Attachment D14 - Memorandum 11-99 Communicating Test Results.pdf

VA SAN DIEGO HEALTH CARE SYSTEM

SAN DIEGO, CA

MEMORANDUM 11-99

April 20, 2016

COMMUNICATING TEST RESULTS

1. PURPOSE: To define 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. This policy supports VHA Directive 1088 “Communicating Test Results to Patients” dated October 7, 2015.

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 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 are also flagged by CPRS via View Alert to the ordering provider or designee.

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.).

MEMORANDUM 11-99

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 available at:

PALMS INDEX OF REFERENCE RANGES

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. Suitable surrogates include the practitioner’s supervisor or preceptor, the primary care provider of the patient, or another member of the patient–aligned care team (PACT) or registered nurse who may take further appropriate action. Users of the electronic health record may indicate surrogates for their view alerts in the system.

MEMORANDUM 11-99

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:

MEMORANDUM 11-99

1) Places the initial order, includes the appropriate contact information, 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, or the designated responsible provider as determined by the Critical Result Cascade. This communication must be documented in the Veterans Health Information Systems and Technology Architecture (VistA).

(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:

(1). The receiver of the information writes down the complete critical values or result, or enters it into the medical record system.

(2). The receiver of the information reads back the critical values or results.

(3). The receiver of the information receives confirmation from the individual who gave the critical values or results.

(c) In all cases when ordering practitioner and surrogate practitioner are unavailable, test results will be

MEMORANDUM 11-99

communicated to the next alternate contact from the Critical Result Cascade (Appendix C)

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) 7 calendar days from the date which the results were available to the ordering practitioner for results requiring action, and

(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, unless it is 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

MEMORANDUM 11-99

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.

(f) When tests are ordered by residents, the supervising practitioner has the responsibility for ensuring that the required communication and documentation occurs.

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:

a. VHA Directive 1088 “Communicating Test Results to Patients”.

7. REVIEW DATE: April 2019

8. FOLLOW UP RESPONSIBILITY:

a. Chief of Staff

MEMORANDUM 11-99

9. RESCISSION:

a. MCM 113-08 NORMAL/ABNORMAL, CRITICAL RESULT

NOTIFICATION/ INDEX OF REFERENCE RANGES.

b. MCM 114-01: REPORTING IMAGING TEST RESULTS

10. DATE OF MEC APPROVAL: April 20, 2016

Invalid signature

X

ROBERT M. SMITH, MD

CHIEF OF STAFF/ MEDICAL DIRECTOR

Signed by: Smith, Robert M. (Do Not Delete)

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CYNTHIA E ABAIR, MHA

ACTING DIRECTOR

Signed by: Abair, Cynthia E. (Do Not Delete)

Distribution: DocuShare Attachments:

A: CRITICAL LABORATORY TEST RESULTING

B: CRITICAL IMAGING FINDINGS

C: CRITICAL COMMUNICATION CASCADE

D: RADIOLOGY DIAGNOSTIC CODES TRIGGERING ALERTS

X Cynthia E. Abair

VA SAN DIEGO HEALTH CARE SYSTEM MEMORANDUM 11-99

Attachment A April 20, 2016

CRITICAL LABORATORY TEST RESULTING

NAME SITE/

SPECIMEN

REFERENCE

LOW

REFERENCE

HIGH

UNITS CRITICAL VALUES

COAGULATION

INR PLASMA 0.9 1.2 >4.0

PTT PLASMA 24.2 36 SEC >150

HEMATOLOGY

BLASTS

BLOOD

>5% (1st

Identification upon review)

HGB BLOOD M=12.4; F=12 M=17.4; F=16 g/dL <7; >20

PLT BLOOD 140 400 K/uL <20; >1,000

WBC BLOOD 4.8 10.8 K/uL <0.5; >100

Neutrophil CSF #/uL >10

CHEMISTRY

GLUCOSE SERUM 70 99 mg/dL <50; >400

POTASSIUM SERUM 3.5 5 mMol/L <2.5; >6

SODIUM SERUM 135 145 mMol/L <120; >160

CALCIUM

SERUM 8.5 10.4 mg/dL <7; >13

MICROBIOLOGY

MALARIA SMEAR BLOOD NEGATIVE POSITIVE

BLOOD CULTURE BLOOD NO GROWTH GROWTH

CSF CULTURE AND

GRAM STAIN

CSF NO GROWTH GROWTH

OTHER STERILE

FLUID CULTURE AND

GRAM STAIN

MULTIPLE

(EXCLUDING

URINE)

NO GROWTH

GROWTH

AFB CULTURE AND

SMEAR

MULTIPLE NEGATIVE POSITIVE

Bioterrorism Agents;

Bacillis Anthracis, Brucella, Francisela, Burkholderia

MULTIPLE

NO GROWTH

POSITIVE

IDENTIFICATION

TOXICOLOGY

DIGOXIN SERUM 0.8 2 ng/ml >2.5

ETHANOL SERUM 0 10 mg/dL >300

LITHIUM SERUM 0.5 1.5 mMol/L >2.0

PHENYTOIN SERUM 10 20 mg/L >30

SALICYLATE SERUM 10 30 mg/dL >50

**Any Critical Values identified by Reference Labs **

Attachment B

MEMORANDUM 11-99

CRITICAL IMAGING FINDINGS

Anatomical Area

Critical Test Results Category Conditions* Complete Alert within 1 hour

Abnormal Test Results Category Conditions* Complete Alert within 3 days

CNS Acute Intracranial hemorrhage 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

Chest Tension pneumothorax Aortic dissection Pulmonary embolism

Mediastinal hematoma

Airway compromise Abdomen Pneumoperitoneum (free Air in abdomen, if no recent surgeries)

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

Uro-genital Ectopic pregnancy 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)

General Significant Line/ or Tube misplacement (e.g. feeding tube in airway)

New finding highly suggestive of malignancy (e.g. new nodule on CXR, diffuse lymphadenopathy on abdominal CT)

*Radiologists only need to treat these conditions as “critical or abnormal” if there is certainty that the ordering provider was aware of the condition when the test was ordered.

Attachment C

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 (ie, 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/Primary Care/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. Mission Valley1 – (858-322-2524)

c. Mission Valley2 - (858-245-0811)

d. Mission Valley3 - (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).

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-http://vaww.sandiego.portal.va.gov/sites/SOCS/default.aspx http://cfapps.san-diego.med.va.gov/applications/enews/ http://cfapps.san-diego.med.va.gov/applications/enews/ http://cfapps.san-diego.med.va.gov/applications/enews/ http://vaww.sandiego.portal.va.gov/sites/SOCS/PrimaryCare/default.aspx http://vaww.sandiego.portal.va.gov/sites/SOCS/PrimaryCare/default.aspx http://cfapps.san-diego.med.va.gov/applications/enews/

Attachment C diego.med.va.gov/applications/enews/ ) and Staff On Call Schedule to find the Acting Primary Care Chief and page her/him.

VA SAN DIEGO HEALTHCARE SYSTEM

Attachment D

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:

• Dictating “diagnostic code 4, 8, 13, 16,1001,1002, 1003, 1100, 1103, 1104, 1105, 1106, 1201” to the transcriptionist at the end of the report.

• Typing in “4, 8 13, 16, ,1001,1002, 1003, 1100, 1103, 1104, 1105, 1106, 1201” for the Diagnostic Code after signing the radiology report.

• Inputting the diagnostic code utilizing Talk-Tech.