Communication, Education, and Training

Question 1

Discuss regulatory guidance: FDA Medical Device Reporting regulations.

Answer 1

The FDA Medical Device Reporting regulations, which are part of the Safe Medical Devices Act (1990), periodically revised, require that user facilities that receive reports of malfunction of medical devices, serious injury, or death associated with their use must report these incidents.

Serious injury is one that is

1) life-threatening,
(2) results in permanent impairment or damage, or
(3) requires medical or surgical intervention to prevent permanent impairment or damage.

Deaths must be reported to both the FDA and the manufacturer and serious injuries to the manufacturer within 10 days of discovery (FDA form 1050).
Manufacturers receiving a 10-day report must obtain further information if possible and then file the report with the FDA. An annual report (FDA form 3419) that includes all incidents (deaths, serious injuries) that occurred during the calendar year must be submitted to the FDA. Users are also required to track medical devices that pose a potential risk to the patient if they malfunction. User facilities do not include physicians’ offices but do include ambulatory care centers, hospitals, nursing homes, rehab centers, home health agencies, blood banks, ambulance services, rescue services, outpatient treatment facilities, diagnostic centers, dialysis centers, and psychiatric facilities.

User facilities must maintain medical device reporting event files and maintain these files for two years.

Question 2

Discuss regulatory guidance

Healthcare-associated infection.

Answer 2

Healthcare-associated infection (HAI) is a localized or systemic infection that occurs 48 hours (beginning with day 3) or more after admission to a healthcare facility because of an adverse reaction to a pathogenic agent or toxin. An infection may be classified as healthcare-associated if it is evident within 48 hours of admission and the patient had contact with healthcare providers at some point in the previous year. According to the CDC, the types of HAI include central line-associated bloodstream infection (CLABSI), ventilator-associated pneumonia (VAP), catheter-associated urinary tract infection (CAUTI), and surgical site infection (SSI). CMS requires that healthcare providers report HAI’s at the federal level, and more than half of the states require some reporting of HAIs, but the specific requirements vary by state with some requiring only reporting of MRSA infections and others requiring
reporting of all types of HAIs.

Question 3

Discuss regulatory guidance

CMS’s Quality Assessment and Performance Improvement (QAPI) rule (42 CFR 482.21) for hospitals.

Answer 3

The Centers for Disease Control and Prevention (CDC) publishes an annual Quality Assessment and Performance Improvement (QAPI) rule requiring hospitals and nursing homes to develop and maintain quality improvement programs involving all departments to reduce incidence of medical errors. The entity must be able to provide evidence of quality improvement if under CMS review.

Program elements for hospitals must include:

• Ensuring an ongoing comprehensive program addressing all aspects of care and showing measurable improvement in selected indicators. Hospitals must measure, assess, and monitor quality indicators and adverse patient events.
• Using data to monitor the effectiveness of patient care and services and to develop program improvement plans.
• Setting priorities for PI activities that focus on high-risk areas. PI activities must monitor and assess medical errors and adverse events, implement preventive actions, and provide feedback and education.
• Establishing PI projects on a scale appropriate for the size and scope of the organization.
• Ensuring the board, administration, and medical staff account for and are responsible for:
  
  • (1) Ongoing PI program,
  • (2) Hospital-wide QAPI’ efforts addressing priorities and evaluations,
  • (3) Patient safety expectations,
  • (4) Provision of adequate resources, and
  • (5) Annual assessment of QAPI programs.

Question 4

Discuss regulatory guidance:

Notifiable disease surveillance (CDC)

Answer 4

The Centers for Disease Control and Prevention (CDC) publishes an annual list of notifiable diseases, which may include infectious diseases (such as syphilis and brucellosis), non-infectious conditions (cancer, lead exposure, pesticide-related illness/injury, carbon monoxide poisoning, and silicosis), and outbreaks (foodborne and waterborne). States and local public health departments may require additional reporting. HIPAA allows PHI to be shared for public health reporting without consent. The general steps that
occur when a patient is diagnosed with a notifiable condition include:

• Confirming the diagnosis: Physician examination, laboratory testing.
• Reporting findings: Reports are usually sent to local or state public health departments. Specific forms may be required for reporting and time limits (such as within 24 hours) may be required.
• Reporting to CDC: State public health review the reports and when appropriate the report is sent by the state public health department to the CDC.
• Collecting and analyzing: The National Notifiable Diseases Surveillance System Team collects and analyzes the reports and sends data to the appropriate program at the CDC.
• Evaluating outbreaks, disease patterns: The CDC looks for disease patterns or outbreaks and determines if assistance is needed in outbreak research and containment.

Question 5

Discuss regulatory guidance:

CMS’s Quality Assessment and Performance Improvement (QAPI) rule (42 CFR 482.21) for nursing homes

5 elements

Answer 5

Present on admission: POA refers to an infection that meets the CMS’s Quality Assessment and Performance Improvement (QAPI)
criteria for site-specific symptoms and diagnosis and is evident two days rule (42 CFR 482.21) for nursing homes must include 5 elements:
prior to admission to a healthcare facility, the day of admission (day 1) 1. Design and scope: Program must be comprehensive and ongoing,
or the next day (day 2). Physician’s diagnosis alone is not adequate aiming for patient safety and high-quality care while supporting
without evidence (documented) of symptoms and/or laboratory patient autonomy and choices.
confirmation as required for the specific type of infection. Governance and leadership: Governing board should provide
adequate resources for QAPI efforts, designate one or more persons
Transfer rule: The transfer rule helps to determine responsibility for to be responsible for QAPI, and ensure time, equipment, and
infections. If an infection meets the site-specific criteria on the day of training needed. The board should establish a culture of quality and
transfer or the day after transfer from one inpatient facility to another safety.
inpatient within the same facility or another, or the day of discharge or Feedback, data systems and monitoring: The home collects data,
the day after discharge, the infection is attributed to the monitors services using performance indicators, and reviews
transferring/discharging facility. findings. All adverse events must be investigated when they occur
and action plans implemented.
80% rule: A patient care area is designated according to the type of 4. Performance improvement projects (PIPs): PIPS should be
patient. If 80% of the patients are of a specific type (such as oncology developed to improve care and services.
patients), the CDC location code designates the area accordingly. Systematic analysis and systemic action: The organization
carries out analysis utilizing a structured approach and root cause
analysis with a focus on continuous improvement.

Question 6

Define the following terms: Present on admission, transfer rule, 80% rule.

Answer 6

Present on admission: POA refers to an infection that meets the CMS’s Quality Assessment and Performance Improvement (QAPI)
criteria for site-specific symptoms and diagnosis and is evident two days rule (42 CFR 482.21) for nursing homes must include 5 elements:
prior to admission to a healthcare facility, the day of admission (day 1) 1. Design and scope: Program must be comprehensive and ongoing,
or the next day (day 2). Physician’s diagnosis alone is not adequate aiming for patient safety and high-quality care while supporting
without evidence (documented) of symptoms and/or laboratory patient autonomy and choices.
confirmation as required for the specific type of infection. Governance and leadership: Governing board should provide
adequate resources for QAPI efforts, designate one or more persons
Transfer rule: The transfer rule helps to determine responsibility for to be responsible for QAPI, and ensure time, equipment, and
infections. If an infection meets the site-specific criteria on the day of training needed. The board should establish a culture of quality and
transfer or the day after transfer from one inpatient facility to another safety.
inpatient within the same facility or another, or the day of discharge or Feedback, data systems and monitoring: The home collects data,
the day after discharge, the infection is attributed to the monitors services using performance indicators, and reviews
transferring/discharging facility. findings. All adverse events must be investigated when they occur
and action plans implemented.
80% rule: A patient care area is designated according to the type of 4. Performance improvement projects (PIPs): PIPS should be
patient. If 80% of the patients are of a specific type (such as oncology developed to improve care and services.
patients), the CDC location code designates the area accordingly. Systematic analysis and systemic action: The organization
carries out analysis utilizing a structured approach and root cause
analysis with a focus on continuous improvement.

Question 7

Define the following terms:

Device days, date of the event, and location of attribution.

Answer 7

Sexual harassment is covered under Title VII of the Civil Rights Act Device days: Device days are counted according to the number of
(1964), which prohibits sexual harassment but applies only to patients with a specific device, recorded at the same time each day by
employers with 15 or more employees. Complaints are submitted to the determining how many patients have the device at that time. Device
Equal Employment Opportunity Commission (EEOC). Employers with days are summed at the end of each month. Device days may be
fewer employees are covered by various state laws and regulatory calculated electronically as long as the electronic calculation is within
agencies. Some non-governmental agencies have limited programs to +/- 5 of the manual count.
assist victims of sexual harassment, including the Legal Advocacy Fund
of the AAUW. Sexual abuse and rape are criminal offenses covered by Date of event: The date of event for HAIs is when the last criterion for
laws against sexual violence and involve law enforcement agencies, the event or site-specific infection is met or when a process (such as
insertion of a central line) is completed. Date of event may also be
usually the local police although the federal authorities may intervene in
sex trafficking and online stalking. Many organizations now have referred to as the infection date. For VAE, the date of event is the first
workplace violence prevention programs that include strategies to date when oxygenation worsens.
prevent sexual abuse, stalking, and rape. The National Sexual Assault
Hotline (1-800-656-4673) refers people to the nearest services. The Location of attribution: LOA is the location (facility, unit) to which an
National Sex Offender Public Website [https://www.nsopw.govA links event (such as a surgical site infection) is attributed.
state, tribal, and territorial sexual offender registries. Numerous
organizations provide assistance to victims, including the National
Organization for Victim Assistance.

Question 8

Discuss regulatory guidance:

Sexual harassment, sexual abuse, and rape.

Answer 8

Sexual harassment is covered under Title VII of the Civil Rights Act Device days: Device days are counted according to the number of
(1964), which prohibits sexual harassment but applies only to patients with a specific device, recorded at the same time each day by
employers with 15 or more employees. Complaints are submitted to the determining how many patients have the device at that time. Device
Equal Employment Opportunity Commission (EEOC). Employers with days are summed at the end of each month. Device days may be
fewer employees are covered by various state laws and regulatory calculated electronically as long as the electronic calculation is within
agencies. Some non-governmental agencies have limited programs to +/- 5 of the manual count.
assist victims of sexual harassment, including the Legal Advocacy Fund
of the AAUW. Sexual abuse and rape are criminal offenses covered by Date of event: The date of event for HAIs is when the last criterion for
laws against sexual violence and involve law enforcement agencies, the event or site-specific infection is met or when a process (such as
insertion of a central line) is completed. Date of event may also be
usually the local police although the federal authorities may intervene in
sex trafficking and online stalking. Many organizations now have referred to as the infection date. For VAE, the date of event is the first
workplace violence prevention programs that include strategies to date when oxygenation worsens.
prevent sexual abuse, stalking, and rape. The National Sexual Assault
Hotline (1-800-656-4673) refers people to the nearest services. The Location of attribution: LOA is the location (facility, unit) to which an
National Sex Offender Public Website [https://www.nsopw.govA links event (such as a surgical site infection) is attributed.
state, tribal, and territorial sexual offender registries. Numerous
organizations provide assistance to victims, including the National
Organization for Victim Assistance.

