PRINTED: 06/23/2015 DEPARTMENT OF HEALTH AND HUMAN … · Accredo HHA nurse to view the patient’s...

(X1) PROVIDER/SUPPLIER/CLIA

DEPARTMENT OF HEALTH AND HUMAN SERVICES

CENTERS FOR MEDICARE & MEDICAID SERVICES

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STATEMENT OF DEFICIENCIES

AND PLAN OF CORRECTION IDENTIFICATION NUMBER:

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NAME OF PROVIDER OR SUPPLIERSTREET ADDRESS, CITY, STATE, ZIP CODE

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SUMMARY STATEMENT OF DEFICIENCIES

(EACH DEFICIENCY MUST BE PRECEDED BY FULL

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IDPROVIDER'S PLAN OF CORRECTION

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DATECROSS-REFERENCED TO THE APPROPRIATE

INDIANAPOLIS, IN 46241

01/02/2015

ACCREDO HEALTH GROUP INC

2825 WEST PERIMETER RD STE 243

00

N 0000

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This visit was for an initial home health

agency state licensure survey.

Survey dates: 12-29, 12-30, and

12-31-2014 and 1-2-2015

Facility Number: 013547

Survey Team: Deborah Franco, RN,

PHNS

Census: 8 Active patients

2 Discharged patients

Sample : Record reviews with home

visit: 2

Record reviews without home

visit: 4

Total: 6

Quality Review: Joyce Elder, MSN,

BSN, RN

January 13, 2015

N 0000 N-0000There is no finding here.

410 IAC 17-12-1(a) N 0440

State Form

Any defiencystatement ending with an asterisk (*) denotes a deficency which the institution may be excused from correcting providing it is determined that

other safegaurds provide sufficient protection to the patients. (see instructions.) Except for nursing homes, the findings stated above are disclosable 90 days

following the date of survey whether or not a plan of correction is provided. For nursing homes, the above findings and plans of correction are disclosable 14

days following the date these documents are made available to the facility. If deficiencies are cited, an approved plan of correction is requisite to

continued program participation.

LABORATORY DIRECTOR'S OR PROVIDER/SUPPLIER REPRESENTATIVE'S SIGNATURE

_____________________________________________________________________________________________________Event ID: T22X11 Facility ID: 013547

TITLE

If continuation sheet of 83

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Home health agency

administration/management

Rule 12 Sec. 1(a) Organization, services

furnished, administrative control, and lines of

authority for the delegation of responsibility

down to the patient care level shall be:

(1) clearly set forth in writing; and

(2) readily identifiable.

Bldg. 00

Based on agency organizational chart

review and interview, the agency failed to

ensure the organization, administrative

control, and lines of authority down to

the patient level and the patient

populations served were clearly identified

on the organizational chart for 1 of 1

home health agency.

The findings include:

1. Administrative document dated

12-11-2014 titled "Accredo Indiana

Nursing Location", dated 12-11-2014,

bearing an Express Scripts logo in the

upper left hand corner, failed to evidence

the identification of Accredo Health

Group, Inc., seeking licensure in Indiana

as a home health agency, as the subject of

the chart. The document failed to

evidence all personnel participating in

developing the patients' medical plan of

care in that pharmacists employed by

Accredo Health Group, Inc., the national

corporation, but not employed by

Accredo Health Group, home health

N 0440 1. Accredo Health Group, Inc.

(Accredo), which is the entity to

whom the provisional license was

granted, is a national corporation

that operates both pharmacies

and home health agencies. From

a global perspective, Accredo is

owned by Accredo Health, Inc.

(AHI). AHI is a subsidiary of

Medco Health Solutions, Inc.

(Medco). Medco is a subsidiary

of Express Scripts Holding

Company (ESI). Accredo

provided an organizational chart,

as Exhibit A, with the initial

application that summarized this

global corporate structure.

During the survey, a simplified

organization chart was provided

to the surveyor and that simplified

chart was inaccurate in that it did

not fully reflect the scope of

services offered to our patients

and did not fully explain the

corporate structure referenced

above. As a result, we believe

that the chart that was provided to

the surveyor caused confusion.

We have updated the

organizational chart and a copy of

that updated chart is attached as

Exhibit A.With respect to

employees who are involved in

the patient’s medical plan of care,

02/12/2015 12:00:00AM

State Form Event ID: T22X11 Facility ID: 013547 If continuation sheet of 83




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agency, participate in developing each

patient's plan of care by entering the

patient medication profile in the

electronic clinical record plan of care.

The document also failed to evidence all

the patient populations served in that the

chart contained a rectangular box labeled

"Infusion Patient."

2. On 12-29-14 at 2:15 PM, the

Alternate Administrator and Nursing

Supervisor, Employee A, indicated the

organizational chart presented was for

Accredo Health Group, Inc, seeking

licensure in Indiana as a home health

agency, which is owned by Accredo

Health Group, Inc., a national

corporation, which is owned by Express

Scripts, a national corporation.

Employee A indicated the agency

provides nursing services for patients

receiving infusions, but also provides

nursing services for patients receiving

inhalation and oral medication under

their medical plans of care. Employee A

indicated pharmacists, not employed by

Accredo Health Group, Inc., home health

agency, and not identified on the

organizational chart, input the patient's

medication profile into each patient's

electronic plan of care. Employee A

indicated she develops each patient's plan

of care but administrative controls

preclude her from adding, deleting, or

the only employees who are

involved in the development of a

patient’s initial plan of care from a

Home Health Agency

perspective, i.e. the drafting of

HFCA Form 485/Form 487,

otherwise referred to as the

nursing Plan of Treatment (POT),

are those employees that are

assigned to a Home Health

Agency (HHA). In this case, the

only employees that participated

in creating/editing the nursing

POT for the patients of the

Indiana HHA were nurses

assigned to the Indiana HHA.

Pharmacists do not participate in

the nursing POT. We believe the

confusion was caused in this

case due to our unique business

model and as a result of a poor

explanation of the interaction of

our systems and employees.

Accredo HHA’s only offers their

services to patients of the

Accredo pharmacies and those

services are solely related to

patient care and training for

medications dispensed by the

Accredo pharmacies. As a result,

we operate under a

company-wide electronic medical

record system which permits an

Accredo HHA nurse to view the

patient’s profile (which includes

medications) in the pharmacy

system, when clinically

necessary. When a patient

enters service with our HHA, our

pharmacy has typically already

received a prescription from the

patient’s physician and that





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modifying any information which was

entered by Accredo Health Group, Inc.,

national corporation's pharmacists.

prescription has been added to

the patient’s profile in our

electronic medical record system,

such that our pharmacy can begin

processing the prescription. The

nurse assigned to the HHA can

access that medication

information when creating the

patient’s POT for purposes of the

HHA treatment/services. The

only individuals who are

responsible for entering patient

information directly related to

services performed by our HHA,

such as the POT or records

relating to nurse site visits, are

nurses assigned to our HHA.2.

Unfortunately, as set forth above,

we do not believe our business

model was adequately explained

to the surveyor. Accredo Health

Group, Inc., the national entity, is

the entity that applied for and was

granted a provisional license.

As correctly noted by Employee

A, nursing staff assigned to the

HHA are responsible for creating

a patient’s Plan of Treatment

(POT). However, with respect to

who may add, delete or modify

the POT, Employee A provided

incorrect information to the

surveyor. A nurse may add,

delete or modify any necessary

information pertinent to the HHA

in the patient’s electronic record,

including medication information.

Accredo has provided additional

education to Employee A

regarding this ability and this

training has been documented.

As a proactive measure, this





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training was also provided to all

nurses assigned to the Indiana

HHA and specific training

regarding the same will be

provided to all new nurses

assigned to the Indiana HHA in

the future. The Indiana HHA

administrator is and will be

responsible to ensure that this

training take place in the future

and the Indiana HHA nursing

supervisor will also audit the

electronic personnel records of all

newly assigned Indiana HHA

nurses two times a year for

compliance with these proactive

training measures for the next

two years.

410 IAC 17-12-1(a)

Home health agency


Rule 12 Sec. 1(a) Administrative and

supervisory responsibilities shall not be

delegated to another agency or organization,

and all services not furnished directly,

including services provided through a branch

office, shall be monitored and controlled by

the parent agency.

N 0441

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Based on clinical record review, review

of the electronic clinical documentation

system "Rx Home", personnel file

review, a corporate memorandum review,

policy review, and interview, the

administrator failed to ensure

administrative responsibilities were not

delegated / completed to another

organization in relation to the

development of patients' medication

N 0441 1. Unfortunately, as set forth in

response to N 440, with respect

to who may add, delete or modify

the patient’s Plan of Treatment

(POT), Employee A provided

incorrect information to the

surveyor. By way of background,

due to our unique business model

and because we receive

prescriptions from prescribers for

medications that are directly

related to our HHA services, an

Accredo employee (such as a

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profile in the medical plan of care for 6

of 6 clinical records reviewed (1, 2, 3, 4,

5 and 6), criminal background checks of

its employees for 2 of 2 direct care

providers (Employees A and B), and

budgeting and accounting systems for 1

of 1 agency.


1. Clinical record #1, start of care (SOC)

12-23-14, diagnoses of other chronic

pulmonary heart disease, portal

hypertension, and pulmonary

hypertension included a plan of care for

certification period 12-23-14 to 2-20-15

that failed to include medications taken

by the patient as reported during nursing

visit of 12-23-14 of Synthroid 0.124 mg

by mouth daily and Pramipexole Di-Hcl

0.5 mg by mouth twice a day which were

not new medications for the patient. The

nurse signed the verbal order for start of

care and faxed the plan of care as it

printed from the Rx Home computer

program, without the corrections to the

medications, and also sent a fax to the

physician with an order for the Synthroid

and Pramipexole to update the

medications.

Employee A indicated during interview

on 12-31-14 at 2:30 PM that the Rx

Home program had patient #1's

pharmacist or pharmacy

technician) enters medication(s)

into the company wide computer

system upon the receipt of a

prescription from the prescriber

but that medication is not entered

into the POT by non HHA

personnel. Rather, a nurse

assigned to the Accredo HHA is

able to extract the patient’s

medication profile from the

computer system into the POT

and the HHA nurse then has the

ability to edit the medication

section on the POT, if necessary.

Accredo has provided additional

education to Employee A

regarding this ability and this

training has been documented.



















two years.2., 3., 4., 5., 6. Please

see above.7.Please see above.

In addition, while it is accurate

that once the Accredo HHA

submits a Plan of Treatment





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medications already entered into the plan

of care by a corporate pharmacist prior to

SOC date and Employee A was

precluded from adding, deleting, or

modifying in any way the medications on

the plan of care to initiate an accurate and

complete plan of care for submission to

the attending physician for authorization.

2. Clinical record #2, SOC 11-18-14,

diagnosis of myasthenia gravis, included

a plan of care for certification period

11-18-14 to 1-16-15 which contained a

medication profile with the patient's

medications.


on 12-31-14 at 2:30 PM a corporate

pharmacist entered patient #2's

medications into the agency plan of care.


diagnosis of primary pulmonary

hypertension, included a plan of care for


which contained a medication profile

with the patient's medications.






(POT) to a physician for signature

it may take that physician some

period of time to sign and return

the POT, that timing is outside the

direct control of Accredo. As a

result, Accredo has an internal

monitoring process that it uses to

ensure the timely receipt of a fully

executed POT from a physician’s

office. Also, nurses can print a

patient’s electronic clinical

record. Because Accredo

operates within an electronic

record system, Accredo HHA

nurses do not routinely have a

need to print paper copies of a

patient’s clinical record. Training

was provided to all nurses

assigned to the Indiana HHA

regarding a nurse’s ability to print

a patient’s clinical record and

specific training regarding the

same will be provided to all new


HHA in the future. The Indiana

HHA administrator is and will be



for all newly assigned nurses and

the Indiana HHA nursing







two years. 8. This is a true

statement and we do not believe

that this is a violation of Indiana

HHA regulations. The only

healthcare providers who are

responsible for entering patient





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diagnosis of alpha 1 anti-trypsin

deficiency, included a plan of care for









diagnosis of primary pulmonary










diagnosis of pulmonary hypertension,

included a plan of care for certification

period 11-14-14 to 1-12-15 which

contained a medication profile with the

patient's medications that included

Ferrous sulfate 325 mg tablet, by mouth

as directed.



information directly related to

services performed by our HHAs,

such as the Plan of Treatment

(POT) or records relating to nurse

site visits, are nurses assigned to

an HHA. Because Accredo (as a

company) operates both

pharmacies and HHAs, a variety

of healthcare professionals will

input pertinent information, both

clinical and non-clinical, into a

patient’s profile. Various

employees of Accredo have

appropriate levels of access to a

patient’s electronic record and

can make entries into the

patient’s record, in accordance

with their role in the patient’s

care. Accredo’s computer

system is accessed by

employees with unique

usernames and password

protection. In addition, Access to

patient information is logged and

employee access is in

compliance with applicable

HIPAA regulations. 9. Criminal

background checks are

conducted on all employees as

part of the on-boarding process at

the time of hire. This policy is set

by the parent company, ESI, and

is applicable to Accredo. A copy

of the Express Scripts “Hiring and

Recruiting Policy“ is attached as

Exhibit B. A copy of Accredo

policy “10-2 Location Specific

Personnel Record Content” is

also being provided and is

attached as Exhibit C. Criminal

background checks were

completed for Employees A, D,





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medications into the agency plan of care

and there was no frequency included on

the Ferrous sulfate medication order. She

indicated "as directed" is not a complete

medication order because it lacks a

frequency, but Employee A was




complete plan of care prior to submission

to the attending physician for

authorization.

