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Medical CCRN : Critical Care Register Nurse Exam

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Exam Number : CCRN
Exam Name : Critical Care Register Nurse
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CCRN test Format | CCRN Course Contents | CCRN Course Outline | CCRN test Syllabus | CCRN test Objectives


A criterion-referenced standard setting process, known as the modified Angoff, is used to establish the passing point/cut score for the exam. Each candidates performance on the test is measured against a predetermined standard.
The passing point/cut score for the test is established using a panel of subject matter experts, an test development committee (EDC), who carefully reviews each test question to determine the basic level of knowledge or skill that is expected. The passing point/cut score is based on the panels established difficulty ratings for each test question.
Under the guidance of a psychometrician, the panel develops and recommends the passing point/cut score, which is reviewed and approved by AACN Certification Corporation. The passing point/cut score for the test is established to identify individuals with an acceptable level of knowledge and skill. All individuals who pass the exam, regardless of their score, have demonstrated an acceptable level of knowledge.

I. CLINICAL JUDGMENT (80%)
A. Cardiovascular (17%)
1. Acute coronary syndrome:
a. NSTEMI
b. STEMI
c. Unstable angina
2. Acute peripheral vascular insufficiency:
a. Arterial/venous occlusion
b. Carotid artery stenosis
c. Endarterectomy
d. Fem-Pop bypass
3. Acute pulmonary edema
4. Aortic aneurysm
5. Aortic dissection
6. Aortic rupture
7. Cardiac surgery:
a. CABG
b. Valve replacement or repair
8. Cardiac tamponade
9. Cardiac trauma
10. Cardiac/vascular catheterization
11. Cardiogenic shock
12. Cardiomyopathies:
a. Dilated
b. Hypertrophic
c. Idiopathic
d. Restrictive
13. Dysrhythmias
14. Heart failure
15. Hypertensive crisis
16. Myocardial conduction system abnormalities
(e.g., prolonged QT interval, Wolff-ParkinsonWhite)
17. Papillary muscle rupture
18. Structural heart defects (acquired and congenital, including valvular disease)
19. TAVR

B. Respiratory (15%)
1. Acute pulmonary embolus
2. ARDS
3. Acute respiratory failure
4. Acute respiratory infection (e.g., pneumonia)
5. Aspiration
6. Chronic conditions (e.g., COPD, asthma, bronchitis, emphysema)
7. Failure to wean from mechanical ventilation
8. Pleural space abnormalities (e.g., pneumothorax, hemothorax, empyema, pleural effusions)
9. Pulmonary fibrosis
10. Pulmonary hypertension
11. Status asthmaticus
12. Thoracic surgery
13. Thoracic trauma (e.g., fractured rib, lung contusion, tracheal perforation)
14. Transfusion-related acute lung injury (TRALI)

C. Endocrine/Hematology/Gastrointestinal/Renal/Integumentary (20%)
1. Endocrine
a. Adrenal insufficiency
b. Diabetes insipidus (DI)
c. Diabetes mellitus, types 1 and 2
d. Diabetic ketoacidosis (DKA)
e. Hyperglycemia
f. Hyperosmolar hyperglycemic state (HHS)
g. Hyperthyroidism
h. Hypoglycemia (acute)
i. Hypothyroidism
j. SIADH
2. Hematology and Immunology
a. Anemia
b. Coagulopathies (e.g., ITP, DIC, HIT)
c. Immune deficiencies
d. Leukopenia
e. Oncologic complications (e.g., tumor lysis syndrome, pericardial effusion)
f. Thrombocytopenia
g. Transfusion reactions
3. Gastrointestinal
a. Abdominal compartment syndrome
b. Acute abdominal trauma
c. Acute GI hemorrhage
d. Bowel infarction, obstruction, perforation (e.g., mesenteric ischemia, adhesions)
e. GI surgeries (e.g., Whipple, esophagectomy, resections)
f. Hepatic failure/coma (e.g., portal hypertension, cirrhosis, esophageal varices, fulminant hepatitis, biliary atresia, drug-induced)
g. Malnutrition and malabsorption
h. Pancreatitis
4. Renal and Genitourinary
a. Acute genitourinary trauma
b. Acute kidney injury (AKI)
c. Chronic kidney disease (CKD)
d. Infections (e.g., kidney, urosepsis)
e. Life-threatening electrolyte imbalances
5. Integumentary
a. Cellulitis
b. IV infiltration
c. Necrotizing fasciitis
d. Pressure injury
e. Wounds:
i. infectious
ii. surgical
iii. trauma
D. Musculoskeletal/Neurological/

