A0 59 SERIES OF 2001

Question 1

HOW MANY SECTIONS

Answer 1

13 with Annex A (Technical Standards and
Minimum Requirements)

Question 2

DOA?

Answer 2

NOVEMBER 19, 2001

Question 3

Section 2 (Authority):
o These rules and regulations are issued to implement ___________________ consistent with E.O. 102 series 1999: REDIRECTING THE FUNCTIONS AND OPERATIONS OF THE DEPARTMENT HEALTH . The Department of Health (DOH), through the BUREAU OF HEALTH FACILITIES AND SERVICES (BHFS) in the Health Regulation Cluster, shall exercise the regulatory functions under these rules and regulations.

Answer 3

R.A. 4688: Clinical Laboratory Law

Question 4

a) Routine hematology (CBC)-
- hemoglobin mass concentration,
- erythrocyte volume fraction (hematocrit)
- leukocyte number concentration (WBC count)
- leukocyte type number fraction
(differential count)
(b) Routine urinalysis
(c) Routine fecalysis
(d) Gram staining

Answer 4

PRIMARY CATEGORY

Question 5

(a) Services of Primary Category
(b) Routine chemistry
(c) Cross matching

Answer 5

SECONDARY CATEGORY

Question 6

(a)Services of Primary and Secondary Category
(b) Special chemistry
(c) Special hematology
(d) Immunology and Serology
(e) Microbiology

Answer 6

TERTIARY CATEGORY

Question 7

Section 6 (Policies):
________approved permit to construct and design lay-out of a clinical laboratory MUST BE SECURED prior to submission of an application for a Petition to Operate

Answer 7

BHFS

Question 8

Section 7 (Requirements and Procedures for Application of Permit to Construct and License to Operate):
o EACH REGION HAS DIFFERENT SCHEDULE for application of renewal
o Late Renewal (2 months after expiry date): ____________
o BHFS/CHD (Center for Health Development) will inspect the lab EVERY 2 YEARS
o An extension laboratory SHALL HAVE SEPARATE LICENSE

Answer 8

P1,000 fine

Question 9

Section 9 (Investigation of Charges of
Complaints):
o Laboratory closure order issued by DOH shall not be rendered ________by any way

Answer 9

ineffective

Question 10

ANNEX A (Technical Standards and Minimum Requirements)

Staffing:

Answer 10

• Pathologist or Physician with 3 MONTH OF TRAINING
• Sufficient number of RMTs
  proportional to the workload
• HOSPITAL-BASED: 1 RMT PER SHIFT
• Staff development and Appropriate Continuing Education Program

Question 11

ANNEX A (Technical Standards and Minimum Requirements)

Physical Facilities:

Answer 11

• Primary = 10 sq. m.
• Secondary = 20 sq. m.
• Tertiary = 60 sq. m.

Question 12

ANNEX A (Technical Standards and Minimum Requirements)

Equipment/Instruments:

Answer 12

o Glasswares/Reagents/Supplies:
o Waste Management
o Quality Control Program
- Internal
- External - lab must participate in External Quality Assurance Program by National Reference Laboratories
o Reporting
o Recording
o Laboratory Fees