technical report

MOH/S/IPSK/47.10(RR)

IMPROVING NOTIFICATION OF CRITICAL RESULTS IN MOH HOSPITALS

A Project under the 9th MP for Improving Patient Safety

Lily M, Sararaks S, Norita TTY, Noor Aishah MD, Shalini S, Low LL, Keah KC, Habibah B, Roslinah A, Ainul Nadziha MH, Manual A, Suria J, Mohd. Sadek Y, Irdayu H, Maimunah AH

Improving Notification of Critical Results in MOH Hospitals

IMPROVING NOTIFICATION OF CRITICAL RESULTS IN MOH HOSPITALS CONTRIBUTORS/AUTHORS Lily Manorammah* Sondi Sararaks+ Tengku Norita Tengku Yazid# Noor Aishah Mohd Dawi* + Shalini Selvarajah Low Lee Lan+ Keah Kwee Chu Ж Habibah Bee* Roslinah Ali+ Ainul Nadziha Mohd Hanafiah+ + Adilius Manual Suria Junus+ Mohd. Sadek Yasin^ Irdayu Hairani+ Maimunah A.Hamid@

INTERNAL REVIEWER

Azman Abu Bakar+ Kalsom Maskon^^

* Kuala Lumpur Hospital # Selayang Hospital + Institute for Health Systems Research Ж Penang Hospital ^ Tengku Fauziah Hospital, Kangar @ Office of the Deputy Director-General of Health Malaysia ^^Medical Development Division, Ministry of Health

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DEDICATION Thirty years ago, George Lundberg, MD. defined a critical value as a result indicating that the patient is in imminent danger unless appropriate therapy is promptly initiated. Application of this concept necessitates laboratories to effectively communicate critical information to personnel beyond the laboratory. We dedicate this work to all patients in Malaysia, whose fundamental right is to obtain safe and effective medical care.

COPYRIGHT © 2011. Institute for Health Systems Research, Kuala Lumpur, Malaysia. A Project for Improving Patient Safety [Lab 7; PS 1/2011 (∑33)]. ISBN NO.

KKM NO.

978-967-5398-19-3

MOH/S/IPSK/47.10(RR)

DISCLAIMER The views, interpretations, implications, conclusions, and recommendations expressed in this paper are those of the authors alone and do not necessarily represent the opinions of the other investigators participating in the project nor the views or policy of the Ministry of Health Malaysia.

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ACKNOWLEDGMENT The authors wish to thank the Director-General of Health Malaysia, for his support in this study. We wish to thank all participating MOH hospital laboratories for sharing their experiences and work practices, as well as in providing valuable feedback. In particular, we extend our sincere gratitude to all hospital directors and staff, whose willing participation has provided invaluable assistance in our effort towards improving laboratory notification practices. Their willing participation and work with us towards improving laboratory notification practices, and ultimately towards better patient management, is invaluable. We would like to thank Penang Hospital, specifically the Department of Pathology for allowing us to pre-test our QuickGuide within their setting, and for providing invaluable feedback towards improving it. Special mention goes to Dr Jamilah Baharom, Head of Department of Pathology, Penang Hospital for critically assessing and proof reading the Quickflip Guide. We would also like to thank all individuals and organizations who had contributed directly or indirectly towards the success of the survey.

FUNDING The authors thank the Medical Research Ethics Committee and the National Institutes of Health Secretariat, Ministry of Health Malaysia, for approving and helping fund this study. Malaysia Research Priority Area Health Policy and Systems (NMRR-08-5661721; Ethics approval by MREC MRG-07-LOI-HSR-1)

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EXECUTIVE SUMMARY INTRODUCTION The concept of critical values, defined as an imminent life threatening laboratory result requiring immediate physician notification has been widely adopted as a standard of good laboratory practice worldwide. It is also mandated by accreditation bodies such as the National Association of Testing Authorities (NATA, Australia) and Standards Malaysia compliance to ISO 15189:2007 (ISO, 2007). Recent focus on patient safety has brought increased attention to the issues of effective communication and critical laboratory value reporting. One of the patient safety goals (McDowell, 2007) is to “improve effective communication among caregivers”. The main objective of this project was to evaluate current practices with respect to notification of critical laboratory practices and implement an intervention package meant to improve the practices in selected laboratories. METHOD PART I A cross sectional mail survey was conducted in 126 MOH hospital laboratories nationwide in 2007 to assess current practices pertaining to notification of critical values. PART II

An extensive literature search exercise was carried out to identify available evidence on critical tests/values. Literature findings were tabled and deliberated at several workshops involving laboratory and nursing personnel as well as clinicians from various disciplines to obtain a consensus on critical values and their limits, as well as in identifying a standard notification procedure. We succeeded in obtaining a preliminary consensus on the definitions, lists of tests and their values, and notification procedures. Two booklets were subsequently developed for use in the Delphi Survey in order to obtain input from a wider audience of pathologists and clinicians, scientific officers, MLTs and nurses. The first booklet containing information on definitions, lists of tests/values and procedures (termed the “full” booklet) (IHSR, 2007) was distributed to consultants (clinical and laboratory) and pharmacists while the second booklet containing notification procedures were distributed among nursing and laboratory personnel for their feedback. All comments were read by the research team and debated. Modifications were made to definitions where necessary. Quantitative tests were applied for analysis (Brown, 1968). Medians and distribution parameters were subsequently generated for all quantitative tests. Part III In this phase, 8 hospitals were studied in a controlled community trial. Structured formats were used to get data on the adequacy of human resources, retention period for recording patient results in laboratories, a critical laboratory value list and system/procedure for notification of critical values in

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respective settings. We focused on 5 Biochemistry 1 and 4 Haematology 2 tests, with the respective critical value based on preliminary suggested values and literature. The intervention package was developed after taking into consideration current practices and recommended practice by the expert group as well as feasibility of its implementation. We developed tools to facilitate notification, both in the laboratory and wards. The procedure adopted in the package addressed crucial elements advocated in Safe Practice Recommendations from the Massachusetts Coalition for Prevention of Medical Errors (Hanna et. al., 2005) Data collectors comprised of selected laboratory personnel and research team members. Data were collected pre- and post intervention. RESULTS Part I Response was received from 123 laboratories (96.8%). Only 58 (48.7%) hospital laboratories had a critical test list. Percentage of hospitals without a critical test list increased from state hospitals (20.0%) to hospitals without clinical specialists (58.7%). On average, there were 11 tests reported per hospital in the list. The top 10 tests in the critical test list varied across hospital category. Potassium was the commonest critical test reported. Almost all (87.9%) hospitals reported that critical results were notified by telephone, with similar trend seen across hospital types. Majority of hospitals (81.0%) did not report a method for documenting notification details. PART II A total of 649 consultants/specialists responded in the Delphi Survey. Of the 560 specialists who responded to the question on usefulness of a critical value list, more than 90% agreed that the list was a useful tool in improving patient safety. Definitions for critical limit and critical results were modified for additional clarity based on the feedback. The definition of a critical test was found to be misleading. The notion of critical test and its definition from initial consensus were dropped from the definitions list. Consensus was achieved for the majority of tests and the critical values that had adequate evidence from literature. Research team decided to drop certain tests from the current developmental list. These were tests with minimal or no literature, and as besides being uncommon tests, there was currently insufficient evidence in literature to identify upper and lower limits. Procedures were refined, but in essence, accepted as it is. PART III The number of critical value identified in the post intervention phase was low because prior to training any laboratory value outside the normal range were wrongly identified as “critical”

1 2

Sodium, Potassium, Glucose, Magnesium and Calcium Haemoglobin, Platelet count, Prothrombin time and Activated Prothrombin Time

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Before implementation of the intervention package, notification of critical laboratory value among intervention hospital ranged from 0.0% to 15.3% and this increased to 78.5% to 100% after implementation of the intervention package. In the control group at baseline, notification ranged from 0.0% to 4.1%. After three month, there was a slight increase to 5.2% to 100%, possibly contributed because at the time of collection of baseline data, laboratory staff was informed of the accreditation requirements for notification of critical laboratory values. Both interventional specialist hospitals and one non-specialist hospitals showed a statistically significant rise in the proportion of critical values that were notified after 3 months postintervention. Generally, the intervention package was effective in both the specialist hospitals in improving notification of critical values. Pre-intervention, in general 41.9% of all critical value notification received in the ward were via telephone and in almost half of the critical value received there was no documentation on the method of notification. Post intervention there was an overall increase to 88.8% in the documentation of notification

Figure 1: Results from the Intervention Group

Figure 2: Results from the Control Group

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DISCUSSION Less than half of MOH hospitals had a list of critical tests during the exploratory phase of the study. The majority, 81.0%, did not have a method for documenting notification of critical results. There was confusion over the various terms “STAT”, “URGENT” and “CRITICAL” used in the laboratories. Availability of the critical laboratory list and number of tests with critical limits was variable among all the literature reviewed (Howanitz, 2002, Tillman, 2003). In this study, averages of 11 tests were in the list, with potassium the commonest. Microbiology and Anatomical pathology tests were not included in the critical laboratory result list. Anand Dighe (2008) concluded in his study that there is no universal alert value list and specific critical limits should be designed to meet the clinical needs of each facility. There is no standard method for establishing a critical value lists. (Wager et. al, 2007) Lum G. (1998), Lippi et. al. (2007), Tillman (2003) and Howanitz, et al. (2002) noted considerable heterogeneity in laboratory compliance with procedures, monitoring, and documentation. Telephone was the commonest mode of notification, similar to the finding in MOH laboratories. Following the Delphi survey a guide for critical value in terms of definition, interventional trial, upper/lower limits and procedures have been developed. In the interventional trial, prior to intervention, rate of identification and notification of the critical value was low. In the post intervention phase, tremendous improvement was seen in specialist hospitals, and efficacy of intervention was high. However, one non specialist hospitals showed no significant improvement. In contrast, one control non-specialist hospital showed significant improvement, most likely due to the baseline audit and feedback to the laboratory on the (ISO 15189:2008 accreditation) requirements for notification of critical laboratory value for medical testing laboratories. Limitations of the study Limitations of this study include: (1) The Delphi Survey methodology used in this study to establish was conducted only amongst MOH personnel, and excludes experts from the university and private sector. However since we received response from various clinical disciplines from all over the country, the values could be used for the patients of various ethnic groups in Malaysia (2) The procedure for notification delineated in the survey did not cover ambulatory patients (3) The procedure did not cover the process of communicating the critical laboratory values/ findings to the patients (4) outcome of the patient due to immediate response by the responsible caregiver (5) The intervention study did not cover Microbiology and Anatomical Pathology. Conclusion MOH needs to improve the awareness of the needs for critical value notification. This needs to be instituted concept in hospitals. With the use of critical values and procedures in MOH, additional studies need to be done to assess the impact on notification errors and work burden to continuously improve the system and contribute to patient safety.

