Licensing, Norms, and Accreditation of CLs

Assessment

Means of determining the effectiveness of laboratory’s quality management system

Norms, standards, accreditation, internal and external audit, proficiency testing

Licensing

A permission granted by a competent authority (DOH) to engage in a laboratory business or occupation

Evidence: LTO

Accreditation

Procedures that recognize that laboratory is meeting designated standards

Norms

Standards of proper acceptable behavior; model; a principle of right action binding upon the members of a group and serving to guide, control, or regulate proper and acceptable behavior

Standards

Provide and form guidelines which are the basis of quality practices

Developed by organizations

Regulation

Any standard that is mandated by a governmental agency or authoritative body

Certification

An independent body gives written assurance that a product, process or service conforms to specific requirements

DOH-HFSRB

Mandates to issue the License to Operate (LTO)

RA 4688

An Act Regulating the Operation and Maintenance of Clinical Laboratories and Requiring the Registration of the Same with the Department of Health, Providing Penalty for the Violation Thereof, and for Other Purposes

DOH AO 2007-07

Revised Rules and Regulations Governing the Licensure and Regulation of Clinical Laboratories in the Philippines

(outdated)

DOH AO 2021-0037

New Rules and Regulations Governing the Regulation of Clinical Laboratories in the Philippines (aligned with UHC Act)

One-Stop Shop Licensing System

Application of LTO for institutional/hospital laboratories

Single DOH-LTO for the hospital, including the laboratories

Within 30 days

Period for compliance of corrective actions

DOH Licensing Assessment Tool

Used by the DOH Licensing Officers who will visit and inspect the laboratory for onsite assessment

Can also be used for self-assessment of the laboratory

AO 2021-0037

AO 2021-0037 Annex B1

Covers general assessment

AO 2021-0037 Annex B2

Covers service capability (equipment / reagents / instruments)

Clinical Pathology

Deals with the chemical and cellular analyses of blood and other body fluids, identification and examination of microbes and parasites

Anatomic Pathology

Provides processing and examination of surgical specimens

Includes: Surgical pathology, cytopathology, immunohistochemical techniques, autopsies, and forensic pathology

Molecular Pathology

Deals with the analysis of certain genes, proteins, and other molecules

CL for Anatomic Pathology Only

Provides services for any of the following, but not limited to: cytology and histopathology

CL for Molecular Pathology Only

Provides services for genetics, immuno/hematopathology and infectious disease

COVID-19 testing laboratories shall be covered by another Order

Physical Plant

Adequate space, program for maintenance, well-ventilated and lighted, clean and safe, etc.

Personnel

Adequate in number, HOL, RMTs, support staff, staff development and continuing education program, biosafety and biosecurity officer

Equipment / Instruments / Reagents / Supplies

Adequate, available and operational, calibration, preventive maintenance and repair program, contingency plan, inventory control

Service delivery

Quality and safety, compliant with standards, proper handling and transportation of samples

Information Management

Administrative policies and procedures, communication and records management

Quality Improvement

Internal quality assurance program, External quality assessment program (especially for Renewal of License), POCT policies

Referral of laboratory examinations

Memorandum of Agreement with DOH-licensed clinical laboratory

Environmental Management

Program of proper maintenance and monitoring of physical facilities, proper disposal of infectious wastes and toxic and hazardous substances, no smoking policy, contingency plan for emergencies, policy for biosafety and biosecurity, guidelines on infection prevention and control

Pathologist

Designated head of the CL

Certified by a professional organization

1 year

Validity of DOH-LTO

Significant deficiencies affecting service capability (lack of personnel & equipment)

No program for QA

Non-compliance on corrective actions

Grounds for Non-Issuance / Renewal of License

Refusal from inspection or monitoring visits by DOH

Refusal or nonparticipation in an External Quality Assessment Program (EQAP)

Absence of action to improve the unsatisfactory or failed EQAP

Demonstrating incompetence or making consistent errors in the performance of lab examinations and procedures

Deviation from the standard test procedures including use of expired reagents

Performing laboratory procedures beyond their authorized service capability

Violation of the Data Privacy Act provisions

Prohibited Acts under AO 2021-0037

Stern warning

Penalty for the 1st violation in a non-institution-based CL

Penalty

Penalty for the 2nd and 3rd violation

Revocation of LTO

Penalty for 4th violation

Re-apply after one year

CL with revoked licenses

Permitting unauthorized/unregistered personnel to perform technical procedures Unauthorized use of the name/signature of a pathologist or RMT to secure an LTO

