Laboratory Services in Hospital

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    Dr. Ripal ShahMedical Director

    Indian Red Cross Society,Ahmedabad

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    Various Hospital Support

    Services Support services

    Auxiliary services

    Dietary services

    Engineering maintenance services

    Hospital security

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    HospitalA hospital is a place for the diagnosis & treatment of

    human ills & restoration of health & well beings of

    those temporarily deprived of these.

    A large no. of professionally and technically skilledpeople apply their knowledge and skill with the helpof complicated equipment and appliance to producequality care for the patient.

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    Hospital support services

    Laboratory facility

    CSSD

    Diet department

    Pharmacy

    Laundry

    Radiology

    Nursing services

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    Auxiliary services Registration & indoor case record (patient file,

    medical record, statistics)

    Stores (Pharmacy store, chemical store, linen store,surgical store, glassware store, narcotic store etc)

    Transport services (trolley, stretchers, wheel chairs

    etc.) Mortuary

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    Dietary services Important for the nutrition of the patients

    Different menu available for patients (salt free, sugarfree, fat free, gluten free, protein less, liquid diet,semi solid diet)

    Different menu for patient attendants (five start

    menu to suit the palate) Well trained dietician.

    Must be hygienic

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    Engineering and

    maintenance services Calibration of equipment

    Validation of equipment In house maintenance of equipment

    Negotiation for purchase

    General maintenance (building, plumbing, carpentry,

    mason, air conditioning)

    Vehicular maintenance

    Boiler maintenance

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    Water, Medical Gas &

    Sanitary System Hospital needs lots of water supply but should rely

    on public water supply.

    Water supply line is concealed and repairing is acomplex job; requires expertise.

    Two components

    # Water supply network system# Sewage distribution system

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    Water supply Sources of water supply

    # Bore well

    # tanker supply# Recycled water

    While supplying water:

    # Continuous reliable water supply

    #Quality of water

    # Cost & proper distribution

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    Medical gas system

    Gases administered to patients; comprises of O2,nitrous oxide, vacuum, compressed air.

    Available in OT, ICU, special room, patient room

    Clean reliable supply of gases on line

    Easy purchase of gases in bulk quantities.

    No nuisances of gas cylinders, breakage

    Sterile areas protection, point to point conectn Rationalized ordering, storing & transport

    Minimum damage to building

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    Safe handling of gases Experienced & trained person handle gases

    Observe all regulation & statutory instructions

    Do not remove, deface labels of manufacturer

    Ascertain gases before putting into services

    Know properties/ hazards associated of gases

    Establish & familiar with emergency situations Never lift a cylinder with cap or guard

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    Layout of pharmacy

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    Lay out of typical laundry

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    Layout of central sterilization &

    supply department

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    Security & loss preventionprogram (1)

    Types of frauds & thefts (embezzlement, pilferage,

    kickback & collusion, equipment thefts, personalproperty theft, payroll fraud, cash theft, fraudulentpractices in purchasing, receiving and storing, Fraudin registers records & billing, computer theft)

    Methods of internal controls

    Establish procedural security

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    Security & loss prevention

    program (2) Security task of a bomb threat

    Alarm system (fire, medical gas, blood bank,narcotic, cols room & walk-in cooler, voltagefluctuation, elevator, security, patients emergency,code blue alarm)

    Code blue= cardiac arrest; Code red= fire alarm;Code black= bomb threat; Code white= securityemergency; Code green= all clear)

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    Laboratory Services Blood bank (Transfusion Medicine)

    Pathology

    Microbiology

    Biochemistry

    Stat lab

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    Blood Bank services Regulated services Service may be of own or out sourced

    Goal: To supply safe blood and blood components toall needy patients in right time and in adequatequantity.

    Policy of government:

    # It is under Drugs & Cosmetics Act (1945)# Administrative control of NACO.

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    Organizations &

    management

    Legal identity

    Types of blood banks Responsibilities

    Ethics in blood bank

    Management system

    Policies, processes & procedures

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    Accommodation & premises

    Space allocation

    Environmental control

    Biological, chemical & radiation safety

    Internal communication system

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    Accommodation

    Registration & Medical examination

    Blood collection (A/C)

    Blood component preparation (A/C) Lab for blood group serology (A/C)

    Lab for TTI testing (A/C)

    Sterilization cum washing Refreshment cum rest room (A/C)

    Store cum records

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    Personnel

    Personal Requirement

    Qualification

    Job Description/Responsibilities Responsibilities of Medical Director/In-charge/Medical

    Officer, Technical Manager & Quality Manager

    Training

    Personal Health

    Confidentiality of Information

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    Equipment Equipment requirement

    Selection & Validation of Information

    Equipment detail record, Unique Identification

    Program for calibration & maintenance ofequipments.

