Using Data to Reduce Error, Standardize Practice and Improve Patient Outcomes

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Using Data to Reduce Error, Standardize Practice
and Improve Patient Outcomes

• James H. Nichols, Ph.D., DABCC, FACB
• Associate Professor of Pathology
• Tufts University School of Medicine
• Director, Clinical Chemistry
• Baystate Health System
• Springfield, Massachusetts
• james.nichols_at_bhs.org

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Baystate Health System
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Baystate Health System

• Baystate Medical Center - tertiary care
• ?572 beds, 3rd largest acute care in NE
• 40,000 discharges/200,000 inpatient days (4.7
  mean LOS)
• 600,000 ambulatory visits
• Western Campus of Tufts School of Medicine
• Franklin and Mary Lane Hospitals
• Over 40 Ambulatory Care Practices (1 million
  visits)
• Home nursing and assisted care (156,000 visits)
• Reference Lab (BRL) - 4 million tests/year
• Clin Chemistry - Core 1 Roche TLA (2500/day)

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Medical Errors

• Institute of Medicine of the National Academies
  report 1999
• Medical errors kill 44,000 - 98,000 patients in
  US hospitals each year.
• Number one problem facing health care Lucien
  Leape, Harvard Professor of Public Health

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Medical Errors

• 2002 Commonwealth Fund report estimated that 22.8
  million people have experienced a medical error,
  personally or through at least one family member
• Reinforces the 1999 IOM report, To Err is Human
• Annual costs estimated at 17 29 billion
• US Agency for Healthcare Research and Quality
  (AHRQ) estimate medical errors are the 8th
  leading cause of death in the US higher than
• Motor Vehicle Accidents (43,458)
• Cancer (42,297)
• AIDS (16,516)

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Laboratory Errors

• Typically think patient, tube or aliquot mix-up.
• Other, more insidious errors to consider
• Overutilization of testing fishing
• Inappropriate use of testing method selection
  or test for symptoms, screening vs management
• Misunderstanding wrong test, assume test is a
  test
• Delays ordering, receipt of result, clinical
  action

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Laboratory Errors

• A minireview of the literature found the majority
  of errors occur in the pre and post analytical
  phases.
• Bonini P, Plebani M, Ceriotti F, Rubboli F. Clin
  Chem 200248691-698.
• Many mistakes are referred to as lab error, but
  actually due to poor communication, actions by
  others involved in the testing process, or poorly
  designed processes outside the labs control.
• Medical errors occur in prevention, diagnosis and
  drug treatment occur. Among errors in diagnosis
  50 were failure to use indicated tests, 32 were
  failure to act on results of tests, and 55
  involved avoidable delay in diagnosis. Leape LL,
  Brennan TA, Laird N, et al. N Eng J Med
  1991324377-84.

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Man
A creature made near the end of the week when God
was tired.
Mark Twain
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Medical Errors

• The Person
• Easier to blame a person than an institution for
  errors.
• In aviation, 90 of quality lapses are judged to
  be blameless.
• The System
• Active failures due to personal interaction with
  system
• Latent conditions, weaknesses in system due to
  design flaws or heirarchical decisions
• Need to engineer systems that prevent dangerous
  errors and are able to tolerate errors and
  contain their effects
• Reason J. BMJ 2000320768-770.

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Automation

• Collects raw data and processes to information
  (trends)
• Reduces practice variability (device prompts)
• Consolidates operator interactions (barcoding)
• Assists decision-making (internal checks for QC
  pass, expiration dates, operator ID)
• When linked to information management and data
  algorithms can warn of possible errors (delta
  checks, device flags like inadequate sample,
  analyzer interferences)

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Improvement
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Hemolysis in the ED

• Coagulation specimens must be rejected if
  hemolyzed and recollected
• Inpatient rates of hemolysis are typically lt1
• ED had rates approaching 20 or more
• Related to implementation of a flexible catheter
  and practice of collecting blood through lines
• Manufacturer even distributed a customer warning
  against collecting blood through this catheter
• Yet, ED unwilling to change practice customer
  satisfaction issue and comfort level of IV lines
• Number of redraws and delays of ED patients led
  to elimination of practice.

