Infection Control 494.30

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Infection Control

V110- Is there documentation relating to dialysis access site assessment?

Documentation must reflect site assessment, potential infections, and actions taken to decrease the transmission of infection with in the dialysis facility.

V111- The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas.

Evidence to me compliance: The dialysis unit must demonstrate use of standard precautions. The healthcare worker must use gloves, gown, or mask whenever needed to prevent contact of healthcare worker with blood, secretions, excretions, or contaminated items. All blood, body fluids, secretions, and excretions (except sweat), non-Intact skin, and mucous membranes may contain transmissible infectious agents.

V112- See Recommendations for preventing transmission of infections among chronic hemodialysis patients. CDC guidelines pages 18-28
Gloves are required whenever caring for patient or touching the patients equipment.
To facilitate glove use, a supply of clean nonsterile gloves and a glove discard container should be placed near each dialysis station.
Hands always should be washed after gloves are removed and between patient contacts, as well as after touching blood, body fluids, secretions, excretions, and contaminated items.
A sufficient number of sinks with warm water and soap should be available to facilitate handwashing.
If hands are not visibly soiled, use of a wireless antiseptic hand rub can be substituted for handwashing.
Items taken to a patient's dialysis station, including those placed on top of dialysis machines, should either be disposed of, dedicated for use on a single patient, or cleaned and disinfected before returning to a common clean area are used for other patients.
Unused medications or supplies (e,g., syringes, alcohol swabs) taken to the patient station should not be returned to a common clean area or used on other patients.

V112- Additional Measures to prevent contamination of clean or sterile items includes:
A) Preparing medications in a room or area separated from the patient treatment area and designated only for medications.
B) Not handling or storing contaminated (used) supplies, equipment, blood samples, or biohazard containers in areas where medications and clean (unused) equipment and supplies are handled/stored.
C) Delivering medications separately to each patient. Common carts should not be used within the patient treatment area to prepare or distribute medications. If trays are used to distribute medications, clean them before using for a different patient.

V112- Blood Spill
For a blood spill, immediately clean the area with the cloth soaked with tuberculocidal disinfectant or a 1:100 dilution of household bleach. The staff member doing the cleaning should wear gloves, and the cloth should be placed in a bucket or other leakproof container. After all visible blood is cleaned, use a new cloth to apply disinfectant a second time.

V112- Surveillance for infections and other adverse events –
Develop and maintain a separate centralize record-keeping system (logbook or electronic file) to record results of patients vaccination status, serologic testing results for viral hepatitis (including ALT), episodes of bacteremia or loss of the vascular access caused by infection (including date of onset, site of infection, genus and species of the infecting organism, and selected antimicrobial susceptibility results), and adverse events (Blood leaks and spills, dialysis machine malfunctions). Designate a staff person to promptly review the results of routine testing each time such testing is performed and periodically review recorded episodes of bacteremia or vascular access infections. Specify procedure for actions required when changes occur in test results or in frequency of episodes of bacteremias or vascular access lost because of infection. Maintain records for each patient that include the location of the dialysis station and machine number used for each dialysis session and the names of staff members who connect and disconnect the patients to and from the machine.

V114- A sufficient number of sinks with warm water and soap should be available to facilitate handwashing.

Interpretive guideline: Sinks need to be easily accessible and readily available in patient treatment area and in other appropriate areas such as the reuse room, medication area, home training room, and isolation area/room to meet the needs of the staff and patients.
Sinks must be plumbed with both hot and cold water; if the flow of the water started through motion detection, adjustments to the systems must assure that warm water is available and encourage staff to wash their hands.

Handwashing sinks should be dedicated only for handwashing purposes and should remain clean. Avoid placing, cleaning, or draining used items in handwashing sinks. Used contaminated items should be handled in designated utility sinks. The facility should have a sink available for patients to wash access sites prior to treatment and their hands after treatment. This is also may be used by staff for handwashing. Soap and a supply of paper towels protected from contamination must be available at each sink.

V112/ V115- Staff members should wear gowns, face shields, eyewear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur(During initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in a dialysis treatment area or in the laboratory.

Interpretive guidelines: Staff should wear PPE appropriate to the anticipated potential exposure. Staff should wear PPE during the initiation and termination of dialysis treatment, manipulation of access needles or catheters, administration of medications through the extracorporeal circuit or by subcutaneous injection, the reprocessing of dialyzer's, and cleaning and disinfecting of patient care supplies and equipment. Protective clothing or gear must be changed if it becomes soiled with blood, body fluids, secretions, or excretions.

Street clothes, scrub suits, or uniforms are sufficient attire with and dialysis unit, except for times when the spurting or spattering of blood, body fluids, potentially contaminated substances, or chemicals might occur. At those times a cover garment which provides an impervious barrier to fluids must be worn. This could be a lab coat, gown, or an apron which incorporates sleeves. The garment may open to the back or front, but must be closed to the front during use for patient care. The protective garment should fully cover the arms and torso from the neck area to the Thigh/knee area, aprons without sleeves are not sufficient PPE for procedures which may result in spurting or spattering of blood. Visitors must be provided impervious cover garments if they are in the treatment area during initiation or termination of dialysis.

Separate PPE (gown, face shield, etc.) should be used in isolation area/room and be removed before leaving the isolation area/room. If the patient's family member or visitors are allowed in the isolation area, staff should provide these individuals with barrier PPE, to be worn during the visit and removed before leaving.

The treatment area includes the reuse room and home training area. Staff must avoid any other activity which would allow self-contamination, such as applying with lip balm or handling/inserting contact lenses in the treatment area, patients may eat or drink at the dialysis station, depending on facility policies.

V116- Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area used on another patient.

Non disposable items that cannot be cleaned and disinfected (tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient.
Unused medications (including multidose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken into the patient station should be used only for that patient and should not be returned to a common clean area or used another patients.

Interpretive guidelines: after use, all equipment and supplies must be considered as potentially contaminated, and should be separated, handled with caution, and either disinfected or discarded. If provided, linen should be removed after use, separated from clean items and laundered. If blood pressure cuffs are used for multiple patients, the covering must be disposable or able to be adequately disinfected.

If the facility provides when the blankets for patient use, these items should be considered as potentially contaminated with blood. If patients bring their own blankets, blankets, pillows, etc. Patient should be instructed about washing the linen they bring to the treatment and using bleach to remove bloodstains.

If the facility provides portable or cellular phones, remote controls, or individual televisions for patient use during treatment, these need to be cleaned if shared among patients.

V117- Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medication or clean supplies in the same or an adjacent area to that were used equipment or blood samples are handled.

When multiple dose medication vials used (including vials containing diluents), prepare individual patient doses in the clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station.

Do not use common medication carts to deliver medications to patients. I trays are used to deliver medications to individual patients, they must be cleaned between patients.

V112/ V118- IV medication vials label for single use, including erythropoietin, should not be punctured more than once. Once a needle has entered a vial label for single use, the sterility of the product can no longer be guaranteed. Residual medication from two or more vial should not be pooled into a single file.
Single use vials/ampules must be used for one patient only, should not be entered more than once, and if entered, may not be stored for future use.
Staff should only enter vials with a new sterile syringe and needle. If both vials are single use and are discarded after the single entry into each, the same syringe may be used. If either vial is multi use, a different syringe must be used for entry into each vial.

V119- If a common supply cart is used to store cleaning supplies in the patient treatment area, this cart should remain in a designated area at a sufficient distance from patient stations to avoid contamination of blood. Such carts should not be moved between stations to distribute supplies.
Do not carry medication vials, syringes, alcohol swabs or supplies in pockets.
Supplies of gloves should be strategically placed so that staff has adequate access for both routine and emergency use.

V112/ V120- Venous pressure transducer protectors should be used to cover pressure monitors and should be changed between patients, not reused. If the external transducer protector becomes wet, replaced immediately and inspect the protector. If fluid is visible on the side of the transducer protector that faces the machine, have qualified personnel open the machine after the treatment is completed and check for contamination. This includes inspection for possible blood contamination of the internal pressure tubing set and pressure sensing port. If contamination has occurred, the machine must be taken out of service and disinfected using either a 1:100 dilution of bleach or commercially available, EPA – registered tuberculocidal germicide before reuse. Frequent bloodline pressure alarms or frequent adjusting of blood drip chamber levels can be an indicator of this problem. Taken separately, these incidents could be characterized as isolated malfunctions. However, the potential public-health significance of the total number of incidents nationwide make it imperative that all incidents of equipment contamination be reported immediately to the FDA (800 – FDA – 1088).

