THE POWER OF MANAGEMENT TOOLS · part of TQM to develop clinical and analytical quality requirements for each test. The laboratory then would translate those requirements into operating

September 2019

THE OFFICIAL NEWSLETTER OF THE PHILIPPINE COUNCIL FOR QUALITY ASSURANCE IN CLINICAL LABORATORIES

by: Aileen Riego-Javier, MD, FPSP

continued on page4

I commend the PCQACL for its continuing mission of delivering the highest quality in laboratory services.

The operations of clinical laboratories affect countless lives everyday. This highlights the significant role of the medical laboratory in patient care. The laboratory professional is a key member of the healthcare team, and the work you do is vital to the health of millions of people. As a laboratory professional, you often work”behind the scenes” in the healthcare field. Few people know much about the critically important testing that you perform everyday. Patients depend on you for accurate, quality testing. This enormous responsibility requires laboratory staff to be extra conscious and cautious about how they work.

Since laboratories, like any other organization, are subject to the Darwinian idea of “survival of the fittest”, they must strive for constant improvement. To earn the trust and loyalty of their clients as well as to face the growing competition, clinical laboratories must continually enhance the quality of their services. In other words, they have to evolve.

Evolution, in the context of health care, is closely linked to total quality management.

To quote Brian Joiner and Peter Scholtes,

“Simply put, total quality management is an approach to management which focuses on giving top value to customers by building excellence into every aspect of the organization. This is done by creating an environment which allows and encourages everyone to contribute to the organization and by developing skills which enable them to study scientifically

and constantly improve every process by which work is accomplished. In total quality management, the emphasis is on studying processes and executing them better and better to provide customers with products and services of ever increasing value at lower cost.”

Let’s just zero in on TOTAL QUALITY MANAGEMENT (TQM) efforts focused on the needs of the customers.

Customers of laboratory services include external customers such as physicians and nurses who order the tests and the patients who are the ultimate beneficiaries of laboratory services, as well as the agencies and organizations who pay for the tests. Laboratory sections are often the internal customers of each other. Phlebotomy and sample processing sections or lab reception areas are good examples of how their services can impact the analytical sections of the laboratory.

There are 3 classes of customers’ perceptions of quality.

The first class is one-dimensional quality, which involves attributes

that are directly related to customer satisfaction. Better fulfillment of the quality requirement leads to improved customer satisfaction. In the laboratory, quicker turnaround and an extensive test menu lead to greater satisfaction of the physicians, nurses, and ultimately, patients.

The second class is expected quality, which

are attributes that are often assumed or taken for

granted. Nobody notices when the requirement is satisfied, but

customers will be unhappy if it is not satisfied. In the laboratory, analytical quality is expected. All our customers assume that the test results are reliable. There is no extra customer satisfaction gained from providing accurate test results, but there would be great dissatisfaction and anger, and possibly legal action, if an error occurred.

The third type of attribute is exciting quality, so-named because it is unexpected. In the laboratory, an exciting quality might be when the phlebotomists remember the names of the patients and are able to address them personally whenever they see them. Initially, new diagnostic services that are made available often invoke a sense of unexpected quality from health care providers.

We need to translate customer needs into quality requirements, process characteristics, process specifications, and control procedures. Customers cannot directly tell us the process

THE OFFICIAL NEWSLETTER OF THE PHILIPPINE COUNCIL FOR QUALITY ASSURANCE IN CLINICAL LABORATORIES2

PHILIPPINE COUNCIL FOR QUALITY ASSURANCE IN CLINICAL LABORATORIES

PSP Building, Unit C 114 Malakas Street,Diliman, Quezon City, Philippines

Tel. No. (632) 926 6604 • Mobile No. (0917) 854 6436Website: www.pcqacl.org • www.facebook.com/Pcqacl

Emil Bryan M. Garcia, MD, FPSPEditor-in-Chief

Annie Pring-Valdez, MD, FPSP, MHA, PhDAssociate Editor

Managing Editor

Contributing WritersAileen Riego-Javier, MD, FPSP

Sarah Jane L. Datay-Lim, MD, FPSP

Paulo Enrico P. Belen, MD, DPSP

Godwin N. Hernaez, MD, MDM, FPSP, CESEAdviser

Taking Laboratory Management to the Next Level:THE POWER OF MANAGEMENT TOOLS

by: Emil Bryan M. Garcia, MD, FPSP

Tools” which was immediately followed by an activity wherein participants applied problem solving tools utilizing concepts such as High Level SIPOC, Project Charter and Voice of the Customer. The second session was facilitated by Dr. Monserrat S. Chichioco, Medical Center Chief of Jose B. Lingad Memorial Regional Hospital in Pampanga. She engaged the participants into the “Improvement Phase” and talked about “How To Effectively Improve and Solve Problems in the Laboratory with the help of Tools”. The delegates were divided into groups and presented their outputs.