    Equipment for storage of blood & component Computer system.

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    External Services & Supplies Policies & procedures for suppliers selection

    Inventory control

    Evaluation of suppliers

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    Blood Bank Operation Donor laboratory

    Phlebotomy procedure Post donation care

    Adverse donor reaction management

    Blood donation camps/drives

    Autologous transfusion procedure

    Handling of samples & blood units

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    Quarantine & storage &

    Labeling

    Refrigerators & freezers

    Quarantine

    Blood/component labelling

    Instructions for transfusion

    Special requirments

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    Testing of Donated Blood Determination of ABO group

    Determination of Rh(D) type

    Determination of unexpected antibodies

    Test for transfusion transmitted infection

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    Compatibility Testing Request for blood & its component

    Sample receiving, acceptance & preservation

    Pre-transfusion testing

    Issue of blood & its component

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    Transfusion Reaction & evaluation

    Error prevention

    Immediate complication

    Delayed complication

    Detection, reporting & evaluation of transfusionreaction

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    Quality control

    ABO & antiD reagents

    Reagent red blood cells

    Red cell panel

    Anti-human globulin reagent Bovine serum albumin

    Enzyme reagents

    Hepatitis B antigen, anti-HCV & anti-HIV 1 & 2 tests

    Tests for syphilis Normal saline & buffered solution

    Blood component

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    Bio-Medical waste disposal & laboratory

    safety in blood bank/blood centre

    Protection of blood bank personnel against

    laboratory infection

    Safety in the laboratory

    Disposal of blood & laboratory material

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    Identification of Deviations

    & Adverse Events

    Policies & procedures when non-conformity is

    detected

    Procedures for release of non-conforming bloodcomponents

    Preservating recurrence of non-conformity

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    Performance Improvement

    Addressing complaints

    Corrective action

    Root cause analysis

    Documentation of corrective action

    Preventive action

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    Document control Procedure for document control & review of

    documents

    Document required

    Maintenance of document in computer software

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    Record Record identification

    Quality & technical records

    Record training period

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    Internal Audit &

    Management Review Policy for internal audit & management review

    Procedure for internal audit

    Procedure for management review

    Documentation of internal audit & management review

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    Other Lab services

    A well equipped Lab services is essential as itsupports the function of the hospital

    It could be high income generating source for thehospital.

    An efficient Lab services reduces hosp stay

    Good Lab services attracts doctors & patients

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    Basic function of Lab services To assist doctor in arriving or confirming diagnosis in

    treatment of patients

    It generates prompt/ reliable reports & also keeparchived reports

    To provide services any part of the day

    Assist in teaching programs for doctors, nurses andlab technologists

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    Workloads

    Admitted patient undergoes average of 8-20 tests duringadmission

    Pt. admitted in medical ward in average 10 days stay,about 20 tests (2/ day) are done/ pt. (excludingradiographic & other tests)

    A 100 bedded hosp with 10 days ALS treat 37 patients(365%10)/ year. The hosp admits 37 x 100= 3700 pt./yr& generates about a max. of 37,00 x 20= 74,000 test/ yr

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    Functional divisions Hosp lab is a conglomerate of many technologies

    and methods & they are under five divisions:

    # Hematology

    # Microbiology

    # Clinical chemistry

    # Histopathology# Urine & stool analysis

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    Functional planning It is involved in floor plan, areas, spaces, equipment,

    organization & staffing

    Increasing demand, over-crowding, lack ofmanpower may lead to poor result

    Program development depends upon projected no.of tests and hosp beds

    Organization: Centralized Lab is better with batchingof samples for economy

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    Location (1)

    Preferable in the ground floor of hosp

    In smaller hosp, between out patient & wards

    In large hosp, patient entry can be prevented bysample collection window

    OPD sample collection:

    # Suitable room at OPD

    # Waiting room patients

    # Vene-pucture room

    # Specimen toilet (male/ female)

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    Area/ Space Should be planned with future workload & expansion

    Adequate working areas for all activities

    Primary space is required for these for thoseprofessional activities including waiting.

    Secondary space is utilized for all supportiveactivities e.g. admin, office, toilet, staff room

    Circulatory space is for personnel/ materialmovement, store, auxiliary areas etc.