7. On 12-29-14 at 2:00 PM, Employee

A, the alternate administrator indicated

the agency's patients' clinical record is

created and maintained in an electronic

system "Rx Home" which is integrated

into Accredo Health Group, Inc., national

electronic patient record. She indicated

the agency registered nurse develops the

plan of care for each part of the patient's

medical plan of care except field #10,

medications. At start of care, the

registered nurse completes an assessment

and compares the medication profile

obtained with the medications already

entered into the electronic plan of care by

a pharmacist employed by Accredo

Health Group, Inc, the corporation.

When the registered nurse detects

medication discrepancies, the registered

nurse cannot amend the medication

and E and a copy of these

background checks were

submitted to the Indiana

Department of Health with the

initial application for licensure.

However, a copy of those

background checks was not in

the individual employee’s

electronic personnel file at the

time of the survey. Since the

survey was completed, a copy of

these background checks has

been placed in the Accredo

electronic personnel records for

these employees. Accredo will

continue to ensure that criminal

background checks are

conducted on all newly assigned

Indiana HHA nurses. The Indiana



background check is completed

for all newly assigned HHA

nurses and also that a copy has

been added to the nurse’s

electronic personnel file. The

Indiana HHA nursing supervisor

will also audit the electronic

personnel records of all newly

assigned Indiana HHA nurses

three times a year for compliance

for the next two years. Also,

please see response to N 444.10.

This is an accurate statement and

we do not believe it is a violation

of Indiana regulations. Budgeting

and accounting functions were

implemented for the Indiana HHA

and in place at the time of the

survey. These functions are

performed by Accredo, the

licensed entity, and were not





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profile in the electronic system prior to

printing and sending the plan of care to


The registered nurse then documents the

necessary revisions to the medication

profile and faxes to the attending

physician for an order to modify the plan

of care. Employee A indicated it may

take days or weeks before the signed plan

of care and order to amend the

medication profile are received back from

the attending physician. Employee A

stated the registered nurse is precluded by

Accredo Health Group, Inc, the national

corporation and by administrative

computer program controls from

submitting a complete, correct, and

accurate medication profile to the

attending physician at the start of care.

When queried if the agency could print a

copy of any of its patients' clinical record,

Employee A indicated she could not do

so because the agency clinical record is

integrated into a corporate national

program, Rx Home, which includes this

agency's and all Accredo Health Group,

Inc., the national corporation's, patients

from other states.

8. Review of a policy titled "Clinical

Record Contents", with "Accredo Health

Group, Inc., An Express Scripts

Company" printed on the policy, last

reviewed by Accredo Health Group, Inc.,

delegated to another

organization. In addition, the

HHA’s budget is approved by the

Governing Body. Accounting and

budgeting information related to

the Indiana HHA can be produced

and should have been provided.

In addition, we also believe that

we meet the intent of the

regulation. Because we are a

nationwide company, a dedicated

finance team comprised of

individuals with specific

education, training and

experience in finance/accounting

assist with budgeting and

accounting functions. We believe

that this complies with the intent

of the regulation, given that

individuals employed by the

licensed entity, with more

specialized experience than a

typical HHA administrator would

have, are assisting with the

process and also because the

Governing Body approves the

annual budget.

We understand the importance of

budgeting and accounting

functions and how without such

functions a healthcare provider’s

ability to continue to provide care

may be questionable. Because

we are a national corporation and

have dedicated accounting and

finance teams, we believe that we

are able to better ensure

continuity of care to patient

populations that are unique and

small. For example, in this case,

we were able to open an HHA





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the national corporation 7-2014, states

"Clinicians, the physician, and

appropriate business contractor staff will

make entries to the patient record.

Professional staff (RN (registered nurse),

LPN/LVN (licensed practical / vocational

nurse), RD (registered dietician),

pharmacist, and any business contractor

staff will make entries in the patient

clinical record to provide permanent and

continuous records of observations,

interventions, and outcomes."

9. Review of personnel files of

registered nurses identified by the agency

as employees failed to evidence a copy of

a criminal background check as required

by IC 16-27-2 within 3 days of providing

patient care for 2 of 2 registered nurses

who provided direct patient care,

Employees A and B. Any agency

policies regarding hiring procedures,

employment procedures, and required

content of agency personnel files to

include criminal background check for

direct care providers were requested.

Employee A, the alternate administrator /

nursing supervisor, was unable to provide

copies of the agency employees' criminal

background checks. She indicated

criminal background checks were not

stored in the agency electronic personnel

file in "Work Place" program, but were

under the control of the human resources

and provide specialty infusion

services to an Indiana patient

population that was as small as

ten (10) patients.

Finally, to prevent a recurrence of

the surveyor being provided

insufficient information relating to

our budgeting and accounting

implementation, training will be

provided to all supervisory

personnel assigned to the Indiana

HHA. The Indiana HHA



training take place and the



personnel records within the next

three months to ensure

compliance with this proactive

training measure.

11. Please see above.






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department of Accredo Health Group,

Inc, the national corporation. Employee

D indicated on 1-2-14 at 2:00 PM that

Accredo Health Group, Inc, the national

corporation, has an "Onboarding" policy /

procedure which addresses the above, but

this was not produced after request.

10. During entrance conference on

12-29-14, concluding at 2:30 PM, a

written request was made for the

accounting and budgeting systems

implemented by the administrator.

Employee A, the alternate

administrator/nursing supervisor,

indicated the agency did not have

anything to produce as all of these

functions were administered by Accredo

Health Group, the national corporation.

Employee D, the alternate director of

nursing, indicated agency personnel did

not have any role in the accounting and

budgeting or billing.

11. During telephone interview with

Employee E, the administrator, on

12-31-14 at 3:00 PM, she indicated the

agency did not have its own accounting

and budgeting system but Accredo Health

Group, Inc., the corporation, does all

accounting, budgeting, and billing for the

agency.

12. Review of an undated and unsigned





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document titled "Nursing Budget:

Indianapolis 2014-2015" states, "Accredo

has a dedicated finance team responsible

for monitoring and recording all

financials associated with the nursing

operations within Accredo and specific to

Indianapolis." On 12-31-14 at 4:30 PM,

Employee A indicated the sentence in

quotations referred to Accredo Health

Group, Inc, the corporation, and she did

not believe anyone at the agency had

access to this data.

410 IAC 17-12-1(b)

Home health agency


Rule 12 Sec. 1(b) A governing body, or

designated person(s) so functioning, shall

assume full legal authority and responsibility

for the operation of the home health agency.

The governing body shall do the following:

(1) Appoint a qualified administrator.

(2) Adopt and periodically review written

bylaws or an acceptable equivalent.

(3) Oversee the management and fiscal

affairs of the home health agency.

N 0442

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Based on power point slides and

memorandum review and interview, the

agency failed to ensure governing body

meeting minutes were provided to

evidence the governing body appointed

an administrator and adopted agency

bylaws for 1 of 1 agency.

N 0442 1. Accredo acknowledges and

admits that there was an

inappropriate delay in providing

the Governing Body meeting

minutes to the surveyor. A copy

of the Accredo annual Governing

Body meeting minutes was not

provided to the surveyor until

January 2, 2014, prior to the

closing call. A copy of the

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1. On 12-29-2014, at 2:30 PM, a written

request for all governing body meeting

minutes relative to the Accredo Health

Group home health agency was made.

2. Employee A, the alternate

administrator / nursing supervisor,

indicated on 12-30-14 at 4:00 PM the

home health agency fell under the

authority of the Accredo Health Group,

Inc., the national corporation, had the

same governing body, followed the same

policies and bylaws as the national

corporation and all of its owned home

health agencies, estimated to be

thirty-three (33). Employee E indicated

awareness of only one (1) Accredo

Health Group, Inc, corporate governing

body meeting in 2014 on 12-17- 2014.

All governing body meeting dates and

minutes from any and all governing body

meetings were again requested to

evidence the appointment of an agency

administrator and adoption of agency

bylaws. A print out of power point slides

from 12-17-14 titled "Annual Governing

Body Meeting" was presented. This

document of power point slides failed to

identify which of the people attending

were members of the governing body,

and failed to evidence governing body

Governing Body meeting minutes

is attached as Exhibit D.

Moving forward, to prevent a

recurrence of this delay, Accredo

will ensure that a paper copy of

the Governing Body meeting

minutes are maintained at the

Indiana HHA such that they can

be produced immediately upon

request.

The Indiana HHA administrator is

and will be responsible to ensure

that a paper copy of the

Governing Body meeting minutes

is maintained at the Indiana HHA

and the administrator will also

audit the binder three times a

year for compliance to ensure

that it is up to date for the next

two years.


The surveyor was provided a list

of the Governing Body members

who attended the December 17,

2014 annual meeting. Accredo is

also providing a list of the

Governing Body members who

attended the annual meeting on

December 17, 2014, along with

their corporate addresses. This

list is attached as Exhibit E.


4. Please see above. For

clarification, the policy number

referenced in the above

paragraph should be listed as

Practice Standard 28-01-06. A

copy of that Practice Standard,

for ease of reference, is attached

as Exhibit F.





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meeting minutes in which an

administrator was appointed for Accredo

Health Group home health agency

Indiana or adoption of Accredo Health

Group home health agency Indiana

bylaws by a quorum of governing body

members.

3. On 12-31-14 meeting minutes of the

governing body were requested again and

the agency presented a memorandum,

undated, signed by an Accredo Health

Group corporation employee, stating it

was an "acknowledgement and

recognition" of the governing board

naming Employee E administrator for the

agency, Employee A as alternate

administrator and nursing supervisor, and

Employee D as alternate nursing

supervisor effective 7-21-14. No other

documentation demonstrating compliance

was provided.

4. A corporate policy # 21-01-06, created

7-3-13 and revised 12-29-14, of Accredo

Health Group, Inc., states, "This

Governing Body shall cause minutes of

each meeting of this Governing Body and

Committee meetings to be be maintained

... a majority of the members of the

governing body shall constitute a quorum

for for conducting business at any

meeting thereof. The vote of a majority

of members of the governing body shall





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be required to approve any action of the

governing body ... the governing body

may fulfill its obligations hereunder by

having one or more members of this

governing body meet with the

management staff of the organization

charged with day to day operations,

provided that minutes are recorded at

such meetings and the governing body

itself subsequently reviews and approves

such minutes."

410 IAC 17-12-1(c)(1)

Home health agency


Rule 12 Sec. 1(c) An individual need not be

a home health agency employee or be

present full time at the home health agency

in order to qualify as its administrator. The

administrator, who may also be the

supervising physician or registered nurse

required by subsection (d), shall do the

following:

(1) Organize and direct the home health

agency's ongoing functions.

N 0444

Bldg. 00

Based on observation and interview, the

administrator failed to organize and

direct the home health agency's ongoing

functions to include providing staff

sufficient to cover the hours of operation,

provision for a method of tracking at the

agency level the activity of the agency in

relation to ability to generate lists of

active and discharged patients and reason

for discharge, provision for orientation of

N 0444 Accredo recognizes and

apologizes for the fact that the

surveyor was provided, at times,

inaccurate and insufficient

information such that it could be

accurately demonstrated that

Accredo was operating in

compliance with Indiana

regulations. Since the survey,

we have provided additional

training to all employees assigned

to the Indiana HHA, including the

current administrator. The

contents of that training are set

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agency staff (Employee B), provision to

ensure the personnel record of the

nursing supervisor was current and

included a criminal background check

(Employee A), provision for agency

employment / hiring policies to include

the contents of the personnel record and

requirement of a copy of a criminal

background check in accordance with IC

16-27-2 for direct care staff, provision for

the treatment of health records of agency

direct care staff health as confidential,

and provision for the administrator's

presence at the agency for any part of the

initial licensure survey conducted the day

before expiration of the agency's

provisional license for 1 of 1 agency.

