A Study to Evaluate Perception and Implementation of Critical Alert Protocol Amongst Laboratory Personnel and Critical Care Team in a Tertiary Care Hospital

Introduction

Critical value reporting is a mechanism by which direct reporting of potentially life-threatening laboratory results are made available to critical care team. Lundberg pioneered the concept of critical value reporting as “values which reflect pathophysiological derangements at such variance with normal to be life-threatening if therapy is not instituted immediately.” ¹ This has been redefined by many international organizations. Clinical Laboratory Improvement Amendments (CLIA ’88) includes requirements on critical value reporting.² The Joint Commission (JC) defines critical result as, “results of tests and diagnostic procedures that fall significantly outside the normal range and may indicate a lifethreatening situation. These results should be provided within an established timeframe so that the patient is promptly treated by a responsible licensed caregiver” and was subsequently addressed by the College of American Pathologists (CAP) Laboratory Accreditation program. ^3,4 Critical value reporting is deemed important and essential by International Organization for Standardization (ISO) in its medical laboratory standard ISO 15189:2012 and National Accreditation Board for Hospitals and Healthcare providers Accreditation standards.^5,6 Critical alert notification and its management are considered an important outcome measurement for reflecting clinical effectiveness, patient safety, and coordinated operational efficiency. For an effective critical value reporting process, it is important to address all the variables involved in the process.⁷

We conducted a study to understand the awareness and perception of documented protocol for critical alerts, its notification and implementation amongst laboratory personnel and clinical care team. The purpose of the study was to have an insight into implementation of current lab practices and identify areas of improvement.

Materials and Methods

Mixed method study design that integrates quantitative and qualitative method was used to conduct this study in two phases for one-year period (December 2018 to November 2019). Phase one included a questionnairebased survey with individual interview and phase two constituted monitoring the implementation of the process. Questionnaire was developed, validated by lab experts, and distributed on ‘Google form’. Lab experts constituted all teaching faculty from tutors to full professors in consultation with senior technicians with more than a decade of experience in Biochemistry lab. A pilot run was done to validate the questionnaire before its distribution to participants. Questionnaire was meant to explore the awareness and perception of participants about critical alerts. List of critical alerts for chemistry parameters used in current practice was the knowledge base for evaluation along with the existing practices followed for critical alert notification. List of critical alerts were developed by lab experts who have been a part of lab practice for over a decade in consultation with clinicians. Majority of the questions (Table 1 and 2) were based on binary answers (‘yes’ or ‘no’) or choice of answers as per current lab protocols and list of parameters from which they had to choose the ones that are meant for critical alert notification. Individual interview of ten technologists and six front-office lab staff was conducted after the survey that focused on the same questions to understand the process.

No interviews were conducted in the ICU / wards since this study was focused on improving lab practices.

Monitoring the implementation of lab protocol for critical alert notification was done over two timeframes with six-month gap between them. After first timeframe, training was given to those who did not comply with the protocol. Extent of compliance was documented.

Non-random, purposive sampling technique was used for recruiting participants for the study. Participants constituted of entire lab team (lab technicians & front office staff, Clinical Biochemistry) and representative population of clinical care team (nursing staff, interns, junior doctors working in inpatient wards of Medicine, Surgery, Paediatrics, Obstetrics & Gynaecology (OBG) and Intensive Care Unit (ICU) of tertiary care hospital). Staff unwilling to complete the questionnaire and those who did not form a part of immediate point of contact for critical alerts were excluded.

Responses to questionnaire were exported to Microsoft Excel version 2105 for analysis. The frequency distribution (in percentage form) for responses was used to describe the outcome of the study. Outcome of the responses for questionnaire and interview was categorized into themes and further described in discussion.

Results

In Phase one, a total of 113 responses from 17 laboratory staff, 42 ICU staff (Medical ICU, Surgical ICU, Paediatric ICU and Neonatal ICU) and 54 ward staff (Medicine, Surgery, OBG and Paediatric) were documented for the questionnaire-based survey (Table 1 and 2). The questionnaire was designed to understand the (a) concept of critical alert and (b) management of critical alert protocol. Interview of lab staff revealed extent of understanding and implementation of the protocol. Arshad A et al., RJAHS 2021; 1(2):20-27 22 Table 1: Questionnaire-based survey for critical alert protocol. 

A. Concept of critical alert: Binary response in the form of yes/no for concept, ability to identify and categorize critical alert parameters and perception of critical alert communication were captured.

a. Lab Staff

All of them were aware of the concept. However, 88% of them identified calcium, phosphorus, chloride, uric acid, lipase and cerebrospinal fluid (CSF) glucose as critical alert parameters amongst 16 listed. All of them identified the remaining as critical parameter. All lab staff felt that it was essential to notify critical alert to clinician and lab protocol for critical alert was found satisfactory.

b. Critical care team – ICU

All of them were aware of the concept. However, there were varying perceptions on the list of critical alert parameters. Only 50% of staff categorized Troponin I as critical alert parameter. One hundred percent of ICU critical care team felt that it was essential to notify critical alert to clinician. Protocol for critical alert was found satisfactory by 90.5% of the staff.

c. Critical care team – ward

94.2% of staff were aware of the concept. More than 50% of staff were unable to identify and categorize parameters as critical. Approximately 76% of staff identified serum potassium and Troponin I as critical alert parameters. One hundred percent of critical care team felt that it was important to notify critical alert to clinician since it was useful information. Protocol for critical alert was found satisfactory by 77.6% of staff.

