D. 8 MCM 11-99.docx

D. 8 MCM 11-99 - VASDHS POLICY AND PROCEDURES AND TJC STANDARDS FOR ANY CRITICAL RESULTS OR URGENT RESULTS

COMMUNICATING TEST RESULTS

1. PURPOSE: To establish policy and procedures for communicating test results to patients as well as defining the processes for communicating critical results to ordering providers or their surrogates.

2. POLICY: It is VHA policy that test results must be communicated to the ordering practitioner, or surrogate practitioner, within a timeframe allowing prompt attention and appropriate clinical action to be taken. The ordering practitioner or designated team member further communicates such test results to patients in a timely manner, so that they may participate in health care decisions.

3. DEFINITIONS: These definitions are provided for implementation of this MCM and do not necessarily coincide with any other common use of these terms.

a. Abnormal Test Result - an abnormal test result is a diagnostic finding that requires attention by the ordering practitioner, but not necessarily in an immediate time frame. Abnormal values are not life-threatening but may require a change in patient management. Abnormal Lab Values are those which are outside of designated Reference Ranges, but which do not fall into the Critical Value range. Abnormal values may be communicated by CPRS via optional View Alert to the ordering provider or surrogate.

b. Critical Value or Result - a critical value or result is defined as a value or interpretation that, if left untreated, could be immediately life threatening or place the patient at serious risk. Critical values or results are those results from laboratory, cardiology, radiology, and other diagnostic areas that upon analysis are determined to be “critical” regardless of the ordering priority. Please refer to Attachments A for Pathology and Laboratory critical values and Attachment B for imaging critical values. Critical values will be immediately and directly communicated to the ordering provider, or designated individual with “Read-Back” documented in the patient’s medical records (CPRS) with provider’s name and time of communication.

c. Diagnostic Practitioner - a diagnostic practitioner is a practitioner who performs or supervises the performance and interpretation of diagnostic tests by privileges or acting under a scope of practice.

d. Direct Communication - direct communication is the transmission of test results by direct, non-electronic dialogue between the diagnostic practitioner and the ordering practitioner, or surrogate practitioner, by telephone or face-to-face conversation, or hand carried report.

e. Electronic Communication - electronic communication is the transmission of test results by electronic means (e.g., view alerts, e-mail, fax, etc.).

f. Ordering Practitioner - an ordering practitioner is a practitioner authorized to enter and sign orders for diagnostic tests by privileges or acting under a scope of clinical practice.

g. Personal Representative - a personal representative is 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). Personal representative is further defined in VHA Handbook 1605.1, Privacy and Release of Information, dated, May 17, 2006 and MCM 1-43 INFORMED CONSENT.

h. Supervising Practitioner: the supervising practitioner is the licensed independent practitioner who supervises the ordering of tests by residents, or by other practitioners authorized to order tests under a scope of clinical practice.

i. Read Back: Verification “read-back” is when the healthcare provider acknowledged and read the critical result back to the person who communicated the result to verify the correctness and accuracy of the verbal communication.

j. Reference Range: The reference range for a given constituent is the set of concentrations, which are found in a group of clinically normal (apparently healthy) persons. The arbitrary interval used to establish normal values is the central 95 percent of apparently healthy persons. It is important to note that 5 percent of these apparently healthy individuals will have values outside the “reference” range. Reference ranges are also not always normally distributed. Laboratory reference ranges are included with results for each test when applicable.

k. Therapeutic Range: The therapeutic range for a given drug is the set of concentrations, which is found to provide the desired pharmacological effects in most patients. A particular therapeutic range is valid only for a specified time following drug administration, and may be modified by conditions such as liver and kidney diseases.

l. Toxic Level: This is a drug concentration limit above which most patients will exhibit undesirable pharmacological effects.

m. Surrogate Practitioner: a licensed independent practitioner who serves as a substitute to the ordering practitioner when the ordering practitioner cannot be reached. Users of the electronic health record may designate one surrogate for their view alerts in the system during a period when they are unavailable to review or receive results.

n. Test Result - test results include the results of laboratory testing, diagnostic imaging, and diagnostic procedures.

o. View Alert: Electronic notification of a result in the Electronic Health Record (e.g. CPRS).

