printed: 02/02/2015 department of health and …printed: 02/02/2015 form approved omb no. 0938-0391...

(X1) PROVIDER/SUPPLIER/CLIA

DEPARTMENT OF HEALTH AND HUMAN SERVICES

CENTERS FOR MEDICARE & MEDICAID SERVICES

02/02/2015PRINTED:

FORM APPROVED

OMB NO. 0938-0391

STATEMENT OF DEFICIENCIES

AND PLAN OF CORRECTION IDENTIFICATION NUMBER:

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

(X4) ID

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SUMMARY STATEMENT OF DEFICIENCIES

(EACH DEFICIENCY MUST BE PRECEDED BY FULL

REGULATORY OR LSC IDENTIFYING INFORMATION)

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IDPROVIDER'S PLAN OF CORRECTION

(EACH CORRECTIVE ACTION SHOULD BE

DEFICIENCY)

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COMPLETION

DATECROSS-REFERENCED TO THE APPROPRIATE

FORT WAYNE, IN 46806

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FORT WAYNE SOUTH DIALYSIS

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V000000

This visit was a federal ESRD

recertification survey.

Survey dates: December 29, 30, and 31,

2014, and January 2, and 5, 2015

Facility #: 012615

Medicaid Vendor #: 201032860

Surveyor: Miriam Bennett, RN, PHNS

Census: 100 In-center

An Immediate Jeopardy was identified on

12/29/14. The Administrator was

notified of the Immediate Jeopardy on

12/29/14 at 3:42 PM. The Immediate

Jeopardy was removed at survey exit.

(V110)

Fort Wayne South Dialysis was found out

compliance with Condition of

Participation 42 CFR 494.30 Infection

Control related to the Immediate

Jeopardy.

Quality Review: Joyce Elder, MSN,

BSN, RN

January 9, 2015

V000000

FORM CMS-2567(02-99) Previous Versions Obsolete

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: UZZK11 Facility ID: 012615

TITLE

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494.30

CFC-INFECTION CONTROL

V000110

Based on observation, policy review,

clinical record review, and interview, it

was determined the facility failed to

ensure staff did not care for Hepatitis B

(HBsAg) positive patients and HBsAg

susceptible patients at the same time in 2

of 2 investigations of a HBsAg positive

patient dialyzing with the potential to

transmit Hepatitis B to susceptible

patients and susceptible staff (See V 131)

and internal infection control audits

failed to identify the policies and

procedures were being rigorously

followed (See V 142).

The cumulative effect of these systemic

problems resulted in the facility being out

of compliance with the Condition for

Coverage 494.30 Infection Control.

The agency was notified on 12/29/14 at

3:42 PM that it was determined the health

and safety of the patients and staff was in

immediate jeopardy.

This deficient practice had the potential

for harm to any agency patient and staff

member that was susceptible to Hepatitis

B. The cumulative effect of these

systemic practices resulted in the

V000110 CONDITION V110 DaVita Fort

Wayne South Dialysis takes the

conditions of coverage very

seriously; immediate steps were

taken to ensure facility provides a

safe and sanitary environment for

ESRD patients and Teammates

(TMs) to minimize any

transmission of infectious agents

in the facility. These actions are

outlined in depth in the Plan of

Correction for V131, and V142.

Governing Body (GB) meeting

was held on 12/29/2014 to review

status of immediate jeopardy,

discuss surveyor findings,

develop and implement

immediate plan of correction in

response. GB meeting held on

1/15/2015 to review formal

statement of deficiencies

received as a result of survey

concluded on 1/5/2015. Members

of the GB including the Medical

Director, and Facility

Administrator (FA) have agreed to

meet bi-weekly to monitor the

facility’s ongoing progress toward

compliance including but not

limited to: 1) Ensuring facility

provides and monitors for sanitary

environment to minimize

transmission of infectious agents

and TMs are compliant with

infection control practices; 2)

Ensuring that designated TMs

providing care to Hepatitis B

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agency's inability to ensure that facility

patients and staff were safe.

