READINESS REVIEW FINDINGS AND COMPLIANCE REPORT · readiness review findings and compliance report pace organization: date (s) of review: reviewer (s) – name, title and department:

READINESS REVIEWFINDINGS AND COMPLIANCE

REPORT

PACE ORGANIZATION:

DATE (S) OF REVIEW:

REVIEWER (S) – NAME, TITLE AND DEPARTMENT:

SUMMARY OF FINDINGS (SITE ONLY THOSE AREAS NOT MET):

ORGANIZATION’S COMPLIANCE PLAN:

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CHANGES MADE THAT BROUGHT ORGANIZATION INTO COMPLIANCE:

PACE ORGANIZATION’S READINESS REVIEW COMPLETEORGANIZATION HAS MET ALL ON-SITE REVIEW CRITERIA

DATE OF COMPLETION:

STATE ADMINISTERING AGENCY:

SAA REPRESENTATIVE SIGNATURE:

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STATE READINESS REVIEW

In developing the application process for potential PACE providers, States expressed concern on the feasibility ofrequiring an entity to be operational at the time of application. The State representatives maintained that potential PACEsites need approval by CMS as a PACE provider before the site is able to market its program and begin to enrollparticipants. Absent CMS approval of a site as a PACE provider, the entity has no authority to enroll participants, providePACE services or receive payment.

As an alternative for sites that are not operational at the time of application, the States recommended that CMS onlyapprove applications from potential PACE organizations that satisfy Federal requirements and have met the requirementsof a State Readiness Review (SRR). The SRR is performed by the State at the applicant’s site. At the time of the SRR,the entity will not be operational and thus will have no enrolled participants. The purpose of this review is to determine theorganization’s readiness to administer the PACE program and enroll participants. The SRR will include a minimum set ofcriteria established by CMS in conjunction with the States. The States are free to add any additional criteria to thereadiness review they deem necessary to help them determine if the applicant: 1) meets the requirements stipulated inthe PACE regulation; 2) has developed policies and procedures consistent with the PACE regulation; and 3) hasestablished the contracts necessary to provide all-inclusive, quality care to its participants.

The SRR will focus on a wide variety of areas, including evidence of the site’s policies and procedures, the design andconstruction of the building, emergency preparedness, the site’s compliance with OSHA, FDA, State and local laws, andadherence life safety codes. There are several areas of the SRR that defer to state and local laws and regulations forcompliance. If the applicant’s state has more stringent laws and regulations, those laws will apply in place of the federalrequirement. However, it is incumbent upon the SRR team to ensure that their state laws or regulations encompass eachof the items identified in the federal requirement.

This program recognizes the unique partnership with the States for implementation of the PACE program and thesubstantial financial commitment States have with PACE organizations. Experience has shown that States are extremelyactive in the PACE program. States will play a significant role in selecting appropriate organizations, developing thePACE programs in the SRR process, and monitoring PACE organizations. Even though CMS will not conduct the SRR,we may accompany the States on the readiness review to provide technical assistance in order to assure compliance withfederal standards.

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Upon completion of the SRR, the State will be responsible for preparing and submitting a report of their findings to CMS.Each time a readiness review is conducted, the State will submit a copy of the completed readiness review, a report thatexplains the State’s review process, and any additional review criteria that were utilized. If the applicant meets all of thecriteria in the readiness review, the State will submit a brief report to CMS on its findings.

If the applicant does not meet all of the established criteria, the State, in conjunction with the applicant, will develop aninitial compliance plan to bring the applicant into compliance. This plan will outline both the unmet criteria and the plan ofcorrection. We have chosen to not specify a timeframe for completion of the initial compliance plan to provide both theState and the applicant with flexibility in meeting the requirements in the SRR. However, we do not anticipate thatcompletion of the initial compliance plan will take an extended period of time since the applicants should be ready to enrollparticipants at the time of the SRR. Once the initial compliance plan has been completed to the satisfaction of the State,the review team will submit a complete report to CMS. The report will include an explanation of the State’s reviewprocess, any additional review criteria that were utilized, the list of unmet criteria, the reason the applicant failed to meetthe criteria, the initial compliance plan, and an explanation of the changes that were made to bring the applicant intocompliance with the requirements.

Once the organization’s census reaches a specified level, CMS will conduct an operational review to ensure that theorganization’s policies have been implemented and that all services are being provided consistent with the PACEregulation.

