Application for an Amendment to an Existing Laboratory ... · hlth 1942 2018/07/23 page 2 of 12 hlth 1942 application for an amendment to an existing laboratory facility or specimen

HOW TO COMPLETE AND SUBMIT THIS APPLICATIONThis completed form with enclosures and any attachments must be signed by an authorized representative of the private or public organization and submitted via the laboratory services secure upload tool located at: http://www.gov.bc.ca/labservicesupload

Only complete forms will be accepted for processing.

For assistance in completing this form, please read Part 2.3 of the Policies and Guidelines, located at: https://www2.gov.bc.ca/assets/gov/health/practitioner-pro/laboratory-services/facilities_approvals_policy.pdf

Personal information on this form is collected under the authority of s.26(1) of the Laboratory Services Act and will be used to process your application for approval to provide benefits under the Laboratory Services Act and for record keeping. This information is protected from unauthorized use and disclosure in accordance with the Freedom of Information and Protection of Privacy Act and may be disclosed only as provided by that Act or the Laboratory Services Act. If you have any questions about the collection of this information, please contact Laboratory Services at: [email protected].

Laboratory Services

HLTH 1942APPLICATION FOR AN AMENDMENT TO

AN EXISTING LABORATORY FACILITY OR SPECIMEN COLLECTION STATION APPROVAL

Under the Laboratory Services Act

HLTH 1942 2018/07/23 PAGE 1 OF 12

TYPE OF AMENDMENT (check all that apply)

FACILITY OPERATOR CONTACT INFORMATION (please complete as applicable)

Change or addition to laboratory services

Significant change to capability or capacity – includes significant change to the physical clinical space of a laboratory facility

Change to an Approval’s limits and conditions

Extension of a time-limited Approval

Date of Application (YYYY / MM / DD) Proposed Date of Change (YYYY / MM / DD)

Operator Name

Operator Phone #Operator Email Address

Facility Name

Laboratory – testing only Laboratory – testing and specimen collection Specimen collection only

Organization type

Publicly Owned Privately Owned

Operator Title

Facility Address (Current)

Facility Address (Proposed)

Laboratory Facility # Specimen Collection Station Facility # Associated Payee #

Services

HLTH 1942APPLICATION FOR AN AMENDMENT TO AN EXISTING LABORATORY FACILITY OR SPECIMEN COLLECTION STATION APPROVAL

PART 1 – FACILITY INFORMATION

DIAGNOSTIC ACCREDITATION PROGRAM (DAP) (please check applicable box)

Accreditation awarded - report and accredited test menu attached

Date of Accreditation (YYYY / MM / DD): Expiry Date (YYYY / MM / DD):

Accreditation in progress

Anticipated date of Accreditation (YYYY / MM / DD):

HLTH 1942 2018/07/23 PAGE 2 OF 12


PART 2 – APPLICANT INFORMATIONThe “applicant” is the authorized representative and/or signatory that is duly authorized to make the declaration/disclosure on behalf of the operator/owner.

Applicant Name

Mailing Address

Applicant Email Address

Date of Application (YYYY / MM / DD)

Applicant Title

Applicant Phone #

Proposed Start Date (YYYY / MM / DD)

RATIONALE FOR APPLICATIONPlease provide detailed information to support your application. Attach as separate document if necessary.

Medical need or unmet capacity (demand)

Urgent health and safety need

Urgent business need

Other (specify):

Attached is a detailed business case and/or supporting documentation that identifies the need for laboratory and/or specimen collection services in the catchment area.

HLTH 1942 2018/07/23 PAGE 3 OF 12


PART 3 – FACILITY OPERATOR INFORMATIONPlease complete as applicable.

Note: Applications involving a foreign ownership are subject to https://www2.gov.bc.ca/assets/gov/health/practitioner-pro/laboratory-services/facilities_approvals_policy.pdf Policy 2.5.5 [Assessment Criteria: Compliance with Canadian and BC Law] may require additional actions from the applicant. For further information, refer to the Policies and Guidelines or contact Laboratory Services Administration at [email protected].