Surface Antigen Positive patients

do not provide care at the same

time for HBV susceptible patients.

GB will review Facility Health

Meeting (FHM) minutes to ensure

action plans are evaluated for

effectiveness, new plans

developed as applicable. Once

compliance is achieved, plan of

correction will be monitored

during GB meeting at a minimum

of quarterly. This plan of

correction will also be reviewed

during FHM and the FA will report

progress, as well as any barriers

to maintaining compliance, with

supporting documentation

included in the meeting minutes.

Completion date: 2/5/2015

494.30(a)(1)(i)

IC-HBV-ISOLATION-STAFFING

Isolation of HBV+ Patients

Staff members caring for HBsAg positive

patients should not care for HBV susceptible

patients at the same time, including during

the period when dialysis is terminated on

one patient and initiated on another.

V000131

Based on observation, clinical record

review, policy review, and interview, the

facility failed to ensure staff did not care

for Hepatitis B positive patients (patients

2 and 3) and Hepatitis B susceptible

patients at the same time in 2 of 2

investigations of a Hepatitis B positive

patients dialyzing with the potential to

transmit Hepatitis B to susceptible

patients and staff, creating the potential

to affect all the facility's 24 Hepatitis B

V000131 V131 New patient seating and

staff assignments developed and

implemented on 12/29/2014 to

separate susceptible staff and

patients from potential exposure

to Hepatitis B by cross

contamination and that

designated TMs providing care to

Hepatitis B Surface Antigen

Positive patients do not provide

care concurrently for HBV

susceptible patients. Each TM

scheduled to work in Isolation will

02/05/2015 12:00:00AM





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susceptible patients and 3 Hepatitis B

susceptible staff. (# 1, 4, 7, 8, 9, 10, 12,

15, 17, 25, 26, 27, 30, 31, 32, and 33 and

employees E, G, and H)

Findings include

1. During interview on 12/29/14 at 10:30

AM, employee D, a registered nurse

(RN), indicated the patient (# 2) dialyzing

in the isolation room (station # 20) was a

Hepatitis B positive patient. Employee D

indicated they were assigned to stations

11-20, and the patients in stations 17, 18,

and 19 were Hepatitis B immune

patients.

A. The staff assignment sheet dated

12/29/14 evidenced symbols of <10 or

>10 by each patient name. At 10:33 AM,

employee D indicated the symbols mean

the patient is Hepatitis B susceptible if it

is <10 or Hepatitis B immune if it is >10.

The patients listed at stations 13 and 14

(patients 1 and 25) were <10 and

assigned to employee D. At 10:34 AM,

employee D indicated these two patients

were far enough away from the isolation

room.

B. The staff assignment sheet dated

12/29/14 evidenced the patient care tech

(PCT) assignment of track 3 included

stations 9, 10, 11, and 12 which had a

be verified as Hepatitis B

immune. Facility Administrator

and Infection Control Manager

will review TM and patient labs

monthly to ensure only Hepatitis

B immune TMs care for Hepatitis

B Antigen Positive patients and

ensure Hepatitis B Surface

Antibodies for patient and TM

scheduling. FA and/or Clinical

Coordinator will monitor and

update as appropriate patient

hepatitis schedule monthly and

review during FHM beginning at

next scheduled meeting by FA or

Clinical Coordinator. FA held

mandatory in-service for all

clinical TMs on 12/29/2014 and

12/30/2014 reviewing Policy &

Procedure #1-05-02 Hepatitis

Surveillance, Vaccination and

Infection Control Measures, and

Policy & Procedure #1-05-09

Infection Control and Isolation

Measures for Known or

Suspected Hepatitis B Surface

Antigen Positive Patients. TMs

educated and informed of facility

initiatives to ensure that

designated TMs providing care to

Hepatitis B Surface Antigen

Positive patients do not provide

care at the same time for HBV

susceptible patients. TMs

instructed using surveyor

observation as examples with

emphasis on, but not limited to,

the following: 1) patient is

considered susceptible if hepatitis

B surface antibodies (HBsAB) is

< 10 mIU/ml; 2) TMs caring for

confirmed or suspect hepatitis B





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Hepatitis B susceptible patient (# 32)

listed in station 9, assigned to employee S

who also took care of stations 10, 11, and

12, potentially cross contaminating with

employee D, the RN.