Question 9

Discuss regulatory guidance:

Documentation and signature requirements for laboratory services for Medicare providers.

Answer 9

Requirements for blood bank operation include: Documentation requirements for laboratory services for Medicare
• Obtaining a blood bank license and renewing annually. providers include:
• Being available for inspection upon request. • All imaging, laboratory tests, and diagnostic tests must be ordered
• Participating in proficiency testing. by the physician treating the beneficiary.
• Obtaining qualified director and adequate numbers of other • Physician’s progress notes must indicate specifically the tests to be
qualified personnel. performed.
• Supervising staff, identifying training needs, and implementing • Documentation must support the medical necessity of the tests to
training. be performed.
• Having appropriate equipment for all functions. • Records that should be available upon request include progress
• Utilizing appropriate infection control practices and disposing notes, physician’s order/intent to order, laboratory results, and
contaminated materials appropriately. attestation/signature log (for signatures that are illegible).
• Carrying out a documented review for collection/preparation of all
blood components. Signature requirements include:
• Maintaining a manual that outlines all policies and procedures. • Remember that unsigned physician orders/requisitions by
• Maintaining correct and legible records that includes significant themselves do not support intent to order.
steps in procedures, test outcomes, ABO/Rh typing result, and • Physicians should sign all orders for diagnostic services.
donor records, and carrying out reporting responsibilities. • If the physician has failed to sign a progress note that supports
• Establishing criteria for blood collection, processing, storage, intent, the physician must complete and attestation statement and
distribution, and testing. submit it with the response; however, attestation statements are
• Labeling in compliance with Code or Federal Regulations. not acceptable for unsigned physician orders/requisitions.
• Storing blood/blood components appropriately and at correct • Documentation of the order/intent to order and medical necessity
temperature with temperature monitoring system in place. must be maintained in the patient record.

Question 10

Discuss regulatory guidance: Blood bank operation.

Answer 10

Requirements for blood bank operation include: Documentation requirements for laboratory services for Medicare
• Obtaining a blood bank license and renewing annually. providers include:
• Being available for inspection upon request. • All imaging, laboratory tests, and diagnostic tests must be ordered
• Participating in proficiency testing. by the physician treating the beneficiary.
• Obtaining qualified director and adequate numbers of other • Physician’s progress notes must indicate specifically the tests to be
qualified personnel. performed.
• Supervising staff, identifying training needs, and implementing • Documentation must support the medical necessity of the tests to
training. be performed.
• Having appropriate equipment for all functions. • Records that should be available upon request include progress
• Utilizing appropriate infection control practices and disposing notes, physician’s order/intent to order, laboratory results, and
contaminated materials appropriately. attestation/signature log (for signatures that are illegible).
• Carrying out a documented review for collection/preparation of all
blood components. Signature requirements include:
• Maintaining a manual that outlines all policies and procedures. • Remember that unsigned physician orders/requisitions by
• Maintaining correct and legible records that includes significant themselves do not support intent to order.
steps in procedures, test outcomes, ABO/Rh typing result, and • Physicians should sign all orders for diagnostic services.
donor records, and carrying out reporting responsibilities. • If the physician has failed to sign a progress note that supports
• Establishing criteria for blood collection, processing, storage, intent, the physician must complete and attestation statement and
distribution, and testing. submit it with the response; however, attestation statements are
• Labeling in compliance with Code or Federal Regulations. not acceptable for unsigned physician orders/requisitions.
• Storing blood/blood components appropriately and at correct • Documentation of the order/intent to order and medical necessity
temperature with temperature monitoring system in place. must be maintained in the patient record.

Question 11

Discuss regulatory guidance:

Computer crossmatch.

Answer 11

Transfusion record documentation must be maintained for at least 5 Under 21 CFR 6096.15 (c), the FDA has established regulations for
years and those required for tracing a blood product from donor to recipient-donor computer crossmatch for transfusions:
disposition maintained for at least 10 years following administration or • User must be able to verify and accept or reject data.
5 years after expiration date. Computerized records must be secure and • Data elements must include the recipient’s unique ID number, RBC
software validated. Records must include all those associated with the antibody screening, ABO/Rh (D) typing, sample, and special
donor, recipient, and blood product, including testing (all steps and transfusion requirements (such as leukoreduction) and the donor’s
results), storage, and disposition. The records must be easily accessible unique identification number, component name, ABO/Rh (D) blood
and allow for tracing of blood products. Donor records must be type, special requirements and RBC antibody screening.
maintained and should include information about storage temperatures • Written procedures should outline decision tables and decision
and visual blood inspections, and preparation of components. Recipient rules.
records should include blood type and information regarding antibodies • The system should provide warning messages when actions are out
history of transfusions, and adverse transfusion reactions. Records of conformance with decision rules.
should also be maintained regarding therapeutic phlebotomy, policies • User validation tests must be run on all new equipment/processes
and procedures, cytapheresis procedures, antibody identification, in the same environment in which they will be utilized and re-
quality control, and shipping. validation carried out according to written program.
• Records must be maintained for all compatibility tests, calibration,
equipment standardization, and performance checks for at least 10
years.
• Implementation of computer crossmatch or change in procedure as
allowed under licensure must be reported to the FDA.
• Unvalidated systems must undergo testing to meet requirements
for validation.

Question 12

Discuss regulatory guidance: Transfusion administration protocol.

Answer 12

Transfusion record documentation must be maintained for at least 5 Under 21 CFR 6096.15 (c), the FDA has established regulations for
years and those required for tracing a blood product from donor to recipient-donor computer crossmatch for transfusions:
disposition maintained for at least 10 years following administration or • User must be able to verify and accept or reject data.
5 years after expiration date. Computerized records must be secure and • Data elements must include the recipient’s unique ID number, RBC
software validated. Records must include all those associated with the antibody screening, ABO/Rh (D) typing, sample, and special
donor, recipient, and blood product, including testing (all steps and transfusion requirements (such as leukoreduction) and the donor’s
results), storage, and disposition. The records must be easily accessible unique identification number, component name, ABO/Rh (D) blood
and allow for tracing of blood products. Donor records must be type, special requirements and RBC antibody screening.
maintained and should include information about storage temperatures • Written procedures should outline decision tables and decision
and visual blood inspections, and preparation of components. Recipient rules.
records should include blood type and information regarding antibodies • The system should provide warning messages when actions are out
history of transfusions, and adverse transfusion reactions. Records of conformance with decision rules.
should also be maintained regarding therapeutic phlebotomy, policies • User validation tests must be run on all new equipment/processes
and procedures, cytapheresis procedures, antibody identification, in the same environment in which they will be utilized and re-
quality control, and shipping. validation carried out according to written program.
• Records must be maintained for all compatibility tests, calibration,
equipment standardization, and performance checks for at least 10
years.
• Implementation of computer crossmatch or change in procedure as
allowed under licensure must be reported to the FDA.
• Unvalidated systems must undergo testing to meet requirements
for validation.

Question 13

Discuss regulatory guidance:

Codebar and ISBT numbering systems.

Answer 13

ome communicable diseases pose a danger to healthcare workers The FDA requires that all blood products and materials used for
(HCWs) and to patients and others who have contact with an infected transfusion be labeled with machine-readable labeling language to
healthcare worker. Work restrictions may vary somewhat depending decrease incidence of errors related to the wrong patient or wrong
on state and local regulations. The CDC, OSHA, and ACIP provide some product. The label must contain at least the unique facility ID, the
recommendations, which include: donor’s lot number, the product code, and the blood type of the donor.
• Hepatitis B: HCWs with acute or chronic HB who do not The two labeling languages in use include:
perform exposure-prone procedures are required only to • Codebar: Labeling that includes an identifying barcode, a
always use standard precautions. Those who do perform description of the contents (such as “RED BLOOD CELLS”), the
exposure-prone procedures should be restricted from those volume, additives, storage requirements, and test results of
procedures until a review panel can determine appropriate FDA required tests (such as HIV and HBV.
restrictions. HCWs should be immunized against HBV. • ISB-128: The international standard for identification and
• Influenza: HCWs with influenza should be restricted from labeling as well as transfer of information about body products,
contact with patients and others during the period when the including blood. ISB-128 provides a standard terminology,
disorder is infectious, which usually begins one day prior to reference tables to apply the appropriate codes, data
onset of symptoms (when the person is unaware of the structures, delivery mechanisms, and standard layout for
infection and contagious) and up to 5 days after onset of labels.
symptoms. HCWs should receive annual influenza vaccinations.

Question 14

Discuss regulatory guidance:

Level of work restriction return to work for health care workers with communicable diseases: hepatitis B, influenza.

Answer 14

ome communicable diseases pose a danger to healthcare workers The FDA requires that all blood products and materials used for
(HCWs) and to patients and others who have contact with an infected transfusion be labeled with machine-readable labeling language to
healthcare worker. Work restrictions may vary somewhat depending decrease incidence of errors related to the wrong patient or wrong
on state and local regulations. The CDC, OSHA, and ACIP provide some product. The label must contain at least the unique facility ID, the
recommendations, which include: donor’s lot number, the product code, and the blood type of the donor.
• Hepatitis B: HCWs with acute or chronic HB who do not The two labeling languages in use include:
perform exposure-prone procedures are required only to • Codebar: Labeling that includes an identifying barcode, a
always use standard precautions. Those who do perform description of the contents (such as “RED BLOOD CELLS”), the
exposure-prone procedures should be restricted from those volume, additives, storage requirements, and test results of
procedures until a review panel can determine appropriate FDA required tests (such as HIV and HBV.
restrictions. HCWs should be immunized against HBV. • ISB-128: The international standard for identification and
• Influenza: HCWs with influenza should be restricted from labeling as well as transfer of information about body products,
contact with patients and others during the period when the including blood. ISB-128 provides a standard terminology,
disorder is infectious, which usually begins one day prior to reference tables to apply the appropriate codes, data
onset of symptoms (when the person is unaware of the structures, delivery mechanisms, and standard layout for
infection and contagious) and up to 5 days after onset of labels.
symptoms. HCWs should receive annual influenza vaccinations.

Question 15

Discuss regulatory guidance:

Level of work restriction/return to work for health care workers with communicable diseases: measles, mumps, rubella, and varicella.

