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accordance with State law and approved medical staff policies and procedures.

Interpretive Guidelines §482.23(c)(4)

Intravenous (IV) medications and blood transfusions must be administered in accordance with

State law and approved medical staff policies and procedures. Further, many of the medications

included in the high-alert categories are administered intravenously. (See also the discussion of

high-risk/high-alert medications in the guidance for §482.25(b).) Hospital policies and

procedures for blood transfusions and IV medications must be based on accepted standards of

practice, and must address at least the following:

Vascular Access Route

Patients may require a form of vascular access to deliver blood or medications, either venous or

arterial, based on the desired treatment plan. Safe administration of blood transfusions and IV

medications includes the correct choice of vascular access. IV medications, such as fluids,

antibiotics, and chemotherapy, may require specific types of access, such as peripheral or central

catheters versus implanted port devices, based on the medication’s chemical properties or safety

concerns. Hospital policies and procedures must address which medications can be given

intravenously via what type of access.

Other Patient Safety Practices

In addition to the basic safe practices that apply to all medication administration (See the

discussion of safe medication administration practices, and medication administration in general,

at §482.23(c)), there are additional safe practices specific to IV medication administration that

require consideration, including but not limited to, the following:

• Tracing invasive lines and tubes prior to administration to ensure the medication is to be

administered via the proper route (for example, peripheral catheter versus epidural catheter

connections);

• Avoiding forcing connections when the equipment offers clear resistance;

• Verifying proper programming of infusion devices (concentrations, flow rate, dose rate).

Patient Monitoring

As discussed in the medication administration guidance for §§482.23(c)(1), (c)(1)(i) and (c)(2),

patients must be monitored for the effects of medications. To the extent that IV medications

have a more rapid effect on the body, it is important that staff administering medications

understand each medication and its monitoring requirements. Policies and procedures for IV

medication administration must address appropriate IV medication monitoring requirements,

including assessment of patients for risk factors that would influence the type and frequency of

monitoring.

For example: a 50 year old patient with a history of renal failure is receiving IV vancomycin

to treat a wound infection. The hospital policy for IV antibiotics, including vancomycin,

requires the patient’s kidney function to be monitored daily with blood draws. Based on

review of the lab results, a practitioner responsible for the care of the patient would be

expected to determine on a timely basis whether or not the antibiotic dose needs to be

adjusted to protect kidney function or prevent drug toxicity while achieving the desired

therapeutic effects. Staff administering the medication would be expected to review the lab

results as well, and to raise with a practitioner responsible for the care of the patient any

concerns they might have about whether an adjustment in the medication is needed.

Hospital policies and procedures related to monitoring patients receiving IV medications are

expected to address, but are not limited to, the following:

• Monitoring for Fluid & Electrolyte Balance

Whenever IV medications and blood transfusions are administered, the patient may become

at risk for fluid and electrolyte imbalance. Hospital policies and procedures must address

monitoring and treatment for fluid and electrolyte imbalances that may occur with blood

transfusions and IV medications.

• Monitoring Patients Receiving High-alert Medications, Including IV Opioids

Policies and procedures related to IV medication administration must address those

medications the hospital has identified as high-alert medications and the monitoring

requirements for patients receiving such drugs intravenously.

At a minimum, hospitals are expected to address monitoring for over-sedation and

respiratory depression related to IV opioids for post-operative patients

Opioids are a class of medication used frequently in hospitals to treat pain. The sedating

effects of opioids make it difficult at times to properly assess the patient’s level of sedation.

It can be erroneously assumed that patients are asleep when they are actually exhibiting

progressive symptoms of respiratory compromise - somnolence, decreased respiratory rate,

and decrease in oxygen levels. These symptoms, if unrecognized, can progress to respiratory

depression and even death.

Certain characteristics, in addition to those discussed in the medication administration

guidance for §§482.23(c)(1), (c)(1)(i) and (c)(2), place patients receiving opioids at higher

risk for oversedation and respiratory depression. These additional factors include, but are not

limited to4F

5:

• Snoring or history of sleep apnea

• No recent opioid use or first-time use of IV opioids

• Increased opioid dose requirement or opioid habituation

• Longer length of time receiving general anesthesia during surgery

• Receiving other sedating drugs, such as benzodiazepines, antihistamines, sedatives, or

other central nervous system depressants

• Preexisting pulmonary or cardiac disease

• Thoracic or other surgical incisions that may impair breathing

Of particular concern are patients receiving IV opioids post-operatively. The effects of

IV opioids in post-operative patients must be monitored vigilantly via serial assessments of

pain, respiratory status, and sedation levels.

Hospitals must have policies and procedures related to the use of high-alert medications,

including IV opioids for post-operative patients. Policies and procedures must address, at a

minimum, the process for patient risk assessment, including who conducts the assessments,

and, based on the results of the assessment, monitoring frequency and duration, what is to be

monitored, and monitoring methods. The policies and procedures must also address whether

and under what circumstances practitioners

prescribing IV opioids are allowed to establish protocols for IV opioid administration and

monitoring that differ from the hospital-wide policies and procedures.

