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Quality in The Clinical Microbiology Laboratory


The expiration date (Usually 1 month for agar plate and 6 month for tube media) ... maintained by freezing them in 10% skim milk ,Trypticase Soy Broth (TSB) with 15 ... – PowerPoint PPT presentation

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Title: Quality in The Clinical Microbiology Laboratory

Quality in The Clinical Microbiology Laboratory
  • Dr.F.Rashedmarandi
  • Reference laboratories of Iran Research center

Total laboratory Quality Program
  • Total quality management( TQM)
  • Continuous quality Improvement (CQI) or
  • Performance improvement (PI)
  • Quality Control (QC)
  • Quality Assurance (QA)

  • TQM evolved as an activity to improve patients
    care by having the laboratory monitor

CQI and PI
  • CQI and PI went a step further by seeking to
    improve patients care by placing the emphasis on
    not making mistake on first place CQI and PI
    advocate continuous training to guard against
    having to correct deficiencies

  • QC is now associated with the internal activities
    that insure diagnostic accuracy. QA is associated
    with those external activities that ensure
    positive patient outcome.

Positive Patient outcome in the Microbiology
  • Reduced length of stay
  • Reduced cost of stay
  • Reduced turn-around time for diagnosis of
  • Change to appropriate antimicrobial therapy
  • Customer ( physician or patients )satisfaction

QC program
  • The laboratory director is primarily responsible
    for QC and QA programs. However all laboratory
    personnel must actively participate in both

The basic elements of QC
  • Specimens collection and transport.
  • Standard operating procedures (SOPM).
  • Personnel
  • Proficiency testing
  • Performance checks
  • Antimicrobial Susceptibility tests
  • Eminence of QC procedures
  • Maintence of QC stocks
  • Patients reports

  • The laboratory is responsible for providing
    instructions for the proper collection and
    transport of specimens .These instructions should
    be available to the clinical staff for use when
    specimens collected

Written collection instruction
  • Test selection criteria
  • Patients selection criteria
  • Timing of specimen collection (e.g.,
  • Before antimicrobial are administration)
  • Optimal specimen collection site
  • Approved specimen collection method
  • Specimen transport medium

  • Specimen transport time and temperature
  • Specimen holding instructions if it cannot be
    transported immediately (e.g. hold at 4C for 24
  • Availability of test (on site or sent to
    reference laboratory )
  • Hours test performed (daily or batch)
  • Turn-around time
  • Result reporting procedures

Information should be filled
  • Patient name
  • Hospital or laboratory number
  • Ordering physician
  • Whether the patient receiving antimicrobial
  • Suspect agent or syndrome

Criteria for unacceptable specimens
  • Unlabeled or mislabeled specimens
  • Use of improper transport medium
  • Excessive transport time
  • Improper temperature during transport or storage
  • Improper collection site for test request
  • Specimen leakage out of transport container
  • Sera that are excessively hemolyzed ,lipemic, or
    contaminated with bacteria

Standard operating procedure Manuel (SOPM)
  • The SOPM is considered part of QC program. The
    SOPM should define test performance , tolerance
    limits, reagent preparation, required quality
    control ,result reporting and references.The
    SOPM should be written in NCCLS format and must
    be reviewed and signed annually by the
    microbiology director.

Sections of SOP
  • Title (name of procedure)
  • Priniciple (reason for performing the test)
  • Preferred specimen patient preparation
  • Transport container (need for anticoagulant,
    preservative, or holding medium)
  • Transportation conditions (wet ice, room
  • Specimen storage in Laboratory (room temperature,
    4C, -20C,- 10C)
  • Criteria for unacceptable specimen (delay in
    transport, leaking container, presence of barium)
  • Special safety precautions (tape plates for AFB
    or brucellae)
  • Reagents or media required and incubation
  • Examination of cultures
  • Guidelines for identification and susceptibility
    testing by culture type (respiratory, urine,
    blood, stool)
  • Required quality control
  • methods for reporting positive, negative, and
    unsatisfactory results
  • Technical notes, including possible sources of
    error and helpful hints
  • References

  • The SPOM should be available in the work area
    .It is the definitive laboratory reference and is
    used often for questions relating to individual
    test .Any obsolete procedures should be dated
    when removed from SPOM and retained for at least
    2 years.