The afternoon session was all about “Strategy Tools”and was facilitated by the third speaker, Dr. Grace J. Dela Calzada, Vice President of PCQACL, who talked about strategies and sustaining the gains of the improvement process.

A total of 74 clinical laboratory professionals, attended the workshop which culminated with a message of gratitude to all the participants by the Chair of the Committee on Continuing Education, Training and Research, Dr. Marissa A. Orillaza.

The first of a series of workshops for the year 2019 was held last April 3, 2019

at the Crowne Plaza Galleria, Ortigas entitled “Taking Laboratory Management to the Next Level: The Power of Management Tools”. This spearheaded by the PCQACL Committee on Continuing Education, Training and Research, chaired by Dr. Marissa O. Orillaza and Co-chaired by Dr. Sarah Datay-Lim with the following members: Dr. Grace J. Dela Calzada, Dr. Elizabeth Arcellana-Nuqui, Dr. Paulo Enrico P. Belen and Dr. Rodelio D. Lim.

The workshop featured three (3) distinguished pathologists who are leaders in the field of laboratory management. Dr. Cheryl May A. Cabrera, Vice-Chairman of the Department of Pathology and Clinical Laboratory of FEU-NRMF Medical Center talked about “Identifying Problems in the Laboratory Using Management

September 2019 3

Working Towards Improvement ofEXTERNAL PROFICIENCY TESTING

in Chemistry & Hematology

The second seminar workshop entitled “Improvement of External Proficiency Testing in Clinical Chemistry and Hematology” was held at Crowne Plaza Hotel last June 19, 2019 by PCQACL spearheaded by CETR (Committee Education,

Training and Research) chair Dr. Marissa A. Orillaza and its members. The morning session was dedicated to Clinical Chemistry, starting off with the basics. Dr. Paulo Enrico Belen, consultant pathologist and quality officer at St. Luke’s Global opened the sessions by laying out the foundation of quality. His lecture focused on review of quality controls, charts, Westgard rules, interpretation and trouble shooting. As laboratory scientists we often assume that everyone knows these basic things but we need to step back and make sure that we are all on the same page. We must be able to interpret the charts and apply the Westgard rules to avoid false rejections and unnecessary trouble shooting like frequent repeats until we get it right. These were some of the memorable messages that were given. After his lecture, the participants were treated with an interactive session wherein they answered some cases to supplement the learning from the lecture.

To take quality controls a step further, a lecture entitled “Six sigmametrics: How to make it work for your laboratory” was given by Dr. Sarah Jane L. Datay-Lim, Laboratory Quality and Safety Consultant Director at The Medical City. Six sigma originated in the manufacturing industries specifically Motorola with the aim of reducing waste and defects to improve quality. This has been adapted in the laboratory setting throughout the years to improve processes but recently it has been adapted in quality control planning as written by Mr. James O. Westgard in his quality books. Six sigma does not aim to replace the current quality control practices but serves as an additional tool to improve quality through better monitoring and application of appropriate Westgard rules and number of runs depending on the sigma scores. The morning

session ended with the lecture about NEQAS by our very own representative from our National Reference Laboratory, Lung Center of the Philippines, Dr. Kaori Calingo. She was able to explain the details of the usual Chemistry NEQAS report. Aside from explaining the different parts of the report, what was amazing about the lecture was that she was able to help the participants understand and interpret these things. In essence, the aim of NEQAS is to improve quality in the laboratory and give feedback to the laboratory regarding its performance.

