HONOURABLE TERRY LAKE
MINISTER OF HEALTH

BILL 7 — 2014

LABORATORY SERVICES ACT

Contents
Part 1 — Definitions
  1  Definitions
Part 2 — Benefits
  Division 1 — Determining Benefits
  2  Minister responsible for administration
  3  Guiding principles
  4  What are benefits
  Division 2 — Benefits
  5  Entitlement to benefits
  6  Non-resident benefits
  7  Payment for laboratory services outside British Columbia
  8  Misuse of identity number
  9  Limits on private insurers
  Division 3 — Laboratory Facilities
  10  Who may provide benefits
  11  Approvals to provide benefits
  12  Agreements respecting laboratory services
  13  Duty to comply
  14  Payments for providing benefits
  15  Prohibitions
  16  Records
  17  General or special direction
  18  Cancellation of approvals for laboratory system reasons
  19  Appointment of administrator of approved laboratory facility
  Division 4 — Transfers and Assignments
  20  Transfer of records
  21  Transfer of rights, property, assets, obligations and liabilities
  22  Assignment of agreements
  Division 5 — Referring Practitioners
  23  Practice guidelines and protocols
  24  Referrals if beneficiary to be charged
  25  Prohibitions on referrals
Part 3 — Administration
  Division 1 — Information Management
  26  Collection, use and disclosure of personal information
  27  Requests for information
  28  Disclosure from health information banks
  29  No market research
  30  Information-sharing agreements
  Division 2 — Delegations
  31  Delegation to administrative body
  32  Operation of administrative body
  33  Application of Public Service Act
  34  Appointment of administrator of administrative body
  Division 3 — Administrative Matters
  35  Advisory committees
  36  Administrative materials
  37  Hearings under this Act
  38  Whistle-blower protection
  39  Immunity from legal proceedings
  40  No compensation
Part 4 — Enforcement
  Division 1 — Audits and Inspections
  41  Appointment of inspectors
  42  Audits and inspections
  43  Powers and duties of inspectors
  44  Laboratory facility records
  45  Laboratory facility equipment
  46  Referring practitioner records
  47  Duties during audit or inspection
  48  Disclosure of information
  49  Irregularities respecting practice
  50  Concerns with beneficiaries
  51  Warrants
  52  Recovery of non-entitled amounts
  53  Settlement of non-entitled amounts
  54  Recovery from referring practitioner
  55  Appeals
  56  Recovery of other amounts
  57  Limit on recovery
  Division 2 — Enforcement Actions and Penalties
  58  Use of evidence and inferences
  59  Enforcement orders
  60  Making enforcement orders
  61  Cancellation of or change to approval if contravention
  62  Injunctions
  Division 3 — Offences and Penalties
  63  Offence Act application
  64  Offences
  65  Fines and incarceration
  66  Actions by corporation or employee
  67  Continuing offences
  68  No benefit from offence
  69  Limitation period
  70  Publication
Part 5 — Regulations
  71  Regulations respecting benefits, beneficiaries and referring practitioners
  72  Regulations respecting laboratory facilities
  73  Regulations respecting information management
  74  Administrative and other regulation-making powers
  75  General regulation-making powers
Part 6 — Transitional Provisions and Consequential Amendments
  76  Transition — definition
  77  Transition — deemed approval of grandparented laboratory facilities
  78  Transition — commission records
  79  Transition — audits and inspections
  80  Transition — actions in progress under Medicare Protection Act
  81  Transition — registered nurses (certified)
  82  Transition — regulations
  83-108  Consequential Amendments
  109  Commencement

HER MAJESTY, by and with the advice and consent of the Legislative Assembly of the Province of British Columbia, enacts as follows:

This Bill enacts the Laboratory Services Act, an Act that will

Part 1 — Definitions

Definitions

1  In this Act:

"administrative body" means a person or body established or designated under section 31 (1) [delegation to administrative body];

"approval" means an approval granted under section 11 [approvals to provide benefits];

"approved laboratory facility" means a laboratory facility that is subject to an approval or to a laboratory services agreement;

"beneficiary" means a person enrolled as a beneficiary under the Medicare Protection Act;

"benefit", other than in section 68 [no benefit from offence], means a laboratory service that is a benefit under section 4 [what are benefits];

"class" means a class established under section 75 (5) (a) [general regulation-making powers];

"college" has the same meaning as in the Health Professions Act;

"commission" means the Medical Services Commission continued under the Medicare Protection Act;

"enforcement action" means

(a) an enforcement order, or

(b) the prosecution of an offence under section 64 [offences];

"enforcement order" means an order made under section 59 [enforcement orders];

"inspector" means a person appointed or retained as an inspector under section 41 [appointment of inspectors];

"laboratory facility" means the following:

(a) in respect of a hospital within the meaning of paragraph (a) or (e) of the definition of "hospital" in section 1 of the Hospital Insurance Act, that part of the hospital that provides laboratory services;

(b) a facility that provides laboratory services;

(c) a specimen collection station associated with a hospital or facility referred to in paragraph (a) or (b) of this definition;

"laboratory medicine physician" means a medical practitioner registered with, and authorized to practise in a prescribed specialty by, the College of Physicians and Surgeons of British Columbia;

"laboratory service", subject to the regulations, means

(a) the taking or collecting, or the analysis, of specimens for the purposes of preventing, diagnosing or treating human injury, disease or illness, or

(b) a prescribed service;

"laboratory services agreement" means an agreement made under section 12 (1) [agreements respecting laboratory services];

"operator", in relation to a laboratory facility, means the following:

(a) the owner;

(b) the person having responsibility for the daily operation of the laboratory facility;

(c) a regional health board or prescribed agency;

"personal information" has the same meaning as in the Freedom of Information and Protection of Privacy Act;

"prescribed agency" means a prescribed person or body that funds, manages or operates a laboratory facility;

"public body" has the same meaning as in the Freedom of Information and Protection of Privacy Act;

"referring practitioner" means a person who

(a) is either

(i) a medical practitioner enrolled under section 13 of the Medicare Protection Act, or

(ii) a person within a class of prescribed health care practitioners, and

(b) makes a request for a beneficiary to receive benefits;

"regional health board" means a regional health board designated under the Health Authorities Act;

"specimen collection station" means a place that is principally equipped for the taking or collecting of specimens.

Part 2 — Benefits

Division 1 — Determining Benefits

Minister responsible for administration

2  The minister is responsible for the administration and provision of benefits under this Act.

Guiding principles

3  In exercising powers and performing duties under this Act, the minister must have regard to the principles expressed in sections 5.1 to 5.7 of the Medicare Protection Act.

What are benefits

4  (1) Subject to subsection (2), a laboratory service is a benefit if it is a medically required service provided

(a) through an approved laboratory facility, and

(b) by or under the supervision of a laboratory medicine physician or a prescribed person who is acting

(i) at the request of a referring practitioner or a prescribed person, and

(ii) in accordance with all applicable protocols approved by the minister.

(2) The minister may make orders as follows:

(a) that a laboratory service or a class of laboratory services are not benefits;

(b) that a laboratory service is a benefit only if provided

(i) on the request of a specified referring practitioner or class of referring practitioners,

(ii) in respect of a specified type of human injury, disease or illness, or

(iii) in a specified laboratory facility or class of laboratory facilities.

Division 2 — Benefits

Entitlement to benefits

5  Subject to this Act, a beneficiary is entitled to receive benefits.

Non-resident benefits

6  A person who

(a) is not a resident of British Columbia, and

(b) provides evidence to an operator that the person is enrolled under an Act, plan or scheme in another jurisdiction of Canada with which British Columbia has made a reciprocal agreement related to the provision of medical or health care services

is, subject to the agreement, entitled to receive benefits under this Act, and this Act applies in respect of those benefits as if the person were a beneficiary under this Act.

Payment for laboratory services outside British Columbia

7  (1) If a beneficiary receives a laboratory service outside British Columbia that would be a benefit if provided in British Columbia, the beneficiary may apply to the minister to have payment made for the laboratory service in the amount the minister determines.

(2) If a beneficiary receives a laboratory service outside British Columbia that would not be a benefit if provided in British Columbia, the beneficiary may apply to the minister to determine if the cost of the laboratory service should be paid and, if so, the amount to be paid for that laboratory service.

(3) A beneficiary is entitled to have payment made under subsection (1) or (2) if the minister is of the opinion that the laboratory service was medically required and

(a) the need for the laboratory service arose unexpectedly while the beneficiary was outside British Columbia, or

(b) the regulations respecting laboratory services provided outside British Columbia have been complied with.

(4) If the government has made, with the government of another jurisdiction of Canada, an agreement that provides for arrangements to pay for medically required services provided in that other jurisdiction, the agreement applies.

