D.30 VANTHCS MEMO 11-14.pdf

DEPARTMENT OF VETERANS AFFAIRS

NORTH TEXAS HEALTH CARE SYSTEM

October 27, 2016 549/11

VANTHCS MEMORANDUM NO. 11-14

COMMUNICATING TEST RESULTS TO PROVIDERS AND PATIENTS

1. PURPOSE:

The purpose of this memorandum is to establish policy for reporting the results of diagnostic tests to practitioners and patients, and for tracking compliance with this policy at VA North Texas Health Care System (VANTHCS).

2. POLICY:

It is the policy of VANTHCS that all test results must be communicated by the diagnostic provider to the ordering provider or designee within a time-frame that allows for prompt attention and appropriate action to be taken. All test results requiring action must be communicated by the ordering provider or designee to patients no later than 7 calendar days from the date on which the results are available. For test results that require no action, results must be communicated by the ordering provider or designee to patients no later than 14 calendar days from the date on which the results are available.

Depending on the clinical context, certain test results may require review and communication in shorter time-frames (see definitions paragraph related to abnormal and normal results).

3. PROCEDURES:

a. Definitions:

(1) Treating Practitioner: A practitioner authorized by privileges or acting under a scope of clinical practice to enter and sign orders for diagnostic tests, to receive reports for test results, and to communicate these results to patients.

(2) Surrogate Practitioner: Licensed or certified health care staff that is delegated by a treating practitioner to receive reports of test results and communicate these results to patients on behalf of the treating practitioner.

D.30 RFP: 36C25722R0015

(3) Diagnostic Practitioner: Practitioner who performs or supervises the performance and interpretation of diagnostic tests by privileges or acting under a scope of practice.

(4) Test Result: Test results include the results of clinical laboratory and anatomic pathology testing, diagnostic imaging, and diagnostic procedures.

(a) Normal Results: Test results that are within normal limits or within the expected limits for the patient or patient population.

(b) Abnormal Results: Test results that fall outside a specified normal reference range and that require attention by a health care provider, but not necessarily in an immediate or urgent time frame.

(c) Urgent Results: Test results that require prompt, although not immediate, follow-up by a health care provider such that failure to do so might result in significant morbidity.

(d) Critical Results: Test results that require immediate evaluation by a health care provider such that failure to take immediate appropriate action might result in severe morbidity or mortality.

(5) Critical Tests: VANTHCS recognizes that many diagnostic tests may yield a critical or urgent result. The facility, however, does not define any specific tests as “critical tests.”

(6) Read-back: The process of an individual receiving the results of a result by writing down and reading back the information to the individual providing this information.

(7) Diagnostic Service: Those clinical services which perform tests or studies that have the potential to yield critical results. These services identify results which are defined as “critical” and are listed in the attachments to this policy (Pathology and Laboratory Medicine Service – Attachment A; Radiology Service – Attachment B; and Nuclear Medicine Service, Attachment C).

(8) Communication Time frame: For critical results, a 60-minute communication timeframe is established.

(9) Authorized Licensed Professionals (ALP): Those licensed professionals who are authorized to receive reports of critical results. This category includes Physicians, Nurse Practitioners, Advanced Clinical Practice Nurses, Registered Nurses, (in circumstances discussed below), Advanced Practice Pharmacists, Clinical Pharmacists, and Physician Assistants. Any member of this group of providers is referred to as an “Authorized Licensed Professional” (ALP) for purposes of this policy.

NOTE: According to VHA Handbook 5005/53, Medical Support Assistant (MSA) GS-0679 Qualification Standard, General Section (GS) 6 Clerks may notify patients of normal laboratory results.

(10) Critical Result Communication: This can occur either in a face-to-face meeting or via telephone. Critical results communication to patients will be by their provider or designee.

(11) Critical Result Pager: Each clinical service and/or service location (e.g., a CBOC) will have one or more “Critical Results Pagers” (CRP).