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TABLE OF CONTENTS page EXECUTIVE SUMMARY ................................................................................................................................... IV TABLE OF CONTENTS.................................................................................................................................... VIII LIST OF TABLES .............................................................................................................................................. IX LIST OF FIGURES.............................................................................................................................................. X LIST OF APPENDIX TABLES .............................................................................................................................. X LIST OF APPENDICES ....................................................................................................................................... X 1

INTRODUCTION ..................................................................................................................................... 11

2

LITERATURE REVIEW ............................................................................................................................. 11 2.1 SAFE PRACTICE RECOMMENDATIONS ................................................................................................. 12 2.1.1 What results require timely and reliable communication? ............................................................. 12 2.1.2 Who should receive the results? ..................................................................................................... 13 2.1.3 Who should receive the results when the ordering provider is not available? ............................... 14 2.1.4 When should the results be actively reported to the ordering provider with explicit time frames . 14 2.1.5 How to notify the responsible provider ........................................................................................... 15 2.1.6 Read-back ....................................................................................................................................... 15 2.1.7 Design reliability into the systems .................................................................................................. 15

3

OBJECTIVES ........................................................................................................................................... 24 3.1 3.2

4

GENERAL OBJECTIVE ................................................................................................................................. 24 SPECIFIC OBJECTIVES................................................................................................................................. 24

METHODOLOGY .................................................................................................................................... 25 4.1 OVERVIEW OF THE RESEARCH DESIGN ................................................................................................ 25 4.2 SUMMARY OF METHODS USED FOR OBJECTIVES 1, 2, 3 & 4................................................................ 26 4.2.1 Objective 1 ...................................................................................................................................... 26 4.2.2 Objective #2, 3 & 4 .......................................................................................................................... 26 4.3 THE INTERVENTIONAL TRIAL (OBJECTIVE #5) ...................................................................................... 27 4.3.1 Research design .............................................................................................................................. 27 4.3.2 Sampling ......................................................................................................................................... 28 4.3.3 Intervention Package ...................................................................................................................... 28 4.4 ETHICAL CONSIDERATIONS ......................................................................................................................... 31

5

FINDINGS............................................................................................................................................... 32 5.1 OBJECTIVE #1....................................................................................................................................... 32 5.2 OBJECTIVE # 2, 3 AND 4 ......................................................................................................................... 32 5.3 OBJECTIVE #5....................................................................................................................................... 33 5.3.1 Laboratory characteristics .............................................................................................................. 33 5.3.2 Identification of critical results ....................................................................................................... 34 5.3.3 Notification of the critical laboratory results in the laboratory ...................................................... 34 5.3.4 Effectiveness of intervention – notification of critical results ......................................................... 34 5.3.5 Documentation of notification in laboratory .................................................................................. 35 5.3.6 Notification in ward ........................................................................................................................ 35 5.3.7 Notification to the doctor ............................................................................................................... 35 5.3.8 Notification of critical values by test/analytes ............................................................................... 35

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5.3.9 6

Fidelity of intervention implementation ......................................................................................... 35

DISCUSSION ........................................................................................................................................... 49 6.3 STATEMENT OF PRINCIPAL FINDINGS .................................................................................................. 49 6.4 STRENGTHS AND WEAKNESSES OF THE STUDY ................................................................................... 49 6.4.4 Phase 1 ............................................................................................................................................ 49 6.4.5 Phase 11 .......................................................................................................................................... 50 6.4.6 Phase 111 ........................................................................................................................................ 51 6.5 COMPARISON WITH INTERNATIONAL DATA ....................................................................................... 51 6.6 IMPLICATIONS/ MEANING OF THE STUDY ........................................................................................... 52 6.7 RESEARCH QUESTIONS FOR THE FUTURE ............................................................................................ 52

7

RECOMMENDATION .............................................................................................................................. 53

8

REFERENCES .......................................................................................................................................... 54

9

APPENDIX TABLES ................................................................................................................................. 56

10

APPENDICES .......................................................................................................................................... 62

LIST OF TABLES page TABLE 1: SUMMARY OF STUDY METHODOLOGY FOR ESTABLISHING CRITICAL LIMITS AND TEST ................................................... 16 TABLE 2: RESULTS OF IMPLEMENTATION OF SAFE PRACTICE RECOMMENDATIONS .................................................................. 20 TABLE 3: TESTS AND VALUES USED TO ASSESS CRITICAL LABORATORY RESULTS NOTIFICATION IN THE STUDY ................................. 28 TABLE 4: HOSPITAL CHARACTERISTICS OF THE INTERVENTION AND CONTROL HOSPITALS IN THE STUDY ........................................ 37 TABLE 5: LABORATORY CHARACTERISTICS – TESTS WORKLOAD* ......................................................................................... 37 TABLE 6: NUMBER OF TESTS DONE (WORKLOAD) FOR THE PAST 7 DAYS ................................................................................ 38 TABLE 7: LABORATORY CHARACTERISTICS – PERSONNEL* .................................................................................................. 39 TABLE 8: LABORATORY CHARACTERISTICS PRE-INTERVENTION – TRAINING AND DOCUMENTATION PERTAINING TO CRITICAL RESULT NOTIFICATION* ................................................................................................................................................ 40 TABLE 9: EXTENT OF NOTIFICATION OF CRITICAL RESULTS (CR) BEFORE AND AFTER INTERVENTION ........................................... 41 TABLE 10: EXTENT OF NOTIFICATION OF CRITICAL RESULTS (CR) BEFORE AND AFTER INTERVENTION BY ANALYTES/TESTS STUDIED. . 42 TABLE 11: EFFECTIVENESS OF INTERVENTION PACKAGE ON NOTIFICATION OF CRITICAL RESULTS................................................. 44 TABLE 12: REASON CITED FOR NOT NOTIFYING CRITICAL RESULTS AND FOR NOT DOCUMENTING NOTIFIED CRITICAL VALUES ............ 45 TABLE 13: EXTENT OF NOTIFICATION AND METHODS OF NOTIFICATION AND RECORDING IN THE LABORATORY AND WARD ........... 46 TABLE 14: EXTENT OF NOTIFICATION AND METHODS OF NOTIFICATION AND RECORDING IN THE LABORATORY AND WARD BY TEST 47 TABLE 15: FIDELITY IN IMPLEMENTATION OF THE INTERVENTION PACKAGE ............................................................................ 48

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LIST OF FIGURES page FIGURE 1: RESULTS FROM THE INTERVENTION GROUP ....................................................................................................... VI FIGURE 2: RESULTS FROM THE CONTROL GROUP .............................................................................................................. VI FIGURE 3: OVERVIEW OF RESEARCH DESIGN ................................................................................................................... 25 FIGURE 4: NUMBER OF CRITICAL RESULTS DETECTED, NOTIFIED & DOCUMENTED, PRE- AND POST-INTERVENTION....................... 36

LIST OF APPENDIX TABLES page APPENDIX TABLE 1: REASON FOR NON-NOTIFICATION & NOTIFIED BUT NOT RECORDED (LABORATORY) ...................................... 56 APPENDIX TABLE 2: NOTIFICATION OF INFORMATION RECEIVED (WARD) .............................................................................. 57 APPENDIX TABLE 3: REASON FOR NON-NOTIFICATION & NOTIFIED BUT NOT RECORDED (LABORATORY) BY TEST ........................... 59 APPENDIX TABLE 4: NOTIFICATION OF INFORMATION RECEIVED (WARD) BY TEST.................................................................... 60

LIST OF APPENDICES page APPENDIX 1: LIST OF PARTICIPANTS IN WORKSHOP 1 ON 22-25 OCTOBER 2007 .................................................................. 62 APPENDIX 2: LIST OF PARTICIPANTS IN WORKSHOP 2 ON 5–7 NOVEMBER 2007 .................................................................. 63 APPENDIX 3: LIST OF LITERATURE ................................................................................................................................. 64 APPENDIX 4: TARGETED RESPONDENTS FOR FULL BOOKLET (IHSR 2007) ............................................................................ 66 APPENDIX 5: TARGETED RESPONDENTS FOR PROCEDURE BOOKLET (IHSR 2007) .................................................................. 66 APPENDIX 6: LIST OF COORDINATORS ON 23-25 FEBRUARY 2008...................................................................................... 67 APPENDIX 7: LIST OF DATA COLLECTORS FOR INVENTION STUDY ......................................................................................... 69 APPENDIX 8: FLOW CHART FOR COLLECTION OF DATA ...................................................................................................... 71 APPENDIX 9: TRAINING MANUAL FOR COLLECTION OF DATA............................................................................................... 72 APPENDIX 10: LABORATORY PRACTICES FOR CRITICAL RESULTS NOTIFICATION (FORM Q1) ....................................................... 83 APPENDIX 11: MASTERLIST FOR CRITICAL RESULT NOTIFICATION (FORM Q2) ........................................................................ 87 APPENDIX 12: CRITICAL RESULT NOTIFICATION (FORM Q3).............................................................................................. 88 APPENDIX 13: TRAINING MANUAL FOR INTERVENTION PACKAGE........................................................................................ 89 APPENDIX 14: CHECKLIST FOR SUPERVISOR –CSI ........................................................................................................... 100 APPENDIX 15: PROGRAMS USED IN ANALYSIS ................................................................................................................ 101

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1

INTRODUCTION

Thirty years ago, George Lundberg, MD. (Lundberg, 2007) defined “a critical value as a result indicating that the patient is in imminent danger unless appropriate therapy is promptly initiated.” Reporting of critical laboratory results 3 is a widespread practice mandated by accreditation bodies as it is a requirement of ISO 15189:2003: Medical Laboratories – the particular requirements for quality and competence (ISO, 2007). As stated in clause 5.8.7 of ISO 15189:2007, laboratory shall have procedures for immediate notification to a physician (or other clinical personnel responsible for patient care) when examination results for critical properties fall within established alert or critical intervals (ISO, 2007). In essence, medical testing laboratories should have a procedure for immediate notification and a list of tests with critical values. There was no available Malaysian data on the practices in medical laboratories in Ministry of Health (MOH) hospitals in terms of availability of lists of tests with critical values, the effectiveness of inclusion of a given test in the critical laboratory value list, or at what critical limit should the test result be considered critical. The main objective of this research project was to improve the process of notification of critical laboratory value in Ministry of Health laboratories and develop a national guideline that will have the following characteristics: • • •

2

feasible and practical to be used in any MOH laboratory setting a reporting procedure with a higher likelihood to be successful in its implementation, given the current environment and workload of the laboratories and hospital wards Ownership by all involved in using the critical laboratory values.

LITERATURE REVIEW

International and national focus on patient safety goals especially “improve effective communication among caregivers” had increased attention to the issues of effective notification of critical laboratory value. Poor communication was found to be the main contributory factor for many incidents and medical errors. The Joint Commission on Accreditation of Hospital Organization (JCAHO) requires health care organizations to track and improve the timeliness of reporting and receipt of critical test results (Dighe et.al. , 2006). Since 30 years from the time of Lundberg’s initial observations and definition of critical value, the concept had been widely adopted by laboratories throughout the world. Most major published studies looking at critical value reporting are outcomes of Q probe studies conducted by the College of American Pathologists. There were not many studies in the literature related to development of upper/lower critical limits of laboratory tests except in Anatomical Pathology and Cytology. In contrast, documented evidence of agreement with clinicians and laboratory personnel is mandated in ISO 15189:2003: Medical Laboratories – the particular requirements for quality and competence in clause 5.8.8 “In order that

3

sometimes called panic values

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local clinical needs can be served, the laboratory shall determine the critical properties and their "alert/critical" intervals, in agreement with the clinicians using the laboratory (ISO, 2003). Wagar et.al. (Dec 2007) reported that sources for critical values were published literature/text books, medical staff 4 recommendation, manufacturer’s recommendations, inter- and intralaboratory comparisons together with internal surveys. In addition, laboratories could benchmark their critical values adopted using published large survey data (Kost, 1990; Dighe et.al. , 2006). Studies to determine methods used in identifying critical values, tests and/or procedures are summarized in Table 1.