Misuse of identity number

8  (1) A person must not knowingly use, in order to obtain benefits under this Act,

(a) an identity number other than the one issued to the person by the commission under the Medicare Protection Act, or

(b) the identity number issued to the person if

(i) his or her enrollment as a beneficiary is cancelled under the Medicare Protection Act, or

(ii) in using his or her identity number, he or she contravenes a restriction imposed under section 11 (2) of the Medicare Protection Act.

(2) A person prescribed for the purposes of this section must promptly report to the minister, in the form and manner required by the minister, if the prescribed person has reason to believe that another person has contravened subsection (1).

(3) No legal proceeding for damages lies or may be commenced or maintained against a person who makes a report, in good faith, under subsection (2).

Limits on private insurers

9  (1) A person must not provide, offer or enter into a contract of insurance with a resident of British Columbia for the payment, reimbursement or indemnification of all or part of the cost of laboratory services that would be benefits if provided through an approved laboratory facility.

(2) Subsection (1) does not apply to any of the following:

(a) all or part of the cost of a laboratory service for which a beneficiary cannot be reimbursed under this Act;

(b) insurance obtained to cover the costs of laboratory services provided outside of Canada;

(c) insurance obtained by a person who is not eligible to be a beneficiary.

(3) A contract that is prohibited under subsection (1) is void.

Division 3 — Laboratory Facilities

Who may provide benefits

10  (1) A person may provide benefits only through a laboratory facility that is subject to an approval or to a laboratory services agreement.

(2) The minister may grant an approval or enter into a laboratory services agreement if all of the following apply:

(a) the laboratory facility that is the subject of the proposed approval or laboratory services agreement is accredited to a standard satisfactory to the minister;

(b) both the laboratory facility and the operator meet all prescribed criteria;

(c) the minister, on considering the matters set out in the regulations, is satisfied that it would be in the public interest to grant the approval or to enter into the laboratory services agreement.

Approvals to provide benefits

11  (1) The minister may

(a) grant to an operator an approval to provide benefits through a specified laboratory facility,

(b) request, for the purposes of determining whether to grant an approval, information in addition to the information required under this Act,

(c) attach limits or conditions to an approval, and

(d) refuse to grant an approval, including refusing on the ground that, in the minister's opinion, the information submitted in support of the application for approval is not adequate.

(2) The minister may change the limits or conditions attached to an existing approval if the minister first gives, in accordance with the regulations, notice and a reasonable opportunity to be heard.

(3) An approval is not transferable, except as permitted under the regulations.

Agreements respecting laboratory services

12  (1) The minister may enter, with one or more persons, into agreements in relation to the provision of benefits.

(2) In a laboratory services agreement, the minister may do one or more of the following:

(a) impose requirements, prohibitions, limits, conditions, standards or procedures in relation to the provision of benefits;

(b) provide for different payments for

(i) different benefits and laboratory facilities and different classes of benefits and laboratory facilities,

(ii) benefits provided in different geographic locations, and

(iii) different volumes of benefits.

(3) A laboratory services agreement is subject to an order of the minister under section 4 (2) [what are benefits], and, for this purpose, the minister may provide in the order that, if a change respecting benefits results from the order, the change does not apply

(a) to all or part of a laboratory services agreement, or

(b) in relation to a laboratory services agreement until a specified date or during a specified period.

(4) If a laboratory facility that is subject to an approval subsequently becomes subject to a laboratory services agreement, the approval is cancelled as of the date the laboratory services agreement takes effect.

Duty to comply

13 In taking any action in relation to the provision of a benefit, a person must comply with

(a) this Act and the regulations made under it, and

(b) all limits and conditions that apply, under an approval or a laboratory services agreement, to the laboratory facility through which the benefit is provided.

Payments for providing benefits

14  (1) The minister may pay to a person an amount determined by the minister in respect of a laboratory service provided through an approved laboratory facility if, at the time the laboratory service is provided,

(a) the laboratory service is a benefit, and

(b) the person to whom the laboratory service is provided is a beneficiary.

(2) A person is not entitled to payment under subsection (1) if the benefit was provided contrary to any of the following:

(a) this Act or the regulations made under it;

(b) any other enactment, including a limit or condition imposed under the Health Professions Act;

(c) a limit or condition that applies, under an approval or a laboratory services agreement, to the approved laboratory facility.

(3) The minister may require any additional information the minister considers necessary to determine whether to make a payment under this section.

(4) Without limiting subsection (2), the minister may refuse payment if the minister is of the opinion that

(a) the information submitted in support of a claim for payment is not adequate, or

(b) the records an operator or former operator is required to keep under this Act in respect of the provision of benefits are incomplete or otherwise inadequate.

Prohibitions

15  (1) Except as permitted under this Act, a person must not charge a beneficiary for

(a) a benefit,

(b) materials, consultations, procedures or the use of a laboratory facility or specimen collection station, or

(c) any other matter that relates to the provision of a benefit.

(2) Subsection (1) does not apply in any of the following circumstances:

(a) if, at the time a laboratory service was provided,

(i) the laboratory service was not a benefit, or

(ii) the person receiving the laboratory service was not a beneficiary;

(b) if a laboratory service is provided in a place that is not an approved laboratory facility;

(c) if the provision of a laboratory service is outside the scope of an approval or laboratory services agreement that applies to an approved laboratory facility.

(3) If subsection (2) (b) or (c) applies, the laboratory service must not be provided unless the person who intends to charge the beneficiary first informs the beneficiary, in a manner the beneficiary can understand, of the following:

(a) if applicable, that the beneficiary is not receiving laboratory services through an approved laboratory facility;

(b) that the laboratory services provided to the beneficiary will not be paid for under this Act;

(c) that the beneficiary must pay the costs of the laboratory service;

(d) the amount the beneficiary must pay.

(4) If a beneficiary is not informed as required under subsection (3), the beneficiary

(a) is not liable to pay for the laboratory service unless the service was provided in an emergency situation that made it impractical to comply with that subsection, and

(b) must be refunded any amount paid for the laboratory service.

(5) An operator must refund to a person an amount paid by the person if that person

(a) receives from the operator a laboratory service that would be a benefit if provided to a beneficiary,

(b) pays to the operator an amount for the laboratory service,

(c) subsequently becomes a beneficiary, and

(d) demonstrates to the operator that the effective date of the person's beneficiary status is a date on or before the date on which the laboratory service was received.

(6) A person entitled to a refund under subsection (4) or (5) may recover the amount, in any court of competent jurisdiction, as a debt due to the person.

(7) A person requesting a benefit on behalf of a beneficiary must not be charged for the benefit in place of the beneficiary if this Part requires that the beneficiary not be charged for the benefit.

(8) If subsection (2) (b) or (c) applies in respect of the provision of a laboratory service to a beneficiary, a person requesting the laboratory service on behalf of a beneficiary must receive, in a manner the person can understand, the information set out in subsection (3).

Records

16 An operator and a former operator must

(a) keep prescribed records in the manner required by the minister, and

(b) produce those records on request of the minister and within the time requested.

General or special direction

17  A regional health board and a prescribed agency must comply with any general or special direction made by order of the minister in relation to an approved laboratory facility.

Cancellation of approvals for laboratory system reasons

18  (1) The minister may cancel an approval if the minister is of the opinion that

(a) it is in the public interest for benefits to be provided to beneficiaries through a different operator, or

(b) cancelling the approval is necessary to enhance efficiencies in the delivery of benefits in one or more areas of British Columbia.

(2) Before cancelling an approval, the minister must give notice in accordance with the regulations.

Appointment of administrator of approved laboratory facility

19  (1) If the minister is of the opinion that the appointment is necessary in the public interest, the minister may, by order,

(a) appoint an administrator to deliver benefits through an approved laboratory facility, and

(b) provide that an operator of the approved laboratory facility must not, during the term of the administrator's appointment, perform duties or exercise powers in respect of that approved laboratory facility.

(2) If the minister appoints an administrator, the minister must give notice to the operator in accordance with the regulations.

(3) If an administrator is appointed,

(a) the administrator may exercise, for the period specified in the appointment order, all powers necessary to deliver benefits, including

(i) operation of the approved laboratory facility, and

(ii) employment and remuneration of staff, and

(b) the administrator must perform all duties, and may exercise all powers, as described in the appointment order.

(4) Subsection (3) (b) of this section applies despite any conflict or inconsistency with the limits or conditions of either of the following, as applicable:

(a) an approval, and, for this purpose, section 11 (2) [approvals to provide benefits] does not apply;

(b) a laboratory services agreement.

(5) At the end of the period of the administrator's appointment, the administrator must promptly provide an accounting to the minister, and any excess of revenue over expenditure must, after deduction of the administrator's fees, be paid to the operator of the approved laboratory facility.

(6) The minister must determine the fees to be paid to the administrator, and if there is insufficient money to pay those fees under subsection (5), the minister

(a) must pay the difference to the administrator, and

(b) may require the operator to repay to the minister the amount paid under paragraph (a) of this subsection.

