Attachment 7 - 11-100 Reporting Diagnostic Test and Critical Results.pdf

SIOUX FALLS VA HEALTH CARE SYSTEM (SFVAHCS)

SIOUX FALLS, SOUTH DAKOTA

REPORTING DIAGNOSTIC TEST AND CRITICAL RESULTS

I. PURPOSE

The purpose of this policy is to state the policy, responsibilities and procedures for informing providers of test results and the ordering provider’s responsibility to report test results to patients.

II. POLICY

A. It is SFVAHCS policy to communicate test results to the ordering practitioner, or surrogate practitioner, within a timeframe allowing prompt attention and appropriate clinical action to be taken. A standardized process is essential to ensure appropriate Provider action and positive patient care outcomes. Providers and patients will receive notification of test results in a timely manner. Patient notification of test results will be documented in the Electronic Medical Record (EMR).

B. SFVAHCS Diagnostic Services including Pathology and Laboratory

Medicine, Diagnostic Imaging (Radiology and Nuclear Medicine), and Cardiovascular Services/EKG will maintain a list of critical results that will be communicated by the diagnostic service to the responsible licensed independent practitioner (LIP) or designee within one hour of result verification. (Attachments A-C)

C. The Medical Executive Committee will annually review the critical result lists and revise as necessary per recommendations by individual Diagnostic Services, Patient Safety, or practitioner input.

D. All Critical Point-Of-Care (POC) glucose results will be documented in the

CPRS template titled Critical Point of Care Glucose. The registered nurse responsible for the patient will document the POC critical glucose results and nursing interventions independent of the laboratory venous results reported. Each glucose<45 or >500 glucometer result will have a CPRS critical POC template completed for each of the corresponding testing times/provider order.

III. DEFINITIONS

A. Asynchronous Communication: When parties involved in

SFVAHCS Policy No. 11-100 November 2019 communication are not present at the same time, such as electronic notification in the Computerized Patient Record System (CPRS), secure messaging, FAX, or letter.

B. Critical Value or Result: Those values or interpretations that, if left untreated for minutes or hours, could be life threatening or place the patient at serious risk.

C. Designee: A designee is a clinical team member who acts on behalf of the ordering provider to receive information and/or notifies patients of test results in a timely manner This is not the same as a surrogate.

D. Diagnostic Provider: A diagnostic provider is a provider who performs or supervises the performance and interpretation of diagnostic tests (i.e.

Radiology, Laboratory, etc.) either through privileges or by acting under a scope of practice.

E. Ordering Provider: An ordering provider is a provider authorized to enter and sign orders for diagnostic tests.

F. Personal Representative: A person, who under applicable law has authority to act on behalf of the individual. This may include power of attorney, legal guardianship of an individual, the executor of the estate of a deceased individual, or someone under Federal, state, local or tribal law with such authority (e.g., parent of a minor).

G. Synchronous Communication: When parties involved in a communication are all present at the same time, such as in person, telephone conversations, or Clinical Video Telehealth (CVT).

H. Test Results: Test results include the results of laboratory and pathology testing, diagnostic imaging, and diagnostic procedures. Test results are categorized as abnormal or normal as determined by a clinical provider and are further defined as follows:

1. Abnormal Test Results: Abnormal test results are results that fall outside a specified normal reference range, are unexpected, or could indicate the presence of disease. An abnormal test may or may not require action and therapeutic intervention, depending on the clinical context. There are three types of abnormal test results that require action or therapeutic intervention:

a. Critical Life Threatening: Any diagnostic finding which must be acted upon by the ordering provider or their designee immediately or within a short window of time and could result in severe morbidity or mortality if left untreated.

b. Urgent Non-Life Threatening: Any diagnostic finding which must be acted upon by the ordering provider or their designee within a relatively urgent timeframe (as clinically indicated to ensure timely, appropriate and effective therapeutic action).

c. Clinically Significant: A diagnostic finding that requires action by the ordering provider, or their designee, but not necessarily in an immediate or urgent time-frame.

