D43 P_LMS CRITICAL RESULT POLICY.pdf

PATHOLOGY & LABORATORY MEDICINE SERVICE

4300 West 7 th

Street, Little Rock, AR 72205

Issue Date:

02/12/21

Document # :

GENQM.002

Owner: Christina English Revision:

Primary Approver: John W. Theus, MD

Document Status: Approved for Operational Use - Not Document Controlled if Printed

Title: P&LMS CRITICAL RESULT POLICY

PURPOSE

The critical result policy provides guidelines for the immediate alert of the ordering provider, which is required to be a licensed care provider that can intervene in patient treatment of life threatening clinical laboratory values, life altering test results and first-time malignancy. It insures that critical results have been verified; appropriate documentation of notification has been completed, and establishes mechanisms to monitor the process.

DEFINITIONS

Critical Test Result (Value) – Any result or finding that may be considered life threatening or that could result in severe morbidity and require urgent or emergent clinical attention.

Critical Test – Test that require rapid communication of results, whether normal, abnormal, or critical.

Read-Back – The process of an individual receiving the results of a critical value or a critical test by writing down and reading back the information to the individual providing this information. This is required for all verbal communication of critical value/test.

Ordering Provider – An ordering provider is a provider authorized to enter and sign orders for diagnostic tests.

CLINICAL SIGNIFICANCE

This policy assures effective communication of critical results and critical tests in a timely manner. Critical values for clinical laboratory tests have been established and approved by the Medical Executive Board. Refer to Appendix 1 (GENQM.033) for a complete listing of clinical laboratory critical values and critical tests. Anatomic pathology directives for first time malignancy are outlined in VHA Handbook 1106.01.

Patient results, whether “EMERGENCY” or “ROUTINE”, defined as critical will be verified and the clinical personnel responsible for care notified IMMEDIATELY by verbal communication or using by using VA approved instant messaging systems for communication of private information (e.g., Skype, Microsoft TEAMS). The individual receiving the critical clinical laboratory value will be required to read back the critical information if being communicated verbally. Critical values/test communicated through instant messaging (IM) do not require read back confirmed since this information is given in a written format to the recipient. However, when communicating a critical value via IM, you must receive a response from the recipient to verify the critical value was received and understood. The time the critical value was noted, the name of the individual contacted, the time and initials of the technologist reporting the critical value th

Street, Little Rock, AR 72205

Owner: Christina English Revision:

Primary Approver: John W. Theus, MD and the statement “Read Back Confirmed”, if required, will be noted in the COMMENT section of the patient report. For critical values/tests communicated by instant messaging (IM), it should be documented the communication was electronic. There is a computer backup to the telephone alert (CPRS Alert/Notification), which alerts the ordering physician of ALL critical laboratory values.

Results for laboratory tests defined as critical tests will be verbally communicated or by using VA approved instant messaging (IM) systems for communication of private information to a licensed clinical care provider that can intervene in the patient’s care.

Documentation of notification of critical tests is also required. Notification of critical values and critical test results will be monitored.

Anatomic pathology specimens diagnosed as first-time malignancy must have documentation in the pathology report that the patient’s provider has been verbally notified of the diagnosis. All cases with unexpected diagnoses of clinical significance and of malignancy not previously established must be reviewed by a second pathologist prior to issuance of the final report. The pathologist will alert the ordering provider of cases when appropriate. Notification of first time malignancy and review by second pathologist will be monitored.

CLINICAL LABORATORY CRITICAL VALUE PROCEDURE

1. Repeat test to verify the result, if applicable. Refer to GENQM.033, Clinical

Laboratory Critical Values, for a listing of what designated critical values require repeat testing. (See individual sections procedures for required documentation of the repeating of results)

2. Once result is repeated/verified, enter the result into the patient chart.

3. Verbally or electronically communicate patient’s full name, full social security number, and critical result to the ordering provider. If you are unable to reach the ordering clinician, page their supervisor (i.e.: Resident, Attending, Service Chief), medical officer of the day (MOD, Medical Nocturnist) or surgical officer of the day (SOD). It is never acceptable to call a registered nurse (RN) or ward clerk.

Refer to GENQM.034, P&LMS Critical Value Telephone Quick Reference, for the communication critical cascade. An ordering provider is an individual who can intervene in the patient’s care such as a physician, an advanced practice nurse, a nurse practitioner or a clinical pharmacy specialist. The exception to this is when communicating a critical value to an operating room (OR), home health care services (HHCS), or referral testing. When calling the OR/HHCS it is acceptable to give the result to the circulating nurse or nurse on call and document in the comments result given to nurse (state name) for Dr. (state name). For testing that is being performed for another laboratory (e.g., UAMS, VA VISN Labs, etc.), critical results should be given directly to the requesting laboratory staff. This communication should be documented in the comments.

