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    LICENSING Lab Management

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    Naeize Tecson
    The document outlines the assessment criteria for licensing a general clinical laboratory. It discusses the key areas that will be evaluated which include: management responsibility, manpower, physical plant/facilities/work environment, equipment/instruments, and reagents/supplies. Under each section, it provides examples of documentation and policies that should be in place to meet the licensing requirements.

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    LICENSING Lab Management

    Uploaded by

    Naeize Tecson
    371 views26 pages
    The document outlines the assessment criteria for licensing a general clinical laboratory. It discusses the key areas that will be evaluated which include: management responsibility, manpower, physical plant/facilities/work environment, equipment/instruments, and reagents/supplies. Under each section, it provides examples of documentation and policies that should be in place to meet the licensing requirements.

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    The document outlines the assessment criteria for licensing a general clinical laboratory. It discusses the key areas that will be evaluated which include: management responsibility, manpower, physical plant/facilities/work environment, equipment/instruments, and reagents/supplies. Under each section, it provides examples of documentation and policies that should be in place to meet the licensing requirements.

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    371 views26 pages

    LICENSING Lab Management

    Uploaded by

    Naeize Tecson
    The document outlines the assessment criteria for licensing a general clinical laboratory. It discusses the key areas that will be evaluated which include: management responsibility, manpower, physical plant/facilities/work environment, equipment/instruments, and reagents/supplies. Under each section, it provides examples of documentation and policies that should be in place to meet the licensing requirements.

    Copyright:

    © All Rights Reserved
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    You are on page 1of 26

    LICENSING

    PREPARED BY: FREYA VIRTUE V. SALAZAR, RMT


    PRESENTED BY: JONNEL P. ANDAYA, RMT
    ACCORDING TO ASSESSMENT TOOL FOR LICENSING A
    GENERAL CLINICAL LABORATORY:

    1. MANAGEMENT RESPONSIBILTY
    2. MANPOWER
    3. PHYSICAL PLANT/ FACILITIES/WORK ENVIRONMENT
    4. EQUIPMENT/INSTRUMENTS
    5. REAGENTS/SUPPLIES
    6. POLICIES AND PROCEDURES
    a) COMMUNICATION AND RECORDS
    b) QUALITY ASSURANCE PROGRAM
    c) REFERRAL OF EXAMINATIONS OUTSIDE OF THE CLINICAL LABORATORY
    1. MANAGEMENT RESPONSIBILITY

    • Mission, vision and objectives (accordance with RA 4688)


    - posted/displayed mission, vision and objectives in a conspicuous are visible to client
    • License to operate/Accreditation Certificate and Other Documents
    - Valid licenses/Certificates (visible to client)
    - Compilation of Clinical AOS, Report of Inspection/Monitoring
    - Copy of Lab floor layout
    - Notarized MOA with Clinicians for Ins.-based laboratory (if Applicable)

    • Policy on continuing program for a staff development and training


    - Documented Policy/Program
    - Proof of training through relevant certificates, memos, written reports, budgetary allocations

    • Policy for hiring, orientation and promotion for all levels of personnel
    - documented procedure/ process on hiring, orientation and promotion of personnel at all levels
    EXAMPLES: VISION AND MISSION
    EXAMPLES: OBJECTIVES
    1. MANAGEMENT RESPONSIBILITY

    • Policy for discipline, suspension, demotion and termination of personnel at all levels
    - documented procedure, process on discipline, suspension, demotion and
    termination of personnel at all levels
    • Policy on Management
    - Conduct of Regular Staff meeting held at least twice a year or as needed.
    - Documented minutes of meeting (reflecting the DATE, TIME, ATTENDANCE,
    AGENDA and ACTION TAKEN signed by Head of Laboratory) ; LOGBOOK provided
    • Procedures for handling complaints and client feedback
    - Written protocol for handling complaints/client feed back
    -Forms for complaints/client feedback
    - Suggestion Box –visible to clients
    - Records of complaints/ client feedback and action taken
    2. MANPOWER

    • Organizational Chart
    - Updated organizational chart indicating the names with latest pictures (at
    least passport size) and designation, reflecting lines of authority, accountability,
    communication, inter-relationship, hierarchy of functions and flow of refferals
    *Clearly Structured*
    • Duties and responsibilities
    • all general laboratory personnel
    *Clearly Spelled Out*
    EXAMPLES: ORGANIZATIONAL CHARTS
    2. MANPOWER

    • Adequate number of qualified personnel with documented training and


    experiencing to conduct the Laboratory procedures performed.