(7) An amount that must be paid to the minister under subsection (6) is a debt due to the government and may be

(a) deducted from any subsequent payment owing, under this Act, by the government to the operator, or

(b) recovered in a court of competent jurisdiction.

Division 4 — Transfers and Assignments

Transfer of records

20  (1) Subject to the regulations, the minister may, by order, require an operator that is a public body to transfer to another public body records relevant to the operation or management of a laboratory facility or the provision of benefits.

(2) Records under subsection (1) may

(a) be identified in the order by name, class or description, and

(b) include personal information.

(3) On the effective date of a transfer, the transferred records cease to be the records of the transferor and become the records of the transferee.

Transfer of rights, property, assets, obligations and liabilities

21  (1) Subject to the regulations, the minister may, by order, require an operator that is a public body to transfer to another public body any right, property, asset, obligation or liability relevant to the operation or management of a laboratory facility or the provision of benefits.

(2) Rights, property, assets, obligations and liabilities under subsection (1) may be identified in the order by name, class or description.

(3) An order under subsection (1) must include, within the order or in an agreement attached to the order, the terms and conditions of the transfer.

(4) On the effective date of a transfer,

(a) the transferred right, property, asset, obligation or liability ceases to be the right, property, asset, obligation or liability of the transferor and becomes the right, property, asset, obligation or liability of the transferee, and

(b) the transferor is released from the transferred right, property, asset, obligation or liability.

(5) The Minister of Finance may make payments out of the consolidated revenue fund for the purpose of subsection (1).

(6) Any payments made by the Minister of Finance under subsection (5) must be attributed to, and must not exceed the amount available in, the voted appropriation of the minister responsible for the right, property, asset, obligation or liability transferred.

(7) A transfer is effective despite any failure to fulfill a provision in an agreement or instrument requiring consent, leave or approval respecting a transfer or assignment of the right, property, asset, obligation or liability, and the failure does not constitute a breach or default of the agreement or instrument.

Assignment of agreements

22  (1) Subject to the regulations, the minister may, by order, require an operator that is a public body to assign to another public body any agreement entered into by the operator relevant to the operation or management of a laboratory facility or the provision of benefits.

(2) On the effective date of an assignment, all rights and obligations of the operator under the agreement cease to be the rights and obligations of the operator and become the rights and obligations of the assignee.

(3) A reference to the operator in an assigned agreement is deemed to be a reference to the assignee.

(4) An assignment is effective despite any failure to fulfill a provision in an agreement requiring consent, leave or approval respecting assignment of the agreement, and the failure does not constitute a breach or default of the agreement.

Division 5 — Referring Practitioners

Practice guidelines and protocols

23  (1) The minister may establish guidelines and protocols to guide referring practitioners with respect to requests for benefits.

(2) A referring practitioner must consider all relevant guidelines and protocols established under subsection (1) when making a determination in respect of a request for a beneficiary to receive benefits.

(3) For the purpose of subsection (1), the minister may adopt by reference, in whole or in part and with any changes the minister considers appropriate, a guideline or protocol established by any person or body.

Referrals if beneficiary to be charged

24  A referring practitioner must not knowingly refer a beneficiary, for the purposes of receiving laboratory services that would be benefits if provided in an approved laboratory facility, to a laboratory facility that is not an approved laboratory facility unless the referring practitioner first informs the beneficiary of the matters referred to in section 15 (3) [prohibitions].

Prohibitions on referrals

25  (1) A referring practitioner must not act contrary to a regulation made under section 71 (e) [regulations respecting benefits, beneficiaries and referring practitioners] in referring a beneficiary to an approved laboratory facility for the purposes of receiving benefits.

(2) A referring practitioner must not refer a beneficiary to an approved laboratory facility in which the referring practitioner has a financial or other interest, except in accordance with the prior written consent of the minister.

Part 3 — Administration

Division 1 — Information Management

Collection, use and disclosure of personal information

26  (1) The minister may collect personal information under this Act for the purposes of administering this Act.

(2) The minister may use and disclose personal information collected under subsection (1) for one or more of the following purposes:

(a) to administer this Act or another enactment for which the minister is responsible;

(b) to exercise powers or perform duties of the minister under an enactment;

(c) to identify an individual who needs or is receiving health services;

(d) to identify a person who is providing health services;

(e) to prevent or manage chronic conditions, at the individual or population level;

(f) to facilitate health insurance and health service billing, including for the purposes of

(i) a payment in respect of health services to be made to or by the government of British Columbia or a public body,

(ii) authorizing, administering, processing, verifying or cancelling such a payment,

(iii) resolving an issue regarding such a payment, or

(iv) an audit by a federal or Provincial government payment agency that makes reimbursement for the cost of health services;

(g) to engage in health system planning, management, evaluation or improvement, including

(i) health service development, management, delivery, monitoring and evaluation,

(ii) the compilation of statistical information,

(iii) public health surveillance, and

(iv) the assessment of laboratory services;

(h) to provide to a committee established under section 5 (1) (o) of the Medicare Protection Act information relevant to the purpose for which the committee was established;

(i) to provide information, for the purpose referred to in section 5 (1) (r) of the Medicare Protection Act, to a person, the commission or a body prescribed for the purposes of that section;

(j) to provide information to a college for the purpose of monitoring, by the college, the practice of the health profession for which the college is responsible.

Requests for information

27  (1) The minister may request, for the purposes of administering this Act, an operator or a prescribed person to provide information or records that contain personal information.

(2) Subject to any other enactment that prohibits disclosure, an operator or prescribed person to whom a request is made under subsection (1) must comply with the request in the manner and at the times requested if the information or records are in the custody or under the control of the operator or prescribed person.

Disclosure from health information banks

28  (1) In this section:

"chief data steward" has the same meaning as in the E-Health Act;

"E-Health Act" means the E-Health (Personal Health Information Access and Protection of Privacy) Act;

"health information bank" means a health information bank that

(a) is established or designated under the E-Health Act,

(b) is in the custody or under the control of the ministry of the minister, and

(c) contains information relevant to the provision of laboratory services;

"personal information" means personal information contained in a health information bank.

(2) Despite any provision of the E-Health Act that would otherwise limit or put conditions on the use or disclosure of personal information, the chief data steward may disclose personal information

(a) to the minister, and the minister may use the personal information for a purpose set out in section 26 (2) (c) to (g) [collection, use and disclosure of personal information] of this Act,

(b) to a committee referred to in section 26 (2) (h) of this Act, and

(c) to a person, the commission or a body referred to in section 26 (2) (i) of this Act.

No market research

29  (1) This section applies despite Part 2 of the Freedom of Information and Protection of Privacy Act and any provision of this Act or a regulation made under it.

(2) The minister must not disclose, for the purpose of market research, any of the following information collected under this Act:

(a) the personal information of any person;

(b) information related to an operator, a laboratory medicine physician or a referring practitioner.

(3) A person to whom the minister discloses, under this Act, information described in subsection (2) must not use or disclose the information for the purpose of market research.

Information-sharing agreements

30  Without limiting any other power of the minister to enter into agreements, the minister may enter into information-sharing agreements, for the purpose of administering this Act, a prescribed enactment of British Columbia or a prescribed enactment of any other jurisdiction, with

(a) the government of Canada or of any jurisdiction in or outside Canada,

(b) a public body within the meaning of the Freedom of Information and Protection of Privacy Act, or

(c) a prescribed body that is public in nature.

Division 2 — Delegations

Delegation to administrative body

31  (1) The minister may, by order, establish or designate one or more administrative bodies for the purposes of administering this Act.

(2) Without limiting any other power of the minister to make a delegation, the minister may, by order, delegate to an administrative body one or more of the minister's powers and duties under this Act.

(3) The minister may

(a) appoint to an administrative body one or more persons, and

(b) designate a chair and one or more vice chairs from among the persons appointed under paragraph (a).

(4) Persons appointed under subsection (3) may be paid

(a) remuneration set by the minister, and

(b) reasonable and necessary travel and out-of-pocket expenses incurred in carrying out the work of the administrative body.

Operation of administrative body

32  (1) An administrative body may

(a) appoint officers and hire employees that the administrative body considers necessary for its work, and

(b) engage or retain specialists or consultants that the administrative body considers necessary to carry out its powers and duties, and may determine their remuneration.

(2) An administrative body may make rules governing the following:

(a) the establishment of panels to conduct the business of the administrative body;

(b) the practices and procedures of the administrative body or its panels;

(c) the quorum of the administrative body or its panels.

(3) The minister may, by order, give to an administrative body any general or special direction with respect to the exercise of the powers and the performance of the duties of the administrative body, including a direction that would replace or rescind a decision of that administrative body in respect of a matter under this Act.