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Street, Little Rock, AR 72205

Owner: Christina English Revision:

Primary Approver: John W. Theus, MD

For detailed guideline for contacting the provider see section, “Guideline for Reporting Critical Lab Values or Critical Test Results” in this procedure.

NOTE: If when communicating a critical value it is discovered the patient is deceased, it is still required that the critical value be communicated to the provider. However, this notification may be met with resistance. If the provider refuses to take the result then document who you did speak to and that the patient is deceased. It is not required to move up the notification cascade (e.g., MOD, COS).

4. The set goal for communication of the critical value is 60 minutes or less from time of discovery by technologist. Due to the life threatening or life altering nature of a critical value the clinical laboratory personnel will strive to communicate the critical value in 30 minutes or less.

5. When communication of the critical value has been completed, the following required information will be documented in the comment section.

a. The time the critical value was noted. The shortcut *CVN will expand to “Critical value noted” then insert “at (time)”.

b. The time the critical value was communicated.

c. The name (the person’s first name alone is NOT adequate) of the care provider the critical value was communicated to. For OR/HHCS results that are communicated to the Nurse, document in the comments result given to nurse (state name) for Dr. (state name). For Referral testing that are communicated to the referring laboratory staff, document in the comments result given to lab staff (state name). For electronic communication document method of communication in the comments. For example, “Electronically communicated to Dr. Smith…” or “Communicated to Dr. Smith via Skype”.

d. The initials of the technologist who communicated the critical value.

e. Confirmation that the result was read back to the technologist, if required.

The shortcut *RBC will expand to the statement “Read Back Confirmed”.

f. For results communicated electronically, the shortcut *EC will expand to the statement “Electronically Communicated”.

6. A critical log will be printed each morning in the appropriate testing department.

The critical log will be reviewed each morning by the section supervisor or designee. Any critical value not documented as communicated will be communicated to the provider immediately and the appropriate documentation will be updated in the comment section of the patient result field. If the critical value is not documented as communicated to a provider or any of the required information listed above in item 4 is missing from the comment section of the result a deviation document will be initiated.

7. If the ordering provider was unable to be contacted, refused the critical result, was obstructive or communication was greater than 60 minutes from time of th

Street, Little Rock, AR 72205

Owner: Christina English Revision:

Primary Approver: John W. Theus, MD discovery by the technologist, a deviation document should be initiated by the technologist. The technologist should include whom they attempted to contact and how many attempts were made to contact the provider on the deviation document.

8. Supervisor or designee of departments reporting critical values will monitor daily

1) time it takes to contact appropriate care provider 2) documentation that the provider read back the result 3) documentation of the provider taking the result and time result was communicated.

9. Critical value monitors will be reported monthly to the P&LMS Quality Management Council.

CRITICAL LABORATORY TEST RESULT PROTOCOL – Critical laboratory test results are those tests for which results are communicated to a clinical care provider regardless of the result. Critical laboratory test monitors will be reported monthly to the P&LMS Quality Management Council.

These include:

Frozen section diagnosis – The set goal for verbal communication of the diagnosis to the provider is within 20 minutes of receipt of specimen into the lab and within 30 minutes from time of order.

Rapid HIV result - The set goal for verbal communication of the result to the provider is within 60 minutes of receipt of specimen into the lab and within 3 hours from time of order.

STAT Urine Pregnancy Test – The set goal for verbal communication of the result to the provider is within 60 minutes of receipt of specimen into the lab.

GUIDELINE FOR REPORTING CRITICAL LAB VALUES AND CRITICAL TEST

RESULTS

1. INPATIENTS: Call/page/IM the ordering provider. If your page to the ordering provider has not been answered in 15 minutes contact the ward/clinic to verify that you have the correct care provider for the current time and correct pager number. If you are unable to reach the ordering clinician, page their supervisor (i.e.: Resident, Attending, Service Chief). After exhausting all resources for reaching the responsible provider page the MOD (medical officer of the day) or the SOD (Surgical officer of the day) before the 60-minute time limit has expired.

Call Chief of Staff if response is negative, refusal, or obstructive.

1. LR MOD pager 1698

2. NLR MOD pager 1880

3. LR SOD pager 1378

4. Chief of Staff (COS on Call) 257-5432

2. OUTPATIENTS: Contact the ordering provider. If you are unable to reach the ordering clinician, page their supervisor (i.e.: Resident, Attending, Service Chief).

If unable to contact a responsible individual after normal duty hours (when clinics th

Street, Little Rock, AR 72205

Owner: Christina English Revision:

Primary Approver: John W. Theus, MD are closed), the technologist will contact the Emergency Department, Ext. 55055 and provide the critical value. Contact Chief of Staff if response is negative, refusal, or obstructive at 257-5432.