V121- Maintain procedures, in accordance with applicable state and local laws and excepted public-health procedures for the handling, storage and disposal of potentially infectious waste.

Interpretive guidelines: potentially infectious waste and soiled laundry should be removed from the patient treatment area throughout the day as the containers are filled in order to maintain an environment that enhances safe patient care. All disposable item should be placed in bags thick enough to prevent leakage.

Any waste contaminated with blood shall be considered infectious and handled according to local, state, and federal regulations governing medical waste disposal.

Biohazardous waste containers should be clearly labeled and sealed prior to being full. Biohazardous waste should be stored in an area that is protected from casual access and from the ability to contaminate the water supply.

V112/V122- Cleaning and Disinfection-
Establish written protocols for cleaning and disinfecting surfaces and equipment in the dialysis unit, including careful mechanical cleaning before any disinfection process (Gross blood spills or items contaminated with visible blood, Hemodialyzer port caps, and interior pathways of dialysis machine, need intermediate level disinfection) (Scissors, hemostats, clamps, blood pressure cuffs, and stethoscopes need low-level disinfection; intermediate level disinfection contaminated with blood)

After each patient treatment, including environmental surfaces at the dialysis station, including the dialysis bed or chair, countertops, and external surfaces of the dialysis machine, including containers associated with the prime waist. Use any soap, detergent, beach urgent germicide. Between uses of medical equipment (i.e., scissors, hemostats, clamps, stethoscopes, blood pressure cuffs), clean and apply a hospital disinfectant (i.e. low level disinfection); if the item is visibly contaminated with blood, use a tuberculocidal disinfectant (intermediate disinfection)

V112/ V124- The HBV serological status of all patients should be known before admission to the hemodialysis unit. Routinely test all patients as required by the referenced schedule for routine testing for HBV. Promptly review results, and ensure the patients are managed appropriately based on testing results.

Prevention and Management of HBV Infection
Preventing HBV transmission among chronic hemodialysis patients requires:
A) Infection control precautions recommended for all hemodialysis patients.
B) Routine serologic testing for markers of HBV infection and prompt review of results.
C) Isolation of HBV positive patients with dedicated room, machine, other equipment, supplies, and staff members.
D) Vaccination.

Vaccinate all susceptible patients. Test susceptible patients monthly for HBsAG, including those who
A) Have not yet received hepatitis B vaccine.
B) Are in the process of being vaccinated.
C) Have not adequately responded to vaccination.

Report HBsAg – positive seroconversions to the local health department as required by law or regulation. When a seroconversion occurs, review all patients routine laboratory test results to identify additional cases. Investigate potential sources for infection to determine if the transition might have occurred within the dialysis unit, including review of newly infected patients recent medical history (Blood transfusions, hospitalization), history of high-risk behavior (injecting drug use, sexual activity), and unit practices and procedures. Repeat testing as described by the CDC.

V-125- Routine testing for hepatitis B: seroconversion
When a seroconversion occurs, review all patients routine laboratory test results to identify additional cases. Investigate potential sources for infection to determine if the transmission may have occurred within the dialysis unit, including review of newly infected patient's recent medical history and unit practices and procedures.

V-126- HBV vaccination-
Vaccinate all susceptible patients and staff members against hepatitis B.

V-127 Hepatitis B screening: patients and staff-
Test all vaccines (patient and staff) for anti-HB's 1- 2 months after last primary vaccine dose. If Anti-HB's is less than 10, consider patient/staff member susceptible, revaccinate with an additional three doses, and retest Anti-HBs.
If Anti-HBs is greater than 10, consider immune, and retest patients annually.
Give booster dose of vaccine to patients Anti-HBs declines to less than 10 and continue to retest patients annually.

V112/V128/V130/V131- HBV Infected Patients-
To isolate HBsAg – positive patients, designate a room for their treatment and dedicate machines, equipment, instruments, supplies, and medications that will not be used by HBV susceptible patients. Most importantly staff members who are caring for HBV positive patients should not care HBV susceptible patients at the same time, including during the period when dialysis is terminated on one patient and initiate on another.

Newly opened unit should have isolation rooms for the dialysis of HBsAg-positive patients. For existing units in which a separate room is not possible, HBV patients should be separated from HBV susceptible patients in an area removed from the mainstream of activity and should undergo dialysis on a dedicated machine. If the machine that has been used on an HBV patient is needed for an HBV susceptible patient, internal pathways of the machine can be disinfected using conventional Protocols and external surfaces cleaned using soap and water or a detergent germicide.

Chronically infected patients are infectious to others and are at risk for chronic liver disease. They should be counseled regarding preventing transmission to others, their household and sexual partner should receive hepatitis B vaccine, and they should be evaluated for presence or development of chronic liver disease according to current medical practice guidelines. Persons with chronic liver disease should be vaccinated against hepatitis A, susceptible.

Refillable concentrate containers must be surface disinfected at the completion of each treatment. Refillable concentrate containers may be kept in isolation area and refilled at the door or removed for cleaning and disinfection. In the disinfection area, the isolation container and pick up tubes must be segregated in a dedicated, designated area away from all other containers and pick up tubes. If the container/pick up two is to be rotated out of the isolation area, it must be bleached before subsequent use.

V129- When dialysis isolation rooms are available locally that sufficiently serve the needs of patients and that geographic area, a new dialysis facility may request a waiver of such requirement. Isolation room waivers may be granted at the discretion of, and subject to, additional qualifications as may be deemed necessary by the Secretary.

V112/132- Infection control training and education practices for hemodialysis units: intensive efforts must be made to educate new staff members and reeducate existing staff members regarding these practices.

Training and education is recommended for both staff members and patients (or their family caregivers). Training should be appropriate to the cognitive level of the staff member, patient, or family member, and rationale should be provided for appropriate infection control behaviors and techniques to increase compliance. The following recommendations are intended to highlight and augment the earlier recommendations.

Training and education for employees at risk for occupational exposure to blood should be provided at least annually, and given to new employees before they begin working in the unit, and documented. At a minimum, they should include information on the following topics:
Proper hand hygiene technique
Proper use of protective equipment
Modes of transmission for blood-borne viruses, pathogenic bacteria, and other microorganisms as appropriate
Infection control practices recommended for hemodialysis units and how they differ from standard precautions recommended for other healthcare settings
Proper handling and delivery of patient medications
Rationale for segregating HBV positive patients with a separate room, machines, instruments, supplies, medications, and staff members
Proper infection control techniques for initiation, care, and maintenance of access sites
Housekeeping to minimize transmission of micro organisms, including proper methods to clean and disinfect equipment and environmental surfaces

Centralized record-keeping to monitor and prevent complications, including routine serologic testing results for HBV and HCV, hepatitis B vaccine status, episodes of bacteremia and loss of access caused by infection, and other adverse events. Records of surveillance for watering dialysate quality should also be maintained.

Training and education of patients (or family member members for patient unable to be responsible for their own care) regarding infection control practices should be given on admission to dialysis and at least annually thereafter and should address the following topics:
Personal hygiene and handwashing technique
Patient responsibility for proper care of access and recognition of signs of infection, also to be reviewed each time the patient has a change in access type
Recommended vaccinations

V143- Ensure that clinical staff demonstrate compliance with current aseptic techniques and dispensing in administering IV medications from vials and ampules.

Interpretive guidelines: the facility must have a mechanism in place to ensure expired medications are not available for use. Open multidose vials should be handled aseptically and used and discarded in accordance with the manufacture's set time frames and/or other accepted standards for use. Staff preparing medication should clean the septum of any multi-dose vial with alcohol before inserting the needle and the injection port using the port to administer medication.

V-144- Require all clinical staff report infection control issues to the dialysis facilities medical director and the quality improvement committee.

Interpretive guidelines: There should be a documented reporting mechanism for infection control issues. The nurse manager, administrator and medical director should each be able to describe the infection control program and recording mechanisms.