2. Normal Test Results: While the significance of a “normal” test result needs to be determined clinically, in the context of this policy it is defined as a diagnostic finding that generally falls within the normal reference range for the test or in the clinical judgement of the provider, considered within normal limits and may or may not require immediate action or change in treatment depending on clinical circumstances.

3. Write Down/Read Back: Term applies to how critical results are communicated to the ordering provider or designee. The ordering provider or designee that receives the critical results(s) must write down the findings and read back the results to the diagnostic provider to verify that the result(s) reported were accurately heard.

IV. RESPONSIBILITY

A. Medical Center Director is responsible for development and implementation of a written policy regarding communication of test results to ordering providers and to patients

B. The Chief of Staff (COS) is responsible for:

1. Providing clinical oversight to ensure the development of efficient communication processes for Critical Results notification.

Monitoring of processes will be reviewed by performance measurement data presented to the Quality, Safety Value (QSV) Committee.

2. Ensuring each service (and section(s) or department(s) within each service) follows processes and procedures consistent with this policy and the VHA Directive 1088 that identify providers and staff who can communicate test results to patients. These policies and procedures should also specify what type of test results providers and staff can communicate, and how the results are communicated.

3. Resolving with service line Directors any gaps detected in test result follow-up processes.

C. Associate Director of Patient Care Services/Nurse Executive is responsible for ensuring effective collaboration between the medical and nursing staff in the management and reporting of diagnostic test results.

D. Service Line Site Directors or Department Management are responsible for:

1. Establishing procedures consistent with VHA Directive 1088 within their department or section for the receipt of test results from diagnostic providers to the ordering provider, or designee, and the communication of test results to patients by the ordering provider, or designee.

2. Reviewing procedures and practices for test result communication to both providers and to patients from each section or department they supervise as applicable.

3. Monitoring the effectiveness of the patient notification process and addressing performance improvement issues as needed. Service Lines are responsible for auditing the notification process. This will consist of a minimum of 30 charts done twice a year.

E. Diagnostic Provider is responsible for:

1. Identifying and communicating all critical test results and urgent non-life threatening abnormal test results to the ordering provider or their designee.

2. Documenting in the medical record the time and means of communication of critical life-threatening results and the name of the ordering provider or designee informed of these results.

3. Ensuring that test results are available in the patient’s electronic medical record as soon as the reports are verified.

F. ED Provider/ Hospitalist during Off Tours are responsible to ensure that documentation of tests/exams ordered outside of regular duty hours is completed, the ordering Provider is notified of the results, and any follow-up actions are addressed. The ED Provider is responsible for critical outpatient results and Hospitalists are responsible for inpatients and CLC critical results.

G. Laboratory, Echo Technician, Imaging, and Respiratory Therapy

(RT)/Electrocardiography (ECG) is responsible to respond to ordered procedures and tests as defined based on order priority status and to contact appropriate staff in a timely manner when a critical result or critical test result is known.

H. Nursing staff is responsible to be familiar with and adhere to health care system processes to ensure timely Provider notification of test results.

V. PROCEDURE

A. Ordering practitioners are responsible for:

1. Routine, ASAP, and Stat Results: Provider writes an order for a test/exam. Request is to be noted as ROUTINE, ASAP, or STAT. If staff that perform the testing are needed to perform the test at the bedside, the ordering Provider or designee will contact the testing department staff and communicate the request.

a. ROUTINE: Standard procedures are followed.

b. ASAP: Testing department will perform the test/exam as soon as possible that day.

c. STAT: Testing department will perform the test/exam immediately.

If the order is written as STAT, and the patient is an outpatient, the Provider will ask the patient to remain until the results of the test/exam are available. If the patient is unable to remain, the Provider will make arrangements for the patient notification of results, i.e., obtain contact phone number or have patient call the station.