Application of Public Service Act

33  The minister may, by order, provide that the Public Service Act applies to a person appointed under section 31 (3) [delegation to administrative body] or 32 (1) (a) [operation of administrative body] of this Act.

Appointment of administrator of administrative body

34  (1) The minister may, by order, appoint a public administrator to discharge the powers and duties of an administrative body under this Act if the minister considers this to be necessary in the public interest.

(2) On the appointment of a public administrator, the persons appointed under section 31 (3) [delegation to administrative body] cease to hold office unless otherwise ordered by the minister.

(3) The minister may specify

(a) the powers and duties of a public administrator appointed under this section,

(b) the terms and conditions for management of the property and affairs of an administrative body during the transition period preceding the ending of the appointment of a public administrator, or

(c) how an administrative body will operate after the ending of the appointment of a public administrator.

Division 3 — Administrative Matters

Advisory committees

35  The minister may establish committees for the purpose of advising the minister respecting any matter under this Act.

Administrative materials

36  (1) The minister may make forms for the purposes of this Act and the regulations made under it.

(2) Unless the minister provides otherwise, use of a form made under subsection (1) is compulsory.

(3) Subject to the regulations, the minister may specify the manner in which

(a) an application under this Act must be made,

(b) a record under this Act must be kept, and

(c) notices or information under this Act must be given.

(4) An application made or a notice given under this Act must provide, and a record made under this Act must contain,

(a) all prescribed information, and

(b) any additional information requested by the minister.

(5) The minister may waive, in respect of a person or a class of persons, any requirement made under this section.

Hearings under this Act

37  For the purposes of a hearing under this Act, sections 34 (3) and (4), 48 and 49 of the Administrative Tribunals Act apply to the minister as if the minister were a tribunal within the meaning of that Act.

Whistle-blower protection

38  A person must not dismiss, suspend, demote, discipline, harass or otherwise disadvantage another person, or deny another person a benefit, because

(a) the other person, acting in good faith and on the basis of reasonable belief, has notified the minister that a person has contravened or is about to contravene this Act,

(b) the other person, acting in good faith and on the basis of reasonable belief, has done or stated an intention of doing anything that is required to be done in order to avoid having any person contravene this Act,

(c) the other person, acting in good faith and on the basis of reasonable belief, has refused to do or stated an intention of refusing to do anything that is in contravention of this Act, or

(d) the person believes that the other person will do anything described in any of paragraphs (a) to (c).

Immunity from legal proceedings

39  (1) This section applies to the following persons:

(a) an administrator appointed under section 19 [appointment of administrator of approved laboratory facility] or 34 [appointment of administrator of administrative body];

(b) a person appointed to an administrative body under section 31 (3) [delegation to administrative body] or who is a member of a committee under section 35 [advisory committees], other than a person who

(i) is appointed or employed under the Public Service Act, or

(ii) sits on a regional health board;

(c) an inspector retained under section 41 (2) [appointment of inspectors];

(d) a person acting under the order or direction of a person referred to in paragraph (b) or (c) of this subsection.

(2) Subject to subsection (3), no legal proceeding for damages lies or may be commenced or maintained against a person referred to in subsection (1) because of anything done or omitted

(a) in the exercise or intended exercise of a power under this Act, or

(b) in the performance or intended performance of a duty under this Act.

(3) Subsection (2) does not apply to a person referred to in that subsection in relation to anything done or omitted in bad faith.

(4) Subsection (2) does not absolve the government from vicarious liability arising out of anything done or omitted by a person referred to in that subsection for which the government would be vicariously liable if this section were not in force.

No compensation

40  (1) In this section, "governmental body" means a regional health board, a prescribed agency or the commission.

(2) Subject to subsection (5), this section applies despite any provision in an approval under this Act, or in any agreement, that relates to laboratory services, laboratory facility reform or compensation to medical practitioners or laboratory facilities.

(3) A decision of the minister made under any of the following sections is final and binding and is not open to review in any court:

(a) section 4 (2) [what are benefits];

(b) section 11 [approvals to provide benefits];

(c) section 12 (3) [agreements respecting laboratory services];

(d) section 18 [cancellation of approvals for laboratory system reasons].

(4) A person has no right of action and must not commence or maintain proceedings as a result of the enactment of this Act or a regulation made under it, or as a result of the exercise by the minister of a power referred to in section 4 (2), 11, 12 (3) or 18,

(a) to claim damages or compensation of any kind from the government or a governmental body, or

(b) to obtain a declaration that damages or compensation is payable by the government or a governmental body.

(5) Subsection (4) does not prevent a person from pursuing any right to enforce a laboratory services agreement that may arise as a result of the exercise by the minister of a power referred to in section 11 or 18.

(6) For greater certainty, this section includes, without limitation, a claim based on the expropriation of property, rights or other interests.

Part 4 — Enforcement

Division 1 — Audits and Inspections

Appointment of inspectors

41  (1) The minister may appoint one or more persons, employed under the Public Service Act, to exercise the powers and perform the duties of an inspector under this Act.

(2) Despite subsection (1), the minister may retain persons as necessary to act as inspectors and, for this purpose, delegate to those persons any power or duty of an inspector.

(3) A person retained under subsection (2) may be paid

(a) remuneration set by the minister, and

(b) reasonable and necessary travel and out-of-pocket expenses incurred in carrying out the work of an inspector.

(4) The Public Service Act does not apply to a person retained under subsection (2) of this section.

Audits and inspections

42  (1) The minister may appoint inspectors to conduct audits and inspections for the following purposes:

(a) to determine compliance with this Act;

(b) to determine whether a laboratory facility

(i) should be approved under section 11 [approvals to provide benefits], or

(ii) continues to meet any conditions of approval imposed under that section;

(c) to fulfill a prescribed purpose.

(2) An inspector may audit or inspect the following in respect of an operator or a former operator, or any other person who provides benefits:

(a) a claim for payment;

(b) the billing and business practices of the person subject to the audit or inspection;

(c) the billing and business practices of a person

(i) who owns, manages, controls or carries on a business for profit or gain, and

(ii) who, in the course of the business, directs, authorizes, causes, allows, assents to, assists in, acquiesces in or participates in the provision of a benefit to a beneficiary;

(d) matters relevant to

(i) compliance with a general or special direction made under section 17 [general or special direction], or

(ii) the consideration of a guideline or protocol established under section 23 [practice guidelines and protocols];

(e) prescribed matters.

(3) If the minister, on behalf of a corporation or other body prescribed under section 36 (1) of the Medicare Protection Act, pays an operator for services provided, or claimed to have been provided, this Part applies to the services as if those services were benefits.

(4) The claims and billing or business practices concerning a corporation or other body prescribed under section 36 (1) of the Medicare Protection Act

(a) need not be under this Act, and

(b) can have arisen at any time since July 24, 1992.

Powers and duties of inspectors

43  (1) An inspector must conduct an audit or inspection in conformity with the practices and procedures set by the minister.

(2) An inspector, at any reasonable time and for the purposes of an audit or inspection, may

(a) enter and inspect any premises, and

(b) subject to section 46 (2) [referring practitioner records], inspect records and equipment found in the premises.

(3) An inspector must not enter a private dwelling under subsection (2) of this section without either the consent of the occupier or a warrant under section 51 [warrants].

Laboratory facility records

44  Without limiting section 43 [powers and duties of inspectors], an inspector may require the production of or electronic access to any record, including the following:

(a) records the inspector considers relevant to

(i) the provision of benefits,

(ii) the making of claims and the payment of appropriate amounts for benefits,

(iii) billing and business practices, or

(iv) compliance with a general or special direction made under section 17 [general or special direction];

(b) records that are relevant to the billing and business practices of persons who own, manage, control or carry on a business for profit or gain and, in the course of the business, direct, authorize, cause, allow, assent to, assist in, acquiesce in or participate in the provision of benefits to beneficiaries;

(c) records that would aid the minister in determining whether to take action under section 11 (2) [approvals to provide benefits], 59 [enforcement orders] or 61 [cancellation of or change to approval if contravention] and that

(i) relate to the limits or conditions of an approval,

(ii) relate to the quality of services provided through an approved laboratory facility, or

(iii) indicate whether a person is in compliance with this Act;

(d) records that would aid the minister in determining whether, in respect of an approved laboratory facility,

(i) the standards of testing and analysis,

(ii) the qualifications, number and skills of personnel who work there, and

(iii) the range and availability of services and equipment

are appropriate to the operation of and functions provided by the approved laboratory facility or whether there has been a significant change in the circumstances from those that applied when an approval was granted or a laboratory services agreement was made in respect of the approved laboratory facility.

Laboratory facility equipment

45  Without limiting section 43 [powers and duties of inspectors], an inspector may require access to any equipment in an approved laboratory facility that would aid the minister in making a determination referred to in section 44 (c) or (d) [laboratory facility records].

