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reporting, recording, and integrating criti- cal values into a patient’s closed-loop EMR. Worldwide harmonization seems to be advancing one country at a time. Australia is moving toward harmonizing critical re- sult management throughout the country.7 In Europe, the most accepted standard for accreditation and certification of clinical labs is ISO EN 15189:2012, which includes immediate notification of critical values as a special requisite. In the United States, CLSI published a new guideline.8


National


standards of care must be considered and compared in order to harmonize critical values practices, but other than simply mentioning standard of care for report- ing times in a tabular summary, the CLSI guideline does not adequately address, analyze, or compare standards of care in different countries. A key contemporary challenge is the har- monization of actual quantitative and qual- itative triggers for emergency notifications, not just harmonization of terminology. The reader can purchase GP478


for $140 to learn


three suggested nomenclature categories (critical-risk results, significant-risk results, and alert thresholds) and consult Appendix B therein for CAP Q-Probes critical values (renamed “alert thresholds” in a tabular summary in SI units) or access the same data free in reference 9. However, as dis- cussed in recent MLO articles,10-11


courts


may not deem such Q-Probes subscriber data admissible in establishing the stand- ard of care during litigation. Additionally, the complexities of three categories and how individual tests with their thresholds are assigned to each of the three categories would be difficult to explain to a jury. Although controversial, repeat testing of hematology and coagulation critical values, especially in regards to pediatrics, should be noted.12


REFERENCES


1. Kost GJ. Critical limits for urgent clinician notifica- tion at U.S. medical centers. JAMA. 1990;263:704-707.


2. Kost GJ. Critical limits for emergency clinician notification at U.S. children’s hospitals. Pediatrics. 1991;88:597-603.


3. Kost GJ. Using critical limits to improve patient outcome. MLO. 1993;25(3):22-27.


4. Kost GJ. The significance of ionized calcium in cardiac and critical care. Availability and critical limits at U.S. medical centers and children’s hospitals. Arch Pathol Lab Med. 1993;117:890-896.


5. The Joint Commission. NPSG.02.03.01 Report critical results of tests and diagnostic procedures on a timely basis.


6. Kost GJ, Hale KN. Global trends in critical values practices and their harmonization. Clin Chem Lab Med. 2011;49(2):167-176.


7. Campbell C, Horvath A. Towards harmonization of critical laboratory result management—review of the literature and survey of Australian practices. Clin Biochem Rev. 2012;33(4):149-160.


8. Young AB, et al. Management of critical- and significant-risk results. Wayne, PA: CLSI GP47. 2015.


9. Wagar EA, et al. Critical values comparison: A College of American Pathologists Q-Probes survey of 163 clinical laboratories. Arch Pathol Lab Med. 2007;131:1769-1775.


10. Kost GJ. Co-creating critical limits for enhanced acute care: proven need and web knowledge base. Part 1: A call to action! MLO 2015. Dec;47(12):34, 36-37.


11. Kost GJ. Co-creating critical limits for enhanced acute care: proven need and web knowledge base. Part 2: Standard of care, what it means and how it is applied. MLO 2016. Jan;48(1):28-29.


12. Sun SP, Garcia J, Hayden JA. Repeat critical hematology and coagulation values wastes re- sources, lengthens turnaround time, and delays clinical action. Am J Clin Path. 2018;149(3);247-252.


CLINICAL CHEMISTRY Test


Glucose


Potassium Calcium Sodium


CO2 content


Magnesium Phosphorus Bilirubin Chloride


Osmolality


Urea nitrogen Uric acid


CSF glucose Creatinine


Ionized calcium4 Lactate


Albumin Ammonia Protein


CSF protein


HEMATOLOGY Hematocrit Hemoglobin Platelets


WBC count PT


PTT Fibrinogen Bleeding time


BLOOD GASES AND PH pCO2


pH pO2


NEWBORN Test


Glucose Potassium


Modified potassium Bilirubin


Hemoglobin Hematocrit


pO2


Facility CH CH CH CH


USMC USMC USMC


Units


CHILDREN Mean (SD)


mmol/L mmol/L mmol/L mmol/L mmol/L mmol/L mmol/L µmol/L mmol/L mmol/kg mmol/L µmol/L mmol/L µmol/L mmol/L mmol/L g/L