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PROPOSED FORMAT FOR THE READINESS REVIEWPACEREGULATIONREQUIREMENT

READINESS CRITERIA CRITERIA MET NOTES

PHYSICALENVIRONMENT(§460.72)

I.A.The PACE centermust bedesigned,constructed,equipped, andmaintained toprovide for thephysical safety ofparticipants,personnel, andvisitors.

EVIDENCE OF COMPLIANCE WITH ALL STATE ANDLOCAL BUILDING, FIRE SAFETY AND HEALTHCODES.

Evidence of the following:

• Fire exit system

• Doorways that provide adequate width to alloweasy access and movement of participants bywheelchair or stretcher;

• Doorways and stairways that provide access freefrom obstructions at all times;

• Lights and handrails in stairways, corridors,bathrooms, and at exits used by participants;

• Toilets and stalls in the public bathrooms that areaccessible to allow use by nonambulatory andhandicapped participants, staff and visitors;

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PACEREGULATIONREQUIREMENT


• Evidence of compliance with the ADA (28 CFR Part36 Title III).

• Facility equipped with call lights for acommunication system that alerts staff ofparticipant problems in bathrooms, therapy areas,etc.

• Design features to safeguard cognitively impairedclients who may wander (e.g. fences, door alarms,detector bracelets, etc.)

Written plan that outlines scheduled maintenance forthe PACE center to include building maintenance.

OTHER (SPECIFY)

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I. B.The PACE centermust ensure asafe, functional,accessible andcomfortableenvironment forthe delivery ofservices to theparticipant.

EVIDENCE OF CERTIFICATION OR LICENSURE BYTHE STATE OR A RECOGNIZED ENTITY FOR ADULTDAY CENTERS THAT ENCOMPASSES APPROPRIATECRITERIA.

Evidence of the following:

• Written policies and procedures for ensuring anenvironment that provides privacy and dignity forparticipants, i.e. doors for exam rooms, privacycurtains, appropriate clothing and linen to coverparticipants during treatment, etc.;

• The center must have lighting and sound levels incare areas, activity and dining rooms appropriatefor individuals with vision, hearing, and cognitiveimpairments;

• Proper ventilation;

• Written policies and procedures for an effectivepest control program to control household pestsand rodents not limited to roaches, ants, flies, andmice;

• Designated areas for smoking that are clearlymarked and limited to participants and staff.

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• Posted signs that prohibit smoking while oxygentherapy is being administered and clearlydesignated universal oxygen signs.

• Written policies and procedures to determine if orwhen participants may smoke without supervision.

• Written policies and procedures on the properstorage, handling, and disposal of all chemicals,compounds and biohazardous waste, includingMaterial Safety Data Sheets for any chemical,cleaning and medical supplies;

• Equipment stored in a manner to ensureparticipant’s safety at all times.

OTHER (SPECIFY)

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I. C.The PACE centermust includesufficient suitablespace andequipment toprovide primarymedical care andsuitable space forteam meetings,treatment,therapeuticrecreation,restorativetherapies,socialization,personal care,and dining.

Evidence of Adequate Space For:(Adequate space would be determined by the provisions, ifany, that are included in the PACE center Life SafetyCode building occupancy license)

• Team meetings

• Medical treatment and other care

• Therapeutic recreation

• Restorative therapies

• Socialization

• Personal care

• Dining

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Evidence of sufficient and maintained equipment for safelytransferring disabled participants on to exam tables andrestorative therapy treatment equipment, such as tubs,beds, etc.

OTHER (SPECIFY)

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I. D.The PACEorganization mustestablish,implement andmaintain a writtenplan to ensurethat all equipmentis maintained inaccordance withthemanufacturer’srecommendationsand keep all

A written maintenance plan that identifies the individualresponsible for the implementation and monitoring of theplan, what logs or records will be required, whatequipment is included, and the maintenance schedulesaccording to manufacturer’s recommendations.

A written plan and monitoring program to check allcontracts related to maintenance agreements.

Written plans and procedures to report device relateddeath and serious injuries to the FDA and/or themanufacturer of the equipment in accordance with theSafe Medical Devices Act of 1990.

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equipment(mechanical,electrical, andpatient care) freeof defect. Thisincludes anyequipment in thepatient’s home.

Evidence of manufacturer’s manuals for all equipment(mechanical, electrical, and patient care).

OTHER (SPECIFY)

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I.E.The PACE centermust meet theoccupancyprovisions of the2000 edition ofthe LSC for thetype of setting inwhich it is located

EVIDENCE OF COMPLIANCE WITH THE CURRENTEDITION OF THE NFPA 101 (2000) LIFE SAFETYCODES.

