DOH-CHD3 Office Memorandum No. 2012-002: Serology NEQAS Participation

This memo is for all Clinical Laboratories in region 3 who failed to participate in 2011 Serology NEQAS, who still intend to provide HIV/AIDS, Hepatitis B and C, and Syphilis serologic testing for CY 2012.

In order for you to include the said serology testing in your services you are hereby given until March 31, 2012 to register at NRL-SACCL and submit your Certificate of Participation at CHD3 for processing of your license.

Note: Acceptance of registration by the NRL-SACCL is from March to June 2012.

DOH CHD3 Office Memorandum No. 2012-002

A career as a Medical Laboratory Scientist

by ckendric

Recorded at LabPlus at Auckland hospital in New Zealand the video presents MLS as a career option in the health industry in New Zealand

CCDPC LABORATORY: Malaria and TB Microscopy Survey

The Collaborating Center for Disease Prevention and Control (CCDPC) Laboratory is currently conducting a survey to assess the current practice on Malaria and TB Microscopy among private clinical laboratories in Central Luzon.  This is of great help in formulating new policies and strategies to improve laboratory diagnosis of Malaria and Tuberculosis.

Please find time to fill-up the form below and you can send it to jeffrey_de_guzman@yahoo.com or idtomis_chd3@yahoo.com.  You may contact this number for queries: (045)9612099 loc 123

TB and Malaria Survey

Quality Management in Clinical Biochemistry

Below is a powerpoint presentation by Dr. Charles D. Stephen that you can use as a guide in putting up quality assurance system in the Clinical Chemistry section of your laboratory.

QUALITY MANAGEMENT OF THE CLINICAL BIOCHEMISTRY LABORATORY

External Quality Assessment Scheme for Clinical Chemistry

The Lung Center of the Philippines was the designated National Reference Laboratory for Clinical Chemistry where the external quality assessment scheme is being conducted.

For initial application, you must inform them of your intention to participate in the scheme. You can contact them with this number (02)924-6101 loc. 388 or send an email at lcp_nrl_cc@yahoo.com.ph.

Registration form and order of payment will be sent via email. Accomplish documents completely and return back to LCP_NRL the soonest. Original copy of all required documents must be submitted.

A minimal amount of P3,500.00 as participation fee will be charged to defray cost of reagent, administrative, and other operating expenses. Payment may be paid in cash or in check payable to Lung Center of the Philippines.

As soon as payment is received EQAS samples will be prepared and delivered on schedule.

A Certificate of Participation (COP) will only be released to the participating clinical laboratory upon submission of EQAS result to LCP-NRL. This COP is required in the application for renewal of license to operate (LTO) for the succeeding year.

NATIONAL EXTERNAL QUALITY ASSESSMENT SCHEME (NEQAS) FOR BACTERIOLOGY, PARASITOLOGY & MYCOBACTERIOLOGY

Below is the 2011 schedule for the National External Quality Assessment Scheme (NEQAS) for Bacteriology, Parasitology, and Mycobacteriology.

Enrollment (EN) is all year round.  Sending of analytes for the proficiency testing (PT)  will be four (4) times in a year except for TB Culture Program (TBC) which will be sent twice a year only.

Batch cut-off (BCO) will be every 30th of scheduled month or 100 labs, whichever comes first.  Labs with incomplete documents before BCOs will not be included in the proceeding PT,  however, these labs will instead be included in the next scheduled PT.

January	EN
	Batch cutoff: 30th of Jan. or 100 labs, whichever comes first
February	EN
	PT
	TBC
March	EN
April	EN
	Batch cutoff: 30th of Jan. or 100 labs, whichever comes first
May	EN
	PT
June	EN
July	EN
	Batch cutoff: 30th of Jan. or 100 labs, whichever comes first
August	EN
	PT
	TBC
September	EN
October	EN
	Batch cutoff: 30th of Jan. or 100 labs, whichever comes first
November	EN
	PT
December	EN

Enrollment Procedure:

1. Fill-up the Enrollment Form correctly and sign
2. Refer to the box below for the amount to be paid or contact the NEQAS office for clarification
3. Send Enrollment Form and Payment to the NEQAS Office for payment evaluation and processing (enrollment will not be accepted without the enrollment form and payment as well as PAYMENTS WITH INCORRECT AMOUNT)
4. The Official Receipt and a notice on when you will expect to receive your Proficiency Test Panels will be sent through registered mail (for enrollments made through courier only) 

NEQAS Office:

NATIONAL EXTERNAL QUALITY ASSESSMENT SCHEME
Department of Microbiology
Research Institute for Tropical Medicine
FILINVEST, Alabang, Muntinlupa City

Programs	Amount
Bacteriology, Parasitology, TB	P 7,500.00
Bacteriology with/without Parasitology or TB	P 7,500.00
Parasitology and TB	P 4,200.00
Parasitology or TB	P 4,200.00