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Phlebotomy Hemolysis Rates
Implement Practice Change
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Middleware

• Data server sits between an analyzer and LIS/HIS
• POCT servers are a form of Middleware
• Allows data processing before sending results
  LIS, also functions as data repository for report
  searches
• Common current uses autoverification, insertion
  of data flags for H/I/L indices
• More sophisticated functions are limited only by
  imagination of the lab

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Clinical Alarms

• Critical pathway ordering practices and variant
  ordering practices
• Hct level and POCT glucose testing
• Medication (propofol) and potential test
  interference (i-Stat)
• Insulin dose, individual response and prediction
  of future dose
• Disease/medication (high blood pressure/loop
  diuretics) vs predicted lab result (low K) vs
  questionable lab results (high K)
• Medical devices (flexible catheters) and
  potential for hemolysis and laboratory
  interference

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POCT Error Management

• POCT diagnostic testing conducted close to the
  site where clinical care is delivered
• POCT error rates are not known in literature
• POCT conducted by nursing but managed by lab
• Requires considerable interdisciplinary
  communication to deliver effectively
• POCT QI can be a tool to uncovering ongoing
  errors and addressing system weaknesses

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Reducing Errors through Automation

• Newer POCT devices have data management
• Prompts operator to perform testing same way
  every time
• Lock-outs act as internal fail-safes to prevent
  a patient result if QC fails, not performed or
  operator is not certified for testing.
• Feb 2004 CLIAC meeting discussion of possible
  changes to CLIA waived category suggested that
  waived tests have
• fail-safe or failure alert mechanisms whenever
  possible
• include QC materials with kits
• specimens requiring significant manipulation not
  be waived

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Medical Errors

• The Person
• Easier to blame a person than an institution for
  errors.
• In aviation, 90 of quality lapses are judged to
  be blameless.
• The System
• Active failures due to personal interaction with
  system
• Latent conditions, weaknesses in system due to
  design flaws or heirarchical decisions
• Need to engineer systems that prevent dangerous
  errors and are able to tolerate errors and
  contain their effects
• Reason J. BMJ 2000320768-770.

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Patient Identification Errors

• POCT results are transmitted to the POCT manager
  when devices are downloaded
• The data manager orders and results the test in
  the LIS
• If the test does not match an active patient
  account the data manager holds the result for
  resolution
• Compliance problems as test cannot be billed, and
  some results transmitted to incorrect patient
  record and inappropriate medical management

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Failure Mode and Error Analysis

• FMEA identifies an error
• Outlines possible steps that could lead to the
  error.
• Identifies the reasoning behind the various
  pathways, why they exist and ways that paths can
  be improved.
• Establishes quantitative monitors and the means
  of measuring improvement.
• FMEA improves motivation by seeking route causes
  of errors rather than placing blame.

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ICU FMEA

• Incidence of patient ID errors in our ICU led to
  an administrative demand for improved compliance
  or loss of privileges (3 strike rule)
• Conducted FMEA analysis
• ID errors due to multiple issues
• Long number entry (9 digits), transposition of
  numbers
• Some devices cant accept leading zeros
• Patient wristbands are not legible (clin
  engineering)
• Need for patient care, share operator IDs
  (retraining)
• Barcoding seen as optimum solution

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Barcoding

• In practice, one of the more challenging projects
  to implement in an institution
• Devices only read specific barcode languages
• Wristbands vary in durability
• Ink isnt permanent (thermal vs inkjet)
• Devices dont require barcode entry!
• Try to engineer around manual entry by adding
  special characters or digits to ID
• These work-arounds lengthen the barcode and
  increase read failure if barcode not flat on
  wrist.
• How to print? Wristbands only or labels that an
  operator can stick onto device or paper towel?
  What about neonates?