2. Provider Notification Process: Provider will review the electronic health record or CPRS alert when test is resulted and notify the patient within the timeline based upon the type of test result (normal/abnormal).

3. Critical Results Notification: The testing department will contact the

Provider/ or designee to notify them of test results. Critical values and test results require a verbal read-back of the result from the Provider or designee and must use a “record and read-back” process to verify the information.

a. When an RN is notified, the RN must notify the Provider and complete the Critical Result Notification template in CPRS.

b. If the Provider/designee receives the test result directly from the testing department, the Provider will document the response to the Critical Result.

c. Critical Point-Of-Care (POC) glucose results will be documented in the CPRS template titled Critical Point of Care Glucose. The registered nurse responsible for the patient will document the POC critical glucose results and nursing interventions independent of the laboratory venous results reported. Each glucose<45 or >500 glucometer result will have a CPRS critical POC completed for each of the corresponding testing times/provider order.

d. Staff who perform an ECG/EKG which is noted to be critical are required to enter a critical result note in CPRS and cosign the provider that the report is given to.

e. If Echo Technician detects a potential critical abnormality the echo technician should notify the cardiologist immediately and enter a critical result note in CPRS and cosign the provider that the report is given to.

B. Patient Notification Process:

1. Inpatients/Residents/Emergency Department: If determined relevant, the Provider will discuss results with the patient. If unable to discuss results with the patient, the next of kin or personal representative will be notified.

2. Outpatients:

a. If results are within normal limits, and the test/exam was ordered ROUTINE, results will be available in the electronic medical record and the ordering Provider or designee will notify the patient of the test results within fourteen calendar days and document the notification. This communication can be conducted asynchronously or synchronously.

b. Critical Life-Threatening test results must be communicated by the ordering practitioner, or designee, to patients no later than twenty-four hours from the date on which the results are available. Synchronous communication must be attempted.

c. Urgent Non-Life-Threatening and Clinically Significant test results must be communicated by the ordering practitioner, or designee, to patients no later than seven calendar days from the date on which the results are available.

Synchronous communication must be attempted.

d. If results are abnormal and require further evaluation, the

Provider or designee will notify the patient, determine an appropriate follow up plan, and document the notification and the follow up plan within seven days.

e. In exceptional circumstances, it may be necessary to delay communication of test results beyond the timeframes identified above. For example, communicating a diagnosis of terminal cancer or Human Immunodeficiency Virus (HIV) in a sensitive, empathic manner may require a face-to-face visit at a time convenient to the patient, which could extend beyond the seven-calendar day time frame. Due to the sensitive nature of certain test results, the determination of how to report these results are best made on a case-by-case basis. Review and discussion of test results need to be provided to the patient, or patient’s personal representative, with an opportunity for questions and discussion.

3. Inpatient results reported after discharge should be addressed by the ordering inpatient practitioner or their designee. The ordering practitioner or their designee may transfer this responsibility to an outpatient practitioner and the handoff must be documented in CPRS.

4. If the patient lacks decision making capacity, results will be communicated to the personal representative of the patient.

5. When tests are ordered by residents, the Attending has the responsibility for ensuring the required communication and documentation occurs.

6. Failed attempts to communicate test results with the patient are documented in the medical record.

7. For patients in the inpatient or emergency care setting, it is not required or expected that each individual test result is communicated to the patient. The ordering practitioner or the patient’s care team should strive to effectively communicate relevant information to the patient about his/her medical condition. Results of specific tests may be included in this communication as appropriate.

8. Mammography Reports: Studies performed by Community

Mammography practitioners must meet VHA and Mammography Quality Standards Act and Program (MQSA) standards, policies and procedures. Community Mammography practitioners are responsible to meet all requirements within this policy for communicating the results of significant abnormal studies performed on patients referred to them by MEDVAMC facilities. This entails providing a written report for all mammography reports within 30 days to the ordering practitioner and the patient. For those reports considered “suspicious or highly suggestive of malignancy”, the interpreting radiologist must communicate the findings verbally to the ordering practitioner within three working days and the ordering practitioner communicates the findings to the patient within five working days.