B. Management of critical alert protocol: Documentation, implementation and record of the protocol was evaluated.

a. Lab Staff

One hundred percent of staff were aware of documented protocol and documented the critical alert. All staff were actively involved in implementing critical alert protocol. First response of 58.8% staff to critical alert was to repeat the test, while 41.2% informed the ICU/ward. All of them verified with patient’s previous value (if available). Majority of the time, front office staff notified about critical alerts by telephone (Table 1). During dayshift, the time taken to communicate to clinical care team was longer in comparison to night shift. This was based on documented time and was also elicited during the interview. Time was calculated in minutes from the time of sample receipt till communication.

b. Critical care team – ICU

Sixty nine percent of staff were aware of protocol and only 81% documented the critical alert, although majority of them were trained for handling the same and they also confirmed that lab informs critical alert. 90.5% of staff were actively involved in implementing critical alert protocol. First response of 81% staff who were notified of critical alert was to inform the clinical team, and 66.7% of the time, it was communicated in person (Table 2). Majority of the staff informed the critical alert at the earliest, although it would take 15 to 30 minutes in few cases.

a. Critical care team – ward

Majority (62.1%) of the staff were aware of protocol and documented the critical alert. Many of them were trained for handling critical alert and were actively involved in implementing critical alert protocol. Staff confirmed that lab informs critical alert and their initial response was to inform the clinical team via telephone at the earliest, though at times it took 15 to 30 minutes (Table 2).

In Phase two, two sample audits were done to evaluate implementation of critical alert with sixmonth gap between them (Table 3). Technical staff responsible for non-compliance in first audit were retrained with regard to list of critical parameters, alert values and documented protocol. However, the second audit revealed that technical staff responsible for non-compliance were found to be different from the first audit findings.

Discussion

Critical alert reporting is an essential element in patient care, and it requires adherence to protocols for it to be effective. Critical alert protocols were made to ensure there was timely and efficient communication of critical values. It included elements like list of critical parameters and alerts, who would inform, how information was communicated, timelines, result call-back option and documentation in designated register. List of critical parameters was derived from published literature and vis-a-vis consultation with the clinicians. The protocol formulation was based on literature review to ensure validity.⁸ This study was done to evaluate the awareness and implementation of documented protocols for critical alert notification. Outcome of two audits reflects extent of protocol implementation. When all the responses were compiled and evaluated, it could be categorized as four themes: (a) Awareness of critical alerts, (b) Initial response to critical value, (c) Mode of informing and to whom information is given (d) Time taken to notify critical alert.

Awareness of critical value

There was 100% awareness amongst lab personnel and nursing staff (both ICUs and wards) about the terminology of critical alert, although there was a lack in understanding the parameters that were of critical importance. Our lab has been accredited for more than a decade and there still seems to be small lacunae in understanding about the critical alert parameters. This could be attributed to the newly recruited staff or negligence on the part of existing technical staff. It is probably due to routine or mundane technical activities that could have shrouded the critical thinking and judgement while answering the survey questionnaire. This could also explain why a few parameters could be missed in routine practice that could be quite detrimental to patient care although unintentional.

Initial response to critical value

Though technical staff performing the test were supposed to inform critical alert to clinical care team, this practice had changed over a period and it shifted to front-office personnel. Forty percent of technical staff were confident about the lab results and hence there was no cross verification by repeating the test. Due to roundthe-clock availability of treating clinician in the ICU, nursing staff informed them in person (81%) and results were ready-to-view on hospital information system. This questionnaire was not administered to consultants in ICU since it was targeting the primary responders. In the ward, nursing staff informed the available treating clinician, while 13.8% were documenting in patient’s record. Surveys have revealed that there is diversity in communication policies with respect to critical alerts. Sixty five percent of European and 80% of Australasian laboratories did not actively communicate a critical result if it was not significantly different from patient’s previous result.^9,10 As suggested by CAP Q-Tracks study, reporting of all critical values including repeat ones, was valuable as it indicates better monitoring.¹¹