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Barcoding

• During implementation, operators continued to
  manually enter patient IDs due to the scanner
  failing on the 1st attempt
• An investigation was conducted into why scanners
  fail
• i-Stat scanners failed more frequently than
  glucose
• Operator interaction with the POCT device was the
  primary determinant in scanner failure

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Scanner Angle
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Scanner Distance
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Scanner Depth of Field
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Scanner Depth of Field
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P0.014
P0.0007
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P0.048
PNS, 0.378
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Barcoding

• Barcode acceptance and difficulties in
  implementation lead to lt100 effectiveness
• Manual entry
• Barcoding patient with the wrong account or
  patient ID
• Patients with multiple wristbands
• Scanning the wrong barcode (lot number instead of
  patient)
• From the AACC listserv, those successful
  institutions communicate the value of barcoding
  and have operators who have acknowledged the
  advantages and implement strategies to enhance
  success

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Communication

• How best to reach clinicians?
• Errors are a system weakness and require an
  interdisciplinary system fix, one person is not
  responsible.
• Utilize available resources
• Hospital Quality Improvement Teams
• Peer-Reviewed Literature
• Practice Guidelines
• Learn to speak clinicalese Use Clinical
  Protocols

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Portland Protocol

• Examined glucose levels and surgical
  complications in 1,585 cardiac surgery patients
  with diabetes (990 preprotocol and 595
  postprotocol)
• Implemented protocol of postoperative intravenous
  insulin to maintain glucose lt200 mg/dL.
• Intensive monitoring and insulin therapy on
  hospitalized inpatients lowers blood glucose
  levels in the first 2 postoperative days with
  concomitant decrease in proportion of patients
  with deep wound infections (2.4 vs 1.5, plt0.02)
• Zerr KJ et al. Ann Thorac Surg 199763356-61.

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Portland Protocol

• ACC/AHA Guidelines for CABG Surgery
• Another patient characteristic that has been
  associated with postoperative mediastinitis is
  the presence of diabetes, especially in patients
  requiring insulin. In addition to the
  microvascular changes seen in diabetic patients,
  elevated blood glucose levels may impair wound
  healing. The use of a strict protocol aimed at
  maintaining blood glucose levels ?200 mg/dL by
  the continuous, intravenous infusion of insulin
  has been shown to significantly reduce the
  incidence of deep sternal wound infection in
  diabetic patients.
• Eagle KA, Guyton RA. JACC 1999341262-1347.

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Portland Protocol
Blood Glucose Insulin Unit/hr
lt125 0
125-175 1
175-225 2
gt225 3

• q1hr until glucose 125-175 with lt15 mg/dL change
  and insulin rate unchanged x4 hrs. Then q2hr.
• Weaning vasopressors (Adrenalin) check q30min
  until stable
• Stop q2hr testing on POD 3
• Test q2hr during the night on telemetry if
  glucose lt200

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Portland Protocol Operational Issues

• Which method to utilize? TAT, Accuracy
• Glucose meter glucose oxidase
• Blood Gas glucose glucose oxidase
• Core laboratory glucose - hexokinase
• Preferred sample? Method, Line Contamination
• Whole blood or plasma
• Fingerstick, line draw or venipuncture

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Unmodified direct-reading biosensor
result relative molality of glucose in plasma
or whole blood (not recommended)
1.18
0.94
Concentration of glucose in plasma (recommended)
Concentration of glucose in whole blood (not
recommended)
1.11
Fig. 1. Conversion factors for different
quantities of glucose.
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Meter Performance Criteria

• ADA 87 All Levels 15
• ADA 94 All Levels 5
• Agence du Médicament lt 100 mg/dL 20 mg/dL
• (95 of data) ? 100 mg/dL 20 (CV lt7.5)
• CSA lt 45 mg/dL 25 (CVlt12.5)
• ? 90 mg/dL 15 (CV lt7.5)
• FDA lt 100 mg/dL 20 mg/dL
• (95 of data) ? 100 mg/dL 20
• ISO lt 100 mg/dL 20 mg/dL
• (95 of data) ? 100 mg/dL 20
• IMSS lt 60 mg/dL 25
• ? 60 mg/dL 20
• NCCLS (C30A) lt 100 mg/dL lt 15 mg/dL
• ? 100 mg/dL 20
• TNO lt 117 mg/dL 20 mg/dL ? 117 mg/dL
  15 mg/dL (CV lt10)

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Quality Specification Modeling

• Monte Carlo simulation to generate random true
  and measured glucose based on mathematical
  model of meters having defined imprecision and
  bias. (N10,000 - 20,000 pairs)
• Analytical error Insulin dose errors
• 5 8 - 23
• 10 16 - 45
• 2x or greater insulin dosage errors gt5 of time
  when analytic error exceeded 10 - 15
• Total error lt 1 - 2 required to provide
  intended insulin gt95 of time.
• Boyd JC. Bruns DE. Quality specifications for
  glucose meters Assessment by simulation modeling
  of errors in insulin dose. Clin Chem
  200147209-214