µmol/L g/L


mg/L


L/L g/L


×109 ×109 s s


/L /L


2.6 (0.5) 2.8 (0.3)


1.62 (0.17) 121 (5) 11 (2)


0.45 (0.04) 0.42 (0.16) —


77 (8)


253 (12) — —


1.7 (0.7) —


0.85 (0.13) —


17 (5) —


34 (5) —


0.20 (0.06) 69 (13) 53 (25) 2.1 (0.9) — —


g/L min


mm Hg —


mm Hg Units


mmol/L mmol/L mmol/L µmol/L g/L L/L


mm Hg


0.77 (0.30) —


21 (6)


7.21 (0.05) 45 (7)


Mean (SD) 1.8 (0.4) 2.8 (0.4) 2.8 (0.4) —


95 (35)


0.33 (0.08) 37 (7)


LOW LIMIT


Range 1.7-3.3 2.0-3.5


1.25-1.87 110-130 6-18


0.41-0.49 0.16-0.65 —


70-90


240-270 — —


1.1-2.8 —


0.60-1.08 —


10-25 —


30-40 —


0.10-0.30 50-100 20-100 0.5-3.5 — —


0.20-12.0 —


15-40


7.10-7.30 30-55


LOW LIMIT


Range 1.1-2.8 2.5-3.7 2.5-3.7 —


50-150


0.24-0.45 30-50


HIGH LIMIT


Mean (SD) 24.7 (8.9) 6.4 (0.5)


3.17 (0.22) 156 (5) 39 (3)


1.77 (0.45) 2.87 (0.39) 257 (68) 121 (5)


318 (10)


19.6 (11.4) 714 (119) —


336 (212) 1.53 (0.11) 4.1 (1.2) 68 (10) 109 (50) 95 (6)


1875 (854)


0.62 (0.05) 208 (29) 916 (220) 42.9 (25.1) 21 (6)


62 (21) —


14.0 (4.0) 66 (23)


7.59 (0.04) 124 (25)


Mean (SD) 18.2 (3.6) 7.8 (0.5) 6.5


222 (86) 223 (23)


0.71 (0.04) 92 (12)


Range


13.9-55.5 5.0-8.0


2.74-3.74 150-170 33-45


1.23-3.00 2.26-3.23 86-342 115-130 300-330 3.9-53.6 595-892 —


221-884 1.35-1.75 2.4-5.5 60-80


35-200 90-100


1000-3000


0.54-0.70 170-250 600-1500 15.0-100.0 15-35


40-100 —


9.5-20.0 50-150


7.50-7.70 100-150


HIGH LIMIT Range


16.7-27.8 6.5-8.0


(See Ref. 3) 86-308 210-250 0.65-0.75 70-100


Children and newborn tables modified with permission by Pediatrics, Vol. 88, pp. 597-603, 1991. CSF, cerebrospinal fluid; WBC, white blood cell; PT, prothrombin time; PTT, partial thromboplastin time; CH, Children’s Hospital; USMC, U.S. Medical Centers. Qualitative critical results for children2


include the following: For hematology—presence of blasts in the blood smear;


new diagnosis or findings of leukemia; presence of drepanocytes (sickle cells); atypical lymphocytes, or abnormal reticulocyte count; abnormal erythrocyte indices (mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglo- bin concentration). For clinical microscopy and urinalysis—elevated white blood cells in cCSF; presence of malignant cells, blasts, or microorganisms in CSF or body fluids; combination of strongly positive test results for glucose and for ketones in urine. For microbiology and parasitology—positive results from Gram stain or culture from blood, CSF, or body cavity fluid; presence of malarial parasites.


XXX DMS POMJOF DPN t .-0 t $-3 11


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