The findings included:

1. Indiana State Department of Health

(ISDH) documents completed with data

provided by the agency, state the hours of

operation of Accredo Health Group, Inc.

at 2825 W. Perimeter Rd, Indianapolis

IN, are 8:30 AM to 5:00 PM Monday

through Friday.

A. On 12-29-14 at 10:30 AM, the

surveyor arrived at the address provided

by the agency at 10:30 AM to conduct the

initial state licensure survey. No agency

employees were present.

forth throughout this response. In

addition, we have identified

opportunities of more efficient

means of capturing and storing

documentation such that it may

be produced to the surveyor in a

timely and organized manner.

Finally, if permitted to continue

operations, Accredo will appoint a

full time administrator who is

located on-site at the Indianapolis

HHA. Please see below

responses to address specific

noted deficiencies.

1.A. Accredo HHA nurses are

typically performing patient visits

between the hours of 8:30 a.m.

and 5:00 p.m., in accordance with

the stated hours of operation.

We apologize for the delay in an

employee responding to the HHA

office for the surveyor to

commence the survey. However,

we do not believe that the

regulations require that a nurse

be physically present at the HHA

during the provided hours of

operation. As set forth below, in

response to N 447, the

Indianapolis Accredo HHA has a

toll free phone number that phone

is designed to route to

appropriate personnel if an

employee is not physically in the

office. Unfortunately, as set forth

below in response to N 447, due

to a technical error with the

telephone company, the call

routing was not working

appropriately. We are working

with the telephone company to

ensure that this issue has been





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B. On 12-29-14 at 1:15 PM,


nursing supervisor, arrived at the agency

and stated the agency has no clerical

staff, that she is the only local employee,

and the agency does not have a provision

to staff during hours of operation if

Employee A is out of the office to see

patients or for any other reason.

2. On 12-31-14 at 2:30 PM, Employee A

indicated the agency's clinical records are

integrated into Accredo Health Group,

Inc., national corporate record system, Rx

Home. Lists of agency patients - active

or discharged, reason for discharge, or

any agency reports could not be extracted

or isolated to provide reports on this

agency's patients or agency business such

as list of employees including date of

hire.

3. The personnel file of Employee B, no

determinable hire date with this agency,

date of first patient contact of 11-21-14

for patient #6, failed to evidence an

expanded criminal background check in

accordance with IC 16-27-2 which was

required because the employee resides in

Kentucky, and failed to evidence any type

of orientation to the position of staff

registered nurse for this Indiana home

health agency.

corrected. Also, if the

Department of Health wishes, we

will provide direct contact

numbers for our Indiana

Administrator and Alternate

Administrator.

Because of the small number of

patients that we were servicing at

the time of the survey, the only

full time on-site nurse assigned to

the Indiana Accredo HHA was the

alternate administrator/nursing

supervisor (Employee A), who

was frequently out seeing

patients, but was available for

calls on her phone.

As indicated above in response to

N 440, Accredo only offers its

HHA services to patients that

receive prescriptions from the

Accredo pharmacy. Due to our

unique service offerings, the

Indiana Accredo HHA is

physically located within a

secured building that also houses

other Accredo functions, including

an Accredo pharmacy. Security

staff manages the traffic in and

out of the building. The security

team was informed that a survey

was expected. The security staff

will be trained on the urgency of

contacting the appropriate

individuals when a representative

from the State of Indiana arrives.

With respect to timing relating to

this survey, Employee E, who

was the administrator, spoke with

the surveyor and alerted her that

she was out-of-state at the time

and that the only other full time

employee assigned to the Indiana





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4. The personnel file for the nursing

supervisor/alternate administrator,

Employee A, hire date 5-5-14, failed to

evidence a copy of a proper criminal

background check from the Indiana State

Police Repository as required by IC

16-27-2 within 3 days of services.

5. On 12-31-14 at 2:30 PM, during phone

interview, Employee E indicated her

duties as administrator could be

accomplished by almost daily telephone

calls with the nursing supervisor /

alternate administrator (Employee A) and

receipt of weekly reports. Employee E

indicated she was in Detroit, Michigan

and would not attend any portion of the

initial licensing survey. She was aware

the agency's provisional license was due

to expire 12-30-14, had contacted the

corporation's legal department to inquire

what would happen if the initial licensure

survey did not occur by 12-30-14, and on

1-2-15 at 2:00 PM indicated she had not

been to the agency in October,

November, or December 2014 (the dates

of the provisional license).

HHA was seeing a patient at the

time. Employee E immediately

contacted the Alternate

Administrator (Employee A), who

was seeing a patient, and

indicated that she would complete

the patient visit and return to the

office by 1:30 p.m. This

information was communicated to

the surveyor by Employee E.

Employee A, the alternate

administrator arrived at the office

at approximately 1:15 p.m.

B. This is correct. Please see

above.

2.Although the regulations do not

specifically state that a list of

agency patients or employees

and the details set forth above

must be maintained in a

consolidated report format,

Accredo recognizes that this

information is typically requested

by the Indiana Department of

Health during a survey.

Unfortunately, Employee A did

not appreciate that a patient

census could be provided and, as

a result, we do not believe the

surveyor was provided sufficient

information to determine

compliance. Accredo has

provided additional education to

Employee A regarding the ability

to produce reports containing

pertinent patient information and

this training has been

documented.









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two years.

As to the individual employee’s

specific date of hire, this

information will be captured in the

employee’s electronic personnel

file. The Indiana HHA



date is captured for all newly

assigned HHA nurses and also

that a copy has been added to the

nurse’s electronic personnel file.

The Indiana HHA nursing




nurses three times a year for

compliance for the next two

years.

3.

As set forth in response to N 441,

criminal background checks are

completed at the time a new

employee is hired. At the time of

the survey, a copy of employee

B’s background check was not in

her electronic personnel file.

Since the survey, the background





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check that was completed at the

time of Employee B’s hire has

been placed in her electronic

personnel file.

To be transparent, that

background check was not

completed by the Indiana State

Police (because the nurse was

originally assigned to a different

state). As a result, Accredo has

also requested an expanded

criminal background check from

the Indiana State Police

according to IC 16-27-2.

Further, as a proactive measure,

the Indiana HHA administrator is


that a background check that is

performed by the Indiana State

Police is completed for all new

assigned HHA nurses and also

that a copy has been added to the

nurse’s electronic personnel file.

The Indiana HHA nursing




nurses three times a year for

compliance for the next two

years.

As indicated above, Accredo will

also ensure that the nurse’s date

of hire is captured in the

employee’s electronic personnel

file, along with the date the nurse

was assigned to see seeing

patients in connection with the

Indiana HHA.

4. Please see above. In addition,





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an Indiana State Police limited

criminal background check was

completed for Employee A during

Accredo’s application for

licensure. The report was

submitted with the licensure

application.

At the time of the survey, a copy

of the report from the Indiana

State Police background check

was not in the electronic

personnel file of the nurse. Since

the survey, a copy of that report

has been placed in Employee A’s

electronic personnel file.

5. As set forth above, to provide

additional direct oversight of any

future ongoing activities, if

permitted to continue operations,

Accredo will appoint a full time

administrator who is located

on-site.

410 IAC 17-12-1(c)(2)

Home health agency


Rule 12 Sec. 1(c)(2) The administrator, who

may also be the supervising physician or

registered nurse required by subsection (d),

shall do the following:

(2) Maintain ongoing liaison among the

governing body and the staff.

N 0445

Bldg. 00

Based on observation, interview, and

review of agency policy, the

administrator failed to ensure revised

policies were provided to the agency

timely l for 1 of 1 agency.

N 0445 1. A copy of Practice Standard

27.06.03 Patient

Inactivation/Discharge was

provided to the surveyor.

However, the copy initially

provided was an old version,

dated 5/22/2012. When it

became apparent that the old

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1. On 12-29-14 at 2:30 PM, a written

request was made to include providing a

copy of agency policy for discharging

patients.

2. On 12-30-14, Employee D provided a

copy of a policy "Patient Inactivation /

Discharge" last revised 5-22-12.

3. During the exit conference on 1-2-15,

beginning at 4:35 PM, Employee E, the

administrator, who participated by

telephone conference, indicated a revised

discharge policy had been emailed to the

alternate administrator 2 days ago.

Employee A indicated she was not aware

the policy had been revised and sent to

her, but months ago she had requested

changes in the policy to bring the agency

into compliance.

4. The policy "Patient Inactivation /

Discharge" indicates the policy was

revised on 10-16-14, but was not

provided to the agency prior to the initial

licensure survey was not received by by


nursing supervisor until 1-2-15.

version had been provided, a

current version, dated

10/16/2014, was promptly

provided to the surveyor. For

ease of reference, a copy of

Practice Standard 27.06.03

Patient Inactivation/Discharge is

attached as Exhibit G.

We believe the old version of the

policy was provided in error due

to the employee not accessing

the Accredo policies that are

maintained electronically but

rather providing a paper copy that

the employee had printed for her

own use previously. Because we

are a nationwide company, to

ensure that all employees have

access to updated policies,

Accredo policies are maintained

electronically and our employees

are instructed to access all

policies electronically.

Moving forward, to prevent a

recurrence of this issue, Accredo

has provided additional training to

all employees assigned to the

Indiana HHA regarding accessing

the current version of all Accredo

policies electronically and specific

training regarding the same will

be provided to all new nurses





training takes place and the



personnel records of all newly

assigned Indiana HHA nurses two

times a year for compliance with





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these proactive training measures

for the next two years.

2., 3., 4. Please see above.

410 IAC 17-12-1(c)(3)

Home health agency


Rule 12 410 IAC 17-12-1(c)(3)

Sec. 1(c)(3) The administrator, who may

also be the supervising physician or



(3) Employ qualified personnel and ensure

adequate staff education and evaluations.

N 0446

Bldg. 00

Based on observation, review of

personnel files, and interview, the

administrator failed to employ sufficient

qualified staff to meet the hours of

operations of the agency for 1 of 1

agency and failed to ensure adequate staff

education for 1 of 1 staff nurses

(Employee B) and for 1 of 1 alternate

nursing supervisor (Employee D).



(ISDH) documents completed with data

provided by the agency state the hours of

N 0446 1., 2., 3. Please see response to

N 444.4.Although the regulations

do not specifically state that

orientation is a required element

of an employee’s hiring process,

Accredo now understands that

this information is requested by

the Indiana Department of Health

during a survey. All employees

complete orientation at the time

of hire. Employee D has been a

nurse with Accredo since 1997.

A copy of Employee D’s resume

was provided as part of the

licensure application. For ease of

reference a copy of Employee D’s

resume is attached as Exhibit H.

Employee B has been a nurse

with Accredo since 2008.

Because these nurses has been

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at 2825 W. Perimeter Rd, Indianapolis,

IN, are 8:30 AM to 5:00 PM Monday

through Friday.

On December 29, 2014, at 10:30 AM,

the surveyor arrived at the address

provided by the agency at 10:30 AM to

conduct the initial state licensure survey.

No agency employees were present.

2. When Employee E, the administrator,

was reached by phone at 11:35 AM,

Employee E indicated she was in Detroit,

Michigan, on other corporation duties

and would not attend the survey.

Employee E indicated no provision was

made for staff to be at the agency during

hours of operation because the sole

employee of the agency in Indianapolis is

a registered nurse (nursing supervisor)

who provides patient care (Employee A).

She indicated other employees may be

hired in the future but it was not cost

effective to have staff present during

hours of operation at this time.

3. At 1:15 PM, Employee A, the

alternate administrator / nursing

supervisor, arrived at the agency and

stated the agency has no clerical staff,

that she is the only local employee, and

the agency does not have a provision to

staff during hours of operation if

employees of Accredo for years

before being assigned to the

Indiana HHA, there was not a

need to perform another

orientation with respect to their

duties relating to patient care. All

newly hired employees will

continue to complete the existing

orientation process. In addition to

the existing process, in an effort

to address any Indiana specific

concerns, Accredo will add a

specific segment to orientation for

any employee’s that are assigned

to the Indiana HHA that directly

pertains to Indiana’s home health

regulations. New employee’s

completion of orientation will be

documented and that

documentation will be placed in

the nurse’s electronic personnel

file. The Indiana HHA











two years.5. Please see response

to N 444.6. Employee D has

acknowledged this error and this

error was not intentional.

Employee D is the alternate

nursing supervisor. Employee D

is not the alternate administrator.

