Administrative Order No. 2012 - 0025

  

November 27, 2012

ADMINISTRATIVE ORDER

No. 2012 – 0025

GUIDELINES IN THE IMPLEMENTATION OF THE QUALITY ASSURANCE SYSTEM OF MALARIA MICROSCOPY IN THE PHILIPPINES

I.     RATIONALE

Microscopy remains the gold standard in malaria diagnosis. The accurate and effective treatment of malaria cases and the elimination of the reservoir of disease transmission largely depend on reliable and accurate diagnosis. The desired reliability, accuracy and efficiency of diagnostic facilities and the maintenance of high quality microscopy services at various health levels of health care delivery system can be attained by implementing a quality assurance system.

Support for early diagnosis and prompt treatment of malaria has scaled up in previous years. Diagnostic services are provided by existing microscopy centers based in selected RHUs, hospitals and barangay health centers established in remote malarious areas. These centers are staffed by microscopists who may be medical technologists, laboratory technicians or community volunteer workers especially trained on malaria diagnosis. The performance of this network of providers needs to be enhanced and maintained, vis a vis standards that are set and therefore a Quality Assurance System has to be established and implemented.

II.    OBJECTIVES

To set the guidelines in the establishment of a quality assurance system for malaria microscopy for local health managers and other service providers toward ensuring and maintain reliable and efficient diagnostic services for malaria.

III.  SCOPE AND COVERAGE

This Administrative Order shall apply to health workers at the national, regional, local, public and private health facilities who are responsible for managing, supervising or providing malaria microscopy services and whose functions and activities contribute to the diagnosis and treatment of malaria.

IV.   IMPLEMENTING GUIDELINES

A.  General Guidelines

1. A 3–level microscopy quality assessment system shall be established.

a. All health facilities providing malaria microscopy services shall go through validation of their blood films by qualified provincial/regional validators. The microscopists of these facilities shall undergo the appropriate training provided by the National Core Group of Trainers (NCGT); the proficiency skills of the microscopist shall be validated regularly by certified provincial/regional validators.

b. All provinces shall have a pool of qualified and certified validators maintained through a regular proficiency assessment every 2 years.

The validators shall be subjected to proficiency assessment by the Research Institute for Tropical Medicine – National Reference Laboratory (RITM – NRL) in coordination with the Malaria Program every 2 years.

c. A national core group of trainers/ validators certified by an independent body shall be sustained by the Malaria Program.

The training competencies of NCGT members shall be regularly assessed through its Regional Accreditation and External Quality Assurance (EQA) program.

2. The Centers for Health Development/Provincial Health Offices/Municipal Health Offices shall extend full support to the malaria microscopy quality assessment system.

3. The head of the health facility providing diagnostic services for malaria shall identify/designate staff to perform malaria microscopy and make the necessary administrative and financial arrangements for the designated staff to participate in a Basic Malaria Microscopy Training Course.

4. The head of the facility and the designated/qualified microscopist shall cooperate/participate in the process of regular assessment of microscopist performance by the validator’s supervisor. The purpose of the validation is to enhance the skills of the microscopists and to help improve the support system for delivering microscopy services such as functionality of microscopes, adequacy of laboratory supplies/reagents and recording system.

5. The medical technologists and microscopist in the different health facilities providing malaria diagnostic services including private hospitals with trained microscopists shall submit their blood films for validation to the validator in – charge of their area as per schedule depending upon the above–mentioned scheme of validation. The purpose of the validation is to enhance their proficiency in accuracy, specificity, sensitivity and species identification and parasite quantification. This is in support to the objective of the National Malaria Program to provide prompt diagnosis and accurate treatment of malaria cases, thus accelerating the transition from control to sustained elimination of the disease.

6. The trained personnel on preventive maintenance of microscopes shall conduct a quarterly regular cleaning/checking for necessary repair or replacement of spare parts of microscopes. The needed repair or replacement of spare parts shall be reported to the regional coordinator who shall immediately act on the matter. Regional malaria coordinators shall appropriate funds for their traveling expenses using the sub–allotted funds from the Infectious Disease Office.