Answer 15

Legal requirements for documenting wounds are often quite general, Work restrictions for healthcare workers (HCWs) with communicable
requiring that documentation be “timely and accurate” without diseases may vary somewhat depending on state and local regulations.
specifying exactly what that entails. However, CMS reimbursement is The CDC, OSHA, and ACIP provide some recommendations, which
predicated on documented information, so correct documentation has, include:
in effect, become a legal requirement. Considerations include: • Measles: Active disease requires restriction from duty until 7
• Coding forsupplies utilized for wound care must be correct. days after onset of rash and with exposure restriction from
• Wounds must be coded properly as traumatic or nontraumatic. duty from the 5th days through the 21st day after exposure
• Debridement must be specified as excisional or nonexcisional. and/or 4 days after onset of rash.
_ • Laboratory and imaging reports and nutritional assessments • Mumps: Active disease requires restriction from duty until 9
that support wound care must be in the patient’s health record. days after onset of parotitis and with exposure restriction from
• Wound size and stage must be documented in order to duty from the 9th through the 26th day after exposure or until 9
determine the patient’s acuity level. days after onset of parotitis.
• • Skin condition must be documented on admission, including • • Rubella: Active disease requires restriction from duty until 5
any wounds that are present or lack of wounds. days after onset of rash and with exposure restriction from the
General rules for charting should also be followed, including recording 7th through the 21st day after exposure.
the date and time of all entries, using accurate measurements, providing • Varicella: Active disease requires restriction from duty until
factual objective information, and using only approved abbreviations in all lesions are dry and crusted and with exposure restriction
order to prevent errors. from duty from the 10th through the 21st (or 28th if VZIG given)
day or until all lesions are dry and crusted if active disease
occurs.

Question 16

Discuss regulatory guidance:

Documenting wounds.

Answer 16

Legal requirements for documenting wounds are often quite general, Work restrictions for healthcare workers (HCWs) with communicable
requiring that documentation be “timely and accurate” without diseases may vary somewhat depending on state and local regulations.
specifying exactly what that entails. However, CMS reimbursement is The CDC, OSHA, and ACIP provide some recommendations, which
predicated on documented information, so correct documentation has, include:
in effect, become a legal requirement. Considerations include: • Measles: Active disease requires restriction from duty until 7
• Coding forsupplies utilized for wound care must be correct. days after onset of rash and with exposure restriction from
• Wounds must be coded properly as traumatic or nontraumatic. duty from the 5th days through the 21st day after exposure
• Debridement must be specified as excisional or nonexcisional. and/or 4 days after onset of rash.
_ • Laboratory and imaging reports and nutritional assessments • Mumps: Active disease requires restriction from duty until 9
that support wound care must be in the patient’s health record. days after onset of parotitis and with exposure restriction from
• Wound size and stage must be documented in order to duty from the 9th through the 26th day after exposure or until 9
determine the patient’s acuity level. days after onset of parotitis.
• • Skin condition must be documented on admission, including • • Rubella: Active disease requires restriction from duty until 5
any wounds that are present or lack of wounds. days after onset of rash and with exposure restriction from the
General rules for charting should also be followed, including recording 7th through the 21st day after exposure.
the date and time of all entries, using accurate measurements, providing • Varicella: Active disease requires restriction from duty until
factual objective information, and using only approved abbreviations in all lesions are dry and crusted and with exposure restriction
order to prevent errors. from duty from the 10th through the 21st (or 28th if VZIG given)
day or until all lesions are dry and crusted if active disease
occurs.

Question 17

Discuss regulatory guidance:

Equipment safety including sharps receptacle for needle disposal.

Answer 17

The United States Pharmacopeia (USP) guidelines to prevent Under the Needlestick Safety and Prevention Act, equipment safety is
prescription and transcribing errors includes: essential because lancets, needles, and other sharp objects pose risks to
• Submitting order electronically and avoiding handwritten laboratory personnel and must be used properly and disposed of safely
transcriptions which can more easily be misread or misinterpreted. in specific (“sharps”) containers designed for safety. Procedures should
• Prescribing only standardized concentrations of intravenous infusions,
such as D5W. be in place for all use of sharps and standard precautions followed.
• Establishing clear protocols for intravenous infusions. Safety lancets with needles that automatically retract should be utilized
• Avoiding the use of unclear abbreviations, such as those on the Joint if possible. Safety needles are also available; but, if using a standard
Commissions do-not-use list. needle, the needle should not be recapped or bent prior to disposal but
• Transcribing original drug orders should be done as soon as possible placed directly into the container, sharp end downward. Sharps
after receiving the order with minimal interruptions and should be containers should be leak-proof, resistant to punctures, clearly labeled,
and placed in a convenient place not accessible by children. Most sharps
verified by another person for accuracy. Digital transcription is safer
than manual. containers are red, but clear containers may also be used so it is easier
to see when they are full. Containers should never be filled to the top
Guidelines to prevent dispensing errors include: because of the risk that a needle or other sharp item may protrude
• Stocking and preparing standardized concentrations for all IV through the opening.
medications.
• Properly labeling intravenous solution bags with completed patient
name, product name, product dosage, final concentration, and infusion
rate (if appropriate).
• Utilizing commercially prepared solutions as much as possible and
limited the use of different dosages/strengths of the same medication
or solution.

Question 18

Discuss regulatory guidance:

The United States Pharmacopeia guidelines to prevent prescription and transcribing errors and dispensing errors.

Answer 18

The United States Pharmacopeia (USP) guidelines to prevent Under the Needlestick Safety and Prevention Act, equipment safety is
prescription and transcribing errors includes: essential because lancets, needles, and other sharp objects pose risks to
• Submitting order electronically and avoiding handwritten laboratory personnel and must be used properly and disposed of safely
transcriptions which can more easily be misread or misinterpreted. in specific (“sharps”) containers designed for safety. Procedures should
• Prescribing only standardized concentrations of intravenous infusions,
such as D5W. be in place for all use of sharps and standard precautions followed.
• Establishing clear protocols for intravenous infusions. Safety lancets with needles that automatically retract should be utilized
• Avoiding the use of unclear abbreviations, such as those on the Joint if possible. Safety needles are also available; but, if using a standard
Commissions do-not-use list. needle, the needle should not be recapped or bent prior to disposal but
• Transcribing original drug orders should be done as soon as possible placed directly into the container, sharp end downward. Sharps
after receiving the order with minimal interruptions and should be containers should be leak-proof, resistant to punctures, clearly labeled,
and placed in a convenient place not accessible by children. Most sharps
verified by another person for accuracy. Digital transcription is safer
than manual. containers are red, but clear containers may also be used so it is easier
to see when they are full. Containers should never be filled to the top
Guidelines to prevent dispensing errors include: because of the risk that a needle or other sharp item may protrude
• Stocking and preparing standardized concentrations for all IV through the opening.
medications.
• Properly labeling intravenous solution bags with completed patient
name, product name, product dosage, final concentration, and infusion
rate (if appropriate).
• Utilizing commercially prepared solutions as much as possible and
limited the use of different dosages/strengths of the same medication
or solution.

Question 19

Discuss regulatory guidance:

United States Pharmacopeia guidelines to prevent drug administration and monitoring errors.

Answer 19

According to the Patient Self-Determination Act (1990) competent The United States Pharmacopeia guidelines to prevent drug
patients have the right to refusal of care, and parents have the right to administration and monitoring errors include:
make this decision for minor children. The act also allows a mental • Being familiar with policies and procedures regarding drug
health patient to develop an advance psychiatric directive (APD) during administration.
a period when a professional mental healthcare provider certifies the • Having readily accessible standardized infusion rate charts.
person is of sound mind. If a patient refuses care, the healthcare • Utilizing programmable infusion devices, such as smart pumps.
provider should try to persuade the patient to agree to care by giving the
reasons and possible consequences of refusal. The patient should be • Standardizing equipment rather than having multiple models and
asked to sign the refusal form and a family member, police officer, or types.
• Ensuring that two qualified individuals independently confirm
bystander should sign as a witness to the patient’s signing or witness the infusion pump setting for high-risk/high-alert drugs and required
refusal to sign. The healthcare provider should complete documentation adjustments in dosage.
of any assessment carried out and any refusal of the patient to • Ensuring that documentation is correct and provides adequate
assessment. The healthcare provider should carefully document the information, including the name of the drug, the infusion rate, any
conversation between the healthcare provider and patient regarding adjustments, and names of those who confirmed dosage/setting.
refusaLof care and consequences and should document the proposed • Tracing infusion tubing from the solution bags to the insertion sites
care as well as the information the healthcare provider gave the patient and clearly labeling tubes when multiple infusions/pumps. This is
about alternate care (such as visit to personal physician) and the especially important if adding medications to an infusion.
willingness to return if the patient has a change of mind. • Avoiding free-flow errors, such as through anti-free-flow devices.
• Monitoring the patient’s response to the medication according to
standardizes critical pathways or flow sheets.

Question 20

Discuss regulatory guidance:

Patient Self-Determination Act and the right to refusal of care.

Answer 20

According to the Patient Self-Determination Act (1990) competent The United States Pharmacopeia guidelines to prevent drug
patients have the right to refusal of care, and parents have the right to administration and monitoring errors include:
make this decision for minor children. The act also allows a mental • Being familiar with policies and procedures regarding drug
health patient to develop an advance psychiatric directive (APD) during administration.
a period when a professional mental healthcare provider certifies the • Having readily accessible standardized infusion rate charts.
person is of sound mind. If a patient refuses care, the healthcare • Utilizing programmable infusion devices, such as smart pumps.
provider should try to persuade the patient to agree to care by giving the
reasons and possible consequences of refusal. The patient should be • Standardizing equipment rather than having multiple models and
asked to sign the refusal form and a family member, police officer, or types.
• Ensuring that two qualified individuals independently confirm
bystander should sign as a witness to the patient’s signing or witness the infusion pump setting for high-risk/high-alert drugs and required
refusal to sign. The healthcare provider should complete documentation adjustments in dosage.
of any assessment carried out and any refusal of the patient to • Ensuring that documentation is correct and provides adequate
assessment. The healthcare provider should carefully document the information, including the name of the drug, the infusion rate, any
conversation between the healthcare provider and patient regarding adjustments, and names of those who confirmed dosage/setting.
refusaLof care and consequences and should document the proposed • Tracing infusion tubing from the solution bags to the insertion sites
care as well as the information the healthcare provider gave the patient and clearly labeling tubes when multiple infusions/pumps. This is
about alternate care (such as visit to personal physician) and the especially important if adding medications to an infusion.
willingness to return if the patient has a change of mind. • Avoiding free-flow errors, such as through anti-free-flow devices.
• Monitoring the patient’s response to the medication according to
standardizes critical pathways or flow sheets.

Question 21

Discuss workforce education:

Compliance training as part of new employee orientation.

