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Validation and Verification of

Healthcare Ventilation Systems

Richard Knight CEng, MCIBSE, FIHEEM

Wrightington Hotel & Country Club

3rd July 2015

Content

• Legal requirements

• Designated roles

• Due diligence

• Objectives

• Commissioning

• Validation

• Verification

• Training

Legislation, why do it?

Workplace health, safety and welfare

APPROVED CODE OF PRACTICE L24:1998 now 2013 for the Workplace

(Health, Safety and Welfare) Regulations 1992

Regulation 5 Maintenance of workplace, and of equipment, devices and systems, requires access to be provided to maintain the ventilation and other systems

was

now

Workplace health, safety and welfare

APPROVED CODE OF PRACTICE L24:1998 now 2013 for the Workplace

(Health, Safety and Welfare) Regulations 1992

Regulation 6 Ventilation, requires in (1) Effective and suitable provision shall be made to ensure that every enclosed workplace is ventilated by a sufficient quantity of fresh or purified air.

The Building Regulations 2000 Ventilation approved document

F1:2010 (AMD 2013) • This requires ventilation systems to be

installed to meet HBN and HTM 03-01 and therefore commissioned and validated to these, (6.17)

• Also the approved document requires the systems to be commissioned as req CIBSE commissioning code M

• Not an exhaustive list

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The Building Regulations 2000 Ventilation approved document

F1:2010 (AMD 2013) The approved document also requires access

to be provided to maintain

1995 HTM 2023

2010

Part F1 Dig.4

Legislation, Guidance and Standards

Additionally what governs the installation and management of vent systems?

• HSE L8: 2000 now 2013 • Building regulations AD L2A and L2B:2010 AMD 2013 • BSRIA AG3 89.3/2001 Commissioning Air Systems

then BG 47:2013, now BG 47:2015

• CIBSE. Commissioning Code M: Commissioning Management:2003 (ref in AD L2A and L2B)

• CIBSE Commissioning Code A: Air Distribution Systems:1996 (2006)

• Others incl specialist sector such as Health HTM 03

What about other legal requirements?

• The Health and Safety at Work etc Act 1974 (HaSaWA)

• The Management of Health and Safety at Work Regulations 1999

• Control of substances hazardous to health ACOP HS(L)5: 2005 now 2013

• Controlling airborne contaminants at work, A guide to local exhaust ventilation (LEV) HSE HS(G)258:2011

What does DoH say? Comply with the legal requirements

This can be achieved by complying with the following:

• HTM 00: 'Policies and principles':2014

• HTM 03-01 Specialised ventilation for healthcare premises Part A design and installation and part B Operational Management: November 2007

• NHS Model engineering Specification C04 Mechanical ventilation and air conditioning systems 1993 including revisions up to 1997

• HTM 05 Fire Code (parts)

• HBN 00-07 - Resilience planning for the healthcare estates:2014

HTM 00 Policies and principles of healthcare engineering (2014 Edition)

Outlines the requirements, these include:

• Policy and operational policy (or procedures) • Statute and regulation • Professional support • Design and installation • Maintenance • Emergency preparedness • Training, information and communications • Design and safe access to engineering services.

HTM 00, Due diligence

“Any design, installation, commissioning or maintenance work should only be carried out by suitably qualified and authorised contractors.”

So this means: • Designers • Commissioners • Validators • Managers

This additionally “Evidence of current authorisation should be by sight of the correct certificate of

approval”

(HTM 00:2014 3.47)

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Designated roles

Recommends the appointment of:

• Designated Persons; (from the Trust Board!)

• Authorising Engineers;

• Authorised Persons;

• Competent Persons.

For each service e.g. water, electricity,

med gas, ventilation systems, etc....

Re affirmed for the fourth time in 7 years By the publication of HTM 00:2014

Commissioning, Validation or Verification?

• Commissioning is carried out by the contractor to set up the systems and demonstrate they work as the design intended

• Validation is carried out by the client when new or after major alterations or changes in air flow, to confirm the system is operating as designed

• Verification what is done at least annually to verify critical ventilation system are working as validated

Commissioning, Validation or verification? Standards

• CIBSE Commissioning A, W, R • Codes and BSRIA Application Guide Set COMPAK 1

this included AG 3/89.3:2001. then BG 47:2013, now BG 47:2015

• HBNs because they give the specialist advice in addition to HTM

• Other HTMs, other DoH guidance • HSE • British standards • European Standards • Other CIBSE

Commissioning

Who are the major players?

