emergency decontamination15-17,11. The provision
136 of safety eyewash or eye/face wash facility is justified by relevant specifications
137 [Clause 6.2 (Safety showers and eyewashers) of AS/NZS 2982:2010]. Safety eyewash or
138 eye/face wash facility must be supplied with potable water [Clause 3.9.4 (Safety shower
139 and eyewash) of AS/NZS 2982:2010]. The medical laboratory must ensure safety
140 showers are maintained in accordance with relevant maintenance specifications
141 [Clause 7.6 (Maintenance and training) of AS 4775―2007; Subclause 10.3
142 (Eyewash facilities) of ISO 15190:2020].
143
144 Fire extinguishers — Fire extinguishers are for laboratory personnel to use for
145 suppression of fire. The provision of fire extinguishers is justified by relevant
146 specifications [Clause 2.6.1 (General) AS 2243.1:2021]. The medical laboratory must
147 ensure the installation meeting relevant installation specifications [Clause 3.2
148 (Extinguisher location) of AS 2444—2001]. The medical laboratory must ensure fire
149 extinguishers are maintained in accordance with relevant maintenance specifications
150 [Clause 10.2 (Routine service process and procedures) of AS 1851—2012;
151 Subclause 11.1.6.2 (Portable fire extinguishers) of ISO 15190:2020]. The medical
152 laboratory can seek further consideration factors from the AHIA relating to fire
153 extinguisher implementation19.
154
155 Fire blankets — Fire blankets are for laboratory personnel to use for suppression of fire.
156 The provision of safety showers is justified by relevant specifications [Clause 2.6.1
157 (General) AS 2243.1:2021]. The medical laboratory must ensure the installation meeting
158 relevant installation specifications [Clause 6.3 (Location) of AS 2444—2001]. The
159 medical laboratory must ensure fire blankets are maintained in accordance with relevant
160 maintenance specifications [Clause 11.2 (Routine service process and procedures) of
161 AS 1851—2012; Subclause 11.1.6.3 (Use of fire blankets) of ISO 15190:2020]. The
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162 medical laboratory can seek further consideration factors from the AHIA relating to fire
163 blankets implementation19.
164
165 First aid facilities and supplies — First aid facilities and supplies are for laboratory
166 personnel to treat minor injuries. The provision of first aid facilities and supplies is
167 justified by relevant specifications [Clause 2.6.1 (General) AS 2243.1:2021; Clause 6.1
168 (General) of AS/NZS 2982:2010; Subclause 10.2 (First aid equipment and procedures) of
169 ISO 15190:2020]. The provision is supported by further justified specifications15,20-22.
170
171 Spill kits — Spill kits are for laboratory personnel to contain and control spills. The
172 provision of spill kits is justified by relevant specifications [Clause 2.6.1 (General)
173 AS 2243.1:2021; Subclause 10.5 (Spill response) of ISO 15190:2020].
174
175 A manual containing safety procedures — A manual containing safety procedures is
176 for laboratory personnel to use providing instructions on how to perform safety
177 procedures. The provision of a manual containing safety procedures is justified by
178 relevant specifications [Clause 2.6.1 (General) AS 2243.1:2021; Subclause 5.6
179 (Safety manual) of ISO 15190:2020].
180
181 The medical laboratory should also consider the provision of the following facilities:
182 emergency release, intercom, and alarm systems for walk-in coolers and freezers8
183 in accordance with maintenance specifications (Clause 5.1.1 of AS/NZS 5149.4:2016);
184 and security door release in accordance with maintenance specifications [Clause 1.12
185 (Systems interface test) of AS 1851—2012].
186
187 Clause 6.3.2 e) of AS ISO 15189:2023 specifies that the medical laboratory must
188 maintain laboratory facilities in a functional and reliable condition. The medical
189 laboratory can support the maintenance of laboratory facilities by implementing
190 comprehensive preventive maintenance programmes. The maintenance of laboratory
191 facilities has three (3) main implementation considerations.
192
193 First, the installed equipment must be maintained based on the manufacturer’s
194 requirements [Clause 6.4.5 a) of AS ISO 15189:2023] and in accordance with relevant
195 accreditation requirements. The medical laboratory must ensure the installed
196 equipment are strictly maintained in accordance with specifications of the National
197 Association of Testing Authorities, Australia, as follows:
198 • National Association of Testing Authorities, Australia. General accreditation guidance: general
199 equipment table. Rhodes (AU): National Association of Testing Authorities, Australia; 2023 Mar.
200
201 Second, the laboratory furniture must be maintained in accordance with relevant
202 specifications. The medical laboratory should have little or no fixed joinery23.
203
204 Third, the physical environmental elements must be maintained in accordance with
205 relevant specifications. The medical laboratory can implement preventive maintenance
206 programmes in accordance with eight (8) common building elements24, as follows:
207 Substructure — Components can include drainage and foundations;
208 Masonry works — Components can include parapets, lintels, beams, columns;
209 Doors, windows and corridors — Components can include doors, double glazing,
210 windows, and window frames. The medical laboratory should have minimal doors
211 between the laboratory areas25;
212 Roofing structures — Components can include felt roofs and tiled roofs;
213 Internal fabric — Components can include internal partitions and demountable
214 partitions;
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215 Internal finishes — Components can include wall finishes, floor finishes, and ceiling
216 finishes26;
217 Services — Components can include: heating, ventilation and air conditioning; electrical
218 services; fire safety, hydraulic services, information technology; luminaries; pneumatic
219 tube system, and plumbing system27.