The frequency of the serial assessments and duration of the monitoring timeframe for post-operative patients receiving IV opioids must be determined based on at least the following

considerations:

• Patient risk for adverse events;

• Opioid dosing frequency and IV delivery method. (push or patient-controlled analgesia

(PCA));

• Duration of IV opioid therapy.

Regardless of the above factors, at a minimum monitoring must include the following:

• Vital signs (blood pressure, temperature, pulse, respiratory rate)

• Pain level;

• Respiratory status;

• Sedation level; sedation levels are important indicators for the clinical effects of opioids.

5 Jarzyna D., Junquist C., Pasero C., et al. American Society for Pain Management Nursing - Guidelines on

Monitoring for Opioid-Induced Sedation and Respiratory Depression. Pain Management Nursing, Vol 12, No. 3

(September), 2011: pp 118-145

Sedation is a useful assessment parameter to observe the effects of opioids since sedation

typically precedes respiratory depression5F

6. See the blue box below for information on

sedation assessment methods.

In addition to vigilant nursing assessment at appropriate intervals, hospitals may choose to use

technology to support effective monitoring of patients’ respiratory rate and oxygen levels.

For additional information regarding recommendations of expert organizations on post-operative

opioid monitoring, including technology-supported monitoring, see blue boxes below. The

practices described in the blue boxes below are not required under the regulations.

The assessment and monitoring process must be explained to the patient and/or the patient's

representative, to communicate the rationale for vigilant monitoring, including that it might be

necessary to awaken the patient in order to assess effects of the medications. In addition,

hospitals are encouraged to educate the patient and his/her representative and/or family members

about notifying nursing staff promptly when there is difficulty breathing or other changes that

might be a reaction to medication.

For Information – Not Required/Not to be Cited

Institute for Safe Medication Practices Guidelines for PCA Monitoring

Assessment of Opioid

Tolerance

Vital

Signs

Pain Sedation Respiratory

Rate Quality SPO2*

&/or

ETCO2**

Baseline Assessment

before PCA

X X X X X X

PCA Initiation or X X X X X X

6 Institute for Safe Medication Practices (ISMP), Medication Safety Alert – Fatal PCA Adverse Events Continue to

Happen…Better Patient Monitoring is Essential to Prevent Harm. May 30, 2013

For Information – Not Required/Not to be Cited

In addition to assessing risk for respiratory depression, the Institute for

Safe Medication Practices recommends hospitals use a standard sedation

scale when assessing patients receiving PCA. Scales such as the Richmond

Agitation Sedation Scale, Pasero, Ramsey, or Glasgow Coma Scale are

useful in assessing sedation.

Institute for Safe Medication Practices (ISMP), Medication Safety Alert – Fatal PCA Adverse

Events Continue to Happen…Better Patient Monitoring is Essential to Prevent Harm. May 30, 2013

Change in Drug/Syringe

Q 15 minutes x 1

hour

Q 1 hour x 4 hours

Then Q 2 hours

PCA Dose Change or

Bolus

Q 1 hour x 4 hours

Then Q 2 hours

X X X X X X

Adverse Event or

Patient Deterioration

(e.g., adverse change in

sedation score)

Q 15 minutes x 1

hour

Q 1 hour x 4 hours

Then Q 2 hours

X X X X X X

Hand-offs/Shift Change X X X X X X

Institute for Safe Medication Practices (ISMP), Medication Safety Alert – Fatal PCA

Adverse Events Continue to happen…Better Patient Monitoring is Essential to Prevent

Harm. May 30, 2013 ISMP adapted these recommendations from the San Diego

Patient Safety Council

* SPO2: Saturation of peripheral oxygen via pulse oximetry

** ETCO2: End-tidal carbon dioxide via capnography

For Information – Not Required/Not to be Cited

The Patient Safety Movement Foundation

PSMF recommends all patients receiving IV opioids have continuous measure-through motion and low perfusion pulse oximetry, and that patients on

supplemental oxygen also have continuous respiration rate monitoring. It also

calls for the monitoring system to be linked with a notification system to clinical

staff who can respond immediately. It calls for an escalation protocol so that if a

staff person does not acknowledge the alert in 60 seconds a second person will be

notified.

The Patient Safety Movement Foundation - Actionable Patient Safety Solution

(APSS) #1: Failure to Rescue: Post-Operative Respiratory Depression. January 13,

2013

Adverse patient reactions require timely and appropriate intervention, per established protocols,

and must also be reported immediately to the practitioner responsible for the care of the patient.

(See the guidance for §482.23(c)(5) and §482.25(b)(6), concerning reporting of adverse

medication-related events.)

For Information – Not Required/Not to be Cited

Anesthesia Patient Safety Foundation

• APSF calls for every patient receiving postoperative opioid analgesics to be managed

based on the following clinical considerations*:

• Individualize the dose and infusion rate of opioid while considering

the unique aspects of each patient’s history and physical status.

• Make continuous monitoring of oxygenation (pulse oximetry) the

routine rather than the exception.