C. On 12/29/14 at 10:30 AM,

employee D indicated they split the

stations with employee E, a RN, because

employee E is Hepatitis B susceptible so

cannot care for the isolation patients.

D. On 12/31/14 at 12:00 PM,

employee A indicated patient # 32 did

not come to dialysis on 12/29/14.

E. The staff assignment sheet dated

12/28/14 evidenced patient #2 dialyzed in

the isolation room from 8:45 AM-12:15

PM, and susceptible patient (#33) was

assigned at station 11 from 6:30-10:30

AM. This sheet also evidenced

susceptible employees E, G, and H were

assigned to stations 9-12. Employees G

and H were assigned specific stations,

but the document failed to evidence

which stations employee E was assigned

to.

F. The staff assignment sheet dated


the isolation room from 12:00-4:00 PM,

and susceptible patient (#7) was assigned

at station 15 from 11:00 AM-3:00 PM,

surface antigen (HbsAg) positive

patient(s) must not care for

surface antibody negative

(susceptible) patients

simultaneously, and 3) TM must

not change patient seating

assignments unless approved by

the charge nurse. Verification of

attendance at in-service is

evidenced by a signature sheet.

FA or designee will audit patient

seating chart/ TM assignment

daily x 2 weeks beginning

12/30/2014 to verify TMs are not

assigned to care for susceptible

and confirmed or suspected

HBsAg patients at the same time.

FA or designee will audit post

treatment records of susceptible

patients to ensure no TM caring

for Hepatitis B antigen positive

patient cared for susceptible

patients simultaneously, these

audits will be completed daily x2

weeks beginning 12/30/2014,

then weekly x4 weeks then

monthly. FA or designee will

conduct observational infection

control audits beginning

12/30/2014 on each shift daily for

two weeks, then once weekly x 1

month to verify TMs are not

caring for susceptible and

confirmed or suspected HBsAg

patients at the same time.

Ongoing compliance will be

monitored during monthly

infection control audit. FA will

review results of all audits with

Medical Director during monthly

FHM, minutes will reflect. FHM

minutes and activities will be





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susceptible patient (# 12) was assigned at

station 14 from 11:15 AM-3:15 PM, and


station 12 from 12:00-4:00 PM. This

sheet also evidenced susceptible

employees E and H were working, but

failed to evidence which stations

employee E was assigned to care for as

track 5 (stations 17, 18, 19, and 20, the

isolation room) was assigned to RNs and

a PCT name.

G. The staff assignment sheet dated






susceptible employees E and H were

working, but failed to evidence which

stations employee E was assigned to care

for as track 5 (stations 17, 18, 19, and 20,

the isolation room) was assigned to RNs

and a PCT.

H. The staff assignment sheet dated






susceptible employees E and H were

working, but failed to evidence which

stations employee E was assigned to.

reviewed during GB meetings to

monitor ongoing compliance. FA

and Medical Director are

responsible for compliance with

this plan of correction Completion

date: 2/5/2015





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I. The staff assignment sheet dated




assigned at station 11 from 6:30-10:30.

Susceptible employee H was assigned to

stations 13, 14, 15, and 16. This sheet

also evidenced susceptible employee E

was working, but failed to evidence

which stations employee E was assigned

to.

J. The staff assignment sheet dated






susceptible employee E was working, but

failed to evidence which stations

employee E was assigned to.

K. The staff assignment sheet dated




assigned at station 11 from 6:30-10:30,

and susceptible employee H was working

at station 5, 6, 7, and 8. This sheet failed

to evidence which RN was caring for the

isolation patient and what other stations

they were assigned to as track 5 (stations

17, 18, 19, and 20, the isolation room)





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were assigned to RNs and a PCT.