7. The Regional Malaria Coordinator shall establish networking and include the Medical Technologists in other GOs and NGOs with laboratories performing malaria microscopy to participate in QA.

8. The Regional Malaria Coordinator shall coordinate with the Infectious Disease Office/NCDPC through external service for the replenishment of laboratory supplies and reagents.

B. Specific Guidelines

1. Level 1 – Training of Microscopist for Malaria Diagnosis

The medical technologist shall undergo a 2–week Basic Malaria Microscopy Training while non–medical technologist shall undergo 5–week Basic Malaria Microscopy Training.

a. Those who obtain a passing mark of at least 80% can be designated as microscopist.

b. Medical technologists with a grade of <80% shall be mentored by the validator for 6 months and take the same 2–week course for the second time.

c. Non–medical technologist with a grade of <80% shall be replaced by another staff as recommended by the head of the facility to undergo training.

d. Those with ≥80% shall be assessed every 3–5 year. They shall undergo a 5 –day refresher course with emphasis on species identification (all microscopist) and quantification (for microscopist assigned in RHU/hospitals/laboratories).

e. Those who fail the refresher course shall be mentored and supervised; weakness and gaps are to be identified; a panel of slides to be sent to them for practice.

2. Level 2 – Quality Assessment of Microscopy Services in Health Facilities

The performances of malaria microscopist shall be regularly assessed through validation of blood films, on–site supervision, feedback and remedial interventions.

a. Blood Film Validation

(1)   Random selection of blood films adopting a selection scheme

Scheme 1

If there are >240 blood films in a previous year, the microscopist shall submit every quarter 30 blood films to complete 120 blood films reviewed in a year

Scheme 2

If there are 200 – 400 blood films, all blood films examined in the quarter prior to validation schedule shall be submitted

Scheme 3

If there are ≤200 blood films in the previous year, all blood films examined in the previous 6 months shall be submitted. The validator shall send a panel of slides to the microscopist every year if validation result is <20% error in the blood films examined in the previous 6 months for the microscopist to read and results of his/her reading shall be recorded in an appropriate form.

(2)   Validation schedule and frequency

The validators shall inform the microscopist and head of microscopy center of the validation schedule and shall advise the microscopist to prepare the blood films appropriate for the selected scheme.

(3)   Validation of Blood Films

Scheme 1 and 2

Upon receipt of blood films and the sealed envelope with the accomplished Form 1, Malaria Blood Films for Validation (Annex A), the validator must accomplish in two weeks’ time the following:

(a)   Read the submitted blood films and record results in Form 2: Malaria Blood Films Report by Validator (Annex B)

(b)   Copy the microscopist’s blood film result to the appropriate column.

(c)    Compare the reading with the blood film readings sent by the microscopist. Indicate the result of the comparison.

Accuracy by species identification, specificity and sensitivity

i.      Accuracy – total number of correctly – read blood films by the microscopist ÷ total number of blood films read by the validator  x 100.

ii.     Sensitivity – total number of true positive films ÷ total number of true positive films + false negative films x 100

iii.    Specificity – total number of true negative films ÷ total number of negative films + false positive blood films x 100.

Parasite Quantification:

Number of blood films read by microscopist with parasite count within ± 20% deviation from the count of the validator ÷ total number of positive blood films x 100.

Assess the quality of thick and thin blood film and quality of staining.

Quality of Blood Film

(a)   A good thin blood film is a properly prepared thin fil which is thick at the beginning end and thin or feathered at the other end which shall not reach the end of the glass slide and shall have areas optimal for microscopy having red blood cells that are in distinctive layer.

(b)   A good thick blood film is circular with 1 cm diameter. The ideal thickness shall allow for printed text to be readable when placed on it.

(c)    A poor blood film is when any of the thin or thick blood film does not comply with the above description.