2.1

SAFE PRACTICE RECOMMENDATIONS

Safe Practice Recommendations from the Massachusetts Coalition for Prevention of Medical Errors described 6 criteria for notification of critical laboratory results (Hanna et al., 2005). This was used in the Hospital for Sick Children in Toronto (Jackson et al., 2009) as the guiding principles to improve notification of critical test results using the Failure Mode and Effect Analysis (FMEA) process. In addition, as a best practice, the National Patient Safety Goals (Haverstick, 2004) require a readback policy to ensure accuracy of information notified 5. Seven criteria were used as a guide in appraising literature for best practice in this study. These are discussed below and summarized in Table 2. 2.1.1 WHAT RESULTS REQUIRE TIMELY AND RELIABLE COMMUNICATION? How critical values were established using the generic definition of “imminently life-threatening result”? Review of published literature showed there was no single mechanism used to establish the critical value test list. In a Q-Probes Survey conducted in 163 laboratories internationally (Wagar et. al, Dec 2007) on “Critical Value Comparison’, approximately one third of laboratories used published literature, while another third used non-laboratory medical staff recommendations, and others used sources such as internal studies, inter-laboratory comparisons, or manufacturers' recommendations respectively Many studies have revealed disparities in the particular cut-offs points for critical limits used by various institutions. In a study on critical value cut-off points conducted by Howanitz et al. (2002) in 623 institutions and the critical limits for potassium was variable example 10% of institutions considered a serum potassium level to be critical if it was 6.0 mmol/L or higher, whereas another 10% did not consider a potassium level to be critical until it reached 6.5 mmol/L. Although some of the differences in critical value cutoffs among institutions may reflect differences in local patient populations or test methods, it is likely that critical values at different institutions denote different levels of patient risk. The literature below illustrates the various methods used: 4

nonlaboratory “For verbal or telephone orders or for telephonic reporting of critical test results, verify the complete order or test result by having the person receiving the information record and ‘read back’ the complete order or test result.”

5

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a) Surveys done for comparisons of the critical limits between organizations: • Wagar et al., Dec 2007 – Critical values comparison – A College of American Pathologist Q-Probes survey of 163 clinical laboratories. • Giuseppe Lippi et al., 2007 – National survey on critical values reporting in a cohort of Italian laboratories. • Perira TC et al., 2008 – A multi-institutional survey of critical diagnosis (critical values) in surgical pathology and cytology. • Tillman et al., 2003 – UK survey of 94 laboratories. • Howanitz et al., 2002 – CAP Q-Probes of 623 institutions. • Kost, 1990 – Critical limits for urgent clinician notification at US Medical Centers - 92 institutions b) Institutional case studies for comparison between hospitals with similar practices: • •

Dighe et al., 2006 – Massachusetts General Hospital: Analysis of critical laboratory value reporting at a large academic medical center. Lum, 1998 – 9 VA Medical centers case study.

c) Outcome literature for certain analytes • Howanitz & Howanitz, 2007 - Evaluation of serum and whole blood sodium critical values. • Howantiz, 2006 - Evaluation of total serum calcium critical values. What test/analytes should be included in the critical value list? This depends on the needs and requirements of the hospital and institution. Anand Dighe (2008) concluded in his study that there is no universal alert value list and specific critical limits should be designed to meet the clinical needs of each facility. This was also found by Howanitz (2002) who reported that the choice of the limit for either the 28 low or 28 high critical values was highly variable, with no value being the same in 80% or more of the 623 laboratories surveyed in the Q probe study in US. Common analytes in the critical value list were potassium, sodium, calcium, glucose, bilirubin and magnesium (for Chemical Pathology) and platelets, haemoglobin/hematocrit, aPTT, PT/INR and WBC (for Haematology) (Wagar et al., April 2009). In contrast, in Anatomic Pathology and Cytology, certain diagnosis is defined as critical findings, and survey methods were used to identify diagnoses that may represent critical findings. (Visscher,2008; Silverman et al., 2008). 2.1.2 WHO SHOULD RECEIVE THE RESULTS? The person who receives the results is crucial to ensure effective actions are taken to prevent any “imminent danger to the patient“ as defined by Lundberg in his initial observations .The physician who ordered the test or delegate (defined as the medical trainee or regulated healthcare professional) was identified as the first person for notification for all critical value in 77% to 89% of the times . (Jackson et al., 2009; Wagar, 2008; Valenstein et al, 2008; Lippi et al., 2007; Wagar et al., Dec 2007).

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In addition, nursing staff was identified as an intermediary to receive the critical laboratory value for in-patients and in the emergency department (ED) in many studies. 2.1.3 WHO SHOULD RECEIVE THE RESULTS WHEN THE ORDERING PROVIDER 6 IS NOT AVAILABLE? In the absence of the ordering provider, nursing staff could receive the notification from the laboratory.Jackson (2009) conceded that for reporting in-patient and emergency departments (which constitutes 80% of all critical test results); notification could be made to the nursing staff, where as for ambulatory clinics and daycare units, reporting would be to the ordering physician or delegate. Wagar et al. (Dec 2007) reported that administrative personnel were allowed to receive inpatient and outpatient critical test results, although Jackson (2009) mentioned that non-regulated healthcare professionals (e.g. clerk) should not receive the results. In addition, Wagar et.al.(Dec 2007) reported that 5% of reporting laboratories permitted an answering service or fax machine to receive results after repeated failure to contact the ordering provider.

2.1.4 WHEN SHOULD THE RESULTS BE ACTIVELY REPORTED TO THE ORDERING PROVIDER WITH EXPLICIT TIME FRAMES It is a requirement that there is “immediate notification to a physician (or other clinical personnel responsible for patient care) when examination results for critical properties fall beyond established critical Iimits” (Clause 5.8.7 in ISO, 2007). The Joint Commission had given great emphasis to monitoring the turnaround time for critical value notification, especially to a responsible licensed health care provider. The notification time frame (interval from critical result noted by technologist to successful reporting) varies, from a median of 4 minutes (self-reported7) (Valenstein et al., 2008), to 9 minutes (from recordings) (Dighe et al., 2006), to an average of 13.7 minutes for outpatients (Howanitz et al., 2002) and up to 60 minutes (Wagar et al., Dec 2007). It is recommended that it should be less than 30 minutes for inpatients and 60 minutes for outpatients (Jackson et al., 2009; Dighe et al., 2006). Delays in critical value reporting among outpatients occurred more often when test requests lack name of the ordering clinician or name/location of clinic (Dighe et al., 2006). Valenstein et al, (2008) had also reported that the median time from specimen collection till time of technologist’s knowledge of the critical result was 48 minutes. The median time from the specimen collection till when the result was accepted by requester was 56 minutes; hence, a median of 8 minutes was achieved for notification (Valenstein et al., 2008).

6 Responsible provider: responsible physician or delegate (e.g. trainee as fellow or resident) who has the authority to respond and act upon the critical test promptly and effectively to ensure quality patient care. (Jackson et al. , 2009) 7 The author acknowledged that the data were self reported and the researchers could not validate all the data submitted.

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2.1.5 HOW TO NOTIFY THE RESPONSIBLE PROVIDER Commonest method for notification was by phone, followed by fax, answering machine/voice mail or computer. Lippi et al. (2007) reported 81% of the results were notified through phone and in minority of the cases (19%), by fax or computer for inpatients. Similarly, Howanitz et al. (2002) reported that as primary means, 99.2% used telephone contact, 29.5% used fax machine or similar transmission device and 10% used computer reports; as a secondary means, 42.5% used computer and 6.9% used an answering machine or voice mail.

2.1.6 READ-BACK The practice of read-back was included in 96% of phone calls made to notify critical values and 89% of the calls were made to the licensed caregiver (Valenstein et al., 2008).

2.1.7 DESIGN RELIABILITY INTO THE SYSTEMS This should include: •

Educating clinical teams and laboratory staff on critical test results parameters (Jackson et al., 2009)

•

Customizing the laboratory information systems (LIS) on a defined list of critical values which require a immediate call. (Jackson et al., 2009; Howanitz et.al , 2002; Dighe et al., 2006)

•

Install LIS callback module to provide data (reports) for daily review and monitoring of critical test results calls (Jackson et al., 2009)

•

Regular (e.g. daily and monthly reporting) monitoring and vigilance is needed to ensure the practices are sustained and early identification of issues and problems (Jackson et al., 2009)

•

A clearly written operational procedure for critical values and critical tests. Wager, 2008; Dighe et al., 2006

•

A concise list of critical values (Wager, 2008)

•

Notification should be to a responsible caregiver rather than to clerical staff (Wager, 2008; Wager et al. ,2007)

•

Create a quality monitor for critical values to enhance notifications (Wager, 2008)

•

An acceptable time interval between test completion and caregiver notification may be 15 to 30 minutes. Outpatient time intervals may be longer, given the requirement to identify a physician on call or a call service (Wager, 2007) 15 | P a g e


Table 1: Summary of Study methodology for establishing critical limits and test No 1

Study Critical Values Comparison A College of American Pathologists Q-Probes Survey of 163 Clinical Laboratories Elizabeth A. Wagar, MD, FCAP; Richard C. Friedberg, MD, PhD, FCAP; Rhona Souers, MS; Ana K. Stankovic, MD, PhD, FCAP. Arch Pathol Lab Med—Vol 131, December 2007

Objective To examine lists of critical values for selected common analytes and to determine the interlaboratory variability. Additional specific questions addressed the source of these values, the inclusion of specific items on a critical values list, and the procedures for establishing such lists.

Sample size & Laboratory Characteristics A total of 163 institutions submitted data: 97% (158) of these institutions in United States, the remaining institutions in Canada (2), Australia (1), Lebanon (1), and South Korea (1). A total of 31% of participating institutions were teaching hospitals, and 15% had a pathology residency training program.

Study design Cross sectional study. This study was conducted according to Q-Probes study format. Participants were asked to provide their high and low critical values for 7 analytes: potassium, total calcium, magnesium, thyroid-stimulating hormone (TSH), hemoglobin, platelet count, and activated partial thromboplastin time (aPTT). Multivariate analysis of variance (MANOVA) to perform a joint analysis of the dependent variables: low and high adult and pediatric critical values was used for Statistical Analyses

Results Adult and pediatric mean critical values + SD were very similar. More than 90% of laboratories reported the following analytes on their critical values lists, in descending frequency: (1) potassium, (2) sodium, (3) calcium, (4) platelets, (5) hemoglobin, (6) aPTT, (7) white blood cell count, and (8) prothrombin time (PT). More than 64% of laboratories additionally reported critical values from clinical microbiology (blood culture, Gram stain), bilirubin, carbon dioxide, magnesium, hematocrit, lithium, and fibrinogen. Critical values for blood gas analytes (pH, PCO2 and PO2) were reported as being on the critical values list of 91 laboratories (56%) aPTT test was used to identify the sources of critical limits: • Approx. 28% to 29% used published literature/textbooks as a primary source for both pediatric and adult aPTT critical values. • A total of 26% and 27% (39 and 43 institutions, respectively) used non-laboratory medical staff recommendations to establish these values. 56% had a written policy establishing, revising and updating their critical values.