Psychosocial (14%)
1. Musculoskeletal
a. Compartment syndrome
b. Fractures (e.g., femur, pelvic)
c. Functional issues (e.g., immobility, falls, gait disorders)
d. Osteomyelitis
e. Rhabdomyolysis
2. Neurological
a. Acute spinal cord injury
b. Brain death
c. Delirium (e.g., hyperactive, hypoactive, mixed)
d. Dementia
e. Encephalopathy
f. Hemorrhage:
i. intracranial (ICH)
ii. intraventricular (IVH)
iii. subarachnoid (traumatic or aneurysmal)
g. Increased intracranial pressure (e.g., hydrocephalus)
h. Neurologic infectious disease (e.g., viral, bacterial, fungal)
i. Neuromuscular disorders (e.g., muscular dystrophy, CP, Guillain-Barr, myasthenia)
j. Neurosurgery (e.g., craniotomy, Burr holes)
k. Seizure disorders
l. Space-occupying lesions (e.g., brain tumors)
m. Stroke:
i. hemorrhagic
ii. ischemic (embolic)
iii. TIA
n. Traumatic brain injury (TBI): epidural, subdural, concussion
3. Behavioral and Psychosocial
a. Abuse/neglect
b. Aggression
c. Agitation
d. Anxiety
e. Suicidal ideation and/or behaviors
f. Depression
g. Medical non-adherence
h. PTSD
i. Risk-taking behavior
j. Substance use disorders (e.g., withdrawal, chronic alcohol or drug dependence)
E. Multisystem (14%)
1. Acid-base imbalance
2. Bariatric complications
3. Comorbidity in patients with transplant history
4. End-of-life care
5. Healthcare-associated conditions (e.g., VAE, CAUTI, CLABSI)
6. Hypotension
7. Infectious diseases:
a. Influenza (e.g., pandemic or epidemic)
b. Multi-drug resistant organisms (e.g., MRSA, VRE, CRE)
8. Life-threatening maternal/fetal complications (e.g., eclampsia, HELLP syndrome, postpartum hemorrhage, amniotic embolism)
9. Multiple organ dysfunction syndrome (MODS)
10. Multisystem trauma
11. Pain: acute, chronic
12. Post-intensive care syndrome (PICS)
13. Sepsis
14. Septic shock
15. Shock states:
a. Distributive (e.g., anaphylactic, neurogenic)
b. Hypovolemic
16. Sleep disruption (including sensory overload)
17. Thermoregulation
18. Toxic ingestion/inhalations (e.g., drug/alcohol overdose)
19. Toxin/drug exposure (including allergies)

II. PROFESSIONAL CARING 7 ETHICAL PRACTICE (20%)
A. Advocacy/Moral Agency
B. Caring Practices
C. Response to Diversity
D. Facilitation of Learning
E. Collaboration
F. Systems Thinking
G. Clinical Inquiry