Issuing fraudulent laboratory results, results for tests not actually performed, or inaccurate results

Changing ownership, location, laboratory head, or laboratory personnel without informing HFSRB/CHD-RLED

Any material false statement in the application of LTO

Grounds for immediate revocation of license

Preventive suspension (pending investigation)

Sanction for complaints in the laboratory

Cease-and-Desist Order and administrative penalty

Sanction for operating without securing license from DOH

Accreditation body

Oversees the assessments and grants accreditation

May also set the standards used in the accreditation process

Accreditation standards

With which a laboratory must comply to gain accreditation

Knowledgeable assessors or inspectors

Seek to establish compliance with the standards by conducting the assessment

User Laboratory

Required to, or voluntarily seeks to, comply with the standards by being assessed

Regularly

Frequency of renewal for Accreditation

Laboratory Quality Manager

Explains the process for meeting standards to staff

Organizes the laboratory in preparation for assessments

Laboratory Director

Seeks information about appropriate norms and standards and about accreditation and certification processes

Uses outcomes to provide better services

Laboratorian

Must be aware of requirements and assessment processes

Contributes to meeting standards

Helps prepare for assessment

Joint Commission International (JCI)

Accreditation Agency for healthcare quality and safety

College of American Pathologists (CAP)

Accreditation Agency that uses unique peer-inspection model (trained laboratory professionals)

DTI-Philippine Accreditation Bureau (PAB)

Agency that accredits medical laboratories against ISO 15189

Approved

Knowledgeable

Standards-based

Objective

Competent

Required Characteristics of Accreditation Bodies

International standards

Broadest consensus / agreement, but less specific

National / Local standards

Highest degree of applicability, but not useful with other countries

Normative document (Norms)

A document that provides rules, guidelines or characteristics for activities or their results

Covers such documents as standards, technical specifications, codes of practice and regulations

Standard document (Standards)

A document established by consensus and approved by a recognized body, that provides for common and repeated use, guidelines or characteristics for activities or their results, aimed at the achievement of the optimum degree of order in a given context

ISO

Preparation - technical committees

Publication - Requires approval by at least 75% of the member bodies casting vote (voluntary consensus)

World’s largest developer and publisher of international standards

Standards are applicable to many kinds of organization

CLSI

Use of voluntary consensus standards and guidelines within healthcare community

Promotes the development and use of voluntary consensus standards and guidelines (not required) within the health care community

Documents are developed by experts working on subcommittees or working group

CEN (European Committee for Standardization)

General terms are openness, transparency, consensus and integration (adoption of standards decided by majority vote)

WHO

Standards for disease-specific diagnostic laboratories

ISO 15189:2007

Medical laboratories—particular requirements for quality and competence

Based on both ISO 17035 and ISO 9001

Areas for Accreditation: Governance & Structure, Resources & Processes, Management System

ISO/IEC 17025:2005

General requirements for the competence of testing and calibration laboratories

Specifies general requirements for competence to carry out tests and/or calibrations, including sampling

Developing quality, administrative, and technical systems that govern operations

Does not cover compliance with regulatory and safety requirements

Self-developed Standards

Many agencies, organizations, or regions develop their own accreditation requirements rather than using internationally recognized standards

Advantages: Optimized for local context, developed in progressive steps, can lead to full international recognition

Weaknesses: Narrow/biased, may not be recognized by other organizations

Country-specific standards

Based on international standards

Adapted to the culture and general condition of the country

Guidelines

Supplement ISO standards with technical guidance for use in laboratories

Can address a specific kind of testing

Normative Statement

Required and essential part of the standards includes the word “shall”

Informative Statement

Information (often a ‘note’) that may be explanatory, or cautionary, or provide an example

Consensus

Represents general agreement in the absence of strong and compelling objection

Compliance

Meets both the text and the spirit of a requirement

Non-conformity

Failure to fulfill the requirements of a specified process, structure or service

May be categorized as major (complete) or minor (partial)

Verification of conformity

Confirmation by examination of evidence