Referring practitioner records

46  (1) Without limiting section 43 [powers and duties of inspectors] but subject to subsection (2) of this section, an inspector may require the production of or electronic access to any record that is

(a) in the possession or control of a referring practitioner or a former referring practitioner, and

(b) relevant to

(i) the provision of a benefit by a person who is the subject of an audit or inspection, or

(ii) the consideration of a guideline or protocol established under section 23 [practice guidelines and protocols].

(2) An inspector may require under subsection (1) the medical records of a referring practitioner or a former referring practitioner who is or was a medical practitioner, but an inspector must not inspect those medical records unless the inspector

(a) is a medical practitioner, or

(b) was formerly a medical practitioner and the minister has, at the time of appointing or retaining the person as an inspector, stated in writing that the person may inspect medical records under this section.

Duties during audit or inspection

47  (1) A person who is the subject of an audit or inspection, and a referring practitioner or former referring practitioner, must do all of the following on the request of an inspector:

(a) produce or provide electronic access to, and permit inspection of, records that an inspector may require to be produced or given access to under this Act;

(b) supply copies of or extracts from the records;

(c) provide access to, and permit inspection of, equipment that an inspector may require access to under this Act;

(d) answer all questions of the inspector respecting any matter relating to the records or equipment, or to the audit or inspection generally.

(2) If required by an inspector, a person referred to in subsection (1) must produce, or provide electronic access to, all books of account and other records that the inspector considers necessary for the purposes of an audit or inspection.

(3) If records that may be required under this Act are not located on the premises of a person referred to in subsection (1), a person who has possession of those records, on the request of an inspector, must produce and permit inspection of those records by the inspector.

Disclosure of information

48  The minister may disclose to the commission information, including personal information, obtained through an audit or inspection conducted under this Act.

Irregularities respecting practice

49  (1) This section applies if the minister has reason to believe that there are irregularities in respect of

(a) the consideration, by a referring practitioner, a former referring practitioner or a class of referring practitioners, of a guideline or protocol established under section 23 (1) [practice guidelines and protocols], or

(b) a referring practitioner's or former referring practitioner's pattern of practice.

(2) In the circumstances set out in subsection (1), the minister may do one or both of the following:

(a) advise the commission or the college with which the referring practitioner, former referring practitioner or class of referring practitioners is registered, or both, of the minister's belief;

(b) provide to the commission or college, or both, information, including personal information and information obtained through an audit or inspection, that the minister considers relevant to the exercise of the powers or the performance of the duties, under any enactment, of the commission or college.

Concerns with beneficiaries

50  If the minister has reason to believe that a beneficiary may have contravened a provision of this Act, the Medicare Protection Act or the regulations or an order made under either Act, the minister may do one or both of the following:

(a) advise the commission of the minister's belief;

(b) provide to the commission any relevant information, including personal information.

Warrants

51  (1) Without notice to any person, the minister may apply to a justice of the peace for an order under this section.

(2) A justice of the peace may issue a warrant authorizing a person to enter and search a place, including a private dwelling, and take any necessary action if satisfied by evidence on oath or affirmation that it is necessary for the purposes of

(a) taking an action authorized under this Act, or

(b) determining whether an action authorized under this Act should be taken.

Recovery of non-entitled amounts

52  (1) An amount is a non-entitled amount for the purposes of this section if the amount is paid by the minister to an operator, a former operator or a person who provided a benefit, who, under this Act or under an approval or a laboratory services agreement, is not entitled to the amount, including any amount paid

(a) for a laboratory service provided to a person who is not a beneficiary,

(b) for a laboratory service that was not a benefit,

(c) in respect of a claim for payment

(i) for a benefit that was not provided, or

(ii) that is not supported by the records kept or produced under this Act,

(d) after relying on a representation of fact that was untrue, or

(e) by mistake.

(2) Without limiting any action the minister could take under section 59 [enforcement orders] or 61 [cancellation of or change to approval if contravention], if the minister determines that the minister has paid a non-entitled amount to an operator, a former operator or a person who provided a benefit, the minister may, by written order, require the operator, former operator or person who provided a benefit, to

(a) repay the non-entitled amount,

(b) pay a prescribed surcharge, and

(c) pay interest on the amounts owing under paragraphs (a) and (b).

(3) Before acting under subsection (2), the minister must give, in accordance with the regulations, notice and a reasonable opportunity to be heard.

(4) The total amount that a person is liable to pay under subsection (2) is a debt due to the government and may be recovered as follows:

(a) the minister may deduct the amount owing from any subsequent payment owing, under this Act or a laboratory services agreement, by the government to the operator, former operator or person who provided a benefit;

(b) the minister may file the order made under subsection (2) in the Supreme Court and, on being filed in the court, the order is enforceable in the same manner as an order of the Supreme Court.

Settlement of non-entitled amounts

53  If the minister believes it to be in the public interest to accept less than 100% payment in settlement of the amount required to be paid by a person under section 52 (2) [recovery of non-entitled amounts], the minister may accept the greater of

(a) the percentage of the amount required to be paid that the minister considers appropriate in settlement, and

(b) the percentage of the amount required to be paid that Treasury Board sets for the purposes of settlement under this section, if Treasury Board sets this percentage.

Recovery from referring practitioner

54  (1) If the minister has paid an amount under this Act in relation to a laboratory service requested by a referring practitioner or a former referring practitioner in contravention of section 14.1 of the Medicare Protection Act, the referring practitioner or former referring practitioner must repay the amount to the minister.

(2) An amount that must be paid to the minister under this section is a debt due to the government and may be

(a) deducted from any subsequent payment owing, under this Act or the Medicare Protection Act, by the commission or the government to the referring practitioner or former referring practitioner, or

(b) recovered in a court of competent jurisdiction.

Appeals

55  (1) A person who is liable to repay an amount under section 52 (2) [recovery of non-entitled amounts] or 54 (1) [recovery from referring practitioner] may appeal to the Supreme Court not more than 30 days after an order is made under that section.

(2) An appeal from a decision of the Supreme Court in respect of the appeal made under subsection (1) lies to the Court of Appeal with leave of a justice of the Court of Appeal.

(3) An appeal under this section does not operate to stay

(a) the liability to repay the amount unless the Supreme Court orders otherwise, or

(b) an order of the Supreme Court unless the Court of Appeal orders otherwise.

Recovery of other amounts

56  (1) If the minister has paid an amount under this Act, other than to an operator, a former operator or a person who provided a benefit, for a service that was not a benefit, or by mistake, the person paid must repay the amount to the minister.

(2) If the minister has paid an amount under this Act for a benefit provided to a person who was not a beneficiary, the person who received the benefit must repay the amount to the minister.

(3) If the minister has paid an amount under this Act after relying on a representation of fact that was untrue, the person who made the misrepresentation must repay the amount to the minister.

(4) An amount that must be paid to the minister under this section is a debt due to the government and may be

(a) deducted from any subsequent payment owing, under this Act, by the government to the person, or

(b) recovered in a court of competent jurisdiction.

Limit on recovery

57  If the minister may recover an amount under section 52 (2) [recovery of non-entitled amounts], 54 (1) [recovery from referring practitioner] or 56 (2) [recovery of other amounts] with respect to the same incident that resulted in a payment under this Act, the minister may recover the amount under only one of those sections.

Division 2 — Enforcement Actions and Penalties

Use of evidence and inferences

58  (1) This section applies to

(a) an inspector, for the purpose of conducting an audit or inspection, including determining whether to conduct an audit or inspection and determining the results of the audit or inspection, and

(b) the minister, for the purpose of making an order or a determination under this Act.

(2) For a purpose set out in subsection (1), an inspector or the minister, as applicable, may do any of the following:

(a) subject to subsection (4), consider, and base a determination or order on, any relevant source of information, including a source created

(i) on a statistical basis, including information derived from sampling, or

(ii) by a comparison between benefits provided through an approved laboratory facility and corresponding laboratory services provided through other facilities, including facilities outside British Columbia;

(b) draw an adverse inference from any failure to produce sufficient information in relation to the matter that is the subject of the determination or order by

(i) a person in respect of whom an audit or inspection is conducted or the determination is to be made, or

(ii) a person against whom the order is proposed to be made.

(3) It is not necessary for an inspector or the minister to consider, under subsection (2) (a), any particular benefit that was provided through an approved laboratory facility.

(4) The minister may make orders respecting the use or application of, or reliance on, statistical methodologies for the purposes of subsection (2) (a).

(5) The minister must publish an order made under subsection (4).

Enforcement orders

59  (1) The minister may make an order described in subsection (2) if

(a) the minister first gives, in accordance with the regulations, notice and an opportunity to be heard, and

(b) following the hearing, the minister determines that a person has

(i) contravened this Act or a regulation made under it, including failing to comply with a previous order made under this section, or

(ii) committed an offence under section 64 [offences].