Verbal coaching was provided to

Employee D to reinforce the

importance of accurate





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patients or for any other reason. On

1-2-15 at 10:00 AM, Employee A

indicated she is in the office on average

20 hours a week.

4. The personnel records of Employee B

(direct care staff nurse), and Employee D

(alternate nursing supervisor) failed to

evidence documentation of any

orientation to their respective positions

with the agency.

5. On 12-30-14 at 4:00 PM, Employee D

verified the above findings regarding

Employee B and herself, Employee D.

6. On 1-2-15 at 11:30 AM, Employee D,

the alternate nursing supervisor, provided

a hand written list of agency employees

in which she identified herself as

alternate administrator of the agency and

at 4:35 PM Employee D signed the exit

conference attendance record and

identified her position as alternate

administrator.

communication regarding her

title.

Based on review of Indiana State

Department of Health (ISDH)

documents, observation, and

interview, the administrator failed

to ensure the accuracy of the

hours of operation and agency

telephone number for 1 of 1

agency.

410 IAC 17-12-1(c)(4)

Home health agency


Rule 12 Sec. 1(c)(4) The administrator,

who may also be the supervising physician

or registered nurse required by subsection

N 0447

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(d), shall do the following:

(4) Ensure the accuracy of public

information materials and activities.

Based on review of Indiana State

Department of Health (ISDH) documents,

observation, and interview, the

administrator failed to ensure the

accuracy of the hours of operation and

agency telephone number for 1 of 1

agency.


1. ISDH documents completed with data

provided by the agency state the hours of


are 8:30 AM to 5:00 PM Monday

through Friday and the phone number of

the agency is (888) 289-2978.

2. On December 29, 2014, at 10:30 AM,

the surveyor arrived at the address

provided by the agency at 10:30 AM to

conduct the initial state licensure survey.

No one was present.

3. The building is a secured facility.

Person AA, a security agent at the front

entrance, was not aware a home health

agency was housed in the building. AA

could not reach agency personnel using

the phone number provided (888)

289-2978 and did not have any further

contact information for the administrator,

N 0447 1. With respect to the hours of

operation, please see response to

N 444. The provided phone

number was accurate and was

functioning at the time of the

survey and during the entire time

that Accredo was operating under

the provisional license. However,

as set for the below, at the time of

the survey, call forwarding was

not functioning properly.2., 3.

Please see response to N 04444.

Please see above.

Due to a technical error within the

phone companies system, if the

call was not answered in the

office, routing of the phone to

offsite contacts was not

functioning properly. Accredo is

working with the telephone

company to ensure that this issue

has been corrected and we will

periodically internally test the

system to ensure proper routing

is completed and that the system

is working as intended.

5., 6., 7. Please see response to

N 0444

8. Employee D is the alternate

nursing supervisor for the Indiana

HHA. Due to the limited number

of patients that were on service

with the Indiana HHA, Employee

D was also assigned to the

Accredo Nursing location in

Louisville, Kentucky. The

frequency of her visits to the

Indianapolis HHA would vary

based on administrative needs

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alternate administrator, nursing

supervisor, or alternate nursing

supervisor when the surveyor provided

the names to person AA.

4. The surveyor attempted to reach the

agency at (888) 289-2978 at 10:45,

11:00, and 11:15 AM. The number did

not provide for the opportunity to leave a

voice message or be transferred for

assistance. A recorded message stated,

"You have reached the Accredo Indiana

nursing office, if you know your party's

extension, please enter it now, if not,

please hold for the next available team

member." The phone rang for 2 minutes

without anyone answering.

5. An employee of Accredo Health

Group, Inc., the corporation, rather than

Accredo Health Group, the home health

agency, person BB, approached the

surveyor at 11:18 AM and indicated

no-one from the home health agency was

present nor was anyone from the agency

expected. Person BB provided a phone

number for the named agency

administrator, Employee E.

6. When Employee E, the administrator,

was reached by phone at 11:35 AM,

Employee E indicated she was aware the

provisional license of the agency expired

the next day on December 30, 2014, and

and also the scheduling of

Indiana patient visits.





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the initial licensure survey was due today

or tomorrow, but was in Detroit,

Michigan, on other corporation duties

and would not attend the survey.

Employee E indicated no provision was

made for staff to be at the agency during

hours of operation in general nor for the

anticipated licensure survey due today or

tomorrow. Employee E indicated she had

contacted the alternate administrator /

nursing supervisor, Employee A, and the

alternate nursing supervisor, Employee

D, who would arrive in approximately 90

minutes.



supervisor, arrived at the agency and

stated the agency had no clerical staff,

that she is the only local employee, and

the agency does not have a provision to

staff during hours of operation if


patients or for any other reason.

Employee A could not explain how an

incorrect phone number for the agency

was provided to ISDH.

8. At 2:30 PM, Employee D, the

alternate nursing supervisor, arrived from

Louisville and indicated she was a

nursing supervisor for Accredo Health

Group, Inc., the national corporation, in

Louisville, and comes to the Indiana





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Accredo Health Group home health

agency about one day a month.

410 IAC 17-12-1(c)(5)

Home health agency


Rule 12 Sec. 1(c)(5) The administrator,

who may also be the supervising physician

or registered nurse required by subsection

(d), shall do the following:

(5) Implement a budgeting and accounting

system.

N 0448

Bldg. 00

Based on document review and

interview, the administrator failed to

implement a budgeting and accounting

system for 1 of 1 agency.


1. During the entrance conference on

12-29-14 ending at 2:30 PM,

documentation of the administrator's

N 0448 2.,,3.Please see response to N

441.02/13/2015 12:00:00AM





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implementation of the agency's

accounting and budgeting system was

requested in writing.

2. On 12-31-14 the agency provided a

document, undated, titled "Nursing

Budget: Indianapolis 2014-2015" which

failed to evidence the name or signature

of the administrator, failed to identify the

source, and failed to include an

accounting and budgeting system. The

document listed some figures for salary,

travel, mileage reimbursement, and

miscellaneous expenses totaling

$233,006 and stated, "Accredo has a

dedicated finance team responsible for

monitoring and recording all financials

associated with the nursing operations

within Accredo and specific to

Indianapolis."

3. Employee E, the administrator,

indicated on 12-31-14 at 3:00 PM, during

a telephone interview, Accredo Health

Group, Inc., the national corporation,

does all the budgeting, accounting, and

finance relative to Accredo Health

Group, Inc, the Indiana home health

agency.





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410 IAC 17-12-1(c)(6)

Home health agency






(6) Ensure that the home health agency

meets all rules and regulations for licensure.

N 0449

Bldg. 00

Based on document review, observation,

and interview, the administrator failed to

ensure the agency met the requirements

for licensure for 1 of 1 agency.



document provided by the agency, dated

11-21-14, signed by the administrator,

Employee E, titled "Statement of

Readiness" included an attestation the

agency was in compliance with 410 IAC

17 and IC 16-27.

2. The administrator failed to ensure the

organization, administrative control, and

lines of authority down to the patient

level and the patient populations served

were clearly identified on the

organizational chart for 1 of 1 home

N 0449 1. At the time of the survey,

Accredo believed it was compliant

with Indiana home health agency

regulations. Prior to seeking a

provisional license, an analysis of

existing policies was conducted to

ensure compliance with State

regulations. Unfortunately due to

employee deficiencies, the

appropriate information was not

communicated to the surveyor.

We have taken steps to remedy

this situation, including extensive

training, and are committed to

operating in compliance with all

home health agency regulations.

Further, as set forth above, to

provide additional direct oversight

of any future ongoing activities, if

permitted to continue operations,

we will appoint a full time

administrator who is located

on-site.2. Please see response to

N 440., 3.Please see response to

N 441.4. Please see response to

N 442. 5. Please see response to

N 444.6. Please see response to

02/13/2015 12:00:00AM





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health agency. (See N 440)

3. The administrator failed to ensure

administrative responsibilities were not

delegated / completed to another

organization in relation to the

development of patients' medication

profile in the medical plan of care for 6

of 6 clinical records reviewed, criminal

background checks of its employees for 2

of 2 direct care providers, and budgeting

and accounting systems for 1 of 1 agency.

(See N 441)


governing body meeting minutes were

provided to evidence the governing body

appointed an administrator and adopted

agency bylaws for 1 of 1 agency. (See N

442)

5. The administrator failed to organize

and direct the home health agency's

ongoing functions to include providing

staff sufficient to cover the hours of

operation, provision for a method of

tracking at the agency level the activity of

the agency in relation to ability to

generate lists of active and discharged

patients and reason for discharge,

provision for orientation of agency staff,

provision to ensure the personnel record

of the nursing supervisor was current and

included a criminal background check,

N 445. 7. Please see response to

N 4468. Please see response to

N 447 9. Please see response to

N 44810. Please see response to

N 450 11.Please see response to

N 447 and response to N 454. 12.

Please see response to N 456

and 472. 13. Please see

response to N 458. 14. Please

see response to N 460.15. Please

see response to N 462. 16.


17. Please see response to N

468.18. Please see response to N

468.19.Please see response to N

490. 20. Please see response to

N 518. 21. Please see response

to N 522. 22. Please see

response to N 524. 23.Please

see response to N 542. 24.


25. Please see response to N

608.





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provision for agency employment / hiring

policies to include the contents of the

personnel record and requirement of a

copy of a criminal background check in

accordance with IC 16-27-2 for direct

care staff, provision for the treatment of

health records of agency direct care staff

health as confidential, and provision for

the administrator's presence at the agency

for any part of the initial licensure survey

conducted the day before expiration of

the agency's provisional license for 1 of 1

agency. (See N 444)


revised policies were provided to the

agency timely. (See N 445)

7. The administrator failed to employ

sufficient qualified staff to meet the hours

of operations of the agency for 1 of 1

agency and failed to ensure adequate staff

education for 1 of 1 staff nurses and for 1

of 1 alternate nursing supervisor. (See N

446)


accuracy of the hours of operation and

agency telephone number for 1 of 1

agency. (See N 447)

9. The administrator failed to implement

a budgeting and accounting system for 1

of 1 agency. (See N 448)





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10. The administrator failed to ensure all

information requested was made

available within the requested timeframe

to determine compliance for 1 of 1

agency. (See N 450)

11. The administrator failed to assure the

the administrator or qualified alternate

was on the premises or capable of being

reached immediately by phone, pager, or

other means for 1 of 1 agency. (See N

454)

12. The administrator failed to provide


responsibility for an ongoing, quality

assurance program for 1 of 1 agency.

(See N 456 and N 472)


that personnel practices for employees

are supported by written policies to

determine date of hire and a copy of a

criminal background check in accordance

with IC 16-27-2 was in the file of 1 of 1

direct care staff. (See N 458)


personnel record of the supervising nurse

included a copy of a a criminal

background check required by IC

16-27-2. (See N 460)






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that all employees providing direct

patient care had a physical examination

by a physician or nurse practitioner of

sufficient scope to ensure the employee

would not spread infectious or

communicable diseases to the patient

within 180 days prior to the date the

employee had direct patient contact for 2

of 2 registered nurses personnel files

reviewed who provided patient care.

(See N 462)


employee health records were maintained

and treated as confidential medical

records for 5 of 5 personnel files

reviewed. (See N 466)

17. The administrator failed to make

available, after request, policies related

to personnel practices of the agency for 1

of 1 agency. (See N 468)

18. The administrator failed to make

available, after request, policies related

to personnel practices of the agency for 1

of 1 agency. (See N 488).

19. The administrator failed to develop

and implement a policy requiring the

agency to continue, in good faith, during

the 5 day period after notice of discharge

was provided to the patient or patient's

legal representative for 1 of 1 agency.





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(See N 490)

20. The administrator failed to ensure its

patients were informed and provided

written information in advance of care

regarding advance directives including a

description of applicable state law for 1

of 2 records reviewed of patients

receiving home visits. (See N 518)


complete vital signs were obtained to

include temperature for 1 of 1 patients

receiving a home visit whose plan of care

included taking of temperature. (See N

522)


medical plan of care was developed in

consultation with the home health agency

staff to include an accurate, complete,

and correct medication orders prior to

sending the medical plan of care to the

attending physician for authorization in 2

of 6 clinical records reviewed. (See N

524)


registered nurse made a necessary

revision to the patient's plan of care

regarding a resolution of an incorrectly

reported medication allergy when the

physician notified the nurse the patient

was not allergic to the medication for 1 of





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1 clinical record reviewed with an

incorrect allergy reported. (See N 542)


registered nurse prepared a clinical note

to resolve a reported medication allergy

in the patients plan of care when the

physician notified the nurse the patient

was not allergic to the medication for 1 of

1 clinical record reviewed with an

incorrect allergy reported. (See N 544)

25. The administrator failed to ensure its

clinical record was maintained in

accordance with accepted professional

standards to include documents

containing the agency's identification and

consent forms stored within the patient's

electronic clinical record that clearly

identify the agency as the provider of

nursing services for 10 of 10 clinical

records reviewed for patient consent

documentation in the clinical record.