2

National survey on critical values reporting in a cohort of Italian laboratories. Giuseppe Lippi, et al. Clinical Chemical Laboratory Medicine. Volume 45, Issue 10, Pages 1411– 1413, October 2007.

3

A survey of laboratory ‘critical (alert) limits’ in the UK.

To investigate local policies within an indicative cohort of Italian laboratories to monitor the situation and establish a performance benchmark

150 laboratory specialists

Cross sectional study. A five-point questionnaire was administered to 150 laboratory specialists attending the SIMEL (Italian Society of Laboratory Medicine) National Meeting in June 2006.

A total of 107 questionnaires (71.3%) were returned with a 100% individual question response rate 80% admit that a comprehensive list of critical values is unavailable in the laboratory and 4% do not promptly communicate critical values. The list of critical values is variable among laboratories, ranging from none to 20 analytes included.

To determine the range of tests with critical limits and the values commonly in use

94 UK Clinical Biochemistry laboratories responded.

Cross sectional study. A questionnaire requesting details of the critical

Twenty-three laboratories had derived their action limits locally from a consensus with their clinicians, experience over many years, and literature.

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No

Study Tillman J, Barth JH. Ann Clin Biochem 2003;40:181–184.

4

Critical laboratory values policies and procedures: a College of American Pathologists Q-probes study in 623 institutions. Howanitz, Peter et al Archives of Pathology & Laboratory Medicine June 1, 2002

Objective

Sample size & Laboratory Characteristics

within clinical biochemistry laboratories in the UK.

To investigate critical values lists in institutions participating in the College of American Pathologists QProbes program and to provide suggestions for improvement.

Study design limits for adult biochemistry values was distributed during October-December 2000, sent to UK Clinical Biochemistry laboratories through their Association of Clinical Biochemists Clinical Audit Group coordinators.

Participants registered and participated in the CAP's voluntary quality improvement program, Q-Probes. 623 institutions, of which 31% teaching institution and 69% nonteaching. 76.1% nongovernmental.

Results Only two laboratories quoted literature alone to support their values. There was considerable variance in the values defined as critical by the responding laboratories.

The mean, standard deviation and range were determined for each analyte, where more than six laboratories responded.

Seven laboratories did not submit actual critical values.

Cross sectional study.

Most institutions based their choices on data from several sources, including manufacturers, hospital committees, and medical staff members.

The study required participants to: (1) select from a supplied list of 28 tests laboratory tests included on their critical values list and provide the limits they use; (2) provide information on up to 3 other chemistry/hematology critical values used in their laboratory not on the provided list; (3) select from supplied lists critical values for their microbiology/drug assays; (4) answer questions on derivation and reporting of critical values;

Critical values lists were determined for routine chemistry and hematology analytes and choice of limits were found to vary widely among participants with no value being the same in 80% or more of laboratories. In contrast, more than 95% of participants reported positive blood cultures, cerebrospinal fluid cultures, and toxic therapeutic drug levels as critical values. Occurrences of critical values ranged from 1 in 120 to 1 957 tests, with more frequent values occurring in larger hospitals.

(5) review medical records of 10 patients with recent critical values to determine effect on medical care delivery; (6) survey 3-10 nursing supervisors on awareness and use of critical values; and (7) survey up to 10 physicians on awareness and use of critical values. 5

A multi-institutional survey of critical diagnosis (critical values in Surgical pathology and cytology. Pereira TC ; Silverman JF et all Am J Clin. Pathology 2008;130 731-735

Establishing anatomic pathology critical diagnosis guidelines as practice improvement and patient safety initiative.

Sent to 225 members of the Association of Directors of Anatomic and Surgical Pathology (ADASP). 73 responses for surgical pathology and 57 for cytology

Cross sectional study. To better identify anatomic pathology critical values (CVs), a survey was sent to 225 members of the Association of Directors of Anatomic and Surgical Pathology (ADASP) for grading 17 possible surgical pathology and 18 possible cytology CVs

There were 73 responses for surgical pathology and 57 for cytology. The majority of the respondents believed in the concept of CVs in anatomic pathology. There was good agreement concerning most of the possible CVs, although there were differences of opinion for some diagnoses. Several additional CVs were suggested, and

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No

Study

Objective


Study design

Results there was discussion of the best terminology for CVs, degree of urgency, and appropriate notification documentation. A few respondents expressed concern about medico-legal implications, such as delay in informing the critical values Based on the results of this survey, a committee had developed national guidelines for critical diagnoses (CVs) in surgical pathology and cytology.

6

How do surgical pathologists evaluate critical diagnoses (critical values)? Masoud Mireskandari 1 Diagn Pathol. 2008; 3: 30. Published online 2008 July 12. doi: 10.1186/1746-1596-3-30.

To determine the perception of Iranian pathologists on the evolving concept of critical diagnoses (critical values) in surgical pathology.

147 pathologists responded; 81 males and 60 females with age ranging 25–67 (mean 39.5) years. 41 participants members of scientific boards of universities with 1–24 (mean 8.5) years of experience 3 participants pathology assistants in year 4 postgraduate study..

7

Critical limits (Alert values for physician notification : Universal or Medical Center specific limits? G Lum. Annals of Clinical and Laboratory Science, 1998. Vol 28, Issue 5, 261271

Although virtually all laboratories have tests with critical limits, surveys have shown that there is no universal alert value list. The objective was to summarize critical limits.

9 VA medical centers in the New England region, which now constitute one consolidated entity,

Cross sectional study. Anonymous questionnaires were distributed to participants at annual meeting of Iranian Pathologist Society, November 2006, Tehran, Iran. They were requested to name five clinical situations,pathologic diagnosis or specific findings in microscopic or macroscopic evaluation of pathology specimens for which a pathologist should communicate the results immediately with clinicians.

Cross sectional study. A survey of the test with the critical limits was conducted.

There were 90 different conditions which were listed as critical values in surgical pathology.. Many of the conditions were similar to the critical diagnosis listed in the two surveys conducted by Pereira TC ; Silverman JF et all Am J Clin. Pathology 2008;130 731-735 However there were large number diagnosis which were not included in the Pererira studies and rationally cannot be considered as critical value Almost all conducted surveys on this issue so far (including the present survey) suffer from lack of supportive scientific evidence (for inclusion of diagnosis into the critical value list list) and is based mainly on experience and common sense of participants in survey. Medical center specific critical limits, designed to meet the clinical needs of each facility, are the norm in the nine medical centers. Universal (100 percent) critical limit tests for clinical chemistry were: Calcium; mean low/high, 6.5/12.4 mg/dL: Glucose 48/432 mg/dL: Potassium 2.8/6.1 mmol/L: Sodium 121/159 mmol/L. Universal hematology tests included: Hematocrit 22.2/59.7 percent; Platelet count 61,000/983,000; white blood count 1.9x1000/29 x1000. Although there was universal agreement that abnormal coagulation tests (PT, PTT) should be included on the hematology critical limit list, there was wide variation in the reporting of coagulation tests (seconds and INR) and patient therapeutic status (anticoagulant or no-anticoagulant). Universal alert values for microbiology were: Positive blood culture: Positive cerebral spinal fluid (CSF) culture: Positive CSF Gram stain. There was no universal agreement

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No

Study

Objective


Study design

Results regarding critically high (potentially toxic) therapeutic drugs, with two medical centers declining to notify physicians of any abnormally high therapeutic drug level. No other qualitative critical limits for other laboratory sections, such as physician notification of an unexpected malignancy (surgical pathology) were universal.

8

Evaluation of Serum and whole blood critical values for Sodium Joan H. Hwantiz

9

Serum sodium commonly is included in critical results lists, but a wide range of values are used

Am. J. Clin. Pathol. 127 (2007), pp. 56–59. ...

To evaluate the appropriateness of critical values for sodium

Evaluation of total serum calcium critical values

Total serum calcium commonly is included in critical results lists; however, a wide range of values are used and there is scant outcome data justifying inclusion of this analyte in these lists.

Joan H. Hwantiz Arch Pathol Lab Med. 2006]

To evaluate the appropriateness of critical values for total serum calcium used.

111,545 sodium results in University Hospital of Brooklyn, Brooklyn, NY (6month period)

Cross sectional study. All critical serum and whole blood sodium results called to clinicians during a 6-month period were evaluated . Patients' electronic medical records were reviewed for clinical responses and patient outcomes

50 402 total serum calcium University Hospital of Brooklyn, Brooklyn, NY (3month period)

Cross sectional study. All critical total serum calcium results found during a 3-month period. The patients' medical records were evaluated for the presence of documented critical results call for calcium, clinician response, and patient outcome. The patients' outcomes were measured by time of clinical response, length of stay in the hospital, and mortality.

Of the 111,545 sodium results occurring during the study, 615 (0.6%) were critical. By using criteria of 120 mEq/L (120 mmol/L) or less and 155 mEq/L (155 mmol/L) or more, they found 166 critically low results and 447 critically high results. In hypernatremic and hyponatremic patients, the lengths of stay were increased above our average, and clinicians responded to more than 50% of results within 4 hours. The mortality rates of hyponatremic and hypernatremic inpatients were 19% and 48%, respectively. Disease severity as measured by length of stay and mortality indicated these critical limits should not be broadened. There were 722 (1.4%) critical results found in a total of 50 402 total serum calcium results. Using our criteria of 7 mg/dL or less as the low and 12 mg/dL or more as the high critical value, they found 171 patients with 608 critically low results and 47 patients with 114 critically high results. Eighty percent of patients with critically low results and 75% of patients with critically high results had length of stays greater than average (5.58 days). Clinicians responded to 49% of the critical results calls within 4 hours. There was an overall mortality rate of greater than 25%, with more than half the mortality occurring in patients who had results within 0.5 mg/dL of the cutoff values used. Although broadening critical values limits would reduce required calls, this does not appear warranted. The disease severity of the patients as measured by length of stay and mortality, as well as the rapidity with which patients were treated, indicate that the current limits are appropriate and should not be widened.

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Table 2: Results of Implementation of Safe Practice Recommendations

No

Literature

1

Improving Communicati on of Critical Test Results in a Pediatric Academic Setting: Key Lessons in Achieving and Sustaining Positive Outcomes. Cheryl Jackson et al. Healthcare Quarterly, 12 (Sp) 2009: 11 6-122.

2

Critical Values Reporting: An Overview

SAFE PRACTICE RECOMMENDATION (Based on Massachusetts Coalition for Prevention of Medical Errors by Doris Hanna et al 2005 ) When results should be Who should receive results How to design, support, and What results require timely actively reported to How to notify the Who should receive the when ordering provider is maintain the systems and reliable communication ordering provider with responsible provider results not available involved explicit time frames The critical values were organized into five lists: • Clinical biochemistry • Hematology • Coagulation • Therapeutic drug monitoring, and • Microbiology

The time frame for communicating Critical Test Results to in-patient units and the ED was established as < 30 minutes, whereas for ambulatory areas, the time frame is < 60 minutes.

Consultation and consensus building directed the process of reviewing and updating critical test values for the rapid response and microbiology laboratories.

Explicit steps and time frames for repeating and escalating calls if first call/page unsuccessful was stated.

To be telephoned immediately upon verification of accuracy. By laboratory staff.

