1. Critical values and troubleshooting
Shaimah Al-Failakawi

2. What is a Critical test?
A test that requires rapid communication of the result to guide with further management decisions of medical urgency irrespective of whether it is normal, significantly abnormal or critical.

3. Difference between critical and abnormal results
Abnormal Results - Significantly abnormal results which are not life threatening, but may result in significant patient morbidity or irreversible harm or mortality. They require medical attention and follow-up action within a medically justified timescale, and for which timing is not as crucial as for critical results.

4. What are critical values?
Also called panic or alert results
Test results falling significantly outside the normal range and/or may represent life- threatening values, even from routine tests. These tests require rapid communication of results to the responsible caregiver. A delay in taking action responding to the result may result in a serious adverse outcome for the patient. The use of the term ‘panic’ is discouraged.

5. Types of critical values
Repeated critical result- Subsequent or Sequential critical results which have improved from a previous critical value and the provider is aware of the previous value. Clinical judgment, based on patient status, determines if these results are to be communicated to the physician as a critical result.
Expected/known critical result- Critical results expected based on the department (e.g. ICU, casualty) and/or diagnosis.
New critical values

6. Actions performed when encountering critical values
Results from critical tests and critical results shall be verified in the laboratory to rule-out pre- analytical errors in sample collection and handling. Ensuring the analytical quality by checking the quality control results on the analysers and repeating the tests, if needed, on another analyser.
Check the patient’s cumulative results for repeat critical values.

7. Communicating critical tests or results
The critical result shall be communicated to the responsible licensed caregiver or the physician whom requested the test.
When the patient’s responsible licensed caregiver is not available within the allotted time frame (15-30 minutes for chemistry and haematology stat tests), the information will be reported to an alternate responsible licensed caregiver.
For inpatient setting, it is acceptable for critical test results and critical results to be communicated to authorized staff members (nurses) whom would then be accountable for communication to the responsible licensed caregiver.
In the event that a patient’s provider cannot be reached or successful contact cannot be established, the on-call laboratory physician will be contacted and informed. The on-call physician shall be conveyed the critical result. Verification of clinician notification should be subsequently conveyed back to the laboratory technologist and documented.

8. Read-back policy
A “read-back” of the information (patient full name, Identification number and critical result) by the personnel on the receiving end. The staff member receiving the test result will write down the result (if possible) and read it back to the technologist or physician providing the result. The technologist or physician providing the test result will confirm the information was read back correctly and shall document the process was performed on the LIS.
Documentation of the critical value notification shall be indicated on the LIS report note section and shall include the name of the authorized staff that received the call and thus the critical result as well as the time the staff member was informed.

9. Repeated/known critical values
In situations where the critical value is expected based on the department (e.g. ICU, emergency departments), diagnosis (expected critical), or there was an improvement of the critical value from a previous value and the provider is aware of the previous value (repeated critical), the laboratory staff shall not inform the responsible caregiver.
These values shall be documented on the LIS report note section and will be included as part of the ‘informed critical results' during indicator measurement.
If a noncritical test result occurs after a critical result, any subsequent critical results are considered new and shall be informed to the authorized caregivers. Therefore these critical results are called the first critical values after a noncritical.

10. Critical values- clinical chemistry
Test Name
Value is Less
Than
Value is More Than
Unit
Acetaminophen -
990
umol/L
(after 4 hrs)
Ammonia
>1 year
< 1 year
200
100
µmol/L
Bicarbonate (serum)
10.00
40.00
mmol/l
Bilirubin (serum) neonatal
first 5 days
340
Calcium (serum)
1.5
3.5
mmol/L
Carbamazepine 63
Digoxin
5.2
nmol/L
Glucose
Plasma – fasting
CSF
2.2 25
Lactate
Serum
2.8
5.0
Magnesium
0.4
3.7
Osmolality
Blood
265
390
mOsm/kg
Phenobarbitone
258
Phenytoin
126
Phosphorus
0.36
Potassium (serum)
2.5
6.5
Sodium (serum)
120
160
Theophyline
111
Valproic Acid
1041
*Tacrolimus (FK506)
15.0
mg/L
*(significant abnormal), timelines depends on the sample status (routine monitoring/stat).

11. Critical values- hematology (adults)
Hematology Critical Values for Adult Patients
Test
Critical Values
Low
High
Total WBC
ANC
< 2.0 x 109/L
< 0.5
>80 x 109/L - Hb
< 70 g/L
> 190 g/L
Plt
< 20 x 109/L
> 1000 x 109/L
Blood Film
Presence of malarial parasites
Presence of blast cells
Presence of fragmented RBCs
(with anemia and thrombocytopenia)
INR *
> 6.0
APTT
> 120 seconds
Fib.
< 1.0 g/L

12. Critical values-hematology (children under 12 yrs of age)
Hematology Critical Values for Infants and Children Under 12 Years of Age
Test
Age Range
Critical Values
Low
High
Total WBC
ANC
All
< 2.0 x 109/L
< 0.5
> 50.0 x 109/L - Hb
Day 0
< 80 g/L
> 220 g/L
Day 1-30
> 230 g/L
1month–12years
> 200 g/L
Plt
Day 0-60
< 50 x 109/L
> 1000 x 109/L
2month–12years
< 20 x 109/L
Blood Film
Presence of malarial parasites
Presence of blasts
Presence of fragmented RBCs (with anemia
and thrombocytopenia)
INR
> 4.0
APTT
> 90 seconds
Fib
< 1 g/L

13. Significant results-microbiology
Test
Critical Result
Blood Culture
Any positive culture will be called to the patient’s nurse, or if unavailable, the charge nurse. The nurse is responsible for notifying the physician. In addition a written report will be released.
CSF Cultures and CSF
Gram Stains
Positive CSF cultures and CSF gram stains will be called to the patient’s nurse, or if unavailable, the charge nurse. The nurse is responsible for notifying the physician. In addition a written report will be released.
Acid-fast Bacilli Smears
Positive
Blood Smears
Positive for malarial parasites
Ocular Specimens
Culture positive for Neisseria gonorrhoeae, Neisseria meningitidis, Pseudomonas aeruginosa
Ear Specimen
Pseudomonas aeruginosa of ear swab
Wound Swabs
Group A Streptococcus of wound swab
Enteric Specimens
Escherichia coli 0157:H7, Vibrio cholerae, Shigella Dysenteriae type I, Salmonella typhi, Salmonella paratyphi A and B
Highly Aggressive
Organisms
Bacillus anthracis, Brucellaspp, Yersinia
pestis, Francisellatularensis, Burkholderia mallei, Burkholderiapseudomallei,
presumptive Clostridium botulinum, etc.
First-time Isolates
Vancomycin-resistant enterococci (VRE) or methicillin-resistant Staphylococcus aureus(MRSA) from clinically infected sites, but not from screening sites, multidrug-resistant Pseudomonasaeruginosa, Acinetobacterbaumannii and carbapenemase-resistant Enterobacteriaceae (CRE).

18. Critical value indicator

19. Tracking the compliance rate

21. Critical value indicator

22. troubleshooting
Shaimah Al-Failakawi

23. equipment Acquisition Installation Validation Maintenance Calibration
Troubleshooting
Service and repair
Records

24. Documentation vs records
Creation
Revision
Control and Distribution
Collection
Review
Storage
Retention

25. The 5 steps
Maintenance
Reagent
Prime
Calibration
Control

27. Implementing a qc program