  • It is laboratory director's responsibility to
    employ sufficient qualified personnel for the
    volume and complexity of the work performed.
  • Document competency and training twice a year
  • Continuing education program should be provided
  • All documentation should maintained in personnel

Proficiency Testing
  • Laboratories are required to participate in an
    external proficiency testing (PT)
  • The laboratory must maintain an average score of
    80to maintain licensure in any subspecialty
  • The laboratory's procedures, reagents, equipments
    and personnel are all checked in the process.

(No Transcript)
PT or External quality control
  • Provide laboratory management with an insight
    into their performance
  • Improve both local and national standards
  • Reveals unsuspected area of difficulty
  • Provides an educational stimulate for
  • Acts as a check on the efficacy of internal
    quality control procedures
  • Demonstrates to colleagues and customers a
    commitment to quality

Performance Checks
  • Instrument
  • Equipment logs should contain the following
  • Instrument name, serial number, and date put use
  • Procedure and periodicity( daily, weekly,
    monthly) for routine function check)

  • Acceptable performance ranges
  • Instrument function failure ,including specific
    details of steps taken to correct the problems
    (corrective action)
  • Date and time of services requests and response
  • Date of routine preventive maintence (PM) which
    should follow manufactures recommondations

  • Maintenance records should be retained in the
    laboratory for the life of instrument. Specific
    guidelines regarding periodicity of testing for
    autoclaves, biological softy cabinets
    ,centrifuges ,incubators, microscope,
    refrigerators ,freezers, water bathes , heat
    blocks and other microbiology laboratory can be
    found in reference books

Commercially Prepared Culture Media
  • The NCCLS subcommittee on media quality control
    collected data over several years regarding the
    incidence of QC failure of commonly used
    microbiology media Based on its finding the
    subcomm ittee published a list of media that did
    not require retesting in the user's laboratory if
    purchased from a manufactures who follow NCCLS

  • The laboratory must inspect each shipment for
  • Cracked media
  • Excessive bubbles
  • Clarity
  • Hemolysis
  • Freezing
  • Unequal filling
  • Visible contamination

User-Prepared and Nonexempt ,commercially
prepared Media
  • QC forms for user-prepared media should contain
  • The amount of prepared
  • The source of each ingredient
  • The lot number
  • Sterliza5tion methods

  • The preparation date
  • The expiration date (Usually 1 month for agar
    plate and 6 month for tube media)
  • The name of prepare
  • All user prepared colures media also should
    checked for

  • Proper color
  • Depth
  • Smoothness
  • Hemolysis
  • Excessive bubbles
  • Contamination

Sterility Check
  • A representative sample of the lot should be test
    for sterility5of any lot is tested when a batch
    of 100 or fewer unit is received and maximum of
    10 units are tested in large batches.Sterility
    is routinely checked by incubating the medium for
    48 hours at the temperature at which it will be

Performance testing
  • When medium dose need to quality controlled
    because it was prepared in house (in the
    laboratory) or because it is complex, several
    basic rules must be followed
  • All media must be tested before use
  • Each medium must be tested with organisms
    expected to give positive reaction as well as
    withy organism expected either not to grow or
    produce a negative reaction

  • The medium should be tested for sterility and PH
  • The organisms selected for QC should represent
    the most fastidious organisms for which the
    medium was designed
  • Testing technique should be different for
    primary plating media that for biochemical or
    subculture media. Primary plating media should
    be tested with dilute suspensions of organisms,
    whereas biochemical media can be tested with
    undiluted organisms
  • QC testing should be performed according to NCCLS
  • Expiration date must be established

