S02 - Attachment 24 - VAMC Numbered Memorandum 113-03-14 Reporting Critical Tests and Critical Test Results.docx

1. April 7, 2014 Numbered Memorandum 113-03-13

REPORTING CRITICAL TESTS AND CRITICAL TESTS RESULTS

1. PURPOSE: The purpose of this policy is to establish standard operating procedures for timely notification of clinical staff of critical and significantly abnormal test results and “critical tests” reported by care lines performing diagnostic tests and/or procedures. The ordering provider (i.e., the physician, physician assistant, or nurse practitioner who ordered the test) or in certain cases, the registered nurse or clinical pharmacist who is responsible for the care of the patient will be notified in a timely manner when specified diagnostic test results show critical results or when they are defined as “critical tests”.

2. POLICY: To ensure patient safety at the Mann-Grandstaff Veterans Affairs Medical Center (VAMC) and report critical tests and critical test results in an appropriate timeframe.

3. DEFINITIONS:

a. Critical Results: “Critical” is any result or finding that may be considered life threatening or that could result in severe morbidity and require urgent or emergent clinical attention.

b. Significantly Abnormal Test Results: These non-emergent, non-life threatening results are reportable values that generate a mandatory alert in Veterans Information System Technology Architecture systems (VISTA), but no verbal report. For Computerized Patient Record System (CPRS) purposes, these results are designated as “critical” high priority alerts.

c. Critical Tests: These are tests that require rapid communication of results, whether normal, abnormal or critical. Critical tests for imaging are listed in the attachments. Results of these tests will be communicated to the responsible provider verbally within established timeframes with documentation in the final report. Critical tests are defined as stat order by ordering provider.

d. “Read Back”: The process of an individual receiving the results of a critical or significantly abnormal result, or critical test by writing down and reading back the information to the individual providing this information.

e. Diagnostic areas: Pathology and Laboratory Medicine, Imaging, Cardiology and other diagnostic areas as defined by the organization.

f. Program areas: Ambulatory Care, hospital including Clinic Based Outpatient Clinics (CBOC’s), home care, intermediate care, long term care and behavioral health care as surveyed by Joint Commission.

g. Pathology and Laboratory Medicine clinical critical values are listed in Attachments A-C. Providers will be notified verbally of these critical values and tests within 30 minutes of result verification. For Radiology and Nuclear Medicine, providers will be notified as directed in this policy by the physician who interprets the Radiology or Nuclear Medicine imaging study.

4. PROCEDURES:

a. Ordering practitioners are responsible for:

(1) Placing the initial order containing accurate contact information for themselves;

(2) Initiating appropriate clinical action and follow-up on abnormal results of any tests ordered by them even if they are not the patient’s Primary Care Provider;

(3) Documenting treatment actions in the medical record in response to critical results/values, critical test results and significantly abnormal tests;

(4) Taking appropriate therapeutic actions;

(5) Communication of non-life threatening outpatient test results no later than 14 calendar days from the date on which the results are available to the ordering practitioners; discussing test results with patients and/or authorized next-of-kin or legal guardian, as appropriate, and documenting these discussions in the (CPRS).

b. Pathology and Laboratory Medicine Reporting:

(1) The Clinical Executive Council will annually review, update, and approve the list of laboratory tests and their defined high and/or low critical values. An updated list of values can be accessed on the S drive S:\Laboratory\Critical Values (See attachments A-C). If there has been no prior definitive diagnosis of malignancy (excluding skin squamous and basal cell carcinomas) the responsible pathologist will report the new malignancy to the ordering provider. This will be documented in the VistA laboratory report by using the SNOMED code P58005.

(2) After establishing that a test result is critical and verifying that the result is correct, clinical laboratory personnel performing the test will enter the result in VistA and immediately contact the responsible provider or if they are not available to a nurse to report the critical value. Attachments E, F, and G outline a reporting algorithm for an outpatient or inpatient critical laboratory result and pathology frozen sections (we consider the latter as “critical tests”). Additionally, the algorithm guides the reporting process in circumstances where the ordering provider is not available.

(3) When reporting critical values of laboratory test results, clinical laboratory personnel will identify themselves, state the emergency nature of the call, verify the name of the person receiving the report, give the name of the laboratory test and the test results. The person receiving the report will write down and read back the patient’s name and the critical results. Laboratory personnel will then document in the comment section of the laboratory test result in VistA the name of the person called, the date and time the call was made, and note that “read-back verification was performed”. If the result was given to a Registered Nurse (RN), a notation of the nurse’s first name and extension must be added to the comment. If at any point in the algorithm a provider/nurse refuses to take the critical call, complete a Patient Safety Event Report using the Patient Safety Report icon on the desktop and notify the laboratory Quality Assurance Coordinator.