• Designers

• Mechanical and electrical contractors

• Duct installers

• AHU manufacturers

• Commissioner

Chapter 8 Validation of specialised ventilation systems HTM 03-01, Details what is required

Design

• Demonstrate that pipework can be installed

• Show volumes and static pressures for all branches and terminals

• Size of ducts

• Show test points to measure pressure and flow

Setting up for success Drawings

Design But if it cannot be measured it cannot be

delivered

Setting up for success Drawings

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Ducts step over to extend length of straight duct to accommodate traverse point, opposed blade damper and >10D between to allow space for air flow to settle down See BSRIA BG 47:2015

Supply diffusers

2500mm

Split supply duct To increase straight branch length

Where D is the distance between the blades of the opposed blade damper and their width

Compliant design leads to correct = delivery

Shown at lower level to illustrate solution

Supply diffuser

Supply diffuser

2500mm

Split supply duct To increase straight branch length

Opposed blade dampers Flexible

Test point

>10D

Where D is the distance between the blades of the opposed blade damper and their width

>100mm

Compliant design leads to correct = delivery

Design

• All terminal flow rates

• All plant design conditions

• All plant winter summer design conditions

• All water/steam flow rates and resistances

• All plant performances e.g. air side resistances

• All plant acoustic performance

Setting up for success Specification

Design

Combined for:

• Controls

• Electrical testing/commissioning

• Water commissioning

• Ventilation commissioning

• Infection prevention

• Validator

• Authored Person......

Setting up for success Commissioning Brief

For the system as it is an Engineering system

As the system has to work not just the individual parts

The HTM details this very well

Design

• The BMS set ups

• The BMS interlocks

• The manual/mechanical interlocks

• The static pressures and volumes throughout the system

• The room pressures

• The electrical protection and VSD setups

• Methods of performance testing etc.

Setting up for success Commissioning Brief Details

Designers Commissioning Brief

• Heaters and coolers perform at design conditions

• Volume exceeds design by amount required by HTM with dirty filters, etc.

• Energy recovery devices perform as design

• Humidifier performs at design conditions

• Etc.

Setting up for success AHU Performance Testing

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Design

• Testing of fire and smoke dampers

• Confirming safe access to all

• Fire detection and alarm cause and effect matrix

• Interim and final duct pressure testing (and AHU)

• Interim and final duct cleaning

• Etc.

Setting up for success System performance testing

Designers, Commissioning Brief

A reissue to the engineering sub-contractor of the:

Specification and drawings

or

Saying its already in the specification

Setting up for success What does this NOT mean

Design

The specification/contract documents include:

• A schedule of all interruptions

• The commissioning brief

• Commissioning schedules for all engineering works

• Commissioning programme incl information receipt, comment and sign off

Setting up for success A Recommendation

Mechanical Contractors

• Ensure the commissioning brief is received by the commissioning team

• Ensure any alterations are feed into the designers commissioning brief

• Ensure the commissioning report is complete and forms a conclusion

Basic document and quality control

Communicate

Mechanical Contractors

• Ductwork companies

• AHU manufacturers

• Electrical contractors

• BMS contractors

• Duct cleaning contractors

Coordinate

Duct installer

• Ducts are installed as required by HVCA DW 144:2005 now 2013

• Ducts are delivered clean and kept clean as required by HVCA TR 19:1998 now 2013

• Duct leakage testing passes the requirements of HVCA DW 143:1998 now 2013

Quality control and Performance test

This requires an effective monitoring system On larger works the contractor confirms compliance and is penalised if found not to be

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AHU Manufacture

Provide type test certificates for components e.g.

• Attenuators, fans, batteries, filters

• Provides pressure testing certificates for all coils, plate recuperators, AHU, etc.

• Fan curves are essential.......

Quality control and Installation

This requires an effective monitoring system On larger works the contractor confirms compliance and is penalised if found not to be

Filters If they do not have BS EN 779

They are not compliant

Commissioner(s)

• Commissions the electrical, wet and ventilation systems,

• To the designers commissioning brief

• To the HTM 03-01A chapter 8 and other clauses

• To CIBSE Comm Codes A, W, R.....

• To BSRIA Comm Codes air water etc.

Standards

Commissioner

• The commissioning report should refer to the brief and commissioning schedules

• Should form a conclusion

• Record the testing methodology (hopefully as defined in the brief )

• Record the performance

• Record the completeness of the installation

• Provide for record calibration certificates

Content Compliant or not?

Turning vanes needed

Blast Plate needed

Dampers not needed Drip tray far too shallow

Partial replacement of AHU, to increase cooling

Replacement Existing remaining

Water eliminator needed coils copper/copper

Poor traverse point

Outside wall with louvre

Setting up for success Including for refurbishments

Common Problems

All to often what the controls are doing!