In addition have evidence of a:Fire Alarm System:• Initiation• Notification• Control

• Air Condition Shutdown• Automatic release of fire doors held open by

magnetic devicesStaff training and DrillsFire evacuation PlansFire Procedures

OTHER (SPECIFY)

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I.F.Establish,implement, andmaintaindocumentedprocedures tomanage medicaland nonmedicalemergencies anddisasters thatthreaten thehealth and safetyof participants,staff, or visitors.

I.G.PACEorganization musttrain all staff(employees andcontractors) onthe actionsnecessary toaddress differentmedical andnonmedicalemergencies.

Evidence of:• Written plan and procedures to manage medical

emergencies, including responding to DNRs, or anyother Advance directives; choking; chest pain;seizures; stopped breathing or cessation of heart;

• Written plan and procedures(s) for the periodicexamination of all emergency drugs to confirmexpiration date(s) and inventory control;

• Written plans and procedures for staff training onand drills for the center’s emergency procedures,including the use of emergency drugs andemergency equipment;

• At least one staff member during hours thecenter(s) have participant’s present will be trainedand certified in Basic Life Support (CPR).

• Verify that emergency drugs and emergencyequipment is readily available, operating, and cleanincluding:

o PORTABLE OXYGENo AIRWAYSo SUCTION EQUIPMENTo PHARMACEUTICALS APPROPRIATE TO

STABILIZE PARTICIPANTS.

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I.H.The PACE centermust haveemergencyequipment, alongwith staff whoknow how to usethe equipment atthe center at alltimes andimmediatelyavailable toadequatelysupportparticipants untilEmergencyMedicalAssistanceresponds to thecenter.

• Written plan and procedures to manage nonmedicalemergencies and any natural disasters affecting thecenter’s geographic location, including:

• Method of containment of fire;

• Evacuation plans and routes;

• Adequate emergency lighting at exits and corridors;

• Plans for power outages, problems with watersupply, and transfer of participants to other sitesthat meet their special needs;

• Periodic drills;

• Plan for assuring the health and safety ofparticipants at home to ensure their continuing careneeds will be met;

• Facility structure and characteristics that willaccommodate an expedient and safe evacuation ofstaff, participants, and visitors;

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OTHER (SPECIFY) � Other(Specify andAttach)

INFECTIONCONTROL(§460.74)

II.At a minimum,the PACE centermust have aninfection controlplan thatincludes:A. Proceduresto identify,investigate,

Written policies and procedures for the investigation,control, and prevention of infections including:

• A written OSHA Exposure Control Plan whichincludes the Universal Precautions and BloodbornePathogen exposure procedures for staff;

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control, andprevent infectionsin every centerand in eachparticipant’splace ofresidence;

B. Procedures torecord anyincidents ofinfection;

C. Procedures toanalyze theincidents ofinfection, toidentify trends,and developcorrective actionsrelated to thereduction offuture incidents.

• Vaccinating participants and staff against diseasesof particular concern for the PACE participant andthe center’s geographic location, i.e. influenza andpneumonia (are required minimally);

• Initial and ongoing health screening andvaccinations for staff and participants in accordancewith OSHA regulations (staff) and CDC guidelinesfor tuberculosis, Hepatitis B and othercommunicable diseases.

• Written plans and procedures for the investigation,evaluation, resolution, and reporting of allincidences of staff and participant infection.

• Written plans and procedures for maintainingrecords of staff and participant infections to includepost-exposure evaluation, training records, andparticipant and staff surveillance reports.

• Written plans and procedures for reporting requiredcommunicable diseases to the appropriate stateand local officials.

• Plans and procedures for staff providing direct careto patients with infection(s);

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• Provision of adequate facilities and suppliesnecessary for infection control to include:

• Hand washing facilities and supplies;

• Laundry facilities and supplies;

• Isolation facilities and supplies

• Written plans and procedures for addressing howlaundry will be handled. If the service is contractedout, written agreements to comply with therequirements.

• Written plans and procedures for the ongoingmonitoring of the contractual agreement provisionsfor laundry and waste disposal.

• Written plans and procedures for the appropriatehandling and disposal of all waste productsincluding blood and urine specimens for outside labtests and other biohazardous wastes.