CLINICAL JUDGMENT
General
Recognize normal and abnormal:
o developmental assessment findings and provide developmentally appropriate care
o physical assessment findings
o psychosocial assessment findings
Recognize signs and symptoms of emergencies, initiate interventions, and seek assistance as needed
Recognize indications for, and manage patients requiring:
o capnography (EtCO2)
o central venous access
o medication reversal agents
o palliative care
o SvO2 monitoring
Manage patients receiving:
o complementary/alternative medicine and/or nonpharmacologic interventions
o medications (e.g., safe administration, monitoring, polypharmacy)
Monitor patients and follow protocols for pre- and postoperative care
Assess pain
Evaluate patients response to interventions
Identify and monitor normal and abnormal diagnostic test results
Manage fluid and electrolyte balance
Manage monitor alarms based on protocols and changes in patient condition Cardiovascular
Apply leads for cardiac monitoring
Identify, interpret and monitor cardiac rhythms
Recognize indications for, and manage patients requiring:
o 12-lead ECG
o arterial catheter
o cardiac catheterization
o cardioversion central venous pressure monitoring
o defibrillation
o IABP
o invasive hemodynamic monitoring
o pacing: epicardial, transcutaneous, transvenous
o pericardiocentesis
o QT interval monitoring
o ST segment monitoring
Manage patients requiring:
o endovascular stenting
o PCI Respiratory
Interpret blood gas results
Recognize indications for, and manage patients requiring:
o modes of mechanical ventilation
o noninvasive positive pressure ventilation (e.g., BiPAP, CPAP, high-flow nasal cannula)
o oxygen therapy delivery devices
o prevention of complications related to mechanical ventilation (ventilator bundle)
o prone positioning
o pulmonary therapeutic interventions related to mechanical ventilation: airway clearance, extubation, intubation, weaning
o therapeutic gases (e.g., oxygen, nitric oxide, heliox, CO2 )
o thoracentesis
o tracheostomy Hematology and Immunology
Manage patients receiving transfusion of blood products
Monitor patients and follow protocols:
o pre-, intra-, post-intervention (e.g., plasmapheresis, exchange transfusion, leukocyte depletion)
o related to blood conservation Neurological
Recognize indications for, and manage patients requiring neurologic monitoring devices and drains (e.g., ICP, ventricular or lumbar drain)
Use a swallow evaluation tool to assess dysphagia
Manage patients requiring:
o neuroendovascular interventions (e.g., coiling, thrombectomy)
o neurosurgical procedures (e.g., pre-, intra-, post-procedure)
o spinal immobilization Integumentary
Recognize indications for, and manage patients requiring, therapeutic interventions (e.g. wound VACs, pressure reduction surfaces, fecal management devices, IV infiltrate treatment) Gastrointestinal
Monitor patients and follow protocols for procedures pre-, intra-, post-procedure (e.g., EGD, PEG placement)
Intervene to address barriers to nutritional/fluid adequacy (e.g., chewing/swallowing difficulties, alterations in hunger and thirst, inability to self-feed)
Recognize indications for, and manage patients requiring:
o abdominal pressure monitoring
o GI drains
o enteral and parenteral nutrition Renal and Genitourinary
Identify nephrotoxic agents
Monitor patients and follow protocols pre-, intra-, and post-procedure (e.g., renal biopsy, ultrasound)
Recognize indications for, and manage patients requiring, renal therapeutic intervention (e.g., hemodialysis, CRRT, peritoneal dialysis)
Musculoskeletal
Manage patients requiring progressive mobility
Recognize indications for, and manage patients requiring, compartment syndrome monitoring
Multisystem
Manage continuous temperature monitoring
Provide end-of-life and palliative care
Recognize risk factors and manage malignant hyperthermia
Recognize indications for, and manage patients undergoing:
o continuous sedation
o intermittent sedation
o neuromuscular blockade agents
o procedural sedation - minimal
o procedural sedation - moderate
o targeted temperature management (previously known as therapeutic hypothermia)
Behavioral and Psychosocial
Respond to behavioral emergencies (e.g., nonviolent crisis intervention, de-escalation techniques)
Use behavioral assessment tools (e.g., delirium, alcohol withdrawal, cognitive impairment)
Recognize indications for, and manage patients requiring:
o behavioral therapeutic interventions
o medication management for agitation
o physical restraints

I. CLINICAL JUDGMENT (80%)
A. Cardiovascular (14%)
1. Cardiac infection and inflammatory diseases
2. Cardiac malformations
3. Cardiac surgery
4. Cardiogenic shock
5. Cardiomyopathies
6. Cardiovascular catheterization
7. Dysrhythmias
8. Heart failure
9. Hypertensive crisis
10. Myocardial conduction system defects
11. Obstructive shock
12. Vascular occlusion
B. Respiratory (18%)
1. Acute pulmonary edema
2. Acute pulmonary embolus
3. Acute respiratory distress syndrome (ARDS)
4. Acute respiratory failure
5. Acute respiratory infection
6. Air-leak syndromes
7. Apnea of prematurity
8. Aspiration
9. Chronic pulmonary conditions
10. Congenital airway malformations
11. Failure to wean from mechanical ventilation
12. Pulmonary hypertension
13. Status asthmaticus
14. Thoracic and airway trauma
15. Thoracic surgery

