36C24419R0074-013.pdf

DEPARTMENT OF VETERANS AFFAIRS MEDICAL CENTER

Erie, Pennsylvania

Medical Center Memorandum No. 113-05 March 12, 2019

COMMUNICATION OF CRITICAL RESULTS FOR LABORATORY TESTS

I. PURPOSE: To establish a policy, procedure and guidelines for communication of critical laboratory test results to the patient healthcare provider in compliance with Joint Commission standards, Veterans Health Administration (VHA) and VISN Guidelines.

II. POLICY: The critical results for laboratory tests will be communicated to the appropriate healthcare provider within established timeframes to allow for proper attention and appropriate action. The appropriate healthcare provider communicates these test results to the patient so that they may participate in their health care decisions.

All critical results must be transmitted by direct communication. If the ordering provider is not available to receive critical results, these values will be communicated to the surrogate provider or the Medical Director/designee of the service. See Attachment A for a list of definitions that apply to this policy.

III. RESPONSIBILITY:

A. Chief of Staff will:

1. Ensure that a policy for communication of critical results is in place.

2. Ensure that periodic monitors are devised to monitor timeliness of result communication and follow-up clinical action, as appropriate, of results to document adherence to VHA and local policies.

3. Review the monitors of test result communication and resolve process deficiencies with Program Managers and Service Chiefs.

B. The Medical Executive Council (MEC) is responsible for approval of Critical Values Test List and notification protocol for Pathology & Laboratory Medicine tests performed within the Medical Center.

C. Pathology & Laboratory Medicine (P&LM):

1. The Medical Director, P&LM, with appropriate consultation/input from patient healthcare providers and review of published reference materials, is responsible for test selection to be included in the critical value list, defining critical levels for these tests and updating the policy as

Attachment K

MCM 113-05, Communication of Critical Results for Laboratory Tests appropriate. The Medical Director, P&LM, will work with the Chief of Staff on identifying and resolving process deficiencies.

2. The Laboratory Supervisor and technologists are responsible for accurate test results, implementing section procedures for prompt notification of critical values to the appropriate healthcare provider and timely release of the result information into the VistA computer system with appropriate documentation.

D. Administrative Officer of the Day (AOD) is responsible for assisting the Urgent

Care Center physician or Hospitalist during off-duty hours, in contacting the outpatient/Community Based Outpatient Clinic (CBOC) patient on whom Pathology & Laboratory Medicine has reported a critical test result.

E. All Medical Directors for Primary Care (PC), Surgical Care, Urgent Care Center

(UCC), Behavioral Health and Geriatric & Extended Care are responsible for establishing a chain of responsibility for receipt of critical results.

F. Healthcare providers are responsible for:

1. Placing the initial order.

2. Responding in a timely manner to pages received from the laboratory.

3. Confirming the critical value(s) by “reading-back” the results to the person communicating the critical value(s).

4. Initiating timely therapeutic action for critical results of any orders that have been placed.

5. Documenting changes in the treatment plan in response to critical test results in the medical record.

6. Discussing test results with their patients and document as appropriate.

IV. PROCEDURES:

A. Critical Value List: The customized Critical Value List that meets the needs of the Medical Center will be available to the patient healthcare providers and P&LM employees (Attachment B).

B. The P&LM employees will follow the following procedure prior to releasing critical result(s).

1. Assure specimen integrity (free of gross lipemia and hemolysis).

2. Verify the critical value (chemistry, hematology, coagulation, toxicology, blood gas sections) by repeating the test to avoid any analytical errors.

The repeat test value must be within +5% of the original value.

3. If the repeat value does not agree within +5% of the original value:

a. Notify the physician of possible specimen or instrument problems.

b. Troubleshoot to find possible cause(s) of the error.

c. Recollect the patient specimen if the sample integrity is questionable.

d. Notify the Laboratory Supervisor or designee.

C. Reporting of Critical Results:

1. The technologist verifying the critical result(s) will notify the appropriate healthcare provider using two (2) patient identifiers. The provider receiving the critical results, via direct communication, will confirm the critical values by writing down the information and “reading back” the results to the communicator to ensure accuracy. In highly emergent cases where read-back would be impractical or impede patient care (example – during a code or in the OR), “repeat back” is allowable.

2. It is expected that the notification process for critical results should be completed within 30 minutes from the time known.