Answer 21

Temporary, per diem, and contract employees as well as students Compliance training, including the Code of Conduct, should be part of
and volunteers can pose complex challenges related to compliance new employee orientation so that the employee has an understanding
issues because these individuals must have training in compliance and of the importance of compliance at the outset. Because the time given to
privacy either through the organization or the agency that provides the compliance during orientation is generally limited, the compliance
individuals. These individuals may not be hired through Human professional should focus on key information. Orientation should
Resources but through contractual agreements. Thus, the contracts include:
should be assessed to ensure that compliance training is included. • General overview of compliance, including information about the
Students can pose particular problems because their levels of knowledge roles of the compliance professional and the compliance committee.
and training may vary widely. Training that is to be provided by other • Code of conduct and how it applies to compliance, such as through
agencies should be verified but many different contractual ethical conduct; accurate documentation, coding, and billing;
arrangements may be present in one organization, so this can be time privacy and confidentiality; fraudulent and abusive actions;
consuming and involve multiple contacts. Additionally, if an organization exclusions; and conflicts of interest.
utilizes volunteers, the compliance professional should monitor • Explanation of sanctions/disciplinary policies.
background checks and appropriate compliance training. • Discussion of mechanisms available to share concerns (such as a
hotline).
• Provide clear explanation of where to go and whom to approach if
they have questions about compliance or other issues.

Participants are more likely to remember information if there is some
interactivity included, such as questioning or discussions, and the
information should be tied to real-life examples as much as possible.

Question 22

Discuss compliance issues related to temporary, per diem, and contract employees and students and volunteers.

Answer 22

Temporary, per diem, and contract employees as well as students Compliance training, including the Code of Conduct, should be part of
and volunteers can pose complex challenges related to compliance new employee orientation so that the employee has an understanding
issues because these individuals must have training in compliance and of the importance of compliance at the outset. Because the time given to
privacy either through the organization or the agency that provides the compliance during orientation is generally limited, the compliance
individuals. These individuals may not be hired through Human professional should focus on key information. Orientation should
Resources but through contractual agreements. Thus, the contracts include:
should be assessed to ensure that compliance training is included. • General overview of compliance, including information about the
Students can pose particular problems because their levels of knowledge roles of the compliance professional and the compliance committee.
and training may vary widely. Training that is to be provided by other • Code of conduct and how it applies to compliance, such as through
agencies should be verified but many different contractual ethical conduct; accurate documentation, coding, and billing;
arrangements may be present in one organization, so this can be time privacy and confidentiality; fraudulent and abusive actions;
consuming and involve multiple contacts. Additionally, if an organization exclusions; and conflicts of interest.
utilizes volunteers, the compliance professional should monitor • Explanation of sanctions/disciplinary policies.
background checks and appropriate compliance training. • Discussion of mechanisms available to share concerns (such as a
hotline).
• Provide clear explanation of where to go and whom to approach if
they have questions about compliance or other issues.

Participants are more likely to remember information if there is some
interactivity included, such as questioning or discussions, and the
information should be tied to real-life examples as much as possible.

Question 23

Discuss regulatory guidance:

Fraud (CMS).

Answer 23

A compliance program must include a plan for compliance training Fraud is misrepresentation done for unauthorized self-benefit while
and education showing clearly how all members of an organization are abuse is conduct that is below acceptable standards and results in
to receive information about compliance. Compliance training should be fraudulent reimbursement, such as for non-medically necessary
provided to all new employees during orientation and on an annual services. According to CMS, the types of healthcare fraud include:
basis thereafter. A record must be retained regarding the content of • Theft of medical identity: Can include misusing another
training and training completion. Topics that are typically covered in person’s medical identity number to obtain services or
training include confidentiality and information security (HIPAA), supplies or stealing a doctor’s identifiers to obtain unlawful
diversity, workplace violence, workplace safety, conflicts of interest, gift, prescriptions or supplies.
whistleblowing, and antiharassment policies. Laws that should be • Billing for unauthorized or unnecessary materials or
reviewed include the False Claims Act, EMTALA, Stark Law, HIPAA, the services: States define “medical necessity,” and healthcare
Anti-Kickback statute, and OSHA guidelines. Education and training may organizations must meet this definition for billing purposes.
be provided by a presenter or through online courses, books, and other • Billing for materials or services not actually provided: This
methods. Specific role-based training, such as for coders, may be is always a fraudulent act and may involve false records.
required for some positions in an organization, and this should be • Upcoding: Intentional or unintentional coding for materials or
outlined in the plan. services reimbursed at a higher rate.
• Unbundling: Billing separately for services/materials that
should be bundled in order to gain increased reimbursement
• Kickbacks: Receiving payment for referring patients for
healthcare services.

Question 24

Discuss compliance training and education

Answer 24

A compliance program must include a plan for compliance training Fraud is misrepresentation done for unauthorized self-benefit while
and education showing clearly how all members of an organization are abuse is conduct that is below acceptable standards and results in
to receive information about compliance. Compliance training should be fraudulent reimbursement, such as for non-medically necessary
provided to all new employees during orientation and on an annual services. According to CMS, the types of healthcare fraud include:
basis thereafter. A record must be retained regarding the content of • Theft of medical identity: Can include misusing another
training and training completion. Topics that are typically covered in person’s medical identity number to obtain services or
training include confidentiality and information security (HIPAA), supplies or stealing a doctor’s identifiers to obtain unlawful
diversity, workplace violence, workplace safety, conflicts of interest, gift, prescriptions or supplies.
whistleblowing, and antiharassment policies. Laws that should be • Billing for unauthorized or unnecessary materials or
reviewed include the False Claims Act, EMTALA, Stark Law, HIPAA, the services: States define “medical necessity,” and healthcare
Anti-Kickback statute, and OSHA guidelines. Education and training may organizations must meet this definition for billing purposes.
be provided by a presenter or through online courses, books, and other • Billing for materials or services not actually provided: This
methods. Specific role-based training, such as for coders, may be is always a fraudulent act and may involve false records.
required for some positions in an organization, and this should be • Upcoding: Intentional or unintentional coding for materials or
outlined in the plan. services reimbursed at a higher rate.
• Unbundling: Billing separately for services/materials that
should be bundled in order to gain increased reimbursement
• Kickbacks: Receiving payment for referring patients for
healthcare services.

Question 25

Discuss the OIG’s recommendation for conducting effective training and education

Answer 25

Development of organizational performance improvement training The OIG’s recommendations for conducting effective training and
for quality and compliance requires a number of steps: education include the following topics:
• Assess training needs in order to provide needs-based training • Staff to attend periodic training programs regarding federal
and to determine the type and extent of training needs. and state statutes, regulations, guidelines, private payor
Assessment must be done while keeping in mind the policies, corporate ethics, and compliance program, including
organizational outcomes to be achieved. Assessing current laws pertaining to fraud and abuse, coding requirements, claim
level of knowledge for targeted information can be helpful. development and submission.
• Use strategic goals to establish specific learning goals and • Prohibitions, such as receiving pay for referrals.
objectives tied to the mission and vision of the organization. • Appropriate diagnostic confirmation.
• Determine methods of outcomes measurement. • The “incident to” rule for claim submission for physician
• Assess appropriate learning styles and teaching techniques in services provided by a nonphysician.
developing teaching strategies. • Alterations of medical records and prescribing without proper
• Develop course materials. authorization.
• Train instructors or assistants as necessary. • Proper documentation requirements.
• Pilot test training materials and program with small group and • Duty to report misconduct.
utilize feedback to make modifications if necessary. • Attendance/Participation should be a condition of employment
• Implement training program. and failure a cause for disciplinary action.
• Conduct measurements to determine outcomes. • Complete records of attendance and materials should be
retained.
• The necessity of further required education courses.

Question 26

Discuss workforce education: Performance improvement training.

Answer 26

Development of organizational performance improvement training The OIG’s recommendations for conducting effective training and
for quality and compliance requires a number of steps: education include the following topics:
• Assess training needs in order to provide needs-based training • Staff to attend periodic training programs regarding federal
and to determine the type and extent of training needs. and state statutes, regulations, guidelines, private payor
Assessment must be done while keeping in mind the policies, corporate ethics, and compliance program, including
organizational outcomes to be achieved. Assessing current laws pertaining to fraud and abuse, coding requirements, claim
level of knowledge for targeted information can be helpful. development and submission.
• Use strategic goals to establish specific learning goals and • Prohibitions, such as receiving pay for referrals.
objectives tied to the mission and vision of the organization. • Appropriate diagnostic confirmation.
• Determine methods of outcomes measurement. • The “incident to” rule for claim submission for physician
• Assess appropriate learning styles and teaching techniques in services provided by a nonphysician.
developing teaching strategies. • Alterations of medical records and prescribing without proper
• Develop course materials. authorization.
• Train instructors or assistants as necessary. • Proper documentation requirements.
• Pilot test training materials and program with small group and • Duty to report misconduct.
utilize feedback to make modifications if necessary. • Attendance/Participation should be a condition of employment
• Implement training program. and failure a cause for disciplinary action.
• Conduct measurements to determine outcomes. • Complete records of attendance and materials should be
retained.
• The necessity of further required education courses.

Question 27

Discuss workforce education:

Necessary elements of negligence, abandonment, and battery.

Answer 27

Negligence indicates that proper care has not been provided, based on The four necessary elements of negligence (failure to follow standards
established standards. Reasonable care uses rationale for decision- of care) are:
making in relation to providing care. State regulations regarding • Duty of care: The defendant (healthcare provider) had a duty
negligence may vary but all have some statutes of limitation, to provide adequate care and/or protect the plaintiffs
governmental immunity, and Good Samaritan laws may provide defense. (patient’s) safety.
Types of negligence include: • Breach of duty: The defendant failed to carry out the duty to
• Negligent conduct: An individual failed to provide reasonable care, resulting in danger, injury, or harm to the plaintiff.
care or to protect/assist another, based on standards and • Damages: The plaintiff experienced illness or injury as a result
expertise. of the breach of duty.
• Gross negligence: Willfully providing inadequate care while • Causation: The plaintiffs illness or injury is directly caused by
disregarding the safety and security of another. the defendant’s negligent breach of duty.
• Contributory negligence: injured party contributing to
his/her own harm. Abandonment occurs if the healthcare provider withdraws from
• Comparative negligence: The percentage amount of providing care contrary to patient’s desire or knowledge and fails to
negligence attributed to each individual involved. arrange for appropriate care by others, resulting in harm to the patient.
Assault occurs if a healthcare provider threatens a patient in some way
that the patient becomes fearful of harm, while battery occurs when the
If the charge of negligence is supported, the patient may collect physical
(lost earnings due to injury), psychological (pain and suffering), and healthcare provider intentionally injures a patient, such as by hitting”or
punitive damages. shoving the person. Assault and battery often occur together.

Question 28

Discuss workforce education:

Types of negligence.