Quantity of Staining

(a)   A good stained thin blood film shall have:

·  Clear background free from debris

·  Pale grayish pink erythrocyte

·  Leucocytes with deep purple nuclei and well defined granules

·  A deep red chromatin of malaria parasites and clear purplish blue cytoplasm

·  For P. vivax or P. ovale parasite, stippling shows up as Schuffner’s dots and for P. falciparum, the larger ring forms shows Maurer’s spots in erythrocytes

(b)   A good stained thick blood film shall have:

·  Clean background free from debris

·  Pale mottled–grey color

·  Deep rich purple leukocytes nuclei  

·  Deep–red chromatin of malaria parasites and clear purplish blue cytoplasm

·  For P. vivax and P. ovale parasites, stippling in the “ghost of host erythrocytes” shows up as Schuffner’s dots, especially seen at the edge of the film.

(c)    An under–stained blood film shows too bluish or purplish film suggesting a high pH.

(d)   An over–stained blood film shows too pinkish film suggesting a low pH.

Total the number of inconsistent findings and results/analysis

(a)   If the number of blood films with error is 20% and more in any quarter, on –site supervision visit shall be conducted immediately.

(b)   If the number of blood films with error is less than 20% in any quarter, supervisory visit to the facility shall be at least once a year.  

Scheme 3

For microscopist with blood films examined in the previous 6 months

(a)   The same set of procedures shall be used under Scheme 1 and 2 in validating, analyzing and recording results.

(b)   If the result shows more than 20% error, an immediate on–site supervisory visit to the concerned microscopist shall be scheduled. There is no need to send panel of 20 slides in this case.

(c)    If the result show less than 20% error, a panel of 20 slides shall be sent to the microscopist to further validate his/her proficiency.

·  Perform the same analysis as indicated in Scheme 1 and 2 when the panel of 20 slides is returned. The analysis shall cover only accuracy and specificity of species identification and quantification (if applicable) but not the quality of blood film and quality of staining.

·  Results of validation shall be submitted to the head of facility.

For microscopist without any blood film examined in the previous 6 months,

(a)   Validator shall send panel of 20 blood films to the microscopist.

(b)   The same steps shall be applied in validation, analysis and appropriate actions as in a(3).

(4)   Feedback and Reporting

A feedback of the results of validation shall be given to the microscopist and his/her supervisor using Form 2a. Validation Summary Report (Annex C) within one month after the validation.

(a)   The validation shall provide feedback to the lead of microscopy center specifying the level of accuracy by species, specificity, sensitivity, staining quality, smear size and labeling as well as his/her recommendations.

(b)   The validator shall send the accomplished Form 2a with the empty slide box shall be sent back to the microscopist; the validator shall save the discrepant slide for discussion with the microscopist.

(c)    The report shall indicate the schedule of the next validation.

(d)   The microscopist shall be provided with the report; copy furnished the head of microscopy center, PHO and CHD heads. The report shall be endorsed by the head of microscopy center before sending it out to proper recipients.

(e)   The validator shall retain hard and electronic copies of the reports.

(f)    The microcsopist shall act on the recommendation and keep or file the validation report for future reference.  

b. On–site Supervision

The microscopist and validator shall have a face to face interaction and discussion of the validation results during the on–site supervisory visit. This allows assessment of the working conditions of the laboratory units to see if the support systems are in place and to assist in instituting corrective measures as needed.

(1)   The frequency of on–site supervision shall depend upon the extent of error detected

·  Immediate on–site supervision if the error is >20%

·  Once a year if the error is <20%

(2)   The steps to be taken in on–site supervision:

(a)   Planning – set the schedule; integrate this in the morning plan. Send communication informing the microscopist of the date of visit to make sure that he or she will be present and that the records and other materials needed for evaluation are ready.

(b)   Conduct the visit:

·  Pay a courtesy call to the Chief of Hospital, Municipal Health Officer or the Barangay Captain/Catchment Midwife as necessary.

·  Assess the working condition of the laboratory unit using Form 3. On site Supervisory Checklist (Annex D)

i.      Interview the microscopist asking questions on general information.

ii.     Select 10 blood films at random and validate the reading and the quality of the blood films selected.

iii.    Inspect and assess the microcopy set–up, laboratory supplies/materials, reagents, equipment, records, biosafety and waste disposal.

iv.    For poor performance validation results in blood film and staining procedures, request the microscopist to demonstrate smearing and staining procedures and observe his/her performance.

v.     Analyze results of assessment, act on all issues and make necessary recommendations.

