1. 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

2. Baystate Health System

3. 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)

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

6. 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)

7. 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

8. 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 2002;48:
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 lab’s 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 1991;324:

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

10. Medical Errors The Person The System
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 2000;320:

11. 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)

12. Improvement

13. Hemolysis in the ED
Coagulation specimens must be rejected if hemolyzed and recollected
Inpatient rates of hemolysis are typically <1%
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.

14. Phlebotomy Hemolysis Rates
Implement Practice Change

15. 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

16. 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

17. 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

18. 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

19. Medical Errors The Person The System
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 2000;320:

20. 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

21. 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.

22. 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 can’t accept leading zeros
Patient wristbands are not legible (clin engineering)
Need for patient care, share operator IDs (retraining)
Barcoding seen as optimum solution

23. 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 isn’t permanent (thermal vs inkjet)
Devices don’t 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?

24. 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

25. Scanner Angle

26. Scanner Distance

27. Scanner Depth of Field

28. Scanner Depth of Field

29. P=0.014
P=0.0007

30. P=NS, 0.378
P=0.048

31. Barcoding
Barcode acceptance and difficulties in implementation lead to <100% 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

33. 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

34. 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 <200 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%, p<0.02)
Zerr KJ et al. Ann Thorac Surg 1997;63:

35. 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 1999;34:

36. Portland Protocol Blood Glucose Insulin Unit/hr <125 125-175 1 1 2
>225 3
q1hr until glucose with <15 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 <200

37. 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

38. 1.18 0.94 1.11 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.

39. Meter Performance Criteria
ADA ‘87 All Levels ± 15%
ADA ‘ All Levels ± 5%
Agence du Médicament < 100 mg/dL ± 20 mg/dL
(95% of data)  100 mg/dL ± 20% (CV <7.5%)
CSA < 45 mg/dL ± 25% (CV<12.5%)
 90 mg/dL ± 15% (CV <7.5%)
FDA < 100 mg/dL ± 20 mg/dL
(95% of data)  100 mg/dL ± 20%
ISO < 100 mg/dL ± 20 mg/dL
IMSS < 60 mg/dL ± 25%
 60 mg/dL ± 20%
NCCLS (C30A) < 100 mg/dL < 15 mg/dL
 100 mg/dL ± 20%
TNO < 117 mg/dL ± 20 mg/dL  117 mg/dL ± 15% mg/dL (CV <10%)

40. Quality Specification Modeling
Monte Carlo simulation to generate random “true” and “measured” glucose based on mathematical model of meters having defined imprecision and bias. (N=10, ,000 pairs)
Analytical error Insulin dose errors
5% %
10% %
2x or greater insulin dosage errors >5% of time when analytic error exceeded %
Total error < % required to provide intended insulin >95% of time.
Boyd JC. Bruns DE. Quality specifications for glucose meters: Assessment by simulation modeling of errors in insulin dose. Clin Chem 2001;47:

41. Portland Protocol
Glucose meters may or may not be applicable for tight management, as can vary by +/-20% in the 100–200 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

44. 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

45. 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.

47. 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

48. 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.

49. Evidence-Based Practice for POCT Focus 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.

50. Evidence Based Practice for POCT pH 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)

51. Evidence Based Practice for POCT pH 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

52. Evidence Based Practice for POCT pH Guidelines I
Gastric contents more acidic
Neuman – pH < 4 can reduce need for x-rays (PPV 100%, Sens 100%, Spec 88% for N = 46 patients and 78 placements.) pH>4 not useful – respiratory or duodenal.
Acid suppressors increase gastric pH and 6.0 may be a better cutoff (81% pH 1 – 4, 88% intestinal >6.0, pulmonary >6.5). Confounds aspirate pH 4 – 6.
pH of gastric fluid may replace 85-95% of x-ray cases. Significant decrease radiation exposure

53. Evidence Based Practice for POCT pH 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.

54. 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?

55. 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

56. 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.
Fecal occult blood tests should not be used to measure occult blood in gastric fluid because of interferences from low pH, certain medications (antacids and vitamin C lead to false negative results) and metal ions (iron and copper salts lead to false positive results). The presence or absence of occult blood in gastric fluid is useful in emergency department or intensive care unit settings for the detection of bleeding due to trauma or a deteriorating gastric condition (stress ulcer syndrome). Gastroccult tests are employed for this purpose. The pseudoperoxidase in hemoglobin reacts with guaiac and a buffered, stabilized hydrogen peroxide solution producing a blue color in the presence of blood. Two in-vitro studies have illustrated that gastroccult is a simple, rapid and convenient method for the evaluation of patients with suspected occult blood in gastric fluid. Gastroccult, unlike hemoccult, is not influenced by pH or sucralfate.(58, 59)  

57. 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.
Derrida et al(60) used gastroccult every four hours to identify blood in gastric juice of 41 ICU patients at risk for gastrointestinal bleeding (patients with overt gastrointestinal bleeding were excluded) and receiving antacid prophylaxis. 27% (14/41) had at least one positive gastroccult reading and received an upper endoscopy. No endoscopy was performed in patients with negative gastroccult findings. In 13/14 patients a source of gastric bleeding was detected. This study suggests that gastroccult testing may aid in detecting occult bleeding in critically ill patients. However, this small study did not perform upper endoscopy on negative patients, which may have documented false negative results obtained with the gastroccult test.  
Conclusions - Currently data is insufficient to recommend the use of gastroccult for ICU patients to detect upper gastrointestinal bleeding. Although this practice is widespread, more studies will be necessary to document the utility of gastroccult testing for this application.  

58. 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

59. 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 doesn’t require test to detect
pH is medically useful, pH paper is a better alternative because it’s 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.

60. 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
Cost estimate for pH replacement $

62. 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