STATEMENT OF DEFICIENCIES (X2) MULTIPLE ...EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (X5) COMPLETE DATE ID PREFIX TAG (X4) ID TAG SUMMARY STATEMENT

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(X1) PROVIDER/SUPPLIER/CLIA

IDENTIFICATION NUMBER:

STATEMENT OF DEFICIENCIES

AND PLAN OF CORRECTION

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PRINTED: 08/20/2013 FORM APPROVED

(X2) MULTIPLE CONSTRUCTION

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Division of Health Service Regulation

MHL041-879 07/25/2013

NAME OF PROVIDER OR SUPPLIER

CROSSROADS TREATMENT CENTER OF GREENSBORO, PC

STREET ADDRESS, CITY, STATE, ZIP CODE

2706 NORTH CHURCH STREET

GREENSBORO, NC 27405

PROVIDER'S PLAN OF CORRECTION

(EACH CORRECTIVE ACTION SHOULD BE

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SUMMARY STATEMENT OF DEFICIENCIES

(EACH DEFICIENCY MUST BE PRECEDED BY FULL

REGULATORY OR LSC IDENTIFYING INFORMATION)

V 000 INITIAL COMMENTS V 000

An annual and complaint survey was completed

on July 25, 2013. Deficiencies were cited. These

complaints were substantiated (Intake #

NC00088081, Intake NC #00089869, Intake

#NC00088889, Intake #NC00089858, and Intake

# NC00089855). These complaints were

unsubstantiated (Intake #NC00089196, Intake

#NC00089808, Intake #NC00089870, Intake

#NC90288 and Intake #NC90330). Deficiencies

were cited.

This facility is licensed for the following service

category: 10A NCAC 27G .3600 Outpatient

Opioid Treatment

V 105 27G .0201 (A) (1-7) Governing Body Policies

10A NCAC 27G .0201 GOVERNING BODY

POLICIES

(a) The governing body responsible for each

facility or service shall develop and implement

written policies for the following:

(1) delegation of management authority for the

operation of the facility and services;

(2) criteria for admission;

(3) criteria for discharge;

(4) admission assessments, including:

(A) who will perform the assessment; and

(B) time frames for completing assessment.

(5) client record management, including:

(A) persons authorized to document;

(B) transporting records;

(C) safeguard of records against loss, tampering,

defacement or use by unauthorized persons;

(D) assurance of record accessibility to

authorized users at all times; and

(E) assurance of confidentiality of records.

(6) screenings, which shall include:

(A) an assessment of the individual's presenting

V 105


LABORATORY DIRECTOR'S OR PROVIDER/SUPPLIER REPRESENTATIVE'S SIGNATURE TITLE (X6) DATE

If continuation sheet 1 of 1396899STATE FORM DOBD11

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V 105Continued From page 1 V 105

problem or need;

(B) an assessment of whether or not the facility

can provide services to address the individual's

needs; and

(C) the disposition, including referrals and

recommendations;

(7) quality assurance and quality improvement

activities, including:

(A) composition and activities of a quality

assurance and quality improvement committee;

(B) written quality assurance and quality

improvement plan;

(C) methods for monitoring and evaluating the

quality and appropriateness of client care,

including delineation of client outcomes and

utilization of services;

(D) professional or clinical supervision, including

a requirement that staff who are not qualified

professionals and provide direct client services

shall be supervised by a qualified professional in

that area of service;

(E) strategies for improving client care;

(F) review of staff qualifications and a

determination made to grant

treatment/habilitation privileges:

(G) review of all fatalities of active clients who

were being served in area-operated or contracted

residential programs at the time of death;

(H) adoption of standards that assure operational

and programmatic performance meeting

applicable standards of practice. For this

purpose, "applicable standards of practice"

means a level of competence established with

reference to the prevailing and accepted

methods, and the degree of knowledge, skill and

care exercised by other practitioners in the field;



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This Rule is not met as evidenced by:

Based on record reviews and interviews, the

facility failed to implement its discharge policy.

The findings are:

Review on 4/18/13 of the facility ' s policy and

procedure manual regarding the discharge

criteria of clients revealed:

- " Discharge Summary: When a patient leaves

services, a written discharge summary is

prepared to ensure that the person served has

documented treatment episodes and results of

treatment. 1. The discharge summary will include:

a. Date of admission, b. Description of services

provided, c. Presenting condition: Description of

the extent to which goals and objectives included

in the Treatment Plan were achieved, d.

Description of the reasons for discharge, e. The

status of the person served at last contact, f.

Counselor ' s recommendations for services or

other supports, g. date of discharge from the

program. 2. The Primary Counselor and Medical

Director will sign all Discharge Summaries within

30 days of discharge. 3. The final signed copy will

be placed in the patient ' s chart. "

Review on 5/12/13 of Deceased Client #2 (DC

#2) ' s record revealed:

- An admission date of 8/2/12

- A diagnosis of Opioid Dependence

- A date of death of 3/18/13

- He was 29 years of age

-A facility discharge summary list dated 5/13/13

with a discharge date of 3/26/13 with the reason

for discharge entered by the Program Director #1

(PD#1) as " left against staff advice - missed 7

consecutive days after being contacted. "

- No documentation of a discharge summary



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#3) ' s record revealed:

-An admission date of 12/28/12

-Diagnoses of Generalized Anxiety Disorder,

Panic Disorder, Post Traumatic Stress Disorder,

Mood Disorder, Depressive Disorder and Opioid

Disorder

-A date of death of 3/1/13

-He was 20 years of age



for discharge entered by the PD#1 as " left

against staff advice - missed 7 consecutive days

after being contacted. "

-No documentation of a discharge summary


#4)' s record revealed:




-He was 35 years of age

- A facility discharge summary list dated 5/13/13


for discharge entered by the PD #1 as " left





#5)' s record revealed:


-A diagnosis of Opioid Dependence


-She was 32 years of age



for discharge entered by the PD #1 as " left




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Review on 4/12/13 of Former Client #1 (FC #1)' s

record revealed:


-A diagnosis of Opioid Dependence

A discharge date of 1/9/13


Interview on 5/13/13 with Counselor #16

revealed:

- " Discharge summaries have to be approved.