The ordering physician or delegate (defined as the medical trainee or regulated healthcare professional) being the first contact. Maintain nursing staff as intermediary to receive in-patient and ED

If the patient's primary service at the time of ordering was not the same as that at time of specimen accessioning and reporting (e.g., an ED patient transferred to the critical care unit). reporting of in-patient/ED results (80% of total results) would be to nursing staff, whereas, for ambulatory/ daycare units, reporting would be to ordering physician or delegate. Critical Test Results would not be left on voicemail and would not be communicated to a nonregulated healthcare professional (e.g., a unit clerk).

Depends on an individual institution's needs and requirements.

25% of laboratories took 8 minutes or longer to call in critical values after they were known.

25% of the labs took 8 minutes or longer to call in critical values after they

89% were given to a licensed caregiver.

27% of laboratories allowed non-practitioners to accept inpatient critical values reports

Educate clinical teams and laboratory staff on Critical Test Results call parameters

Read back policy (Based on Patient Safety Goals)

Implement read back as a required function with LIS upgrade.

Customize LIS to identify individual results requiring a call based on defined list of Critical Test Result Install LIS callback module to provide data (reports) for daily review and monitoring of CTR calls Regular (e.g., daily and monthly reporting) monitoring and vigilance needed to make sure practices are sustained and ensure early identification of issues and problems.

A clearly written operational critical values and critical tests procedure.

Read back of the results was included in 96% of critical values notification

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No

Literature

No Need to Panic Critical Values in Your Laboratory," the American Society for Clinical Pathology 2008 Annual Meeting, presented by Elizabeth A. Wagar, MD http://cme. medscape.co m/viewprogr am/18958

3

Laboratory critical values policies and procedures: a College of American Pathologists Q-probes

SAFE PRACTICE RECOMMENDATION (Based on Massachusetts Coalition for Prevention of Medical Errors by Doris Hanna et al 2005 ) When results should be Who should receive results How to design, support, and What results require timely actively reported to How to notify the Who should receive the when ordering provider is maintain the systems and reliable communication ordering provider with responsible provider results not available involved explicit time frames Results were called in 1.5 were known. A critical values list should minutes or less in 25% of also be concise. Of reporting laboratories, laboratories. 75% or more had Potassium, Sodium, Notification should be to Calcium, Platelets, 17 institutions attempted responsible caregiver rather Hemoglobin/hematocrit , to measure interval time than clerical staff. Creating a Glucose, aPTT, PT/INR, between nurse receiving quality monitor for critical WBCs, Bilirubin, Carbon information and values enhances dioxide and Magnesium as communication of result notifications.[9] components of their critical to physician/midlevel values list. provider (i.e. physician An acceptable time interval assistant). Of 96 critical between test completion and calls measured, median Other frequently reported caregiver notification may be time=3 minutes, range analytes included lithium, 15-30 minutes. Outpatient up to 26 minutes. In Gram's stain, fibrinogen, time intervals may be longer, addition, only 34% phosphorus, blood gases given the requirement to provided the critical (pH, partial pressure of identify a physician on call or value to a physician or carbon dioxide, partial a call service.[ midlevel provider. pressure of oxygen, and creatinine (reported by 50% or more of participating labs)

Biochemistry: Ammonia, Arterial pH; Bilirubin; Calcium; CO2 ; Chloride; Creatine; Glucose; Potassium ; Sodium ;Urea; Uric acid.

On average, completion of notification required about 6.1 minutes for inpatients and 13.7 minutes for outpatients (self reported).

99.2% used telephone.

Haematology: aPTT; Hb; Hematocrit; Platelet count;

Slightly greater than 5% of critical value

10% used computer reports as primary

29.5% used fax machine or similar transmission device.

Based on more than 13000 critical values, to nurses (37.8%); a clerk (31.5%); or staff nurse (18.3%) For outpatients, call made to clerk (42.1%) , registered nurse

The calls were abandoned after 46mins –for outpatients. For in-patients, If no one can be found by lab personnel to accept the critical value after a short period of time, a physician

Fail safe mechanism to be implemented: Automatic notification of preprogrammed critical results: •

Read back policy (Based on Patient Safety Goals) call

The majority of participants (71.4%) had no policy on how repeat critical calls should be handled.

LIS automatically delivering results to

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No

Literature

study in 623 institutions. Howanitz, Peter et al Archives of Pathology & Laboratory Medicine June 1, 2002.

SAFE PRACTICE RECOMMENDATION (Based on Massachusetts Coalition for Prevention of Medical Errors by Doris Hanna et al 2005 ) When results should be Who should receive results How to design, support, and What results require timely actively reported to How to notify the Who should receive the when ordering provider is maintain the systems and reliable communication ordering provider with responsible provider results not available involved explicit time frames PT and WBC. telephone calls were means. (21.2%) or physician representing the lab will physician pager abandoned, with the ordering the test evaluate the resultslargest percentage (16.7%) significance and More than 95% of 42,25 used computer • Automated e-mail or abandoned for determine whether further participants reported as a secondary faxes to physician outpatients. action need to be taken. positive blood cultures, means. cerebrospinal fluid cultures, For outpatients: Patient and toxic therapeutic drug 6.9% used an record brought to physician in levels as critical values. answering machine ED who will contact the or voice mail system. patient and discuss results.

Read back policy (Based on Patient Safety Goals)

91% were made by person who performed the test. 4

Analysis of Laboratory Critical Value Reporting at a Large Academic Medical Center Anand S. Dighe, et al, Am J Clin Pathol. 2006;125(5): 758-764.

5

Notification of critical results – CAP Q-probes study of 121 institutions. Paul N.

Tests with critical values represented approximately 0.25% of the total test results reported. Of these, • Chemistry tests - 68.6% • Hematology 31.4% • Potassium -21.2% • Partial thromboplastin time -14.6%

Median time was 9 minutes, maximum 22 minutes (using computerized system).

Communication by telephone, placed by LIS system to patient’s location.

Delay in critical value reporting correlated with testing performed on outpatients and test requests lacking name of ordering clinician or location.

Laboratory staff monitor LIS application.

The list of tests was not provided in the study, as study focused on time taken.

The median time was 4 minutes from technologist's knowledge of critical result until time result was reported successfully (self reported).

Telephone communication.

For all critical results combined, no call or other form of rapid notification

Target to reach responsible caregiver.

However, results may reach an operations associate (OA, i.e. clerical staff members who perform clinical support functions.

Medical Laboratory Technologist – 90.3%

Not mentioned

Documentation of the phone call.

Mean time taken was 1.8 minutes (median 1 minute) from OA to caregiver.

Physician - 93%.

Registered nurse –91.2% Midlevel provider –83.3%

By •

LIS system that automatically flags each test result requiring critical callback.

Licensed practical nurse – 45.6% Medical student –12.3%

Laboratories that used a script with standardized words reported higher proportion of results that were read back (96.9%)

A total of 3240 (95.9%) of the 3379 critical result notification calls included results being read back; 89.4% of initial calls were made to a

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No

Literature

Valenstein,et alArchives of Pathology and Laboratory Medicine: Vol. 132, No. 12, pp. 1862–1867. 2008

6

Critical Values Comparison. A College of American Pathologists Q-Probes Survey of 163 Clinical Laboratories Elizabeth A. Wagar, et al. Arch Pathol Lab Med—Dec 2007. Vol 131.

SAFE PRACTICE RECOMMENDATION (Based on Massachusetts Coalition for Prevention of Medical Errors by Doris Hanna et al 2005 ) When results should be Who should receive results How to design, support, and What results require timely actively reported to How to notify the Who should receive the when ordering provider is maintain the systems and reliable communication ordering provider with responsible provider results not available involved explicit time frames took place for 10 (0.3%) of • Call center staff the 3545 critical results. The median time from Ward clerk, secretary – –0.9% specimen collection to 17.5% when technologist first knew about critical result was 48 minutes, and median time from specimen collection to time when someone accepted result was 56 minutes. More than 90% had the following, in descending frequency: potassium, sodium, calcium, platelets, hemoglobin, aPTT, WBC and prothrombin time (PT). More than 64% additionally reported microbiology tests (blood culture, Gram stain), bilirubin, carbon dioxide, magnesium, hematocrit, lithium and fibrinogen. Critical values for blood gas analytes (pH, PCO2, and PO2) were on the critical values list of 91 laboratories (56%).

98% of the institutions did make the first attempt to contact within the first hour.

Results direct via telephone (98%) within first hour. 5% permitted use of answering machine/fax machine after repeated failure to contact a caregiver. Vast majority use technical personnel exclusively (81%) or a mixture of technical and non-technical personnel.

Physians or licensed caregiver.

Inpatient -Administrative personnel (27%). OutpatientsAdministrative personnel48%. Only 5% of the reporting lab permitted an answering service or fax machine to receive results after repeated failure to contact

There should be a policy and procedure for reporting of critical value results

Read back policy (Based on Patient Safety Goals) licensed caregiver.

Read back policy was largely enforced by the laboratory. 12% of the reporting laboratory did not maintain documentation of the read back record.

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3 3.1

OBJECTIVES GENERAL OBJECTIVE

To assess current practices of immediate notification of critical values in MOH hospitals and to develop a national guidelines and interventional package for notification of critical laboratory values. 3.2

SPECIFIC OBJECTIVES 1. To determine the extent of good practice in immediate notification of critical values 2. To identify critical limits for laboratory tests that requires notification 3. To delineate procedures and processes to be put in place for notification of critical/panic values. These procedures are to be done for: a. within the laboratory b. in the ward 4. To develop a guideline required for notification of critical laboratory practices encompassing: a. Definitions to be used b. Types and values for tests considered to be critical c. Notification processes 5 To assess the effectiveness of an intervention package to improve notification of critical laboratory results in selected MOH hospitals.

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4

METHODOLOGY

4.1

OVERVIEW OF THE RESEARCH DESIGN

This study consisted of multiple phases, described here according to the objectives. The exploratory study was done first to answer objective 1, and objectives 2, 3 and 4 were carried out in a sequence of steps, as briefly described in Figure 3. Objective 5 consists of an interventional trial conducted in 4 interventional hospitals and 4 control hospitals in Malaysia.