The afternoon sessions were equally interesting as well, starting off with the lecture of Dr. Arvin C. Faundo, renowned Hematopathologist and expert in Cellular therapies, affiliated in respected institutions in the Philippines such as Philippine General Hospital and St. Luke’s Global to name a few. His lecture was about the standardization of complete blood count, a companion to the monograph published a few years ago by PCQACL. It was interesting to hear how the monograph was developed and the thoughts behind the contents of the book. His funny quips surely made the afternoon alive, sharing his experiences in the laboratory and how we should turn away from the practices that are not recommended anymore. Back to back with Dr. Faundo was another hematopathologist, Dr. Rose Lou Marie C. Agbay, Consultant Director for Molecular Pathology at The Medical City. Even though most of the hematology procedures are now automated with the advent of newer machines, it was emphasized that we still have to go back to the smear. Her lecture highlighted the importance of morphology and just like the morning session with Dr. Belen, she gave the participants a good review of the basic morphology of cells as well as international standards quoting the papers published by the

continued on page4

THE OFFICIAL NEWSLETTER OF THE PHILIPPINE COUNCIL FOR QUALITY ASSURANCE IN CLINICAL LABORATORIES4

Pre-Convention Workshopon Blood Bank QC

specifications that we should use. For example, most laboratorians have received calls from physicians who demand faster performance of the tests they have ordered. If we listen directly to the customer and go into the lab, we may be able to reduce the testing time perhaps by 50%, from 12 to 6 minutes; however, the real problem may be that the transport of the specimen is taking 60 minutes. Consequently, reducing our test performance time by 6 minutes will have little impact on the assay turn-around time. Therefore, even though we did respond as the customer demanded, we did not address the real issue.

Another example is that physicians do not really know what precision and

accuracy is needed for laboratory tests. Physicians can tell us how they use and interpret lab data, but the laboratory must translate those needs into quality requirements, precision and accuracy specifications, and quality control procedures. Given that analytical quality is an expected characteristic and that the laboratory will need to take complete responsibility for ensuring the quality of its tests, it should be an important part of TQM to develop clinical and analytical quality requirements for each test. The laboratory then would translate those requirements into operating specifications for precision, accuracy, and quality control.

I commend once more the PCQACL for taking a proactive stance to improve

the quality of laboratory testing in our country. As we continue to strive for high standards for a better and improved healthcare system and for global competitiveness, may we be reminded of what a pathologist, Dr. David Coleman said in the novel,” The Final Diagnosis”, written by a layman, Arthur Hailey:

“I suppose the real thing is that all of us- physicians, the hospital, medical technology- exist only for one thing: for patients, for healing of the sick. I believe we forget this sometimes. I think we become absorbed in medicine, science, better hospitals, and we forget that all these things have only one reason for existence- PEOPLE, people who need us, who come to Medicine for help.”

from page1... TQM and the Clinical Laboratory

Pre-Convention Workshopon Blood Bank QC

pass but to improve our quality instead of just focusing on improving our scores. Interactive sessions in the afternoon were also given and to our participants’ delight, all those who answered were given special prizes. Truly, with the help of these seminar workshops and with the guidance of different experts in the field, we can achieve improvement in these busy areas of the clinical laboratory.

proficiency testing in hematology. Similar to Dr. Kaori’s lecture, all the parts of the report were explained, including interpretation. What made us value this lecture more are the tips on how we can troubleshoot and apply what we can learn from EQAS. We must always remember that we have to change our mindset about quality and external proficiency testing: EQAS is not a quiz to

International Council for Standardization in Haematology (ICSH). Her tips were not just practical but backed up with studies. We were all challenged to level up and follow not just national but international standards when it comes to smear review and interpretation. Last but not the least, Ms. Hasmin Miroy, RMT, PCQACL Trustee,from Biorad Philippines and certified life coach, discussed external

from page3...Working Towards Improvement...

September 2019 5

The 2019 PCQACL convention commenced with two pre-convention workshops participated

by more than 150 delegates from Luzon, Visayas and Mindanao.

The morning sessions were focused on Clinical Chemistry Quality Assurance lectures and short exercises facilitated by no less than the Chief Executive Officer of the Royal College of Pathologists of Australasia Quality Assurance Program (RCPAQAP), Professor Tony Badrick.

The participants were divided into 3 groups coded by red, green and blue colors. Online short quizzes using the menti app on the following sub topics: (1) Setting performance specifications-red team; (2) Method validation-green team, and (3) Moving average about Quality Control- blue team; highlighted the morning workshop where all given answers by the participants were explained by Prof. Badrick whether they are the best answers to the questions.