220 External walls — Components can include curtain walling and external walls.
221
222 The medical laboratory must ensure the facilities are strictly constructed and installed
223 in accordance with specifications of the relevant National Construction Code, as follows:
224 • Australian Building Codes Board. Building Code of Australia. Volume One. Canberra (AU): Australian
225 Building Codes Board; 2023 May. (National Construction Code);
226 • Australian Building Codes Board. Building Code of Australia. Volume Two. Canberra (AU): Australian
227 Building Codes Board; 2023 May. (National Construction Code); and
228 • Australian Building Codes Board. Plumbing Code of Australia. Volume Three. Canberra (AU): Australian
229 Building Codes Board; 2023 May. (National Construction Code).
230
231
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232 Clause 6.3.3 (Storage facilities) of AS ISO 15189:2023
233
234 Clause 6.3.3 a) of AS ISO 15189:2023 specifies that the medical laboratory must provide
235 adequate storage space with suitable environmental conditions to maintain continual
236 integrity of specified items. The medical laboratory must ensure the storage space has
237 controllable temperature and humidity measures and is vermin-proof to support the
238 maintenance of integrity of items. The six (6) specified items include:
239
240 Samples28,29 — The storage facilities for samples are for the medical laboratory to store
241 samples pre-examination and post-examination when not in use. Different types of
242 samples require different environmental conditions in the specific storage area. The
243 medical laboratory should store samples in accordance with the recommended
244 temperatures30: refrigerator (2 °C to 8 °C); freezer (≤ -20 °C); and deep freezer (≤ -70 °C).
245 It is important to note that household type refrigerators and freezers31 are not
246 recommended for sample storage due to freeze/thaw cycles used for defrosting32. It is
247 highly likely that analytes are degraded by such freeze/thaw cycles. The medical
248 laboratory must ensure adequate floor areas are allocated for sample storage for
249 pre-examination and post-examination.
250
251 Equipment33 — The storage facilities for equipment are for the medical laboratory to
252 store and recharging of mobile equipment when not in use. The equipment must be
253 located where exposure to sunlight is within the specified solar intensity acceptable
254 limited (≤ 100 W/m2) [Clause 2.2 (Protection against sunlight) of AS/NZS 2982:2010].
255 When the equipment is stalled in place, the medical laboratory needs to ensure the aisle
256 width of working spaces between floor-position equipment must be within the specified
257 distance [Clause 2.10 (Aisles) of AS/NZS 2982:2010]. The medical laboratory must also
258 consider the clearance requirements around the equipment for maintenance. The
259 medical laboratory needs to determine whether the equipment is suitable to be stored in
260 a polluted micro-environment. The pollution degrees are established in accordance with
261 creepage distances and clearances that can be breached by solid particles, dust, and
262 water [Subclause 4.5.2 (Degrees of pollution in the micro-environment) of
263 IEC 60664-1:2020]. The four (4) pollution degrees include: Pollution Degree 1 (no
264 pollution or only dry, non-conductive pollution occurs. The pollution has no influence);
265 Pollution Degree 2 (only non-conductive pollution occurs except that occasionally a
266 temporary conductivity caused by condensation is to be expected. This condensation
267 may occur during periods of on-off load cycles of the equipment); Pollution Degree 3
268 (conductive pollution occurs or dry non-conductive pollution occurs which becomes
269 conductive due to condensation which is to be expected); and Pollution Degree 4
270 (continuous conductivity occurs due to conductive dust, rain or other wet conditions).
271 The medical laboratory also needs to determine whether the equipment is suitable to be
272 stored in proximity to areas with explosive atmospheres. Three (3) types of hazardous
273 area are classified [Section 5 (Hazardous area classification methodology) of
274 AS/NZS IEC 60079.10.1:2022]: Zone 0 (area in which an explosive gas atmosphere is
275 present continuously, or for long periods, or frequently); Zone 1 (area in which an
276 explosive gas atmosphere is likely to occur occasionally in normal operation); and Zone 2
277 (area in which an explosive gas atmosphere is not likely to occur in normal operation,
278 but, if it does occur, will exist for a short period only). The medical laboratory can seek
279 further information from the AHIA relating to the storage facility for equipment for
280 specified floor areas (10.00 m2 and 20.00 m2)34,35. The medical laboratory must ensure
281 adequate floor areas are allocated for equipment storage36.
282
283 Reagents37,38 — The storage facilities for reagents are for the medical laboratory to store
284 non-hazardous and hazardous substances and articles when not in use. The location
285 must not be in the proximity from direct heat, sunlight, or highly variable temperatures
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286 [Subclause8.5.1 e) of ISO 15190:2020]. The sunlight exposure must be within the
287 specified solar intensity acceptable limited (≤ 100 W/m2) [Clause 2.2 (Protection against
288 sunlight) of AS/NZS 2982:2010]. The medical laboratory must implement additional
289 relevant control measures to ensure the laboratory personnel safety remains
290 acceptable39. When chemicals are stored in the medical laboratory, acceptable enclosed
291 storage and open storage practices must be observed [Clause 7.4 (Method of keeping
292 chemicals) of AS 2243.2:2021]. Chemicals can also be stored in a separate store, so that
293 acceptable limits can be achieved [Clause 8.5 (Method of storage) of AS 2243.2:2021]. It
294 is important to note that the maximum quantities of hazardous chemicals in storage
295 within the medical laboratory are specified [Clause 7.3.2 (Maximum quantities of
296 hazardous chemicals in storage within a laboratory) of AS 2243.2:2021]. The medical
297 laboratory must not exceed the specifications.