Answer 28

Negligence indicates that proper care has not been provided, based on The four necessary elements of negligence (failure to follow standards
established standards. Reasonable care uses rationale for decision- of care) are:
making in relation to providing care. State regulations regarding • Duty of care: The defendant (healthcare provider) had a duty
negligence may vary but all have some statutes of limitation, to provide adequate care and/or protect the plaintiffs
governmental immunity, and Good Samaritan laws may provide defense. (patient’s) safety.
Types of negligence include: • Breach of duty: The defendant failed to carry out the duty to
• Negligent conduct: An individual failed to provide reasonable care, resulting in danger, injury, or harm to the plaintiff.
care or to protect/assist another, based on standards and • Damages: The plaintiff experienced illness or injury as a result
expertise. of the breach of duty.
• Gross negligence: Willfully providing inadequate care while • Causation: The plaintiffs illness or injury is directly caused by
disregarding the safety and security of another. the defendant’s negligent breach of duty.
• Contributory negligence: injured party contributing to
his/her own harm. Abandonment occurs if the healthcare provider withdraws from
• Comparative negligence: The percentage amount of providing care contrary to patient’s desire or knowledge and fails to
negligence attributed to each individual involved. arrange for appropriate care by others, resulting in harm to the patient.
Assault occurs if a healthcare provider threatens a patient in some way
that the patient becomes fearful of harm, while battery occurs when the
If the charge of negligence is supported, the patient may collect physical
(lost earnings due to injury), psychological (pain and suffering), and healthcare provider intentionally injures a patient, such as by hitting”or
punitive damages. shoving the person. Assault and battery often occur together.

Question 29

Discuss workforce education:

Right to refuse

Answer 29

The purpose of the Joint Commission’s “Do-Not-Use” List is to prevent The right to refuse services rests with adults, so ordinarily an adult (or
errors and protect patient safety by eliminating abbreviations, an emancipated minor who has been granted the rights of adulthood)
acronyms, and symbols that can be easily mistaken or misconstrued. In can refuse any medication, treatment, counseling, or placement although
many cases, abbreviations have been eliminated in favor of words (QD is this is not always true. Court orders override these rights, and if the
replaced with daily and QID with 4 times daily). Many symbols court has declared a person is incompetent, this person’s guardian
(@,.µg) are replaced with words. Acronyms (SOB) are replaced with makes the decisions. Additionally, if the court has ordered specific
words. MS could be misinterpreted as morphine sulfate or magnesium treatment, therapy, or placement, then the individual must comply even
sulfate. MS04 and MgSO4 may be mistaken for each other. Abbreviations against the individual’s wishes. Children, including adolescents, have no
of medication names should generally be avoided. Other items on the do- rights to refusal, but they should be consulted as much as possible, and
not-use list include avoiding “U,” “u,” “IU” and variations of “QD” and their wishes should be respected and incorporated into the plan of care.
“QOD.” Leading zeros should be used with decimal numbers, such as “0.5 For example, if an adolescent does not want to have a particular
mg” but trailing zeros “5.0 mg” should not be used with medication treatment, then options should be explored because forcing an
orders or medication documentation, although they may be used in adolescent to do something often results in poor outcomes.
other circumstances, such as laboratory reports.

Question 30

Discuss workforce education:

Do-not-use list

Answer 30

The purpose of the Joint Commission’s “Do-Not-Use” List is to prevent The right to refuse services rests with adults, so ordinarily an adult (or
errors and protect patient safety by eliminating abbreviations, an emancipated minor who has been granted the rights of adulthood)
acronyms, and symbols that can be easily mistaken or misconstrued. In can refuse any medication, treatment, counseling, or placement although
many cases, abbreviations have been eliminated in favor of words (QD is this is not always true. Court orders override these rights, and if the
replaced with daily and QID with 4 times daily). Many symbols court has declared a person is incompetent, this person’s guardian
(@,.µg) are replaced with words. Acronyms (SOB) are replaced with makes the decisions. Additionally, if the court has ordered specific
words. MS could be misinterpreted as morphine sulfate or magnesium treatment, therapy, or placement, then the individual must comply even
sulfate. MS04 and MgSO4 may be mistaken for each other. Abbreviations against the individual’s wishes. Children, including adolescents, have no
of medication names should generally be avoided. Other items on the do- rights to refusal, but they should be consulted as much as possible, and
not-use list include avoiding “U,” “u,” “IU” and variations of “QD” and their wishes should be respected and incorporated into the plan of care.
“QOD.” Leading zeros should be used with decimal numbers, such as “0.5 For example, if an adolescent does not want to have a particular
mg” but trailing zeros “5.0 mg” should not be used with medication treatment, then options should be explored because forcing an
orders or medication documentation, although they may be used in adolescent to do something often results in poor outcomes.
other circumstances, such as laboratory reports.

Question 31

Discuss workforce education:

Whistleblowing

Answer 31

Hazardous waste is waste that poses a threat to the health of A whistleblower is an individual who exposes illegal or unethical
individuals or to the environment. The Environmental Protection practices of an organization in order to facilitate change. The
Agency classifies hazardous wastes according to characteristics: whistleblower may bring forth charges internally, such as by reporting
• Ignitable: Liquids and non-liquids that can ignite and cause to a supervisor, or externally, such as by reporting to a government
fires. agency or the media. Whistleblowers are protected under numerous
• Corrosive: Based on pH or the ability to corrode steel. federal (up to 20 different statutes) and state laws, which are sometimes
• Reactive: Wastes that are unstable, may react with water, or contradictory and often confusing. Different laws apply to different
result in toxic gases. They may also explode. occupations and subject matter. Depending upon the statute under
• Toxic: Wastes that are harmful if ingested or absorbed. which a person is acting as a whistleblower, different time limits for
filing a complaint exist, so it’s imperative that whistleblowers
Wastes may also be classified as listed wastes. These include wastes understand the laws that apply to them. In most cases, OSHA’s Office of
from manufacturing and industrial processes. Hazardous wastes are the Whistleblower Protection Program usually enforces statutes as
often produced in manufacturing, nuclear power plants (nuclear delegated by the Secretary of Labor. Reprisals against whistleblowers,
wastes), and healthcare facilities (needles, materials contaminated with while illegal, are not uncommon, so individuals often risk their jobs and
body fluids). Nuclear wastes are classified as mixed waste because they reputations when trying to do the ethical thing.
contain a radioactive component as well as a hazardous component.
Hazardous wastes can result in disease (such as from needle punctures),
injury (from fire and explosions), and death (from toxic exposure,
disease).

Question 32

Discuss workforce education:

Hazardous waste

Answer 32

Hazardous waste is waste that poses a threat to the health of A whistleblower is an individual who exposes illegal or unethical
individuals or to the environment. The Environmental Protection practices of an organization in order to facilitate change. The
Agency classifies hazardous wastes according to characteristics: whistleblower may bring forth charges internally, such as by reporting
• Ignitable: Liquids and non-liquids that can ignite and cause to a supervisor, or externally, such as by reporting to a government
fires. agency or the media. Whistleblowers are protected under numerous
• Corrosive: Based on pH or the ability to corrode steel. federal (up to 20 different statutes) and state laws, which are sometimes
• Reactive: Wastes that are unstable, may react with water, or contradictory and often confusing. Different laws apply to different
result in toxic gases. They may also explode. occupations and subject matter. Depending upon the statute under
• Toxic: Wastes that are harmful if ingested or absorbed. which a person is acting as a whistleblower, different time limits for
filing a complaint exist, so it’s imperative that whistleblowers
Wastes may also be classified as listed wastes. These include wastes understand the laws that apply to them. In most cases, OSHA’s Office of
from manufacturing and industrial processes. Hazardous wastes are the Whistleblower Protection Program usually enforces statutes as
often produced in manufacturing, nuclear power plants (nuclear delegated by the Secretary of Labor. Reprisals against whistleblowers,
wastes), and healthcare facilities (needles, materials contaminated with while illegal, are not uncommon, so individuals often risk their jobs and
body fluids). Nuclear wastes are classified as mixed waste because they reputations when trying to do the ethical thing.
contain a radioactive component as well as a hazardous component.
Hazardous wastes can result in disease (such as from needle punctures),
injury (from fire and explosions), and death (from toxic exposure,
disease).

Question 33

Discuss workforce education:

Needlestick Safety and Prevention Act (2000)

Answer 33

OSHA provides 3 basic forms to report work-related injuries, which is OSHA’s bloodborne pathogens standards comply with the Needlestick
any injury resulting in loss of consciousness, restricted activity, job Safety and Prevention Act (2000). Employees must have an active
transfer, absence from work, medical treatment beyond immediate first voice in reviewing and selecting needle safety devices in order to reduce
aid, or work injury or illness diagnosed by licensed healthcare provider: risk of injury, and a list of employee participants in the selection process
• Form 300 (Log of Work-Related Injuries and Illnesses): must be on file. Each institution must maintain a needlestick and injury
Includes identification of the person with case number, log that includes the following information:
employee’s name, and title, and a description of the case with • Description of how the incident occurred and the extent of
date of injury/illness onset, where the event occurred and injury.
description of the injury or illness including body part affected, • The brand and type of product involved in the incident.
and object/substance that caused injury or illness. • The location where the incident occurred.
• Form 300A (Summary of Work-Related Injuries and Illnesses):
Must be filed annually between February 1 and April 30 of the All incidents involving needles and sharps must be reported and
year following the year covered by the form. Includes a documented even if no serious injury or illness occurred as a result on
summary of number of cases, number of days away from work the incident. All employees with possible exposure to bloodborne
or on restricted work or transfer, and types of injuries and pathogens should receive hepatitis B vaccination.
illnesses.
• Form 301 (Injury and Incident Report): Includes specific
information about the injury, including information about the
employee and healthcare provider, the type of injury, and the
treatment. Must include a complete description of how the
injury/illness occurred and the extent of the injury/illness.

Question 34

Discuss workforce education:

Occupational Safety and Health Administration (OSHA) reporting forms

Answer 34

OSHA provides 3 basic forms to report work-related injuries, which is OSHA’s bloodborne pathogens standards comply with the Needlestick
any injury resulting in loss of consciousness, restricted activity, job Safety and Prevention Act (2000). Employees must have an active
transfer, absence from work, medical treatment beyond immediate first voice in reviewing and selecting needle safety devices in order to reduce
aid, or work injury or illness diagnosed by licensed healthcare provider: risk of injury, and a list of employee participants in the selection process
• Form 300 (Log of Work-Related Injuries and Illnesses): must be on file. Each institution must maintain a needlestick and injury
Includes identification of the person with case number, log that includes the following information:
employee’s name, and title, and a description of the case with • Description of how the incident occurred and the extent of
date of injury/illness onset, where the event occurred and injury.
description of the injury or illness including body part affected, • The brand and type of product involved in the incident.
and object/substance that caused injury or illness. • The location where the incident occurred.
• Form 300A (Summary of Work-Related Injuries and Illnesses):
Must be filed annually between February 1 and April 30 of the All incidents involving needles and sharps must be reported and
year following the year covered by the form. Includes a documented even if no serious injury or illness occurred as a result on
summary of number of cases, number of days away from work the incident. All employees with possible exposure to bloodborne
or on restricted work or transfer, and types of injuries and pathogens should receive hepatitis B vaccination.
illnesses.
• Form 301 (Injury and Incident Report): Includes specific
information about the injury, including information about the
employee and healthcare provider, the type of injury, and the
treatment. Must include a complete description of how the
injury/illness occurred and the extent of the injury/illness.