    - List of Personnel with designation (other functions of special assignments)


    - Area of assignments indicated in the Posted work schedule signed and
    approved by HOL
    - Proof of Attendance
    - Proof of qualifications: UPDATED COPY OF 201 FILES :

     Resume
     PRC ID and Certificate
     PSP Board Certificate (HOL)
     Notarized
    EmploymentContract
     Training Certificated
     Annual Health Status
    (Latest Medical Certificate)
    2. MANPOWER

    • Authority to practice (if applicable)


    - Copy of certificate signed by Head of the GOVERNMENT FACILITY
    • The general laboratory shall be headed and management by a Clinical and / or Anatomic
    Pathologist Certified by the PHILIPPINE BOARD OF PATHOLOGY (PBP)
    - This shall apply to all general laboratories be they Government or private, institution
    based of free standing
    • The head shall have administrative and technical suoervison of the activities in the
    laboratory
    - Provide Logbook ( for documented proof of Supervisory visit at least ONCE A MONTH or
    as needed.)
    QUALIFICATION OF HEAD OF LABORATORY:

    1. NO Pathologist in the Area


    • Physician with complete training in Clinical Laboratory Medicine, Q. A., and Lab.
    Mgt. by BRL, CHD or PSP certified by BHFS ( Certification from PSP that there is no
    pathologist in the Area)
    * May handle only 1 clinical laboratory
    2. NO Clinical Pathologist certified by PSP
    • Anatomic Pathologist with 2 yrs. Training in Clinical Pathology
    • Anatomic Pathologist with no training in Clinical Pathology
    • Licensed phycician with residency training in Clinical Pathology for at least 2 yrs.
    QUALIFICATION OF HEAD OF LABORATORY:

    3. In laboratories offering Clinical Pathology services only


    • Clinical Pathologist
    • Both CP & AP
    • AP & Associate CP
    4. In laboratories offering both Anatomic & Clinical Pathology
    • Both AP & CP
    • CP & Associate AP
    • AP & Associate CP
    Medical Technologist staff
    (additional proof of qualifications -as applicable)
    • Valid HIV-Trained RMT for lab with HIV services
    (required full time RMT for OFW facility )
    • Certificate of training on DSSM for lab with AFB services
    • Certificate of Training on Bacteriology
    (Tertiary Category)
    3. PHYSICAL PLANT/ FACILITIES/ WORK ENVIRONMENT

    • Program of proper maintenance and monitoring of physical plant and facilities


    - Documented program for the proper maintenance and monitoring of physical plant
    and facilities
    - Proposed schedule for Preventive maintenance
    - Updated proof of actual implementation of maintenance as to structure, ventilation,
    lighting & water supply
    *PROVIDE LOGBOOK
    • Policy guidelines on laboratory biosafety and biosecurity
    - Documented procedure/ process on laboratory biosafety and biiosecurity
    - Good Laboratory Practice that includes use of PPE and other precautionary measures
    3. PHYSICAL PLANT/ FACILITIES/ WORK ENVIRONMENT

    • Procedures for the proper disposal of waste and hazardous/infectious substance that shall
    conform to the standards set by the DOH
    - Documented policy on disposal of wates that conform with Healthcare/ Waste Management
    manual
    - Prof of proper management of wates form point of generation, segregation
    (color-coded waste bins), disinfection up to the final disposal
    *NEED MOA W/ INFECTIOUS WASTE COLLECTOR
    3. PHYSICAL PLANT/ FACILITIES/ WORK ENVIRONMENT

    • Procedures for the proper disposal of waste and hazardous/infectious substance that shall
    conform to the standards set by the DOH
    - Documented policy on disposal of wates that conform with Healthcare/ Waste Management
    manual
    - Prof of proper management of wates form point of generation, segregation
    (color-coded waste bins), disinfection up to the final disposal
    *NEED MOA W/ INFECTIOUS WASTE COLLECTOR
    3. PHYSICAL PLANT/ FACILITIES/ WORK ENVIRONMENT
    • Space components of the laboratory complex are required to be
    adjacent with one another in view of functional relationship,
    human traffic and efficient conduct of operations with SIGNAGE
    PER AREA.

    • Required flooring: Use ceramic non skid tiles or approved


    equivalent

    • Required working counter with at least 0.40 meter wainscoting as


    applicable: Counter top with laminated, ceramic, granite or
    approved equivalent and provided with stainless sink with a depth
    of at least 8 inches and goose-neck faucet.