4. RESPONSIBILITIES:

a. Chief of Staff or Designee:

1) Ensures that data on the timeliness of reporting critical tests and critical values or results is collected.

2) Ensures the assessment of the data collected, and determines whether there is a need for improvement, and appropriate action is taken to improve and measure the effectiveness of those actions.

3) Ensures that communication of results to practitioners and patients is periodically monitored to document adherence to VHA and local policies.

4) Reviews monitors of test result communication.

5) Resolves process deficiencies with service chiefs.

b. Clinical Service Chiefs: Establish a chain of responsibility within their department for receipt of test results and communication of results to patients. In the event that a practitioner is not available, a system of surrogate practitioners (surrogate practitioners could include preceptors, on-call practitioners, supervisors, and service chiefs) should be developed and maintained.

c. Diagnostic Practitioner or Designee:

1) Identifies and communicates expediently all critical, emergent, or abnormal test values or results to the ordering practitioner, the practitioner’s surrogate, or the supervisor, as appropriate.

2) Ensures that verified test results reports are available in the patient’s electronic medical record in a timely manner.

3) Documents the time and means of such communication, and the name of the practitioner contacted, in the medical record. This documentation is not required for abnormal tests that are not critical or emergent.

4) Collects data on the timeliness of reporting critical tests and critical values or results to the ordering provider. Assesses data collected and determines whether there is a need for improvement, and ensures action is taken to improve and measures the effectiveness of those actions.

d. Ordering Practitioner:

1) Places the initial order and identifies the surrogate practitioner, when applicable.

2) Initiates appropriate clinical action, and follows up the results of any orders, which they have placed.

3) Assigns a qualified surrogate practitioner to receive critical, emergent, or abnormal test result notifications when they, themselves, are unavailable to review results in a timely manner to prevent avoidable delays in treatment or response.

4) Documents treatment actions in response to critical, emergent, or abnormal results in the patient’s electronic medical record.

5) Communicates test results to patients in accordance with the procedures established in this Health Care System Memorandum.

5. PROCEDURES:

a. Process for communicating test results by diagnostic practitioners to ordering practitioners:

1) Critical Values or Results

(a) Critical values or results must be transmitted within 60 minutes by direct communication from the diagnostic practitioner or laboratory to either the ordering practitioner or surrogate practitioner. This communication must be documented in the electronic medical record.

(b) For reporting of critical values or results, the complete test result must be verified by having the person receiving the information record “read back” the complete test values or results. It is expected that:

(c) In all cases when ordering practitioner and surrogate practitioner are unavailable, test results will be communicated to the next alternate contact from the Critical Result Cascade (Appendix C)

(d) In the point-of-care setting, the identity of the testing individual and person notified need not be recorded when the individual performing the test is the same person who treats the patient.

2) Abnormal Test Results: Abnormal test results may be transmitted from the diagnostic practitioner, or surrogate, to the ordering practitioner, or surrogate, by view alert within the electronic health record, direct, or electronic communication. The ordering practitioner, or surrogate, needs to document any change in care plan that is the result of the abnormal result.

b. Processes for ordering practitioners to communicate test results to patients:

1) Results, including normal test results, are communicated to patients within:

(a) Seven calendar days from the date which the results were available to the ordering practitioner for results requiring action.

(b) Within 14 days from the date which the results were available to the ordering practitioner for results that do not require any action.

2) Tests ordered while the patient is an inpatient, but results reported after discharge are treated as outpatient tests. These tests are communicated by the ordering inpatient provider, or their surrogate, according to the standards in this Policy. It is the ordering provider’s responsibility to communicate results unless there has been a clear handoff of that responsibility to another provider.

3) If the patient lacks decision making capacity, results will be communicated to the personal representative of the patient following the procedures defined in this policy. See Definitions.

4) Communication to Patients

(a) Communication with patients can occur in person, by telephone or in writing. Ordering providers can use the provider test result letter in the Computerized Patient Record System (CPRS) as a mechanism to communicate with patients. Patient Identifiable Information (PII) is not to be communicated to patients by email, it may be communicated through the MyHealtheVet secure messaging system. Results should not be left on voicemail.