298
299 The medical laboratory must ensure the hazardous substances and articles to relevant
300 classes and divisions in accordance with the hazard or the most predominant of the
301 hazards they present, including mixtures and solutions, are classified in accordance with
302 the Australian Code for the Transport of Dangerous Goods by Road and Rail (ADG Code),
303 as follows:
304 • National Transport Commission. Australian Code for the Transport of Dangerous Goods by Road & Rail.
305 7th ed. Melbourne (AU): National Transport Commission; 2023 Mar. Edition 7.8.
306
307 The nine (9) classes are40: Class 1 (explosives); Class 2 (gases); Class 3 (flammable
308 liquids); Class 4 (flammable solids; substances liable to spontaneous combustion;
309 substances which, on contact with water, emit flammable gases); Class 5 (oxidising
310 substances and organic peroxides); Class 6 (toxic and infectious substances); Class 7
311 (radioactive material); Class 8 (corrosive substances); and Class 9 (miscellaneous
312 dangerous substances and articles, including environmentally hazardous substances).
313 The ADG Code, also assigns packing group numbers, excluding substances of Class 1,
314 Class 2 and Class 7, Division 5.2 and Division 6.2 and other than self-reactive substances
315 of Division 4.1, to substances and articles in accordance with the degree of danger they
316 present. The three (3) packing groups are41: Packing Group I (PG I) (substances
317 presenting high danger); Packing Group II (PG II) (substances presenting medium
318 danger); and Packing Group III (PG III) (substances presenting low danger). The
319 ADG Code (Column 5 of Table 3.2.3)42 details the packing group number assigned to the
320 article or substance (PG I, PG II or PG III). The medical laboratory must note the
321 ADG Code information when hazardous substances are stored. The medical laboratory
322 should also consult with applicable Australian Standards for specific hazardous chemical
323 stores that are commonly used: AS 1940:201743 for Class 3 dangerous goods and
324 AS 3780―200844 for Class 8 dangerous goods. The medical laboratory can seek further
325 information from the AHIA relating to the storage facility for reagents for specified floor
326 area (9.00 m2)45.
327
328 Consumables37,46 — The storage facilities for consumables are for the medical
329 laboratory to store consumables when not in use. The location must not be in the
330 proximity from direct heat, sunlight or highly variable temperatures [Subclause8.5.1 e)
331 of ISO 15190:2020]. The medical laboratory should not hold excessive supplies other
332 than those for immediate use47. Consumables that do not have assigned expiration dates
333 should be subject to the inventory practice of ‘first-in, first-out (FIFO)’ to ensure stock
334 rotation48. The medical laboratory can support such inventory control by implementing
335 a software system to monitor the material movement49. The medical laboratory can seek
336 further information from the AHIA relating to the storage facility for consumables for
337 specified floor area (9.00 m2)45.
338
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339 Documents50,6 — The storage facilities for documents are for the medical laboratory to
340 store documents when not in use. The location should be a secure area that protects
341 documents from misuse and loss and from unauthorised access, modification and
342 disclosure [Clause 7 (Storage) of ISO 19475:2021]. The medical laboratory must ensure
343 the storage environmental conditions are able to retain documents to specified retention
344 periods: laboratory methods and procedures (≥ 4 years)51. The medical laboratory can
345 seek further information from the AHIA relating to the storage facility for documents for
346 specified floor areas (10.00 m2 and 20.00 m2)34,35.
347
348 Records6,52,53 — The storage facilities for records are for the medical laboratory to store
349 records when not in use. The location should be a secure area that protects non-current
350 records from misuse and loss and from unauthorised access, modification and disclosure
351 [Clause 9.6 (Storing records) of AS ISO 15489.1:2017]. The medical laboratory should
352 consider the length of storage and the conditions required to retain and store the records
353 [Clause 2.3.3 (Internal environment) of AS/NZS 1015:2011; Clause 5.2.4 (Storage and
354 preservation) AS ISO 10013:2022]. The medical laboratory must ensure the storage
355 environmental conditions are able to retain records to specified long-term retention
356 periods: records of accidents and dangerous occurrences (≥ 30 years)54, reports of
357 constitutional genetic testing (≥ 100 years)55, and pathology request forms (no minimum
358 retention time)51. The medical laboratory can seek further information from the AHIA
359 relating to the storage facility for the storage facility for records for specified floor areas
360 (10.00 m2 and 20.00 m2)34,35.
361
362 Clause 6.3.3 b) of AS ISO 15189:2023 specifies that the medical laboratory must store
363 patient samples and materials used in examination processes in a manner that prevents
364 cross-contamination and deterioration. The storage facilities for samples and materials
365 post-examination must remain clean with regular decontamination to minimise
366 contamination and cross-contamination. In addition, the medical laboratory should
367 establish a structured flow of rotation to ensure samples and materials stay in the
368 designated locations and are properly marked to indicate the status, reducing the risk
369 of accidental contamination. The medical laboratory should store samples
370 in accordance with the recommended temperatures30: refrigerator (2 °C to 8 °C);
371 freezer (≤ -20 °C); and deep freezer (≤ -70 °C). It is important to note that household
372 type refrigerators and freezers31 are not recommended for sample storage due to
373 freeze/thaw cycles used for defrosting32. It is highly likely that the analytes are
374 degraded by such freeze/thaw cycles. The medical laboratory must prevent
375 cross-contamination and deterioriation for samples and materials during storage
376 post-examination.