(2) If subsection (1) applies, the minister may do one or more of the following:

(a) order a person to do anything that, in the opinion of the minister, is necessary to bring the person into compliance;

(b) attach limits or conditions to the order, including requiring proof, at the cost of the person against whom the order is made, that the person has complied with the order;

(c) without giving further notice or an opportunity to be heard under section 11 (2) [approvals to provide benefits], change the limits or conditions of an approval;

(d) include a requirement to pay the costs, or part of the costs, of the audit or hearing, or both.

(3) A person against whom an order is made must comply with the order.

(4) Despite subsection (1) (b) (i), an order must not be made under this section in respect of a matter described in section 23 (2) [practice guidelines and protocols].

Making enforcement orders

60  (1) Despite section 59 (1) (a) [enforcement orders], the minister may make an enforcement order without a hearing if the person who is to be subject to the order, having been given notice in accordance with the regulations, agrees to waive the right to a hearing.

(2) If a person who is subject to an enforcement order is a referring practitioner or a laboratory medicine physician, the minister may provide a copy of the enforcement order to the appropriate college.

(3) The minister may publish information, including personal information, respecting enforcement orders.

Cancellation of or change to approval if contravention

61  (1) The minister may cancel or change the limits or conditions of an approval if, following a hearing under section 59 [enforcement orders] and without giving further notice or an opportunity to be heard under section 11 (2) [approvals to provide benefits], the minister

(a) has reasonable grounds for making an enforcement order under section 59 in relation to the laboratory facility that is subject to the approval, and

(b) is of the opinion that it is not in the public interest for benefits to be provided through the laboratory facility that is subject to the approval.

(2) If the minister has reasonable grounds to believe that an operator or employee of a laboratory facility that is subject to an approval is or has been the subject of an action taken under any of sections 15, 37, 45.1 and 46 of the Medicare Protection Act, the minister may do either of the following:

(a) if the minister is of the opinion that it is not in the public interest for benefits to be provided through the laboratory facility, cancel the approval;

(b) change the limits or conditions of the approval.

(3) Before acting under subsection (2), the minister must give, in accordance with the regulations, notice and a reasonable opportunity to be heard.

(4) Nothing in this section limits the minister's powers under section 18 [cancellation of approvals for laboratory system reasons] or 59.

Injunctions

62  (1) Without notice to any person, the minister may apply to a judge of the Supreme Court for an order under this section.

(2) If satisfied by evidence on oath or affirmation that there has been or will be a contravention of this Act or an enforcement order, a judge of the Supreme Court may grant an injunction restraining a person from contravening, or requiring a person to comply with, this Act or the enforcement order.

(3) If satisfied by evidence on oath or affirmation that the person is interfering with or obstructing, or will likely interfere with or obstruct, a person who is exercising powers or performing duties under this Act, a judge of the Supreme Court may order a person to do or refrain from doing those things the judge considers necessary.

(4) A judge of the Supreme Court may grant an interim injunction or order until the outcome of an application commenced under this section.

Division 3 — Offences and Penalties

Offence Act application

63  Sections 4 and 5 of the Offence Act do not apply in respect of this Act or the regulations made under it.

Offences

64  A person who does any of the following commits an offence:

(a) misrepresents the nature or extent of a benefit for which payment may be made under this Act;

(b) knowingly obtains or attempts to obtain a benefit or payment for a benefit to which the person is not entitled under this Act;

(c) contravenes section 8 [misuse of identity number], 16 [records], 29 [no market research] or 38 [whistle-blower protection];

(d) knowingly provides false or misleading information to a person who is exercising a power or performing a duty under this Act, or a person acting under the order or direction of that person;

(e) wilfully interferes with, or obstructs, a person who is exercising a power or performing a duty under this Act, or a person acting under the order or direction of that person;

(f) knowingly assists another person to commit an offence under this Act.

Fines and incarceration

65  A person who commits an offence listed in section 64 [offences], or established under the regulations and identified as an offence to which this section applies, is liable on conviction to a fine not exceeding $200 000 or to imprisonment for a term not exceeding 6 months, or to both.

Actions by corporation or employee

66  (1) If a corporation commits an offence under this Act, an employee, an officer, a director or an agent of the corporation who authorized, permitted or acquiesced in the offence commits the offence whether or not the corporation is convicted.

(2) If an employee commits an offence under this Act, an employer who authorized, permitted or acquiesced in the offence commits the offence whether or not the employee is identified or convicted.

Continuing offences

67  If a person commits an offence under this Act and continues to commit the offence, separate penalties may be imposed in respect of the offence for each day the original offence continues.

No benefit from offence

68  If a person gains a benefit in committing an offence, the person is liable on conviction, in addition to any penalty imposed under this Act, to a fine in an amount not exceeding the amount of the benefit.

Limitation period

69  A proceeding for an offence under this Act may not be commenced in any court more than 3 years after the facts on which the proceeding is based first come to the knowledge of the minister.

Publication

70  The minister may publish information, including personal information, respecting prosecutions for offences.

Part 5 — Regulations

Regulations respecting benefits, beneficiaries and referring practitioners

71  The Lieutenant Governor in Council may make regulations respecting benefits, beneficiaries and referring practitioners as follows:

(a) prescribing services that are, or are not, laboratory services;

(b) prescribing classes of health care practitioners for the purposes of this Act;

(c) respecting the enrollment of health care practitioners as referring practitioners;

(d) prescribing specialties for the purposes of the definition of "laboratory medicine physician" in section 1 [definitions];

(e) respecting payment for laboratory services provided outside British Columbia;

(f) respecting the referral, by referring practitioners, of beneficiaries to laboratory facilities for the purposes of receiving benefits;

(g) respecting verification of the identity and enrollment, under the Medicare Protection Act, of a person requesting benefits under this Act;

(h) prescribing classes of persons for the purposes of sections 4 (1) (b) (i) [what are benefits] and 8 (2) [misuse of identity number];

(i) for the purposes of section 4 (1) (b) (i), respecting the circumstances in which a request may be made by a prescribed person and attaching limits and conditions to the making of a request.

Regulations respecting laboratory facilities

72  (1) The Lieutenant Governor in Council may make regulations respecting laboratory facilities as follows:

(a) respecting applications and requirements for approval, including prescribing criteria that a laboratory facility and an operator must meet;

(b) respecting the granting of approvals, including matters the minister must consider before granting an approval;

(c) respecting matters the minister must consider before entering into a laboratory services agreement;

(d) respecting the accreditation of applicants for approvals or of persons seeking to enter into a laboratory services agreement;

(e) respecting renewals and transfers of approvals;

(f) prescribing agencies for the purposes of the definition of "prescribed agency" in section 1 [definitions].

(2) Without limiting subsection (1) (b), regulations made under that subsection may require the minister to consider any matter related to ensuring the efficient delivery of benefits in British Columbia, including in respect of location, proximity to other laboratory facilities and current and anticipated capacity and need.

(3) The Lieutenant Governor in Council may make regulations respecting approved laboratory facilities as follows:

(a) respecting the operation and management of approved laboratory facilities;

(b) respecting the accreditation of

(i) approved laboratory facilities, and

(ii) laboratory facilities that provide laboratory services on contract to approved laboratory facilities;

(c) respecting the provision of benefits through approved laboratory facilities, including limiting the benefits that may be provided through a class of approved laboratory facilities;

(d) respecting the charging of beneficiaries for matters referred to in section 15 (1) [prohibitions];

(e) respecting changes to and the cancellation of approvals.

(4) The Lieutenant Governor in Council may make regulations respecting transfers and assignments for the purposes of Division 4 [Transfers and Assignments] of Part 2, including

(a) respecting circumstances in which transfers or assignments are prohibited,

(b) imposing limits or conditions on transfers and assignments, and

(c) respecting terms and conditions of transfers and assignments.

Regulations respecting information management

73  The Lieutenant Governor in Council may make regulations respecting the management of information as follows:

(a) if the collection, use or disclosure of personal information is authorized under this Act,

(i) clarifying or limiting the purposes for which collection, use or disclosure is authorized, and

(ii) limiting or putting conditions, in addition to any limits or conditions already provided for in this Act, on that collection, use or disclosure;

(b) defining "health services" and "health system" for the purposes of section 26 [collection, use and disclosure of personal information];

(c) for the purposes of section 27 [requests for information], prescribing persons to whom, and purposes for which, requests for information may be made;

(d) prescribing activities or circumstances that do or do not comprise market research for the purpose of section 29 [no market research];

(e) prescribing enactments for the purposes of section 30 [information-sharing agreements] and bodies for the purposes of section 30 (c);

(f) requiring the keeping of records and the making of reports respecting the collection, use or disclosure of personal information under this Act.