L. The staff assignment sheet dated


the isolation room from 12:00-4:00 PM,

and susceptible patient (#7) was assigned

at station 15 from 11:00 AM-3:00 PM,


station 14 from 11:15 AM-3:15 PM, and


station 12 from 12:00-4:00 PM. This

sheet also evidenced susceptible

employee E was assigned to stations 1, 2,

3, and 4 from 4:30 AM-5:00 PM, but

failed to evidence which stations the RNs

were assigned to care for as track 5

(stations 17, 18, 19, and 20, the isolation

room) are assigned to RNs and a PCT.

M. The staff assignment sheet dated



PM, susceptible patient (# 17) was


AM, susceptible patient (# 33) was

assigned to station 11 from 6:30-10:30

AM, and susceptible employee E was

working from 5:00-9:00 AM. This sheet

failed to evidence which RN was caring

for the isolation patient and what other

stations they were assigned to as track 5

(stations 17, 18, 19, and 20, the isolation

room) are assigned to RNs and a PCT.





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N. The staff assignment sheet dated





AM.

O. The staff assignment sheet dated



PM, susceptible patient (# 17) was


AM, susceptible patient (# 33) was

assigned to station 11 from 6:30-10:30

AM, and susceptible employee H was

assigned to stations 9, 10, 11, and 12.

This sheet failed to evidence which RN

was caring for the isolation patient and

what other stations they were assigned to

as track 5 (stations 17, 18, 19, and 20, the

isolation room) are assigned to RNs and a

PCT.


PM, employee A, the facility

administrator, indicated only the last 3

stations (17, 18, and 19) closest to the

isolation room have to hold patients who

have Hepatitis B antibodies and the staff

caring for stations 17-20 have to have HB

antibodies, but they were not sure if the

policy specifies more than that.






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PM, employee A indicated patient # 1 is

still receiving the series of Hepatitis B

vaccinations and needs one more shot.


PM, employee C indicated the Hepatitis

B report is current and includes the most

recent labs and vaccinations.


PM, employee A indicated the nurses are

listed at the top of the assignment sheet

and they all help cover the entire floor

and all patients, but when employees D

and E work they split the floor since

employee E cannot care for the isolation

patients due to being susceptible to

Hepatitis B. At 2:10 PM, employee A

indicated all staff help cover all patients

when staff take breaks. At 2:20 PM,

employee A indicated the facility has 24

susceptible patients and three susceptible

staff (E, G, and H).

6. Clinical record #2, the Hepatitis B

positive patient, contained a treatment

flow sheet dated 12/29/14 that evidenced

employees D, M, and R provided care to

the patient between 7:04 AM through

10:54 AM.

A. The treatment sheet dated

12/29/14 for Hepatitis B susceptible

patient (#25) evidenced the patient was at





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station # 14 and was provided care by

employees D, M, and H between 5:35

AM and 9:05 AM. The facility failed to

properly assign staff to Hepatitis B

positive and immune patients, and failed

to protect susceptible staff and patients

from cross contamination. Employees E,

G, and H are Hepatitis B susceptible.

B. The treatment sheet dated 12/29/14

for Hepatitis B susceptible patient (#1)

evidenced the patient was provided care

by employees D, M, H, S, and T between

6:25 AM and 10:30 AM. The facility

failed to properly assign staff to Hepatitis

B positive and immune patients, and

failed to protect susceptible staff and

patients from cross contamination.

Employees E, G, and H are Hepatitis B

susceptible.

C. The treatment sheet dated

12/29/14 for Hepatitis B immune patient

(#27) evidenced the patient was at station

# 10 and was provided care by employees

E, R, S and U between 6:20 AM and

10:20 AM. The facility failed to properly

assign staff to Hepatitis B positive and

immune patients, and failed to protect

susceptible staff and patients from cross

contamination. Employees E, G, and H

are Hepatitis B susceptible. The facility

failed to ensure employee R did not cross

over to Hepatitis B susceptible patients





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and staff after having provided care to

patient #2.