(3)   Feedback and Reporting

(a)   The microscopist and head of the facility shall discuss the validation finding and present their comments and recommendations.

(b)   A written report duly signed by the validator supervisor shall be submitted to the head of the microscopy center and the microscopist, copy furnished the PHO and CHD not later than two weeks from the conduct of on–site visit.  

c. Consolidation of Validation Results in Health Facilities

(1)   Validators shall consolidate results of validation undertaken among microscopists in different health facilities under his/her assignment using Form 4. Consolidated Validation Report (Annex E)

(2)   The report shall include key findings, brief analysis of the results, actions taken and recommendations for further action.

(3)   The consolidated reports shall be submitted to the CHD, PHO, Provincial Health Team Office (PHTO) and Municipal Health Office within one month after the validation.

d. Further Review and Validation by Supervising Validators

In situation of disagreements on the validation results, a member of the NCG of Trainors/Validators within the region shall conduct further assessment/review and make the final decision.  

3. Level 3 – Proficiency Assessment of Provincial, Regional Validators and

Certification of the National Core Group of Trainers/Validators

This level of the QAS requires all regional/provincial/municipal validators to undergo proficiency assessment every 2 years by the RITM – NRL and likewise require the accreditation of the NCGT through the WHO Regional Accreditation and EQA Program every 2–3 years.

(a)   Proficiency Assessment for Regional/Provincial/Municipal Validators

High level of proficiency and high quality of microscopy shall be maintained at each level of health facility through monitoring of the performance of microscopists by the validators. It is therefore essential for the validators to likewise undergo regular proficiency assessment. A candidate validator for proficiency assessment shall be identified by the PHO of each province. In the absence of a candidate from the province, the PHO shall coordinate with the CHD and request the same to provide a validator for the province. PHO/CHO – candidate validators must pass the Proficiency Assessment for validator conducted by RITM – NRL.

To become a validator, a candidate medical technologist (regional, provincial, municipal health offices/facilities and other private institutions) shall meet the following minimum requirements:

(1)   Medical Technology Graduate

(2)   Must have passed the Basic Malaria Microscopy Training conducted by any of the following DOH offices: Infectious Disease Office (IDO), CHD, RITM – NRL within the past 3 years.

(3)   Must have at least with 3 years’ experience as malaria microscopist.

(4)   Must be willing to accept the responsibility of a validator

(5)   Must be endorsed by the IDO/CHD/PHO/MHO/Chief of Hospital

(6)   Must be holding a permanent position 

Proficiency Assessment Mechanism

(1)   Participants shall read a set of 48 reference slides for a period of 4 days in an independent and blinded manner.

(2)   Participants shall be graded on species identification and parasite quantification against the reference readings.

i.      Those who obtained a grade of ≥90% are qualified as validators and are recommended to undergo regular assessment every 2 years.

ii.     Those who obtained a grade of <90% are recommended to continue performing microscopy under the supervision of a regional/provincial validator and shall be considered for re–assessment after 1 year.

(b)   Certification of the National Core Group of Trainers/Validators

(1)   A certified regional /provincial validator shall become a member of the NCG of Trainers/Validators if:

·  Endorsed by the IDO/NCDPC/PHO

·  Willing to accept the responsibilities of a national validator and trainer

·  Officially designated by the head office.

(2)   NCG of Trainers/Validators shall be assessed every 2–3 years and certified through the WHO Regional Accreditation and External Quality Assurance (EQA) Program

(3)   NCG of Trainers/Validators must obtain a mark of 90% on detection of parasitemia, 90% on species identification and 50% of the blood films read that fall within ± 20% of the true parasite count

V.     REPEALING CLAUSE

All previous Orders and other related issuances inconsistent or contrary to the provisions of the Administrative Order are hereby repealed or modified accordingly.

All other provisions of existing issuances which are not affected by this Order shall remain valid and in effect.

VI.   EFFECTIVITY

This Order shall take effect immediately.

ENRIQUE T. ONA, MD, FPCS, FACS

Secretary of Health