377
378 Clause 6.3.3 c) of AS ISO 15189:2023 specifies that the medical laboratory must provide
379 storage and disposal facilities for hazardous materials and biological materials. Suitable
380 facilities must be provided for the safe temporary storage of wastes until they are
381 disposed of by acceptable means [Clause 7.7 (Storage for solid and liquid wastes) of
382 AS/NZS 2982:2010]. Clause 6.3.3 c) of AS ISO 15189:2023 has stated four (4)
383 specifications, as follows:
384
385 Storage facilities for hazardous materials — The provision of storage facilities for
386 hazardous materials is for the medical laboratory to store hazardous materials
387 appropriately. The medical laboratory can store the hazardous materials classified
388 in accordance with the ADG Code. The medical laboratory must take into account any
389 specific storage requirements for the applicable hazardous class of the materials
390 [Section 7 (Waste storage) of AS 3816:2018].
391
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392 Disposal facilities for hazardous materials — The provision of disposal facilities for
393 hazardous materials is for the medical laboratory to dispose of hazardous materials
394 appropriately. The medical laboratory must ensure the disposal of hazardous materials
395 meeting the requirements of the relevant regulations [Clause 4.9.13 (Waste disposal) of
396 AS 2243.2:2021; Section 9 (Waste treatment and disposal) of AS 3816:2018]. The
397 medical laboratory must take further considerations when handling nanomaterial waste
398 [Clause 4.9.13 (Waste disposal) of AS 2243.2:2021].
399
400 Storage facilities for biological waste — The provision of storage facilities for
401 biological waste is for the medical laboratory to store biological waste appropriately. The
402 medical laboratory must ensure the receptacles used need to have specific colours and
403 markings [Clause 5.5 (Receptables ― Colours and markings) of AS 3816:2018].
404
405 Disposal facilities for biological waste — The provision of disposal facilities for
406 biological waste is for the medical laboratory to dispose of biological waste appropriately.
407 The medical laboratory must ensure the disposal of biological waste meeting the
408 requirements of the relevant regulations [Section 9 (Waste treatment and disposal) of
409 AS 3816:2018]. If dilution pits and vents in the liquid waste disposal system is to be used,
410 the locality safety distance (≥ 6 m) from mechanical ventilation outdoor air intakes is to
411 be strictly followed [Clause 3.9.5 (Disposal of liquid waste) of AS/NZS 2982:2010].
412
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413 Clause 6.3.4 (Personnel facilities) of AS ISO 15189:2023
414 Clause 6.3.4 of AS ISO 15189:2023 specifies that the medical laboratory must provide
415 relevant personnel facilities for laboratory personnel. Consideration must be given to
416 ensuring that laboratory personnel have after-hours access without having to travel
417 outside the immediate work area56. Clause 6.3.4 of AS ISO 15189:2023 specifies four (4)
418 facilities, as follows:
419 Toilet facilities — The provision of toilet facilities is for laboratory personnel to dispose
420 of waste appropriately. The medical laboratory must provide toilets for all laboratory
421 personnel while they are at work57. Toilets must be located outside the medical
422 laboratory area in non-hazardous areas [Clause 2.15 (Lunch rooms and toilets) of
423 AS/NZS 2982:2010]. The medical laboratory must ensure the ratio of toilets to the
424 number of workers and the specifications for toilets are in accordance with the
425 National Construction Code, as follows:
426 • Australian Building Codes Board. Building Code of Australia. Volume One. Canberra (AU): Australian
427 Building Codes Board; 2023 May. (National Construction Code).
428 • Australian Building Codes Board. Building Code of Australia. Volume Two. Canberra (AU): Australian
429 Building Codes Board; 2023 May. (National Construction Code).
430 The medical laboratory should ensure each staff toilet closet occupy a specified floor area
431 (≥ 3.00 m2)58.
432 Supply of drinking water — The provision of potable water is for laboratory personnel
433 to consume to reduce the likelihood of dehydration. The medical laboratory must supply
434 potable water to laboratory personnel for consumption with adequate access. The water
435 must be provided free of charge for laboratory personnel59. Potable water outlets must
436 be installed outside the medical laboratory area in non-hazardous areas [Clause 2.2.4
437 (Eating facilities) of AS 2243.1:2021; Clause 3.9.3 (Drinking water) of
438 AS/NZS 2982:2010]. The water temperature should be provided at a specified
439 temperature (≤ 24° C)59.
440 Storage facilities of personal protective equipment — The storage facilities for
441 personal protective equipment are for laboratory personnel to store personal protective
442 equipment when not in use. The storage facilities should be separated from storage
443 facilities for personal clothing to prevent cross-contamination60. The storage facilities
444 should be accessible and secure60.
445 Storage facilities of personal clothing — The storage facilities for personal clothing
446 are for laboratory personnel to store spare personal items. The storage facilities should
447 be accessible and secure60.
