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LABORATORY MANAGEMENT > 5 - LICENSING > Flashcards

5 - LICENSING Flashcards

1
Q
  • Facility that is involved in pre-analytical, analytical, & post-analytical procedures
  • Where tests are done on specimens from the human body to obtain information about the health status of a patient for the prevention, diagnosis, & treatment of diseases
A

Clinical Laboratory

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2
Q

tests included in the clinical laboratory

A
  • Anatomic Pathology
  • Clinical Chemistry
  • Clinical Microscopy
  • Endocrinology
  • Hematology
  • Immunology & Serology
  • Microbiology
  • Toxicology
  • Molecular and Nuclear Diagnostics
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3
Q

Provider of:
1. License to Operate (LTO)
2. Permit to Construct (PTC)
3. Certificate of Registration

A

Department of Health

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4
Q
  • Formal authorization to perform laboratory tests
  • Ensure that the clinical laboratory is compliant with the requirements of DOH
  • Valid for 1 year
A

License to Operate (LTO)

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5
Q

Given to applicants who wish to establish / construct or alter / renovate a clinical laboratory

A

Permit to Construct (PTC)

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6
Q

Permit for research and teaching laboratories

A

Certificate of Registration

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7
Q

Accrediting Organizations

A
  • Health Facilities and Services Regulatory Bureau
  • Center for Health Development
  • National Reference Laboratory
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8
Q

A DOH-licensed laboratory should:

A
  • Continuously comply with its rules and regulations, licensing standards and requirements
  • Participate in EQAP that may be administered by a designated NRL or other local and international EQAP approved by the DOH surveys and other activities that will be required from them by the DOH
  • In times of Pandemic and Public Health Event, be mandated to submit timely reports and data
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9
Q

Line agency / unit of the Health Regulation Team of DOH that focuses on the regulation of health facilities and services

A

Health Facilities and Services Regulatory Bureau

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10
Q
  • Set minimum standards for regulation of health facilities and services
  • Disseminate regulatory policies and standards for information and compliance
  • Issue permits to construct, License to Operate, and Certificate of Accreditation
  • Monitoring of health facilities and services to ensure continuous compliance of health facilities with regulatory standards
  • Provide technical assistance, consultation, and advisory services to stakeholders regarding health facilities regulation
  • Conduct research to regulation of health facilities and services
  • Act on complaints against hospitals and other health facilities
A

Functions of Health Facilities and Services Regulatory Bureau

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11
Q
  • Line agency / unit of DOH under the Field Implementation & Coordination Team
  • One for each region
A

Center for Health Development

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12
Q
  • Strictly enforce the provisions of AO 2021-0037
  • Submit quarterly report on Suspension / Revocation / Cease and Desist Order issued on CL not later than the 15th day of the following month after the covered quarter
  • Provide consultation and technical assistance to stakeholders in line with the regulation of CL
  • Respond promptly to complaints relative to the operation of CL under its jurisdiction
A

Functions of Center for Health Development

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13
Q
  • Highest level of laboratory in the country
  • Responsible for facilitating NEQAS to ensure compliance of all laboratories to the standards set in the Philippines
A

National Reference Laboratory

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14
Q
  • Provide laboratory reference / referral services for confirmatory testing
  • Train laboratory personnel and recognize other training institutions
  • Maintain the National External Quality Assessment Scheme (NEQAS)
  • Perform technical evaluation of reagents and diagnostic kits
A

Functions of National Reference Laboratory

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15
Q

Requirements for Licensing Reference

A

AO 2021-0037 Annex A

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16
Q

Requirements for Licensing Sections

A
  1. Physical Plant
  2. Personnel
  3. Equipment / Instruments / Reagents / Glassware / Supplies
  4. Service Delivery
  5. Information Management
  6. Quality Improvement
  7. Referral of Laboratory Examinations
  8. Environmental Management
17
Q
  • Compliance to the local and national regulations for constructing / maintaining / repairing a clinical laboratory
  • Compliance with the required space and minimum area requirements
A

Physical Plant

18
Q
  • Head of Pathology – Pathologist
  • Registered Medical Technologist
  • Support Staff
    1. Laboratory technician
    2. Laboratory aide
    3. Encoder
    4. Receptionist
  • POCT coordinator and operator (if applicable)
A

Personnel

19
Q
  • Availability of operational equipment
  • Performance of calibration, preventive maintenance, and repair programs
  • Contingency plans in case of equipment breakdown and malfunction
  • Inventory and proper storage of reagents, glassware, and supplies
  • Use of FDA-approved and NRL-validated devices, reagents, and test kits
A

Equipment / Instruments / Reagents / Glassware / Supplies

20
Q
  • Compliance with the allowed services for each classification
  • Operation of mobile clinical laboratories (MCL) shall only be 100km from the address of the main laboratory
A

Service Delivery

21
Q
  • Administrative Policies and Procedures
  • Communication and Records Management
    1. Includes maintaining the confidentiality of all records
A

Information Management

22
Q
  • Use of a system for continuous quality improvement activities
  • Required participation in Internal Quality Assurance Program and External Quality Assurance Program
A

Quality Improvement

23
Q
  • Partnership with a referral laboratory through a Memorandum of Agreement
  • Referral of tests may be made if:
    1. The test is not part of the service capability of the laboratory
    2. There is an equipment breakdown or other similar instances
A

Referral of Laboratory Examinations

24
Q
  • Proper maintenance and monitoring of physical facilities
  • Proper disposal procedure for infections / toxic / hazardous waste
  • No smoking policy
  • Contingency plans for accidents and emergencies
  • Policy for biosafety and biosecurity
  • Policy guidelines on infection prevention and control
A

Environmental Management

25
Q

Violations and Penalties

A

Section IX of AO 37-2021

26
Q

any act against the general, specific and procedural guidelines provided by the AO and other related issuances and laws

A

Violation

27
Q

Non-Institution-Based Clinical Laboratory

1st offense

A

Stern warning

28
Q

Non-Institution-Based Clinical Laboratory

2nd offense

A

30,000 pesos

29
Q

Non-Institution-Based Clinical Laboratory

3rd offense

A

50,000 pesos

30
Q

Non-Institution-Based Clinical Laboratory

4th offense

A

Revocation of DOH-LTO

31
Q

Penalty for Institution-Based Clinical Laboratory

A

Will follow penalties for hospitals

32
Q

RA 4688 (Section 4)

Imprisonment

A

One month to one year

may be either or both

33
Q

RA 4688 (Section 4)

Fine

A

1,000 to 5,000 pesos

may be either or both

34
Q

Operating a CL with no PTC and LTO

A
  • Cease-and-desist order
  • Fine: 50,000 pesos

LABORATORY MANAGEMENT (13 decks)

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