Complex services with multiple sections (e.g., Surgical Service, Medicine Service), may have a CRP for each section (e.g., one for Endocrine, one for Cardiology, etc.). It will be up to each service to decide how many CRP’s will be needed for their service and how CRP responsibilities will be distributed to ALP’s within the service. Each service will be responsible for maintaining and sharing their current CRP listing on the VANTHCS intranet.

b. Notification Process – Critical Results: Upon identification of a critical result, the testing service will follow the communication cascade below.

Providers will be paged in order. If there is no response in 15 minutes, the next provider is to be paged.

(1) Outpatient Cascade:

(a) Regular work week (8:00 a.m. to 4:30 p.m., Monday through Friday)

1 Ordering ALP

2 Critical Result Pager (CRP) for section.

3 Chief of Section, if applicable

4 Chief of Service

(b) Regular work week after hours (4:30 p.m. to 8:00 a.m., Monday through Thursday), and holidays and weekends (Friday 4:30 p.m. through Monday 8:00 a.m.). If a holiday falls on Tuesday, after hours will be 4:30 p.m., Monday, to 8:00 a.m., Wednesday.

2 Emergency Department (ED) – The Medical Officer of the Day, (MOD) may be contacted at extension 71975. The MOD will determine:

a Whether immediate evaluation and/or treatment in an ED is needed, and b If immediate evaluation is needed, the ED will attempt to contact the patient by telephone to advise him/her to go to an ED. This contact will be documented in the chart and the ordering AC will be alerted as a cosigner of the note.

c If immediate ED care is not needed, or if the patient cannot be contacted, the ED provider will make a note in the chart, and alert the ordering AC as a cosigner. NOTE: This does not apply to inpatients or those with a covering provider on-call.

(2) Inpatient Cascade:

(a) Regular work week (8:00 a.m. to 4:30 p.m., Monday through Friday)

2 Attending for ordering ALP’s team

3 Section Chief

4 Service Chief

(b) 4:30 p.m. to 8:00 a.m. during the workweek, holidays, and weekends

2 Cross cover ALP

3 Attending for cross cover team

4 Service Chief

(c) All critical results communicated will require write-down /read-back (see VANTHCS Memorandum No. 00-07, Read-Back Requirements) to ensure the result is communicated accurately.

(d) For all testing services, the communicating physician, therapist or technologist will document in VistA the name of the ALP who received and read back the critical value, and the time the message was communicated.

(3) Exception - Inpatient Intensive Care Units (MICU, CCU, TICU, and

SICU):

(a) At all times: Critical results may be called to any available physician in the ICU.

(b) At all times: If the critical result is a PTT for a patient who is on an anticoagulation (Heparin drip) protocol, the critical result may be communicated directly to the RN who is taking care of the patient.

(c) At all times: If the critical result is a blood glucose value for a patient who is on an insulin drip protocol, the critical result may be communicated directly to the RN who is taking care of the patient.

(e) In all of the above cases, the receiving party will perform write-down/read-back.

(f) ICUs may be contacted at the following numbers:

CCU: 72181. 72182 or 72184 MICU: 71659, 71660 or 71661 SICU: 71619, or 71620 TICU: 71624 or 71625

(4) Exception - Protime Clinic:

(a) Normal duty hours, 8:00 a.m. to 4:30 p.m.: Anticoagulation Clinic will be notified of critical lab results via the Critical Lab Pager, at (214) 749-2215. A second method is to contact a clinic provider at extension 71963. Write-down/read-back must be done.

(b) After normal duty hours, 4:30 p.m. to 8:00 a.m. and weekends: Call the ED as per paragraph 3b. (1) (b) (2) above.