C. Endocrine/Hematology/Gastrointestinal/Renal/Integumentary (20%)
1. Endocrine
a. Adrenal insufficiency
b. Diabetes insipidus (DI)
c. Diabetic ketoacidosis (DKA)
d. Diabetes mellitus, types 1 and 2
e. Hyperglycemia
f. Hypoglycemia
g. Inborn errors of metabolism
h. Syndrome of inappropriate secretion of antidiuretic hormone (SIADH)
2. Hematology and Immunology
a. Anemia
b. Coagulopathies (e.g., ITP, DIC)
c. Immune deficiencies
d. Myelosuppression (e.g., thrombocytopenia, neutropenia)
e. Oncologic complications
f. Sickle cell crisis
g. Transfusion reactions
3. Gastrointestinal
a. Abdominal compartment syndrome
b. Abdominal trauma
c. Bowel infarction, obstruction and perforation
d. Gastroesophageal reflux
e. GI hemorrhage
f. GI surgery
g. Liver disease and failure
h. Malnutrition and malabsorption
i. Necrotizing enterocolitis (NEC)
j. Peritonitis
4. Renal and Genitourinary
a. AKI
b. Chronic kidney disease (CKD)
c. Hemolytic uremic syndrome (HUS)
d. Kidney transplant
e. Life-threatening electrolyte imbalances
f. Renal and genitourinary infections
g. Renal and genitourinary surgery
5. Integumentary
a. IV infiltration
b. Pressure injury
c. Skin failure (e.g., hypoperfusion)
d. Wounds

D. Musculoskeletal/Neurological/Psychosocial (15%)
1. Musculoskeletal
a. Compartment syndrome
b. Musculoskeletal surgery
c. Musculoskeletal trauma
d. Rhabdomyolysis
2. Neurological
a. Acute spinal cord injury
b. Agitation
c. Brain death
d. Congenital neurological abnormalities
e. Delirium
f. Encephalopathy
g. Head trauma
h. Hydrocephalus
i. Intracranial hemorrhage
j. Neurogenic shock
k. Neurologic infectious disease
l. Neuromuscular disorders
m. Neurosurgery
n. Pain: acute, chronic
o. Seizure disorders
p. Space-occupying lesions
q. Spinal fusion
r. Stroke
s. Traumatic brain injury (TBI)
3. Behavioral and Psychosocial
a. Abuse and neglect
b. Post-traumatic stress disorder (PTSD)
c. Post-intensive care syndrome (PICS)
d. Self-harm
e. Suicidal ideation and behavior

E. Multisystem (13%)
1. Acid-base imbalance
2. Anaphylactic shock
3. Death and dying
4. Healthcare-associated conditions (e.g., VAE, CAUTI, CLABSI)
5. Hypovolemic shock
6. Post-transplant complications
7. Sepsis
8. Submersion injuries (i.e. near drowning)
9. Hyperthermia and hypothermia
10. Toxin and drug exposure

II. Professional Caring & Ethical Practice (20%)
A. Advocacy/Moral Agency
B. Caring Practices
C. Response to Diversity
D. Facilitation of Learning
E. Collaboration
F. Systems Thinking
G. Clinical Inquiry

