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63 Cards in this Set
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An act regulatingthe operation & maintenance of clin labs & requiring the registration of the samewith the DOH, providing penalty for the violation thereof, & for other purposes |
Republic Act No. 4688 |
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Republic Act No. 4688 approved |
June 18, 1966 |
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Any person,firm or corporation, operating & maintaining a clin lab in whichbody fluids, tissues, secretions, excretions & radioactivity from beings oranimals are analyzed for the determination of the presence of pathologicorganisms, processes and/or conditions in the persons or animals from whichthey were obtained, shall register and secure a license annually at the office of the Secretary of Health |
Section 1 Republic Act No. 4688 |
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shall be exempt from the provisions of this section iftheir services are extensions of government regional or central laboratories |
Government hospital laboratories doing routineor minimum laboratory examinations |
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Head of the labpratory Section 1, Republic Act No. 4688 - duly qualified in laboratory medicine - authorized by the Secretary of Health and to berenewed annually |
Licensed physician |
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shall be granted or renewed by the SOH for the operation & maintenance of a clinical laboratory unless such laboratory is underthe administration, direction & supervision of an authorized physician |
No license |
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-shall becharged with the responsibility of strictlyenforcing the provisions of this Act -shall beauthorized to issue such rules & regulations as may benecessary to carry out its provisions |
Secretary of Health (through the Bureau of Research and Laboratories) |
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Punishments incases of violations against the provisions of this Act: a)imprisonmentfor not less than 1 month but not more than 1 year b)fine of notless than P1000 nor more than P500 c)both fine andimprisonment, at the discretion of the court. |
Section 4 Republic Act No. 4688 |
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authorized to be appropriated, out of any funds in theNational Treasury not otherwiseappropriated, to carry into effect the provisions of this Act |
P50,000 or so Section 6 Republic Act No. 4688 |
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AO No. 274 Series of 1976 |
Rules & Regulations Governing Affiliation of MT Schools, Colleges & Universities in Government Hospitals under the DOH |
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13 Responsibilities of the DOHL (and labs) note: quarterly reports on theaffiliation fees & budgetary outlay showing the proposed amount for eachpersonnel must be submitted to the SOH thru the AccreditationCommittee together with the report of the status/or problems of the AffiliationProgram |
-must be licensed as specifiedin RA 4688 -position of MT should be providedfor each of the sections of clin chem, clin mic, microbio, hema, bb andsero & histopath -adequate lab space -sufficient equipment and supplies -2 interns at any time in each section -must have a training program for MT interns -at least 1 member of the professional staff to everygroup of interns not exceeding 10 in each section should be provided -staff & personnel of the laboratory must be assistedby a laboratory instructor to monitor attendance, behavior, performanceincluding guidance in readings and application to the theoretical knowledge -no more than 10 MT interns shall beallowed to train during the night shift in understaffed hospitals. No intern isto be assigned without the regular professional staff on duty at all times (1:10) -intern’saffiliation fee for thelaboratory must be spent for laboratory needs utilized exclusively for training & not for payment of furniture or appliances -directorof the hospital is responsible for the admission of the number ofinterns approved by the Committee -priority is given to interns residing within the areaor region of the hospital |
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must have a training program for MT interns: |
-must be amember of the specialty society in lab med -trainingprogram should be prepared in coordination with the training officer & mustbe submitted to the Committee on Affiliation with the contract of affiliation -objectivemeasure or evaluation of the baseline skills & knowledge prior to allowinginterns to handle actual specimens -includes: (next slide) -min number of examinations or samples of eachsection to accommodate interns (per annum): (next next slide) |
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must have a training program for MT interns: -includes: |
-objective of training -procedures & methods to be taught -principles of the methods -right work attitudes & ethical values -required quota to develop accuracy & precision -objective evaluation of performance in each section -time schedule -lectures, seminars & conferences -methodology of training |
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must have a training program for MT interns: -min number of examinations or samples of each section to accommodate interns (per annum) note: for eachadditional intern, another half of the requirement shall be added |
clin chem clin mic microbio hema bb & sero histopath & cyto |
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clin chem |
3000 exams |
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clin mic |