(See N 608)





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410 IAC 17-12-1(c)(7)

Home health agency




registered nurse required by subsection (d)

of this rule, shall do the following:

(7) Upon request, make available to the

Commissioner or his or her designated

agent all:

(A) reports;

(B) records;

(C) minutes;

(D) documentation;

(E) information; and

(F) files;

required to determine compliance within

seventy-two (72) hours of the request or, in

the event the request is made in conjunction

with a survey, by the time the surveyor exits

the home health agency, whichever is

sooner.

N 0450

Bldg. 00


administrator failed to ensure all

information requested was made

available within the requested timeframe

N 0450 1.Accredo maintains policies

relating to the above and the

following polices/practice

standards were provided to the

surveyor at the time of the survey:

· Policy 4-7 - Personal Protective

01/30/2015 12:00:00AM





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to determine compliance for 1 of 1

agency.


1. On 12-29-14, at 2:30 PM, a written

request was made to include providing a

copy of agency policies for administering

of TB [tuberculin skin test] and related

policies, universal precautions,

communicable disease, governing body

meeting dates and minutes of governing

body meetings, appointment of the

administrator by the governing body, and

quality and performance improvement

program / policies / procedures.

2. On 12-31-14, at 4:00 PM, a verbal

request was made for any policies

regarding hiring, employment, health and

personnel records, criminal background

checks, orientation, competencies, job

descriptions for the administrator,

alternate administrator, nursing

supervisor, alternate nursing supervisor,

agency definition of what comprises the

patients' electronic clinical record, and

the policies in #1 above.

3. On 1-2-15 at 4:00 PM, a request for

any further documentation demonstrating

compliance was made to the nursing

supervisor / alternate administrator,

Employee A, and the alternate nursing

Equipment, attached as Exhibit I;

· Policy 4-5 - Standard

Precautions and Bag Technique,

attached as Exhibit J; · Job Aid -

Fall Program, attached as Exhibit

K; · Practice Standard 27.01.16

- Infection Control Plan, attached

as Exhibit L; · Practice Standard

28.01.06 - Governing Body of

Accredo owned Home Health

Agencies, attached as Exhibit F;

and · Practice Standard

28.01.12 - Immunization

Requirement for Home Health ,

attached as Exhibit M; In

addition, the following

polices/practice standards should

have also been provided: ·

Policy 4-3 - Surveillance,

Analysis, and Prevention of

Infection, attached as Exhibit N; ·

Policy 4-4 - Bloodborne

Pathogens and Control of

Tuberculosis, attached as Exhibit

O; · Policy 4-6 - Hand Hygiene,

attached as Exhibit P; · Policy

4-10 - Communicable Disease,

attached as Exhibit Q; · Policy

4-11 - Tuberculosis Control,

attached as Exhibit R; · Policy

4-13 – Hepatitis B Vaccine

Provision, attached as Exhibit S;

· Policy 4-16 - Health Clearance,

attached as Exhibit T; and ·

Practice Standard 28.01.03 –

Hand Hygiene, attached as

Exhibit U; With respect to

requests for information relating

to the Governing Body, please

see response to N 442. With

respect to information pertaining

to quality improvement, please





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supervisor, Employee D. Nothing was

provided. The exit conference was

conducted 1-2-15 at 4:35 PM, at which

time the above policies and requests had

not been made available for

determination of compliance with IC

16-27 and 410 IAC 17. During the exit

conference, Employee E, the

administrator, stated some of the

requested documentation had been

emailed to the Employee A 2 days ago.

The following documentation was then

accessed by Employee A: a list of names

and addresses of members of the

governing body, a revised discharge

policy (which did not meet licensing

requirements), an acknowledgment of

receipt of nursing supervisor job

description for Employee A, the nurse

supervisor / alternate administrator. No

further documentation was provided

demonstrating compliance.

see response to N 456. In

addition, as indicated above,

Accredo will provide additional

training regarding accessing the

current electronic copies of

Accredo policies and practice

standards. 2.In addition to the

above listed policies/practice

standards in response to N 450 #

1, Accredo maintains policies

relating to the above and the

following polices/practice

standards were provided to the

surveyor at the time of the survey:

· Policy - Plan of Treatment,

attached as Exhibit V; · Job Aid -

HR Onboarding, attached as

Exhibit W; and · Practice

Standard 27.06.02 - Medication

Profile, attached as Exhibit X;

The following policies also

existed at the time of the survey

and should have been provided to

the surveyor to evidence

compliance with Indiana

regulations: · Policy 9-1 – Clinical

Records, attached as Exhibit Y; ·

Policy 9-2 – Clinical Record

Contents, attached as Exhibit Z; ·

Policy 9-5 – Transfer of Patient

Records, attached as Exhibit AA;

· Policy 10-3 – Personnel Record

Maintenance, attached as Exhibit

BB; · Practice Standard 27.01.17

– Employee Safety in Home

Environment, attached as Exhibit

CC; · Practice Standard 27.01.19

– Adverse Drug Experience and

Patient Complaint, attached as

Exhibit DD; · Practice Standard

27.01.21 – Medication Delivery by

Company Nurse, attached as





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Exhibit EE; · Practice Standard

27.01.26 – Patient Consent for

Services, attached as Exhibit FF;

· Practice Standard 28.01.01 –

Advanced Directives, attached as

Exhibit GG; For additional policies

that also existed at the time of the

survey and that should have been

provided to the surveyor to

evidence compliance with Indiana

regulations, please see those

additional policies identified in this

response. With respect to job

descriptions, since the survey, an

audit of the employee’s personnel

files has been performed and we

have ensured that a document

acknowledging receipt of the

employee’s job description is

contained within each employee’s

electronic personnel file. The

Indiana HHA administrator is and

will be responsible to ensure that

this documentation is maintained

in newly assigned employee’s

personnel files and the Indiana

HHA nursing supervisor will also

audit the electronic personnel

records of all newly assigned

Indiana HHA nurses two times a

year for the next two years for

compliance.3. Accredo

recognizes and apologizes for the

fact that the surveyor was

provided, at times, inaccurate and

insufficient information such that

it could be accurately

demonstrated that Accredo was

operating in compliance with

Indiana regulations.

For additional training and

documentation that Accredo has





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completed and/or will be

implementing, please see the

entirety of this response. With

respect to the assignment of a full

time on-site administrator, please

see response to N 444.

Further, in addition to the above

listed policies/practice standards

in response to N 450 # 1 and # 2,

Accredo provided the following to

the surveyor at the time of the

survey:

· Job Aid - Discharge from

Nursing, attached as Exhibit HH;

· Practice Standard 01.03.16

- Quality Meetings, attached as

Exhibit II; and

· Practice Standard 27.06.03

- Patient Inactivation/Discharge,

attached as Exhibit G;

For additional policies that also

existed at the time of the survey

and that should have been

provided to the surveyor to

evidence compliance with Indiana

regulations, please see those

additional policies identified in this

response.

410 IAC 17-12-1(d)

Home health agency


Rule 12 Sec. 1(d) The person or similarly

qualified alternate shall be on the premises

or capable of being reached immediately by

phone, pager or other means. In addition,

the person must be able to:

(1) respond to an emergency;

N 0454

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(2) provide guidance to staff;

(3) answer questions; and

(4) resolve issues;

within a reasonable amount of time, given

the emergency or issue that has been

raised.


administrator failed to assure the the

administrator or qualified alternate was

on the premises or capable of being

reached immediately by phone, pager, or

other means for 1 of 1 agency.

Findings include:


(ISDH) documents state the hours of


are 8:30 AM to 5:00 PM Monday

through Friday and the phone number of

the agency is (888) 289-2978.

2. On 12- 29- 2014 at 10:30 AM, the

surveyor arrived at the address provided

by the agency to conduct the agency's

initial state licensure survey.

3. The building is a secured facility.

Person AA, a security agent at the front

entrance, was not aware a home health

agency was housed in the building.

Person AA could not reach agency

personnel using the phone number

provided (888) 289-2978 and did not

N 0454 1,2,3,4,5,7 Please see response

to N 444.02/13/2015 12:00:00AM





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have any further contact information for

the administrator, alternate administrator,

nursing supervisor, or alternate nursing

supervisor when the surveyor provided

the names to person AA.

4. The surveyor attempted to reach the

agency at (888) 289-2978 at 10:45,

11:00, and 11:15 AM. The number did

not provide for the opportunity to leave a

voice message or be transferred for

assistance. A recorded message stated,

"You have reached the Accredo Indiana

nursing office. If you know your party's

extension, please enter it now. If not,

please hold for the next available team

member." The phone rang for 2 minutes

without anyone answering.

5. An employee of Accredo Health

Group, Inc., the corporation, rather than

Accredo Health Group, the home health

agency, person BB, approached the

surveyor at 11:18 AM and indicated no

one from the home health agency was

present nor was anyone from the agency

expected. Person BB provided a phone

number for the named agency

administrator, Employee E.

6. At 11:35 AM, Employee E, the

administrator, was reached by phone at a

number not provided to the Indiana State

Department of Health, over one hour





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after arrival at the agency during hours of

operation.



supervisor, arrived at the agency 2 3/4

hours after the surveyor arrived during

the agency hours of operation, and stated

the agency has no clerical staff, that she

is the only local employee, and the

agency does not have a provision to staff

during hours of operation if Employee A

is out of the office to see patients or for

any other reason, and the correct phone

number of agency was provided.

410 IAC 17-12-1(e)

Home health agency


Rule 12 Sec. 1(e) The administrator shall

be responsible for an ongoing quality

assurance program designed to do the

following:

(1) Objectively and systematically monitor

and evaluate the quality and

appropriateness of patient care.

N 0456

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(2) Resolve identified problems.

(3) Improve patient care.

Based on interview and review of

Accredo Health Group national

corporation documents, the administrator

failed to provide documentation of the

administrator's responsibility for an

ongoing, quality assurance program for 1

of 1 agency.

Findings include:


12-29-14 ending at 2:30 PM,


implementation of the agency's quality

assurance and performance improvement

plan, policies, and procedures was



E, the administrator, indicated during

phone interview the agency will follow


corporation's, quality assurance and

performance improvement program,

policies, and procedures. She indicated

no data had yet been collected from

agency clinical record audits or other

sources because the agency has had so

few patients and that she had not not set

any agency specific monitors, standards,

or goals for quality assurance.

N 0456 1. A quality assurance and

performance improvement plan

was implemented at the Indiana

HHA and in place at the time of

the survey. During the survey,

Employee D, the alternate

nursing supervisor, explained the

tools that captured information

related to quality assurance and

performance improvement

program. At the time of the

survey, the surveyor requested

specific results for the Indiana

HHA. However, at that time, the

Indiana location had only seen

patients for approximately 90

days and Accredo’s program

reviews data on a quarterly

basis. As that period of time had

not passed, we informed the

surveyor that results were not

available and that the data would

be evaluated in January (after the

end of the calendar quarter) for

quality assurance and

performance improvement

review. As an example of the

manner in which the data is

presented to the governing body

for all Accredo HHAs, the

surveyor was shown Power Point

presentation slides containing

excerpts of this type of

information. A copy of those

Power Point slides is attached as

Exhibit JJ. In addition, Accredo

has polices relating to quality

assurance and performance

improvement plans. The

following policies are attached: ·

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3. On 12-30-14, a print out of power

point slides from 12-17-14 titled "Annual

Governing Body Meeting" was presented

which included slides with data from


corporation's, fall prevention program,

central venous line infection rates, hand

sanitizer utilization, and influenza

vaccination rate which, according to

Employee A, contained 2013 and 2014

aggregated data from all corporate owned


agencies (approximately 33 nationally).

There was no information directly related

to this home health agency.

4. Accredo Health Group corporate

policy # 21-01-06, created 7-3-13 revised

12-29-14, states under the heading of

Governing Body Bylaws, "The

Governing Body will engage in the

following collaborative activities on

behalf of the Corporation for all Accredo

owned licensed home health agencies ...

8. Bears overall responsibility for the

quality of patient care, organizational

systems and processes, to include

granting authority to the local licensed

HHA [home health agency] administrator

for leadership and coordination of the

development, planning, implementation,

and evaluation of the quality management

activities."