Mode of informing and to whom information is given

Majority of the critical alerts from the lab were informed by registration assistant / front office person by telephonic message. Sometimes lab staff informs the critical alerts via laboratory information system (LIS), which requires a vigilant nursing staff to take appropriate action. In case of out-patients, the results were informed directly to the treating clinician. Patient was tracked down and informed to meet their physician. This was a difficult task because of incorrect numbers registered with their medical record. There is no system at the level of medical records to ascertain the validity of phone numbers. In such cases, it was documented as a part of report notes, though it might delay the required care. As a tertiary care hospital, patients from nearby rural centres also utilize the services and there is varying degree of literacy. So, importance of providing accurate details during patient registration is of paramount importance. Hospital-based study in Gujarat reported that telephonic communication and documentation of critical alerts was a costly practice.¹² Survey of 136 labs by Schapkaitz E and Mafika Z showed reporting of critical alerts were undertaken telephonically (5.6%) and via call center (19.4%) by technologist on duty.¹³ Majority of labs notified the critical value to either the doctor or nurse who was directly involved in patient’s care. It revealed that reporting of critical alert to direct caregiver makes a significant difference, since patient’s clinical condition and significance of critical alert may require immediate intervention.

There was no mention of critical value call back in either of the groups that were administered the questionnaire. Probably this could be due to lack of this option as a response to the question. During interview, front-office staff verified that ‘result call back’ option was practiced as a routine procedure when the results were informed.

Majority of nursing staff informed the clinical care team in person, while less than 40% informed telephonically to the treating clinician. This disparity in transmission of information can be attributed to availability of the treating clinician. Our study is similar to the meta-analysis by Lam Q et al., that revealed 38% of European labs had a formal protocol when the responsible clinician was not available/contacted.9 Sixty four percent of French and 15% of Australian labs communicated directly to patient or via the police or ambulance service. Thirty four percent of European and 39% of Australasian labs formally documented when the delivery of critical alerts had to be abandoned.¹⁴ A review by Q-Tracks study revealed that critical alert reporting to an appropriate and responsible healthcare professional had shown to improve critical value reporting.10 Elizabeth et al., reported that 56% of participating labs had policy or procedures for managing critical values, while 27% of labs allowed non-healthcare professionals to accept critical results for inpatients. However, there was no consensus on handling outpatient critical values during nights and weekends.¹⁵ Dietzen Dennis suggested electronic alerts in electronic medical records, e-mail and middle ware solutions as possible modes of relaying information without interrupting the workflow of caregivers.¹⁶

Studies have explored call centre facility for critical report communication as an option.¹⁴ Dighe et al., inferred from his study that it would be ideal to centralize communication in the form of service center staffed with technologists/ trained personnel to ensure protocol implementation and simultaneously unburdens the lab.¹⁷

Time taken to notify critical alert

In our study, time taken for critical alert notification by lab showed variability during day and night shift. Although night shift had limited staff, the information was relayed earlier in comparison to dayshift. This could be attributed to increased sample load due to both outpatient and inpatient samples. This contrasts with the findings of Dighe SA et.al., that indicated that there were challenges to communication during night shift due to lab staffing and provider availability.¹⁷ A study conducted by Desai KN and Chaudhari S in Shree Krishna Hospital, Gujarat reported that time taken to inform was 21, 30 and 20 minutes for inpatient, out-patient, and emergency departments.¹⁸

Ninety one percent of nursing staff informed the clinical care team at the earliest, while at times it took 15 to 30 minutes. It may be inferred that this delay could be due to difference in attitude and perception of urgent notification by clinical care team. Whether this delay in 30 minutes would have been detrimental to patient’s well-being remains to be a matter of debate, since our objective did not cover the follow-up after critical alert notification. The documentation of time taken to inform the clinician forms a key factor in performance improvement and protocol compliance.

Critical alert protocol adherence and implementation seemed to be better amongst lab staff in comparison to critical care staff in the wards. However, ICU critical care staff were compliant and adhered strictly to protocols in comparison to ward. A study by Dighe SA et al., showed that 23.8 % of responders in their survey did not record the time period.¹⁷ Lab survey revealed that there was an unavoidable delay in reporting due to additional time required to reach the caregiver.¹³ The Clinical and Laboratory Standards Institute (CLSI) guidelines recommends that a laboratory or healthcare organization should conduct risk analysis to determine and categorize lab results as critical-risk or significant-risk. Reports falling under critical-risk might require immediate intervention, hence requires notification, while a significant risk has to be notified, though may not require immediate intervention.

When such categorization is done, it will assist in communication and management of patient care with appropriate intervention.⁹ Outcome of two audits revealed that there is a requirement for re-training and constant monitoring of critical alert notification to ensure thorough implementation. In the first timeframe, the lab staff not complying with critical alert notification were trained and with the second audit, it was revealed that non-compliant technicians were different from those in the first audit. It was evident from these audits that there was a casual attitude towards the process. By default, all technicians should be retrained that helps to improve the work processes.

Conclusion

In conclusion, laboratory and clinical care teams were aware of the importance of critical alert notification and its protocol. However, there were gaps in its implementation that was evidenced during audits. Work processes requires constant monitoring and periodic retraining to improve efficiency and prompt clinical care.

Conflict of Interest

None.