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TransportationServices(§460.76)

III.The PACEorganizationshould takeappropriate stepsto ensure thatparticipants canbe safelytransported fromtheir homes tothe center and toappointments.A. Requirementsfor theorganization’stransportationprogram include:1. Maintenance

of transporta-tion vehiclesaccording tothe manu-

Evidence of appropriate state vehicle inspections.

If commercial vehicles (greater then 12 seats, usually) arebeing used, a commercial license is required by all drivers.

If the service is contracted out, written agreements tocomply with the contract requirements under §460.70.

Written plans and procedures for the ongoing monitoringof the contractual agreement provisions for transportationservices.

Evidence of the ability to provide adequate and safetransportation of center participants:

• Sufficient staff

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facturer’srecommenda-tions.

2. Transportationvehiclesequipped tocommunicatewith the PACEcenter.

3. Trainingtransportationpersonnel onthe specialneeds ofparticipantsandappropriateemergencyresponses.

4. As a part ofthe multi-disciplinaryprocess,communica-ting relevantchanges intheparticipant’scare plans totransportationpersonnel.

• Written policies and procedures for the training andmonitoring of drivers including:

• Proper transfer of nonambulatory andambulatory participants;

• Proper use of equipment needed to transfer andsecure participants;

• Emergency procedures during transfer,transport, and arrival of participants.

• Ability for communication between the driver andcenter during transportation activities.

• Evidence of written policies and procedures on themaintenance of vehicles utilized in the transport ofparticipants.

• Written plans and procedures for communicatingbetween the multidisciplinary team and thetransport staff the needs of the participants beingtransported.

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• Written plans and procedures for monitoring theperformance of all drivers.

• Written procedures to check or audit for thefollowing information on the drivers:• Current driver’s license• Record of any traffic violations or accidents that

may constitute a potential hazard for thetransport of participants.

OTHER (SPECIFY)

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Dietary Services(§460.78)

IV.PACE center isrequired toprovide food thatis nourishing,palatable, well-balanced, andmeets acceptablesafety standards:

Evidence of certification or licensure from state or localhealth agencies for the preparation and/or serving of food(including the last Department of Health Inspection).

Written policies and procedures that ensure the safeDelivery of food and nutritional supplements including:

• Safe procurement of food and nutritionalsupplements;

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A. Procure foodfrom sourcesapproved orconsideredsatisfactory byFederal, State,Tribal or localauthorities thathave jurisdictionover the servicearea;

B. Store,prepare,distribute, andserve food undersanitaryconditions;

C. Dispose ofgarbage andrefuse properly

• Safe storage of food and nutritional supplementsboth perishable and nonperishable to preventcontamination (at required temperatures – freezerbelow 0 degrees F or below and refrigerator 41degrees or below);

• Safe handling of food and nutritional supplements;

• Safe preparation of food and medication, includingpolicies for admixtures;

• Safe and adequate water supply;

• Safe and proper disposal of sewage;

• Provisions for substitute foods or nutritionalsupplements;

• Safe garbage storage and disposal;

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• Training of staff in safe food delivery; and

• Written policies and procedures for emergency foodsupplies and emergency nutritional supplements.

Written policies and procedures for dietitian, physician,and pharmacist involvement to determine the nutritionaladequacy of menus and the caloric and nutritional needsfor the participant population.

OTHER: List outside vendors/contracts:

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Bill of Rights(§460.110)V.The PACEorganization musthave writtenpolicies andimplementprocedures to

Written policies and procedures governing the participantBill of Rights including:

• The parameters on the use of physical or chemicalrestraints;

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ensure that theparticipant, his orherrepresentative,and staffunderstand theirrights.

• The reporting of mental or physical abuse orneglect.

Written policies and procedures for distributing the Bill ofRights to the participant and his or her representativeupon enrollment.

Written policies and procedures to ensure that theparticipant and his or her representative understand theirrights.

The participant Bill of Rights should be in English and anyother principal language of the community and bedisplayed in an area frequented by the public.Evidence of compliance with State requirement, if any, forspecific criteria of the principle language

The participant Bill of Rights should be in a large print forthe elderly to read.

Written policies and procedures to respond to andrectify a violation of a participant’s rights.

OTHER (SPECIFY)

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PersonnelQualifications(§460.64)

VI.The PACE centermust havequalified staff toprovide care to itsfrail elderlyparticipants.

Signed contracts for all contractors and contractedpersonnel by the time the PACE center becomesoperational.

Written position descriptions for all staff (employees andcontractors).