Note: Please download the updated enrollment form and see the new payment scheme here >>ritm.gov.ph>>




NATIONAL EXTERNAL QUALITY ASSESSMENT SCHEME (NEQAS) FOR BACTERIOLOGY, PARASITOLOGY & MYCOBACTERIOLOGY ENROLLMENT FORM

Disclaimer: This is for information purpose only.  For complete details and clarifications please contact the RITM NEQAS office with telefax number:  (02) 850-1949 or visit www.ritm.gov.ph 

IMPLEMENTATION OF EXTERNAL QUALITY ASSESSMENT PROGRAM AS A REGULATORY REQUIREMENT FOR LICENSING OF CLINICAL LABORATORIES

Pursuant to Administrative Order No. 2007-0027 entitled "Revised Rules and Regulations Governing the Licensure and Regulation of Clinical Laboratories in the Philippines, " a clinical laboratory is required to have a Quality Assurance Program (QAP).

The QAP shall include an Internal and External Quality Control Program. The Internal QAP covers inputs, processes and outputs as well as practice of continuous Quality Improvement Program covering all aspects of laboratory performance.

On the other hand for External Quality Assessment Program (EQAP) a clinical laboratory is required to participate in the National External Quality Assessment Scheme (NEQAS) administered by the designated
National Reference Laboratories (NRLs) or in other local or international EQAP recognized by the Department of Health.

The NEQAS shall be conducted to ensure that laboratory procedures are done in accordance with standards and laboratory results are accurate and within the standard range for quality health care.

As provided in Department Order No. 393-E s. 2000, five institutions were designated as the National Reference laboratories namely:

• Research Institute for Tropical Medicine - National Reference Laboratory for Dengue, Influenza, Tuberculosis and other Mycobacteria, Malaria and other parasites, Bacterial enteric diseases, Measles and other Viral exanthems, Mycology, Enteroviruses, Antimicrobial resistance and Emerging Diseases; NRL for confirmatory testing of blood units.

• San Lazaro Hospital - National Reference Laboratory for HIV/AIDS, Hepatitis, Syphilis and other Sexually Transmitted Infections (STls).

• East Avenue Medical Center- National Reference Laboratory for Environmental and Occupational Health; Toxicology and Micronutrient Assay

• National Kidney and Transplant Institute - National Reference Laboratory for Hematology including Immunohematology, Immunopathology and Anatomic Pathology (consistent with previously issued D.O. 301-1 s. 1999)
• Lung Center of the Philippines- National Reference Laboratory for Biochemistry.

The following specific guidelines shall be enforced to initially implement the NEQAS:

1. A certificate of participation/registration in NEQAS shall be a licensing
requirement for the renewal of license to operate a clinical laboratory for 2009
in the following areas:

      a. Hematology - Primary, Secondary and Tertiary Clinical Laboratories in the
National Capital Region (NCR).

      b. Clinical Chemistry - Tertiary Clinical Laboratories in the National Capital
Region (NCR) and Center for Health Development IV-A CALABARZON.

      c .. HIV/AIDS , Hepatitis B & C Proficiency Testing - All HIV Accredited Testing
Laboratories and Secondary and Tertiary Clinical Laboratories performing
Hepatitis Band C tests.

      d. Drug and Water Proficiency Testing - All Water and Drug Testing
Laboratories.

2. A Certificate of Participation shall be issued by the NRLs to the participating clinical laboratory every time NEQAS is conducted. For the initial implementation of NEQAS, only one (1) certificate is required for the renewal of license to operate.

3. NEQAS/Proficiency Testing for Drug and Water Testing Laboratories requires participation and a satisfactory rating on the survey. For Microbiology, TB and Parasitology, participation in the three component is required and a certificate of participation is issued by the Microbiology Department of RITM. A certificate of participation in Antimicrobial Resistance Surveillance Program (ARSP) is recognized as NEQAS for Microbiology component only, and participation in the TB and Parasitology component is still required.

4. The schedule of fees per participation is as follows:
      a. Hematology P 2,000.00
      b. Clinical Chemistry P 2,000.00
      c. HIV/AIDS, Hepa B & C P 2,500.00
      d. Drug Proficiency Testing P 1,000.00
      e. Water Proficiency Testing P 2,500.00
      f. Microbiology P 5,000.00


Republic of the Philippines Department of Health, DEPARTMENT MEMORANDUM No. 2009 - 0086"

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Activities and Guidelines in the Performance of External Quality Assessment Program (EQAP) of the National Reference Laboratory for HIV/AIDS, Hepatitis B & C and STIs

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Reagent Strips

By Jeffrey V. de Guzman

Image from yerconlab.en.alibaba.com

Routine chemical examination of the urine has changed dramatically since the early days of urine testing, owing to the development of the reagent strip method for chemical analysis.  Reagent strips currently provide a simple, rapid means for performing 10 medically significant chemical analyses, including pH, protein, glucose, ketones, blood, bilirubin, urobilinogen, nitrite, leukocytes, and specific gravity.