Question 35

Discuss workforce education:

Advance directives, DNR, durable power of attorney

Answer 35

Patients or family must provide informed consent for all treatment the In accordance to Federal and state laws, individuals have the right to
patient receives. This includes a thorough explanation of all procedures self-determination in health care, including decisions about end of life
and treatment and associated risks. Patients/family should be apprised care through advance directives such as living wills and the right to
of all options and allowed input on the type of treatments. assign a surrogate person to make decisions through a durable power
Patients/family should be apprised of all reasonable risks and any of attorney. Patients should routinely be questioned about an advanced
complications that might be life threatening or increase morbidity. The directive as they may present at a healthcare organization without the
American Medical Association has established guidelines for informed document. Patients who have indicated they desire a do-not-
consent: resuscitate (DNR) order should not receive resuscitative treatments for
• Explanation of diagnosis. terminal illness or conditions in which meaningful recovery cannot
• Nature and reason for treatment or procedure. occur. Patients and families of those with terminal illnesses should be
• Risks and benefits. questioned as to whether the patients are hospice patients. For those
• Alternative options (regardless of cost or insurance coverage). with DNR requests or those withdrawing life support, staff should
• Risks and benefits of alternative options. provide the patient palliative rather than curative measures, such as
• Risks and benefits of not having a treatment or procedure. pain control and/or oxygen, and emotional support to the patient and
• Providing informed consent is a requirement of all states. family. Religious traditions and beliefs about death should be treated
with respect.

Question 36

Discuss workforce education:

Informed consent

Answer 36

Patients or family must provide informed consent for all treatment the In accordance to Federal and state laws, individuals have the right to
patient receives. This includes a thorough explanation of all procedures self-determination in health care, including decisions about end of life
and treatment and associated risks. Patients/family should be apprised care through advance directives such as living wills and the right to
of all options and allowed input on the type of treatments. assign a surrogate person to make decisions through a durable power
Patients/family should be apprised of all reasonable risks and any of attorney. Patients should routinely be questioned about an advanced
complications that might be life threatening or increase morbidity. The directive as they may present at a healthcare organization without the
American Medical Association has established guidelines for informed document. Patients who have indicated they desire a do-not-
consent: resuscitate (DNR) order should not receive resuscitative treatments for
• Explanation of diagnosis. terminal illness or conditions in which meaningful recovery cannot
• Nature and reason for treatment or procedure. occur. Patients and families of those with terminal illnesses should be
• Risks and benefits. questioned as to whether the patients are hospice patients. For those
• Alternative options (regardless of cost or insurance coverage). with DNR requests or those withdrawing life support, staff should
• Risks and benefits of alternative options. provide the patient palliative rather than curative measures, such as
• Risks and benefits of not having a treatment or procedure. pain control and/or oxygen, and emotional support to the patient and
• Providing informed consent is a requirement of all states. family. Religious traditions and beliefs about death should be treated
with respect.

Question 37

Discuss workforce education:

Human subject protection

Answer 37

Patients and residents’ Bill of Rights in relation to what they should The Food and Drug Administration, Code of Federal Regulations, Title
expect from a healthcare organization are outlined in both standards of 21, Volume 1, regulates protection of human subjects and states that
the Joint Commission and National Committee for Quality Assurance. any researcher involving patients in research must obtain informed
Rights include: consent, in language understandable to the patient or the patient’s agent.
• Respect for patient, including personal dignity and psychosocial, The elements of this informed consent must include an explanation of
spiritual, and cultural considerations. the research, the purpose, and the expected duration as well as a
• Response to needs related to access and pain control. description of any potential risks. Potential benefits must be described
• Ability to make decisions about care, including informed consent, and possible alternative treatments. Any compensation to be provided
advance directives, and end of life care. must be outlined. The extent of confidentiality should be clarified.
• Procedure for registering complaints or grievances. Contact information should be provided in the event the patient/family
• Protection of confidentiality and privacy. has questions. The patient must be informed that participation is
• Freedom from abuse or neglect. voluntary and that he/she can discontinue participation at any time
• Protection during research and information related to ethical issues without penalty. Informed consent must be documented by a signed,
of research. written agreement.
• Appraisal of outcomes, including unexpected outcomes.
• Information about organization, services, and practitioners.
• Appeal procedures for decisions regarding benefits and quality of
care.
• Organizational code of ethical behavior.
• Procedures for donating and procuring organs/tissue.

Question 38

Discuss workforce education: Patients’ and residents’ Bill of Rights

Answer 38

Patients and residents’ Bill of Rights in relation to what they should The Food and Drug Administration, Code of Federal Regulations, Title
expect from a healthcare organization are outlined in both standards of 21, Volume 1, regulates protection of human subjects and states that
the Joint Commission and National Committee for Quality Assurance. any researcher involving patients in research must obtain informed
Rights include: consent, in language understandable to the patient or the patient’s agent.
• Respect for patient, including personal dignity and psychosocial, The elements of this informed consent must include an explanation of
spiritual, and cultural considerations. the research, the purpose, and the expected duration as well as a
• Response to needs related to access and pain control. description of any potential risks. Potential benefits must be described
• Ability to make decisions about care, including informed consent, and possible alternative treatments. Any compensation to be provided
advance directives, and end of life care. must be outlined. The extent of confidentiality should be clarified.
• Procedure for registering complaints or grievances. Contact information should be provided in the event the patient/family
• Protection of confidentiality and privacy. has questions. The patient must be informed that participation is
• Freedom from abuse or neglect. voluntary and that he/she can discontinue participation at any time
• Protection during research and information related to ethical issues without penalty. Informed consent must be documented by a signed,
of research. written agreement.
• Appraisal of outcomes, including unexpected outcomes.
• Information about organization, services, and practitioners.
• Appeal procedures for decisions regarding benefits and quality of
care.
• Organizational code of ethical behavior.
• Procedures for donating and procuring organs/tissue.

Question 39

Discuss workforce education:

Liability

Answer 39

Dan ers must be marked with anorooriate signs and symbols. With the marked increase in utilization of electronic health records
Sign/Symbol Interpretation Sign/Symbol Interpretation (EHRs) has come increased concern regarding liability because the EHR
Flame: Poison: Includes documents all actions in real time. For example, if there is .a delay
Includes materials, gases, or between the time a patient event occurs and the healthcare provider
flammable substances that are responds, the duration of time is documented in the record and cannot
materials and extremely toxic and may be altered. This can give the appearance of negligence even if the delay
gases and those result in death or severe was unavoidable. Additionally, errors tend to increase with any major
that are self- illness. change, and there is a learning curve in adjusting to new technology, so
heating or self- information may be entered into EHRs incorrectly and a facility may be
reactive. liable if it did not provide adequate staff education. Providers who are
Corrosion: Irritant: Includes accustomed to seeing reports on paper may not access electronic
Includes material, gases, or reports in a timely manner. Hardware and/or software incompatibilities
substances that substances that are may cause information, such as medicine orders, to be altered or
can cause skin irritants to skin, eyes, deleted. If healthcare providers provide patients access to them via
burns, metal and/or respiratory tract, email or messaging and do not respond promptly to those messages,
corrosion, and acutely toxic, or have a then they may be liable for malpractice.
eye damage. narcotic effect.
Health hazard: Biohazard: Includes
-.., Includes biological substances,
carcinogens, 440,11114st such as body fluids, that
toxic pose a threat to humans.
substances, and Appears on sharps
respiratory containers that hold
irritants, contaminated needles.

Question 40

Discuss workforce education:

Signs and symbols

Answer 40

Dan ers must be marked with anorooriate signs and symbols. With the marked increase in utilization of electronic health records
Sign/Symbol Interpretation Sign/Symbol Interpretation (EHRs) has come increased concern regarding liability because the EHR
Flame: Poison: Includes documents all actions in real time. For example, if there is .a delay
Includes materials, gases, or between the time a patient event occurs and the healthcare provider
flammable substances that are responds, the duration of time is documented in the record and cannot
materials and extremely toxic and may be altered. This can give the appearance of negligence even if the delay
gases and those result in death or severe was unavoidable. Additionally, errors tend to increase with any major
that are self- illness. change, and there is a learning curve in adjusting to new technology, so
heating or self- information may be entered into EHRs incorrectly and a facility may be
reactive. liable if it did not provide adequate staff education. Providers who are
Corrosion: Irritant: Includes accustomed to seeing reports on paper may not access electronic
Includes material, gases, or reports in a timely manner. Hardware and/or software incompatibilities
substances that substances that are may cause information, such as medicine orders, to be altered or
can cause skin irritants to skin, eyes, deleted. If healthcare providers provide patients access to them via
burns, metal and/or respiratory tract, email or messaging and do not respond promptly to those messages,
corrosion, and acutely toxic, or have a then they may be liable for malpractice.
eye damage. narcotic effect.
Health hazard: Biohazard: Includes
-.., Includes biological substances,
carcinogens, 440,11114st such as body fluids, that
toxic pose a threat to humans.
substances, and Appears on sharps
respiratory containers that hold
irritants, contaminated needles.

Question 41

Discuss mechanisms to evaluate workforce understanding of compliance responsibilities

Answer 41

Establishing a culture of compliance begins with the board of directors A compliance program can only be effective if the workforce has a
and administration making a commitment to compliance and focusing complete understanding of their responsibilities for compliance, so
on success of compliance rather than errors. The positive aspects of monitoring understanding is part of overall monitoring to determine if a
compliance (better patient care, safety, staff protection, improved program is effective; however, monitoring can pose challenges,
reimbursement) should be emphasized rather than negative aspects especially in an organization with a large workforce. Mechanism of
(violation penalties, time, costs). Compliance issues should be aligned evaluating workforce understanding include:
with risk management so that areas of concern are readily identified. • Providing education and requiring meaningful feedback, such as by
Education and expectations regarding compliance for new staff asking individuals to report to others or to explain what they have
members should begin with job descriptions and should be included in learned.
job interviews and orientation programs. Training and testing all • Including tests as part of training programs.
members of an organization (governing body, administrators, • Doing follow-up in departments to determine if compliance
physicians, all staff members) and associates (vendors) in appropriate measures have been appropriately enacted and supported by the
compliance should be an ongoing process. Information about workforce.
compliance issues should be provided in a variety of formats. Errors in • Engaging workforce members in conversations about compliance.
compliance should be addressed and analyzed in order to prevent • Asking workforce members to participate in drawing up
recurrence and to build understanding. Ethical behavior should be compliance plans for their departments.
recognized and rewarded and considered as part or routine reviews. • Asking workforce members to explain how they see their roles in
Methods of effective monitoring, including the use of technology, should compliance.
be instituted. • Reviewing outcomes measures.
• Relying on supervisory staff to evaluate understanding and
determine areas of weakness.