Evidence (by the State completion of the assurance page,in the application, for this element) that the requiredmembers of the multidisciplinary team (primary carephysician, registered nurse, social worker, recreationaltherapist or activities coordinator, PACE center manager,home care coordinator, and PACE center personal careattendants, drivers) are/will be employees or contractors ofthe PACE center.

Evidence that appropriate professionallicenses/certifications have been verified by primarysource (licensing/certification board) and backgroundchecks have been done on all staff – employees andcontractors (per state law requirements). If no directparticipant care employees are yet hired then this reviewwould entail the evidence of the procedures that will becompleted to comply with this area.

OTHER (SPECIFY)

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TRAINING ANDCOMPETENCY(§460.66 AND§460. 71)

VII.A. The PACEorganization mustprovide training tomaintain andimprove the skillsand knowledge ofeach staffmember withrespect to theindividual’sspecific dutiesthat results in hisor her continuedability todemonstrate theskills necessaryfor theperformance ofthe position.

B. The PACEorganization mustdevelop a trainingprogram for eachpersonal careattendant to

Written individual competency and training programs forall team positions, specific to each position that includes atleast the following:

• Competency program to ensure that each staffmember initially and ongoing demonstratescompetency in the skills needed to provideappropriate, culturally competent care toparticipants. The competency program mustinclude:

• Initial hires and ongoing skills demonstration;

• Skills demonstration method of evaluationbased on standard protocols;

• Competent evaluator (including peer evaluator);

• Skills that reflect scope of practice andappropriate for the PACE center, home settingand level of care.

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establish theindividual’scompetency infurnishingpersonal careservices andspecialized skillsassociated withspecific careneeds ofindividualparticipants.

• Training should be specific and within the scope ofpractice. To include at least the following:

• Training and demonstrated competency on thetransport of nonambulatory participants fordrivers and any other applicable staff;

• Training and demonstrated competency on allemergency equipment and all other equipmentnecessary for the performance of his or herspecific position;

• Training and demonstrated competency oncenter emergency procedures;

• Training and demonstrated competency onrestraint use;

• Training and demonstrated competency onparticipant rights, including dignity and privacy,to all participants;

• Training and demonstrated competency inresponse to participant grievances or centerquality improvement activities; and

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• Training and demonstrated competency intherapeutic communication specific to the PACEsetting and population.

Written training manual for personal care attendants toensure that they exhibit competency in basic skills forproviding personal care, including:

• How to maintain a clean, safe and healthyenvironment;

• Appropriate and safe techniques in personalhygiene and grooming;

• Safe transfer techniques and ambulation;

• Observation, reporting, and documentation ofpatient status and the care or service furnished.

• Training in therapeutic communication specific tothe PACE setting and population; and

• Other elements consistent with their assignedduties.

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GENERALPROVISIONS

VIII.Generalprovisions

Evidence of all current licensure required in the State:� ADHC� HH� Clinic� HMO� Ambulatory Care Center� Other - specify

Written plans and procedures regarding the safeguardingof participant data and records according to HIPAAcompliance for security (electronic and paper).

Written plans and procedures regarding the confidentialityand retention of participant health information.

Written plan and procedures for all participantreassessments which include periodic reassessments andreassessments at the participant or caregiver’s request.

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Verify the PACE organization’s actual service area.

Verify the process the PACE organization has in place toensure participant access to care 24 hours a day, 7 days aweek.

Verify that all required services will be provided by thePACE organization.

Evidence of a health information system to collect,analyze, and report participant data.

Identify any additional sites:

OTHER (SPECIFY)

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General SafetyRequirements

IX.Overall PACEcenter safetyrequirements

Evidence of state pharmacy licensure. � MET� NOT MET� N.A.

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Written plans and procedures for narcotic inventory controland disposal.

All Medications are locked in a cabinet, room or cart.

Written plans and procedures for refrigerator temperaturelogs used for medication and food storage.

Written plans and procedures for oxygen storage that is incompliance with fire safety and FDA laws.

Evidence of CLIA certification if the PACE center isperforming waived lab services on site or in the home, e.g.glucose meter testing, urine testing, fecal occult testing,blood testing, cholesterol screening, or hemoglobin orhematocrit testing.

OTHER (SPECIFY)

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This version completed October 28, 2003

Documents

READINESS REVIEW FINDINGS AND COMPLIANCE REPORT · readiness review findings and compliance report pace organization: date (s) of review: reviewer (s) – name, title and department: