Past Happenings

NEQAS

NATIONAL EXTERNAL QUALITY ASSESSMENT SURVEYS (NEQAS) is conducted not solely to obtain information on the state of laboratory practice. More importantly such information should be utilized to conduct educational activities to help improve the underperformers and to benchmark with whose laboratories that excel. These data should also be important tools to standardize laboratory practice around the Philippines and harmonize with Asia and the wider global community.

PCQACL had provided several National External Quality Assessment Surveys (NEQAS), as follows:
  • 10 in Hematology
  • 8 in Clinical Chemistry
  • 2 in Blood Banking
  • 3 in Coagulation
For this purpose, three (3) NEQAS Committees were formed, namely:
  • Committee on NEQAS in Hematology, chaired by Dr. Januario Veloso, Jr.
  • Committee on NEQAS in Clinical Chemistry, chaired by Dr. Ariel Vergel De Dios
  • Committee on NEQAS in Blood Banking, chaired by Dr. Manuel Barnes
Additional Committees were formed and headed by the following Pathologists:
  • Committee on NEQAS in Immunology – Dr. Dorothy Agdamag
  • Committee on NEQAS in Parasitology – Dr. Manuel Barnes

PCQACL had planned to expand NEQAS to other clinical laboratory sections such as Immunology, Bacteriology, Parasitology, and other relevant fields, while at the same time advocated for government to establish National Reference Laboratories.

The objectives of the PCQACL NEQAS were as follows:
  1. To obtain information on the degree of variation of results of Laboratory examinations among clinical laboratories in the Philippines;
  2. To determine which methods of laboratory examinations lead to greater accuracy, reproducibility and least variation of results among clinical laboratories;
  3. To determine the common causes of systematic and random variation of laboratory results as an input to educational interventions to improve the performance of clinical laboratories; and
  4. To facilitate medical research utilizing laboratory data from several participating clinical laboratories

PRESENTATIONS on NEQAS

On June 14, 2002, PCQACL launched the NEQAS at the Quezon City Sports Club where it concurrently held its 1st symposium too. Administrators of hospitals, Pathologists, and Medical Technologists of different clinical laboratories attended the affair. An overview of Quality Assurance in the Clinical Laboratory and the background and activities of PCQACL were given. The results of the NEQAS in Clinical Chemistry and Hematology were presented.

NEQAS results were also presented at conventions and seminars of the PSP, PAMET, PSQua, PCHA and PSHBT. The Hematology NEQAS had also been presented in several international forums, notably the Sysmex Asia-Pacific Scientific Forums.

Another Symposium on NEQAS was held on February 28, 2004, at the Veterans Memorial Medical Center. The results and findings of the 4 NEQAS surveys in Hematology and Clinical Chemistry were discussed. Presentations on Quality Management in the clinical laboratory in India and the Philippines were given. A workshop on the comparison of the results of platelet counts on two hematology analyzers was also held.

PCQACL and Accreditation

In the Philippines, there are many professional and government organizations actively involved in laboratory standardization and accreditation activities, including the PCQACL, DOH, and the DTI. The main accreditation schemes are the DOH-QMS and ISO 15189. Accreditation is usually sought for special purposes, such as, but not limited to reimbursement of medical expenses and Residency Training program; and also to gain competence for offering specialized services.

A consensus meeting among stakeholders of Clinical Laboratories was held on February 05, 2009. Participants included representatives of the DOH, the NRLs, PCQACL, PSP, PAMET, PSQua, PSHBT, and Biorad/Lifeline.

The consensus reached were as follows:
  1. that accreditation of Clinical Laboratories is necessary to improve the quality of laboratory services in our country;
  2. to use the DOH-QMS Standards as a National Standard for Accreditation for quality management of Clinical Laboratories;
  3. the National Accreditation System will be voluntary as accreditations are and will be offered to the clinical laboratories who desire to improve the quality of their services;
  4. the PCQACL shall lead the implementation of the National Accreditation System, in collaboration with PSP, PAMET, NRLs, PSQua, PCAHO, PSHBT and other stakeholders who may desire to join in the future; and
  5. when the Accreditation System is in place, an international recognition from ILAC or APLAC shall be sought.

PCQACL and DOH-QMS

As early as 2004, the DOH-Quality Management System Standards (DOH-QMS) in the Clinical Laboratory were developed to assist Laboratories to improve the quality of their services with the vision of being used as the Standards for a National Accreditation Scheme for Clinical Laboratories. This was developed by a Task Force composed of representatives of the DOH, NRLs, PCQACL, PSP, and PAMET who drafted and finalized the Standards in 2 years.

The QMS Standards were formulated initially using WHO consultant, Dr. David Browning’s “Standards for Medical Laboratories” and utilized other international and national standards such as those of the PCAHO, ISO, JCI, CLSI, and CAP. Notably, ISO 15189 and its predecessors were also reviewed. The DOH-QMS Standards serve as the Development Standards for DOH hospital laboratories supported by the NCHFD-DOH.