Testing methodology consists of dipping the strip completely, but briefly, into a well-mixed urine specimen; removing excess urine by touching the edge of the strip to the container .  Even though this is a simple procedure, improper technique can result in errors.

In addition to the use of correct testing technique, performance of quality control and care of reagent strips must be observed in order to guarantee quality patient care.  All clinical laboratories must have a quality assurance program in place.  Quality assurance program includes procedures for quality control of specimen collection and handling, reagents and test performance, instrument calibration and maintenance, reporting of results, personnel performance and requirements, safety, and documentation that the program is being followed.

Reagent strips must be protected from deterioration caused by moisture, volatile chemicals, heat, and light.  Strips are packaged in opaque containers with desiccant, and when not in use, these bottles should be stored tightly closed in a cool area.  Bottles should not be opened in the presence of volatile fumes.  All bottles are stamped with an expiration date that represents the functional life expectancy of the chemical pads.  This date must be honoured even if there is no noticeable deterioration of the reagents.

Unexpired strips should be tested for chemical reactivity with controls of known negative and abnormal concentrations.  Distilled water is not recommended for use as a negative control because reagent strip chemical reactions are designed to perform at an ionic concentration consistent with urine.  Additional or confirmatory procedures employing different chemical principles must be available for the substances being tested by reagent strip and should be used when questionable results are obtained or, in some instances, to confirm all positive results.

Observing all these procedures in routine urinalysis produces a win win situation between the laboratory and the patients.  Our business is to provide a quality health care for our patients.  But still, some laboratories do not comply with all these standards.  An example of such violations is the cutting of reagent strips into halves.

To quote one of their reason, “We cut urine strips into halves since cut and whole strips will produce equal results, thus minimizing our costs and consequently the charge to our patients”.

I’m sure you are scratching your head right now.  And if you happen to be the inspector, what would be your answer to this?

Reference: Susan King Strasinger: Urinalysis and body fluids.F.A. Davis Company, 1997

Application Form For The Renewal of License To Operate General Clinical Laboratories In Central Luzon

Below is the copy of the application form for initial and renewal of license to operate a general clinical laboratory.  This can actually be downloaded from the DOH website.  The only difference is that the list of personnel and equipment must also be submitted for the renewal of license even without changes.

This is intended for clinical laboratories under the jurisdiction of Center for Health Development 3.  Always prepare a duplicate copy of all the documents submitted.


Application For License To Operate A General Clinical Laboratory in the Philippines -


Please see the latest checklist of application documents here

Hemoglobin Determination Methods in the Philippines

This article is intended to address the common violation of clinical laboratories with regards to haemoglobin determination.  Majority of the non-hospital based freestanding clinical laboratories specially primary categories do not even perform the test but a result is being released by multiplying a factor (0.333) to the hematocrit of the patient.  Poor patients, they are paying for the test but without knowing that it is actually not being done by the medical technologist involved.  Such thing is very unprofessional and with all the notices and warnings issued by the regulatory officers, this practice still exist.

The approved standard for quantitative blood  haemoglobin determination in the Philippines is by using the hemiglobincyanide (HiCN) or commonly known as the cyanmethemoglobin method.  To perform this method, blood is mixed with Drabkin's solution, a solution that contains ferricyanide and cyanide. The ferricyanide oxidizes the iron in the hemoglobin, thereby changing hemoglobin to methemoglobin. Methemoglobin then unites with the cyanide to form cyanmethemoglobin.  All forms of hemoglobin likely to occur in circulatory blood, with the exception of sulfhemoglobin, are determined. Cyanmethemoglobin produces a color which is measured in a colorimeter, spectrophotometer, or automated instrument.  The color is suitable for measurement in filter as well as in narrow-band spectrophotometers, because its absorption band at a wavelength of 540 nanometers is broad and relatively flat.  The color relates to the concentration of hemoglobin in the blood.  Standards prepared from either crystalline hemoglobin or washed erythrocytes and stored in a brown glass container and in sterile condition are stable for at least nine months (change 2%).

Since very few primary category clinical laboratory are equipped with hemoglobinometer  or a photometer, the regulatory officers consider manual methods which include the Haden-Hausse and Sahli-Hellige methods. In both methods, blood is mixed with dilute hydrochloric acid. This process hemolyzes the red cells, disrupting the integrity of the red cells' membrane and causing the release of hemoglobin, which, in turn, is converted to a brownish-colored solution of acid hematin. The acid hematin solution is then compared with a color standard.