(4) The ordering provider will also receive an alert in VistA for all clinical laboratory test results (except for General Microbiology) that are listed as critical. Selected significantly abnormal tests (not emergent) will also generate a mandatory alert in VistA but will not require a verbal report to the health care provider. These tests are listed in Attachment C.

c. Diagnostic Imaging Reporting:

(1) Radiologists and Nuclear Medicine Physicians will use the current voice recognition dictation system when reporting Radiology and Nuclear Medicine test interpretations in the electronic medical record. Reporting priority will be given to tests requested as “Stat” and “Urgent”. An official interpretation (final report) shall be generated and archived following any examination, procedure, or officially requested consultation regardless of where the exam was performed (Medical Center, CBOC, or outside provider) as soon as possible, and to meet the current performance measure of greater than 95 percent of all imaging examinations within 48 hours of completion.

(2) Diagnostic reporting codes will be applied to all abnormal imaging studies. Automatic CPRS mandatory electronic alert messages will be generated by the assignment of codes as defined below in Table 1.

(3) For the purposes of notifying clinicians of critical or significantly abnormal radiology/nuclear medicine findings either verbally and/or electronically, the diagnostic reporting codes identified below will be used.

(4) Code 99-Critical Abnormality: Any new radiology/nuclear medicine finding that may be considered life threatening or could result in severe morbidity and require urgent or emergent clinical attention will be coded as 99. Examples of the types of critical abnormal findings that fall into the Code 99 category may include cerebral hemorrhage/hematoma, acute stroke, unstable spinal fracture, pneumothorax (unsuspected or tension), pneumoperitoneum (not post op), aortic dissection, major pulmonary embolism, ruptured or leaking aneurysm, and significant misplacement of tubes or catheters (i.e. enteric tube in lungs. Use of this code requires both electronic and verbal notification to the ordering provider within 60 minutes of discovering the abnormal result. This notification will be documented in the written report. Table 1 above outlines a reporting algorithm for an outpatient or inpatient critical imaging result. Additionally, the algorithm guides the reporting process in circumstances where the ordering provider is not available. Also, if an ordering provider or their surrogate is not available, communication to any other staff (such as RN) requires a “read back” to the reporting Radiologist communicating the abnormal result. This read-back interaction must be documented in the imaging report or progress note by the interpreting physician. In the dictated report, the following documentation is required: 1) specific provider name (not just “the Emergency Department physician”) and 2) specific time the communication occurred.

Table 1

Code

Notification Electronic Notification

(5) Code 15- New Reportable Infectious Abnormality: Any new abnormality considered suspicious of active tuberculosis or other reportable infectious disease that is a significant public health risk will be assigned Code 15. Both a verbal and electronic notification will be made to the ordering provider within three hours of discovering the finding. Table 1 above also includes the reporting algorithm for an outpatient or inpatient infectious abnormality critical result. This algorithm also guides the reporting process in circumstances where the ordering provider is not available. In addition, the Infection Control Officer will be notified. These notifications will be documented in the report or progress note. In the dictated report, the following documentation is required: 1) specific provider name (not just “the Emergency Department (ED) physician”) and 2) specific time the communication occurred.

(6) Code 1003- New Unexpected Finding Suspicious or Highly suggestive of Malignancy: Any finding that is an unexpected abnormality suspicious or highly suggestive of malignancy will be coded 1003, generating a mandatory CPRS alert to the ordering provider for appropriate follow-up action. A list of unacknowledged alerts will be forwarded to the Tumor Registrar on a weekly basis.

(7) Code 10-Abnormality: An abnormality or unexpected finding that is not considered to be an urgent and immediate life threatening finding but needs attention and follow-up action as soon as possible will be coded 10 generating a mandatory alert to the ordering provider for appropriate follow-up action. Examples of such abnormalities may be acute fractures, new pneumonias, aortic aneurysms, etc.

(8) Code 14 – Amended Report: The report has been changed in some way and a review is required.

(9) Preliminary Reports: If a preliminary report is released in CPRS it is labeled “Preliminary Report (Released/Not Verified)”, annotated with the preliminary interpreting resident (or radiologist) and retained as part of the medical record. If the final interpreting (verifying) provider does not accept the preliminary report he/she should create an addendum and then finalize the report. This action creates a mandatory CPRS alert. The names of both the preliminary and final interpreting (verifying) providers are retained in the medical record. In addition, if the final report differs significantly from the preliminary report (thus impacting the patient’s care) the ordering provider must be verbally notified as soon as possible with the notification specifically documented in the final report. This process also generates a mandatory alert to the ordering provider for appropriate follow-up action.

d. Mammography Reports: Studies performed by Community Mammography providers must meet Veterans Health Administration (VHA) and Mammography Quality Standards Act (MQSA) standards, policies and procedures. Community Mammography providers are responsible to meet all requirements within this policy for communicating the results of significant abnormal studies performed on patients referred to them by Michael E. DeBakey Veterans Affairs Medical Center (VAMC) facility. This entails providing a written report for all mammography reports within 30 days to the ordering provider and the patient. For those reports considered “suspicious or highly suggestive of malignancy”, the interpreting radiologist must communicate the findings verbally to the ordering provider within three (3) working days and to the patient within five (5) working days. For the purposes of alerting clinicians of abnormal mammography findings, the diagnostic reporting codes identified below will be used.