During the Medicine week in August 2008, the DOH-QMS Standards is one of 8 Hospital Operational Manuals of the DOH that was launched by then Secretary of Health, Dr. Francisco Duque, Jr. These Manuals guide DOH and other government hospitals in upgrading their services. An additional 2 other Hospital Operational Manuals were also launched shortly thereafter.

The DOH-QMS Standards is made up of 7 Groups of Standards, namely:
  1. Management Responsibility
  2. Resource Management
  3. Service Delivery
  4. Monitoring Performance
  5. Quality Improvement (QI) Activities
  6. Information Management
  7. Environmental Management

Under these groups are 39 Specific Standards and 142 Criteria. The requirements to meet the criteria are stipulated in the Assessment Tool. A Technical Working Group (TWG), chaired by Dr. Tomas P. Maramba for the Awareness and Assessment Training of this Standard was created by DOH-NCHFD to implement the QMS Standards, first in the 6 NRLs and the LGU Laboratories. The Training Committee of this TWG is composed of Dr Marissa Orillaza, as chair, and the members are: Dr. Grace Dela Calzada, Ms Julie Dayandayan, Dr Ms Myrna Reyes, Ms Minda Quitoriano, and Ms Angelita Jimenez. The Training Team has conducted the QMS Awareness Training since the latter half of 2009 to the NRLs, and the LGU hospitals around the Philippines, completing 47 provinces, as of October 2011. PAMET President, Leila Florento, PhD is part of the Training Team. To date, the same Team had conducted Quality Improvement Plan trainings to all the 6 NRLs and are now assisting/ monitoring the 5 NRLs who participated in its implementation.

The same training team prepared the Training Manuals for Trainers, Assessors and Staff of Clinical Laboratories. They have conducted the Training of Trainers and Assessors of the DOH-QMS, also participated by the NRLs.

The DOH-QMS Standards are adapted to the local situation to assure that local clinical laboratories can be trained to comply with the standards. Since 2010, there are now a total of 47 Provinces whose LGU hospitals and laboratories have been given DOH-QMS Awareness Training. They are expected to present to the governing bodies of these LGU facilities their implementation plan for the Standard such as designating required Offices to implement the Standard and creating a Quality Manual, Technical Procedures Manual, SOPs, among other documentation required.

PCQACL and ISO 15189

The Department of Trade and Industry thru its Philippine Accreditation Office (DTI-PAO) is the local accrediting body for ISO 15189 Standard for Medical Testing Laboratories that it has adopted as a Philippine National Standard. Below is the PAO ACCREDITATION MARK

There are rules and regulations that accredited Labs must strictly follow in using this accreditation mark. Violators shall be duly addressed.

The PCQACL, represented by Dr. Orillaza and Dr. Dela Calzada, was invited in DTI’s launching of ISO 15189 as a Philippine National Standard [PNS] on June 9, 2009, at the Philippine Trade Training Center, Roxas Blvd, Manila, by the PAO in cooperation with the European Union TRTA. Supported by the EU TRTA, DTI conducted the ISO 15189 Awareness training and the Assessors’ Training in September 2009, and the Advanced Assessors’ Training for 15189 in November 2009. A foreign expert/trainer was sent over. The Officers of the PCQACL who made up the MLATC were amongst the successful participants.

The DTI-PAO recognized its need for support in its accreditation services in the medical laboratory setting and convened the Medical Laboratory AccreditationTechnical Committee [MLATC] in support of the adoption of ISO 15189 as a Philippine National Standard.

The MLATC is composed of stakeholders of clinical laboratories including the PCQACL, and its member organizations, the PSP, PCAHO, among other institutions such as the NRLs, Clinical Laboratories - both Government and Private, Hospital and Free-standing, industry partners, and the Government sector composed of the DTI, DOH, and PhilHealth. It was tasked to come up with the country’s supplementary requirements to ISO 15189 by July 2009.

The 1st meeting was on January 21, 2009 which continued to be a regular monthly meeting till August 2009. Dr Bill Veloso, as Vice President of PSP, was appointed as MLATC Chairman. The other PCQACL officers were Dr. Marissa A. Orillaza, Vice-Chair, assigned to represent Government Tertiary Hospitals and the NRLs. Among the members are Dr. Tomas P. Maramba, representing the Philippine Society for Quality in Health Care; Dr. Grace J. Dela Calzada, representing the PCQACL; and Ms. Sonal Pandya representing BIO-RAD, a PCQACL Corporate Member representing the diagnostic industry. Ms Sonal was chosen in view of her membership in the international committee of the ISO. Other pathologists in the committee included Dr. Nelson T. Geraldino, assigned to represent Private Tertiary laboratories; Dr. M.P. Santos, assigned to represent Private/Government tertiary, secondary, primary free- standing laboratories; Dr. Elizabeth Telan, assigned to represent the 5 NRLs; while PAMET was represented by its president Leila Florento, PhD who is also a member of the PCQACL Board of Trustees.

The MLATC’s output is the LA/SR08: Supplementary Requirements for Accreditation in the Field of Medical Testing, with 1st Issue on September 2009. ISO 15189 Assessors are expected to make full use of this requirements when assessing an applicant laboratory.

 

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