CLINICAL JUDGMENT
General
Manage patients receiving:
o continuous sedation
o extracorporeal membrane oxygenation (ECMO)
o nonpharmacologic interventions
o pharmacologic interventions
o intra-procedural and post-procedural care
o post-operative care
o vascular access
Conduct physical assessment of critically ill or injured patients
Conduct psychosocial assessment of critically ill or injured patients
Evaluate diagnostic test results and laboratory values
Manage patients during intrahospital transport
Manage patients undergoing procedural sedation
Manage patients with temperature monitoring and regulation devices
Provide family-centered care Cardiovascular
Manage patients requiring:
o arterial catheterization (e.g., arterial line)
o cardiac catheterization
o cardioversion
o CVP monitoring
o defibrillation
o epicardial pacing
o near-infrared spectroscopy (NIRS)
o umbilical catheterization (e.g., UVC, UAC)
Manage patients with:
cardiac dysrhythmias
hemodynamic instability Respiratory
Manage patients requiring:
o artificial airways (e.g., endotracheal tubes, tracheotomy)
o assistance with airway clearance chest tubes
o high-frequency oscillatory ventilation (HFOV)
o mechanical ventilation
o noninvasive positive-pressure ventilation (e.g., CPAP, nasal IMV, high-flow nasal cannula)
o prone positioning
o respiratory monitoring devices (e.g., SpO2, SVO2, EtCO2)
o therapeutic gases (e.g., oxygen, nitric oxide, heliox, CO2)
o thoracentesis
Hematology and Immunology
Manage patients receiving:
o plasmapheresis, exchange transfusion or leukocyte depletion
o transfusion
Neurological
Conduct pain assessment of critically ill or injured patients
Manage patients with seizure activity
Provide end-of-life and palliative care
Manage patients requiring:
o neurologic monitoring devices and drains (e.g., ICP, ventricular drains, grids)
o spinal immobilization Integumentary
Manage patients requiring wound prevention and/or treatment (e.g., wound VACs, pressure reduction surfaces, fecal management devices, IV infiltrate treatment)
Gastrointestinal
Manage patients with inadequate nutrition and fluid intake (e.g., chewing and swallowing difficulties, alterations in hunger and thirst, inability to self-feed)
Manage patients receiving:
o enteral and parenteral nutrition
o GI drains
o intra-abdominal pressure monitoring Renal and Genitourinary
Manage patients requiring:
o electrolyte replacement
o renal replacement therapies (e.g., hemodialysis, CRRT, peritoneal dialysis)
Multisystem
Manage patients requiring progressive mobility
Behavioral and Psychosocial
Conduct behavioral assessment of critically ill or injured patients (e.g., delirium, withdrawal)
Manage patients requiring behavioral and mental health interventions
Respond to behavioral emergencies (e.g., nonviolent crisis intervention, de-escalation techniques)

I. CLINICAL JUDGMENT (80%)
A. Cardiovascular (5%)
1. Acute pulmonary edema
2. Cardiac surgery (e.g., congenital defects, patent ductus arteriosus)
3. Dysrhythmias
4. Heart failure
5. Hypovolemic shock
6. Structural heart defects (acquired and congenital, including valvular disease)

B. Respiratory (21%)
1. Acute respiratory distress syndrome (ARDS)
2. Acute respiratory failure
3. Acute respiratory infection (e.g., pneumonia)
4. Air-leak syndromes
5. Apnea of prematurity
6. Aspiration
7. Chronic conditions (e.g., chronic lung disease/bronchopulmonary dysplasia)
8. Congenital anomalies (e.g., diaphragmatic hernia, tracheoesophageal fistula, choanal atresia, tracheomalacia, tracheal stenosis)
9. Failure to wean from mechanical ventilation
10. Meconium aspiration syndrome
11. Persistent pulmonary hypertension of the newborn (PPHN)
12. Pulmonary hemorrhage
13. Pulmonary hypertension
14. Respiratory distress (RDS)
15. Thoracic surgery
16. Transient tachypnea of the newborn

C. Endocrine/Hematology/Gastrointestinal/Renal/Integumentary (27%)
1. Endocrine
a. Adrenal insufficiency
b. Hyperbilirubinemia
c. Hyperglycemia
d. Hypoglycemia
e. Inborn errors of metabolism
2. Hematology and Immunology
a. Anemia
b. Coagulopathies (e.g., ITP, DIC)
c. Immune deficiencies
d. Leukopenia
e. Polycythemia
f. Rh incompatibilities, ABO incompatibilities, hydrops fetalis
g. Thrombocytopenia
3. Gastrointestinal
a. Bowel infarction/obstruction/perforation (e.g., mesenteric ischemia, adhesions)
b. Feeding intolerance
c. Gastroesophageal reflux
d. GI abnormalities (e.g., omphalocele, gastroschisis, volvulus, imperforate anus, Hirshsprung disease, malrotation, intussusception, hernias)
e. GI surgeries
f. Hepatic failure (e.g., biliary atresia, portal hypertension, esophageal varices)
g. Malnutrition and malabsorption
h. Necrotizing enterocolitis (NEC)
i. Pyloric stenosis
4. Renal and Genitourinary
a. Acute kidney injury (AKI)
b. Chronic kidney disease
c. Congenital genitourinary conditions (e.g., hypospadias, polycystic kidney disease, hydronephrosis, bladder exstrophy)
d. Genitourinary surgery
e. Infections
f. Life-threatening electrolyte imbalances
5. Integumentary
a. Congenital abnormalities (e.g., epidermolysis bullosa, skin tags)
b. IV infiltration
c. Pressure injury/ulcer (e.g., device, incontinence, immobility)
d. Wounds:
i. non-surgical
ii. surgical