Pre-Convention Workshop - AM Sessionby: Annie Pring-Valdez, MD, FPSP, MHA, PhD

He emphasized that performance goals for laboratory testing have most often been developed for total analytical error and for imprecision (SD) and bias. A total analytical error goal requires that the combination of errors from all sources is within some acceptable limit. From a clinician’s standpoint, this is the most useful goal, because an incorrect laboratory result, regardless of which component(s) of total analytical error has caused it, is harmful. A total analytical error goal also enables a simple and cost-effective assessment of the suitability of a particular assay because there is only one error source to estimate.

Furthermore, total analytical error should be estimated either directly by the distribution-of-differences method or by simulation. A systems engineering approach that uses allocation of the total analytical error goal into error source goals provides a cost-effective approach to meeting total analytical error. Because outliers can cause serious laboratory error, the inclusion of outlier rate estimates from large studies would be helpful in assessing assay quality.

An internationally agreed hierarchy of preferred methods for establishing performance goals was likewise presented (Stockholm Consensus Conference on Quality Specifications in Laboratory Medicine):1. Studies on clinical outcomes2. Clinical decisions in general, data

from: (1) biological variation and (2) clinicians’ opinions

3. Published professional recommendations

4. Performance goals set by regulatory bodies or organisers of External Quality Assessment Schemes.

5. Goals based on the current state of the art as demonstrated by data from EQA or from current approaches

He further suggested in the end that laboratories should set routine performance goals based on the clinical use of the test results.

The discussion on method validation started with challenging questions thrown to the participants: “What are the factors you need to take into consideration when considering a new instrument or method?” and “Consider implementing a ward based PoCT device, what validation process should you use?”

The active participation of the delegates was evident by the multiple answers shown on the screen. The answers were discussed in detail by taking into consideration the different phases of Method Validation namely:a) Pre-development phase

- Need- Business case- FeasibilityBased on the answers given by the

participants, the most important factor to consider in the pre-development phase is the “Need.”

b) Development phase- Verification- Validation- Suitability and robustnessValidation is the most important

factor to consider in the development phase which was the overwhelming answer of the participants. c) Post development phase

- Quality management- Cost and stock control- Training and competence- Distribution- Post launch audit

The blue team assigned to answer the questions expressed that quality management appears to be the most important factor in the post development phase.

continued on page6

THE OFFICIAL NEWSLETTER OF THE PHILIPPINE COUNCIL FOR QUALITY ASSURANCE IN CLINICAL LABORATORIES6

Moving Forward for Quality Assurance in Microbiology

In summary, the total process of method development requires the analyst to engage in a range of activities outside of the bench and to exercise a set of skills beyond analytical. The authors support training and continuing professional development in the total method development process as described in the 2018 RCAPQAP report.)

The third exercise where the participants were really familiar was answering the questions on the topic “Moving average about quality control”. They shared that the QC rules used in their respective laboratories is per

The pre-convention of the 16th Annual Convention included a microbiology workshop during the

afternoon that was conducted by Ms. Melissa Mondoy from the Research Institute for Tropical Medicine (held at Ballroom B, Crowne Plaza Manila Galleria). It started initally with a pre-test to gauge the participant’s stock knowledge on core concepts in Microbiology quality assurance. These were followed by lectures on hot topics such as, basic quality assurance in microbiology, SOP writing, validation and verification of microbiology culture media, quality assurance in culture

from page5...Pre-Convention Workshop - AM Session

institution’s preference. Majority are using the 2 QC level with 2SD as the frequency of QC challenge. If these methods fail, they perform delta checking. Quality control failures are addressed by re running the QC, if failed, they re-calibrate. Documentation of all these procedures is very crucial in the process.

It was also recommended to look into the handout on “Collective Opinion Paper on the 2013 AACB Workshop of Experts seeking harmonization of Approaches to Setting a Laboratory Quality Control Policy” for additional inputs on the topic.

Pre-Convention Workshop - PM Session

by: Paulo Enrico P. Belen, MD, DPSP

media and antibiotic susceptibility testing, and microbiology external quality assurance programs.