OWNERSHIP TYPE

Public Ownership

(complete part 3.a)

Private Ownership

Sole Proprietor (complete part 3.b)

Partnership (complete part 3.c)

Corporation (complete part 3.d)

Other (specify):

3.a PUBLICLY OWNED FACILITYHealth Authority Name

Health Authority Address

3.b PRIVATELY OWNED FACILITY - SOLE PROPRIETOR INFORMATIONForeign Ownership

Sole Proprietor Name

Yes No

Sole Proprietor Address

3.c PRIVATELY OWNED FACILITY - PARTNERSHIP INFORMATION (please complete as applicable)Foreign Ownership

Partnership Name

Yes No

Partnership Address

Operator Name (Registered Legal Name)

Operator Mailing Address

Partner Information Partner Information

Partner Name % Owned % Owned

Business Address

Partner Name

Business Address

HLTH 1942 2018/07/23 PAGE 4 OF 12

3.d PRIVATELY OWNED FACILITY - CORPORATION INFORMATION (please complete as applicable)Foreign Ownership

Corporation Name

Yes No

Corporation Address

Corporation Number

Officer/Director Name

% Owned % Owned

Officer/Director Title/Position

Officer/Director Name

Officer/Director Title/Position

Date of Incorporation (YYYY / MM / DD)

Officer/Director Business Address Officer/Director Business Address

Shareholder Name

Shareholder Business Address

Shareholder Name

Shareholder Business Address


PART 3 – FACILITY OPERATOR INFORMATION CONTINUED

Officer/Director Information Officer/Director Information

Shareholder Information Shareholder Information

HLTH 1942 2018/07/23 PAGE 5 OF 12

4.a CURRENTLY APPROVED LABORATORY FEE-FOR-SERVICEOutpatient Test Volume InformationEstimate the total monthly volume of outpatient laboratory services and outpatient specimen collection station throughput provided by the facility based on hours of operation and equipment capacity.


PART 4 – LABORATORY FACILITY SERVICES

Facility # (if applicable)Receiving Laboratory Name (if applicable)

Average Monthly Volume of All Outpatient Laboratory Services (if applicable)

Average Monthly Volume of All Outpatient Specimen Collection Throughput (if applicable)

CURRENTLY APPROVED FEE-FOR-SERVICE CATEGORIES CURRENT MONTHLY CURRENT MAXIMUM (please complete all that apply) VOLUME MONTHLY VOLUME

Specimen Collection

Category 1 - General laboratory tests

Category 2A - Hematology

Category 2B - Microbiology

Category 2C - Clinical Chemistry

Category 2M - Category 3 minus all Microbiology fee items

Category 3 - Full Approval (minus the Specialty Categories)

CURRENTLY APPROVED FEE-FOR-SERVICE CURRENT MONTHLY CURRENT MAXIMUM SPECIALTY CATEGORIES VOLUME MONTHLY VOLUME

Category 2G - Cytogenetics

Category 2V - Virology

Category 2S - Specialized

CURRENTLY APPROVED ADDITIONAL FEE-FOR-SERVICE FEE ITEMS

CURRENT MONTHLY CURRENT MAXIMUM VOLUME MONTHLY VOLUME

FEE ITEM # FEE ITEM DESCRIPTION

HLTH 1942 2018/07/23 PAGE 6 OF 12

4.b PROPOSED CHANGES TO LABORATORY FEE-FOR-SERVICEProposed Outpatient Test Volume InformationProvide the projected monthly volume and potential maximum monthly volume of outpatient laboratory services and outpatient specimen collection station throughput that will be provided by the facility based on hours of operation and equipment capacity.