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Outside Air Temp

Off Frost Coil Temp

Off Cooler Temp

Reheat Valve Pos

Supply Temp

Theatre Temp

Supply Humidity

Theatre Humidity

Controls

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Incorrectly located test point

Measuring air flows

Validation

So as earlier

• Validation is carried out by the client when new or after major alterations or changes in air flow, to confirm the system is operating as designed

Validation

So as earlier

This does include, the:

• Air flows

• Air velocities

• Plant performance

• Controls

• Water flow rates....... Not just the air flow rates or the air side performance

Advantages

Can commissioning and validation of ventilation systems be an advantage to:

reduced risk during delivery and especially in use • Clients,

• Designers,

• Installers,

• Main Contractors,

• Commissioners.

reduced total time to implement “prepare for success”

reduced time to install and commission

reduced time pressures at end of job

reduced time to commission and having to manage fails

Personal risk to all reduced

Verification

Verification

Compares:

• The condition of the system

• The operation of controls

• The operation of fire precautions

• The performance of the system

All with respect to the validation Report

Objectives

Just the same as when carrying out electrical periodic inspection tests

Must form a conclusion, is it compliant, is it safe to use?

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What did the order say? For a verification of a healthcare ventilation

system

You would hope, it would say something like?

Please carry out verification of xxxxx at yyyy in accordance with HTM 03-01 for the sum of......

Output: Getting the report the HTM requires

What did the order say?

For a verification of a healthcare ventilation system

You would hope, it would say something like? Please carry out verification of xxxxx at yyyy in

accordance with HTM 03-01 for the sum of...... Watch out for order confirmations Confirming works carried out to their quotation

of.......perhaps limiting the works

What did the order say?

For a verification of a healthcare ventilation system

You would hope, it would say something like? Please carry out verification of xxxxx at yyyy in

accordance with HTM 03-01 for the sum of...... Watch out for reports Stating or recording the works carried out,

thereby limiting the scope of the report

For the report

• As with commissioning reports and validation reports they should be unconditional

• Just confirming at the beginning of the report in accordance with HTM 03-01

Annual inspection and verification requirements

Should be inspected annually

The inspection shall establish:

a. the system is still required;

b. the AHU conforms to the minimum standard (see Chapter 3);

c. the fire containment has not been breached;

d. the general condition of the system is adequate for purpose;

e. the system overall is operating in a satisfactory manner. (4.2)

Recommends use of check sheets

in appendices 1 and 2 (4.3)

Annual inspection and verification requirements

Critical ventilation systems

All ventilation systems shall be inspected quarterly and verified

annually (4.4)

the quarterly inspection should be as 4.1-4.3 (4.5)

the annual inspection shall be to ensure the system:

a. achieves the minimum standards specific to the application

b. is operating to an acceptable performance level

c. remains fit for the purpose

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Annual inspection and verification requirements

Definition of a critical system

a. operating theatres of any type, including rooms used for interventional

investigations (for example catheter laboratories);

b. patient isolation facility of any type;

c. critical care, intensive treatment or high dependency unit;

d. neonatal unit;

e. Category 3 or 4 laboratory or room;

f. pharmacy aseptic suite;

g. inspection and packing room in a sterile services department;

h. MRI, CAT and other types of emerging imaging technologies that require particularly stable environmental conditions to remain within calibration;

j. any system classified as an LEV system under the COSHH Regulations;

k. any other system that clearly meets the definition. (4.7)

Annual inspection and verification requirements

Annual verification

a. the system is still required;

b. the AHU conforms to the minimum standard (see Chapter 3);

c. the fire containment has not been breached;

d. the general condition of the ventilation system is adequate;

e. the fabric of the area served is satisfactory;

f. the system performance is adequate with respect to the functional requirement – this will require:

(i) a full measure of the supply and extract air-flow rates;

(ii) the calculation of room air-change rates if applicable;

(iii) the measurement of room differential pressures if applicable;

(iv) the measurement of room noise levels;

(v) air-quality checks if appropriate;

(vi) a check on the control functions.(HTM 03-01B 4.9)

Annual inspection and verification requirements

Fabric condition a. the ceiling should be complete and, if tiled, all tiles should be

clipped down and sealed; (note HTM 60 banned the use of tiles as fire barriers, clinical rooms are often required to be fire rated see HTM 05-02)

b. the walls and floors should be free from significant construction and finish defects;

c. windows and their trickle vents should be sealed and locked shut; d. the doors should close completely and the door closers should be

correctly adjusted to hold them against the room pressure; e. all service penetrations and access panels should be sealed to

prevent uncontrolled air flow between rooms and service voids; f. steps should have been taken (if necessary) to prevent portable

equipment and stock items from obstructing low-level supply, transfer or extract air-flow paths..(4.11)

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Annual inspection and verification requirements

Critical ventilation systems-verification standards All ventilation systems should achieve not less than 75% of the air change rates given in appendix 2,

or its design (4.16) (would not recommend this for LEV and other legislation)