448
449 Clause 6.3.4 of AS ISO 15189:2023 recommends the medical laboratory to provide space
450 for relevant personnel activities. Clause 6.3.4 of AS ISO 15189:2023 has listed three (3)
451 examples, as follows:
452 Space for meetings — The meeting area is for laboratory personnel to have briefings,
453 group discussions, or working sessions between some or all the laboratory personnel.
454 The medical laboratory is recommended to provide a suitable meeting area based on the
455 size of the organisation, the dgree of bureaucracy, the number of visitors, and whether
456 the arrangements are open or cellular plan61.
457 Space for quiet study — The quiet study area is for laboratory personnel to write up
458 notes, read and review information in privacy. The medical laboratory should consider
459 to control the background noise level around the study area62.
460 Space for rest — The rest area is for laboratory personnel to use for rest and respite
461 during meal breaks. The medical laboratory should consider to control the backgroud
462 noise level around the rest area62.
463
464 The medical laboratory should provide appropriate space for eating facilities, according
465 to the following considerations:
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466 Space for eating facilities — The space for eating facilities is for laboratory personnel
467 to use for consumption, preparation and storage of drinks and food. The medical
468 laboratory should locate eating facilities outside the medical laboratory area to prevent
469 cross-contamination [Clause 2.2.4 (Eating facilities) of AS 2243.1:2021; Clause 2.15
470 (Lunch rooms and toilets) of AS/NZS 2982:2010]. The main factor which determines the
471 area size is the number of laboratory personnel who are likely to consume meals on the
472 premises63. The medical laboratory is recommended to provide a separate eating area
473 when specified number of laboratory personnel consumes meal at the medical
474 laboratory at the same time (≥ 10 laboratory personnel)64. Each eating area should have
475 a specified space area for each person at any one time (≥ 1 m2)64.
476
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477 Clause 6.3.5 (Sample collection facilities) of AS ISO 15189:2023
478 Clause 6.3.5 of AS ISO 15189:2023
479
480
481
482
483
484
485
486
487
488
489 AS ISO 20658:202365
490
491
492 Standards Australia. Requirements for the collection and transport of samples for medical laboratory examinations.
493 AS ISO 20658:2023. 2nd ed. Sydney (AU): Standards Australia; 2023 May. Prepared by the Standards Australia
494 Technical Committee on Clinical Laboratory Testing and In Vitro Diagnostic Test Systems (HE-029).
495
496
497
498
499
500
501
502
503
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504 Harmonisation or specialisation?
505 Motivation for harmonisation —
506 Motivation for specialisation —
507
508
509 Implications for Impeccable ISO 15189:2022 Lead Auditors
510
511
512 Implications for Impeccable ISO 15189:2022 Lead Implementers
513
514
515
516
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517 References
518
519
520
521
522
523 1. Palgrave Macmillan, editor. The statesman's yearbook 2024: the politics, cultures
524 and economies of the world. London (GB): Springer Nature, Palgrave Macmillan; 2023
525 Nov. International Labour Organization (ILO); p. 16.
526 2. Palgrave Macmillan, editor. The statesman's yearbook 2024: the politics, cultures
527 and economies of the world. London (GB): Springer Nature, Palgrave Macmillan; 2023
528 Nov. International Organization for Standardization (ISO); p. 44.
529 3. Union of International Associations, editor. Yearbook of international
530 organizations 2023 - 2024: guide to global civil society networks. 60th ed. Vol. 1,
531 Organization descriptions and cross-references. Leiden (NL): Brill; 2023 Jul. WHO ‒
532 World Health Organization; p. ????
533 4. Palgrave Macmillan, editor. The statesman's yearbook 2024: the politics, cultures
534 and economies of the world. London (GB): Springer Nature, Palgrave Macmillan; 2023
535 Nov. World Health Organization (WHO); p. 20-21.
536 5. Australasian Health Infrastructure Alliance. Australasian health facility
537 guidelines: part C - Design for access, mobility, safety and security. Revision 6.0 ed. St.
538 Leonards (AU): Australasian Health Infrastructure Alliance; 2021 Nov. Section 6.8, Access
539 control; p. 81.
540 6. Atkin B, Brooks A. Total facility management. 5th ed. Hoboken (NJ): John Wiley &
541 Sons, Wiley-Blackwell; 2021 Apr. Chapter 17, Information management; p. 373-409.
542 7. Gasdorf T. Emergency devices. In: Dittrich E, editor. The sustainable laboratory
543 handbook: design, equipment, operation. Weinheim (DE): John Wiley & Sons, Wiley-VCH;
544 2015 Apr. p. 333-338.
545 8. Australasian Health Infrastructure Alliance. Australasian health facility
546 guidelines: part B - Health facility briefing and planning: 0550 – Pathology unit. Revision
547 7.0 ed. St. Leonards (AU): Australasian Health Infrastructure Alliance; 2022 May. Section
548 3.9.4, Refrigeration/freezer needs; p. 29.
549 9. DiBerardinis LJ, Baum JS, First MW, Gatwood GT, Seth AK. Guidelines for
550 laboratory design: health, safety, and environmental considerations. 4th ed. Hoboken
551 (NJ): John Wiley & Sons; 2013 Apr. Appendix A, Emergency showers; p. 483-484.