3. MEDICATION MANAGEMENT CLINIC (COUMADIN CLINIC): Call/IM the critical result to the Clinical Pharmacy Specialist at ext. 72364. If you are unable to reach the Clinical Pharmacy Specialist, page their supervisor (i.e.: Service Chief). After hours, report the critical value to the ED physician at extension 55055. Contact Chief of Staff if response is negative, refusal, or obstructive at 257-5432.

4. DISCHARGED PATIENTS: Call/page/IM the ordering provider during normal business hours. If your page to the ordering provider has not been answered in 15 minutes; page their supervisor (i.e.: Resident, Attending, Service Chief). After exhausting all resources for reaching the responsible provider page the MOD (medical officer of the day) or the SOD (Surgical officer of the day) before the 60-minute time limit has expired. Contact Chief of Staff if response is negative, refusal, or obstructive at 257-5432

1. LR MOD pager 1698

2. NLR MOD pager 1880

3. LR SOD pager 1378

4. Chief of Staff (COS on Call) 257-5432

5. COMPENSATION AND PENSION (C&P): If the patient location is C&P, the critical value will be communicated to the ordering physician. If you are unable to reach the ordering clinician, page their supervisor (i.e.: Resident, Attending, Service Chief). After hours, report the critical value to the ED physician at extension 55055. Contact Chief of Staff if response is negative, refusal, or obstructive at 257-5432.

6. HOME HEALTH CARE SERVICES (HHCS): The critical value will be called/IM to the ordering provider. If your page to the ordering provider has not been answered in 15 minutes contact the HBPC office, 75080 during regular hours, after hours contact the nurse on call using cell phone number 772-4219.

7. COMMUNITY BASED OUTPATIENT CLINICS (CBOC): All CBOC critical laboratory results will be called/IM directly to the referring CBOC during regular office hours or to the designated after hours contact. See below for list of CBOC contact numbers.

El Dorado CBOC 1702 Northwest Ave. El Dorado, AR 71730 Office: 870-875-5900 Fax: 870-875-5921 th

Street, Little Rock, AR 72205

Owner: Christina English Revision:

Primary Approver: John W. Theus, MD

After hours, report critical values to the ED physician at extension 55055. Call Chief of Staff on call if response is negative, refusal or obstructive at 257-5432.

Mountain Home CBOC 759 Hwy 62 E., Mountain Home, AR 72653 Office: 870-594-8387/877-338-8003 Fax: 870-701-5045 After hours, call their Clinic Cell Phone at 571-882-4658 and ask for the physician on-call to call you back about critical lab results.

Mena CBOC 300 S. Morrow Rd. Mena, AR 71953 Office: 42714/42715 Fax: 501-609-2751 After hours, report critical values to the ED physician at extension 55055. Call Chief of Staff on call if response is negative, refusal or obstructive at 257-5432.

Pine Bluff CBOC 2906 Market St., Pine Bluff, AR 71603 Office: 870-580-8200 Fax: 870-850-8245 Dr. Bryan Raymundo: 661-714-4008 Dr. Teresa Travis: 501-912-3953 Karen McPherson, APRN: 870-692-6137 After hours, report critical values to the ED physician at extension 55055. Call Chief of Staff on call if response is negative, refusal or obstructive at 257-5432.

Searcy CBOC 1120 S. Main St. Searcy, AR 72143 Office: 501-207-4700 Fax: 501-207-4707 After hours, report critical values to the ED physician at extension 55055. Call Chief of Staff on call if response is negative, refusal or obstructive at 257-5432.

Conway CBOC 1520 East Dave Ward Drive Conway, AR 72032 Office: 501-548-0500 Fax: 501-548-0678 After hours, report critical values to the ED physician at extension 55055. Call Chief of Staff on call if response is negative, refusal or obstructive at 257-5432.

Russellville CBOC 3106 West 2nd CT Russellville, AR 72081 Office: 479-880-5100 Fax: 479-880-5297 th

Street, Little Rock, AR 72205

Owner: Christina English Revision:

Primary Approver: John W. Theus, MD

After Hours, report critical values to the ED physician at extension obstructive at 257-5432.

Hot Springs CBOC 177 Sawtooth Oak St. Hot Springs, AR 71901 Office: 501-520-6250 Fax: 501-520-6291 Lab: 501-520-6309 After hours, report critical values to the ED physician at extension obstructive at 257-5432.

8. REFERRAL PATIENTS: Critical values for outside hospital referral patient testing will be called directly back to the referring laboratory.

NOTE: Refer to Appendix 2 (GENQM.034) for the P&LMS Critical Value Telephone Quick Reference.

ANATOMICAL PATHOLOGY NOTIFICATION

1. If the evaluation of any anatomic pathology specimen concludes that there is malignancy, and that there has been no prior definitive diagnosis of that malignancy (excluding skin squamous and basal cell carcinomas), the patient’s provider must be notified by verbal communication as soon as possible (ideally, within 1 working day of the time that diagnosis was made).