D. Musculoskeletal/Neurological/Psychosocial (13%)
1. Musculoskeletal
a. Congenital or acquired musculoskeletal conditions
b. Osteopenia
2. Neurological
a. Agitation
b. Congenital neurological abnormalities (e.g., AV malformation, myelomeningocele, encephalocele)
c. Encephalopathy
d. Head trauma (e.g., forceps and/or vacuum injury)
e. Hemorrhage:
i. intracranial (ICH)
ii. intraventricular (IVH)
f. Hydrocephalus
g. Ischemic insult (e.g., stroke, periventricular leukomalacia)
h. Neurologic infectious disease (e.g., viral, bacterial, fungal)
i. Neuromuscular disorders (e.g., spinal muscular atrophy)
j. Neurosurgery
k. Pain (acute, chronic)
l. Seizure disorders
m. Sensory impairment (e.g., retinopathy of prematurity, hearing impairment, visual impairment)
n. Stress (e.g., noise, overstimulation, sleep disturbances)
o. Traumatic brain injury (e.g., epidural, subdural, concussion, physical abuse)
3. Behavioral and Psychosocial
a. Abuse and neglect
b. Families in crisis (e.g., stress, grief, lack of coping)

E. Multisystem (14%)
1. Birth injuries (e.g., hypoxic-ischemic encephalopathy, brachial plexus injury, lacerations)
2. Developmental delays
3. Failure to thrive
4. Healthcare-associated conditions (e.g., VAE, CAUTI, CLABSI)
5. Hypotension
6. Infectious diseases (e.g., influenza, respiratory syncytial virus, multidrugresistant organisms)
7. Life-threatening maternal/fetal complications (e.g., eclampsia, HELLP syndrome, maternal-fetal transfusion, placental
abruption, placenta previa) 8. Low birth weight/prematurity
9. Sepsis
10. Terminal conditions (e.g., end-of-life, palliative care)
11. Thermoregulation
12. Toxin/drug exposure (e.g., neonatal abstinence syndrome, fetal alcohol syndrome, maternal or iatrogenic).

II. Professional Caring & Ethical Practice (20%)
A. Advocacy/Moral Agency
B. Caring Practices
C. Response to Diversity
D. Facilitation of Learning
E. Collaboration
F. Systems Thinking
G. Clinical Inquiry