Infection control and patient safety issues should be continuously recorded and discussed in QAPI meetings, and the response taken to address these issues should be documented. Records of tracking infection should be part of the facilities QAPI program.

Dialysis Access
Prevention of intravascular catheter related infections

V147- Recommendations for placement of intravascular catheters and adults and children
1. Healthcare worker education and training
A) Educate healthcare workers regarding the appropriate infection control measures to prevent intravascular catheter related infections.
B) Assess knowledge of and adherence to guidelines periodically for all persons manage intravascular catheters.

2. Surveillance
A) Monitor the catheter sites visually of individual patients. If patient has tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or bloodstream infection, the dressing should be removed to allow thorough examination of the site.

Interpretive guidelines: staff must maintain aseptic technique for care of all vascular accesses, including intravascular catheters. The initiation and termination of the dialysis process and manipulation and tension on the catheter provide frequent opportunity for contamination, minimizing the use of intravascular catheters and protection of the insertion site and the catheter hub from contamination through education training about rigorous care is important in reducing catheter related infection.

Catheter insertion sites should be routinely assessed by staff at each treatment. Most catheter sites recovered with you transparent dressing or gauze. Patients with catheter should be instructed to replace the dressing if the catheter site has sufficient bleeding or drainage to dampen or soiled dressing between treatments.

The facility should have an initial and ongoing training program for infection control practices, which includes information on the prevention of intravascular catheter related infection.

Facility policy should address the training and qualifications of staff who may access catheters, in accordance with any state licensure requirements, as well as the frequency for periodic practice audits to verify staff knowledge and adherence to infection control guidelines for intravascular catheters.

V147- Central venous catheters, including PICCs, hemodialysis, and pulmonary artery catheters in adult and pediatric patients.

6. Catheter and catheter site care
B) Antibiotic lock solutions: do not routinely use antibiotic lock solutions to prevent catheter related bloodstream infections.

V148- Central Venous catheters, including PICCs, hemodialysis, and pulmonary artery catheters in adult pediatric patients.
1) Surveillance
A) Conduct surveillance to determine infection rates, monitor trends in those rates, and assist in identifying lapses infection control practices.
C) Investigate events leading to unexpected life-threatening or fatal outcomes. This includes any process variation for which a reoccurrence would likely present an adverse outcome.

Interpretive guideline: this requirement should be considered out of compliance if there is lack of evidence of surveillance for catheter related infections. A log or another tracking mechanism, such as the dialysis module of the national healthcare safety network, should be used. The log and the patient's medical record should contain detailed information on catheter infections and other adverse events, such as, but not limited to prolonged bleeding, stenosis/clotting, allergic reactions, pyrogenic reactions, cardiac arrest, hospitalizations, and deaths. Refer to V637 QAPI

Physical Environment V400
Physical Environment

V401- The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and public a safe, functional, and comfortable and treatment environment.

Interpretive guidelines: safe environment means there are no obstacles which would present risks for trips and falls such as loose floor tiles. No areas that would pose infection control risks, such as broken worksurfaces, and no outside doors that remain propped open allowing entry of unauthorized individuals, insects, animals, or creating a hazard in the event of a fire.
All lighting heating and air-conditioning are operational.

Comfortable environment means providing sufficient space for patient privacy and access for needed equipment; and maintaining a reasonable noise level, requiring the use of ear phones on television or while other entertainment devices are in use which may disturb others. Monitoring comfortable temperatures addressed at V405

V402- Building. The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, staff and the public.

Interpretive guidelines: the plumbing, electrical and heating, ventilation and air-conditioning systems must be appropriately constructed and effectively maintain.
All buildings and building systems must be maintained free from defects and/or hazards to ensure safety and functionality. Integrity of all surfaces, (i.e. countertops, floors, walls) must be intact, clean and free from damage. Intact surface integrity allows for effective cleaning and limits the potential for microbial growth on a porous surface.

Systems to ensure patient safety must be in place, such as a method for patients to call for help from the restroom and exam rooms. Access to the patient treatment areas, reprocessing areas, water treatment systems, supply storage and dialysis equipment must be restricted to authorized personal only. Access limitation does not preclude visits or tours by individuals authorized and supervised by facility personnel.

V403- Equipment maintenance. The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer's recommendations.

Interpretive guidance:
Preventative maintenance and repair of all equipment must be in accordance with the equipment manufactures instructions.
Staff must operate and maintain the equipment in accordance with manufactures instructions.
Malfunctioning machines awaiting repair must be removed from service unlabeled or tagged to prevent use.

Hemodialysis delivery system:
High flux dialyzers may only be used with machine specified by the manufacture as capable of accurately monitoring and controlling fluid removal.
If Heparin pumps are incorporated into the delivery system, the pumps must be maintained as clean and functional.
As required by manufactures, testing of safety features, i.e. alarms, pressure holding test, and independent verification of dialysis pH and conductivity should be conducted prior to each dialysis treatment.

Ancillary equipment: Ancillary equipment may include, but is not limited to: Functional and clean patient scales, centrifuge, refrigerators, incubators for in-house performance of water/dialysate cultures, emergency generators, blood-pressure monitoring equipment, infusion pumps, patient thermometers, eyewash stations, conductivity and pH meters, Hoyer lifts, and equipment required provide in-house laboratory testing (blood glucose meters, heat blocks, equipment for activated clotting times, supplies for testing for occult blood and hematocrit levels).
Maintenance of refrigerators should include the monitoring of temperatures to ensure these are appropriate for the items stored.
If a generator is present, documentation should be available regarding testing and maintenance manufactures instructions.
Record should be available regarding the daily cleaning and testing and periodic calibration of pH and conductivity meters as recommended by the manufacturer.
Documentation of periodic calibration of patient scales, blood pressure devices, blood volume monitors, and laboratory equipment, as applicable, should be available.

Emergency equipment:
Emergency equipment should be clean, functional, and accessible.

Patient treatment chairs, facility wheelchairs, and waiting area chairs must be maintained to allow effective cleaning/disinfection.
Torn upholstery must be repaired or replaced; broken mechanisms (foot rest, reclining levers) must be repaired or the equipment removed from use.

The facility equipment maintenance program should include documentation regarding all equipment or devices used for patients, whether maintained by the facility or by durable medical equipment suppliers.

V404- Patient care environment.
1. The space for treating each patient must be sufficient to provide needed care and services, prevent cross-contamination, and to accommodate medical emergency equipment and staff.

Sufficient space to provide needed care what allow:
All dialysis equipment, supplies and items for each patient.
Caregivers to provide emergency care including CPR, the use of emergency equipment including access to needed supplies, stretcher and emergency personnel.
The provision of personal privacy when needed i.e., sufficient space to allow for use of some type of privacy screens.

Sufficient space to prevent cross-contamination would allow space to:
Prevent blood or bloody fluid spatters from one patient or station to another.
Prevent contact between machines, chairs and other equipment.
Reasonably accommodate patient belongings.
Provide privacy and aseptic care of catheters including dressing changes.
Safely dispose of bodily waste/fluids and hazardous-waste.
Readily access Heather's place receptacles.

The space allowance should take into consideration the space taken up by patients dialysis chairs when reclined with the foot rests up.

V405- The dialysis facility must:
1) Maintain a comfortable temperature within the facility.
2) Make reasonable accommodations for patients were not comfortable at this temperature.

If patients chooses to use a blanket or other covering, there vascular access site, bloodline connections, and face must be visible throughout the treatment. Head coverings on the patient is acceptable, as are gloves.

V406- The dialysis facility must make accommodations to provide for patient privacy of patients are examined or treated and body exposure is required.
Privacy must be provided for the use of a bedpan or commode during dialysis, initiating and discontinuing treatment when the vascular access is placed an intimate area, for physical exams, and for sensitive communications.
There should be sufficient numbers of privacy screens or other methods of visual separation available and used to afford patients full visual privacy when indicated. Exam room should have a door or other method to ensure privacy can be provided. Arrangements for private conversations may need to be outside of the patient treatment area in a private location.

V407- Patients must be in view of staff during hemodialysis treatment to ensure patient safety (video surveillance will not meet this requirement).
Evidence of compliance: each patient, including his/her face, vascular access site and bloodline connections, must be able to be seen by a staff member throughout the dialysis treatment. Allowing patients to cover access sites or bloodline connections provides an opportunity for accidental needle dislodgment or a line disconnection to go undetected. This dislodgment or disconnection could result in exsanguination and death in minutes.