Note: For a list of outpatient categories and services, please see: https://www2.gov.bc.ca/assets/gov/health/practitioner-pro/laboratory-services/facility_approval_categories_june_2018_-_revised.pdf

For a complete list of outpatient fee items, please see: https://www2.gov.bc.ca/assets/gov/health/practitioner-pro/laboratory-services/laboratory_services_schedule_of_fees.pdf


PART 4 – LABORATORY FACILITY SERVICES CONTINUED

PROJECTED MONTHLY POTENTIAL MAXIMUM VOLUME MONTHLY VOLUME

Specimen Collection

Category 1 - General laboratory tests

Category 2A - Hematology

Category 2B - Microbiology

Category 2C - Clinical Chemistry

Category 2M - Category 3 minus all Microbiology fee items

Category 3 - Full Approval (minus the Specialty Categories)


Category 2G - Cytogenetics

Category 2V - Virology

Category 2S - Specialized

PROPOSED ADDITIONAL FEE-FOR-SERVICE FEE ITEMS

FEE ITEM # FEE ITEM DESCRIPTION

PROPOSED FEE-FOR-SERVICE CATEGORIES


PROPOSED FEE-FOR-SERVICE SPECIALTY CATEGORIES

HLTH 1942 2018/07/23 PAGE 7 OF 12

Provide both current and proposed (if applicable) information about the facility’s square footage, chair count, hours of operation, physician/practitioner details, and equipment data.

Note: See https://www2.gov.bc.ca/assets/gov/health/practitioner-pro/laboratory-services/facilities_approvals_policy.pdf for definitions of “Capability” and “Capacity.”

5.a SQUARE FOOTAGE

5.b PATIENT THROUGHPUT & CHAIR COUNT

5.c HOURS OF OPERATION


PART 5 – CAPABILITY, CAPACITY, AND SIGNIFICANT CHANGE

Proposed total square footage of facilityCurrent square footage of facility

Proposed square footage used for the provision of outpatient servicesCurrent square footage used for the provision of outpatient services

Current hours of operation

Sunday Monday Tuesday Wednesday Thursday Friday Saturday

LABORATORY HOURS OF OPERATION

New hours of operationSunday Monday Tuesday Wednesday Thursday Friday Saturday

Current hours of operation

Sunday Monday Tuesday Wednesday Thursday Friday SaturdaySPECIMEN COLLECTION STATION HOURS OF OPERATION

New hours of operationSunday Monday Tuesday Wednesday Thursday Friday Saturday

Beds/Stretchers

Current Number

Phlebotomy Chairs

Current Maximum Number

Proposed Number

Proposed Maximum Number

5.d LABORATORY MEDICINE PHYSICIAN INFORMATIONPlease provide the name, speciality, and practitioner number of each physician/practitioner who will be providing and/or supervising the provision of benefits at the facility.

Note: Applicants are responsible for advising facility physicians/practitioners that their MSP Practitioner Number will be included on the application form. The applicant must retain a record of such notification.

LABORATORY MEDICAL DIRECTORName Specialty MSP Practitioner Number (if applicable)

LABORATORY MEDICINE PHYSICIAN(S)Name Specialty MSP Practitioner Number (if applicable)

Name Specialty MSP Practitioner Number (if applicable)




HLTH 1942 2018/07/23 PAGE 8 OF 12


PART 5 – CAPABILITY, CAPACITY, AND SIGNIFICANT CHANGE CONTINUED5.e EQUIPMENT INFORMATIONProvide a description of the capacity and capabilities of the major equipment, including Point of Care Testing equipment, to be used by the laboratory facility.

New Equipment Year/Make/ModelName/Brand of Equipment Capability (Max Output/day) Capacity (Max Output/day)

Yes No

Yes No

Yes No

Yes No

Yes No

HLTH 1942 2018/07/23 PAGE 9 OF 12

If requesting a change to the current limits and conditions, provide the current restricted condition(s) as reflected on the facility’s Approval, and provide the proposed changes to that existing condition. If there are no restricted conditions associated with the facility’s current approval, please leave this section blank.

Note: Facility Approval is subject to the following standard conditions:1. Approval is restricted to payment for outpatient fee-for-service laboratory benefits only when specifically requested by a referring practitioner as defined under the Laboratory Services Act and Regulation. 2. Approval is subject to continued accreditation by the Diagnostic Accreditation Program. Changes in accreditation may result in changes to the Approval.3. Approval is subject to cancellation where no services are provided for a period of six consecutive months.


