25 May 1992
ADMINISTRATIVE ORDER
No. 122 series 1992
HEPATITIS B SURFACE ANTIGEN (HBsAg) AND HUMAN
IMMUNODEFICIENCY ANTIBODY (HIV Ab) POSITIVE UNITS OF BLOOD: DOH POLICY,
PROCEDURES TO BE FOLLOWED AND SANCTIONS FOR VIOLATIONS
The Bureau of Research and
Laboratories (BRL) is mandated by the Rules and Regulations governing Blood
Banks (Administrative Order No. 57 series 1989) promulgated pursuant to
the Blood Bank Law (R.A. 1517) to ensure the safety of the blood that is
collected, processed and transfused to patients. For this purpose, the BRL
formulated the “Technical Standards Governing the Collection, Processing and
Operation of Blood Banks in the Philippines” (Bureau Order No. 5 series 1990)
and issued Bureau Circular No. 1 series 1990 (Disposal of HBsAg and HIV Ab
positive Units of Blood) and Bureau Circular No. 2 series 1990 (Screening of
all blood units for HBsAg, HIV Ab, malaria and syphilis).
1. As stated
in the two (2) Bureau Circulars (Nos. 1 and 2 series 1990), it is the policy of
the Department of Health that:
a. All units of blood shall be tested for HBsAg, HIV Ab,
malarial parasites and STS by the blood collecting center (Blood Bank) prior to
issuance.
b. Only units of blood which are negative for all of the
above tests shall be issued by a Blood Bank to a transfusion facility
(hospital).
c. Any unit of blood found to be positive for HBsAg or
HIV Ab by either the Blood Bank or hospital laboratory should be reported and
submitted to the BRL in Metro Manila or to the Regional Health Laboratory in
the regions/provinces.
2. To ensure
the implementation of these policies, the following procedure are to be
followed:
a. A blood collecting center/Blood Bank shall test each
donor/unit of blood for HBsAg, HIV Ab, malarial parasites and serologic test
for syphilis (STS) prior to issuing the unit of blood.
Although
this Administrative Order focuses on laboratory testing of blood, it is
understood that all donors shall be screened by history, physical examination
and laboratory tests as prescribed in “Section 6, VI Donor Requirements
(Screening)” in Bureau Order No. 5 series 1990 (Technical Standards).
b. No unit of blood may be issued by a blood bank to a
transfusion facility/hospital unless it has been tested for the above
infectious agents and found to be negative except when expressly exempted by
the BRL under conditions stipulated in Bureau Circular No. 1 series 1991
(Exemptions from the requirement of screening of units of Blood for hepatitis B
surface antigen (HBsAg) and Human Immunodeficiency Virus (HIV) Antibody by
Blood Banks prior to issuance to hospitals).
c. A hospital laboratory MAY retest a unit of blood for
HBsAg of HIV Ab in accordance with hospital practice/policy or upon request of
the attending physician/consultant.
d. If the unit of blood is found to be positive for HBsAg
or HIV Ab, the laboratory personnel should:
(1) Inform the blood bank by telephone and issue a written
report on the results.
(2) Inform the BRL /Regional Health Laboratory and arrange
for its transport to that laboratory.
(3) Store the unit of blood under the proper conditions.
e. The issuing blood bank should replace immediately the
unit of blood without additional charge.
f. If the blood bank desires, it may obtain a segment of
donor tubing from the unit of blood together with the written report and retest
the blood sample.
g. If the blood bank is not satisfied with the hospital
laboratory report due to discrepancy with its own testing, it may request in
writing the BRL to confirm the proper result of HBsAg/HIV Ab testing. The
written request should indicate the method and brand of reagent used by both
the blood bank and hospital laboratory.
h. Upon submission of the blood bag and written request
to the BRL, the appropriate laboratory fee shall be paid by the blood bank.
i. If the BRL confirms the unit to be positive for HBsAg/HIV
Ab, the blood bag shall be retained by BRL for proper disposal. This incident
shall be considered a violation of this policy by the blood bank attributable
to the date it was issued to the hospital.
j. If the BRL finds that the unit of blood is negative
for HBsAg, repeated by ELISA, it will be returned to the hospital for
disposition. If the BRL finds that the unit of blood is negative for HIV Ab by
at least two (2) screening methods, the unit shall be discarded as per WHO
Guidelines on HIV Testing Strategies and therefore retained by BRL. In both
cases, the hospital will be billed for the unit of blood under question.
k. All results of testing for HBs Ag/HIV Ab by BRL shall
be recorded on report forms and copies will be sent to the Blood Bank and
hospital laboratory.