(1) Code 1104- BI-RADS 4 Mammogram (Suspicious abnormality – Biopsy should be considered), Code 1105- BI-RADS 5 Mammogram (Highly suggestive of malignancy – Appropriate action should be taken), Code 1106- BI-RADS 6 Mammogram: (Known biopsy – proven malignancy – Appropriate action should be taken): Mammogram findings with suspicious abnormalities or confirmed malignancies (BI-RADS Categories 4, 5 and 6) will be communicated directly by the interpreting radiologist or designee to the ordering provider within three working days. If verbal communication to the ordering provider is not possible, the ordering provider’s designee or Service Chief shall be notified within the three day limit. The interpreting radiologist will document this communication in his/her report. Additionally, a mandatory View Alert about the radiological report shall be sent via CPRS to the ordering provider. Prompt verbal notification to the patient by the contract or fee basis agency should be made within five (5) working days and does not obviate the need to provide written communication to the patient within 30 days. When a biopsy reveals proof of malignancy, the summary results and recommended course of action are communicated by the interpreting radiologist to the ordering provider via a CPRS View Alert and direct verbal notification.

Code

Mammography Diagnostic Reporting Code Definition Verbal Notification Electronic Notification

BI-RADS

Codes

BI-RADS 4 Mammogram: Suspicious abnormality-Biopsy should be considered.

Y

( 4 )

( D )

BI-RADS 5 Mammogram: Highly suggestive of malignancy - Appropriate action should be taken

( 5 )

( E )

BI-RADS 6 Mammogram: Known biopsy-Proven malignancy – appropriate action should be taken.

( 7 )

No Category

(2) If the ordering provider is unavailable, any other staff communication requires “read back” to the designated individual communicating the abnormal results. This read-back interaction must be documented in the imaging report or progress note by the interpreting provider. All Code 1104, 1105 and 1106 studies will be monitored for timeliness and compliance.

(3) In the dictated report, the following documentation is required: 1) specific provider name (not just “the ED physician”) and 2) specific time the communication occurred.

e. Cardiology: Electrocardiogram (EKG)

(1) At the completion of the EKG, a copy with a preliminary report is left with the provider. The final interpretation by a cardiologist is completed within 24 hours.

(2) Four diagnoses are considered urgent:

(a) ST elevation indicating a Myocardial Infarction

(b) Ventricular Tachycardia

(c) Heart Rate ≤30

(d) Heart Rate 200

(3) The following actions must be taken for these diagnoses.

(a) The EKG Technician performing the test must immediately notify the ordering physician.

(b) The ordering physician must take appropriate action according to approved protocol.

(c) The Cardiologist interpreting the EKG will assure that appropriate action was taken by the ordering physician.

f. Cardiology: Echocardiogram

(1) The following diagnoses are considered urgent and if these conditions are noted during the procedure, the cardiologist will take the appropriate actions:

(a) Pericardial Tamponade/Large pericardial effusion

(b) Cardiac rupture

(c) Ventricular septal defect

(d) Severe mitral regurgitation/papillary muscle rupture after myocardial infarction

(e) Severe prosthetic valvular dysfunction (regurgitation or stenosis)

(2) Three additional conditions must be addressed within 30 days:

(a) Critical aortic stenosis

(b) Critical mitral stenosis

(c) Severe mitral regurgitation

g. Echocardiograms are read on a daily basis. The cardiologist must take appropriate action by calling the primary provider and/or the patient within 24 hours for any urgent diagnoses, i.e. diagnoses requiring immediate medical attention.

5. RESPONSIBILITIES:

a. The Medical Center Director will assure a mechanism is in place for tracking compliance with this policy and periodic monitors document adherence to local and VHA policy. In addition a system of surrogate providers who could include team leaders, supervisors, service chiefs and Care Line Executives will also be assured.

b. The Chief of Staff is responsible for reviewing monitors of test communication results and for resolving process deficiencies with Service Chiefs, should they occur.

c. The Clinical Executive Council is responsible for reviewing and approving critical values and tests annually as well as the procedures for notification of the responsible healthcare provider.

d. Care line executives and Service Chiefs are responsible for establishing a chain of responsibility for receipt of critical values and critical tests.

e. The Chief of Radiology will assure that all imaging providers and medical technologists are properly trained and report critical abnormalities/values and results of critical tests as described.

f. The Chief of Medicine is responsible to assure that this policy is followed in Cardiology.