    • Required Ventilation for technical working area: artificial means


    (ie. Exhaust fan/Fume hood, air condition)

    • For tertiary level laboratories, microbiology and histopathology


    sections shall be provided separate exhaust fans each. However,
    primary and secondary level laboratories, common exhaust fan
    can be used.

    • Room with should be at least 3 meters.


    4. EQUIPMENT/INSTRUMENTS

    Adequate equipment shall be in good working order:


    • Equipment listed available in the laboratory
    • Equipment are operational
    • Provision for personal protective equipment
    • Long Sleeve (if applicable) Laboratory gown with name or ID, closed shoes for laboratory
    use only, google, gloves, mask
    Program for calibration, preventive maintenance and repair for the equipment.
    • Record of schedule and updated certificate of calibration and maintenance of equipment (ex:
    centrifuge, microscope, hema machine..) ; Record of reports of preventive maintenance and
    repair (Provide a Logbook).
    Contingency plan in case of equipment breakdown
    ex: brown out (use of UPS, Electric generator)
    5. REAGENTS AND SUPPLIES

     Adequate supply of properly stored and inventoried reagents and supplies for the laboratory
    examinations to be provided.
    • Records of supplies/ reagents with expiration date, their usage/ consumption and disposal
    are available.
    • Certificate of Product Registration (CPR) and Evaluation of National Refrence Lab.(NRL) Food
    and Drug Administration FDA (if applicable)
     Reagents and supplies are Stored under the required conditions. (Used of REFRIGERATORS)
    • Temperature monitoring records as follow:
     Room Temp. Monitoring
     Reagent storage refrigerator reading
    5. REAGENTS AND SUPPLIES

    Reagents and supplies are StoAppropiate storage area/technique for


    flammable. Combustible and hazardous chemical/reagents
    • (MSDS) Material Safety Data Sheet – available for all reagents/ supplies and
    accessible to all personnel at all times
    Organized per section with NATIONAL FIRE PROTECTION ASSOCIATION
    (NFPA) LAbel
    6. POLICIES AND PROCEDURES

     Documented policies, protocols, procedures, guidelines in the operation and


    maintenance of the laboratory including POLICY ON SECURITY OF SUPPLIES,
    SPECIMENS and CONFIDENTIALITY OF RECORDS *SIGNED AND APPROVED BY
    HOL;
     Documented policies,procedures and quality assurance program on Point of
    Care Testing (if hospital based)with list of apparatus & calibration record;
     Documented technical procedures provided in each section
    6. POLICIES AND PROCEDURES

    a. Communication and Records


     Documented procedures for receipt and performance of routine and STAT
    requests for laboratory examinations.
    Documented procedures of results of routine and STAT laboratory
    examinations.
    Laboratory report forms bearing the name of the head or associate and
    facsimile signature with PRC ID No.; bearing the name of RMT and
    original signature with PRC ID No. who performed the examinations
    a. Communication and Records

     Upgraded records of result (logbooks/ lectronically stored data with back up) including entry,
    releasing & endorsement records; Policy for Laboratory Information System (LIS) (if
    available)
     Documented procedures for reporting of work load, quality control, inventory control
     Updated reports, documents (Hard or soft copy with back up)
     Worksheets/ machine print out per section as proof of actual performance
     Documented procedures for reporting and analysis of incidents, adverse events.
     Compilation of written reports with resolutions
     Documented procedure for the retention of records which follows standards promulgated by
    the Department of Health
    b. Quality Assurance Program

     Documented Internal Quality Assurance Program including Internal Quality Control and
    Continuous Quality Improvement
     Updated QC reports conducted (QC GRAPH ;Levey Jennings Chart)
     Availability of reference materials and appropriate reagents & equipments used
    ex: HEMA cell control, CHEM control,
     Documented Procedure in the actual performance of EQAP activities administered by the NRLS
    (after 1 year of operation)
     Certificate of participation of the laboratory:
     NRL- NKTI (Hematology)
     NRL- LCP (Chemistry)
     NRL- SLH/SACCL (Immunology/Serology)
     NRL- RITM (Parasitology & Microbiology)
    c. Referral of Examinations Outside of the Clinical Laboratory

     Documented Procedures on referral and outsourcing of examinations to other licensed clinical


    laboratory
     Records of outsourced examinations (PROVIDE LOGBOOK)
     MOA, DOH license or its equivalent on referral of laboratory services to outside duly services to
    outside dulylicensed laboratory (with special / higher service capability than the referring
    laboratory)

    Note: For the presence of other laboratories in the vicinity, If any, indicate the kind of
    laboratory & provide details (ex: Research Lab, teaching Lab, Special clinical Lasboratory,
    others, specify:

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