(c) Notification of Patients by Authorized Licensed Providers and provision of an appropriate clinical response: The appropriate practitioner (as outlined above), will document in a CPRS note the patient notification of the critical results and the appropriate clinical response that is made.

c. Notification Process—Non-Critical Results: All test results requiring action must be communicated by the ordering provider or designee to patients no later than 7 calendar days from the date on which the results are available. For test results requiring no action, results must be communicated by the ordering provider or designee to patients no later than 14 days from the date on which the results are available. Depending on context, certain results may require review and communication in shorter time frames. Patients enrolled in MyHealtheVet Premium Accounts are able to view certain test results in earlier time frames (usually 3 days after the date on which the results are available). All communication should occur within a time frame that minimizes risk to the patient.

(1) Content and Method of Communication: Content of communication should be sufficiently detailed to allow the patient to be informed and engaged in their health care. Discussions can occur synchronously (in person or by telephone) or non-synchronously (in writing, template-generated letters, or via secure messaging in MyHealtheVet).

(2) Documentation: Patient notification and subsequent clinical action must be documented in CPRS by the ordering provider(s) or designee(s) in response to critical, urgent, and clinically significant test results that require therapeutic intervention or action. If results are discussed within a patient visit, this should be documented with the visit progress note.

(3) Exceptions: In exceptional circumstances, it may be necessary to delay communication of test results beyond the time frames identified above. Due to the sensitive nature of certain results, the determination of how to report these results is best made on a case-by-case basis. Review and discussion of test results must be provided to the patient or patient’s personal representative with an opportunity for questions and discussion.

(4) Communicating test results to patients after discharge: When results of tests ordered and performed while the patient is inpatient become available after discharge, they are communicated by the ordering inpatient provider or designee unless the responsibility has been transferred to the primary care provider or designee and that transfer is documented in CPRS.

(5) Taking additional measures in the following special situations:

If the patient lacks decision making capacity, communicate test results to the personal representative of the patient.

4. RESPONSIBILITIES:

a. All Service Chiefs are responsible for ensuring their service’s employees are educated regarding this policy and the requirement for compliance.

b. The ALP is responsible for accepting the critical result and reading it back accurately and for documenting a response to the critical result in CPRS in a timely manner. This will include both the notification of the patient or surrogate of the critical result and initiating an appropriate clinical response. Note:

Documentation of the communication of test results to patients will be in accordance with VHA Directive 1088.

c. Testing service technologists, physicians, or therapists are responsible for documenting in CPRS the name of the ALP notified, that accurate read-back was obtained, and the time of communication.

d. Clinical Service Chiefs in Dallas, Medical Chiefs at Bonham, Tyler, and Fort Worth Outpatient Clinic, and Medical Chiefs at Community Based Outpatient Clinics (CBOCs) are responsible for assuring up to date rosters of clinics, physicians and other ALPs, their pager numbers, and CRP numbers are updated on the VANTHCS intranet site and readily available to Pathology & Laboratory Medicine Service, Nuclear Medicine Service, and Radiology Service.

e. Clinical Service Chiefs in Dallas, Medical Chiefs at Bonham, Tyler, and Fort Worth Outpatient Clinic, and Medical Chiefs at all CBOCs are responsible for the assignment of CRPs in line with the organization and needs of their services or facilities.

f. ALPs carrying the CRP’s will be responsible for receiving critical results for ordering providers who have rotated off service or are away from a specific clinic or facility.

g. Testing Services are responsible for periodic updating of the list of results which are classified as “critical.” Critical result values are listed in the attachments to this policy. Updates will occur no less frequently than every three

(3) years.

h. The Testing Services will develop service-specific processes to monitor compliance with this policy. The Testing Services will report their data to the Patient Safety Committee on a quarterly basis.

i. Medical Administration Service (MAS) will assure Patient Information Collection Management (PICM) processes are in place. These processes must include contacting the Veteran to obtain updated demographic and insurance information in a timely fashion. This may be done at the point of initial intake, time of clinic check-in, telephonically, or through mailings, as appropriate.

Information for patients who cannot be reached prior to their appointments or who prefer to give information in person may be updated at the point of service or on the same day of the appointment, including cases of urgent or emergent care.