3. The following table denotes the provider responsibilities for receiving critical values. Monthly provider schedules will be posted on the main bulletin board in P&LM. Surrogate provider notices will be received Monday – Friday via email to all P&LM staff. (Page 4)

OUTPATIENT† INPATIENT UCC

M - Sat Sunday 7 days/week + Holidays

7 days/week + Holidays

8a – 4p & Extended Hours††

4p – 8a 24 hours 24 hours 8a-8P

Appropriate

Provider

Hospitalist†††

CBOC COUMADIN PATIENTS

M - F M-F Weekends/

Holidays 7:30a – 4p 4p – 7:30a 7:30a-

6p 6p-

7:30a

24 hours

Anticoag clinic

† Outpatient includes Ambulatory Surgery †† Extended Hours: Monday-Friday: 4p – 7p

Saturday: 8a – 4p ††† Contact ordering Hospitalist, if applicable

4. The notification procedure of critical values to the appropriate healthcare provider is as follows (Attachment C):

a. The P&LM technologist will make two (2) attempts (by telephone, instant message and/or pager), five (5) minutes apart to contact the appropriate healthcare provider. All attempts to contact a provider will be documented to include the time and date that the attempt to contact was made. This documentation will be given to the Laboratory Supervisor.

b. If the provider does not respond, the Medical Director of the service, or their designee, will be notified of the critical results.

5. For critical values on Outpatients or CBOC patients between the hours of

4pm and 8am, the Hospitalist will make the determination as to whether the patient should be called back to the Urgent Care Center or an emergency department for immediate evaluation or contact be made during the regular duty day. If the determination is made that the patient must be recalled immediately, the Administrative Officer of the Day (AOD) will assist the Hospitalist in contacting the patient. If the determination is made that the patient should be recalled on the following day, the hospitalist must communicate this information to the oncoming Hospitalist.

6. For critical values on UCC patients between the hours of 8am and 8pm, the UCC physician will make the determination as to whether the patient should be called back to the Urgent Care Center or an emergency department for immediate evaluation or contact be made during the regular duty day. If the determination is made that the patient must be recalled immediately, the Administrative Officer of the Day (AOD) will assist the UCC physician in contacting the patient. If the determination is made that the patient should be recalled on the following day, the UCC physician must communicate this information to the oncoming Hospitalist. After 8pm, the process is the same as step 5 directly above.

7. Critical values for arterial blood gases will be phoned to the appropriate healthcare provider by the respiratory therapist or medical technologist.

8. Critical values for laboratory tests obtained at Point-of-Care testing sites will be repeated for verification. The authorized personnel performing the testing must notify the appropriate healthcare provider of the critical value and document in CPRS as specified in MCM 113-13, Ancillary Testing Program.

9. Critical results phoned to P&LM or the Anticoag clinic from reference laboratories will be read back by the receiver. This "read back" will consist of patient's full name, full SSN or date of birth and critical values to ensure accuracy. The receiver must then notify the appropriate healthcare provider following the above steps.

10. For critical test results reportable to outside healthcare agencies, the

Infection Control Coordinator will be notified by P&LM.

D. After provider notification occurs, the results will be released into the VistA system. VistA will automatically flag critical results with an asterisk (*).

Appropriate documentation will be made in "comments" by the releasing staff member describing the following:

1. The time that the staff member became aware of result.

2. The provider who was notified.

3. The notifying staff member.

4. The date and time that notification occurred.

5. That two patient identifiers were used in the process.

EXAMPLE:

Time Result Known [enter TIME] (use Vista canned comment TRK)

Critical results repeated, phoned to, and read back by: (use Vista canned comment CRIT)

Provider notified/Notifying staff member on DATE @ TIME

Two patient identifiers used (use Vista canned comment 2ID)

E. Computer "Electronic Alert" – A view alert is automatically generated upon verification of abnormal and critical results and transmitted to the ordering and primary patient healthcare provider. This alert will remain until it is read by the provider or after it is purged from the system; 365 days for critical results and 30 days for abnormal results.

F. The healthcare providers, when appropriate, upon notification of critical values, should initiate patient evaluation and document the action taken/treatment given in the patient’s medical record.

G. A current updated list of telephone numbers/pager numbers of the patient healthcare providers in the inpatient/outpatient areas will be maintained in all sections of P&LM.

H. The Laboratory Supervisor will closely monitor as a part of P&LM's Performance Improvement Program, the compliance of laboratory staff in timely communication of values. All identified problems and corrective action(s) will be taken as necessary.

V. REFERENCES:

A. Test of Clinical Chemistry – Tietz, N.W., W.B. Saunders Co., 4th Edition 2006

B. Pharmacological Bases of Therapeutics, Goodman & Gilman, 12th Edition 2011

C. The Joint Commission Comprehensive Accreditation Manual for Hospitals, Home

Care, Behavioral Health, and Laboratory, (current editions)

D. Pathology Consultation on Reporting of Critical Values, American Journal of

Clinical Pathology 2011; 135: 55-513

E. Laboratory Critical Values Policies and Procedures, Arch Pathol. Lab. Med., Vol

126, June 2002

F. VHA Directive 1088, Communicating Test Results to Providers and Patients

VI. FOLLOW UP RESPONSIBILITY: Medical Director and Laboratory Supervisor, Pathology & Laboratory Medicine

VII. REPORTING REQUIREMENTS: Pathology & Laboratory Medicine must report all critical values to patient healthcare providers. The provider(s) will communicate the critical values to the patient as appropriate.