552 10. Gasdorf T. Emergency devices. In: Dittrich E, editor. The sustainable laboratory
553 handbook: design, equipment, operation. Weinheim (DE): John Wiley & Sons, Wiley-VCH;
554 2015 Apr. p. Section 26.2, Body showers; p. 334.
555 11. Australasian Health Infrastructure Alliance. Australasian health facility
556 guidelines: part B - Health facility briefing and planning: 0550 – Pathology unit. Revision
557 7.0 ed. St. Leonards (AU): Australasian Health Infrastructure Alliance; 2022 May. Section
558 4.2.5, Emergency shower/eye wash; p. 40.
559 12. DiBerardinis LJ, Baum JS, First MW, Gatwood GT, Seth AK. Guidelines for
560 laboratory design: health, safety, and environmental considerations. 4th ed. Hoboken
561 (NJ): John Wiley & Sons; 2013 Apr. Appendix B, Emergency eyewash units; p. 485.
562 13. Gasdorf T. Emergency devices. In: Dittrich E, editor. The sustainable laboratory
563 handbook: design, equipment, operation. Weinheim (DE): John Wiley & Sons, Wiley-VCH;
564 2015 Apr. p. Section 26.3, Eye-washer; p. 334.
565 14. Garg A. Monitoring tools for setting up the hospital project: department-wise
566 planning. Singapore (SG): Springer Nature Singapore, Springer; 2023 Nov. Section 9.8.1.8,
567 Emergency eyewash station; p. 336.
568 15. International Labour Organization. Safety in the use of chemicals at work. Geneva
569 (CH): International Labour Organization, International Labour Office; 1993 Jan. Section
570 14.2.5; p. 54.
 Page 16 of
571 16. Safe Work Australia. Code of Practice: first aid in the workplace. Canberra (AU):
572 Safe Work Australia; 2019 Jul. Eye wash and shower equipment; p. 15.
573 17. World Health Organization. Laboratory design and maintenance. Geneva (CH):
574 World Health Organization; 2020 Sep. Subsection 2.2.2, Chemicals; p. 4. (Laboratory
575 biosafety manual, fourth edition and associated monographs).
576 18. Australasian Health Infrastructure Alliance. Bay - Emergency shower. Revision 3
577 ed. St. Leonards (AU): Australasian Health Infrastructure Alliance; 2017 Mar. Room data
578 sheet. Room code BES.
579 19. Australasian Health Infrastructure Alliance. Australasian health facility
580 guidelines: part B - Health facility briefing and planning: 0550 – Pathology unit. Revision
581 7.0 ed. St. Leonards (AU): Australasian Health Infrastructure Alliance; 2022 May. Section
582 3.10.5, Fire safety; p. 32.
583 20. Safe Work Australia. Code of Practice: first aid in the workplace. Canberra (AU):
584 Safe Work Australia; 2019 Jul. Automated external defibrillators; p. 14-15.
585 21. Safe Work Australia. Code of Practice: first aid in the workplace. Canberra (AU):
586 Safe Work Australia; 2019 Jul. Section 3.1, First aid kits; p. 12-13.
587 22. Safe Work Australia. Code of Practice: first aid in the workplace. Canberra (AU):
588 Safe Work Australia; 2019 Jul. Section 3.4, First aid facilities; p. 15-16.
589 23. Australasian Health Infrastructure Alliance. Australasian health facility
590 guidelines: part B - Health facility briefing and planning: 0550 – Pathology unit. Revision
591 7.0 ed. St. Leonards (AU): Australasian Health Infrastructure Alliance; 2022 May. Section
592 3.9.2, Laboratory furniture; p. 29.
593 24. Wiggins JM. Facilities manager's desk reference. 3rd ed. Hoboken (NJ): John Wiley
594 & Sons, Wiley-Blackwell; 2020 Dec. Chapter 25, Maintenance – Definitions and strategies;
595 p. 357-370.
596 25. Australasian Health Infrastructure Alliance. Australasian health facility
597 guidelines: part B - Health facility briefing and planning: 0550 – Pathology unit. Revision
598 7.0 ed. St. Leonards (AU): Australasian Health Infrastructure Alliance; 2022 May. Section
599 3.6.2, Doors, windows and corridors; p. 26.
600 26. Australasian Health Infrastructure Alliance. Australasian health facility
601 guidelines: part B - Health facility briefing and planning: 0550 – Pathology unit. Revision
602 7.0 ed. St. Leonards (AU): Australasian Health Infrastructure Alliance; 2022 May. Section
603 3.8, Finishes; p. 28-29.
604 27. Australasian Health Infrastructure Alliance. Australasian health facility
605 guidelines: part B - Health facility briefing and planning: 0550 – Pathology unit. Revision
606 7.0 ed. St. Leonards (AU): Australasian Health Infrastructure Alliance; 2022 May. Section
607 3.10, Building service requirements; p. 29-34.
608 28. Australasian Health Infrastructure Alliance. Australasian health facility
609 guidelines: part B - Health facility briefing and planning: 0550 – Pathology unit. Revision
610 7.0 ed. St. Leonards (AU): Australasian Health Infrastructure Alliance; 2022 May. Storage
611 - Slides and tissue blocks; p. 15.
612 29. Australasian Health Infrastructure Alliance. Australasian health facility
613 guidelines: part B - Health facility briefing and planning: 0550 – Pathology unit. Revision
614 7.0 ed. St. Leonards (AU): Australasian Health Infrastructure Alliance; 2022 May. Storage
615 - Specimens; p. 14.