• Assess the need for supplemental oxygen, especially if pulse

oximetry or intermittent nurse assessment are the only methods of

identifying progressive hypoventilation.

• When supplemental oxygen is indicated, monitoring of ventilation

may warrant the use of technology designed to assess breathing or

estimate arterial carbon dioxide concentrations. Continuous

monitoring is most important for the highest risk patients, but

depending on clinical judgment, should be applied to other

patients.

APSF also has issued a video on opioid induced ventilatory impairment:

http://apsf.org/resources_video4.php

*Stoelting, RK.,Weinger MB. Dangers of postoperative opioids: Is there a Cure? APSF Newsletter

2009;24:2.

Blood Components and Blood Administration Procedures

According to the U.S. Department of Health and Human Services, 13,785,000 units of whole

blood and red blood cells were transfused in the United States in 2011

6F

7. The collection, testing,

preparation, and storage of blood and blood components are regulated by the Food and Drug

Administration. However, administration of blood products via transfusion is governed by

§482.23(c)(4). Blood transfusions can be life-saving. However,

like IV medications, blood transfusions are not without risk of harm to patients. Transfusion

reactions and/or errors can be fatal.

In addition to the safe practices and other safety considerations that apply to all IV medication

administration, policies and procedures must address blood administration procedures that are

consistent with accepted standards of transfusion practice, including but not limited to:

• Confirming the following prior to each blood transfusion:

• the patient’s identity

• verification of the right blood product for the right patient

The standard of practice calls for two qualified individuals, one of whom will be administering

the transfusion, to perform the confirmation.

• Requirements for patient monitoring, including frequency and documentation of

monitoring

• How to identify, treat, and report any adverse reactions the patient may experience during

or related to transfusion.

Staff Training and Competencies

Intravenous (IV) medications and blood transfusions must be administered by qualified

personnel, regardless of whether they are practitioners or non-practitioners. Generally IV

medications and blood transfusions are administered to patients by registered nurses (RNs),

consistent with State law governing scope of practice, and approved medical staff policies and

procedures.

Among other things, personnel must be able to demonstrate competency in venipuncture, in

accordance with State law and hospital policy. If other types of vascular access are utilized, staff

must have demonstrated competency in appropriate usage, care, and maintenance. Staff must

also be trained in early detection of and timely intervention for IV opioid-induced over-sedation

and respiratory depression.

7 The 2011 National Blood Collection and Utilization Survey Report. Retrieved September 27,2013 from

http://www.hhs.gov/ash/bloodsafety/2011-nbcus.pdf

Education and training regarding these procedures are typically included in the nurse’s hospital

orientation. Nursing staff who receive training for intravenous medication administration and/or

blood transfusion administration during hospital orientation or during other continuing education

programs would meet the requirements of this regulation. Content of the training must address

each required component of the approved medical staff policies and procedures.

Other non-practitioners, for example, licensed practical nurses or licensed vocational nurses,

with demonstrated competence may also administer IV medications and blood transfusions if

they are acting in accordance with State law, including scope of practice law, and the hospital’s

approved medical staff policies and procedures. (77 FR 29050, May 16, 2012)

For non-practitioners, the appropriate competencies must be documented in the qualified staff

person’s employee record.

All State law and scope of practice requirements must be met regarding the administration of

intravenous medications and blood transfusions, as applicable.

Survey Procedures §482.23(c)(4)

• Interview nursing staff on different units who administer IV medications and blood

transfusions. Are staff knowledgeable with respect to:

• Venipuncture techniques;

• Safe medication administration practices, including general practices applying to all

types of medications and practices concerning IV tubing and infusion pumps;

• Maintaining fluid and electrolyte balance;

• Patient assessment for risk related to IV medications and appropriate monitoring;

• Early detection and intervention for IV opioid-induced respiratory depression in post-operative patients;

• With respect to blood transfusions:

• Blood components;

• Process for verification of the right blood product for the right patient; and

• Transfusion reactions: identification, treatment, and reporting requirements.

• Review the files for a sample of staff who administer blood products and IV medications,

for evidence that competency was assessed and training was provided as appropriate.

• If able, observe blood transfusion and IV medication administration to assess staff

adherence to accepted standards of practice.

o Were safe medication administration practices used?

o Was the transfused patient correctly identified and matched to the correct blood

product prior to administration?

o Was the appropriate access used for IV medications?

o Were appropriate steps taken with regard to IV tubing and infusion pumps?

o Are patients being monitored post-infusion for adverse reactions?

• If staff appear to not be following accepted standards of practice for patient risk assessment

related to IV medications, particularly opioids, and appropriate monitoring of patients

receiving IV medications and/or blood transfusions, review policies and procedures for IV

medication administration and blood transfusion to determine if they address safe practices

considerations.

• Review a sample of medical records.

o Are blood transfusions and IV medications administered in accordance with State

law and approved medical staff policies and procedures?

• Are blood transfusions and IV medications administered by personnel who are

working within their scope of practice in accordance with State law and approved

medical staff policies?