VIII. RESCISSION: MCM 113-05, Communication of Critical Values for Laboratory Tests, dated October 27, 2017.

(Original signed 3/12/19) John A. Gennaro Medical Center Director

Attachments: A. Definitions B. Critical Decision Levels for Laboratory Tests C. Decision Tree for Pathology and Laboratory Medicine

ATTACHMENT A

DEFINITIONS

A. "Appropriate" Healthcare Provider – During business hours, refers to that provider who ordered the laboratory testing OR, for those tests ordered by outside providers, the patient's primary care provider. Outside of normal business hours, refers to either the Urgent Care Center physician or Hospitalist.

B. Critical Results – Diagnostic, abnormal findings that always require rapid communication of results, even if from routine tests. These results are associated with a high likelihood of short-term poor outcome and requires either immediate therapeutic intervention or close clinical monitoring.

C. Critical Tests (STATS) – A test or examination that always requires rapid communication of results, whether those results are normal or abnormal. This priority status is applied to laboratory test requests when the information has immediate implications for patient care.

These are discussed in MCM 113-04, Laboratory Critical Tests (STAT Testing).

D. Direct Communication is transmission of test results by telephone or face-to-face conversation.

ATTACHMENT B

CRITICAL DECISION LEVELS FOR LABORATORY TESTS

DEPARTMENT LABORATORY TESTS NOTIFICATION OF CRITICAL LEVEL

* LOW* * HIGH*

CHEMISTRY Glucose <50 mg/dl >400 mg/dl

Sodium <122 mmol/l >156 mmol/l

Chloride <82 mmol/l >123 mmol/l

Potassium <3.0 mmol/l >6 mmol/l

CO2 <13 mmol/l >46 mmol/l

Calcium ≤7.0 mg/dl ≥13 mg/dl

Phosphate <1.5 mg/dl >9 mg/dl

Magnesium <1.0 mg/dl >4.6 mg/dl

Urea Nitrogen >100 mg/dl

Creatinine >6.3 mg/dl

Uric Acid >16 mg/dl

Lactic Acid ≥30.6 mg/dl

Troponin I ≥0.03 ng/ml

TOXICOLOGY Digoxin >2.0 ng/ml

Theophylline >20 ug/ml

Phenobarbital >40 ug/ml

Phenytoin (Dilantin) >20 ug/ml

Tegretol >15 ug/ml

Gentamicin 1. (Peak) 2. (Trough) 1.>12 ug/ml 2. >2.0 ug/ml

Lithium >2 mmol/l

Valproic Acid >150 ug/ml

ETOH ( Alcohol) >80 mg/ml

HEMATOLOGY Hemoglobin <7 gm/dl >20 mg/ml

Hematocrit <21% >60%

WBC Count <2,000mm2 >22,000/mm2

Platelet Count ≤50,000 mm2 >800,000/mm2

Presence of blasts on blood smear(new diagnosis on findings of leukemia)

Results called

COAGULATION INR(International Ratio) ≥ 4.0

APTT(Activated Partial Throboplastin >116 seconds

MICROBIOLOGY Blood/Culture All Positives emailed to

*AFB Smear/culture Providers and Infection

CSF Gram Control Practitioner.

Stain/culture/Crytococcal antigen

*Stool Cuture-Shigella, Salmonella, Campylobacter

Results also called to floor RN for Inpatients

Yersinia, E. coli 0157/Shiga Toxin

Malaria Smears

Gram Stain of Sterile Body Fluids

*MRSA

*C. Dificile Toxins

ATTACHMENT B (Con’t)

CRITICAL DECISION LEVELS FOR LABORATORY TESTS (Con’t)

Bacterial isolates positive for ESBL.

KPC-CRE

*Influenza Herpes, Chlamydia, N.gonorrhea and other identified pathogens reportable to Public Health Agencies

Clinical Microsopy and Urinalysis

Elevated WBC count in CSF Presence or malignant cells/blasts, Microorganisms in CSF or body fluids

Blood Bank Transfusion Reaction Work-up Results

Positive Antibody Screen ABO/Rh Tying discrepancy

Results called Initial Antibody detection

And/or increase in strength of reaction

Incompatible crossmatch between ABO/Rh type specific donor-recipient blood

Arterial Blood Gases

PH

PCO2

PO2

≤7.2 ≤18 mmHg <50 mmHg

≥7.6 ≥70 mmHg

Ancillary Testing

(POCT)

Blood Glucose Testing < 50 mg/dl >400 mg/dl

Surgical Pathology First time malignant diagnosis (except basal cell/squamous cell carcinoma of skin)

Change in diagnosis that would have a critical impact in patient treatment

Results called

ATTACHMENT C

DECISION TREE FOR PATHOLOGY & LABORATORY MEDICINE

*Coumadin Patients: M-F 7:30A-6P Call Anti-Coagulation Clinic, otherwise call Hospitalist