-urinalysis (complete urinalysis) – 1500 samples -parasitology (direct fecal smear & concentrationtest/Kato thick smear) – 1500samples |
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microbio |
-gram staining, acid test staining – 800 samples -isolation & identification of organisms – 1000 samples |
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hema |
-peripheral blood study (hemoglobin, wbc count,Schilling, hematocrit and rbc morphology or CBC) – 1,200 samples -sedimentation rate, platelet count, bleeding & clotting time, malarial smears & other tests – 800samples |
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bb & sero |
-blood typing – 900tests -complete cross-matching – 600 tests -serology -VDRL – 300tests -Widal Test – 300tests |
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histopath & cyto |
500 tests |
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Responsibilitiesof the Affiliating Universities/Schools/Colleges of MT |
-requirements before applying for affiliation: -universities, schools and colleges shall: |
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Responsibilities of the Affiliating Universities/Schools/Colleges of MT -requirements before applying for affiliation: |
-approval from DepEd and the Boardof MT -compliance with the provisions of RA 5527 and PD 498 |
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Responsibilities of the Affiliating Universities/Schools/Colleges of MT -universities, schools and colleges shall: |
-provide a lab instructor -pay or replace damage, breakage of losses by theMT interns of lab property, equipment or supplies -make sure that all interns before the start ofinternship must have completed the theoretical aspect -pay the hospital the amount of P35 for each internmonthly. Payment is done within the first 5 days of the month -make a request of affiliation (6 copies) to the Chiefof Hospital & must be renewed every school year -see to it that laboratory instructor & studentsobserve & abide rules and regulations -see to it that students & instructor are in properuniforms & provided with a laboratory gown |
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JointResponsibilities of Affiliating Universities, Schools & Colleges in MTL |
-pathologist -12 months internship -monthly conference -cooperation and harmonious working relations among staff and interns |
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prepares thetraining program in coordination with the training officer |
pathologist |
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12monthsinternship |
-clin chem – 2 months -clin mic – 2 months -microbiology – 2 months -hematology – 2 months -bb & sero – 1 month -histopath – 1 month the remaining 8 weeks will beassigned in any section |
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Monthlyconference |
-evaluate implementation of the program -changes of the program -problems of the implementation |
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AO No.118-B Series No. of 1992 |
Rules & Regulations Governing the Accreditation of Clin Labs for Training of MT Interns |
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BasicAccreditation Requirements AO No.118-B Series No. of 1992 |
-name ofestablishment -place,municipality & province -name,citizenship, home address of the head -name,citizenship, home address of the owner -copy of avalid permit -trainingprogram for MT interns -volume ofexaminations performed in the previous year for each section |
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AccreditationFees AO No.118-B Series No. of 1992 |
-initial application: P500 -renewal: P250 -penalty: P200 (filed within90 days after expiration) |
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Inspection |
-directorof BRL -eachlaboratory must prepare all the necessary records -directorsof Regional Health Offices, Provincial, City & Municipal Health Officers |
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inspect thepremises and facilities |
director of BRL Inspection |
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report to theBRL the existence of unaccredited clinical laboratories training medicaltechnology interns |
directors of Regional Health Offices, Provincial, City & Municipal Health Officers |
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Terms andConditions AO No.118-B Series No. of 1992 |
-transfer location: inform BRL in writing within 15 daysafter transfer -penalty: suspension or revocation of certificate |
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Expiration of Accreditation Certificate AO No.118-B Series No. of 1992 |
2 years after the date of approval (indicated at the upperright corner) |
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Renewal AO No.118-B Series No. of 1992 |
60 days before expiration |
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Violations AO No.118-B Series No. of 1992 |
-traininginterns without a pathologist or MT -falsestatement in the application -failure tocorrect deficiencies within a reasonable time -refusal toallow inspection -repeatedfailure to submit an annual report |
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AO No. 59 Series of 2001 |
Rules & Regulations Governing the Establishment,Operation & Maintenance of Clin Labs in the Philippines |
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Classificationof Laboratories |
by: -function -institutional character -service capability |
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Classification of Labs by Function |
-clinical patho -anatomic patho |
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anatomic patho |
-surgicalpatho -immunohistopatho -cytology -autopsy -forensicpatho |
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Classification of Labs by Institutional Character |