Objective 5

Objective 2,3 and 4

Objective 1

Figure 3: Overview of Research Design Team/Event

Output

Cross sectional survey to assess current practices of immediate notification of critical values in MOH hospitals

Preliminary baseline data on the current practices in MOH hospitals

Research team

Search for literature on critical values/tests etc

Laboratory representatives,Nursing personnel, & research team members

Workshop IA: to develop evidence based lists of tests /critical values Workshop IB: to delineate processes currently in place or that could be instituted for notification of critical tests. Documentation & Recommendations

Meeting of Laboratory representatives with clinician representatives & research team

Workshop II: to develop evidence based lists of tests and critical values, reviewed by clinician representatives Documentation & Recommendations

Delphi survey

Delphi report which contains List of critical values & procedure for notification

Development of instruments for data collection and the intervention package itself

Audit forms for assessment: Q1, Q2 and Q3 Intervention package developed

Selection of hospitals for the study

8 hospitals ( 4 control & 4 intervention)

Phase 1: Audit 1 (hospitals =8)

Evaluation the baseline data on current practices with respect to notification of critical laboratory practices

Intervention (4 hospitals)

Phase 2: Audit 1 (hospitals =8) 3 months post intervention

Implementation of the intervention package Assessment on Fidelity of Implementation of Intervention

Evaluate the effectiveness of the intervention package

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4.2

SUMMARY OF METHODS USED FOR OBJECTIVES 1, 2, 3 & 4

The sections below provide a summary of what was done to answer the first 4 objectives of this project. Interim reports have subsequently been produced for these objectives. 4.2.1 OBJECTIVE 1 Objective 1: To determine the extent of good practice of immediate notification of critical values. [Lily et. al. 2008. Interim Report: Improving Notification of critical results in MOH Hospital. Institute for Health Systems Research, Kuala Lumpur, Malaysia. A Project for Improving Patient Safety [Lab4; Loi PS 2/2008 (Σ6)]. A cross sectional national survey was conducted in 126 MOH hospital laboratories to assess existing practices of immediate notification of critical values. The selection of the MOH hospital laboratories were based on those laboratories that participated in MOH Laboratory National Indicator Program (NIA). New hospitals 8 and special institutions 9 were not included in the survey. Hospitals were only considered to have a list of critical tests if they also had critical limit values for notification, demonstrated by a list. Hospitals that reported having a critical test list but gave normal reference ranges were classified to not have a critical test list. This includes “stat” tests, “urgent” tests and others with no critical limit values for notification. A letter was sent to 126 laboratories of various categories in all hospitals (composed of major specialist, minor specialist and hospitals without specialists) in early July 2007. The laboratories were requested to provide information on the critical tests, the critical values and mechanisms for notification of the results. No standardized format was provided for hospitals to provide feedback. A reminder letter was sent in August with a format on the required information when initial feedback showed confusion as to what was required. The format allowed collection of critical tests and definition of critical panic values. Follow-up telephone calls were made to improve response rate. 4.2.2 OBJECTIVE #2, 3 & 4 Objective #2, 3 and 4: Determining critical values and tests and developing guidelines for the process of notification Objective #2, 3 and 4: Determining the critical values and tests and development of guidelines for the process of notification [Lily et al. 2009. 2nd Interim Report: Improving Notification of laboratory critical results in MOH Hospital- Delphi Survey Report. Institute for Health Systems Research, Kuala Lumpur, Malaysia. A Project for Improving Patient Safety [Lab6; PS 5/2009 (∑19)]. Researchers conducted extensive literature search for available evidence on critical tests. Attempts were made to ensure the search covered all disciplines and those studies done major developed countries (USA, UK/Europe, Canada and Australia). The critical tests identified were compiled according to laboratory disciplines and they were used as input in two sequential workshops 8

Sultan Ismail Hospital, Johor and Ampang Hospital, Selangor IPR, National Blood Centre [Pusat Darah Negara], National Leprosy Centre [Pusat Kusta Negara], all the NIHs and the public health laboratories

9

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attended by representatives from laboratory, clinicians and nursing personnel. The two workshops succeeded in obtaining consensus on the definitions, lists of tests and their values, as well as the notification procedures. In the first workshop the pathologists reviewed available literature and retrieved additional ones to develop the first draft of “List of Critical Tests and Values” based on available evidence. In addition, they refined the definitions to be used. Nurses reviewed existing procedures according to what was practiced in their respective hospitals, literature on issues/requirements for notification process and delineated procedures based on good practice. The output of this work was used as input to the second workshop and presented to clinicians from various disciplines, senior laboratory personnel and nursing teams. The next stage in the development of the list of tests and procedures involved the use of the Delphi technique to obtain expert opinion from a wider group of clinicians, pathologists and nursing team. Two booklets were developed for the Delphi survey. The first booklet contained information on the lists of tests/values and procedures (termed the “full” booklet) (IHSR, 2007), distributed to all clinical and laboratory specialists. The second booklet contained the procedures for notification only and it was distributed to the hospital managers, nursing and laboratory personnel for their feedback .We planned for two rounds of the Delphi survey if consensus could not be reached in one round. Researchers identified officers from laboratories from all MOH hospitals to be the study coordinators () in their respective hospitals and region.We trained the coordinators centrally. Training included understanding the Delphi technique procedures and the contents of the booklets to enable them to explain to respondents in their own hospitals. The results of the first round was analysed and shared with all respondents. No second round of the survey was carried out as consensus was reached in round one. The output of the Delphi survey was then used to develop the “Q Quick Guide (2010) for improving Notification of Critical Laboratory Results in MOH Hospitals”. 4.3

THE INTERVENTIONAL TRIAL (OBJECTIVE #5)

Objective #5: To assess the effectiveness of an intervention package to improve notification in selected MOH hospitals 4.3.1 RESEARCH DESIGN A controlled trial was conducted 8 hospitals, 4 interventional and 4 control Ministry of Health (MOH) hospitals. Structured formats were used to obtain baseline data on the availability of adequate human resources, retention period of patient results, a list of test with critical value and the current system/procedure for notification of critical results. We focused on 5 Biochemistry 10 and 4 Haematology 11 tests, with the respective critical value based on literature. The intervention package was developed based practicality, current practices and good practice. We developed tools for notification in the laboratory and wards. The procedure adopted in the package covered many crucial elements advocated in Safe Practice Recommendations from the Massachusetts Coalition for Prevention of Medical Errors (Hanna et. al., 2005)

10 11

Sodium, Potassium, Glucose, Magnesium and Calcium Haemoglobin, Platelet count, Prothrombin time and Activated Prothrombin Time

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Data collectors were selected from laboratory personnel and researcher team. Data was collected pre- and post intervention. All records of selected Chemical Pathology and Hematology tests one week prior to the day of audit were selected from the laboratory records. Among these, tests with critical values that were notified were tracked from the laboratory to the respective wards and relevant information from ward/patient’s medical records retrieved. Information was extracted on number of tests done, number of critical values, notification status of critical values, method of notification and documentation. The following tests (identified in the top ten tests in the list of critical value during Part 1 of this study (Lily et.al, 2008) and critical value obtained from literature review was used in the implementation of the intervention package (Table 3). Table 3: Tests and values used to assess critical laboratory results notification in the study Adult Test Chemical Pathology

Haematology

Potassium Sodium Glucose Calcium Magnesium Haemoglobin Platelet PT APTT

Lower limit (mmol/L) 2.8mmol/L 125 mmol/L 2.8 mmol/L 1.5 mmol/L 0.41 mmol/L 6.0g/dL 20(109 L)

Upper limit (mmol/L) 6.0 mmol/L >155 mmol/L 20 mmol/L 3.0 mmol/L 2.0 mmol/L 19.0g/dL 1000(109 L) >2.5times the upper limit 80ec or >2times the upper reference range

Pediatrics Lower limit (mmol/L) 2.8 mmol/L 125 mmol/L

Upper limit (mmol/L) 6.0 mmol/L >155 mmol/L

1.7 mmol/L 0.5 mmol/L 7.0g/dL 50(109 L)

3.1 mmol/L 1.8 mmol/L 20.0g/dL 1000(109 L)

4.3.2 SAMPLING This is part of a larger study looking at patient safety in Malaysia. In the sample selected for community trial, all hospitals in Malaysia were stratified by Peninsular Malaysia or Sabah/Sarawak, and by either hospital with or without specialist (in total 4 strata). From this, 8 hospitals were selected, the intervention hospital by simple random sampling and the control hospital chosen to match the intervention hospital within the same stratum. For all the participating hospitals, all records of selected Chemical Pathology and Hematology tests one week prior to the day of audit were selected from the laboratory records. A cut off point of 1 week was selected as researchers felt follow up of test results at the ward level would be difficult for tests done more than 1 week prior to the audit. 4.3.3 INTERVENTION PACKAGE In the development of the intervention package, the intention was to improve notification of critical laboratory results in hospitals. This involved the development of tools for recording the results informed in the laboratory and wards. The intervention package consisted of the following: training, audit process, and materials specially designed for use during the implementation of the intervention. 4.3.3.1 TRAINING

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4.3.3.1.1 TRAINING OF DATA COLLECTORS The aim of the training was to highlight the method of collection of data using the data collection formats (Q1 – Q3) (Refer to Appendix 10 & Appendix 12) .The data collectors were also given a training on the correct practices for notification of critical value and requirements stated in ISO 15189 standards so that they can advise the audittee if they do not comply to the requirements for notification of critical result while collecting the data based on Q1 form. To assist them during data collection guidance notes was given to them (Appendix 9). 4.3.3.1.2 PROMOTING AWARENESS This involved creating awareness of the need for notification, and training on procedures that need to be implemented in the laboratory and wards. We designed posters to create awareness on the important steps required in critical result notification and the important steps in receiving critical results to serve as reminders for the laboratory staff and the health care providers in the wards respectively (Refer Appendix 13) 4.3.3.1.3 TRAINING OF LABORATORY STAFF AND WARD STAFF During the training, all the healthcare providers in the selected hospitals were trained on how to implement the intervention package with an aim to cause system change. During the training:•

Results from the preliminary survey were shared with all participants to emphasis on the need for change.

•

Procedure for identification and notification of critical results in the laboratory and ward was introduced.

•

Use of rubber stamps with the relevant details of notification and reminders in the form of poster and stickers on the important steps in critical result notification in the laboratory

•

Use of a booklet “Procedure for receiving critical results by Ward staff” Format C2 for recording the details of the notification of the critical results received from the laboratory to improve documentation and reminders in the form of poster on the important steps in receiving critical results, and a flipchart with the lists of tests and their critical value.

•

Emphasis was made on “Read back” mechanism to ensure there is no miscommunication.

4.3.3.2 AUDIT PROCESS The audit process was done in two phases. Before the start of the intervention, data was collected to form the baseline data using Q1-Q3 forms. After 3 months, after the start of the intervention, a repeat audit was done using the same forms to effectiveness to assess the effectiveness of the intervention measures and to improvement in the notification process in the ward and laboratory (Appendix 13). During each visit, the records are checked for one week period for the selected tests. Each researcher as well as the data collectors with collect the test results for the selected 5 Chemical Pathology and 4 Hematology tests and check whether the vales are within the critical limits. If it is within the critical limit, has it been notified, record maintained about the notification and if it has not been done, the reasons for not doing so. The audit will then be extended to the ward, to check if the notification from the laboratory has been documented and the information given to the doctor concerned. The researchers would also assess whether the implementation tools such as the 29 | P a g e


structured documenting tools such as stamp pad and the booklet in the ward has been used Immediate feedback would be given to the healthcare providers. An audit by the identified by the supervisor in the laboratory to be completed by supervisor one day /week using the Format CS1 and provide any additional booklets etc for recording (Appendix 14). 4.3.3.2.1 INSTRUMENTS FOR AUDIT Form Q1 (Appendix 10) was developed to obtain baseline data in all the laboratories with respect to number of technical staff working in the sections of the laboratory where the study was being conducted with the aim of adequacy of staff. In the same form data was also collected on their current practices for notification which included availability of a system/procedure/SOP/instruction for notification of critical results which should include mode of notification, retention period of records and training provided to the staff. Form Q2 (Appendix 11) – To obtain summary of the critical results for the selected tests. Form Q3 (Appendix 12) – Details of notification process in laboratory and ward. 4.3.3.3 ENABLING MATERIALS 4.3.3.3.1 RECORDING OF NOTIFICATION BY LABORATORY Rubber Stamp (Format C1) (Refer Appendix 13) We designed a rubber stamp to ensure vital information are not missed out: patient’s name, ID and ward, as well as date and time of notification, test name and result, laboratory number, name and designation of result recipient, if read-back was done by the recipient, name and signature of informer. 4.3.3.3.2 RECORDING OF NOTIFICATION BY WARD Booklet (Format C2) (Refer Appendix 13) Information received about the patient’s critical result was recorded in this A5-size booklet. For completeness, information required to be filled in this booklet were: the patient’s name and ID/RN, test name and result, name of laboratory personnel who notified the result, date and time of notification, if read-back was done by the recipient, name of doctor if result informed to him/her and the category of doctor (House Officer, Medical Officer, Registrar or Specialist), if the patient was not in the ward was result notified to the ward where patient was transferred to, or if the patient had been discharged was any action taken, name and designation of result recipient 4.3.3.3.3 LIST OF CRITICAL TESTS AND VALUES The list of Chemical Pathology and Haematology tests with the critical values Chemical Pathology Adult No