In between didactic activities, the participants were given opportunities to have some “hands on activities” in equipment monitoring chart, review and auditing of SOP’s, sterility testing, and antibiotic susceptibility testing. Furthermore, opportunities for “Q and A” were given to participants to ask our expert.

The workshop ended with suggestions of topics for future lectures in antibiogram generation and topics on emerging microbial diseases in the Philippines. The participants went home happy with re-inforced knowledge and some “goody bags” to enjoy.

September 2019 7

The 2019 Board of Trustees were introduced during the third and last day

of the 15th PCQACL Annual Convention last September 27, 2018. The officers are as follows:

2019 PCQACL Executive Officers:

Dr. Godwin N. Hernaez President

Dr. Grace J. Dela Calzada Vice-President

Dr. Estela Marie C. Tanchoco Secretary

Dr. Ricardo E. Eclarin Treasurer

Ms. Erlinda C. Pijuan Auditor

Dr. Emil Bryan M. Garcia PRO

Ms. Laurie Anne Reyes Assistant Secretary

Ms. Iza Lourdes D. Rusiana Assistant Treasurer

Board of Trustees:Dr. Paulo Enrico P. BelenMs. Gina A. NobleMs. Noeme Cristina C. CaracasDr. Anacleta P. ValdezDr. Edna May Lasap-GoDr. Sarah Jane Datay-Lim

The Board held their 1st meeting for FY 2019 on January 17, 2019. Since then, a total of nine (9) board meetings were held and despite several challenges encountered during the first few months, the board continued to deliver and implement several improvements and reforms in the council.

First is the creation of the Committee on Information and Communication Technology System (ICTS), which is directly under the office of the PCQACL Secretary and chaired by Mr. Gerrick Joseph C. Dolor. Its main responsibilities are geared towards effective and efficient data management. These includes:- Setting policies on information storage,

access, sharing, software certification and accreditation.

KEEPING THE ADVOCACY ON QUALITY… The BOARD

of 2019by: Emil Bryan M. Garcia, MD, FPSP

- Establishing SOPs for use and adoption of health/clinical lab data standards

- Creating SOPs to establish a secure health/lab information exchange

- Migration from conventional methods to latest technology

- Evaluation of interactive technologies

The Membership Committee, chaired by Dr. Estela Marie Tanchoco started updating the list of active institutional members in order to address the issue of quorum during the last business meeting, constantly sending communication to members, either through text blasts, emails or courier, about status of their membership.

The Committee on By-Laws, headed by Atty. Marco Cicero Domingo and Dr. Grace J. Dela Calzada took advantage of the passage of the Revised Corporate Code of the Philippines (RA 11232) and started the rigorous process of drafting amendments to the council’s By-Laws in accordance with the said law. This was given priority by the board and was a constant agenda in all of the board meetings, to be presented for ratification to the plenary during this year’s annual convention business meeting.

The Committee on Annual Convention, as early as the first board meeting, started preparations for this year’s convention, sustaining the gains of previous conventions and delivering enhanced innovations such as the improvement on the seat management, implementation of an entirely new and user-friendly online system that would include a website to facilitate

registration, payments and membership renewal among others.

The Committee on Education, Training and Research, chaired by Dr. Marissa Orillaza, conducted three (3) exceptional workshops, gathering a total of more than 500 participants for all of the activities and started planning for a scientific program for the annual convention that adheres to the mandate of PCQACL of advocating best quality practice in Laboratory Medicine.

Committee on Advocacy and External Relations, spearheaded by Dr. Elizabeth Arcellana Nuqui and Ms. Erlinda C. Pijuan began communications to possible speakers and come up with a strong force of highly esteemed convention faculty from our international partners.

The Committee on Finance had its own share of obstacles as it needed to replace the untimely, vacated position of the Treasurer which was generously accepted by Ms. Erlinda C. Pijuan setting into motion a series of reforms within the committee.

All of these are just but some of the outputs of the 2019 Board, in keeping with its oath to faithfully discharge their functions for the advancement of the council, not to mention the constant guidance of the Immediate past president and chair of the Committee on Special Projects, Dr. Aileen Riego-Javier, who continues to be an essential source of wisdom for the council.

The 2019 Executive Officers will serve until December 31, 2019.