Question 42

Discuss establishing a culture of compliance

Answer 42

Establishing a culture of compliance begins with the board of directors A compliance program can only be effective if the workforce has a
and administration making a commitment to compliance and focusing complete understanding of their responsibilities for compliance, so
on success of compliance rather than errors. The positive aspects of monitoring understanding is part of overall monitoring to determine if a
compliance (better patient care, safety, staff protection, improved program is effective; however, monitoring can pose challenges,
reimbursement) should be emphasized rather than negative aspects especially in an organization with a large workforce. Mechanism of
(violation penalties, time, costs). Compliance issues should be aligned evaluating workforce understanding include:
with risk management so that areas of concern are readily identified. • Providing education and requiring meaningful feedback, such as by
Education and expectations regarding compliance for new staff asking individuals to report to others or to explain what they have
members should begin with job descriptions and should be included in learned.
job interviews and orientation programs. Training and testing all • Including tests as part of training programs.
members of an organization (governing body, administrators, • Doing follow-up in departments to determine if compliance
physicians, all staff members) and associates (vendors) in appropriate measures have been appropriately enacted and supported by the
compliance should be an ongoing process. Information about workforce.
compliance issues should be provided in a variety of formats. Errors in • Engaging workforce members in conversations about compliance.
compliance should be addressed and analyzed in order to prevent • Asking workforce members to participate in drawing up
recurrence and to build understanding. Ethical behavior should be compliance plans for their departments.
recognized and rewarded and considered as part or routine reviews. • Asking workforce members to explain how they see their roles in
Methods of effective monitoring, including the use of technology, should compliance.
be instituted. • Reviewing outcomes measures.
• Relying on supervisory staff to evaluate understanding and
determine areas of weakness.

Question 43

Discuss establishing a culture of compliance:

Environmental concerns (Identifying risks)

Answer 43

Disaster/emergency preparedness plans should be in place based on the Development of a patient safety program must include evaluation and
Hospital Emergency Incident Command System (HEICS), which provides a management of environmental safety hazards and risks.
model for management, responsibilities, and communication. Key Environmental concerns include:
stakeholders include the CPHQ the disaster response team, the • Identifying security risks, such as infant/child abduction and
administration, the public health department, police, first responders, and establishing processes to increase security, such as the use of
fire departments. Disasters can include a multi-casualty influx of individuals alarms, identification badges, locks, better lighting, and security
from a community emergency, such as a train accident, an epidemic, fire or officers.
other internal hospital problem requiring evacuation, or inadequate staffing • Evaluating power/utility requirements, including emergency
to safely treat ED individuals. Plans should include/address: power, and maintaining, testing, and inspecting utilities.
• Readily available information and disaster preparedness drills. • Monitoring medical equipment, including ensuring routine
• Activation of the plan, including the individual(s) responsible. maintenance, testing and regular inspection.
• Chain of command. • Completing risk assessment of physical plant, including buildings,
• Facility damage assessment, usually conducted by plant safety officer. grounds, equipment, and related systems, such as electrical,
• Hospital/ED capacity to receive individuals. lighting, IT, ventilation, and plumbing.
• Triage, including in community and in the ED. • Handling, storing, and disposing of hazardous wastes, including
• Transfer protocols for distributing individuals to other facilities. identifying wastes that are corrosive, ignitable, reactive, or toxic
• Staffing, including telephone tree to notify staff to report to facility. and following state and EPA regulations and educating staff.
• Intra- and Inter-facility communication and communication with pre- • Checking equipment and buildings for fire dangers and conducting
hospital EMS personnel. fire safety drills.
• Supplies on hand and methods to obtain added supplies.
• Delineation of receiving and treatment areas.

Question 44

Discuss establishing a culture of compliance:

Emergency preparedness

Answer 44

Evaluation of the environment for safety may include ensuring that: Disaster planning should include plans for both internal and external
• All alarms and fire-safety equipment are in place and functioning disasters. Five critical elements of preparation include:
properly. • Communication plans: Includes phone trees or other
• Safety measures are posted in all laboratories and adequate notification systems and external notification of community
training of staff and students is conducted. agencies/resources.
• Lighting is adequate. • Essential supplies: IVs, dressing supplies, essential
• Access to campus is controlled during school hours. medications should be stockpiled.
• Security cameras are in place and functioning properly. • Staff roles and responsibilities: Staff members should be
• - Staff members (and in large schools, students) wear identifying trained in disaster preparedness and understand their roles
badges. and responsibilities.
• Dress code (such as no wearing of gang colors) is enforced. • Power/Utilities: Backup systems should provide power for up
• Periodic checking for drugs is carried out (such as with dogs). to 96 hours.
• Metal detectors are utilized. • Clinical patient care: Plans for provision of care under
• Eye protection and personal protective equipment is available for varying circumstances, including alternate plans.
high-risk areas (such as laboratories).
• Equipment is maintained and immediately repaired when Internal disasters, such as fires, flooding, storm damage, and terrorist
necessary. attacks, often result in the evacuation of patients and the need for
• Ventilation system is clean and functioning properly. transportation services to transfer patients. External disasters, such as
• Drinking water is assessed for contamination. hurricanes, tornadoes, terrorist attacks (can be considered internal or
• Outdoor pollutants, such as pesticides, are controlled and limited. external), floods, pandemics, and transportation disasters, more often
• Toxic hazards, such as asbestos and chemicals, are identified and result in a large influx of patients and the need to discharge non-critical
removed or stored safely. patients to make room for new patients.

Question 45

Discuss establishing a culture of compliance:

Planning and responding to internal and external disasters

Answer 45

Evaluation of the environment for safety may include ensuring that: Disaster planning should include plans for both internal and external
• All alarms and fire-safety equipment are in place and functioning disasters. Five critical elements of preparation include:
properly. • Communication plans: Includes phone trees or other
• Safety measures are posted in all laboratories and adequate notification systems and external notification of community
training of staff and students is conducted. agencies/resources.
• Lighting is adequate. • Essential supplies: IVs, dressing supplies, essential
• Access to campus is controlled during school hours. medications should be stockpiled.
• Security cameras are in place and functioning properly. • Staff roles and responsibilities: Staff members should be
• - Staff members (and in large schools, students) wear identifying trained in disaster preparedness and understand their roles
badges. and responsibilities.
• Dress code (such as no wearing of gang colors) is enforced. • Power/Utilities: Backup systems should provide power for up
• Periodic checking for drugs is carried out (such as with dogs). to 96 hours.
• Metal detectors are utilized. • Clinical patient care: Plans for provision of care under
• Eye protection and personal protective equipment is available for varying circumstances, including alternate plans.
high-risk areas (such as laboratories).
• Equipment is maintained and immediately repaired when Internal disasters, such as fires, flooding, storm damage, and terrorist
necessary. attacks, often result in the evacuation of patients and the need for
• Ventilation system is clean and functioning properly. transportation services to transfer patients. External disasters, such as
• Drinking water is assessed for contamination. hurricanes, tornadoes, terrorist attacks (can be considered internal or
• Outdoor pollutants, such as pesticides, are controlled and limited. external), floods, pandemics, and transportation disasters, more often
• Toxic hazards, such as asbestos and chemicals, are identified and result in a large influx of patients and the need to discharge non-critical
removed or stored safely. patients to make room for new patients.

Question 46

Discuss establishing a culture of compliance:

Evaluation of the environment for safety

Answer 46

Evaluation of the environment for safety may include ensuring that: Disaster planning should include plans for both internal and external
• All alarms and fire-safety equipment are in place and functioning disasters. Five critical elements of preparation include:
properly. • Communication plans: Includes phone trees or other
• Safety measures are posted in all laboratories and adequate notification systems and external notification of community
training of staff and students is conducted. agencies/resources.
• Lighting is adequate. • Essential supplies: IVs, dressing supplies, essential
• Access to campus is controlled during school hours. medications should be stockpiled.
• Security cameras are in place and functioning properly. • Staff roles and responsibilities: Staff members should be
• - Staff members (and in large schools, students) wear identifying trained in disaster preparedness and understand their roles
badges. and responsibilities.
• Dress code (such as no wearing of gang colors) is enforced. • Power/Utilities: Backup systems should provide power for up
• Periodic checking for drugs is carried out (such as with dogs). to 96 hours.
• Metal detectors are utilized. • Clinical patient care: Plans for provision of care under
• Eye protection and personal protective equipment is available for varying circumstances, including alternate plans.
high-risk areas (such as laboratories).
• Equipment is maintained and immediately repaired when Internal disasters, such as fires, flooding, storm damage, and terrorist
necessary. attacks, often result in the evacuation of patients and the need for
• Ventilation system is clean and functioning properly. transportation services to transfer patients. External disasters, such as
• Drinking water is assessed for contamination. hurricanes, tornadoes, terrorist attacks (can be considered internal or
• Outdoor pollutants, such as pesticides, are controlled and limited. external), floods, pandemics, and transportation disasters, more often
• Toxic hazards, such as asbestos and chemicals, are identified and result in a large influx of patients and the need to discharge non-critical
removed or stored safely. patients to make room for new patients.

Question 47

Discuss establishing a culture of compliance:

Fire prevention procedures

Answer 47

A healthcare organization should ensure that employees have adequate Fire prevention procedures include:
guidance and clarification regarding compliance. Each organization • Ensure that exterior lighting is adequate and trees and shrubs are
should have a compliance officer and in many cases a compliance trimmed and intrusion alarms are in place and functioning.
committee to whom an employee can address questions and concerns • Store trash cans away from the building (in case of intentional
regarding compliance. Clearly written information should be readily fires).
available and posted where it can be accessed easily. The types of • Ensure sprinkler systems are properly inspected and functioning.
questions received should be monitored and assessed to determine if • Dispense adequate numbers of fire extinguishers throughout the
more education is needed for staff members regarding specific areas of campus.
compliance. Various methods of questioning should be available to staff, • Ensure all laboratory procedures are fire safe and monitored.
including in-person, email, messaging, and telephone, and staff member • Ensure that adequate smoke alarms are installed and maintained.
should be frequently reminded that questions are welcomed and of • Maintain the heating system and carry out routine service.
value to the organization in promoting compliance. Responses to • Train kitchen staff in fire safety, maintain stoves and ovens, and•
questions should be provided promptly whenever possible and without install a fire suppression system in the stove hood.
any negative response about the person’s need for information or lack of • Conduct routine fire drills.
knowledge. • Assess and maintain all electrical systems and equipment on a
regular basis.
• Teach students fire safety awareness and how to respond to fires.
• Have annual (or more often) evaluations carried out by the fire
department to identify risks.
• Develop a fire evacuation plan and widely disseminate.