Test

1 2 3 4 5

Potassium Sodium Glucose Calcium Magnesium

Lower limit (mmol/L) 2.8 125 2.8 1.5 0.41

Upper limit (mmol/L) 6.0 >155 20 3.0 2.0

Pediatrics Lower limit Upper limit (mmol/L) (mmol/L) 2.8 6.0 125 >155 1.7 0.5

3.1 1.8

30 | P a g e


Haematology No

Test

Lower limit

1 2 3 4

Haemoglobin Platelet PT APTT

6.0g/dL 9 20(10 L)

Adult Upper limit 19.0g/dL 9 1000(10 L) >2.5times the upper limit 80ec or >2times the upper reference range

Pediatrics Lower limit Upper limit 7.0g/dL 9 50(10 L)

20.0g/dL 9 1000(10 L)

4.3.3.4 REMINDERS 4.3.3.4.1 FLIPCHART Designed like a flip calendar,(Refer Appendix 13) to serve as a reminder for health care providers in the wards and was an easily accessible reference. 4.3.3.4.2 STICKER The sticker (Refer Appendix 13) with the 5 critical steps in the notification process was designed so that it could be stuck on the machine in the laboratory, and serve as a reminder for the staff. 4.3.3.5 FIDELITY OF INTERVENTION IMPLEMENTATION During intervention, the research assistant would carry out fidelity checks via telephone calls to the intervention laboratory. An audit by the identified by the supervisor in the laboratory to be completed by supervisor one day/week using the Format CS1. (Appendix 14). 4.4 ETHICAL CONSIDERATIONS The Medical Research and Ethics Committee approved this study. Confidentiality of respondents was maintained, and responses pooled, not linked to individual respondents. Response was voluntary. MOH staff that wanted to immediately implement this notification in their department/hospital(s) were encouraged to do so. In addition, at baseline assessment of hospitals, all laboratories were briefed on the minimal requirements for critical results, including control hospitals. This is because researchers felt it was unethical not to inform laboratories that immediate notification is required for critical results to ensure patient safety. Hence, the difference between control and intervention hospitals was that the latter received enabling mechanisms as part of the intervention package to assist in notification. Both intervention and control hospitals were told of the requirement for immediate notification.

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5

FINDINGS

Results of objectives 1, 2, 3 and 4 are briefly described in sections 5.1 and 5.2. Details of these have been reported elsewhere. 5.1

OBJECTIVE #1

Objective #1: to determine the extent of good practice of immediate notification of critical values. Lily et al 2008. Interim Report: Improving notification of critical results in MOH hospitals: Institute for Health Systems Research, Kuala Lumpur, Malaysia. A Project for Improving Patient Safety [Lab4; Loi PS 2/2008 (Σ6)]. Response was received from 123 laboratories (97.6%). Among these laboratories, 119 laboratories (97%) sent lists of tests that were identified as either critical or “stat” tests. Three labs gave a written response that they do not have any critical tests. Out of 119 labs that had a list, only 58 laboratories (67.2%) sent to the researchers, list of critical tests with critical values. The total number of critical tests reported was an average of 11 per hospital (sd =5 tests), with a median of 11, mode of 11, minimum of 3 and maximum of 26. The upper and lower critical limits for the 10 most common tests showed marked variation among the laboratories. Potassium was the commonest critical test reported, and the top 10 type of tests varied with hospital category. The majority (87.9%) of the hospitals reported critical results were notified by telephone, and this mode of communication did not differ across hospital category. The majority (81.0%) of the hospitals did not report a method for documenting notification details. This documentation practice differed across hospital category, with almost half of state hospitals not stating how documentation was done. Only 13.8% of hospital laboratories reported that details of notification were kept in record books and 3 hospital laboratories reported using the Laboratory Information system (LIS) Following this survey, it was recognized that: a) The importance of critical value reporting is still poorly recognized in MOH hospital laboratories. Internationally accredited practices for communication and recording are also not currently implemented. b) MOH needs to improve the awareness and institution of critical value notification and application of this concept in hospitals. We need to develop a standard list of critical test/values and a method or procedure for notification. The procedure has to span across laboratories, nursing and clinical disciplines to ensure there is an optimal system in place to ensure patient safety. 5.2

OBJECTIVE # 2, 3 AND 4

Objective # 2, 3 and 4: Determining the critical values and tests and developing guidelines for the process of notification [Lily et al. 2009. 2nd Interim Report: Improving Notification of laboratory critical results in MOH Hospital- Delphi Survey Report. Institute for Health Systems Research, Kuala Lumpur, Malaysia. A Project for Improving Patient Safety [Lab6; PS 5/2009 (∑19)]. 32 | P a g e


A total of 649 consultants/specialists responded. Of the 560 specialists who responded to the question on the usefulness of critical value list, more than 90% agreed that the list of critical results was a useful tool in improving patient safety. Definitions for critical limit and critical results were modified for additional clarity based on the feedback. The definition of a critical test was found to be misleading and to prevent further confusion the model notion of critical test and its definition were dropped. Consensus was achieved for the majority of tests and the critical values. However, many tests were dropped from the current developmental list, due to lack of feedback and literature of the upper and lower limits. Procedures were refined but in essence, accepted as it is. The Delphi Survey was conducted only amongst MOH personnel, and excludes experts from the university and private sector. Overall response was mediocre (42.5% and 76% for full and procedure booklet respectively). However, response was poor from some hospitals and from some disciplines (e.g. pharmacists. In contrast, we received requests for permission to use information from the booklets (critical limits and procedures) from some hospitals, indicating a need for a local Malaysian critical value and procedure guide to assist the laboratory in establishing immediate critical value notification. In comparison with international data, the median upper and lower critical values in this report for 9 most common analytes in Chemical Pathology and Hematology were similar with internationally reported analytes. The procedure we had suggested for use covered many of the recommendations advocated in Safe Practice Recommendations from the Massachusetts Coalition for Prevention of Medical Errors (Hanna et. al., 2005). The time frame suggested by many of the respondents is that it should be shorter than 30 minutes. The key for critical tests is that the results must be made available to the healthcare provider within the timeframes established by the organization. Critical results and values must be acknowledged by the receiver to ensure prompt action. A phone call is the most common reporting mechanism. One of the problems, which many laboratories in MOH struggle to achieve, is timely notification to the ordering physician. Still, tracking down the appropriate caregiver in a timely manner via telephone can be difficult, due to the fact that many of the request forms very often do not have the name of the requesting consultant. 5.3

OBJECTIVE #5

Objective #5: To assess the effectiveness of an intervention package to improve these practices in selected MOH hospitals. The following sections describe the results for this objective. Hospital characteristics are in Table 4. 5.3.1 LABORATORY CHARACTERISTICS Specialist Hospital in Peninsular Malaysia (PMi_Spec_M) had the largest workload (total number of tests =32,042) while Non-specialist hospital in Sabah/Sarawak (SSc-NonSpec_R) recorded the least number of test (total number of tests =695). All laboratory test results were recorded in the Laboratory Information System (LIS) except for 3 hospitals. Records of the test results are retained for more than 36 months (Table 5 & Table 6). Each laboratory has various categories of staff with specialist hospitals having larger numbers of pathologist, scientific officer, MLT and AMLT (Table 7).

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Among the laboratory characteristics assessed included were training, list of critical values and notification of critical values to the ward. All the laboratories did not conduct any formal training for handling critical test results. A critical test list was only available in 4 out of the 8 hospitals (Table 8). The telephone was the most widely used mode of communicating critical laboratory results. During collection of the baseline data in the 8 hospitals, it was found that four laboratories did not have specific guidelines about the details of information that should be recorded while communication of critical values. Three of four of the above laboratories were in non-specialist hospitals while one was in a specialist hospital located in the Sabah/Sarawak region. It was also noted during the initial stage two components of the notification process, namely the ‘read-back’ practice and documentation of reasons for not informing critical results were absent in all hospitals in this study (Table 8). 5.3.2 IDENTIFICATION OF CRITICAL RESULTS Figure 4 shows the flow of results for notification and documentation from laboratory until notification to doctor. There were a low percentage of tests identified with critical value, ranging from 0.6% to 5.6%. However a few hospitals had a high number of tests with critical value before intervention, which was mainly due to misidentification of values as critical i.e. any results which were above or below the normal reference-range values were identified as critical value In three of the non-specialist intervention and control hospitals there was a decrease in the number of critical values identified in the pre and post intervention phase of the study again due to the use of wrong values (Table 9). 5.3.3 NOTIFICATION OF THE CRITICAL LABORATORY RESULTS IN THE LABORATORY Table 9 shows the difference in the number of test results which were identified as having critical value before and after introduction of the intervention package in the participating hospitals. Notification of critical results ranged 0.0% to 15.3% before implementation and this increased from 78.5% to 100% after implementation of the intervention package. In the control group it ranged from 0.7% to 4.1% before and increased to 5.2% to 100% after implementation of the intervention package (Table 9) Both specialist hospitals and one non-specialist hospitals that received the interventional package showed a statistically significant rise in the proportion of critical results that were notified postintervention. Compared with the control group, the intervention package led to significantly higher rate of notification of critical results in 3 of 4 hospitals (Table 9). There is minimal variation is percentage of tests with critical results across the different analysis studied (Table 10) 5.3.4 EFFECTIVENESS OF INTERVENTION – NOTIFICATION OF CRITICAL RESULTS Generally, the intervention package was effective in both the specialist hospitals in improving notification of critical values. The 95% confidence interval (CI) of the interventional package based on prevalence of critical results were between 64% to 100%. However, the package was not effective in one non-specialist intervention hospital in Peninsular Hospital showing no improvement while both intervention and control hospitals in Sabah/Sarawak region showed significant improvement. (Table 11)