All ventilation systems should achieve not less than 75% of the pressure values given in appendix 2,

or its design (4.17)

All ventilation systems should achieve the sound levels in table 2 (4.18)

There is absolutely no interest in anything less than 100% for the European healthcare ventilation standard

Annual inspection and verification requirements

Critical ventilation systems-verification standards

UCV theatres Generally as part A, note velocities remain at 100%, filter challenge only needed if the HEPAs are damaged, disturbed or replaced (Note after 4.20)

Category 3 and 4 labs and rooms

Refer to current guidance from “advisory committee on dangerous pathogens” and HSE (4.25) would suggest this is 100% of design and guidance

Pharmacy aseptic suites

Refer to current guidance from ”European guide to good manufacturing practice” (4.26) link given should read http://ec.europa.eu/health/documents/eudralex/index_en.htm would suggest this is 100% of design and guidance

Critical system verification failure

Should a system fail it should be taken out of service

If for medical reasons the system has to remain in use, the senior manager of the department should be informed in writing is “suboptimal”. A copy of the notice should be sent to the infection control committee (4.29)

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Appendix 1 –

Annual inspection of critical

ventilation systems

Appendix 2 – Operating suite annual verification

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• The appendices do not cover all the verification requirements of HTM 03-01B

• The HTM has many, many more requirements for Verification see chapters 3, 4 and 5 of Part B, and Part A

What should be verified

The appendices do not cover all the verification requirements of HTM 03-01B

What should be verified

Sadly most commissioning reports and validation reports do not cover all the validation requirements of HTM 03-01A

What should be validated

Some common problems

Theatre X

Report Content

Good Headings

This looks a bit odd?

Theatre X

Its a clean room!

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Any one for a swim

The verification (or validation) report should ask and answer Is there a statement regards Legionella risk? (3.1)

- Fan

Air Flow Direction

If the trap dries out the flood can occur

-ve -ve

Demonstration fire barriers

Are fire precautions in accordance with Firecode? (3.7)

Also as last years EFA Exactly as when we test electrical circuits

Does the report record all the extracts including those in the corridors?

Some one nicked the extract grille We seem to be seriously short of extract for this theatre Has some on stolen others?

How were the measurements made?

• For example are the air volumes measured correctly as required by for example CIBSE, BSRIA (these named in HTM)

• So this would mean recording where duct measurements

taken, grille correction factors

• If these could not be done, then the figures obtained can not be relied on

• In all cases the report should be clear • Not just say “not possible.....”

Motorised damper fitted Honeywell N2024-SW2

The diagram from Honeywell installation manual for this actuator Confirms this not fitted with spring return as required by HTM 03-01A 6.29

Did the dampers close?

Could the filters

support combustion?

Much evidence the insect screen fitted as required by HTM, does not stop feathers

The filter correctly asserts it has been manufactured to meet BS 779 But would “support combustion” not permitted by HTM Do Verifications pick these up? (3.12)

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Can the AHU be accessed?

(3.13.....et al)

AHU intakes and discharges

Verifications should ask and answer are Intake and discharge points situated where they

will cause vitiated air to be drawn into a System? (3.21)

Fresh Air Intake

Exhaust air discharge

If no diagram not easy to say in report, same for all AHU components

Fire dampers

Have all fire dampers been tested as part of the annual verification (4.13)

They are often not installed correctly often easy to inspect, if not say they cannot be seen, and recommend an access door

Controls

a check on the control functions is required in the verification. (4.9f vi)

The objective to protect the patient These should be checked, these were not working correctly see staining

The objective to keep systems available And this closed a NICU for a week all because the controls were not setup correctly

Water carry over from the chiller battery

One of the many uses of inco pads

Pressure stabiliser damaged and unstable in operation generating noise the blade also appears to be installed the wrong way around

UCV Grids These were greater than 6% out of tolerance In this case the verifier did not measure the supply ventilation rate.

In other cases the verifier has reported over 100 air changes....

Because the verification was not carried out correctly the closed fire dampers were missed for years

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And what about the extracts in the corridors

Training

• Qualification

• Competency

• Assessment

• Appointment

HTM 00:2014 (and the earlier versions) has a chapter on this and so does HTM 03-01 This includes the AE, AP, CP, Verifier etc.

Training

General

All personnel employed in the design, operation and maintenance of engineering services, including maintenance personnel and operators, should receive adequate, documented training. Personnel should not commence their duties until this training has been completed, competency has been validated and detailed operating instructions have been provided. (6.1)

Those required to monitor and/or maintain ventilation equipment will need to show that they are competent to do so.

From HTM03-01B:2007 1.19

What is this guy on!!

PDF and Slides Richard Knight

Thank you

• Richard Knight

• Mobile 077 949 14 211

• Email millham.orchard@tiscali.co.uk