CLINICAL JUDGMENT
General
Assess pain considering patients gestational age
Follow protocol for newborn car seat testing, hearing and congenital heart disease screening
Follow protocol for feeding and supplementation
Identify and monitor normal and abnormal diagnostic test results
Implement interventions to keep neonates safe (e.g., transponder use, safe sleep)
Manage monitor alarms based on protocol and change in patient condition
Manage patients receiving complementary alternative medicine and/or nonpharmacologic interventions
Manage patients receiving medications (e.g., safe administration, monitoring, polypharmacy)
Monitor patients and follow protocols for pre- and postoperative care
Recognize indications for, and manage patients requiring, central venous access
Recognize normal and abnormal:
o developmental assessment findings and provide developmentally appropriate care
o family psychosocial assessment findings
o physical assessment findings
Recognize signs and symptoms of emergencies, initiate interventions, and seek assistance as needed
Cardiovascular
Apply leads for cardiac monitoring
Identify, interpret and monitor cardiac rhythms
Monitor hemodynamic status and recognize signs and symptoms of hemodynamic instability
Recognize early signs of decreased cardiac output
Recognize normal fetal circulation and transition to extra-uterine life
Recognize indications for, and manage patients requiring:
o 12-lead ECG
o arterial catheter
o cardioversion
o invasive hemodynamic monitoring Respiratory
Interpret blood gas results
Manage medications and monitor patients requiring rapid sequence intubation (RSI)
Recognize indications for, and manage patients with, tracheostomy
Recognize indications for, and manage patients requiring:
o assisted ventilation
o bronchoscopy
o chest tubes
o endotracheal tubes
o non-invasive positive pressure ventilation (e.g., bilevel positive airway pressure, CPAP, high-flow nasal cannula)
o oxygen therapy delivery device
o prone positioning (lateral rotation therapy)
o rescue airways (e.g., laryngeal mask airway [LMA])
o respiratory monitoring devices (e.g., SpO2, EtCO2) and report values
o therapeutic gases (e.g., oxygen, nitric oxide, heliox, CO2)
o thoracentesis
Hematology and Immunology
Manage patients receiving transfusion of blood products
Monitor and manage patients with bleeding disorders
Monitor patients and follow protocols:
o pre-, intra-, post-intervention (e.g., exchange transfusion)
o related to blood conservation
Neurological
Manage patients with congenital neurological abnormalities



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Medical Register test

AnPac Bio type III clinical gadget Passes extensive NMPA Registration assessments and may beginning medical Trial in Q1, 2022 | CCRN Dumps and Latest Questions

PHILADELPHIA, Jan. 04, 2022 (GLOBE NEWSWIRE) -- AnPac Bio-scientific Science Co., Ltd. (“AnPac Bio,” the “enterprise” or “we”) (ANPC), a US and China-based biotechnology company focused on early melanoma screening and detection, announced these days that on December 30, 2021, the business’s classification III clinical machine for lung melanoma auxiliary analysis has achieved and passed stringent and rigorous registration tests on the checking out laboratory designated with the aid of the national clinical items Administration (NMPA), China’s regulatory agent for medical products. China’s wide type III medical equipment registration tests included scientific equipment performance assessments concerning accuracy, precision, stability, linearity, accuracy and repeatability in pattern addition, move-contamination, electromagnetic compatibility (EMC), and reliability and efficiency below a considerable number of environmental conditions. Completion of the NMPA registration assessments is a big milestone towards acquiring a category III scientific device registration certificate. Following completion of the registration examine, the last predominant step earlier than final approval of a registration certificate will be clinical trials that allows you to begin in the first quarter of 2022 with two certified clinical trial clinical institutions.

AnPac Bio all started its legitimate scientific device registration technique in December 2018 via filing an software for clinical equipment classification with the NMPA. since then, AnPac Bio has obtained the choice of the product classification (suggested as classification III) from the NMPA, performed giant medical gadget optimization, completed rigorous inside medical machine checking out, gone through extensive exterior third-party checking out and validation, and acquired a certificate of certain inspection capability from the targeted scientific device registration check laboratory.

The above-mentioned category III scientific device designation is in keeping with AnPac Bio’s novel cancer differentiation evaluation (CDA) technology, which has been used in melanoma risk evaluation assessments for conventional inhabitants and medical reports and has already accrued greater than 240,000 samples together with accepted population screening, in addition to huge retrospective and prospective medical stories with main medical institutions. If AnPac Bio is successful in acquiring the category III registration certificates from the NMPA for its CDA gadget, it is going to add additional markets and channels for the enterprise to promote its tests. AnPac Bio might be in a position to penetrate the scientific segment of the market, together with hospitals and medical institutions for lung cancer auxiliary diagnosis assessments, which is a big market, and may additional fuel the business’s income boom.

Story continues

Dr. Chris Yu, CEO and Chairman of AnPac Bio commented: “we're very enthusiastic about this big milestone and principal accomplishment. by passing this difficult and rigorous scientific equipment registration verify, we've demonstrated their technical and commercialization capabilities. Lung melanoma is an enormous cancer and there are very few accredited registration certificates for lung melanoma, so acquiring a category III clinical equipment registration certificate for lung cancer auxiliary prognosis would enhance their competitive place in the industry and place us for improved revenues. this is one in all AnPac Bio’s most critical initiatives, together with their plan to commercialize and market their CDA look at various as a laboratory developed verify (LDT) within the u.s.. They now predict massive extra progress in acquiring class III scientific device registration certificate in China and LDT within the US in 2022.”