Media failure log
  • Date 2/14/98
  • Media TMS slants
  • Lot In house preparation 2/13/98
  • Expiration date 6 month from preparation
  • Quantity 2 racks
  • Failure failure to give proper
  • reaction with
  • ,s.aureus and other
    coag-neg S
  • Action taken Qc repeated with S.epidermidis
  • Memo sent to all techs
    and all tubes discarded
  • .New TMS prepared
  • Technologist MAR

Use of Stock Cultures
  • To operate a quality control program, stock
    culture must be maintained by all laboratories
    .They are available from many sources.
  • Commercial sources
  • Proficiency testing
  • Patients isolates
  • American Type Culture Collection (ATCC)

  • When quality control testing appears have failed,
    it is usually the stock culture rather than the
    test itself that has failed. Organisms may mutate
    with repeated sub culturing. for best results ,a
    stock culture should be grown in a large volume
    of broth ,then divided among enough small freezer
    vials to last a year

  • With this technique a new vial can be removed
    from the freezer weekly so that organism do not
    have to be continually subcultured .An organism
    may need to be subcultured twice after thawing to
    return it to a healthy state. Media selection for
    freezing is at the discretion of individual
    laboratories but should not contain sugar. If
    organism utilize sugar while being maintained
    ,the acid products that result may kill organism
    with time.

Popular Media for Stock Cultures
  • Schaeler broth with glycerol
  • Chopped meat (anaerobes)
  • Tryptic Soy agar deeps (at room temperature)
  • Cystein-tryptic agar (CTA) without carbohydrates

  • Nonfastidious (rapidly growing), aerobic
    bacterial organisms can be saved up to 1 years on
    TSA slants .Long term storage of aerobes or
    anaerobes can be accomplished either by
    lyophilizartion (freeze drying) or freezing ,at
    -70C.Frozen ,no fastidious organism should be
    thawed ,reisolated and refrozen every 5 years
    fastidious organisms should be thawed reisolated
    ,and refrozen every 3 years. Stock isolated may
    be maintained by freezing them in 10 skim milk
    ,Trypticase Soy Broth (TSB) with 15 glycerol .

Stain and Reagents
  • Containers of stains and reagents should be
    labeled as to contents, concentration ,storage
    requirements, date prepared (or received) date
    placed in service ,expiration date, source
    (commercial manufacture or user prepared) and lot
    number .All stains and reagents should be stored
    according manufacture's recommendations and
    tested with positive and negative controls before

  • All stain Hippurate Instrument
  • Bacitracin Nitrate inoculum
  • B-lactamase Optochin Temperature
  • CAMP PYR Moisture
  • Catalase Typing se Difficulty
  • Coagulase VP
  • FeCl3 X and V strips endpoint
  • Gelatin Cation content
  • Germ tube Thymidin

  • The lot number, date received, condition received
    ,and expiration date must be recorded for all
    shipments of antisera.In addition ,the antisera
    should be dated when opened .New lots must be
    tested concurrently with previous lots, and
    testing must include positive and negative

Maintence of QC records
  • All QC results should be recorded on an
    appropriate QC form. Corrective action should be
    noted on this form .If temperature is adjusted or
    a biochemical test repeated, the new reading
    within the tolerance limits should be listed. In
    many laboratories the supervisor reviews and
    initials all forms weekly and the director then
    reviews each one monthly. QC records should be
    maintained for at least 2 years except those on
    equipment ,which must be saved for the life of

Patient Report
  • The laboratory should established a system for
    supervisory of all laboratory reports. This
    review should involve checking the specimens
    workup to verify that the correct conclusion were
    drawn and no clerical errors were made in
    reporting results. Reports should be given only
    given only authorized by law to receive them.

  • Clinician should be notified about panic
    values immediately. Panic values are
    potential-threatening results, for example
    positive Gram stain for CSF or a positive blood
    culture. All patients records should be
    maintained for least 2 years.
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