616 30. Australian Commission on Safety and Quality in Health Care, National Pathology
617 Accreditation Advisory Council,. Requirements for the retention of laboratory records
618 and diagnostic material. 9th ed. Sydney (AU): Australian Commission on Safety and
619 Quality in Health Care; 2022. Commentary C1.2(i); p. 13.
620 31. American Society of Heating, Refrigerating and Air-Conditioning Engineers,.
621 2022 ASHRAE handbook—Refrigeration. Peachtree Corners (GA): American Society of
622 Heating, Refrigerating and Air-Conditioning Engineers; 2022 Jun. Chapter 17, Household
623 refrigerators and freezers; p. 17.1-17.13. Prepared by the American Society of Heating,
 Page 17 of
624 Refrigerating and Air-Conditioning Engineers Technical Committee on Residential
625 Refrigerators and Food Freezers (TC 8.9).
626 32. Australian Commission on Safety and Quality in Health Care, National Pathology
627 Accreditation Advisory Council,. Requirements for the retention of laboratory records
628 and diagnostic material. 9th ed. Sydney (AU): Australian Commission on Safety and
629 Quality in Health Care; 2022. Commentary C1.2(ii); p. 13.
630 33. Atkin B, Brooks A. Total facility management. 5th ed. Hoboken (NJ): John Wiley &
631 Sons, Wiley-Blackwell; 2021 Apr. Chapter 13, Maintenance management; p. 266-291.
632 34. Australasian Health Infrastructure Alliance. Store - Files, 10m2. Revision 6 ed. St.
633 Leonards (AU): Australasian Health Infrastructure Alliance; 2022 Jun. Room data sheet.
634 Room code STFS-10.
635 35. Australasian Health Infrastructure Alliance. Store - Files, 20m2. Revision 6 ed. St.
636 Leonards (AU): Australasian Health Infrastructure Alliance; 2022 Jun. Room data sheet.
637 Room code STFS-20.
638 36. Heinekamp C. Introduction: laboratory typologies. In: Dittrich E, editor. The
639 sustainable laboratory handbook: design, equipment, operation. Weinheim (DE): John
640 Wiley & Sons, Wiley-VCH; 2015 Apr. Section 1.5.7, Determination of areas for the
641 laboratory equipment; p. 11.
642 37. Australasian Health Infrastructure Alliance. Australasian health facility
643 guidelines: part B - Health facility briefing and planning: 0550 – Pathology unit. Revision
644 7.0 ed. St. Leonards (AU): Australasian Health Infrastructure Alliance; 2022 May. Storage
645 - Hazardous substances; p. 16.
646 38. Australasian Health Infrastructure Alliance. Australasian health facility
647 guidelines: part B - Health facility briefing and planning: 0550 – Pathology unit. Revision
648 7.0 ed. St. Leonards (AU): Australasian Health Infrastructure Alliance; 2022 May. Storage
649 - Reagents; p. 15.
650 39. DiBerardinis LJ, Baum JS, First MW, Gatwood GT, Seth AK. Guidelines for
651 laboratory design: health, safety, and environmental considerations. 4th ed. Hoboken
652 (NJ): John Wiley & Sons; 2013 Apr. Section 15.4.3, Chemical storage; p. 225.
653 40. National Transport Commission. Australian Code for the Transport of Dangerous
654 Goods by Road & Rail. 7th ed. Melbourne (AU): National Transport Commission; 2023
655 Mar. Edition 7.8. Chapter 2.0.1.1, Definitions; p. 68-69.
656 41. National Transport Commission. Australian Code for the Transport of Dangerous
657 Goods by Road & Rail. 7th ed. Melbourne (AU): National Transport Commission; 2023
658 Mar. Edition 7.8. Chapter 2.0.1.3; p. 70.
659 42. National Transport Commission. Australian Code for the Transport of Dangerous
660 Goods by Road & Rail. 7th ed. Melbourne (AU): National Transport Commission; 2023
661 Mar. Edition 7.8. Table 3.2.3, Dangerous goods list; p. 219-355.
662 43. Standards Australia. The storage and handling of flammable and combustible
663 liquids. AS 1940:2017. 6th ed. Sydney (AU): Standards Australia; 2021 Jun. Incorporating
664 Amendment No. 1 (2019) and Amendment No. 2 (2021). Prepared by the Standards
665 Australia Technical Committee on Flammable and Combustible Liquids (ME-017).
666 44. Standards Australia. The storage and handling of corrosive substances. AS
667 3780―2008. 2nd ed. Sydney (AU): Standards Australia; 2009 Feb. Reissued
668 incorporating Amendment No. 1 (2009). Prepared by the Joint Standards
669 Australia/Standards New Zealand Technical Committee (CH-009).
670 45. Australasian Health Infrastructure Alliance. Store - General. Revision 6 ed. St.
671 Leonards (AU): Australasian Health Infrastructure Alliance; 2021 Jun. Room data sheet.
672 Room code STGN.
673 46. Australasian Health Infrastructure Alliance. Australasian health facility
674 guidelines: part B - Health facility briefing and planning: 0550 – Pathology unit. Revision
675 7.0 ed. St. Leonards (AU): Australasian Health Infrastructure Alliance; 2022 May. Storage
676 - Media; p. 15.
