Quality in The Clinical Microbiology Laboratory

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Quality in The Clinical Microbiology Laboratory

• Dr.F.Rashedmarandi
• Reference laboratories of Iran Research center

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Total laboratory Quality Program

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

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TQM

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

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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

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QC

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

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Positive Patient outcome in the Microbiology
laboratory

• Reduced length of stay
• Reduced cost of stay
• Reduced turn-around time for diagnosis of
  infection
• Change to appropriate antimicrobial therapy
• Customer ( physician or patients )satisfaction

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QC program

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

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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

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SPECIMEN COLLECTION AND TRANSPORT

• 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

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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

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

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Information should be filled

• Patient name
• Hospital or laboratory number
• Ordering physician
• Whether the patient receiving antimicrobial
  therapy
• Suspect agent or syndrome

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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

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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.

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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
  temperature).
• 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
  conditions
• 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

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• 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.

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Personnel

• 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
  file

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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
  area.
• The laboratory's procedures, reagents, equipments
  and personnel are all checked in the process.

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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
  improvements
• Acts as a check on the efficacy of internal
  quality control procedures
• Demonstrates to colleagues and customers a
  commitment to quality

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Performance Checks

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

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• 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

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• 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

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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
  guidelines

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

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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

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• 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

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

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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
  used.

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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

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• 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
  recommendation
• Expiration date must be established

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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.epidermidis
• ,s.aureus and other
  coag-neg S
• Action taken Qc repeated with S.epidermidis
  failed
• Memo sent to all techs
  and all tubes discarded
• .New TMS prepared
• Technologist MAR

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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)

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• 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

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• 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.

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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

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• 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 .

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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
  use.

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

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Antisera

• 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
  controls.

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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
  instrument

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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.

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• 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.