THE OFFICIAL NEWSLETTER OF THE PHILIPPINE COUNCIL FOR QUALITY ASSURANCE IN CLINICAL LABORATORIES8

1. RITM UPCOMING TRAININGS HIV and other Transfusion

Transmissible Infections Proficiency Training Workshop

(Full Course) DATE: October 21-26, 2019 VENUE: RITM Training Center,

Muntinlupa

HIV and other Transfusion Transmissible Infections

Proficiency Training Workshop (Refresher Course)

DATE: October 28-29, 2019 VENUE: RITM Training Center,

Muntinlupa

2. HFDB-NUHL Asian Network for Clinical

Laboratory Standardization and Harmonization on GLP

DATE: October 2-3, 2019 VENUE: Ciudad Christhia Resort,

San Mateo, Rizal

3. PHILIPPINE ASSOCIATION OF MEDICAL TECHNOLOGISTS

55th PAMET Annual Convention

DATE: December 2-4, 2019 VENUE: PICC, Pasay City, Metro

Manila

4. PHILIPPINE COLLEGE OF HOSPITAL ADMINISTRATORS

PCHA 44th Annual Convention

DATE: November 16-17, 2019 VENUE: The Manila Hotel, Manila

5. PHILIPPINE SOCIETY OF PATHOLOGISTS

Symposium -Conference on Anatomic Pathology

DATE: January 18-19, 2020 VENUE: Seda Hotel, Bonifacio

Global City, Taguig City

Clinical Laboratory Services& Patient-Centered Care

by: Annie Pring-Valdez, MD, FPSP, MHA, PhD

Patient-centered care has taken center stage in the discussions of quality provision of healthcare. The fundamental goal of patient-centered care is a higher

quality of care that produces improved patient outcomes.

In patient-centered care, an individual’s specific health needs and desired health outcomes are the driving force behind all health care decisions and quality measurements. Patients are partners with their health care providers, and providers treat patients not only from a clinical perspective, but also from an emotional, mental, spiritual, social, and financial perspective.

We all agree that clinical laboratories play a crucial role in caring for the patient. Laboratory information is vital to healthcare providers in the management of their patients. The timing of the laboratory tests is important, the outcome of the tests is important, the delivery of the results is important, and the reporting that the referring physician receives is important.

What is now the challenge that clinical laboratories will face?

The challenge for laboratories, then, is how to adapt their business model to accommodate this new patient-centric model when all of their experiences have driven them to focus on volume or accessions.

Correlating clinical laboratory services with patient-centered care may seem difficult because laboratorians usually do not interact with patients. However, the first step to improving this aspect of health care quality is to shift the focus from specimens to patients. Medical laboratory professionals tend to examine their services with respect to the number of samples and billable tests.

According to Jennifer Dawson of the CLSI Quality Management Systems Expert Panel, “For laboratory professionals, providing patient-centered care means identifying, respecting and caring about patients’ values, preferences, differences, needs and expectations. This requires effectively listening to, clearly communicating with and educating our patients about laboratory testing. As the laboratory scientists who play a critical role in patients’ care, we have the duty to ensure that our patients and their providers understand preparation requirements for testing, receive information about the meaning of laboratory tests and our services meet their needs and expectations. Providing direct access testing and patient access to laboratory test results are other ways we can become more patient focused. These are obvious areas to focus on in order to work towards this goal, however there are critical skills laboratory personnel can develop to become more patient-centered.

Knowing this, what can the laboratory do to contribute to patient-centered care?

This is where the Philippine Council for Quality Assurance in Clinical Laboratories (PCQACL) plays its role of being be the leader in promoting quality services provided by clinical laboratories in the Philippines by means of training, education and research. For more than fifteen years of promoting quality services provided by clinical laboratories, big or small, private or public, free-standing or hospital-based, education and training thru its scientific seminars and highly relevant annual convention topics; laboratory executives/managers, medical laboratory scientists and other healthcare providers share expertise and learn best laboratory practices from international and local guests.

This year’s convention theme provides the best opportunity to learn and face the challenges of this patient-centric model and let PCQACL be our partner.

Professor Dawson of the CLSI stated in one of her published articles: “Clinical laboratories are not a black box where specimens go in and test results come out. Clinical laboratories are the places where scientists with important, often critical, medical information is identified and communicated to patients and their care providers. We owe it to ourselves and our patients to look for ways to make laboratory service more patient-centered and share our expertise with the rest of the patient care team.”