V408- Emergency preparedness. The dialysis facility must implement processes and procedures to manage medical and nonmedical emergencies that are likely to threaten the health or safety of the patients, staff, or public. These emergencies include, but are not limited to, fire, equipment or part failures, care related emergencies, water supply interruption, and natural disasters likely to occur in the facilities geographic area.

Medical emergencies which may be anticipated in the dialysis setting include, but are not limited to, cardiac arrest, air embolism, adverse drug reactions, suspected pyrogen reactions, profound hypotension or hypertension and significant blood loss. Dialysis staff should be aware of how to recognize and respond emergent patient medical conditions.

Regularly scheduled treatments are essential for dialysis patients. In the event of a natural or man-made disaster, immediate actions must be taken to ensure proper restoration of these treatments or to plan for the safe transfer of patients to alternate locations for their treatments. Each dialysis facility must have a facility specific disaster/emergency plan to be able to respond accordingly. Disaster/emergency plan should address failure of basic systems such as power, source water, air conditioning or heating systems as well as treatment specific failures such as facility water treatment system or supply delivery.

Responsible staff and patients should be knowledgeable regarding the emergency plan should the facility be nonoperational after disaster.

Not expired emergency/evacuation supplies, including site dressings, saline, IV tubing, should be available to accommodate evacuated dialysis patients.

V409- Emergency preparedness of staff.
The dialysis facility must provide appropriate training and orientation in emergency preparedness to staff. Staff training must be provided and evaluated at least annually and include the following:
Ensuring that staff can demonstrate a knowledge of emergency procedures, including informing patients of what to do, where to go.
Including instructions for occasions when the geographic area the dialysis facility must be evacuated.
The contact if an emergency occurs when the patient is not in the dialysis facility. This contact information must include an alternate emergency phone number for the facility for instances when the dialysis facility is unable to receive phone calls during an emergency situation.
How to disconnect themselves from the dialysis machine if an emergency occurs.

V410- Ensuring that, at a minimum, patient care staff maintain current CPR certification. All direct patient care staff including nurses and patient care techs must have current basic CPR certification.

V411- Insuring that nursing staff are properly trained in the use of emergency equipment and emergency drugs.
The minimum emergency equipment required as defined in the V413. The emergency drugs to be kept on-site may be determined by the medical director and the defined by facility policy.

If the facility and has chosen to use a defibrillator rather than an AED, recognize that use of a defibrillator requires recognition of arrhythmias and knowledge of protocols to properly use the defibrillator. An AED can be used by any person with appropriate instruction. If a traditional defibrillator is present, written protocols approved by the medical director and the staff member trained and competent use equipment should be present whenever patients are dialyze in the facility.

V412- Emergency preparedness patient training. The facility must provide appropriate orientation and training to patients, including the area specified in paragraphs of this section.
Patients must have sufficient knowledge of emergency procedures to know how to handle emergencies, both in and out of the facility. Refer to V409 for the required areas of this emergency education.

V413- Emergency equipment.
Emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and all emergency drugs, must be on the premises at all times and immediately available.

Interpretive guidance:
On the premises and immediately available may include the use of an emergency response team if the facility is located inside the building which includes such a response team. Response time for personnel and equipment should be demonstrated is been less than four minutes.

V414- Emergency plans.
The facility must have a plan to obtain emergency medical assistance when needed.
All members of the facility staff must be able to demonstrate knowledge of how to obtain emergency medical assistance i.e. 911 system or equivalent for the locality.

V415- Evaluate at least annually the effectiveness of the emergency and disaster plans and update them as necessary.
Interpretive guidance: this annual evaluation process should include review of any medical or nonmedical emergencies that occur during the year to determine opportunities for improvement, as well as reevaluation of plans/procedures for current appropriateness and feasibility.

Facility must conduct drills or mock emergencies at least annually in order to determine the staffs skill level/educational needs as effectiveness of their plan.

V416- Contact its local disaster management agency at least annually to unsure that such agency is aware of the dialysis facility needs int he event of an emergency.

V417- Fire safety.
The dialysis facility must comply with the applicable provisions of the 2000 edition of the life and safety code of the National Fire Protection Association.

V418-Dialysis facilities participating in Medicare as of October 14, 2008 utilizing non sprinklered buildings on such date may continue to use such facilities if such buildings were constructed before January 1, 2008 and state law so permits.

V419- If CMS finds that the fire and safety code imposed by the facility state law adequately protects the dialysis facility's patients, CMS may allow the state survey agency to apply the state's fire and safety code instead of the life safety code.

V420- After consideration of state survey agency recommendations, CMS may waive, for individual dialysis facilities and for appropriate periods, specific provisions of the life safety code, the following requirements are met:
The waiver would not adversely affect the health and safety of the dialysis facility's patients.
Rigid application of specific provisions of the life safety code would result in an unreasonable hardship for the dialysis facility.

Patient Rights V450
Patient Rights V450

V451- The dialysis facility must inform patients of their rights and responsibilities in the beginning of treatment and must protect and provide for the exercise of those rights.

When they begin their treatment means within the first six treatments after admission to the facility. See V451 for additional info as needed.

V452- Patient rights.
The patient has the right to respect, dignity, and recognition of his or her individuality and personal needs, and sensitivity to his or her psychological needs and ability to cope with end-stage renal disease.
And all verbal and nonverbal communications, patient must be treated with respect, dignity, and sensitivity. Interactions among patients, staff, and other should demonstrate observance of patients rights and consideration of the patients physical condition, emotional state, and cultural background.
Patients must be able to question procedures or staff performance without fear of reprisal.
See V452 for additional information including restraints.

V453- Receive all information in a way that he or she can understand.
Staff should consider patients literacy levels, whether they have communication disorders (decreased vision/blindness, hearing loss, or speech impairment), and whether another language or other English as their primary language.
Methods to validate that provided information was understood should be employed; examples would include "teach back,"asking the patients reflect back to the staff member what they understood, return demonstration of they skill.
Additional interpretive guidance is offered in section V453.

V454- Privacy and confidentiality in all aspects of treatment.
Patients have the right to privacy and confidentiality in both the verbal and physical aspects of the treatment. See section V454 for additional interpretive guidance.

V455- Privacy and confidentiality and personal medical records.
Patient should be able to expect the facility to maintain confidentiality of their medical record information. Patient's health records must be protected from the casual access. Hardcopy medical record should be stored in a secure location when not in use. Computer screens containing patient information should not be left open and unattended with patient specific information on display and computer system should require passwords and permissions to access medical records.

The facility must inform patients of their privacy rights under the HIPAA act.
See V455 for additional interpretive guidance.

V456- Being informed about and participate, if desired, and all aspects of his or her care, and he informed of the right to refuse treatment, to discontinue treatment, and to refuse to participate in experimental research.

Self cannulation maybe performed by the patient in any facility upon receiving appropriate training and demonstrating competence, should they so choose, the facility must encourage patient participation in care planning. Examples of ways to promote this participation include, but are not limited to, offering the patient the option to participate and IDT care planning or to attend a planning meeting in person or by teleconference from home. "Chair side" review of plan of care is also acceptable, if sufficient privacy can be provided. Patients also have the right to accept or decline to participate in her care.

Patients must be notified of changes to their dialysis prescription and the reason for those changes. Patient should be encouraged to disclose any concerns they have with the proposed changes. Patients have the right to refuse to change without fear of discharge.

V457- Be informed about his or her right to execute advanced directives, and the facilities policy regarding advance directives.

The standard requires the facility to inform patients about advance directives, including the right to formulated answer. The standard does not require that all patients have an advanced directive. See V457 for additional interpretive guidance.

V458- Be informed about all treatment modalities and settings, including but not limited to, transplantation, home dialysis modalities (Home hemodialysis, peritoneal dialysis, continuous ambulatory peritoneal dialysis, continuous cycling peritoneal dialysis), and in facility hemodialysis. The patient has the right to receive resource information for dialysis modalities not offered by the facility, including information about alternative scheduling options for working patients.

V459- Be informed of facility policies regarding patient care, including, but not limited to, isolation of patients.