Practice Standard 01.03.16,

Quality Meetings, attached as

Exhibit II; and · Practice

Standard 27.01.16, Infection

Control Plan, attached as Exhibit

L 2,3. Please see above4. For

clarification, the policy number

referenced in the above

paragraph should be listed as

Practice Standard 28-01-06. In

addition, please see above.5.

Please see above.





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5. No further documentation

demonstrating compliance with the

quality assurance requirement was

presented prior to exit.

410 IAC 17-12-1(f)

Home health agency


Rule 12 Sec. 1(f) Personnel practices for

employees shall be supported by written

policies. All employees caring for patients in

Indiana shall be subject to Indiana licensure,

certification, or registration required to

perform the respective service. Personnel

records of employees who deliver home

health services shall be kept current and

shall include documentation of orientation to

the job, including the following:

(1) Receipt of job description.

(2) Qualifications.

(3) A copy of limited criminal history

pursuant to IC 16-27-2.

(4) A copy of current license, certification,

or registration.

(5) Annual performance evaluations.

N 0458

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Based on personnel file review and

interview, the agency failed to ensure that

personnel practices for employees are

supported by written policies to

determine date of hire and a copy of a

criminal background check in accordance

with IC 16-27-2 was in the file of 1 of 1

direct care staff (Employee B).

N 0458 1.Employee personnel records

are maintained electronically by

the individual HHA location. All

employee records required to be

maintained by Indiana regulation

will be stored in the electronic file

that is maintained by the Indiana

HHA.



that all employee records

required to be maintained by

Indiana regulation are stored in

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1. During entrance conference on

12-29-14, beginning at 1:30 PM,

Employee A indicated the agency's

personnel records were stored

electronically in a program called "Work

Place."

2. The personnel file of Employee B, no

determinable hire date with this agency,

date of first patient contact of 11-21-14

for patient #6, failed to evidence an

expanded criminal background check in

accordance with IC 16-27-2 which was

required because the employee resides in

Kentucky.

4. On 12-30-14 at 4:00 PM, all policies

related to hiring practices, employment

requirements, orientation, provision of

job descriptions, content of personnel

records, requirement for the agency to

obtain and maintain in the personnel file

of direct care staff a copy of the

employees' criminal background check

from the Indiana State Police Repository

in accordance with IC 16-27-2, agency

method of determining date of hire and

health requirements including

tuberculosis screening for direct care staff

who have become, or will become,

employees of this agency while

the electronic file that is

maintained by the Indiana HHA




assigned Indiana HHA nurses two

times a year for compliance.

2. Please see response to N 441,

N 444 and N 450.

4., 5. Please see response to N

441 and N 450.

6. Unfortunately, Employee A

provided incorrect information to

the surveyor. The administrator

has access to all HHA

employees’ personnel files and

this information should have been

promptly provided to the surveyor.

In addition, please see response

to N 441 and N 450.

7. Please see response to N 446

and N 447.





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simultaneously employed by another

state's Accredo Health Group, Inc. home

health agency, were requested but not

provided prior to exit.

5. On 1-2-15 at 2:00 PM, Employee D,

the alternate director of nursing, verified

the findings in the personnel records

reviewed and indicated the agency uses


corporation, employment policies which

are in an "Onboarding" policy under the

control of human resources from Accredo

Health Group, Inc, the corporation. This

policy was requested but not provided

prior to exit. Employee D brought paper

personnel documents (stored in

Louisville at a different Accredo Health

Group facility) after the initial licensure

survey had begun (Employees B, C, D)

but which she conceded were not part of

the agency's personnel files.

6. On 1-2-15 at 2:00 PM, Employee A,

the alternate administrator / nursing

supervisor, provided a memo from

Express Scripts, dated 12-31-14, that

stated, "All your active employees" had

been screened through 11-2014 and "no

[criminal] charges were located."

Employee A indicated the agency does

not have access to nor may the agency

obtain copies of the criminal history

background checks of agency employees





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because this function is the exclusive

domain of human resources of Accredo

Health Group, Inc., the national

corporation, a subsidiary of Express

Scripts.

7. On 12-31-14 at 2:05 PM, Employee E,

the administrator, indicated the date of

hire for Employee B, which was not in

Employee B's personnel file, should be

5-2-14, but was unable to provide a

policy or basis for determining the hire

date stated. She indicated Employee B

was an infusion nurse employed by

Accredo Health Group, Inc., in Kentucky.

Employee E had provided patient care for

the agency patient #6 on 11/21/14.

410 IAC 17-12-1(g)

Home health agency


Rule 12 Sec. 1(g) As follows, personnel

records of the supervising nurse, appointed

under subsection (d) of this rule, shall:

(1) Be kept current.

(2) Include a copy of the following:

(A) Limited criminal history pursuant to IC

16-27-2.

(B) Nursing license.

(C) Annual performance evaluations.

(D) Documentation of orientation to the job.

Performance evaluations required by this

subsection must be performed every nine

N 0460

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(9) to fifteen (15) months of active

employment.

Based on review of the personnel file and

interview, the agency failed to ensure the

personnel record of the supervising nurse

included a copy of a a criminal

background check required by IC 16-27-2

(Employee A).

Findings include:




evidence a copy of a criminal background

check from the Indiana State Police

Repository as required by IC 16-27-2

within 3 days of provision of services.

2. On 12-30-14 at 4:00 PM, the alternate

nursing supervisor, Employee D,

confirmed the above findings and

indicated the alternate administrator /

nursing supervisor's personnel file was

not current. Employee D indicated the

agency stores its personnel records in an

electronic format in a program called

"Work Place." The agency follows the

human resources policies of Accredo

Health Group, Inc., the corporation, titled

"Onboarding." A copy of this policy was

requested but was not provided prior to

exit.


N 441, N 444 and N 450.02/13/2015 12:00:00AM





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3. On 1-2-15 at 2:00 PM, Employee A,

the alternate administrator / nursing

supervisor, provided a memo from

Express Scripts, dated 12-31-14, that

stated, "All your active employees" had

been screened through 11-2014 and "no

[criminal] charges were located."

Employee A indicated the agency does

not have access to the criminal history

background checks of agency employees

because this function is the exclusive

domain of human resources of Accredo

Health Group, Inc., the national

corporation, a subsidiary of Express

Scripts.

410 IAC 17-12-1(h)

Home health agency


Rule 12 Sec. 1(h) Each employee who will

have direct patient contact shall have a

physical examination by a physician or nurse

practitioner no more than one hundred

eighty (180) days before the date that the

employee has direct patient contact. The

physical examination shall be of sufficient

scope to ensure that the employee will not

spread infectious or communicable diseases

to patients.

N 0462

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Based on personnel file review and

interview, the administrator failed to

N 0462 1. At the time of the survey,

Accredo believed it was compliant

with the applicable regulation.

The electronic personnel files for

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ensure that all employees providing direct

patient care had a physical examination

by a physician or nurse practitioner of

sufficient scope to ensure the employee

would not spread infectious or

communicable diseases to the patient

within 180 days prior to the date the

employee had direct patient contact for 2

of 2 registered nurses personnel files

reviewed who provided patient care

(Employees A and B).





evidence documentation of a physical

examination within 180 days prior to

patient care. A copy of a prescription pad

with Employee A's name on it, included

notations dated 4-23-14 that stated,

"Patient is clear and free of any current

communicable diseases. She has no

restrictions at this time." The

prescription pad notation failed to

indicate the date and scope of any

physical examination that was the basis

of this determination, the form was

written and signed by a medical assistant

and co-signed, signature illegible, by a

person Employee A indicated was her

primary care physician.

each nurse contained dated

documentation signed by a

physician that stated the nurse

was free of communicable

diseases.

We now understand that the

State prefers additional detail and

will have all our currently

assigned employees and any

newly assigned employees obtain

documentation that also indicates

a physical examination was

performed by the physician to

arrive at the determination that

the employee is free of

communicable diseases.



that this documentation is placed

in the employee’s electronic

personnel file and the Indiana

HHA nursing supervisor will also

audit the electronic personnel

records of all newly assigned

Indiana HHA nurses two times a

year for the next two years for

compliance.

2. At the time of the survey,

Accredo believed they it was

compliant with the applicable

regulation. The electronic

personnel files for each nurse

contained dated documentation

signed by a physician that stated

the nurse was free of

communicable diseases.

In addition, please see above.






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2. The personnel file for staff nurse,

Employee B, date of hire not determined,

failed to evidence documentation of a

physical examination by a physician or

nurse practitioner of sufficient scope to

ensure the employee would not spread

infectious or communicable diseases

within 180 days prior to services

provided to patient #6 on 11-21-14.


verified the above findings.

410 IAC 17-12-1(j)

Home health agency


Rule 12 Sec. 1(j) The information obtained

from the:

(1) physical examinations required by

subsection (h); and

(2) tuberculosis evaluations and clinical

follow-ups required by subsection (i)

must be maintained in separate medical files

and treated as confidential medical records,

N 0466

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except as provided in subsection (k).

Based on observation, personnel record

review, and interview, the agency failed

to ensure employee health records were

maintained and treated as confidential

medical records for 5 of 5 personnel files

reviewed (Employees A, B, C, D, and E).


1. During review of personnel files on

12-30-14 with Employee D, the

electronic health records of all 5

identified agency employees (Employees

A, B, C, D, and E) were observed to be

scanned into a separate folder but were

not marked as confidential.

2. The electronic file of Employee E

contained a health record for Person CC

dated 8-9-13. Person CC was not listed

on the agency employee roster.

3. On 12-30-14 at 4:00 PM, Employee D

indicated Person CC was not an agency

employee, Person CC's health form

should not have been in Employee E's

electronic personnel file, and the agency's

personnel files were not treated as

confidential in that Accredo Health

Group, Inc, the corporation. Employees

with a log in for "Work Group" could

access personnel files to include

N 0466 1.Accredo employee health

records are maintained

confidentially and in compliance

with applicable HIPAA

regulations. Health files are

maintained electronically and

some information is also

maintained (in duplicate) in hard

copy form.

Access to the health record

portion of the employee’s

electronic folders is limited to the

appropriate administrator,

alternate administrator and

nursing supervisor(s) of the

Accredo HHA.

With respect to the information

that is maintained in hard copy,

that information is kept in a

locked filing cabinet with limited

key access.

2. Person CC is an employee of

Accredo, but not assigned to the

Indianapolis Accredo HHA.

Accredo acknowledged that this

record should not have been in

the electronic personnel files for

the Indianapolis Accredo HHA

employees during the survey.

This document was inadvertently

scanned into the incorrect

electronic personnel record. This

was a human error and the

document has been removed

from the incorrect personnel file

and filed in the correct personnel

file.



4. Accredo has a policy pertaining

to the confidential nature of

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confidential health records. Employee D

stated it was corporate policy to obtain

health information including a physical

exam for all employees.

4. On 1-2-15 at the exit conference at

4:35 PM, Employee E, who participated

by telephone conference, indicated nurse

managers of Accredo Health Group, the

corporation, other than Employee E, the

administrator, could access agency

employees' personnel records to include

confidential health records.

4. After request, policies or evidence of

security measures demonstrating

compliance with the confidential

treatment of the agency personnel's health

records, which were stored in a corporate

computer program, were not provided.

employee’s personnel files and

this policy should have been

made available to the surveyor. A

copy of Policy 10-3 - Personnel

Record Maintenance, is attached

as Exhibit BB. This policy should

have been provided to the

surveyor.

410 IAC 17-12-1(k) and (l)

Home health agency


Rule 12 Sec. 1(k) The following records

shall be made available, on request, to the

department for review:

(1) Personnel records and policies that

document the home health agency's

compliance with subsection (f).

(2) Records of physical examinations that

document the agency's compliance with

subsection (h).

(3) Records of the following:

N 0468

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(A) Tuberculosis evaluations.

(B) Appropriate clinical follow-up for positive

findings.

(C) Any other records that document the

home health agency's compliance with

subsection (i).

(l) The department shall:

(1) treat the information described in

subsection (k) as confidential medical

records; and

(2) use it only for the purposes for which it

was obtained.


agency failed to make available, after

request, policies related to personnel

practices of the agency for 1 of 1 agency.


1. On 12-29-14 at 2:30 PM, a written

request was made to provide a copy of

agency policies for administration of TB

[tuberculin skin test] and related policies,

universal precautions, and communicable

disease.

2. On 12-31-14 at 4:00 PM, a verbal

request was made for any policies

regarding hiring procedures, employment

policies, policies concerning health and

personnel records, as well as the policies

in #1 above.