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5.3.5 DOCUMENTATION OF NOTIFICATION IN LABORATORY Documentation of notification in laboratory was mainly via the Laboratory Information System (LIS). In the post intervention phase of the study, only one out of the four interventional hospitals (Specialist hospital M in Peninsular Malaysia) kept a duplicate copy of the notification record (Appendix Table 1). 5.3.6 NOTIFICATION IN WARD Pre-intervention, in general 41.9% of all critical value notification received in the ward were via telephone and in almost half of the critical value received there was no documentation on the method of notification. Post intervention there was an overall increase up to 88.4% in the use of telephone for notification (Appendix Table 2). Post-intervention, in most interventional hospitals, the wards received the notification through the telephone. In addition, in two control hospitals (PMi_Spec_M and SSi_NonSpec_KB) demonstrated that most notification were via telephone (Appendix Table 2). Documentation of the information received was generally not available pre-intervention and post intervention showed no major improvement though SSi_Spec_M showed some improvement. In contrast to two control hospitals (PMc_Spec_S and SSc_NonSpec_R showed improvement. (Appendix Table 2) Reasons for not notifiying critical results or documenting them include “busy” and “forgot” to do so (Table 12). 5.3.7 NOTIFICATION TO THE DOCTOR There is a increase of in the percentage of critical notified to the doctor in both intervention and control hospitals. (Table 13) 5.3.8 NOTIFICATION OF CRITICAL VALUES BY TEST/ANALYTES Generally, notification for the most tests/analytes improved significantly with improvement greater in the interventional hospitals compared to the control hospitals (Table 10). The percentage of notification by tests is shown in Table 10 and Table 14. The reasons not notifying critical values and not documenting include being busy and forgetting to do so (Appendix Table 3). Receipt of notification of critical laboratory value in the ward were mainly via telephone irrespective of analyze. (Appendix Table 4). 5.3.9 FIDELITY OF INTERVENTION IMPLEMENTATION The fidelity test to test the implementation of intervention package was collected by respective immediate supervisors from all the four intervention hospitals (Table 15). The total number of fidelity forms received varied between hospitals, from 3 in a non-specialist hospital to 24 in a specialist hospital. Verification was conducted by supervisors on all critical results detected in the four hospitals. However, the notification rate ranged from 64.8% to 99.5% during implementation of the intervention. (Table 15). 35 | P a g e


Figure 4: Number of Critical Results Detected, Notified & Documented, pre- and post-intervention Critical Result Total: [Pre (n=1182), Post(n=1038)]

YES Notified & recorded [Pre (n=31), Post(n=280)]

NOT Notified [Pre (n=1151), Post(n=758)]

Notification recorded [Pre (n=31), Post(n=249*)]

YES recorded [Pre (n=13), Post(n=129)]

NOT recorded [Pre (n=18), Post(n=120)]

How was notification received? [Pre (n=31), Post(n=249*)] E:g Via Phone (Pre: 13 Post: 220) Can’t Remember (Pre: 1 Post: 0) Result Receive Urgent (Pre: 0 Post: 1) Other (Pre: 1 Post: 0)

Record of information received? [Pre (n=31), Post(n=249*)]

YES information received [Pre (n=13), Post(n=129)]

NO information received [Pre (n=18), Post(n=120)]

Critical value recorded [Pre (n=13), Post(n=129)]

YES [Pre (n=13), Post(n=128)]

NO [Pre (n=0), Post(n=1)]

Notification to doctor [Pre (n=31), Post(n=249*)]

YES notify to doctor [Pre (n=13), Post(n=116)]

NOT notified to doctor [Pre (n=18), Post(n=133)]

Dr’s name [Pre (n=13), Post(n=116)]

YES Dr’s Name available [Pre (n=12), Post(n=57)]

Dr’s Category [Pre (n=12), Post(n=57)] st

Note: *reason for how was notification received taken only from 1 test notified

NO Dr’s Name not available [Pre (n=1), Post(n=59)]

36 | P a g e


Table 4: Hospital characteristics of the intervention and control hospitals in the study Characteristics

Hospital MOH classification Total admission (2008) Total doctors (2007) Bed occupancy rate (BOR),(2008)

Specialist Hospital Pen. Malaysia Sabah/Sarawak Intervention Control Intervention Control PMi_spec_M PMc_spec_S SSi_spec_M SSc_spec_S Melaka Seremban Miri Sibu 66855 317 88.4

56902 245 74.3

21129 46 65.4

Non-specialist Hospital Pen. Malaysia Sabah/Sarawak Intervention Control Intervention Control PMi_nonsp_T PMc_nonsp_KK SSi_nonsp_KB SSc_nonsp_R Tapah Kuala Kangsar Kota Belud Ranau

29151 90 65.6

6029 14 34.2

7106 16 43.1

9743 6 65.0

6671 6 66.9

Table 5: Laboratory characteristics – Tests Workload*

Characteristics

Total workload Laboratory information systems (LIS) Record of test results Retention period of test results (month)

Specialist Hospital Pen. Malaysia Sabah/Sarawak Intervention Control Intervention Control PMi_spec_M PMc_spec_S SSi_spec_M SSc_spec_S Melaka Seremban Miri Sibu 32042 13896 9336 10823 Yes Yes No Yes Yes Yes Yes Yes ≥ 36 ≥ 36 ≥ 36 ≥ 36

Non-specialist Hospital Pen. Malaysia Sabah/Sarawak Intervention Control Intervention Control PMi_nonsp_T PMc_nonsp_KK SSi_nonsp_KB SSc_nonsp_R Tapah Kuala Kangsar Kota Belud Ranau 1950 4159 4133 695 No Yes Yes No Yes Yes Yes Yes ≥ 36 ≥ 36 ≥ 36 ≥ 36

* All details were collected before the implementation of the intervention package (only intervention group)

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Table 6: Number of tests done (workload) for the past 7 days Intervention Workload for inpatient Chemical Haematology pathology Total n n (%) (%)

Hospital

Peninsular Malaysia Specialist hospital

Peninsular Malaysia Nonspecialist hospital

Sabah/ Sarawak Specialist hospital

Sabah/ Sarawak Non-specialist hospital

Control

Workload for outpatient Chemical Haematology pathology Total n n (%) (%)

Total

Workload for inpatient Chemical Haematology pathology n n (%) (%)

Workload for outpatient Chemical Haematology pathology Total n n (%) (%)

Pre

32042

28518 (89.0)

3524 (11.0)

12712

11812 (92.9)

900 (7.1)

13896

11874 (85.4)

2022 (14.6)

12544

11292 (90.0)

1252 (10.0)

Post

29586

25319 (85.6)

4267 (14.4)

13602

13013 (95.7)

589 (4.3)

13711

4530 (33.0)

9181 (67.0)

7153

3183 (44.5)

3970 (55.5)

Pre

1950

137 (7.0)

1813 (93.0)

3365

234 (7.0)

3131 (93.0)

4159

1436 (34.5)

2723 (65.5)

6906

3600 (52.1)

3306 (47.9)

Post

327

327 (100.0)

0 (0.0)

80

80 (100.0)

0 (0.0)

1385

173 (12.5)

1212 (87.5)

1858

1012 (54.5)

846 (45.5)

Pre

9336

7621 (81.6)

1715 (18.4)

8262

6856 (83.0)

1406 (17.0)

10823

8235 (76.1)

2588 (23.9)

5490

4806 (87.5)

684 (12.5)

Post

8607

4704 (54.7)

3903 (45.3)

6755

3191 (47.2)

3564 (52.8)

14823

8640 (58.3)

6183 (41.7)

5528

4702 (85.1)

826 (14.9)

Pre

4133

1239 (30.0)

2894 (70.0)

3081

1164 (37.8)

1917 (62.2)

695

390 (56.1)

305 (43.9)

1503

866 (57.6)

637 (42.4)

Post

3376

1474 (43.7)

1902 (56.3)

1743

1096 (62.9)

647 (37.1)

611

399 (65.3)

212 (34.7)

1207

645 (53.4)

562 (46.6)

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Table 7: Laboratory characteristics – Personnel* Personnel working on: Weekdays (Chem)# Pathologist Scientific officer MLT AMLT Weekends (Chem)# Pathologist Scientific officer MLT AMLT Weekdays (Hae) # Pathologist Scientific officer MLT AMLT Weekends (Hae) # Pathologist Scientific officer MLT AMLT

Specialist Hospital Pen. Malaysia Sabah/Sarawak Intervention Control Intervention Control PMi_spec_M PMc_spec_S SSi_spec_M SSc_spec_S Melaka Seremban Miri Sibu 2 0 3 4 0 0 0 0 4 2 5 0 3 0 2 0 19 5 18 4 13 4 17 4 2 0 1 1 0 0 0 0

Non-specialist Hospital Pen. Malaysia Sabah/Sarawak Intervention Control Intervention Control PMi_nonsp_T PMc_nonsp_KK SSi_nonsp_KB SSc_nonsp_R Tapah Kuala Kangsar Kota Belud Ranau 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 1 2 3 1 3 2 3 2 2 0 1 1 0 0 0 0

na na na na

0 2 5 0

na na na na

6 0 7 0

na na na na

0 0 6 0

na na na na

0 0 4 0

na na na na

0 0 3 1

na na na na

0 0 1 1

na na na na

0 0 2 1

na na na na

0 0 3 0

2 4 19 2

0 2 5 0

3 5 18 1

4 0 4 1

0 3 13 0

0 0 4 0

0 2 17 0

0 0 4 0

0 0 1 2

0 0 2 0

0 1 3 1

0 0 1 1

0 0 3 0

0 0 2 0

0 0 3 0

0 0 2 0

na na na na

0 2 5 0

na na na na

6 0 7 0

na na na na

0 0 6 0

na na na na

0 0 4 0

na na na na

0 0 3 1

na na na na

0 0 1 1

na na na na

0 0 2 1

na na na na

0 0 3 0

Note: na - not available, MLT – Medical Lab Technologist, AMLT – Assistant Medical Lab Technologist, Chem – Chemical Pathology, Hae – Haematology * All details were collected before the implementation of the intervention package (only intervention group) # Number of personnel during office hour (unshaded area) # Number of personnel after office hour (shaded area)

39 | P a g e


Table 8: Laboratory characteristics Pre-Intervention – Training and Documentation pertaining to Critical Result Notification* Characteristics

Training List of tests with critical values Notification of critical values to ward Method Recording details Date Time Person informing from lab Person received Patient name Patient ID Test name Test value Read-back done Reason for not informing

Specialist Hospital Pen. Malaysia Sabah/Sarawak Intervention Control Intervention Control PMi_spec_M PMc_spec_S SSi_spec_M SSc_spec_S

Non-specialist Hospital Pen. Malaysia Sabah/Sarawak Intervention Control Intervention Control PMi_nonsp_T PMc_nonsp_KK SSi_nonsp_KB SSc_nonsp_R

Melaka

Seremban

Miri

Sibu

Tapah

Kuala Kangsar

Kota Belud

Ranau

No Yes

No Yes

No No

No No

No No

No Yes

No No

No Yes

Phone & urgent dispatch

Phone

Phone

Phone

Phone

Phone

na

Phone

Yes Yes No Yes Yes Yes Yes Yes No No

Yes Yes Yes Yes Yes Yes Yes Yes No No

No No No No No No No No No No






Note: na - not available *All details were collected prior to implementation of the intervention package Coding used for naming hospital laboratorys: PM=peninsular Malaysia; SS=Sabah/Sarawak; spec=specialist; nonsp=non-specialist hospital

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Table 9: Extent of Notification of Critical Results (CR) before and after intervention Intervention Hospital type

Total tests done

Tests with CR*

% tests with CR (of total tests)

Control CR Notified

Total tests done

Total

%

(A)

(B)

Tests with CR*

% tests with CR (of total tests)

CR Notified

Comparison of % CR Notified # (p value ) +

Total

%

Int vs. control

(C)

(D)

(B vs. D)

Pre

20219

491

2.4

14

2.9

20398

691

3.4

17

2.5

0.818

Post

20707

255

1.2

211

82.7

17357

783

4.5

69

8.8

technical report

technical report

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