6. REFERENCES: Comprehensive Accreditation Manual for Hospitals, Joint Commission on Accreditation of Healthcare Organizations College of American Pathologists’ Standards

7. RECISSION: Numbered Memorandum 113-03-13, dated April 26, 2013.

8. FOLLOW-UP RESPONSIBILITY: Chief of Ambulatory Care

Concur/Nonconcur Concur/Nonconcur

//ss// //ss//

Nancy Benton, PhD, RN, CNS J. Ronald Johnson, FACHE AD/Patient Care Services Associate Director

Concur/Nonconcur Approved/Disapproved

//ss// //ss//

William H. Campbell, MD, FACHE Linda K. Reynolds, MA, FACHE Acting Chief of Staff Medical Center Director Attachment (6)

Distribution: All services (via OUTLOOK)

DS/cm

Test Name

Attachment A

Test Name

Attachment A

CRITICAL LIMITS (PANIC VALUES)

The following stain and culture results are viewed as critical results and need to be called to the attending physician immediately.

1. Positive malaria or other parasite identification from the blood.

2. Positive fecal parasite identification.

3. Positive stool culture for Salmonella, Shigella, E. coli H0157, Vibrio, Yersinia or Campylobacter.

4. Positive Pseudomonas culture from the eye.

5. Positive stool specimen for Staphylococcal enteritis; pure growth of Staphylococcus aureus.

6. Positive throat culture for Beta Streptococcus pyogenes group A.

7. Positive Methicillin Resistant Staphylococcus aureus (MRSA)* (Except the agar screening done on discharge from the hospital the MOD does not need to follow up, Infection Control should do so on the next duty day.

8. Positive Vancomycin-Resistant Enterococcus (VRE)*

9. Positive Clostridium Difficile (C-Diff)*

10. Positive for Extended-spectrum beta-lactamase gram negative bacteria (ESBL)*

11. Positive for any Multi-drug resistant organism (MRDO)*

12. Positive Wound Culture

13. Positive Pertussis*

14. Positive HIV*

* Call Infection Control at x7301 or 7306

Attachment B

Spokane VAMC Reportable Values Abnormal laboratory tests that are not emergent (Healthcare provider will receive an Alert in VistA, but no verbal report)

Attachment C

Critical Imaging Tests (This is defined as an imaging examination requested as a STAT order, telephonically called to the radiologist as a STAT exam and reading, and clearly provides the complete contact information of the provider to be contacted in the “Reason for test” field. These examinations will be tracked for timeliness.)

Critical Pathology Tests All frozen sections are considered critical tests and will be monitored for timeliness.

Attachment D

Attachment E

Attachment E

Attachment F

Attachment G

2. April 18, 2011 Numbered Memorandum xx-xx-11

Attachment 24

Attachment B

Attachment H Attachment G image1.emf oleObject1.bin

INPATIENT DURING BUSINESS HOURS CRITICAL VALUE/CRITICAL TEST REPORTING PROCESS

No

Yes

Critical value?

Call Nursing Supervisor

ED Attending Treat or Call Patient

Call/page floor RN assigned to patient

RN reached within 15 min?

Ordering provider reached within 15 min X3 attempts

A

Diagnostic testing done

Results reported in VistA

Staff performing the test will telephone or page the ordering provider to report critical value

Mandatory alert to provider in VistA for all critical values

Includes date & time contact made and name of person contacted.

Documentation of "Read-back" verification

B

Receiving provider to document in CPRS using critical value template image2.emf oleObject2.bin

INPATIENT AFTER BUSINESS HOURS CRITICAL VALUE/CRITICAL TEST REPORTING PROCESS

Ordering provider reached within 15 min X3 attempts

Receiving provider to document in CPRS using critical value template

MOD

image3.emf oleObject3.bin

OUTPATIENT DURING BUSINESS HOURS

CRITICAL VALUE/CRITICAL TEST REPORTING PROCESS

Call/page Teamlet RN of the PCP

Ordering provider reached within 15 min X3 Attemps

A & B

Provider Notified within 15 min?

Call Team Practice Partner

Team Provider Treat or Call Patient

image4.emf oleObject4.bin

OUTPATIENT AFTER BUSINESS HOURS

CRITICAL VALUE/CRITICAL TEST REPORTING PROCESS

Staff performing the test will telephone or page the ED provider to report critical value

Call the MOD

ED Provider reached w/in 15 min X3 Attempts

Nurse Notified within 15 min?

Nursing Supervisor Ext. 7991