Question 48

Discuss ensuring that employees have adequate guidance and clarification regarding compliance

Answer 48

A healthcare organization should ensure that employees have adequate Fire prevention procedures include:
guidance and clarification regarding compliance. Each organization • Ensure that exterior lighting is adequate and trees and shrubs are
should have a compliance officer and in many cases a compliance trimmed and intrusion alarms are in place and functioning.
committee to whom an employee can address questions and concerns • Store trash cans away from the building (in case of intentional
regarding compliance. Clearly written information should be readily fires).
available and posted where it can be accessed easily. The types of • Ensure sprinkler systems are properly inspected and functioning.
questions received should be monitored and assessed to determine if • Dispense adequate numbers of fire extinguishers throughout the
more education is needed for staff members regarding specific areas of campus.
compliance. Various methods of questioning should be available to staff, • Ensure all laboratory procedures are fire safe and monitored.
including in-person, email, messaging, and telephone, and staff member • Ensure that adequate smoke alarms are installed and maintained.
should be frequently reminded that questions are welcomed and of • Maintain the heating system and carry out routine service.
value to the organization in promoting compliance. Responses to • Train kitchen staff in fire safety, maintain stoves and ovens, and•
questions should be provided promptly whenever possible and without install a fire suppression system in the stove hood.
any negative response about the person’s need for information or lack of • Conduct routine fire drills.
knowledge. • Assess and maintain all electrical systems and equipment on a
regular basis.
• Teach students fire safety awareness and how to respond to fires.
• Have annual (or more often) evaluations carried out by the fire
department to identify risks.
• Develop a fire evacuation plan and widely disseminate.

Question 49

Discuss the importance of participation in continuing education to maintain professional competence

Answer 49

Verifying and tracking participation in ongoing compliance training The compliance professional constantly faces the challenge of staying
is important because it shows the commitment of the organization to current with regulations and compliance issues, and this requires
compliance education and shows a good faith effort in the event that ongoing continuing education. Continuing education units (CEUs) must
violations occur. Tracking is also important in order to generate data be in one or more of the 10 identified areas of knowledge required of the
regarding educational progress and return on investment. Verifying and compliance professional. CEUs may be obtained in a variety of different
tracking must be documented with a clear paper trail. If direct training manners, such as through reading approved articles, self-study, course
takes place, records of attendance and content (including documents attendance, and attending conference events. When first applying for
provided or utilized) should be retained. When providing online or CHC certification, the compliance professional must provide proof of one
computer-based education, the software utilized should require the staff year or 1500 hours of direct work in compliance or successful complete
person to sign in and should indicate the time needed to complete the of a CCB-accredited university certificate program and completion of 20
lesson and the score on testing. Self-study (such as through written continuing education units (CEUs), including 10 CEUs from direct (live,
texts) should be verified through written tests, summaries, or reports. face-to-face) training, earned within the 12 months prior to the exam
Completion of training should be 100% for all mandatory training, and date. Certification must be renewed every 2 years, and completion of 40
the organization should aim for a high percentage of participation for CEUs is required for recertification. Half of these CEUs must include
non-mandatory training. A software program, such as Excel may be used direct training and all must be earned within the 2-year period before
to track record and track participation. the date of renewal.

Question 50

Discuss the importance of verifying and tracking participation in ongoing compliance training programs

Answer 50

Verifying and tracking participation in ongoing compliance training The compliance professional constantly faces the challenge of staying
is important because it shows the commitment of the organization to current with regulations and compliance issues, and this requires
compliance education and shows a good faith effort in the event that ongoing continuing education. Continuing education units (CEUs) must
violations occur. Tracking is also important in order to generate data be in one or more of the 10 identified areas of knowledge required of the
regarding educational progress and return on investment. Verifying and compliance professional. CEUs may be obtained in a variety of different
tracking must be documented with a clear paper trail. If direct training manners, such as through reading approved articles, self-study, course
takes place, records of attendance and content (including documents attendance, and attending conference events. When first applying for
provided or utilized) should be retained. When providing online or CHC certification, the compliance professional must provide proof of one
computer-based education, the software utilized should require the staff year or 1500 hours of direct work in compliance or successful complete
person to sign in and should indicate the time needed to complete the of a CCB-accredited university certificate program and completion of 20
lesson and the score on testing. Self-study (such as through written continuing education units (CEUs), including 10 CEUs from direct (live,
texts) should be verified through written tests, summaries, or reports. face-to-face) training, earned within the 12 months prior to the exam
Completion of training should be 100% for all mandatory training, and date. Certification must be renewed every 2 years, and completion of 40
the organization should aim for a high percentage of participation for CEUs is required for recertification. Half of these CEUs must include
non-mandatory training. A software program, such as Excel may be used direct training and all must be earned within the 2-year period before
to track record and track participation. the date of renewal.

Question 51

Discuss workforce education:

Compliance training for physicians

Answer 51

Many laws and regulations govern the relationship between employee Compliance training for physicians generally begins with an emphasis
and employee, as well as compensation and benefits, and the human on documentation standards. Physicians’ documentation should be
resources department and management must ensure that the reviewed through internal auditing to determine if it meets accepted
organization remains in compliance and must be able to determine standards and to provide a guide for areas of weakness. Accurate and
when misconduct places the organization at risk for noncompliance. The appropriate documentation is essential for compliance with regulations
compliance professional must maintain open channels of _ and for reimbursement. Additionally, physicians should receive
communication with management and human resources and discuss education regarding laws and regulations: Anti-kickback Statute, the
areas of risk within the organization, providing regular education and False Claims Act, the Physician Self-Referral (Stark) law, the Civil
training and ensuring that any changes in laws and regulations are Monetary Penalties Law, exclusion authorities and Criminal Health care
promptly communicated in person, in training sessions, and through Fraud Statute. and the Stark law as well as policies regarding gift giving
written communications. Personnel in human resources and and receiving. Physicians must especially be aware of limitations on self-
management should have extensive experience and training in referrals and penalties and should understand the use of safe harbors
compliance issues and should be familiar with laws and regulations. The related to the Anti-Kickback Statute. Physicians should be made aware
employee handbook should be reviewed by legal counsel and should be of changes in regulations and trends in their areas of specialty.
regularly keep up-to-date with changes and should clearly outline Physicians may be more accepting of training if they are provided
expectations regarding compliance. continuing medical education credits and if physicians are directly
involved in the training process.

Question 52

Discuss providing human resources and management with training to recognize compliance risks associated with misconduct

Answer 52

Many laws and regulations govern the relationship between employee Compliance training for physicians generally begins with an emphasis
and employee, as well as compensation and benefits, and the human on documentation standards. Physicians’ documentation should be
resources department and management must ensure that the reviewed through internal auditing to determine if it meets accepted
organization remains in compliance and must be able to determine standards and to provide a guide for areas of weakness. Accurate and
when misconduct places the organization at risk for noncompliance. The appropriate documentation is essential for compliance with regulations
compliance professional must maintain open channels of _ and for reimbursement. Additionally, physicians should receive
communication with management and human resources and discuss education regarding laws and regulations: Anti-kickback Statute, the
areas of risk within the organization, providing regular education and False Claims Act, the Physician Self-Referral (Stark) law, the Civil
training and ensuring that any changes in laws and regulations are Monetary Penalties Law, exclusion authorities and Criminal Health care
promptly communicated in person, in training sessions, and through Fraud Statute. and the Stark law as well as policies regarding gift giving
written communications. Personnel in human resources and and receiving. Physicians must especially be aware of limitations on self-
management should have extensive experience and training in referrals and penalties and should understand the use of safe harbors
compliance issues and should be familiar with laws and regulations. The related to the Anti-Kickback Statute. Physicians should be made aware
employee handbook should be reviewed by legal counsel and should be of changes in regulations and trends in their areas of specialty.
regularly keep up-to-date with changes and should clearly outline Physicians may be more accepting of training if they are provided
expectations regarding compliance. continuing medical education credits and if physicians are directly
involved in the training process.

Question 53

Discuss risk-specific compliance training

Answer 53

While some training, such as that related to privacy issues and Risk-specific compliance training targets specific areas within an
organization and may be based on benchmark data or internal data that
confidentiality, is necessary for all employees, it is often more effective
to include role-based training for specific groups of employees so that suggests an area is vulnerable. Risk-specific/Targeted compliance
they have more mastery of the compliance regulations that apply training is often developed in collaboration with risk management
directly to their job functions and roles. For example, while physicians professionals after a risk assessment is conducted. For example, risk-
and nurses must understand the requirements of accurate specific compliance training may focus on privacy regulations for
documentation for coding and billing, those who are actually employed nursing staff and environmental safety regulations for housekeeping
in coding and billing need to have an in-depth understanding of the staff. Risk-specific compliance training can save time and be more cost-
requirements and regulations regarding coding and billing, such as effective than trying to train all personnel on the same compliance
avoidance of upcoding or unbundling. Those involved in developing issues even if those issues don’t apply directly to their job functions.
contractual agreements must have an understanding of how the Anti- When risk-specific compliance training is designed, it should focus on
kickback and Stark laws apply to contracts. The compliance professional achieving the desired goals and outcomes, so responses to the training
should work with unit and department administration and staff should be monitored to determine if compliance improves. Additionally,
members to determine their specific needs and develop training the training should be appropriate for the targeted group in terms of
programs that are appropriate. Role-based training may be carried out language, content, and presentation, and participants should have a clear
in different ways, such as through staff meetings, training sessions, and understand of the reason for the training.

Question 54

Discuss compliance role-based training

Answer 54

While some training, such as that related to privacy issues and Risk-specific compliance training targets specific areas within an
organization and may be based on benchmark data or internal data that
confidentiality, is necessary for all employees, it is often more effective
to include role-based training for specific groups of employees so that suggests an area is vulnerable. Risk-specific/Targeted compliance
they have more mastery of the compliance regulations that apply training is often developed in collaboration with risk management
directly to their job functions and roles. For example, while physicians professionals after a risk assessment is conducted. For example, risk-
and nurses must understand the requirements of accurate specific compliance training may focus on privacy regulations for
documentation for coding and billing, those who are actually employed nursing staff and environmental safety regulations for housekeeping
in coding and billing need to have an in-depth understanding of the staff. Risk-specific compliance training can save time and be more cost-
requirements and regulations regarding coding and billing, such as effective than trying to train all personnel on the same compliance
avoidance of upcoding or unbundling. Those involved in developing issues even if those issues don’t apply directly to their job functions.
contractual agreements must have an understanding of how the Anti- When risk-specific compliance training is designed, it should focus on
kickback and Stark laws apply to contracts. The compliance professional achieving the desired goals and outcomes, so responses to the training
should work with unit and department administration and staff should be monitored to determine if compliance improves. Additionally,
members to determine their specific needs and develop training the training should be appropriate for the targeted group in terms of
programs that are appropriate. Role-based training may be carried out language, content, and presentation, and participants should have a clear
in different ways, such as through staff meetings, training sessions, and understand of the reason for the training.