(b) The provider should document the communication of the results in the medical record including changes in care that were the outcome of the communication or result.

NOTE: Due to the sensitive nature of certain test results, such as psychological tests, the determination of how to report these results are best made on a case-by-case basis. Review and discussion of the test results need to be provided to the patient, or appropriate representative(s) in person, with an opportunity for questions and discussion.

(c) Abnormal Results must be communicated by licensed or certified health care staff. It is not required that the ordering practitioner personally communicates every result and this task may be delegated to other licensed health care staff when clinically appropriate.

(d) Under some circumstances, Normal Test Results may be notified to patients by Advanced MSAs (see VA Handbook 5005/53, Medical Support Assistant (MSA) GS-0679 Qualification Standards).

(e) Inclusion of other team members in the communication process should follow robust principles of teamwork including clarity of task delegation, clarity of roles of team members, clarity of key responsibilities on test result related action, and contingency planning.

5) When, despite best efforts, it is not possible to contact the patient (e.g., the patient has moved and left no contact information), all attempts to communicate with the patient are documented in the medical record.

c. Inpatient, emergency, or urgent care often involves extensive, repetitive testing with rapidly changing clinical conditions. Therefore, for patients in the inpatient, emergency, or urgent care setting, it is not required or expected that each individual test result is communicated to the patient. The ordering practitioner, or the care team, should strive to effectively communicate relevant information to the patient about the patient's medical condition. Results of specific tests may be included in this communication as appropriate.

6. REFERENCES: VHA Directive 1088 “Communicating Test Results to Patients”.

7. RECERTIFICATION DATE: October 2027.

8. FOLLOW UP RESPONSIBILITY: Chief of Staff (11), Chief, PALMS (113).

9. RECOMMENDED REVIEW DATE: October 2025.

10. RESCISSION: MCM 11-99 dated September 4, 2019.

11. DATE APPROVED BY MEC: December 7, 2022.

Distribution: SharePoint Attachments, A, B, C, D

D. 8 MCM 11-99 - 36C26224R0121

CRITICAL LABORATORY TEST RESULTING

COAGULATION

>4.5

HEMATOLOGY

BLASTS

BLOOD

>5% (1st Identification upon review)

CHEMISTRY

MICROBIOLOGY

POSITIVE

GROWTH

GROWTH

NO GROWTH

GROWTH

POSITIVE

Bioterrorism Agents; Bacillis Anthracis, Brucella, Francisela, Burkholderia

MULTIPLE

NO GROWTH

POSITIVE IDENTIFICATION

TOXICOLOGY

**Any Critical Values identified by Reference Labs **

CRITICAL IMAGING FINDINGS

Complete Alert within 1 hour Abnormal Test Results Category Conditions* Complete Alert within 3 days

Intracranial mass with new herniation

Brain tumor (no mass effect)

Cervical spine fracture

Thoracic or lumbar spine fracture with cord compression

Tonsillitis

Retropharyngeal Abscess

Breast

Biopsy recommendation on mammogram

Aortic dissection

Pulmonary embolism

Mediastinal hematoma

Airway compromise

Acute Infections, e.g., Appendicitis, Diverticulitis, Cholecystitis, Intra- Abdominal Abscess

Portal venous gas

Acute laceration of the liver, spleen, or kidney

Retroperitoneal hemorrhage

Hemoperitoneum

Pneumatosis of bowel wall

Testicular or ovarian torsion

Tubo-ovarian abscess

Vascular

DVT

Acute arterial embolism/occlusion

Bone

New finding suggestive of new fracture (other than those described in Critical Category)

*Radiologists does not need to treat these conditions as “critical or abnormal” if there is certainty that the ordering provider is already aware of the condition when the test is reviewed by the radiologist.

CRITICAL COMMUNICATION CASCADE

First, go to REVIEW BY ORDER NUMBER to find the Ordering Location. The Primary Care locations are always indicated by “Prim Care”. Otherwise, the ordering locations are Inpatients and Specialty Services.