V460- Be informed of facility policies regarding the reuse of dialysis supplies, including hemodialyzers.
This only applies to facilities at practice reprocessing and reuse dialyzer or dialysis supplies.

V461- Be informed by the physician, nurse practitioner, clinical nurse specialist, our physicians assistant treating the patient for ESRD of his or her own medical status is documented in the patient's medical record, unless the medical record contains a documented contraindication.
Medical records should show a patient's medical status was discussed with a patient/designee by physician or nonphysician practitioner. There should be few if any cases when a patient/designee cannot be informed about the patient's medical status.

V462- Be informed of services available in the facility and charges for services not covered under Medicare.
Patients must be made aware of charges for services that may not be covered under Medicare. If a facility plans to bill a patient for items and/or services which are usually covered by Medicare, but may not be considered reasonable and necessary in a particular situation, the patient must be informed and offered an advance beneficiary notice to sign.

V463- Receive the necessary services outlined in the patient plan of care.
Patients have the right to receive individualized care as determined by the facility interdisciplinary team and to be included on that team. The care specified in the plan of care should be delivered to the patient or the plan of care should be revisited.

V464- Be informed of the rules and expectations of the facility regarding patient conduct and responsibilities.
Some examples of facility expectations for patient contact and responsibilities include, but are not limited to, treating others (staff, patients, visitors) with mutual respect; following the plan of care (i.e. taking ordered medications, following fluid and diet restrictions); keeping appointments and or notifying the facility if he or she is will be late or miss a scheduled appointment, notifying the facility of changes in residence and contact information; and providing information on payers and changes in insurance.

V465- Be informed of facilities internal grievance process.

V466- Be informed about of external grievance mechanisms and processes, including how to contact the ESRD Network and state survey agency.

V467- Be informed of his or her right to file internal grievances or external grievances or both without reprisal or denial of services.
Be informed that he or she may file internal or external grievances, personally, anonymously or through a representative of the patients choosing.

V468- Right to be informed regarding the facilities discharge and transfer policies.
The patient has a right to be informed of the facilities policy for transfer, routine or involuntary discharge, and discontinuation of services to patients.

V469- Receive written notice 30 days in advance of an involuntary discharge, after the facility followed involuntary discharge procedures described in 494.180. In the case of immediate threats to the health and safety of others, an abbreviated discharge procedure maybe followed.

V470- Posting of rights.
The dialysis facility must prominently display a copy of the patients rights in the facility, including the current state agency and ESRD network mailing addresses and telephone complaint numbers, where it can be easily be seen and read by patients.

Patient Assessment V500
Patient Assessment

V501- The facilities IDT team, consists of, at a minimum, the patient or the patients designee (if the patient chooses), a registered nurse, physician treating the patient for ESRD, a social worker, and a dietitian. The IDT team is responsible for providing each patient with an individualized comprehensive assessment of his or her needs. The comprehensive assessment must be used to develop the patient's treatment plan and expectations for care.
See V501 for additional interpretive guidance.

V502- Assessment criteria.
The patient's comprehensive assessment must include, but is not limited to, the following: evaluation of current health status and medical condition, including comorbid conditions.
Nonphysician practitioners functioning in lieu of physicians may conduct medical portions of this evaluation, in accordance with state law and facility policy.
Nursing assessment must be conducted by registered nurse and include evidence of assessment of the clinical needs of the patient.
Documentation of the etiology of the patient's kidney disease and a listing of any comorbid conditions should be in the medical record. While copies of the H&P from hospital admissions may be included, the assessment should address the patient's current presentation and health status, including the patient's medical condition related to his or her kidney disease.

V503- Evaluation of the appropriateness of the dialysis prescription.
A HD prescription includes the number of treatments per week, length of treatment time, dialyzer, specific parameters of the dialysis delivery system (i.e. electrolyte composition of the dialysate, blood flow rate, dialysate flow rate), anticoagulation, and the patient's target weight. The appropriate HD prescription is individualized to meet the dialysis needs of the patient. For example, if the patient experiences intradialytic muscular cramping or a fall in blood pressure, a reevaluation of the related components of the dialysis prescription (i.e., target weight, ultra filtration rate, dialysate sodium level) would be indicated; if a patient's laboratory values show an elevated or low potassium, a change in the dialysate potassium may be indicated.
See V503 for PD prescription information.

V504- Blood-pressure, and fluid management needs.
Because of the adverse effects of end-stage renal disease, many patients experience lability of blood pressure and fluid management, the management of which may require reassessment of medication needs, adjustments and target weight, and changes in the plan of care.

The comprehensive assessment should include evaluation of the patience pre/intra/post and interdialytic blood pressures, interdialytic weight gains, target weight, and related interdialytic symptoms (i.e. hypertension, hypotension, muscle cramping) along with an analysis for potential causes.

See V504 for pediatric considerations

V505- Laboratory profile.
Lab work up should include, but not be limited to, CMP, dialysis adequacy, CBC, iron studies, and screening for HBV.
IDT evaluation should reflect recognition of values/results that would need to be addressed in the patient POC.
As laboratory results may vary, that IDT must evaluate the values as they become a valuable and take indicated actions.

V506- Immunizations history, and medication history.
Immunization history should include whether the patient has received standard immunizations (pneumococcal, hepatitis, and influenza) and has been screened for tuberculosis. Immunization record is expected to include at least the patient's immunization history as of the effective date of this regulation.

The CDC recommends that all dialysis patients:
Be tested at least once for baseline TB skin test results and be re-screened if TB exposure is detected. Chest x-rays may be used for individuals for whom the TB skin test is not an option.
Be offered influenza and the pneumococcal vaccine and have immunization history for these vaccines tracked. Both are universally recommended for this population and relate directly to infection control issues.

V507- Evaluation of factors associated with anemia, such as hematocrit, hemoglobin, iron stores, potential treatment plans for anemia, including administration of erythropoiesis stimulating agents.
Each patient's hematologic status must be evaluated for determination of their individual anemia management needs.

V508- Evaluation of factors associated with renal bone disease.
Disturbances in the mineral and bone metabolism are common in patients with end-stage renal disease, often resulting in hyperparathyroidism and chronic kidney disease mineral and bone disorder if not managed effectively.

Evaluation should include the patient's laboratory values for calcium, phosphorus, and parathyroid hormone along with you the patient's current CKD mineral and bone disorder medications (i.e. phosphate binders, vitamin D analogs, calcimimetic agents), over-the-counter medications, dietary factors, medical conditions that impact this issue.

V509- Evaluation of nutritional status by dietitian.
Examples of nutritional parameters to be addressed include but are not limited to:
Nutritional status
Hydration status
Metabolic parameters such as glycemic control (diabetic) and cardiovascular health
Anthropometric data such as height, weight, weight history, weight changes, volume status, amputations.
Appetite and intake
Ability to chew and swallow
G.I. issues
Use of prescribed and over-the-counter nutritional, dietary, or herbal supplements
Previous diets and nutrition education
Route of nutrition
Self-management skills
Attitude to nutrition, health and well-being
Motivation to make changes to meet nutrition and other health goals.

See section V509 for additional interpretive guidance.

V510-Evaluation of psychosocial needs by social worker.
Examples of psychosocial parameters to be addressed by qualified social worker include, but are not limited to:
Cognitive status and capacity to understand
Ability to meet basic needs
Ability to follow the treatment prescription
Mental health history, capacities, and need for counseling
Substance abuse history, if any
Current ability to cope with and adjust to dialysis
Expectations for the future and living with kidney failure and treatment
Education on employment status, concerns, and goals
Home environment including current living situation
Legal issues (i.e. court-appointed guardian, advance directive, and health care proxy)
Need for advocacy with traditional (nursing home) and nontraditional housing (i.e. homeless shelters, group homes)
Financial capabilities and resources
Access to available community resources
Eligibility for federal, state, or local resources

V511- Evaluation of dialysis access type and maintenance (for example, AV fistula, AV graft, and PD catheter).
Each HD patient should have an evaluation for the most appropriate type and location of vascular access and of the capacity of the vascular access to facilitate adequate dialysis treatments.