C. The RN receiving the result is responsible for:

1. Ensuring the accuracy of exchanged information by writing down the critical results and reading the result(s) back to the reporting individual.

2. Evaluating the critical results to determine if it is an anticipated or unanticipated abnormal result for this patient.

a. If the practitioner has written orders to direct the appropriate follow up for an anticipated abnormal result, the RN is responsible to see that the orders are carried out as written.

b. If the critical result is unanticipated for the patient, the RN must immediately notify the appropriate practitioner via direct verbal communication (face to face or telephone).

3. The individual reporting the critical results will document in the patient’s electronic medical record. The RN will enter the result, name of the practitioner who received and the notification, and if verbal orders are issued in response to the critical results. These must be written down and read back to the practitioner.

VI. REFERENCE

A. VHA Directive 1088, Communication Test Result to practitioners and Patients

B. SFVAHCS Policy No. 11-91 Critical Test Results

C. Mammography Quality Standards Act (ref: 21 C.F.R. 900.12(c), et.seq.)

D. VHA Directive 1330.01, Health Care Services for Women Veterans

E. VHA Directive 1605.01, Privacy and Release of Information

F. Accreditation Manual for Hospitals, Joint Commission, current addition

G. College of American Pathologists’ Standards

H. VHA Handbook 1105.3 Mammography Program Procedures and Standards

VII. RESCISSIONS

SFVAHCS Policy No. 11-100, Reporting Diagnostic Test and Critical Results”, dated February 2019

VIII. FOLLOW-UP RESPONSIBILITY

Chief of Staff Review Date is annually: November 2020

IX. THIS POLICY WILL REMAIN IN EFFECT UNTIL RESCINDED.

LISA J. SIMONEAU, FACHE, PMP

Director

Attachments:

A. Laboratory Critical Results B. Imaging Critical Results C. Cardiology Critical Results D. Call Tree for Critical Test Results

1. INFORMATION: SFVAHCS Policy No. 11-100, “Reporting Diagnostic Test and Critical Results” dated November 2020

2. ORIGINATOR: Administrative Officer to the Chief of Staff

3. REQUIRED CONCURRENCE:

Associate Director for Patient Care Services/Nurse Executive, Service Line Site Director, Primary/Spec Med SL Service Line Site Director, EC&R SL

Service Line Site Director, Surgical/Specialty Care SL Service Line Site Director, Mental Health SL Program Director, QSV Lab Manager, Radiology, Chief, Human Resources Management

4. KEY WORDS: Ordering/Reporting, Patient Test, Results

5. RESCISSIONS: SFVAHCS Policy No. 11-100 dated February 2019

6. REVIEW DATE: November 2020

Attachment A: LABORATORY CRITICAL RESULTS

Chemistry

Carbamazepine Above 13 mcg/ml Carbon Monoxide Greater than 10% Calcium ≤6 mg/dl; ≥13 mg/dl CO2 Below 15 mEq/L CRP ≥ 270 mg/L Digoxin Above 3.0 ng/ml Dilantin Above 25 mcg/ml Glucose Below 45 mg/dl

Above 500 mg/dl HIV Positive single use chromatographic immunoassay.

pCO2 (Arterial Blood) Below 20 mmHg

Above 60 mmHg pH (Arterial Blood) Below 7.2

Above 7.6 PO2 (Arterial Blood) Below 50 mm Hg Potassium Below 3.0 mEq/L

Above 6.5 mEq/L Sodium Below 118 mEq/L

Above 155 mEq/L Valproic acid Above 150 mcg/ml Troponin ≥0.12ng/ml Lithium ≥1.5 mmol/L Lactic Acid ≥ 3.0 mEq/L

Hematology

Hemoglobin Below 7 gm/dl WBC Below 1.5 k/cmm Peritoneal fluid total polynuclear count

Above 250 cells/uL

Platelets 10 k/cmm and below

Prothrombin time/INR INR > 4.5

Partial thromboplastin time Above 125 seconds

Blood bank

Emergency released uncrossmatched blood units on a patient with a clinically significant antibody or if incompatibility is detected at any stage of testing.