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    Laboratory space unit (LSU)

    Basic unit planning for Hosp lab is LSU

    It is a module for space and all lab planning basedon LSU

    Primary LSU: 10x20 =a module of 200 sq mt.

    Rectangular module is better than square module

    because of it gives deep bays (more economical &circular space)

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    Internal designs & fittings

    (1)

    Height of working bench should be 75-90 cm.

    Width of bench should be 60 cm; good forequipment & comfort of technicians

    Optimum size of bench length is 2 mtr; continuouslength of 6 mtr gives flexibility.

    Lab requires sink for staining slides etc. High level natural ighting is desirable

    All benches should have good flourecent lighting andsufficient electrical points.

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    Internal designs & fittings

    (2 ) Lab surfaces should be washable, heat/ stain

    chemical/ proof & easy for decontamination

    Staff locker room & toilets

    Utility services: Water, Gas, Compressed air

    Colored piping system for easy recognition

    Partitions for easy working & dust prevention

    A/C: Formalin in Histopath. A/c is must here; ifpossible in all Lab

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    Lab staffing (1) Under direction of a qualified doctor: MD/PhD

    Authorized signatory/ full or part time

    No. of MLTs depends on:

    # No. of samples/ day

    # Range of tests to be performed (Cl Chem/ Hemat/

    Micro/ Histopath/ other specialized)#Emergency service

    # Leave reserve

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    Lab staffing (2)

    MLT responsible for most technical work undertechnical supervisor (then doctor)

    No. of personnel (30 tests/day/ tech.)

    Large hosp study with 8 technicians: 2804 tests /tech/ month (requirement14 tech)

    Very high utilization of tech shows low quality

    Non productive activities (Doc/ Admin work) Scheduling: Multi-tasking & various shifts

    Sufficient leave entitlements

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    Tests performed annually/

    MLTLaboratory units Tests

    Hematology 13,400

    urinalysis 390,120

    Serology 11,520

    Biochemistry 9,600

    Bacteriology 7,680

    Histology 3,840

    parasitology 9,600

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    Lab staffing (3)Avoid monotony ( it is long cycle, repeat task job

    leads to early fatigue, psychological stain, poor time

    keeping, low productivity & Quality)# In service CME, instrumentation, QC addscommitments to staff

    Equipment: Reduces dependence of MLT; No. ofsamples/ day; No. & range to be performed

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    EquipmentEquipment = instruments, reference materials, consumables,reagents, analytical systems.

    Equipment availability with respect to work.

    Equipment shall be shown (upon installation and in routineuse) to be capable of achieving the performancerequired.

    Program for calibration and monitoring of functioning. Theequipment shall be calibrated from NPL, India or

    calibration laboratory accredited by NABL or its MRApartner having accreditation for the specific scope.

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    General list of equipment

    Robot cell counter

    Centrifuge

    Microhenematocirtcentrifuge

    Refrigerators

    Blood bank refrigerators

    Water still

    Pressure sterilizer

    Pipette washer

    Flame photometer

    Spectrophotometer

    Hot air oven Incubator

    Calorimeter

    Analytical balance

    Blood gas analyzer

    Auto analyzer

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    Automation Ensures speed, accuracy, less manpower

    Autoanalyser can take large tests at rapid rate

    Decision to buy: Cost per test/ equip cost/ no. oftests/ reagent cost/ semi- fully automated

    Calibration & breakdown support

    Interfacing with software

    AMC/ CMC & uptake time

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    Policies & procedures (1) Lab samples: collected by ward staff or lab staff

    collects personally.

    All request must be in writing Sample receiving: (blood, faces, urine, pus, body

    fluids, swabs etc) sufficient racks, ID, instruction toPt, hand washing facility

    FANC requires separate cubicle

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    Policies & procedures (2) Request forms should have all important info

    (demographic & clinical details, last tests)

    Time of accepting samples; Priority of tests: routine& emergency samples

    Sample container: as specified

    Identification of samples: Most Important Reports double checked & signed

    Records to be kept for monthly/ yrly review

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    Record request forms,

    test results and reports,

    instrument printouts, procedures, worksheets,

    complaints and action taken,

    instrument maintenance and calibration records,

    quality control records,

    package inserts,

    supplier records,

    staff training and competency records .

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    Miscellaneous Lab safety & TTI

    Liaison with clinicians: difference between diagnosis

    & report: discussion needed Technicians motivation: discuss various issues,

    periodical meeting & try to solve problems

    Cross training

    Lab waste disposal