3. Sanctions
for Violations of DOH Policy on contaminated blood:
a. Definition: A violation of the policy will include:
(1) Issuing a unit of blood that has not been screened for
HBsAg/HIV/malaria/syphilis.
(2) Issuing a unit of blood that is positive for
HBsAg/HIV/malaria/syphilis.
(3) Failure to report and submit to BRL or appropriate
Regional Health Laboratory by the blood bank or hospital laboratory a unit of
blood which is found to be positive for HBsAg/HIV Ab. If the report is not done
within twenty four (24) hours, this would constitute a violation.
(4) When a unit of blood is found to be positive for
HBsAg/HIV/malaria/syphilis by the BRL upon random testing of blood issued by a
blood bank or in the inventory of a blood bank stored at a place reserved for
units cleared (and labelled) for issuance.
b. Each act of issuance or failure to report or random
testing as stated above (3a) shall be considered as one violation regardless of
the number of units involved.
c. Sanctions to be applied for each violation as defined
in 3a and stipulated in 3b, resulting in the issuance, non–reporting, or
finding at random testing by BRL of HIV positive blood shall be:
(1)
For the
FIRST violation – the license to
operate the blood bank or hospital laboratory shall be suspended for two (2
weeks) and the medical technologist shall undergo refresher training if found
necessary. The physician–in–charge shall demonstrate that he is competent in
HBsAg/HIV Ab testing and promise the adequately supervise the blood
bank/hospital laboratory.
(2)
For the
SECOND violation – the license to
operate the blood bank or hospital laboratory shall be suspended for one (1)
month and the medical technologist and/or physician–in–charge involved shall be
reported to the Professional Regulation Commission for negligence and malpractice.
(3)
For the
THIRD violation – the license to
operate the blood bank or hospital laboratory shall be revoked. The medical
technologist and physician – in – charge shall be reported to the Professional
Regulation Commission for malpractice and recidivism without prejudice to
pursuing a criminal court action.
d. Sanctions to be applied for each violation as defined
in 3a and stipulated in 3b resulting in the issuance of unscreened blood, or
issuance, non–reporting or finding on random testing by BRL of HBsAg/HIV/malaria/syphilis
positive blood, shall be:
(1) For the FIRST violation – the license to operate the blood bank or hospital
laboratory shall be suspended for one (1) week. If the violation was due to a
technical error, the medical technologist shall undergo refresher training at
the BRL or other training laboratory acceptable to BRL during the period of
suspension.
(2) For the SECOND violation – the license to operate the blood bank or hospital
laboratory shall be suspended for two (2) weeks and the medical technologist
shall undergo refresher training if found necessary. The physician–in–charge
shall demonstrate that he is competent in HBsAg/HIV Ab testing and promise to
adequately supervise the blood bank/hospital laboratory.
(3) For the THIRD violation – the license to operate the blood bank or hospital
laboratory shall be suspended for one (1) month and the medical technologist
and/or physician–in–charge involved shall be reported to the Professional
Regulation Commission for negligence and malpractice.
(4) For the FOURTH violation – the license to operate the blood bank or hospital
laboratory shall be revoked. The Medical Technologist and physician–in–charge
shall be reported to the Professional Regulation Commission for malpractice and
recidivism without prejudice to pursuing a criminal court action.
4. The BRL shall
monitor the implementation of this policy, investigate any complaints and
recommend to the Undersecretary of Health for Standards and Regulations any
sanctions that would be applied to issuing blood banks or hospital laboratories
in accordance to Administrative Order No. 57 series 1989 (Revised Rules and
Regulations Governing the Collection, Processing and Provision of Human Blood
and the Establishment and Operation of Blood Banks).
5. Any Administrative Order or Circular or Provision thereof
inconsistent with this Administrative Order is hereby repealed.
6. This
Administrative Order shall be effective two (2) weeks after publication in a
newspaper of general circulation.
ANTONIO O. PERIQUET,
M.D.
Secretary of Health
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