Administrative and other regulation-making powers

74  (1) The Lieutenant Governor in Council may make regulations as follows:

(a) without limiting section 72 (1) (a) [regulations respecting laboratory facilities], respecting applications under this Act, including prescribing timelines in which applications may be made;

(b) respecting records that must be kept under this Act, including the period of time for which records must be kept;

(c) respecting reports that must be made and notices that must be given under this Act, including

(i) the content of the report or notice,

(ii) the making of the report or the service of the notice, and

(iii) the waiver of notice if service is not reasonably practicable;

(d) prescribing purposes for which an audit may be conducted;

(e) respecting matters that may be the subject of an audit;

(f) respecting hearings under this Act, including providing for

(i) the form and manner of hearings, including by written submissions,

(ii) practices and procedures to be followed, including timelines in which processes and exchanges or submissions of records must be completed,

(iii) the conduct of negotiations or a pre-hearing conference for possible settlement of the issues before a hearing is commenced,

(iv) the means by which particular facts may be proved or the mode in which evidence may be given at a pre-hearing conference or a hearing,

(v) the requirements for the attendance of witnesses, the conduct of witnesses or the compelling of witnesses to give evidence under oath or in some other manner, and

(vi) costs to be awarded against a party for failing to comply with a regulation made under this paragraph;

(g) respecting deemed receipt of a copy of an order made under this Act;

(h) respecting fees and surcharges that may be charged under this Act;

(i) respecting the interest payable on non-entitled amounts and surcharges owing under this Act;

(j) respecting any other matter for which regulations are contemplated by this Act.

(2) If an administrative body is established or designated under section 31 [delegation to administrative body], the Lieutenant Governor in Council may prescribe that an enactment applies to the administrative body, and may make regulations for the purposes of applying the enactment to that administrative body.

(3) If an advisory committee is established under section 35 [advisory committees], the Lieutenant Governor in Council may make regulations respecting

(a) the remuneration of members, and

(b) the payment of members' reasonable and necessary travel and out-of-pocket expenses incurred in carrying out the work of the committee.

General regulation-making powers

75  (1) The Lieutenant Governor in Council may make regulations referred to in section 41 of the Interpretation Act.

(2) A person must not read any section of this Part as limiting the general powers to make regulations described in subsection (1).

(3) The Lieutenant Governor in Council may make regulations

(a) exempting a person, a laboratory service, an approved laboratory facility or a class of persons, laboratory services or approved laboratory facilities from one or more provisions of this Act or a regulation made under it, or

(b) authorizing the minister to waive or modify one or more requirements of a regulation made under this Part in respect of a person, a laboratory service, an approved laboratory facility or a class of persons, laboratory services or approved laboratory facilities.

(4) If the Lieutenant Governor in Council makes an exemption under subsection (3) (a),

(a) the Lieutenant Governor in Council may attach limits or conditions to the exemption, and

(b) a person or approved laboratory facility that is subject to the exemption must comply with all applicable limits and conditions.

(5) Without limiting subsection (3), a regulation made under this Part may

(a) establish classes of laboratory services, benefits, persons and approved laboratory facilities, and

(b) make regulations that are different for different classes, including limiting the application of the regulation to one or more classes.

(6) Without limiting subsection (3) (b), a regulation made under this Part may confer a discretion on the minister.

(7) A regulation made under this Act may adopt by reference, in whole or in part and with any changes the Lieutenant Governor in Council considers appropriate, a regulation, code, standard or rule

(a) enacted as or under a law of another jurisdiction, including a foreign jurisdiction, or

(b) set by a provincial, national or international body or any other body that may make codes, standards or rules.

(8) Unless otherwise stated, a regulation, code, standard or rule referred to in subsection (7) is adopted as amended from time to time.

Part 6 — Transitional Provisions and
Consequential Amendments

Transitional Provisions

Transition — definition

76  In this Part, "grandparented laboratory facility" means the following:

(a) in respect of a hospital within the meaning of paragraph (a) or (e) of the definition of "hospital" in section 1 of the Hospital Insurance Act, that part of the hospital that, on the date this section comes into force, provides laboratory services;

(b) in respect of a diagnostic facility within the meaning of the Medicare Protection Act, that part of the diagnostic facility that, on the date this section comes into force, is approved to provide laboratory services under that Act;

(c) a specimen collection station that, on the date this section comes into force, is associated with a hospital or diagnostic facility referred to in paragraph (a) or (b);

(d) a laboratory that, on the date this section comes into force, is funded, managed or operated by a prescribed agency.

Transition — deemed approval of grandparented laboratory facilities

77  (1) Subject to this Part, on the date this section comes into force,

(a) the Hospital Act, the Hospital Insurance Act or the Medicare Protection Act, as applicable, including any approval, certification or other authorization under any of those Acts, ceases to apply to a grandparented laboratory facility,

(b) a grandparented laboratory facility must not receive compensation under the Hospital Insurance Act or the Medicare Protection Act for a laboratory service that is a benefit under this Act, except in relation to services provided as benefits under either the Hospital Insurance Act or the Medicare Protection Act before the coming into force of this section, and

(c) a grandparented laboratory facility is deemed to be an approved laboratory facility, subject to an approval, for all purposes under this Act.

(2) For the purposes of this Act, a grandparented laboratory facility remains subject to the limits and conditions, if any, imposed on the operator of the grandparented laboratory facility under the Hospital Act, the Hospital Insurance Act or the Medicare Protection Act that were in effect immediately before the coming into force of this section, unless the minister provides otherwise by order.

(3) Subject to subsection (4), an order made under subsection (2) may

(a) refer to a limit or condition or a type of limit or condition,

(b) be made applicable to a grandparented laboratory facility or a class of grandparented laboratory facilities, and

(c) be made without giving notice or an opportunity to be heard.

(4) An order made under subsection (2) of this section more than 3 years after the date this section comes into force

(a) may not be made in respect of a class of grandparented laboratory facilities, and

(b) is subject to the requirements of section 11 (2) [approvals to provide benefits].

(5) A limit or condition described in subsection (2) that refers or relates to the commission must be read as referring or relating to the minister.

(6) If a grandparented laboratory facility that is deemed to be an approved laboratory facility under subsection (1) subsequently becomes subject to a laboratory services agreement, the following occur as of the date the laboratory services agreement takes effect:

(a) the limits or conditions referred to in subsection (2) and any order made under that subsection cease to apply;

(b) the deemed approval is cancelled.

Transition — commission records

78  (1) The commission must, as soon as possible after the date this section comes into force, transfer to the minister all records in the possession or control of the commission that are relevant to a grandparented laboratory facility.

(2) Despite subsection (1), the commission may keep copies of records relevant to any action or proceeding under the Medicare Protection Act that is in progress on the date this section comes into force.

Transition — audits and inspections

79  (1) An audit or inspection may be made under the Hospital Act, the Hospital Insurance Act or the Medicare Protection Act in relation to the operation, before the coming into force of this section, of a grandparented laboratory facility.

(2) For the purposes of an audit or inspection under subsection (1),

(a) the Hospital Act, the Hospital Insurance Act and the Medicare Protection Act, as they read immediately before the coming into force of this section, apply, and

(b) the minister or the commission may take any action under the Hospital Act, the Hospital Insurance Act or the Medicare Protection Act that the minister or the commission could have taken had this Act not been enacted.

Transition — actions in progress under Medicare Protection Act

80  (1) If, on the date this section comes into force,

(a) a laboratory facility or a grandparented laboratory facility is the subject of

(i) an application made under section 33 (1) of the Medicare Protection Act, or

(ii) an action of the commission under section 33 (2) of the Medicare Protection Act, and

(b) the commission has not made a final decision in respect of the application or action,

the commission must not grant an approval or impose, attach or amend conditions under that section in relation to a laboratory service that is a benefit under this Act.

(2) If, on the date this section comes into force, the commission is taking an action under section 36, 37 or 40 of the Medicare Protection Act in relation to an approved diagnostic facility that is a grandparented laboratory facility under this Act, the commission may

(a) continue the action, and take any appropriate further action, in accordance with the Medicare Protection Act as it read immediately before the coming into force of section 91 of this Act, except that the commission must not impose or vary the terms and conditions of an approval to which the grandparented laboratory facility is subject, and

(b) advise the minister respecting what terms and conditions it would have imposed or varied had paragraph (a) of this subsection not prohibited the commission from doing so.

Transition — registered nurses (certified)

81  (1) In this section, "registered nurse (certified)" means a registered nurse who, on the date this section comes into force,

(a) is certified under section 8 (3) of the Nurses (Registered) and Nurse Practitioners Regulation, B.C. Reg. 284/2008, and

(b) is enrolled under the Medicare Protection Act for the purpose of requesting diagnostic services that will be benefits within the meaning of paragraph (c) of the definition of "benefits" in section 1 of that Act.