This methods of determination of haemoglobin as haeminchloride (acid haematin) though not recommended because of their unreliability, are sufficient for routine examination provided they are properly done.

Below is the procedure for the Sahli-Hellige method.

Materials Required:

• ·         Distilled water

• ·         Sahli-helligehemoglobinometerkit containing:

o   Small bottle of dilute (approx. 0.1N) hydrochloric acid. Prepare this solution by adding 1 ml of concentrated HCl to 99 ml of distilled water. POUR ACID INTO WATER. Replenish this peri-odically–it must be of proper strength.

o   Graduated tube, with a scale on two sides. On one side is the percentage scale, and on the opposite side is the gram scale. The percentage scale reads from 0 to 170. The gram scale reads from 0 to 24.

• ·          Pipette, marked at the 20 mm 3 level

• ·         Stirring rod

• ·         Color comparator, with a window in the side. On the right and left sides of this opening is the color standard for comparison. The center has an open slot to hold the graduated tube.  

Procedure 

1. With a medicine dropper, place 5 drops of the 0.lN HCl in the bottom of the graduated tube. Place the tube in the color comparator.
2. Using well-mixed venous blood or fingertip blood, fill the pipette to the 20 mm mark.
3. Wipe blood from the outside of the pipette. Transfer blood to the Sahli tube. Note the time.
4. Aspirate distilled water into the pipette two or three times and transfer these washings to the tube.
5. Shake until the blood is well mixed and the tube is a uniform color.
6. Add distilled water, drop by drop, each time mixing the solution with the stirring rod. Keep adding water and mixing until the color of the solution matches the standards on either side. Remove the stirring rod from the tube each time before com-paring. Natural light makes more accurate readings possible.
7. Five minutes after time noted, read the result from the scale on the tube by noting the graduation mark at the lower edge of the meniscus. Read and report both scales.

Application for Renewal of License To Operate (LTO) of Non-hospital Based Clinical Laboratories in the Philippines

This is in accordance to Republic Act No. 4688 s. 1966, “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” and DOH Administrative Order No. 2007-0027: Revised Rules and Regulations Governing the Licensure and Regulation Of Clinical Laboratories in the Philippines.

Every clinical laboratory shall be organized to provide quality, effective and efficient laboratory services.  A checklist for licensure of a general clinical laboratory is available which may serve as a guide for self-assessment of the facility.  To access the tool click the link here.

The LTO shall be issued only to clinical laboratories that comply with the standards and technical requirements formulated by the BHFS.

The procedural guideline is as follows:

1.  Filing of application begins on the first day of October until the last day of November of the current year. A ten (10) percent discount on the renewal fee shall be granted if a complete application is filed during this period.
2.  Applicants can acquire the prescribed application form for LTO from the BHFS, CHD that has jurisdiction over the existing clinical laboratory, or at the DOH website (www.doh.gov.ph)
3.  The accomplished form together with the necessary attachments is to be submitted to the CHD that has jurisdiction over the existing clinical laboratory.  Incomplete attachments would not be accepted.  Trainings and seminars attended must be of the current year.
4.  The applicant shall be required to pay a non-refundable application fee for LTO upon submission of the accomplished form.
5.  Renewal of license for compliant clinical laboratories shall be processed not later than five (5) working days after the expiration date of its license.
6.  The LTO of a clinical laboratory shall be automatically cancelled without notice when it fails to submit a duly accomplished application form and to pay the proper fee on or before the expiration date stated in its license.

Moratorium on the Issuance of Permit to Construct and License to Operate Free Standing Clinical Laboratories Nationwide

Due to the increasing number of clinical laboratories, there is greater competition for a limited number of patients needing laboratory examinations.  Many laboratories lower the prices of their services often leading to poor laboratory practices, and worst, releasing of laboratory results without actually performing examinations.  Spot checking of these clinical laboratories revealed unacceptable practices such as cutting of urine strips, use of expired reagents and minimal supervision of pathologists to name a few.  These prevailing practices adversely affect the quality of service and in turn health care delivery system.

In order to address this problem, the Bureau of Health Facilities and Services shall spearhead the creation of a quality assurance and monitoring program.  The quality assurance and monitoring program will be composed of a two-fold scheme namely regular conduct of spot-checking and development of an organized external quality assurance system.  The main objective of this program is to ensure good laboratory practice and maintenance of high quality performance among clinical laboratories in the Philippines.

In view of such undertaking, a moratorium on free-standing clinical laboratories will be imposed starting April 1, 2003 until such time that the quality assurance and monitoring program has been organized and in place.  Only applications for permit to construct received by the bureau on or before March 31, 2003 shall be processed.  The moratorium on freestanding clinical laboratories shall not apply to drug testing laboratories.

Republic of the Philippines Department of Health-BUREAU OF HEALTH FACILITIES AND SERVICES, BUREAU CIRCULAR No. 3  s. 2003