-hospital-based-lab -non-hospital-based-lab |
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Classification of Labs by Service Capability (services) |
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Classification of Labs by Service Capability (space, equipment/instruments) |
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Requirements & Procedures for Application of Permit to Construct and License to Operate |
-applicationfor permit to construct -applicationfor new license -applicationfor renewal of license -permit andlicense fees -penalties -inspection& monitoring -issuance of license -terms & conditions -violations -QC -waste disposal -recording |
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Applicationfor permit to construct (Requirements & Procedures for Application of Permit to Construct and License to Operate) |
-letter of application to the Director of Bureau ofHealth Facilities and Services (BHFS) -4 sets of Site Development Plans & Floor Plans(approved by an architect or engineer) -DTI/SEC registration (for private laboratories) |
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Applicationfor new license (Requirements & Procedures for Application of Permit to Construct and License to Operate) |
Notarized application form |
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Applicationfor renewal of license (Requirements & Procedures for Application of Permit to Construct and License to Operate) |
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Permit andlicense fees (Requirements & Procedures for Application of Permit to Construct and License to Operate) |
-non-refundable -must be paidto the cashier of BHFS/ Centers for Health Development (CHD) |
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Penalties (Requirements & Procedures for Application of Permit to Construct and License to Operate) |
P1,000 for laterenewal after 2 months from expiry date |
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Inspection& Monitoring (Requirements & Procedures for Application of Permit to Construct and License to Operate) |
Director of BHFS/CHD |
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Issuance of License (Requirements & Procedures for Application of Permit to Construct and License to Operate) |
Director ofCHD |
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Terms and Conditions (Requirements & Procedures for Application of Permit to Construct and License to Operate) |
-nontransferable -extensionlaboratory has a separate license -license mustbe displayed in a visible location or area of the lab |
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Violations (Requirements & Procedures for Application of Permit to Construct and License to Operate) |
-operation oflab without a pathologist or medical technologist -change ofownership, location head of laboratory or personnel without informing the BHFSand/or the CHD -refusal toallow inspection -grossnegligence -any act oromission detrimental to the public |
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Note (Requirements & Procedures for Application of Permit to Construct and License to Operate) |
Secretary of Health: may suspend or revoke the operation of labs Provincial, City & Municipal HealthOfficers: report theexistence of unlicensed labs |
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-represents thetechniques & procedures that monitor per performance characteristics -a system oftechniques to ensure with a specified degree of confidence that the resultobtain from each series at analysis is true & correct -main purposeis to detect andrepair performance – remove sporadic spikes – to theprior chronic level, either by prompt action to restore the status quo or,preferably, by preventing the damage from occurring in the first place -deals with thecauses, sources of errors, mistakes & the procedures used to recognize & minimize errors; part of QA |
Quality Control (Requirements & Procedures for Application of Permit to Construct and License to Operate) |
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provideappropriate and standard methods, reagents, etc |
internal/intralab QC |
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given by a National Reference Lab |
external/interlab QC |
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Purposes/Objectivesof QC |
to check for: -quality ofreagents -stability ofthe machine -technical(operator) errors |
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-involves the analysis of control samples together with thepatient specimen -detects changes in performance between the present operation & the stable operation -important for the daily monitoring of accuracy & precision ofanalytical methods -detects both random & systematic errors in a daily basis -allows identification of analytic errors within a one – weekcycle |
internal/intralab QC |
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-involvesproficiency testing programs that periodically provide samples of unknownconcentrations to participating clinical laboratories -important inmaintaining long–term accuracy of the analytical methods -also used todetermine state-of-the-art interlaboratory performance -the College ofAmerican Pathologists (CAP) proficiency program is the gold standard forclin lab external QC testing |
external/interlab QC |
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Waste Disposal (Requirements & Procedures for Application of Permit to Construct and License to Operate) |
following theDOH guidelines |
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Recording (Requirements & Procedures for Application of Permit to Construct and License to Operate) |
lab must be kept for at least 1 year |