 Page 18 of
677 47. World Health Organization. Laboratory design and maintenance. Geneva (CH):
678 United Nations, World Health Organization; 2020 Sep. Subsection 2.2.1, Consumables
679 and reagents; p. 4. (Laboratory biosafety manual, fourth edition and associated
680 monographs).
681 48. Singer DC, Stefan R-I, van Staden JF. Laboratory auditing for quality and
682 regulatory compliance. Boca Raton (FL): Taylor & Francis Group, CRC Press; 2005 Jul.
683 Supplies organization; p. 27-28. (Swarbrick J, series editor. Drugs and the pharmaceutical
684 sciences; vol. 150).
685 49. Dittrich E. Sustainability certification – Assessment criteria and suggestions. In:
686 Dittrich E, editor. The sustainable laboratory handbook: design, equipment, operation.
687 Weinheim (DE): John Wiley & Sons, Wiley-VCH; 2015 Apr. Section 27.2.6, Consumables;
688 p. 349.
689 50. Wiggins JM. Facilities manager's desk reference. 3rd ed. Hoboken (NJ): John Wiley
690 & Sons, Wiley-Blackwell; 2020 Dec. Chapter 38, Document management services; p. 592-
691 605.
692 51. Australian Commission on Safety and Quality in Health Care, National Pathology
693 Accreditation Advisory Council,. Requirements for the retention of laboratory records
694 and diagnostic material. 9th ed. Sydney (AU): Australian Commission on Safety and
695 Quality in Health Care; 2022. Table 1, General minimum retention times; p. 14-15.
696 52. Australasian Health Infrastructure Alliance. Australasian health facility
697 guidelines: part B - Health facility briefing and planning: 0550 – Pathology unit. Revision
698 7.0 ed. St. Leonards (AU): Australasian Health Infrastructure Alliance; 2022 May. Section
699 2.2.8, Pathology requests; p. 12.
700 53. Australasian Health Infrastructure Alliance. Australasian health facility
701 guidelines: part B - Health facility briefing and planning: 0550 – Pathology unit. Revision
702 7.0 ed. St. Leonards (AU): Australasian Health Infrastructure Alliance; 2022 May. Section
703 2.2.9, Records and specimen retention; p. 12.
704 54. Dragovic D, Pryse M, Smith PA, Varvaressos T, McWilliam S, Cooper J, McWilliams
705 A, Devchand P, Chiong A, Horsfall C, Mecevic M, Mullens K. Australia. In: Farrell J, chief
706 editor,, editor. Document retention: an international review. 2nd ed. London (GB):
707 Herbert Smith Freehills; 2013 Nov. p. 4-17.
708 55. Australian Commission on Safety and Quality in Health Care, National Pathology
709 Accreditation Advisory Council,. Requirements for the retention of laboratory records
710 and diagnostic material. 9th ed. Sydney (AU): Australian Commission on Safety and
711 Quality in Health Care; 2022. Table 6, Minimum retention times for genetics (including
712 biochemical genetics, cytogenetics, molecular genetics and newborn screening); p. 20-
713 21.
714 56. Australasian Health Infrastructure Alliance. Australasian health facility
715 guidelines: part B - Health facility briefing and planning: 0550 – Pathology unit. Revision
716 7.0 ed. St. Leonards (AU): Australasian Health Infrastructure Alliance; 2022 May. Section
717 2.4.6, Staff areas; p. 22-23.
718 57. Safe Work Australia. Code of Practice: managing the work environment and
719 facilities. Canberra (AU): Safe Work Australia; 2018 May. Section 3.3, Toilets; p. 21-22.
720 58. Australasian Health Infrastructure Alliance. Toilet - Staff. St. Leonards (AU):
721 Australasian Health Infrastructure Alliance; 2021 Jan. Room data sheet. Room code WCST.
722 59. Safe Work Australia. Code of Practice: managing the work environment and
723 facilities. Canberra (AU): Safe Work Australia; 2018 May. Section 3.2, Drinking water; p.
724 21.
725 60. Safe Work Australia. Code of Practice: managing the work environment and
726 facilities. Canberra (AU): Safe Work Australia; 2018 May. Section 3.6, Personal storage; p.
727 24-25.
728 61. Worthington J. Conference and meeting facilities. In: Duffy F, Cave C, Worthington
729 J, editors. Planning office space. London (GB): Architectural Press; 1976. p. 157-163.
 Page 19 of
730 62. Bains A. Acoustic factors. In: Duffy F, Cave C, Worthington J, editors. Planning
731 office space. London (GB): Architectural Press; 1976. p. 133-139.
732 63. Drury J. Eating. In: Duffy F, Cave C, Worthington J, editors. Planning office space.
733 London (GB): Architectural Press; 1976. p. 173-179.
734 64. Safe Work Australia. Code of Practice: managing the work environment and
735 facilities. Canberra (AU): Safe Work Australia; 2018 May. Section 3.5, Eating facilities; p.
736 23-24.
737 65. Standards Australia. Requirements for the collection and transport of samples for
738 medical laboratory examinations. AS ISO 20658:2023. 2nd ed. Sydney (AU): Standards
739 Australia; 2023 Dec. Prepared by the Standards Australia Technical Committee on
740 Clinical Laboratory Testing and In Vitro Diagnostic Test Systems (HE-029).
741