Patient provider notification should occur in all cases with unexpected findings of clinical significance. Such cases include but are not limited to:

Significant disagreement between frozen section and final diagnosis.

Significant disagreement and/or change between primary pathologist and outside pathologist consultation.

The communications must be documented in the specimen report by the pathologist who notifies the patient’s provider.

The pathologist will code the pathology report with the procedure code PC- 3099.

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Street, Little Rock, AR 72205

Owner: Christina English Revision:

Primary Approver: John W. Theus, MD

2. All cases with unexpected diagnoses of clinical significance, and diagnosis of malignancy not previously established (excluding skin squamous and basal cell carcinomas), must be reviewed by second pathologist and comment documenting findings entered into the final report.

The pathologist will code the pathology report with the procedure code PC- 3089.

3. The histology supervisor or designee will generate a report weekly to insure notification of first time malignancy and review by second pathologist has been documented in the final report. The assistant chief pathologist will be given a list of pathology reports that do not have appropriate documentation and proceed with corrective action. Quality Assurance monitors for AP will be reported quarterly to the Tissue Committee.

PROVIDER NOTIFICATION OF UNEXPECTED FINDINGS

Patient provider notification should occur in all cases with unexpected findings of clinical significance. Such cases include but are not limited to:

1. Positive stain for acid-fast bacilli

2. GMS stain positive for a dimorphic fungus (e.g., histoplasmosis, blastomycosis)

3. Diagnosis of Pneumocystis jirovecii

ANATOMIC PATHOLOGY SPECIMENS COLLECTED INCORRECTLY

The pathologist must verbally notify the provider of specimens submitted with insufficient tissue for diagnosis or if the specimen was lost during processing. The pathologist will code the pathology report with the procedure code PC-3099. The pathologist will also alert the ordering provider electronically.

CRITICAL CLINICAL LABORATORY VALUES FOR SAMPLES COLLECTED

INAPPROPRIATELY

The laboratory is often presented with laboratory samples that are collected inappropriately, and as a consequence a “critical value” is inappropriately generated.

When it is clearly apparent that this is the case, the results of laboratory analysis on the specimen can be canceled by the technologist. It is VERY IMPORTANT AND ABSOLUTELY ESSENTIAL that the ward be notified of the problem so that a repeat specimen can be sent to the lab. A “Redraw Request Form” will be completed. Refer to P&LMS Deviation/ Mislabeled Specimen Reporting Procedure for instructions on handling unacceptable specimens and requesting redraws. It is equally important to DOCUMENT the problem in the comments section at the time of data entry of the laboratory results. It is necessary the test be repeated and verified to confirm the analytical result. Some information also needs to be conveyed as to the reason for the cancellation of the test.

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Street, Little Rock, AR 72205

Owner: Christina English Revision:

Primary Approver: John W. Theus, MD

For samples collected inappropriately it is ESSENTIAL that the following information be entered into the comments section:

(1) Result of the analysis. (unless grossly hemolyzed)

(2) Indication that the result was repeated and verified.

(3) Reason for cancellation of the test result (i.e., results inconsistent with life, previous value not consistent with current result, results of other analysis, e.g., electrolytes, heparin measurement clearly show inappropriate specimen collection, etc.).

(4) Request for repeat specimen

(5) Documentation of notification (person making the call/IM, person contacted, and time communicated).

If when calling for a redraw it is discovered that the patient is deceased, cancel the test and document reasons as stated above; however, make note in the comments that we were unable to obtain a redraw due to patient being deceased. DO NOT verify results, even if requested by the provider.

For any unusual results that a redraw of the specimen is not possible and a request for verifying results is received, inform the provider that this will require a pathologist review. Leave results as pending and call the pathologist on call or the pathology resident on call (pager# 688-2820) for review of the case. Ensure you provide the provider’s name and contact information to the resident for proper follow up. If it is determined that the results can be verified, state the following in the comments: 1) Approved for release by Dr. (name of resident); 2) Questionable specimen integrity. Interpret with caution.

PATIENT CONFIDENTIALITY

This department is required to follow all patient and privacy release of information policies as established in MCM 136-4 “Privacy and Release of Information”.

RELATED PROCEDURES

P&LMS Deviation/ Mislabeled Specimen Reporting Procedure P&LMS Review and Reporting of Results

REFERENCES

1. LabCorp Directory of Services and Interpretive Guide

2. P&LMS Laboratory Manual

3. Veterans Health Administration (VHA) Handbook 1106.1

4. College of American Pathologist; All Common Checklist

5. Joint Commission on Accreditation of Healthcare Organization; NPSG

6. Medical Center Memorandum 113-3

7. VHA Directive 1088