D. The staff assignment sheet dated

12/29/14 evidenced the Hepatitis B

susceptible staff (employees D, H and G)

were assigned to work and the PCTs H

and G were assigned to stations 1, 2, 3,

and 4. Per employee D interview at

10:30 AM, RN employee E was assigned

to stations 1-10. The treatment sheet

dated 12/29/14 for Hepatitis B immune

patient (# 26) evidenced employees D

and U provided care at station 3 between

6:20 AM and 9:50 AM. The facility

failed to properly assign staff to Hepatitis

B positive and immune patients, and

failed to protect susceptible staff and



susceptible. The facility failed to ensure

employee R did not cross over to

Hepatitis B susceptible patients and staff

after having provided care to patient #2.

7. Clinical record # 3, the second

Hepatitis B positive patient, contained a

treatment flow sheet dated 12/15/14 that

evidenced employees D and T provided

care to the patient between 1:45 PM and

4:05 PM. The record evidenced this

patient also has a diagnosis of Hepatitis

C.





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12/15/14 evidenced the RNs on staff

were employee E from 5 AM to 5 PM,

employee D 9 AM to closing, employee

X from 5 AM to 9 AM, and employee Y

from 5 PM to closing. The facility failed

to identify which stations were assigned

to the RNs. PCT employee T was

assigned to stations 9-12.

B. The treatment sheet dated 12/15/14



by employees E, O, T, and Y between

11:05 AM and 3:00 PM at station 16.

The facility failed to properly assign staff

to Hepatitis B positive and immune

patients, and failed to protect susceptible

staff and patients from cross


are Hepatitis B susceptible.

C. The treatment sheet dated


patient (#15) evidenced the patient was

provided care by employees A, D, G, and

T between 11:00 AM and 5:07 PM at

station 9. The facility failed to properly


immune patients and failed to protect








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D. The treatment sheet dated


patient (#28) evidenced the patient was

provided care by employees D, O, P, and

Y between 11:05 AM and 3:00 PM at

station 16. The facility failed to properly


immune patients and failed to protect




E. The treatment sheet dated 12/15/14



by employees D, G, T, and Y between

3:45 PM and 7:25 PM, at station 12. The

facility failed to properly assign staff to

Hepatitis B positive and immune

patients, and failed to protect susceptible

staff and patients from cross



F. The treatment sheet dated 12/15/14



by employees D, G, H, and P between

12:00 PM and 4:40 PM at station 4. The

facility failed to properly assign staff to

Hepatitis B positive and immune patients

and failed to protect susceptible staff and







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susceptible.


PM, employee A indicated the medical

director is on vacation and out of the

country and the back up medical director

goes on vacation tomorrow. Employee A

indicated they will notify the next

physician who will be covering vacation

time and is also a medical director at

another facility.


PM, employee I, the physician covering

medical director vacation, indicated they

were notified about the IJ last night, the

policies and procedures are reviewed at

the monthly meetings, protocol is the

same across the country for Hepatitis B.

This is an easy fix, and there have never

been any conversions at this facility.

Employee I also indicated all staff go

through hand washing, personal

protective equipment (PPE), and

infection control protocols.


AM, employee J, the back up medical

director, indicated Hepatitis B vaccines

are reviewed, staff are inserviced via

company, and medical director reviews

policies as far as if they are medically

appropriate and give approval or

direction if changes are needed.





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Employee J indicated the facility should

have dedicated staff for the Hepatitis B

positive and immune patients in order to

prevent sero-conversion.


AM, employee A indicated the medical

director is the only staff left to inservice

and will be notified of the IJ upon arrival

back from vacation.


PM, employee M indicated the facility

performs monthly infection control

attestations and audits making sure staff

are doing proper hand washing, central

venous catheter access care, and PPE use.

Employee M indicated isolation rooms

staff are to wash hands prior to entering

and leaving, and wear gown, gloves and

shield in room and no equipment or

anything comes out of the isolation room.