V512- Evaluation of the patient's ability, interest, preferences, goals, including the desired level of participation in the dialysis care process; preferred modality (hemodialysis/ peritoneal dialysis), and setting, (for example, home dialysis), and the patient's expectations for care outcomes.
Evaluation of the abilities, interest, preferences and goals would be demonstrated by at least one member of the team documenting an assessment of the patient's current interest in life and ability to pursue those interest, preferences for treatments, and goals, including what here she expects from dialysis treatment. Patients must be encouraged to participate in their care, within the limits of their capacity and desire.

V513- Evaluation of suitability for a transplantation referral, based on criteria developed by the prospective transplantation center surgeon. If the patient is not suitable for transplantation referral, the basis for non-referral must be documented in the patient's medical record.

V514- Evaluation of family and other support systems.
This evaluation should start with an interview of the patient. If one or more members of the IDT need to seek additional protected health information about the patient from the family or other supporting individuals, they must obtain the patient's permission to discuss these topics with those individuals. It is not a breach of HIPAA privacy requirements for staff to ask other caregivers for information they may know about the patient to help the IDT provide care for the patient. See V514 for additional interpretive guidance.

V515- Evaluation of current patient physical activity level. Evaluation for referral to vocational and physical rehab services.
These requirements are not intended to indicate that the facility is responsible for fully assessing each patient's activity level capabilities. It is expected that the IDT would be able to evaluate each patient's activity level to the extent necessary to determine whether the patient is a candidate for referral to the proper professional for evaluation of possible rehab services.

V516- Frequency of assessment for patients admitted to the dialysis facility.
An additional comprehensive assessment must be conducted on all new patients (that is, all admissions to the dialysis facility), within the ladder of 30 calendar days or 13 hemodialysis sessions beginning with the first dialysis session.

V517- A follow-up comprehensive reassessment must occur within three months after the completion of the initial assessment to provide information to adjust the patient's plan of care.

V518- Assessment of treatment prescription. The adequacy of the patients dialysis prescription, must be assessed on an ongoing basis as follows:
Hemodialysis patients: at least monthly by calculating delivered Kt/V or an equivalent measure.
PD patients: at least every four months by calculating delivered weekly Kt/V or equivalent measure.
Monthly assessment of dialysis adequacy for all HD patients, and at least every four months for PD patients must be demonstrated.

The facility must have a method or procedure in place for obtaining the blood samples used for that Kt/V or an equivalent measure. The facility must ensure the method/procedure used would result in an accurate result. At the time of the publication of these regulations, the recommended method stipulated for drawing blood sample to measure Kt/V included the following:
Pre-and post samples are drawn at the same treatment
Presample is drawn just prior to the start of treatment
Slow flow or stop flow technique is used for the post sample; staff should slow the blood pump speed 50-100 ml/min for 15 seconds before drawing blood; in the event equipment in use does not allow for slow flow, then stop flow may be substituted.
After 15 seconds, staff should draw the post dialysis BUN sample from the arterial port closest to the patient.

V519- Patient reassessment. A comprehensive reassessment of each patient and revision of the plan of care must be conducted at least annually for stable patients.

V520- At least monthly for unstable patients including, but not limited to, patients with the following:
Extended or frequent hospitalizations
Mark deterioration in health status
Significant change in psychosocial needs
Concurrent or nutritional status, unmanaged anemia and inadequate dialysis.

Extended hospitalizations include hospitalizations longer than 15 days.
Frequent hospitalizations would include more than three hospitalizations in a month.

Marked deterioration in health status would be specifically identified and documented by the IDT. The following conditions have been suggested by representatives of the renal community:
Change in ambulation severe enough to interfere with the patient's ability to follow aspects of the treatment plan
Hypotension, restlessness, itching or other symptoms severe enough to prevent completion of the majority of the dialysis treatment.
Sudden onset of recurrent cardiac arrhythmias
Return to fight infections
Chronic congestive heart failure with chronic hypotension
Advanced or metastatic cancer or other organ system disease which interferes with the patient's ability to follow the treatment plan
Chronic or recurrent peritonitis.

Significant change in psychosocial needs to include any event that interferes with the patient's ability to follow aspects of the treatment plan. Such events may include instability in one's own or immediate family members employment, physical or emotional abuse, deterioration in mental or functional status, amputation, housing instability, death or major illness in the family, consideration of terminating treatment, and loss emotional support. In addition, any patient considered at risk for involuntary discharge or transfer must be considered unstable.

Poor nutritional status would include failure to thrive symptoms, with loss of body weight and low serum albumin.

Unmanaged anemia would include continued lab findings of hemoglobin/hematocrit values which are out of range as defined by community accepted standards or CMS clinical performance measures. Referred to the measures assessment tool (mat) which lists the current professional accepted clinical standards and current CMS CPM's.

Inadequate dialysis would include a trend of results for Kt/V or URR which does not meet minimum expectations as defined by community accepted standards or CMS CPM's for three-month period of time. Refer to the mat. Inadequate dialysis would also include symptoms related to fluid management such as volume overload or depletion; intradialytic symptoms such as syncope or congestive heart failure; hypertension; or the need for extra treatments for fluid removal.

Facilities must have a method for classifying patients as unstable. Documentation should be available of a monthly reassessment and plan of care revision that addresses the issues related to the classification of the patient as unstable until issues have been resolved by the IPT, or determined to be chronic and the active care plan adequately addresses the issue.

Plan of Care V540
Plan of Care V540

V541- The interdisciplinary team must develop and implement a written, individualized comprehensive plan of care that specifies the services necessary to address the patient's needs, as identified by the comprehensive assessment and changes in the patient's condition, and must include measurable and expected outcomes and an estimated timetable to achieve these outcomes. The outcome specified in the patient's plan of care must be consistent with current evidence-based professionally except clinical practice standards.

The IDT consists of, at a minimum, the patient or the patients designee, a registered nurse, a physician who is treating the patient for end-stage renal disease, social worker, and a dietitian. Each team member must meet the qualifications outlined in the condition for personal qualifications.

The facility must recognize the patient or his or her designee as a member of the interdisciplinary team and encourage the patient's participation in developing and updating the plan of care. The patients needs, wishes, angles must be considered in making decisions about the plan of care. The patient chooses to use a designee, there must be written authorization from the patient for sharing of protected health information of the designee.
See V541 for additional interpretive guidance.

V542- Development of patient plan of care. The IDT team must develop a plan of care for each patient.
There must be an IDT plan of care developed for each patient. Facilities must have a system for developing patient's plan of care. The IDT members are expected to interact and share information from the comprehensive assessment to facilitate the development of the plan of care.

V543- The plan of care must address, but not be limited to, the following: dose of dialysis. IDT must provide the necessary care and services to manage the patient's volume status.
Volume status is measured in terms of the dialysis patients target weight, or estimated dry weight- EDW. What the patient would weigh if he or she were dry. The patient at their EDW should be asymptomatic and normotensive on minimum blood-pressure medications, while preserving organ perfusion and maintaining existing residual renal function. A patient at their EDW attains normotension for most of their interdialytic period, while avoiding orthostatic hypotension or postural symptoms either during or after dialysis. Excess fluid accumulation may have adverse effects (i.e. hypertension, LVH, cardiovascular complications, hospitalizations). Removal of too much fluid or removing it too fast in one dialysis treatment or going below the patient's target weight may cause hypotension, muscle cramping, and clotting of the vascular access. Each patient should be weighed before and after each treatment. The UF component of the hemodialysis prescription should be optimized with the goal to render the patient you euvolemic and normotensive. With successful fluid management, the number of medications a patient needs for blood pressure control may be able to be reduced. There should be a target weight identified for each patient and evidence that failure to achieve the target weight through the dialysis treatment is addressed.

V544- Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or to meet an alternative equivalent professionally except clinical practice standing for adequacy of dialysis.

Referred to the measures assessment tool (MAT) which list those for dialysis adequacy.

V545- Nutritional status. The IDT must provide the necessary care and counseling services to achieve and sustain an effective nutritional status. A patient's Albumin level and bodyweight must be measured at least monthly. Additional evidence-based professional accepted clinical nutrition indicators may be monitored, as appropriate.

V546- Mineral metabolism. Provide the necessary care to manage mineral metabolism and prevent or treat renal bone disease.

The lab markers of calcium, phosphorus and parathyroid hormone are generally used to monitor mineral metabolism. Expect the facility to have established goals for patients calcium, phosphorus and PTH levels which reflect professionally accepted clinical practice standards and CMS CPM's. Refer to the MAT tool which list the targets for CKD mineral and bone disorders.