3. On 1-2-15 at 4:00 PM, a request for


N 450.02/13/2015 12:00:00AM





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any further documentation demonstrating

compliance was made to the nursing


Employee A, and the alternate nursing

supervisor, Employee D. Employee D

indicated a corporation policy

"Onboarding" addressed the employment

/ hiring practices of Accredo Health

Group, the corporation, but, after request,

this policy was not provided. The exit

conference was conducted 1-2-15 at 4:35

PM, at which time the above policies and

requests had not been made available for

determination of compliance with IC

16-27 and 410 IAC 17. During the exit

conference, Employee E, the


telephone conference, stated some of the

requested documentation had been

emailed 2 days ago to Employee A. The

documents presented included a copy of

Employee A's acknowledgement of

receipt of a job description, but the

agency failed to produce the job

description for review. No further

documentation was provided

demonstrating compliance.

410 IAC 17-12-2(a)

Q A and performance improvement

Rule 12 Sec. 2(a) The home health agency

must develop, implement, maintain, and

evaluate a quality assessment and

performance improvement program. The

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program must reflect the complexity of the

home health organization and services

(including those services provided directly or

under arrangement). The home health

agency must take actions that result in

improvements in the home health agency's

performance across the spectrum of care.

The home health agency's quality

assessment and performance improvement

program must use objective measures.

Based on interview and review of

Accredo Health Group national

corporation documents, the administrator

failed to provide documentation of the

administrator's responsibility for an

ongoing, quality assurance program for 1

of 1 agency.

Findings include:


12-29-14 ending at 2:30 PM,


implementation of the agency's quality

assurance and performance improvement

plan, policies, and procedures was



E, the administrator, indicated during

phone interview the agency will follow


corporation's, quality assurance and

performance improvement program,

policies, and procedures. She indicated


N 4564. For clarification, the

policy number referenced in the

above paragraph should be listed

as 28-01-06.


5. Please see response to N 456.

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no data had yet been collected from

agency clinical record audits or other

sources because the agency has had so

few patients and that she had not not set

any agency specific monitors, standards,

or goals for quality assurance.

3. On 12-30-14, a print out of power

point slides from 12-17-14 titled "Annual

Governing Body Meeting" was presented

which included slides with data from


corporation's, fall prevention program,

central venous line infection rates, hand

sanitizer utilization, and influenza

vaccination rate which, according to

Employee A, contained 2013 and 2014

aggregated data from all corporate owned


agencies (approximately 33 nationally).

There was no information directly related

to this home health agency.

4. Accredo Health Group corporate

policy # 21-01-06, created 7-3-13 revised

12-29-14, states under the heading of

Governing Body Bylaws, "The

Governing Body will engage in the

following collaborative activities on

behalf of the Corporation for all Accredo

owned licensed home health agencies ...

8. Bears overall responsibility for the

quality of patient care, organizational

systems and processes, to include





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granting authority to the local licensed

HHA [home health agency] administrator

for leadership and coordination of the

development, planning, implementation,

and evaluation of the quality management

activities."

5. No further documentation

demonstrating compliance with the

quality assurance requirement was

presented prior to exit.

410 IAC 17-12-2(i) and (j)


Rule 12 Sec. 2(i) A home health agency

must develop and implement a policy

requiring a notice of discharge of service to

the patient, the patient's legal representative,

or other individual responsible for the

patient's care at least five (5) calendar days

before the services are stopped.

(j) The five (5) day period described in

subsection (i) of this rule does not apply in

the following circumstances:

(1) The health, safety, and/or welfare of the

N 0488

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home health agency's employees would be

at immediate and significant risk if the home

health agency continued to provide services

to the patient.

(2) The patient refuses the home health

agency's services.

(3) The patient's services are no longer

reimbursable based on applicable

reimbursement requirements and the home

health agency informs the patient of

community resources to assist the patient

following discharge; or

(4) The patient no longer meets applicable

regulatory criteria, such as lack of

physician's order, and the home health

agency informs the patient of community

resources to assist the patient following

discharge.

Based on policy review and interview,

the agency failed to develop and

implement a policy requiring 5 days

notice of discharge of service to the

patient or patient's legal representative

for 1 of 1 agency.


1. On 12-29-14 at 2:30 PM, a written

request was made for a copy of the

agency discharge policy.


copy of a policy #27-06.03 "Patient

Inactivation / Discharge" last revised

5-22-12 and indicated the policy did not

require 5 days of notice to the patient or

N 0488 1. Please see response to N 445.

In addition, during the survey,

Employee A explained Accredo’s

discharge process and explained

that patients who will be

discharged from nursing services

are provided a minimum of a 5

day notice prior to discharge.

Accredo has identified that

although it is providing the 5 day

minimum notice in compliance

with Indiana regulations, that this

practice is not explicitly set forth

in the Practice Standard

referenced below (Practice

Standard 27.06.03). As a result,

Accredo has developed an

addendum to the above

referenced Practice Standard that

applies to Indiana patients to

address the Indiana regulation. A

copy of that addendum is

attached as Exhibit KK.2., 3., 4.

Please see above and also see

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patient's representative prior to discharge.

3. During the exit conference on 1-2-15




policy meeting the requirement had been

emailed to the alternate administrator 2

days ago. Employee A indicated she was

not aware the policy had been revised and

sent to her, but she had requested changes

in the policy to bring the agency into

compliance.

4. Review of policy #27-06.03 "Patient

Inactivation / Discharge", revised on

10-16-14, and received by Employee A,

the alternate administrator, on 1-2-15,

failed to provide for 5 days notice of

discharge "Home infusion patients are to

receive a copy of of the patient

medication profile. This information

should be provided to the patient within 5

business days, but no greater than 30

business days, of discharge from all

clinical services ... "

5. During interview with Employee A on

12-29-14 at 2:15 PM, Employee A

indicated the agency has patients with

infusion therapy on their plans of care,

but also serves patients with oral or

inhalation therapy medical plans of care

and that providing a medication profile is

response to N 445.





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not the same as providing notice of

discharge.

410 IAC 17-12-2(k)


Rule 12 Sec. 2(k) A home health agency

must continue, in good faith, to attempt to

provide services during the five (5) day

period described in subsection (i) of this

rule. If the home health agency cannot

provide such services during that period, its

continuing attempts to provide the services

must be documented.

N 0490

Bldg. 00

Based on policy review and interview,

the agency failed to develop and

implement a policy requiring the agency

to continue, in good faith, during the 5

day period after notice of discharge was

provided to the patient or patient's legal

representative for 1 of 1 agency.


1. On 12-29-14, at 2:30 PM, a written

N 0490 1.,2.,3.,4. Please see response to

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request was made to provide a copy of

the agency discharge policy.


copy of a policy #27-06.03 "Patient

Inactivation / Discharge" last revised

5-22-12, failed to require the agency to

continue, in good faith, during the 5 day

period after notice of discharge was


representative, to continue to provide

services, and if the agency cannot provide

services, requiring the agency to

document its attempts to provide

services.

3. During the exit conference on 1-2-15,




policy meeting the requirement had been

emailed to the alternate administrator 2

days ago. Employee A indicated she was

not aware the policy had been revised and

sent to her, but she had requested changes

in the policy to bring the agency into

compliance.

4. Review of policy #27-06.03 "Patient

Inactivation / Discharge", revised on

10-16-14, and received by Employee A,

the alternate administrator, on 1-2-15,

failed to require the agency to continue to

provide services, in good faith, during the





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5 day period after notice of discharge was


representative.

410 IAC 17-12-3(e)

Patient Rights

Rule 12 Sec. 3(e)

(e) The home health agency must inform

and distribute written information to the

patient, in advance, concerning its policies

on advance directives, including a

description of applicable state law. The

home health agency may furnish advanced

directives information to a patient at the time

of the first home visit, as long as the

information is furnished before care is

provided.

N 0518

Bldg. 00

Based on observation, interview, and

review of clinical records, the home

health agency failed to ensure its patients

were informed and provided written

information in advance of care regarding

advance directives including a

description of applicable state law for 1

of 2 records reviewed of patients

N 0518 1. Accredo provides each Indiana

patient with a copy of the Indiana

advanced directives information,

unless the patient is under the

age of 18 years old.

Patient # 3 was inadvertently

provided with the prior version of

the Indiana advanced directives

information that was obtained

from the Indiana Department of

Health’s website prior to the new

form being available.

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receiving home visits (Patient #3).


1. During home visit to patient #3 on

1-2-15 at 9:00 AM, the patient had an

advance directive brochure provided by

the agency, undated, which failed to

describe applicable state law because it

failed to describe physician order for

scope of treatment.

2. After the home visit of patient #3,

Employee A indicated she had run out of

the form the agency provided "Advance

Directives" published by the Indiana

State Department of Health, revised

7-2013, and had used the above noted

brochure instead.

All Accredo HHA nurses have

been trained on the necessity to

obtain the current version from

the Department of Health’s

website to provide to new patients

and specific training regarding the

same will be provided to all new


HHA in the future. The Indiana











two years.

2. Please see above

410 IAC 17-13-1(a)

Patient Care

Rule 13 Sec. 1(a) Medical care shall follow

a written medical plan of care established

and periodically reviewed by the physician,

dentist, chiropractor, optometrist or

podiatrist, as follows:

N 0522

Bldg. 00

Based on observation and review of

clinical record, the registered nurse,

N 0522 1. The temperature was not taken

as the patient did not have a

thermometer and the nurse did

not have a thermometer with her

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Employee A, failed to obtain complete

vital signs to include temperature for 1 of

1 patients receiving a home visit whose

plan of care included taking of

temperature. (#3).


1. During home visit to patient #3 on

1-2-15 at 9:00 AM, start of care (SOC)

12-19-14, diagnosis of primary

pulmonary hypertension, with plan of

care for certification period of 12-19-14

to 2-16-15, receiving skilled nursing

services for education and monitoring

related to Adempas oral therapy, the

registered nurse took the patient's vital

signs but failed to take the patient's

temperature. Patient 3's plan of care

included an order to monitor vital signs

to include temperature. During the visit,

the patient indicated not being able to

locate a thermometer in his home.

2. On 1-2-15 at 10:00 AM, Employee A

indicated she had not been issued a

thermometer with her nursing bag but

relied on the patients to have a

thermometer in the home to take their

temperature when vital signs were

ordered on the plan of care.

on that visit. However, the nurse

verified that the patient presented

no signs of being febrile. Accredo

will ensure nurses have

thermometers available if the

patient does not have their own

thermometer.2. Please see

above.





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410 IAC 17-13-1(a)(1)

Patient Care

Rule 13 Sec. 1(a)(1) As follows, the medical

plan of care shall:

(A) Be developed in consultation with the

home health agency staff.

(B) Include all services to be provided if a

skilled service is being provided.

(B) Cover all pertinent diagnoses.

(C) Include the following:

(i) Mental status.

(ii) Types of services and equipment

required.

(iii) Frequency and duration of visits.

(iv) Prognosis.

(v) Rehabilitation potential.

(vi) Functional limitations.

(vii) Activities permitted.

(viii) Nutritional requirements.

(ix) Medications and treatments.

(x) Any safety measures to protect

against injury.

(xi) Instructions for timely discharge or

referral.

(xii) Therapy modalities specifying length of

treatment.

(xiii) Any other appropriate items.

N 0524

Bldg. 00

Based on clinical record review, review

of policies, and interview, the agency

failed to ensure the medical plan of care

was developed in consultation with the

home health agency staff to include an

accurate, complete, and correct

medication orders prior to sending the

medical plan of care to the attending

physician for authorization in 2 of 6

clinical records reviewed (1 and 6).

N 0524 1. Unfortunately, as set forth in

prior responses, the surveyor was

provided with incorrect

information. Please see

response to N 440 and N 441.