Employee M indicated before 12/29/14

the seating for patients was 3 chairs prior

to the isolation room had to have patients

with antibodies to HepB or over 10, and

the facility has 1 nurse and 1 PCT who

are susceptible and cannot take care of

HepB positive patients.


PM, employee R indicated they do

infection control daily and have hand

washing reminders. Employee R





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indicated they now have patients with

greater than 10 antibodies all on one side

of the room, but it was not this way

before yesterday.


PM, employee A indicated there was no

further information to submit for review.

15. The facility's policy titled "Infection

Control and Isolation Measures for

Known or Suspected Hepatitis B Surface

Antigen Positive Patients," # 1-05-09,

revised September 2014, states "Patient

Seating and Teammate Assignments, ...

29. Surface antibody positive (immune)

patients are seated between the confirmed

or suspect hepatitis B surface antigen

(HBsAg) positive patient and the

susceptible patient to serve as a

geographic buffer. 30. Teammates

caring for confirmed or suspect hepatitis

B surface antigen positive (HBsAg)

positive patient(s) do not care for surface

antibody negative (susceptible) patients

simultaneously. 31. When preparing

patient assignments, teammates who care

for confirmed or suspected hepatitis B

surface antigen (HBsAg) positive

patient(s) will only be assigned to

simultaneously care for surface antibody

positive (immune) patients. ... 33.

When possible, only HBV immune

teammates should be assigned to care for





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the Hepatitis B antigen positive patients."

494.30(b)(1)

IC-O-SIGHT-MONITOR

ACTIVITY/IMPLEMENT P&P

The facility must-

(1) Monitor and implement biohazard and

infection control policies and activities within

the dialysis unit;

V000142

Based on administrative record review

and interview, the facility failed to ensure

a quality assessment and performance

improvement (QAPI) program was in

place that included observation of high

risk tasks for compliance with infection

control methods, identification and

resolution of infection control practices,

and noncompliance and the management

of patients with regards to their hepatitis

B status for 1 of 1 QAPI program

reviewed creating the potential to affect

all the facility's 24 Hepatitis B


susceptible staff.

Findings include


AM, employee A indicated the QAPI

program addresses the infection control

audits monthly and they do in-house

audits for compliance with hand washing,

personal protective equipment use,







contamination. Ongoing facility

audits initiated 12/30/2014 to

observe and monitor TM

practices during high risk tasks

for compliance with infection

control methods, practices, and

management of patients with

regards to patients Hepatitis B

status and monitor patient seating

and staff assignments. Clinical

Service Specialist (CSS) will hold

in-service for all members of

Facility Health Team by 2/5/2015.

In-service will include but not be

limited to: Review of Policy &

Procedure #1-14-06 Continuous

Quality Improvement Program

emphasizing team must ensure

system is in place for effective

monitoring and auditing of TM

practices regarding Hepatitis B

and provision of care for infection

control. Team must ensure facility

infection control monitoring and

02/05/2015 12:00:00AM





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central venous catheter access, and watch

for breaches of policies and procedures.

2. The infection control audit dated

11/2014 failed to evidence the facility

monitored for patient seating and staff

assignments to separate susceptible staff

and patients from potential exposure to

Hepatitis B by cross contamination.

3. The staff assignment sheet dated





is <10, or Hepatitis B immune if it is

>10. The patients listed at stations 13 and

14 (patients 1 and 25) were <10 and



are far enough away from the isolation

room.









employee D, the RN.

B. On 12/29/14 at 10:30 AM,

identify infection control problems

such as TM non-compliance with

policies and procedures related to

infection control,

performing/documenting routine

serologic testing for Hepatitis B

virus, Hepatitis B Surveillance;

and ensure designated TMs



are immune and do not provide


susceptible patients by analyzing

data collected including facility

internal audits, and review of

patient seating and staff

assignments; conducting

evaluation of areas not meeting

facility goals, identifying root

causes for underperformance,

develop recommendations and

action plans to minimize infection

transmission and promote

immunizations. Team must

review current action plans in

place, evaluate effectiveness, and

initiate new plans as needed to

meet goals along with tracking

performance over time to ensure

improvements are sustained.