V547- Anemia. The IDT must provide the necessary care and services to achieve and sustain the clinically appropriate hemoglobin/hematocrit level. The patient's hemoglobin/hematocrit must be measured at least monthly. The dialysis facility must conduct an evaluation of the patients anemia management needs.

V548- For a home dialysis patient, the facility must evaluate whether the patient can safely, aseptically, and effectively administer erythropoiesis stimulating agents and store this medication under refrigeration if necessary.

V549- The patient's response to erythropoiesis stimulating agents, including blood pressure levels and utilization of iron stores, must be monitored on a routine basis.

The facility must monitor patient's blood pressure and act upon significant abnormalities for the patient. Hypertension may have many causes; failure to develop and implement a plan to control high blood pressure should be cited at the V543.
See V549 for additional interpretive guidance.

V550- Vascular access. The IDT must provide vascular access monitoring and appropriate, timely referral to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration comorbid conditions, other risk factors, and whether the patient is potential candidate for AV fistula placement.

V551- The patient's vascular access must be monitored to prevent access failure, including monitoring of arteriovenous grafts and fistulae for symptoms of stenosis.
Monitoring strategies may included physical examination of the vascular access; observance of changes in adequacy or in pressures measured during dialysis; difficulties in cannulation; or achieving hemostasis. Precipitating events should also be noted, such as hypotension or hypovolemia. Surveillance strategies include device-based methods such as access flow measurements, direct or derived static venous pressure ratios, duplex ultrasound, etc.

For patients with grafts and fistulas, the medical records should show evidence of periodic monitoring and surveillance of the vascular access for stenosis and signs of impending failure. The documentation of this may be on the dialysis treatment record, progress notes, or on a separate log. A member of the facility staff must review the vascular access monitoring/surveillance documentation to identify adverse trends and take action of indicated.

V552- Psychosocial status. The IDT must provide the necessary monitoring of social work interventions. These include counseling services and referrals for social services, to assist the patient in achieving and sustaining appropriate psychosocial status as measured by the standard as mental and physical assessment tool chosen by the social worker, at regular intervals, or more frequently on an as needed basis.

V553- Modality.
Home dialysis. The IDT must identify a plan for the patients home dialysis or explain why the patient is not a candidate for home dialysis.

V554- Transplantation status. The patient is a transplant referral candidate, the IDT must develop plans for pursuing transplantation. The patient's plan of care must include documentation of the:
A) Plan for transplantation, if the patient accepts the transplantation referral.
B) Patients decision, if the patient is a transplantation referral candidate but declines the transplantation referral.
C) Reason for the patients non-referral as a transplantation candidate as documented in accordance with 494.80 (a) (10).

V555- Rehabilitation status. The IDT must assist the patient achieving and sustaining an appropriate level of productive activity, as described by the patient, including the educational needs of pediatric patients, and make rehab and vocational rehab referrals as appropriate.

V556- Implementation of the patient plan of care.
1. The patient's plan of care must:
A) Be completed by the IDT, including the patient the patient desires.
B) be signed by the team members, including the patient or the patients designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided.

V557- Implementation of the initial plan of care must begin within the latter of 30 calendar days after admission to the dialysis facility or 13 outpatient hemodialysis sessions after beginning with the first outpatient dialysis session.

V558- Implementation of monthly or annual updates of the plan of care must be performed within 15 days of the completion of the additional patient assessments specified and 494.80 (D).

V559- If the expected outcome is not achieved, the IDT must adjust the patient's plan of care to achieve the specified goals. When a patient is unable to achieve the desired outcomes, the team must:
A) Adjust the POC to reflect the patient's current condition.
B) Document in the the record the reasons why the patient was unable to achieve the goals.
C) Implement the plan of care changes to address the issues identified previously.

V560- The dialysis facility must ensure that all dialysis patients are seen by a physician, nurse practitioner, clinical nurse specialist or physician's assistant providing end-stage renal disease care at least monthly, as evidenced by monthly progress note placed in the medical record, and periodically while the hemodialysis patients receiving interfacility dialysis.

V561- Transplantation referral tracking. The IDT must:
1. Track the results of each kidney transplant center referral.
2. Monitor the status of any facility patients who are on the transplant wait list.
3. Communicate with the transplant center regarding the patient transplant status at least annually, and when there is a change in transplant candidate status.

V562- Patient education and training. The patient care plan must include, as applicable, education and training for patients and family members or caregivers or both, in aspects of the dialysis experience, dialysis management, infection prevention and personal care, home dialysis and self-care, quality-of-life, rehabilitation, transplantation, and the benefits and risks of various vascular access types.

QAPI- V625

V626- The dialysis facility must develop, implement, maintain, and evaluate an effective, data-driven, quality assessment performance improvement program with participation by the professional members of the IDT. The program must reflect the complexity of the dialysis facilities organization and services (including those services provided under arrangement), and must focus on indicators related to improve health outcomes and the prevention and reduction of medical errors. The dialysis for facility must maintain and demonstrate evidence of its queue API program for review by CMS.

V627- Program scope.
1. The program must include, but not be limited to, an ongoing program that achieves measurable improvement and health outcomes and reduction of medical errors by using indicators or performance measures associated with improved health outcomes and with the identification and reduction of medical errors.

V628- The dialysis facility must measure, analyze, and track quality indicators are other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. Use performance components must influence or relate to the desired outcomes or be the outcomes themselves. The program must include, but not be limited to, the following: See V628 for interpretive guidance.

V629- Adequacy of dialysis.

V630- Nutritional status.

V631- Mineral metabolism and renal bone disease.

V632- Anemia management.

V633- Vascular access.

V634- Medical injuries and medical errors identification.
1. Hand hygiene
2. Patient falls
3. incorrect dialyzer or dialyzing solution.
4. Medication omissions or errors.
5. Non-adherence to procedures

"Error"is defined as the failure of a planned action to be completed as intended (error of execution) or the use of a wrong plan to achieve the aim (error of planning). An error may be an act of commission or an act of omission.

"Medication error "is defined as any error occurring in the medication is process. Examples include wrong dosage prescribed, wrong dosage administered for a prescribed medication, failure to give by the provider, or take by the patient, a medication, or administration of a medication to which the patient is allergic.

"Adverse drug" is defined as an injury due to medication. Examples include a wrong dosage leading to injury (i.e. a rash, confusion, or loss of function) or an allergic reaction occurring in a patient not known to be allergic to a given medication.

V636- Patient satisfaction and grievances.

V637- Infection control; with respect to this component the facility must:
A) analyze and document the incidence of infection to identify trends to establish baseline information on infection incidences
B) develop recommendations and action plans to minimize infection transmission, promote immunization
C) take action to reduce future incidents.

V638- Monitoring performance improvement. The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time.

V639- Prioritizing improvement activities. The dialysis facility must set priorities for performance improvement, considering prevalence and severity of identified problems and giving priority to improvement activities that affect clinical outcomes or patient safety.

V640- The facility must immediately correct any identified problems that threaten the health and safety patients.
Dangerous levels of contaminants in product water
Unsafe levels of electrolytes in dialysate
Failure to conduct an accurate preassessment
Setting and an inaccurate fluid removal rate
Failure to provide adequate observation of patient, patient vascular access, patients equipment
Defective clinical equipment
Lack of qualified staff perform crucial test or to meet critical patient needs
Evidence that staff assigned to perform crucial tests or to meet critical patient needs are not competent
Potential for cross-contamination between infected and noninfected patients
Dai-Ichi's machine provided safety devices (muting machine alarms, bypassing the air detector, etc.)

Medical Records V725

V726- The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of end-stage renal disease services and all other home dialysis patients whose care is under the supervision of the facility.

V727- Protection of the patient's record.
The dialysis facility must:
1. Safeguard patients records against loss, destruction, or unauthorized use.
2. keep confidential all information contained in the patient's record, except when releases authorized pursuant to one of the following:
A) transfer the patient to another facility.
B) Certain exceptions provided for in the law.
C) provisions allowed under the third-party payment contract.
D) approval by the patient.
E) inspection by authorized agents of the secretary, as required for the administration of the dialysis program.