PART 6 – CHANGE TO THE LIMITS AND CONDITIONS OF AN APPROVAL

Current conditions

Proposed change to conditions

HLTH 1942 2018/07/23 PAGE 10 OF 12

To extend or renew a time limited Approval, provide the current temporary end date and proposed timeframe.


PART 7 – EXTENSION OF AN EXISTING TIME LIMITED APPROVAL

Current Term of the Approval (YYYY/ MM / DD) Proposed Extension of the Approval (YYYY / MM / DD)

Please provide detailed information below (or attach document) to support your request

HLTH 1942 2018/07/23 PAGE 11 OF 12

Sections 7(2)(f ) and 8(1)(c) of the Laboratory Services Regulation, found at: http://www.bclaws.ca/civix/document/id/complete/statreg/52_2015 requires that an application for approval of a laboratory facility must include information about any existing, or potential conflicts of interest the applicant has reason to be aware of in respect to referring practitioners who may request benefits to be provided through the laboratory facility.

For the relevant policies, see Policy 2.5.3 of the Approval-Related Policies and Guidelines for Laboratory Facilities Providing Outpatient Laboratory Services on a Fee-For-Service Basis and the Laboratory Facilities Conflict of Interest Policy, found at: http://www2.gov.bc.ca/assets/gov/health/practitioner-pro/laboratory-services/facilities_approvals_policy.pdf

8.a FACILITY OPERATOR DECLARATIONATTENTION: The person completing/signing this Disclosure Form (the “authorized signatory”) must be duly authorized to make the declaration/disclosure on behalf of the operator/owner required to make the declaration/disclosure. Part 8 must be completed/signed by all applicants to ensure processing of application.

Is there an existing or potential conflict of interest to disclose in relation to the laboratory facility? Check one box below:

Yes, there is an existing or potential conflict of interest to disclose in relation to the laboratory facility. If yes, provide details of the existing or potential conflict of interest in Part 8.b.

No, there is no existing or potential conflict of interest to disclose in relation to the laboratory facility. If no existing or potential conflict of interest is indicated, sign and complete signatory declaration at the end of this form (part 9).

I am unsure if the circumstances constitute, or may constitute, an existing or potential conflict of interest. If unsure, provide details of the potential conflict of interest in Part 8.b.

Laboratory Facility Name(s)

Full names of all relevant practitioners, family members, laboratory facility owners (including the declarant), or business associates, who hold, or may hold, a relevant financial or material interest

Any relevant affiliations or relationships with the owner, or intended owner of the laboratory facility, and the details of any interest or benefit that may relate to a conflict of interest

Any other information, including dates, that is relevant to understanding and assessing the nature, scope and degree/extent of an existing, or potential, conflict of interest

Additional Information (if required) that is relevant to understanding and assessing the nature, scope and degree/extent of an existing or potential conflict of interest. Include any details regarding proposed avoidance or mitigation measures related to any existing or potential conflicts of interest (append listing if required).


PART 8 – CONFLICT OF INTEREST DECLARATION AND DISCLOSURE

8.b CONFLICT OF INTEREST DISCLOSURE (please complete as applicable)

HLTH 1942 2018/07/23 PAGE 12 OF 12

Submit this completed form with enclosures through the Ministry of Health’s secure upload tool, located at: http://www.gov.bc.ca/labservicesupload

Attention Authorized Representative (signatory): The person completing/signing this application form (the “authorized signatory”) must be duly authorized to make the declaration/disclosure on behalf of the operator/owner.

Name

Title

Signature Date (YYYY / MM / DD)


PART 9 – APPLICATION AUTHORIZATION

Documents

Application for an Amendment to an Existing Laboratory ... · hlth 1942 2018/07/23 page 2 of 12 hlth 1942 application for an amendment to an existing laboratory facility or specimen