Any transfusion reaction investigation that is indicative of a hemolytic transfusion reaction or other serious reaction.

Microbiology

Blood cultures Positive gram stain, ID and susceptibility Clostridium difficile Positive PCR CSF Positive antigen test, growth or gram stain MRSA, VISA, VRSA, VRE All sites except surveillance Strep pneumo Penicillin resistant, fluoroquinolone resistant and on this antibiotic Resistant gram negative rods ESBL, Carbapenem resistant, Amp C or multiple resistance to all aminoglycoside and 3rd & 4th cephalosporins

Legionella Positive urine EIA, positive DFA or growth Mycobacterium Positive smear or growth

Viral culture or DFA Positive results for respiratory viruses from inpatients only

India Ink Positive results Influenza Positive results for inpatients and CLC residents Pertussis Positive results Transfusion Reaction workup-culture

Positive Results

Anatomic Pathology

If the evaluation of any anatomic pathology specimen concludes there is an unexpected diagnosis of clinical significance, the patient’s practitioner must be personally notified by verbal communication as soon as possible (ideally, within 1 working day of the time that diagnosis was made). Such diagnoses may include, but are not limited to, change of a frozen section diagnosis after review of the permanent section if clinically significant and/or unexpected mycobacterial, fungal or other significant infectious organisms identified on special stains.

All frozen sections called with routine single frozen section specimens within twenty minutes of receipt in lab.

Attachment B: IMAGING CRITICAL RESULTS

**The following pathophysiologic categories that are new findings and require immediate clinical attention will be considered critical results**

RADIOLOGY CRITICAL RESULTS

Testicular or Ovarian Torsion Pneumoperitoneum Acute Intracranial Hemorrhage Cervical Spine Fracture Aortic Dissection Mediastinal or Retroperitoneal Hematoma Intracranial Mass with new Hematoma Pulmonary Embolism or DVT Hemoperitoneum Thoracic or Lumbar Spine Fracture with cord compression Acute laceration of the liver, spleen or kidney Airway Compromise Appendicitis Abscess

Pneumatosis of Bowel Wall Portal Venous Gas Acute Arterial Embolism/Occlusion

Tension Pneumothorax

NUCLEAR MEDICINE CRITICAL RESULTS

V/Q scans = higher probability pulmonary emboli Myocardial Perfusion Studies () if the area of ischemia is greater than 25% of left ventricular volume.

Attachment C: CARDIOLOGY CRITICAL RESULTS

Critical EKGs ST elevation or LBBB unless known to be chronic Severe narrow complex tachyarrhythmias (Heart rates > 200 per minute) Any wide complex Tachycardia Bradycardia (<30 BPM)

Critical Echocardiograms Large pericardial effusion Significant valve obstruction Unusual echo density, vegetation or tumor Ruptured Chordae Aortic Dissection Cardiac Rupture

Critical Vascular Results Identification of any of the following vascular results are considered a critical result:

Cold extremity ABI index below .5 Graft Imaging- Occlusive clot/thrombus with ultrasound imaging

Attachment D: Call Tree for Critical Results Test Results

Call Triage

a. Ordering practitioner

b. Backup contact will be a surrogate that consists of another practitioner or the

Service Line Chief (after hours call the AOD at ext. 6355 to connect the diagnostic personnel to the Service Line Leader.)

If a surrogate cannot be reached contact the Chief of Staff at extension 6729 or by paging their Administrative Officer at 251 during business hours. After hours the Chief of Staff can be contacted by calling the AOD at ext. 6355.