For Inpatients and Specialty Clinics (such as Renal, Pulmonary, Heme/Oncology, Dialysis, etc.), the order of notification is as follows:

1. The ordering intern, resident or attending staff physician (call to RN only in MICU, SICU, or DOU).

2. No response after 2 pages, call the “fellow on call” for the medical subspecialty (i.e., Medicine, Surgery, Psychiatry, Neurology, etc.).

a. See the Staff on Call Schedule for assigned surrogate at http://vaww.sandiego.portal.va.gov/sites/SOCS/default.aspx

3. No response after 2 calls or text pages call the “attending on call” twice

4. No response after 2 calls or text pages call the Section Chief twice

5. No response after 2 calls or text pages call the Service Chief

a. In case the Service Chief is on leave (no response within 10 minutes), check the VHA E-news (http://cfapps.san- diego.med.va.gov/applications/enews/) to find the Acting Service Chief and page her/him.

For Primary Care, the order of notification is as follows:

http://vaww.sandiego.portal.va.gov/sites/SOCS/PrimaryCare/default.aspx Monday-Friday between 7:00 am and 6:00 pm:

1. Page or phone the ordering provider twice

2. No response after 2 pages, page the supervisor twice:

a. Chula Vista- (858-245-1224)

b. Kearney Mesa1 – (858-322-2524)

c. Kearney Mesa2 - (858-245-0811)

d. Kearney Mesa3 - (858-322-2524)

e. La Jolla - (858-888-5690)

f. Oceanside - (858-699-9882)

g. Sorrento Valley - (858-322-1025)

h. Escondido - (719-406-2916)

i. El Centro - (760-596-9820)

j. Home Based Primary Care – (858-208-6573).

k.

3. No response after 2 pages, page the Primary Care Service Chief, ( 858-232-6182).

4. In case the Primary Care Service Chief is on leave (no response within 10 minutes), check the VHA E-news/Intranet homepage to find the Acting Primary Care Service Chief (under Acting Service Chiefs) and page her/him.

Monday –Friday between 6:00 pm and 7:00 am, and on weekends and holidays:

1. Call the Primary Care Service Critical Results cell phone (858-263-8930).

2. No response after 2 pages, page the Primary Care Service Chief, ( 858-232-6182). In case the Primary Care Director is on leave (no response within 10 minutes), check the VHA E-news (http://cfapps.san-diego.med.va.gov) and Staff On Call Schedule to find the Acting Primary Care Chief and page her/him.

RADIOLOGY DIAGNOSTIC CODES TRIGGERING ALERTS

The following Diagnostic Codes trigger a mandatory View Alert:

· Diagnostic Code 4 – ABNORMALITY, Attention Needed

· Diagnostic Code 8 – POSSIBLE MALIGNANCY, Follow-up Needed

· Diagnostic Code 13 – SUSPICIOUS ABNORMALITY

· Diagnostic Code 16 – FOLLOW-UP REQUIRED

· Diagnostic Code 1001 - SIGNIFICANT ABNORMALITY, ATTN NEEDED

· Diagnostic Code 1002 - CRITICAL ABNORMALITY

· Diagnostic Code 1003 - POSSIBLE MALIGNANCY

· Diagnostic Code 1100 - BIRADS CATEGORY 0 - Additional imaging or prior images needed.

· Diagnostic Code 1103 - BIRADS CATEGORY - Probably benign.

· Diagnostic Code 1104 - BIRADS CATEGORY - Suspicious abnormality.

· Diagnostic Code 1105 - BIRADS CATEGORY - Highly suggestive of malignancy.

· Diagnostic Code 1106 - BIRADS CATEGORY 6 - Known biopsy proven malignancy.

· Diagnostic Code 1201 - ABDOMINAL AORTIC ANEURYSM PRESENT

· Diagnostic Codes may be initiated on VistA and CPRS in one of three ways:

1201, 1214 1215, 1216, 1217” for the Diagnostic Code after signing the radiology report in VISTA.

· Inputting the diagnostic code utilizing Powerscibe 360 image1.emf image2.emf