V728- Obtaining written authorization from the patient or legal representative before releasing information that is not authorized by law.

V729- Completion of patient records and centralization of clinical information.
1. Current medical records and those of discharge patients must be completed promptly.

V730- All clinical information pertaining to a patient must be centralized in the patient's record, including whether the patient has executed an advance directive. These records must be maintained in a manner such that each member of the interdisciplinary team has access to current information regarding the patient's condition and prescribe treatment.

Centralized means the patient's health information is maintained in a common location, such as the chart or electronic record system.

V731- The dialysis facility must complete, maintain, and monitor homecare patients records, including the records of patients who receive supplies and equipment from a durable medical equipment supplier.

V732- Record retention and preservation. All patient records must be retained for 6 years from the date of the patient's discharge, transfer or death.

V733- Transfer patient record information. When a dialysis patient is transferred, the dialysis facility releasing the patient must send all requested medical record information to the receiving facility within one working day of the transfer.

Nurse interview

Click to the far right for a nurse interview

Nurse interview

V627- How has the facility leadership defined your role in patient safety

V627, 634, 715, 756- What do you do to prevent or reduce errors or near misses in your facility?

How are these events addressed when they happen?

V456- How are patients encouraged to participate in their POC?

V456,466,636- What types of patient concerns do you document?
How are patients encouraged to voice complaints without fear of reprisal?
What is your facilities system for reproting resolution to the patient?

V757, 758- Are there sufficient number of staff to care for patients medical, nutritional, and psychosocial needs?

V503, 504- How often do you monitor patients in center?
(Before, during, after)

V132, V562- What does this facility do for infection prevention and control?

V559- How do you monitor, recognize, and address patients failure to meet outcomes targets addressing learning barriers?

V626- 628- How do you participate in QAPI and learn about QAPI activities?

Nurse Manager- How do you track and trend data for QAPI?

V409, 412- What have patients been taught about emergency management?

V452- How would you work with patients who have mental illness, Cognitive impairment, cultural or language barriers as a way to prevent involuntary transfers or involuntary discharges?

V467- Is there anything else you would like to tell me about your facility?

V553, 554- How are interested patients evaluated for for other treatment modalities?
(Home or transplant)

V514, 552- Who is available to help with patients/family or partner concerns for patients?

V509, 510- When is it appropriate to refer patients to the dietician or social worker? How do you go about doing this?

V506- How often do you review your patients immunizations and medication history with them?

V126- Were you offered a Heb B vaccine?
Are patients offered Hep B vaccine?

V124- How do you care for patients who are hep B susceptible?

V628- QAPI- What practice audits of patient care are done at this facility and which ones have you performed?

V640- How are problems that threaten the health and safety of patients and require immediate correction addressed in QAPI?

V629-637, 712- Nurse Manager- How does the medical director take responsibility in QAPI for in center dialysis patient indicators?

V559, 726- How often are patient charts, flowsheets, records reviewed for accurate documentation and used to revise the POC to meet outcome goals?

Dietician Interview

Click to the far right for a dietician interview

Dietician Interview

V465,466, 467, 627- What types of patient and staff concerns, suggestions/complaints, errors and near misses are staff taught to respond to, report, and record? How comfortable are you to report? What is your facilities system for reporting?

V626- 756- How do you participate in QAPI and learn about QAPI activities?

V757, 758- Are there sufficient number of staff to care for patients medical, nutritional, and psychosocial needs?

V509, 542- How do you assess patients nutritional needs and collaborate with the IDT to develop a congruent POC and address outcomes?

V456- How are patients encouraged to participate in their POC?

V559,562- How do you assess patients for learning barriers, and provide education when patients are failing to meet outcome goals?

V452, 766, 767- How would you work with patients who have mental illness, Cognitive impairment, cultural or language barriers as a way to prevent involuntary transfers or involuntary discharges?

V132- What training have you had in infection prevention?

V409, 412- What were you taught about emergency preparedness? How do you help patients get elsewhere in an emergency?

V467- Is there anything else you would like to tell me about this organization?

V545- What are some nutritional issues you address with patients? Can you identify patients with whom you have worked significantly with?
(consider for your chart sample)

V545, 562- If your facility does not allow patients to eat at mealtimes during dialysis, how do you counsel them to make sure they are meeting their nutritional needs on treatment days? How do you collaborate with nursing homes to help patients meet their nutritional needs?

What are your responsibilities related to diet education when patients switch dialysis modes or frequency of dialysis?

V126- Were you offered a Heb B vaccine?
Are patients offered Hep B vaccine?

V520- How do you identify patients as unstable and increase their frequency of IDT assessments and care planning?

Patient interview

Click to the far right for a Patient interview

Patient Interview

V465/V466/V627- How do the staff at this facility encourage you to give input? If you ever had a complaint how would you file it here or elsewhere?

V452/454- Does staff treat you with respect and dignity and protect your privacy during dialysis?

V456/V541- How does staff encourage you to participate in care planning and consider your needs, wishes, and goals?
How does staff help you overcome barriers to your goals?
Does staff discuss changes in your prescription/therapy before making them?

V458- What were you told about other treatment options?
How did you choose in center dialysis?
Are you satisfied with in-center dialysis?

V451, 562, 464- What have you been told about your condition?, risks and benefits of dialysis and access type, infection prevention, personal care, home dialysis, self care, quality of life, rehabilitation, transplant, your rights and responsibilities, and what to do here or at home during an emergency, including if you were unable to get to dialysis?

V401, 402- How clean, safe, and comfortable is this facility?

V113- Do you see staff washing their hands?

V681, 713- Have you ever had any problems or symptoms during dialysis? How quickly was staff able to resolve the issues?

V757- Are there enough staff at this facility to meet your needs (techs, doctors, dietitians, nurses, social workers)

V552/V628- Have you been offered a survey that asks how your health symptoms affect your energy, activity level, and lifestyle? If problems were identified, how were they addressed?

V467- Is there anything you would like to tell me about this facility?

Social Worker Interview

Click to the far right for interview with social worker

Social Worker Interview

V465,466, 467, 627- What types of patient and staff concerns, suggestions/complaints, errors and near misses are staff taught to respond to, report, and record? How comfortable are you to report? What is your facilities system for reporting?

V757, 758- Are there sufficient number of staff to care for patients medical, nutritional, and psychosocial needs?

V510, 542- How do you assess patients psychosocial status and collaborate with the IDT team to develop a POC and address outcomes?

V456- How are patients encouraged to participate in their POC?

V559,562- How do you assess patients for learning barriers, and provide education when patients are failing to meet outcome goals?

552, 628- When do you offer patients a KDQOL-36 or age appropriate survey, share the results with the IDT, and use them for POC and QAPI? What are your refusal and annual completion thresholds?

V452, 766, 767- How would you work with patients who have mental illness, Cognitive impairment, cultural or language barriers as a way to prevent involuntary transfers or involuntary discharges?

V626,636,756- How do you participate in QAPI and what topics do you bring to QAPI meetings?
How are patient satisfaction, grievance, and involuntary discharges addressed in QAPI?

V132- What training have you had in infection prevention?

V409, 412- What were you taught about emergency preparedness? How do you help patients get elsewhere in an emergency?

V467- Is there anything else you would like to tell me about your facility?

V451- What are patient rights and responsibilities? How often do they learn about them? How do you teach patients to self advocate?

V454- What do you do to ensure privacy and confidentiality when you communicate with patients?

V457- What do you tell patients about their right to establish an Advance Directive? What are the facilities policies on honoring an Advance directive? Are patients told about these policies?

V520- How do you identify patients as unstable and increase their frequency of IDT assessments and care planning?

V552- What are some psychosocial issues you address with patients? Can you identify patients for whom you have provided significant psychosocial services to?

(surveyor note consider including in your sample)

V758- What percent of your time here do you spend doing clinical (counseling and rehab goal setting) versus non clinical tasks (Transportation, transient dialysis, insurance, referrals)

V126- Were you offered a Heb B vaccine?
Are patients offered Hep B vaccine?

Please note that this checklist is a hypothetical example and provides basic information only. It is not intended to take the place of, among other things, workplace, health and safety advice; medical advice, diagnosis, or treatment; or other applicable laws. You should also seek your own professional advice to determine if the use of such checklist is permissible in your workplace or jurisdiction.