5. REFERENCES: Joint Commission Comprehensive Accreditation Standards for Laboratories; College of American Pathologists Laboratory General Checklist, Standards GEN.40935, COM.30000 and COM.301000. NPSG.02.03.01. VHA Handbook 1605.1 “Privacy and Release of Information”; VHA Directive 1088, “Communicating Test Results to Providers and Patients”. VHA HIV Policy (See VHA Handbook 1004.1), VA Handbook 5005/53 and VHA Directive 1910 “Patient Information Collection Management (PICM) Processes.

6. RESCISSIONS: VANTHCS Memorandum No. 00-09 dated June 24, 2011;

VANTHCS Memorandum No. 11-14 dated July 18, 2011.

Jeffery L. Milligan Director

Attachments

Distribution: A

Attachment A

Pathology and Laboratory Medicine Service

Communication Timeframes:

Critical Results: 60 minutes

Critical Laboratory Values1 (In Conventional Units)

CHEMISTRY

SERUM ANALYTE LESS THAN GREATER THAN

Calcium (total) 6.9 mg/dL 13.0 mg/dL

Bicarbonate 10 mmol/L 40 mmol/L

Glucose 50 mg/dL 500 mg/dL

Magnesium 1.0 mEq/L 3.3 mEq/L

Potassium 2.7 mmol/L 6.2 mmol/L

Sodium 120 mmol/L 160 mmol/L

Ionized Calcium 0.80 mmol/L 1.40 mmol/L

HEMATOLOGY

BLOOD ANALYTE LESS THAN GREATER THAN

Absolute neutrophils .02k/ul (Inpatient) .05k/ul (Outpatient)

Hematocrit 21% 57%

Hemoglobin 7 g/dL 19 g/dL

Platelets .30k/ul .1,000k/ul

PT/INR (International Normalized Ratio)

INR >6

PTT 100 seconds (Inpatient) 50 seconds (Outpatient)

PTT (Heparin) 100 seconds (Inpatient) 50 seconds (Outpatient)

Blood smear for malaria or other parasites

Critical if positive, especially P. falciparum

IMMUNOLOGY

Cryptococcal antigen (CSF) Positive

Legionella Urine Antigen Positive

1 Critical values are those lab values, above or below the reference or therapeutic ranges, for which a laboratory-initiated phone call is necessary. These values are considered so abnormal that they cannot wait until routine clinical monitoring discovers the abnormality.

MICROBIOLOGY

Acid-fast Smear or Culture Positive smear or growth on culture

Any Culture Highly unusual antimicrobial resistance detected (e.g., Enterococcus species and Staphylococcus species resistant to Vancomycin)

Highly significant or unusual microorganisms (e.g., Listeria, Legionella, or Brucella)

Gram stain suggesting gas gangrene or other systemic toxemia.

Blood Culture Growth

CSF and other Sterile Body fluids (Pleural, Peritoneal, and Synovial) Culture, Gram Stain or preps

Growth; organisms present on stains or preps.

Surgical Wound Culture Positive for Streptococcus pyogenes (Group A)

Stool Clostridium difficile toxin B (PCR) Positive for toxin B

ARTERIAL BLOOD GASES

ANALYTE (arterial) LESS THAN GREATER THAN pH 7.200 7.600 pCO2 10 mm Hg 65 mm Hg pO2 40 mm Hg N/A sO2 70% N/A