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12-23-14, diagnosis of other chronic

pulmonary heart disease, portal

hypertension, and pulmonary



that failed to include medications taken

by the patient as reported during nursing

visit of 12-23-14 of Synthroid 0.124 mg

(milligrams) p.o. (by mouth) daily and

Pramipexole Di-Hcl 0.5 mg p.o. twice a

day which were not new medications for

the patient.


on 12-31-14 at 2:30 PM that the Rx

Home program had patient #1's

medications already entered into the plan

of care by an Accredo Health Group, Inc.,

the national corporation, pharmacist prior

to SOC date and agency nurse, Employee

A, was precluded from adding, deleting,

or modifying in any way the medications

on the plan of care to initiate an accurate

and complete plan of care for submission

to the attending physician for

authorization. Employee A had faxed the

plan of care as it printed from the Rx

Home computer program, without the

corrections to the medications, and also

sent a fax to the physician with an order

for the Synthroid and Pramipexole to





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update the medications.


diagnosis of pulmonary hypertension,



contained a medication profile with the

patient's medications including "Ferrous

sulfate 325 mg tablet , p.o. as directed."


on 12-31-14 at 2:30 PM an Accredo

Health Group corporate pharmacist

entered patient #6's medications into the

agency plan of care and there was no

frequency included on the Ferrous sulfate

medication order. The order states to

take "as directed" which is not a complete

medication order, but Employee A was




complete plan of care for submission to



A, the alternate administrator, indicated

the agency's patients' clinical record is

created and maintained in an electronic

system "Rx Home" which is integrated

into Accredo Health Group, Inc., the

national corporation's, electronic patient

record. She indicated the agency

registered nurse develops the plan of care





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for each part of the patients' medical plan

of care except field #10, medications. At

start of care, the registered nurse

completes an assessment and compares

the medication profile obtained with the

medications already entered into the

electronic plan of care by a pharmacist

employed by Accredo Health Group, Inc,

the corporation. When the registered

nurse detects medication discrepancies,

the registered nurse cannot amend the

medication profile in the electronic

system if needed to send an accurate and

complete plan of care to the attending

physician for authorization. The agency

nurse must document necessary revisions

to the medication profile and fax to the

attending physician for an order to update

the plan of care until the next

certification period. Employee A

indicated it may take days or weeks

before the signed plan of care and order

to amend the medication profile is

received back from the attending

physician. Employee A stated the

registered nurse is precluded by Accredo

Health Group, Inc, the national

corporation, computer program

administrative controls, from submitting

a complete, correct, and accurate

medication profile to the attending

physician at the start of care.





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410 IAC 17-14-1(a)(1)(C)

Scope of Services

Rule 14 Sec. 1(a) (1)(C) Except where

services are limited to therapy only, for

purposes of practice in the home health

setting, the registered nurse shall do the

following:

(C) Initiate the plan of care and necessary

revisions.

N 0542

Bldg. 00

Based on clinical record review and

interview, the registered nurse failed to

make a necessary revision to the patient's

plan of care regarding a resolution of an

incorrectly reported medication allergy

when the physician notified the nurse the

patient was not allergic to the medication

for 1 of 1 clinical record reviewed with

an incorrect allergy reported (#2).



11-18-14, diagnosis of myasthenia gravis,



identified patient allergy to Benadryl.

N 0542 1. Upon further detailed review of

Clinical Record #2, Benadryl is

not listed as an allergy. The

prescriber’s orders do include

providing Benadryl 25mg in the

event of an anaphylactic

reaction. To ensure patient

confidentially, a redacted copy of

the POT in question is attached

as Exhibit LL. 2. Please see

above.

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The plan of care included an order for

Benadryl 25 mg, as needed for

anaphylactic reaction, which had not

been administered to the patient.

2. Employee A indicated on 12-31-14 at

2:30 PM, the allergy had been

investigated when the order for Benadryl

was noted and the physician instructed

Employee A the patient is advised against

taking Benadryl based on patient's

diagnosis but that there was no allergy to

Benadryl. Employee A indicated the

patient had not been administered

Benadryl prior to the incorrectly reported

allergy resolution and she should have

corrected the plan of care and made a

clinical note entry documenting the

resolution provided by patient's physician

but did not do so.

410 IAC 17-14-1(a)(1)(E)

Scope of Services

Rule 14 Sec. 1(a) (1)(E) Except where

services are limited to therapy only, for

purposes of practice in the home health

setting, the registered nurse shall do the

following:

(E) Prepare clinical notes.

N 0544

Bldg. 00

Based on clinical record review and

interview, the registered nurse failed to

prepare a clinical note to resolve a

reported medication allergy in the

patients plan of care when the physician

N 0544 1. Please see response to N 542.

Because Benadryl was not listed

as an allergy, a clinical note was

not required.

2. Please see above and also see

response to N 542.

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notified the nurse the patient was not

allergic to the medication for 1 of 1

clinical record reviewed with an incorrect

allergy reported (#2).


1. Clinical record of patient #2, start of

care (SOC) 11-18-14, diagnosis of

myasthenia gravis, included a plan of

care for certification period 11-18-14 to

1-16-15 which identified patient allergy

of Benadryl. The plan of care included

an order for Benadryl 25 milligram as

needed for anaphylactic reaction, which

had not been administered to the patient.

2. Employee A indicated on 12-31-14 at

2:30 PM, the allergy had been

investigated when the order for Benadryl

was noted and the physician instructed

Employee A the patient is advised against

taking Benadryl based on patient's

diagnosis but that there was no allergy to

Benadryl. Employee A indicated the

patient had not been administered

Benadryl prior to the reported allergy

resolution and she should have corrected

the plan of care and made a clinical note

entry documenting the resolution of the

incorrectly reported allergy but did not do

so.





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410 IAC 17-15-1(a)(1-6)

Clinical Records

Rule 15 Sec. 1(a) Clinical records

containing pertinent past and current

findings in accordance with accepted

professional standards shall be maintained

for every patient as follows:

(1) The medical plan of care and

appropriate identifying information.

(2) Name of the physician, dentist,

chiropractor, podiatrist, or optometrist.

(3) Drug, dietary, treatment, and activity

orders.

(4) Signed and dated clinical notes

contributed to by all assigned personnel.

Clinical notes shall be written the day service

is rendered and incorporated within fourteen

(14) days.

(5) Copies of summary reports sent to the

person responsible for the medical

component of the patient's care.

(6) A discharge summary.

N 0608

Bldg. 00

Based on interview, review of consents,

and review of policy, the agency failed to

ensure its clinical record was maintained

in accordance with accepted professional

standards to include documents

N 0608 1. Accredo disputes the allegation

that its clinical records are not

maintained in accordance with

accepted professional standards.

Patient consent forms are signed

by patients upon admission to

HHA services and the consent

form does in fact show Accredo

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containing the agency's identification and

consent forms stored within the patient's

electronic clinical record that clearly

identify the agency as the provider of

nursing services for 10 of 10 clinical

records reviewed for patient consent

documentation in the clinical record.

(#1-10).


1. On 12-29-14 at 1:30 PM during the

entrance conference, Employee A

indicated the consents for the agency's

patients are stored in an electronic

program called "Work Group" but

clinical visit notes were stored in an

electronic program called "Rx Home".

On 1-2-15 at 4:35 PM, Employee E

indicated Accredo Health Group, Inc., the

national corporation, was transitioning

their information technology set up such

that in the near future, consents will be in

the Rx Home clinical record system.

2. Consents for patients #1-10 printed

from the "Work Group" electronic

program were reviewed and each

contained a document / form titled

"Patient Consent and Acknowledgement"

which included the patient's name,

company "Accredo", state Indiana, that

states, "Thank you for choosing Accredo,

we look forward to serving your specialty

as the provider of both pharmacy

and nursing services. As

explained in response to N 440

and N 441, only patients who are

receiving medications from the

Accredo pharmacy are serviced

by the Accredo HHA. As a result,

the consent form encompasses

both pharmacy services and

nursing services. We believe our

consent forms are in compliance

with applicable Federal and State

law. If there are specific

concerns, we would gladly

engage in a collaborative

discussion with Department of

Health to provide an additional

consent form to Indiana HHA

patients that would alleviate any

concerns that the Department of

Health may have. Patient

consent forms are stored

electronically in the clinical

record. For ease of reference, a

copy of the current patient

consent form is attached as

Exhibit MM.2. Please see above.

In addition, because our patients

understand that they are also

receiving medication from the

Accredo specialty pharmacy that

is directly related to the nursing

services provided by Accredo, we

do not believe the addendum

caused any patient confusion

simply because the document

had the name of “Accredo

Specialty Pharmacy” in the upper

right hand corner. However, in an

abundance of caution and in an

effort to alleviate any potential

concern, the words Specialty





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pharmacy needs. As a pharmacy, we

have an obligation to ... by signing the

acknowledgement below, you are

indicating ... that you are consenting to

receive pharmacy services as a patient

from Accredo ... By signing this

Agreement & Acknowledgement, you are

agreeing to receive pharmacy services

from Accredo and our pharmacists

and nurses. ... You have the right to

choose the pharmacy you use to receive

your prescriptions and professional

services, which may include

consultation with pharmacists and

nurses ... I authorize the release of any

medical or other information necessary to

provide therapy, services, or products."

On page 2 it states, "Accredo is required

by certain state pharmacy regulations to

provide you with information about

advance directives and your rights ...

Advance Directive Acknowledgement: If

receiving nursing care from Accredo, I

further acknowledge that I have been

given an explanation of the rights under

my state law to accept or refuse treatment

and my right to formulate advance

directives regarding such." Each patient

also signed an addendum providing

notice of additional rights for Indiana

patients which has "Accredo Specialty

Pharmacy" on the form in the upper right

hand corner, but provides the name,

address, and phone number of Accredo

Pharmacy will be removed from

the addendum.3. Please see

above.4. Please see response to

N 444. In addition, please see

Policy 9-2 Clinical Record

Contents, attached as Exhibit

Z. 5.Unfortunately, Employee D

provided an incorrect form to the

surveyor. Upon noticing the

error, Employee D provided the

correct form to the surveyor that

indicated that the Indiana

provisionally licensed HHA was

the provider of record. In

addition, the copy sent to the

physician for signature does

indeed have the Indianapolis HHA

listed as the provider in section

#7 of the Plan of Treatment. A

copy of the correct Plan of

Treatment that was shown to the

surveyor and that was executed

by the prescriber is available for

review upon request.6.This is

correct. Please see above and

for an explanation as to why

patients may receive services

from the Accredo pharmacy and

HHA, please see response to N

440 and N 441.





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Health Group, Inc. in the body of the

notice. Patients #1-10 electronically

signed the consents.

3. On 12-29-14 during the entrance

conference which began at 1:30 PM,

Employee A indicated the consent forms

are sent by the pharmacy corporation,

Express Scripts, electronically to the

agency's patients prior to the start of the

patients' medical plan of care which

always includes specialty infusion, oral,

or inhalation medication education and/or

administration for treatment of immune

disorders and/or pulmonary hypertension.

Employee A indicated these medications

are thousands of dollars for each cycle

and are often referred to as "specialty

pharmaceuticals". Employee A, at the

start of care, explains the nursing services

that will be provided and instructs the

patient on the intricacies of Accredo's /

Express Scripts corporate form and its

role in obtaining pre-authorization for the

"specialty" medication in the patient's

plan of care. Employee A acknowledged

the consent form the agency patients sign

for nursing services identifies Accredo

Pharmacy as the entity obtaining consent

rather than Accredo Health Group, Inc.,

the Indiana home health agency. For this

reason, Employee A indicated she

explains at start of care to the patient they

will receive nursing services from this





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agency and she answers all the patients'

questions.


indicated the agency's patients' clinical

records were integrated into Accredo

Health Group, Inc., national corporate

record system, Rx Home. Lists of agency

patients - active or discharged, reason for

discharge, or any agency reports could

not be extracted or isolated to provide

reports on this agency's patients. On

1-2-15 at 2:34 PM, Employee A

indicated all the agency clinical records

contained, in addition to agency

generated clinical notes, physician orders,

plan of care, referral, and discharge

summary, other entries from corporate

pharmacists (in addition to the

pharmacists entry of patients' medications

in the plan of care), reimbursement

employees of the corporation, and

corporate nurses at the national call

center. Employee A could not define

what comprises the agency clinical

record.


D, provided a printed copy of patient #8's

electronic plan of care, stored in Rx

Home program. The provider was

identified in field #7 of the plan of care

as Accredo Health Group at Louisville,

1700 Eastpoint Parkway, suite 50,





06/23/2015PRINTED:

FORM APPROVED

OMB NO. 0938-0391




A. BUILDING

B. WING

(X3) DATE SURVEY

COMPLETED


(X4) ID

PREFIX

TAG




PREFIX

TAG



DEFICIENCY)

(X5)

COMPLETION



01/02/2015



00

Louisville, KY 40223. Employee A

indicated the agency's clinical record is

integrated into an electronic program

which defaults to the Louisville agency

location owned by Accredo Health

Group, Inc., the national corporation,

unless a command is entered to change

the agency location to #197, Indianapolis,

when printing a paper copy of the plan of

care.

6. A policy "Clinical Records", reviewed

7-2014, states on page 2, item 8, "When a

patient is receiving services from more

than one Company entity (e.g., licensed

home care agency and pharmacy), each

entity will maintain a separate clinical

record documenting the services that the

entity provided if required by state

regulations."


PRINTED: 06/23/2015 DEPARTMENT OF HEALTH AND HUMAN … · Accredo HHA nurse to view the patient’s...

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