FHM minutes must reflect

discussion, actions and

evaluation by team. Verification

of attendance at in- evidenced by

TMs signature on in-service

sheet. FA or designee will audit

patient seating chart/ TM

assignment daily x 2 weeks, audit

post treatment records of

susceptible patients daily x 2

weeks, then weekly x 4 weeks

then monthly; conduct





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observational infection control on

each shift daily x 2 weeks, then

once weekly x 1 month beginning

12/30/2014 to verify compliance.

Ongoing compliance will be

monitored during monthly

infection control audits. FA

and/or Clinical Coordinator will

monitor and update as

appropriate patient hepatitis

schedule monthly and review

during FHM beginning at next

scheduled meeting by FA or

Clinical Coordinator. Team will

review monthly hepatitis

surveillance and ensure that

assignment sheets reflect

patient’s current status. FA will

bring results of all internal audits

including those related to

infection control, HBV

monitoring/surveillance, and

patient vaccination status for

review with Medical Director

during monthly FHM, minutes will

reflect. CSS will attend or review

meeting minutes x 3 months to

ensure minutes are

comprehensive and reflective of

actions taken. FHM minutes and

activities will be reviewed during

GB meetings to monitor ongoing

compliance, minutes will reflect.

FHM minutes and activities will be






date: 2/5/2015





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Seating and Teammate Assignments, 29.

Surface antibody positive (immune)




















494.110(a)(2)(ix)

QAPI-INDICATOR-INF

V000637





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CONT-TREND/PLAN/ACT

The program must include, but not be

limited to, the following:

(ix) Infection control; with respect to this

component the facility must-

(A) Analyze and document the incidence of

infection to identify trends and establish

baseline information on infection incidence;

(B) Develop recommendations and action

plans to minimize infection transmission,

promote immunization; and

(C) Take actions to reduce future incidents.

Based on administrative record review

and interview, the facility failed to ensure

a quality assessment and performance

improvement (QAPI) program was in

place that included observation of high

risk tasks for compliance with infection

control methods, identification and

resolution of infection control practices,

and noncompliance and the management

of patients with regards to their hepatitis

B status for 1 of 1 QAPI program

reviewed, creating the potential to affect

all the facility's 24 Hepatitis B


susceptible staff.

Findings include













contamination. Ongoing facility

audits initiated 12/30/2014 to

observe and monitor TM

practices during high risk tasks

for compliance with infection

control methods, practices, and

management of patients with

regards to patients Hepatitis B

status and monitor patient seating

and staff assignments. All

patients will be offered hepatitis

vaccination series upon

admission and per CDC

recommendations and all patients

will be educated using CDC

Vaccination Information

Statement, all patients refusing

vaccination will receive education

by rounding physician, within the

first 30 days after admission and

offered series annually.

Vaccination tracker in place to

ensure all patients in process of

receiving hepatitis series are

02/05/2015 12:00:00AM





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room.









employee D, the RN.

B. On 12/29/14 at 10:30 AM,

tracked to ensure completion of

series as per policy and

procedure. Facility Health Team

will review monthly Hepatitis B

surveillance report and ensure

CDC recommendations for

testing and immunization of

susceptible patients. Team will

review susceptible patients

monthly and ensure that daily

assignments reflect patient status

to verify care of susceptible

patients in accordance with

infection control policies and

procedures. CSS will hold

in-service for all members of

Facility Health Team by 2/5/2015.