HCO3 10 mmol/L 40 mmol/L

O2Hb% 70% N/A

COHb% N/A 15%

MetHb N/A >30%

Lac N/A >4.0 mmol/L

THERAPEUTIC DRUGS GREATER THAN

Acetaminophen 35 ug/mL

Amikacin (Peak or, Unknown) 35 ug/mL

Amikacin (Trough) 10 ug/mL

Carbamazepine 20 ug/mL

Digoxin 2.5 ng/mL

Free Phenytoin 3 ug/mL

Gentamicin (Peak or, Unknown) 12 ug/mL

Gentamicin (Trough) 2.5 ug/mL

Lithium 1.5 mEq/L

Phenobarbital 60 ug/mL

Phenytoin (Dilantin) 30 ug/mL

Salicylate 300 ug/mL

Theophylline 25 ug/mL

Tobramycin (Peak or Unknown) 12 ug/mL

Tobramycin (Trough) 2.5 ug/mL

Valproic Acid 170 ug/mL

Vancomycin (Trough) 20 ug/mL

Critical Results Monitor: The time interval measured is from the identification of a critical result to its communication to a provider. 90% should be reported within 60 minutes of their identification and should require no more than 2 pages/calls to accomplish.

A sample of cases with critical results will be reviewed by P&LMS each month to document the time required to notify the appropriate provider of the result.

Attachment B

Radiology Service

Communication Timeframes:

Critical Results - A test result that is beyond the normal variation with a high probability of a significant increase in morbidity and/or mortality in the near future. This may include, but is not limited to:

(1) Any finding that has the potential to be life threatening or could cause serious harm and that requires an urgent intervention or change in patient management (i.e., pulmonary emboli, deep venous thrombosis);

(2) Any finding that might result in prolongation of patient pain or discomfort, if known to the Radiologist (i.e., acute fracture);

(3) Any finding that would result in the cancellation of significant on-going or imminent treatment, if known to the Radiologist;

(4) Specific conditions:

a. Pneumothorax

Acute tension pneumothorax

b. Intracranial hemorrhage

c. Ruptured aneurysm

d. Leaking aortic aneurysm

e. Aortic dissection

f. Occlusive intracranial stroke

g. Foreign object

1 post-surgical foreign object

2 depends on location and object

h. Ectopic pregnancy

i. Free air peritoneum

j. Testicular torsion

k. Deep venous thrombosis

l. Acute hemorrhage

Hemothorax

m. Life threatening cardiovascular/respiratory problem/pulmonary emboli

n. Life threatening neurological problem

o. Significant skeletal muscular/vascular injuries

p. Vertebrae fracture unstable

q. Perforated viscus

r. Bowel obstruction

s. Spinal cord compression

t. Incorrect location of venous access, catheter or tube (ET tube)

u. Possible tuberculosis

v. Any other condition determined by Radiologist as requiring immediate intervention for treatment.

Monitoring Critical Radiology Results: Radiology Service will measure the time taken to communicate the result to a provider for critical results identified on a sample of cases monthly.

A sample of cases with critical results will be reviewed by Radiology Service monthly to document the time required to notify the appropriate provider of the result in the case of critical results and total turnaround time.

Attachment C

Nuclear Medicine Service

Communication Timeframes:

1. Critical Nuclear Medicine imaging results:

a. Lung Scan – high probability of acute pulmonary embolism.

b. Gastrointestinal Bleeding Scan – positive for active bleeding.

c. Myocardial Perfusion Scan (Cardiac Stress Test) – high risk abnormal

d. Bone Scan – Unexpected significant result, such as metastasis with possible orthopedic jeopardy.

e. Hepatobiliary (HIDA) Scan – positive for acute cholecystitis.

f. PET Scan/Hybrid Imaging – any new finding with high probability for significant increase in morbidity and/or mortality that requires urgent attention.

g. Any other study result that, in the professional opinion of the interpreting Nuclear Medicine Physician, may significantly impact patient management and/or clinical outcome.

2. Documentation and notification of critical imaging results:

Upon contacting the Ordering Provider, or Designee, the reporting of the results and any recommendation(s) for follow-up are documented in the report of results in CPRS.

This documentation will include the date, the time the result was noted by the reading staff as being critical (when appropriate), the time that notification of Provider/Designee was accomplished, as well as the name of the person notified.

3. Monitoring Critical Results:

A sample of charts with critical results derived from the above procedures will be reviewed by Nuclear Medicine Service monthly to document the time required to notify the appropriate provider of the result.