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Portland Protocol

• Glucose meters may or may not be applicable for
  tight management, as can vary by /-20 in the
  100200 mg/dL range.
• Blood gas and some analyzers perform better than
  glucose meters, may be more appropriate in these
  cases.
• Should be a clinical not a laboratory decision,
  role of laboratory to inform not dictate method

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Clinical Protocols

• Clinical protocols provide a pathway of care to
  manage patients with specific disorders in the
  most effective manner for optimum patient
  outcome.
• Incorporating laboratory testing into clinical
  protocols standardizes practice, reduces practice
  variability, ensures appropriate ordering of
  tests and can assist the interpretation of test
  results.
• Clinical protocols are a good means of
  communicating with clinicians and providing
  reminders or important components of
  decision-making

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2004 National Patient Safety Goals - JCAHO

• Improve the accuracy of patient identification
• Improve the effectiveness of communication among
  caregivers
• Improve the safety of using high-alert
  medications
• Eliminate wrong-site, wrong patient,
  wrong-procedure surgery
• Improve the safety of using infusion pumps.
• Improve the effectiveness of clinical alarm
  systems.
• Reduce the risk of healthcare-acquired infections.

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NACB Laboratory Medicine Practice Guidelines
Evidence Based Practice for POCT

• Clinicians, staff and laboratorians need guidance
  to apply POCT in the most effective manner for
  patient benefit.
• This guidance should be based on a concurrence of
  the scientific evidence to date.
• This need for evidence-based practice was the
  concept behind the NACB Laboratory Medicine
  Practice Guidelines for POCT

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Evidence-Based Practice for POCT

• POCT is an increasingly popular means of
  delivering laboratory testing.
• When used appropriately, POCT can improve patient
  outcome by providing a faster result and
  therapeutic intervention.
• However, when over-utilized or incorrectly
  performed, POCT presents a patient risk and
  potential for increased cost of healthcare.
• This LMPG will systematically review the existing
  evidence relating POCT to patient outcome, grade
  the literature, and make recommendations
  regarding the optimal utilization of POCT devices
  in patient care.
• Develop liaisons with appropriate professional,
  clinical organizations ACB, ADA, ACOG, CAP, etc.

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Evidence-Based Practice for POCTFocus Group
Chairs

• Cardiac Robert H. Christenson, Ph.D.
• Diabetes Christopher Price, Ph.D.
• Reproduction Ann M. Gronowski, Ph.D.
• Infectious Disease Robert Sautter, Ph.D.
• Coagulation Marcia Zucker, Ph.D.
• Parathyroid Lori J. Sokoll, Ph.D.
• Drugs Ian Watson, Ph.D.
• Bilirubin Screening Steven Kazmierczak , Ph.D.
• Critical Care Greg Shipp, Ph.D.
• Renal William A. Clarke, Ph.D.
• Occult Blood Kent Lewandrowski, M.D.
• pH James Nichols, Ph.D.
• Introductory Comments Ellis Jacobs, Ph.D.

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Evidence Based Practice for POCTpH Guidelines I

• Does the use of pH paper for assisting the
  placement of nasogastric tubes, compared to
  clinical judgment (air, pressure) improve the
  placement of tubes on inpatient, endoscopy, home
  care and nursing home patients?
• We recommend the use of pH testing to assist in
  the placement of nasogastric tubes. The choice of
  measuring pH with an intragastric electrode or
  testing tube aspirates with a pH meter or pH
  paper will depend on consideration of the
  clinical limitations of each method, and there is
  conflicting evidence over which method is better.
  (Class II prospective comparative trials and
  expert opinion)

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Evidence Based Practice for POCTpH Guidelines I

• Assuring correct NG or NI tube placement
• Measure length of tube
• Direct visualization of oropharynx
• Auscultation of stomach by air insufflation
• Aspiration of gastric contents
• Irrigation of tube with 10 to 50 mL water
• Direct palpation of tube within stomach during
  intra-abdominal procedures
• Gold Standard - Abdominal roentgenogram to
  confirm position
• pH may be faster, safer and more economical