In-service will include but not be

limited to: Review of Policy &

Procedure #1-14-06 Continuous

Quality Improvement Program

emphasizing team must ensure

system is in place for effective

monitoring and auditing of TM

practices regarding Hepatitis B

and provision of care for infection

control. Team must ensure facility

infection control monitoring and

identify infection control problems

such as TM non-compliance with

policies and procedures related to

infection control,

performing/documenting routine

serologic testing for Hepatitis B

virus, Hepatitis B Surveillance;

and ensure designated TMs



are immune and do not provide


susceptible patients by analyzing

data collected including facility





02/02/2015PRINTED:

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OMB NO. 0938-0391




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B. WING

(X3) DATE SURVEY

COMPLETED


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TAG




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TAG



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internal audits, and review of

patient seating and staff

assignments; conducting

evaluation of areas not meeting

facility goals, identifying root

causes for underperformance,

develop recommendations and

action plans to minimize infection

transmission and promote

immunizations. Team must

review current action plans in

place, evaluate effectiveness, and

initiate new plans as needed to

meet goals along with tracking

performance over time to ensure

improvements are sustained.

FHM minutes must reflect

discussion, actions and

evaluation by team. Verification

of attendance at in- evidenced by

TMs signature on in-service

sheet. FA and/or Clinical

Coordinator will monitor and

update as appropriate patient

hepatitis schedule monthly and

review during FHM beginning at

next scheduled meeting by FA or

Clinical Coordinator. Team will

review monthly hepatitis

surveillance and ensure that

assignment sheets reflect

patient’s current status. FA will

bring results of all internal audits

including those related to

infection control, HBV

monitoring/surveillance, and

patient vaccination status for

review with Medical Director

during monthly FHM, minutes will

reflect. CSS will attend or review

meeting minutes x 3 months to

ensure minutes are





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comprehensive and reflective of

actions taken. FHM minutes and




FHM minutes and activities will be






date: 2/5/2015

494.150(c)(2)(i)

MD RESP-ENSURE ALL ADHERE TO P&P

The medical director must-

(2) Ensure that-

(i) All policies and procedures relative to

patient admissions, patient care, infection

control, and safety are adhered to by all

individuals who treat patients in the facility,

including attending physicians and

V000715





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nonphysician providers;

Based on document review, and

interview, the medical director failed to

ensure the facility staff followed infection

control policies and procedures to include

adherence to assigning dedicated staff to

the Hepatitis B positive and immune

patients only, creating the potential to

affect all the facility's 24 susceptible

patients and 3 susceptible staff.

Findings include




















V000715 V715 Governing Body meeting

was held on 1/14/2015. Medical

Director Responsibilities reviewed

with Medical Director,

emphasizing the importance in

executing his roles and

responsibilities to ensure TMs

adhere to the policies,

procedures, and processes

relative to infection control, and

safety in the provision of patient

care. Medical Director

acknowledges that he is

responsible to ensure facility TMs

are trained and follow policy &

procedure, and deficiencies

identified need corrected timely

with the support of facility team.

Plans of Correction have been

developed and initiated to correct

identified deficiencies and sustain

compliance. Medical Director will

review progress of TM education,

results of internal audits, and

adherence to this plan of

correction during bi-weekly

Governing Body and monthly

Facility Health Meetings. FA will

report progress, as well as any

barriers to maintaining

compliance, with supporting

documentation included in the

meeting minutes. Action plans will

be evaluated for effectiveness,

new plans developed as

applicable to achieve 100%

compliance with TM adherence to

policy and procedure, minutes will

reflect. Once compliance is

achieved FHM minutes and


02/05/2015 12:00:00AM





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room.









employee D, the RN.

B. On 12/29/14 at 10:30 AM,
















FA and Medical Director are



date: 2/5/2015





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6. Employee file G, date of hire (DOH)

10/13/14 evidenced the employee

declined the Hepatitis B vaccination and

Hep B surface antigen level was <3.

7. Employee file E, DOH 11/12/12

evidenced the employee declined the

Hepatitis B vaccination and Hep B

surface antigen level was negative.

8. Employee file H, DOH 2/19/07

evidenced the employee declined the

Hepatitis B vaccination and Hep B

surface antigen level was negative.








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printed: 02/02/2015 department of health and …printed: 02/02/2015 form approved omb no. 0938-0391...

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