About AnPac BioAnPac Bio is a biotechnology business focused on early cancer screening and detection, with one hundred fifty issued patents as of September 30, 2021. With two licensed scientific laboratories in China and one CLIA and CAP authorized medical laboratory within the u.s., AnPac Bio performs a set of melanoma screening and detection tests, including CDA (cancer Differentiation evaluation), bio-chemical, immunological, and genomics exams. in response to Frost & Sullivan, AnPac Bio ranked third international among organizations offering next-technology early melanoma screening and detection applied sciences in terms of the number of medical samples for melanoma screening and detection, based on approximately 43,980 medical samples as of September 30, 2021. AnPac Bio’s CDA expertise platform has been proven in retrospective validation reports to be able to become aware of the chance of over 20 distinctive melanoma types with excessive sensitivity and specificity.

For greater counsel, please discuss with: https://www.Anpacbio.com.

For investor and media inquiries, please contact:

company:Phil Case, marketing and Investor RelationsPhone: +1-267-810-6776 (US)email: phil_case@AnPacbio.com

Investor relations:Ascent Investor members of the family LLCTina Xiao, PresidentPhone: +1-917-609-0333 (US)e mail: tina.xiao@ascent-ir.com

protected Harbor statement

This announcement incorporates forward-searching statements in the meaning of area 27A of the Securities Act of 1933 and part 21E of the Securities alternate Act of 1934. These forward-looking statements are made below the “safe harbor” provisions of the deepest Securities Litigation Reform Act of 1995 and are relating to the business's future monetary and operating performance. The company has attempted to identify ahead-looking statements by means of terminologies including "believes," "estimates," "anticipates," "expects," "plans," "projects," "intends," "capabilities," “goal,” “intention,” “predict,” “outlook,” “seek,” “aim” “objective,” “count on,” “consider,” “continue,” “placed,” “forecast,” “likely,” "may additionally," "may," "might," "will," "may still," "approximately" or other words that bring uncertainty of future hobbies or effects to determine these forward-searching statements. These statements are based on latest expectations, assumptions and uncertainties involving judgments about, among other things, future financial, competitive and market situations and future business decisions, all of that are complicated or unimaginable to foretell accurately and many of which might be past the company's manage. These statements also involve everyday and unknown dangers, uncertainties and other elements that can cause the business's genuine outcomes to be materially different from these expressed or implied by means of any forward-searching commentary. known and unknown hazards, uncertainties and other elements consist of, but are not limited to, the implementation of their enterprise model and increase techniques; trends and competition in the melanoma screening and detection market; their expectations concerning demand for and market acceptance of their melanoma screening and detection tests and their means to expand their consumer base; their potential to attain and retain intellectual property protections for their CDA technology and their endured analysis and development to retain tempo with know-how trends; their ability to acquire and preserve regulatory approvals and registration certificates from the NMPA, the FDA and the critical U.S. states and have their laboratories licensed or authorised by using authorities together with the CLIA; their future business construction, monetary circumstance and consequences of operations and their ability to achieve financing charge-effortlessly; skills changes of government laws; accepted financial and business circumstances in China and somewhere else; their skill to employ and keep key personnel; their relationship with their essential company companions and valued clientele; and the length of the coronavirus outbreaks and their knowledge antagonistic affect on the economic conditions and fiscal markets and their company and economic performance, reminiscent of resulting from reduced business actions because of quarantines and commute restrictions instituted through China, the U.S. and a lot of other countries all over to comprise the spread of the virus. additionally, all forward-searching statements are area to the “possibility elements” distinct once in a while in the business's most latest Annual file on kind 20-F and other filings with the U.S. Securities and alternate commission. on account of these and other dangers, uncertainties and assumptions, undue reliance should still now not be placed on these ahead-looking statements. furthermore, these statements talk handiest as of the date of this press free up and, except as may be required via legislations, the enterprise undertakes no responsibility to revise or update publicly any ahead-looking statements for any intent.




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