The Human Tissue (Authorisation) (Specified Type A Procedures) (Scotland) Regulations 2020

Draft Regulations laid before the Scottish Parliament under section 59(3)(ad) of the Human Tissue (Scotland) Act 2006 for approval by resolution of the Scottish Parliament.

Draft Scottish Statutory Instruments

2020 No.

Human Tissue

The Human Tissue (Authorisation) (Specified Type A Procedures) (Scotland) Regulations 2020

Made

2020

Laid before the Scottish Parliament

2020

Coming into force in accordance with regulation 1

The Scottish Ministers make the following Regulations in exercise of the powers conferred by sections 16B(1) and (2) of the Human Tissue (Scotland) Act 2006(1) and all other powers enabling them to do so.

In accordance with section 16B(4) of that Act they have consulted with such persons as they consider appropriate.

In accordance with section 59(3)(ad)(2) of that Act, a draft of this instrument has been laid before and approved by resolution of the Scottish Parliament.

Citation and commencement

1.  These Regulations may be cited as the Human Tissue (Authorisation) (Specified Type A Procedures) (Scotland) Regulations 2020 and come into force on the day on which section 23 of the Human Tissue (Authorisation) (Scotland) Act 2019(3) comes into force for all purposes.

Type A procedures

2.  The pre-death procedures specified in the second column of the table in the schedule are specified as Type A procedures for the purposes of sections 16D to 16F of the Human Tissue (Scotland) Act 2006(4).

Name

Authorised to sign by the Scottish Ministers

St Andrew’s House,

Edinburgh

Date

regulation 2

SCHEDULE Specification of Pre-Death Procedures

1.  In this schedule—

“arterial line” means a cannula inserted into an artery,

“blood component” means any of the following constituents of human blood—

• red cells,

• white cells,

• platelets, and

• plasma,

“blood product” means any therapeutic product derived from human blood or plasma,

“intravenous fluids” means any electrolyte solution intended for intravenous administration,

“pre-established airway and ventilatory support” means any method of airway or ventilatory support administered to the person for the primary purpose of the person’s medical treatment prior to any decision to withdraw life sustaining treatment,

“pre-established suprapubic catheter” means a suprapubic catheter inserted into the person for the primary purpose of the person’s medical treatment prior to any decision to withdraw life sustaining treatment.

Class of procedure	Type of procedure
Collection of bodily fluids and microbiological samples	Taking of a blood sample
	Taking of a urine sample including by way of a pre-established suprapubic catheter
	Taking of a chest secretion sample (excluding bronchoscopy)
	Swabbing or scraping of the body including inside of the mouth, nostril or ear canal but excluding the swabbing or scraping of any part of any other body orifice
Radiological imaging	Carrying out of an X-Ray without transferring the person from their existing location
	Carrying out of ultrasound imaging without transferring the person from their existing location
	Carrying out of transthoracic echocardiography without transferring the person from their existing location
Cardiovascular monitoring	Carrying out of electrocardiogram
	Cardiac output monitoring by way of an arterial line
	Carrying out of central venous pressure monitoring
	Arterial blood pressure monitoring including by way of an arterial line
Respiratory monitoring and support	Measuring of oxygen saturation
	Sustaining the appropriate operation of any pre-established airway and ventilatory support
Administration of medication or other product	Administration of antimicrobials
	Administration of intravenous fluids
	Administration of medication to manage blood pressure
	Administration of blood, blood components and blood products

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations specify medical procedures which may be carried out on a person for the purpose of increasing the likelihood of successful transplantation of a part of the person’s body after the person’s death and which are not for the primary purpose of safeguarding or promoting the physical or mental health of the person, known under the Human Tissue (Scotland) Act 2006 (“the Act”) as “pre-death procedures” (see section 16A inserted by section 23 of the Human Tissue (Authorisation) (Scotland) Act 2019).

These Regulations specify the “Type A procedures”. Type A procedures are those pre-death procedures which Ministers consider are appropriate to be carried out in accordance with section 16E of the Act without the need for further conditions or restrictions on their performance such as only in specified circumstances or following further authorisation.

A pre-death procedure may only be carried out on a person if it has been specified as either a Type A procedure or Type B procedure (see section 16D of the Act).

No business and regulatory impact assessment has been prepared for these Regulations as no impact upon business, charities or voluntary bodies is foreseen.

(1)

2006 asp. 4. Section 16B was inserted by section 23(1) of the Human Tissue (Authorisation) (Scotland) Act 2019 asp 11 (“the 2019 Act”).

(2)

Section 59(3)(ad) was inserted by 23(2) of the 2019 Act.

(3)

2019 asp 11.

(4)

Sections 16D to 16F were inserted by section 23(1) of the 2019 Act.