(2) A registered nurse (certified) is deemed to be a referring practitioner for the purposes of this Act unless his or her enrollment as a referring practitioner is cancelled in accordance with the regulations made under sections 71 (c) [regulations respecting benefits, beneficiaries and referring practitioners] and 74 (1) (f) [administrative and other regulation-making powers] of this Act.

Transition — regulations

82  (1) The Lieutenant Governor in Council may make regulations the Lieutenant Governor in Council considers necessary or advisable for the orderly transition from the Health Authorities Act, the Hospital Act, the Hospital Insurance Act or the Medicare Protection Act to this Act.

(2) A regulation made under subsection (1) may provide that a provision of the Health Authorities Act, the Hospital Act, the Hospital Insurance Act or the Medicare Protection Act applies, with or without modification, to a grandparented laboratory facility or a class of grandparented laboratory facilities.

(3) The Lieutenant Governor in Council may make regulations providing for the application of section 51 of the Evidence Act, with or without modification, to a grandparented laboratory facility or a class of grandparented laboratory facilities.

(4) The authority to make or amend a regulation made under subsection (1) or (3), but not the authority to repeal a regulation made under subsection (1) or (3), ends 3 years after the date on which this section comes into force.

 
Consequential Amendments

E-Health (Personal Health Information Access
and Protection of Privacy) Act

83 Section 26 (2) of the E-Health (Personal Health Information Access and Protection of Privacy) Act, S.B.C. 2008, c. 38, is amended by adding the following paragraph:

(g.1) prescribing activities or circumstances that do or do not comprise market research for the purpose of section 20 [no market research].

Health Authorities Act

84 Section 7.1 of the Health Authorities Act, R.S.B.C. 1996, c. 180, is amended by striking out "made by regulation of the minister" and substituting "made by order of the minister".

Health Care Costs Recovery Act

85  Section 1 of the Health Care Costs Recovery Act, S.B.C. 2008, c. 27, is amended in the definition of "health care services" by adding the following paragraph:

(a.1) benefits as defined in the Laboratory Services Act.

Health Professions Act

86 Section 25.94 (4) of the Health Professions Act, R.S.B.C. 1996, c. 183, is amended by adding "within the meaning of the Pharmaceutical Services Act" after "market research".

Hospital Insurance Act

87 Section 5 of the Hospital Insurance Act, R.S.B.C. 1996, c. 204, is amended

(a) in subsection (1) (a) and (b) by striking out "and laboratory", and

(b) in subsection (2) by adding the following paragraph:

(d) laboratory services that are benefits within the meaning of the Laboratory Services Act.

88 Section 8 is amended

(a by renumbering section 8 as section 8 (1),

(b) in subsection (1) by striking out "and laboratory", and

(c) by adding the following subsection:

(2) Every hospital must provide for beneficiaries those laboratory services that are benefits within the meaning of the Laboratory Services Act.

89 Section 29 (2) is amended

(a) by repealing paragraph (s) and substituting the following:

(s) the equipment and use of X-ray, operating and case rooms; , and

(b) by adding the following paragraph:

(x.1) the verification of the identity and enrollment, under the Medicare Protection Act, of a person requesting benefits under this Act; .

Medicare Protection Act

90 Section 1 of the Medicare Protection Act, R.S.B.C. 1996, c. 286, is amended

(a) in paragraph (c) (ii) (A) of the definition of "benefits" by striking out "on order of" and substituting "on request of", and

(b) by repealing the definition of "diagnostic facility" and substituting the following:

"diagnostic facility" means a facility, place or office principally equipped for prescribed diagnostic services, studies or procedures, and includes any branches of a diagnostic facility; .

91 The following section is added before Part 1:

Application to laboratory services

2.1  This Act does not apply to laboratory services that are benefits within the meaning of the Laboratory Services Act.

92 Section 3 (3) is amended by striking out "health care and diagnostic facility services" and substituting "health care and prescribed diagnostic services".

93 Section 5 (1) (s) is amended by striking out "health care and diagnostic services" and substituting "health care and prescribed diagnostic services".

94 Section 5.01 is amended by striking out "section 11 (1) (a), (b), (c) or (c.1)." and substituting "section 11 (1) (a), (a.1), (b), (c) or (c.1)."

95 Section 11 (1) is amended by adding the following paragraph:

(a.1) knowingly requesting a practitioner to request a laboratory service that

(i) is a benefit within the meaning of the Laboratory Services Act, and

(ii) is not medically required; .

96 Section 12 (b) (i) is repealed and the following substituted:

(i) his or her enrollment is cancelled, or .

97 The following section is added to Part 2:

Sharing information if belief of contravention

12.1  If the commission has reason to believe that a person may have contravened a provision of this Act, the Laboratory Services Act or the regulations or an order made under either Act, the commission may do one or both of the following:

(a) advise the minister of the commission's belief;

(b) provide to the minister any relevant information, including personal information.

98 The following section is added:

No referrals for laboratory services if no benefit rendered

14.1  Except with the prior written consent of the minister, a medical practitioner or a prescribed health care practitioner must not request, for the purposes of or in relation to a service that is not a benefit under this Act, a laboratory service that is a benefit within the meaning of either this Act or the Laboratory Services Act.

99 Section 15 (1) is amended

(a) in paragraph (d) by striking out "section 17, 18 or 19," and substituting "section 14.1, 17, 18, 19 or 35,", and

(b) by adding the following paragraph:

(d.1) contravention of section 25 of the Laboratory Services Act.

100 Section 28 is amended by striking out "another province of Canada in respect of which" and substituting "another jurisdiction of Canada with which".

101 Section 29 (5) is repealed and the following substituted:

(5) If the government has made, with the government of another jurisdiction of Canada, an agreement that provides for arrangements to pay for medically required services rendered in that other jurisdiction, the agreement applies.

102 Section 30 (1) is repealed and the following substituted:

(1) If the commission has paid an amount under this Act

(a) for a service that was not a benefit or that was provided in contravention of section 14.1, or

(b) by mistake,

the person paid must repay the amount to the commission.

(1.1) If the commission has paid an amount under this Act for a benefit provided to a person who was not a beneficiary, the person who received the benefit must repay the amount to the commission.

103 Section 36 is amended

(a) by repealing subsection (3) and substituting the following:

(3) Medical records may be requested or inspected under this section or section 40 only by an inspector who

(a) is a medical practitioner, or

(b) was formerly a medical practitioner, if the commission has, at the time of appointing the person as an inspector, stated in writing that the person may inspect medical records under this section or section 40, or both. , and

(b) by repealing subsection (8) (c) and substituting the following:

(c) answer all questions of the inspector respecting any matter relating to the records, or to the audit generally.

104 Section 49 (2) is amended by adding the following paragraph:

(c.1) to communicate information to the minister for the purposes of section 61 of the Laboratory Services Act if a person is the subject of

(i) a notice of hearing under section 15 or 37 of this Act, or

(ii) an application for an injunction under section 45.1 of this Act; .

105 The following section is added:

Laboratory facilities

50.1  Except as provided for under the Laboratory Services Act, nothing in this Act authorizes the commission to act in relation to a grandparented laboratory facility within the meaning of that Act.

Medicare Protection Amendment Act, 2003

106 Section 2 of the Medicare Protection Amendment Act, 2003, S.B.C. 2003, c. 95, is repealed and the following substituted:

2 Section 15 (1) is amended by repealing paragraphs (d) and (d.1) and substituting the following:

(d) a determination by the commission that the practitioner has

(i) attempted to contravene section 14.1, 17, 18, 18.1, 19 or 35,

(ii) contravened section 14.1, 17, 18, 18.1, 19 or 35, or

(iii) authorized, assisted or allowed another person to contravene or attempt to contravene section 14.1, 17, 18, 18.1, 19 or 35,

(d.1) a determination by the commission that the practitioner has

(i) attempted to contravene section 25 of the Laboratory Services Act,

(ii) contravened section 25 of the Laboratory Services Act, or

(iii) authorized, assisted or allowed another person to contravene or attempt to contravene section 25 of the Laboratory Services Act.

Pharmaceutical Services Act

107 Section 63 (2) of the Pharmaceutical Services Act, S.B.C. 2012, c. 22, is amended by adding the following paragraph:

(d.1) prescribing activities or circumstances that do or do not comprise market research for the purpose of section 25 [no market research].

Tobacco Damages and Health Care Costs Recovery Act

108 Section 1 (1) of the Tobacco Damages and Health Care Costs Recovery Act, S.B.C. 2000, c. 30, is amended in the definition of "health care benefits" by adding the following paragraph:

(a.1) benefits as defined under the Laboratory Services Act.

Commencement

109  This Act comes into force by regulation of the Lieutenant Governor in Council.

 
 
Explanatory Note

This Bill enacts the Laboratory Services Act, an Act that will