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Evidence Based Practice for POCTpH Guidelines I

• Gastric contents more acidic
• Neuman pH lt 4 can reduce need for x-rays (PPV
  100, Sens 100, Spec 88 for N 46 patients and
  78 placements.) pHgt4 not useful respiratory or
  duodenal.
• Acid suppressors increase gastric pH and 6.0 may
  be a better cutoff (81 pH 1 4, 88 intestinal
  gt6.0, pulmonary gt6.5). Confounds aspirate pH 4
  6.
• pH of gastric fluid may replace 85-95 of x-ray
  cases. Significant decrease radiation exposure

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Evidence Based Practice for POCTpH Guidelines I

• Method to determine pH controversial
• Continuous monitor or pH tipped NG tube preferred
  for those patients that are equipped, but
  expensive.
• Question whether pH probes are measuring gastric
  contents or cell surface pH
• Aspirate pH may not generate sufficient volume,
  may differ from intragastric pH, as antacid, drug
  salts, protein and bile may interfere with some
  methods.
• pH meter more accurate than pH paper, but paper
  simpler (0.5 1.0 increments), cheaper, easier
  to use and quality assure, and can be performed
  bedside.
• X-ray confirmation still the gold standard and
  recommended in indeterminate cases.

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Question Five Can gastroccult testing of gastric
fluid from a nasogastric tube be used to detect
gastrointestinal bleeding in high-risk intensive
care unit patients receiving antacid prophylaxis?
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Recommendation Five

• We cannot currently recommend for or against the
  use of gastroccult to detect gastric bleeding in
  intensive care unit patients receiving antacid
  prophylaxis.
• Grade of Evidence III small study, clinical
  evidence

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Gastroccult Tests

• FOBT should not be used to measure occult blood
  in gastric fluid because of interferences from
  low pH, certain medications and metal ions.
• The presence of occult blood in gastric fluid can
  be useful to detect stress ulcer syndrome, so
  specific gastroccult tests are utilized.

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Bleeding in ICU Patients

• A small study with 41 patients showed that 13/14
  patients with positive gastroccult tests had a
  source of upper GI bleeding as seen by upper
  endoscopy.
• Study suggest gastroccult testing may aid in
  detecting occult bleeding in critically ill
  patients.
• However, patients with negative gastroccult tests
  did not undergo upper endoscopy which may have
  documented false negative results.

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Baystate Gastroccult Testing

• Discontinued without incident
• Approached Chief of GI and Division of Healthcare
  Quality with clinical utility.
• Researched literature
• Developed recommendation and justification
• Draft letter to medical staff reviewed by select
  clinicians
• General announcement and test removal

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Gastroccult Discontinuation

• No peer-reviewed literature indicating improved
  outcomes based on Gastroccult
• Use of test after NG tube placement leads to
  positive results solely due to trauma of tube
  insertion
• Overt bleeding is a medical concern and doesnt
  require test to detect
• pH is medically useful, pH paper is a better
  alternative because its easier to QC, already
  available on units and lower cost
• Elimination would reduce hospital burden of
  training and POCT documentation on nursing staff
  and reduce risk of developer mixup with hemoccult.

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Gastroccult Cost Savings

• Reagent (12,000 tests/year)
• Cards 21,000
• Developer 5,000
• Labor
• Nursing (5 min/test, 45K 125d) 22,000
• Competency (1100 x 15 min) 6,000
• Lab oversight (4hr x 8 units x 12 mo) 8,500
• Total Annual Savings Estimate 62,500
• Total billed previous year 12
• Cost estimate for pH replacement 250

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Summary

• Medical errors are a significant problem and the
  laboratory should be aware of the many
  opportunities to reduce errors
• Interdisciplinary teams and positive attitudes
  are important factors in achieving successful
  outcomes and changes to practice
• Need to engineer systems (not people) that
  prevent dangerous errors and are able to tolerate
  errors and contain their effects
• Automation, information management and
  communication are effective strategies to reduce
  errors.
• The next challenge for laboratorians is to better
  integrate the data we have at hand and condense
  the literature into standard practice pathways
  that assist clinicians in appropriate
  decision-making for optimal patient care