Counselors do it after approval. 7 day no show. "

Interview on 5/16/13 with the Clinical Director

(CD) revealed:

- " Counselors do discharge summary. Methasoft

system (facility ' s computer program), name

pops up on each form. Whoever discharges

client their name appears on discharge summary.

"

-When asked if there was a reason why PD #1 ' s

name would be on discharges she replied: "

Would be no other reason why. Everybody

discharges their own people. "

- " Counselors are responsible for discharges. "

Interview on 5/16/13 with The Program Director

#1 (PD #1) revealed:

-Regarding who does Discharge Summaries: " If

patient misses 7 days and counselor has it noted

counselor will send me and [Assistant Program

Director #1 (APD #1)] and [CD] an email stating

they need to discharge. We make sure counselor

has made contact. And it ' s documented on the

no show list, make sure they are not hospitalized

or incarcerated (if so keep open for 30 days). On

8th day (of no show) they are discharged.

Counselor does that (the discharge summary) all



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done in Methasoft (facility ' s computer program).

(Counselor) finds patient in computer goes to

discharge and brings up service (which has

patient identifier on it). There ' s a drop down box

with all the reasons patient has been discharged.

They print that out and put it in the (client ' s) file.

"

-No reason was provided as to why the

Counselors did not complete their own discharge

summaries and why PD #1 entered the reasons

for discharge for each client.

Interview on 5/16/13 with the Medical Director

revealed:

-Regarding Discharges: " My role is anyone they

are considering discharge they run it by me and

we discuss it. We taper them down and then

refer them to a higher level of care if they need it.

"

-No reason was provided as to why the

Counselors did not complete their own discharge

summaries and why PD #1 entered the reasons

for discharge for each client.

V 109 27G .0203 Privileging/Training Professionals

10A NCAC 27G .0203 COMPETENCIES OF

QUALIFIED PROFESSIONALS AND

ASSOCIATE PROFESSIONALS

(a) There shall be no privileging requirements for

qualified professionals or associate professionals.

(b) Qualified professionals and associate

professionals shall demonstrate knowledge, skills

and abilities required by the population served.

(c) At such time as a competency-based

employment system is established by rulemaking,

then qualified professionals and associate

professionals shall demonstrate competence.

(d) Competence shall be demonstrated by

V 109



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exhibiting core skills including:

(1) technical knowledge;

(2) cultural awareness;

(3) analytical skills;

(4) decision-making;

(5) interpersonal skills;

(6) communication skills; and

(7) clinical skills.

(e) Qualified professionals as specified in 10A

NCAC 27G .0104 (18)(a) are deemed to have

met the requirements of the competency-based

employment system in the State Plan for

MH/DD/SAS.

(f) The governing body for each facility shall

develop and implement policies and procedures

for the initiation of an individualized supervision

plan upon hiring each associate professional.

(g) The associate professional shall be

supervised by a qualified professional with the

population served for the period of time as

specified in Rule .0104 of this Subchapter.


Based on record reviews and interviews 2 of 9

Qualified Professionals (QPs) failed to

demonstrate knowledge, skills and abilities

required by the population served (the Program

Director #1 (PD #1) and Assistant Program

Director #1 (APD #1). The findings are:

Review on 4/10/13 of the PD #1 ' s record

revealed:

- A hire date of 11/1/10

- A job description of Program Director

Review on 6/14/13 of an email from the Vice



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President of Operations revealed:

- PD #1 was terminated on 5/24/13

Review on 4/10/13 of the APD #1 ' s record

revealed:


- A job description of the Assistant Program

Director

Review on 7/25/13 of the Plan of Protection dated

7/25/13 written by the Director of Nursing,

(Registered Nurse #1/Director of Nursing)

Assistant Program Director, (Assistant Program

Director #2) Program Director (Program Director

#2) and Vice President of Operations revealed:

- APD #1 was transferred to another role within

the agency outside of Greensboro on 6/3/13


revealed:

- " After you all (State surveyors) left the first time,

[the PD #1] had a staff meeting and passed

around the rules and regulations and a book on

IRIS (Incident Response Improvement System) .

He told us the rules and regulations about

reporting deaths had changed. So, I asked him,

these rules have changed after April (2013) and

he said ' these laws change all the time ' ...he

said there was a loop hole where he wouldn ' t

have to report the deaths ...it was one of those

shady things that went on around here. If you

asked him any questions, he would not answer it.

He would talk around it. The day the State came

out (on 4/8/13), they (the PD #1, the APD #1 and

the Clinical Director (CD)) came around and told

us, ' there ' s only one death that has occurred. "

[Counselor #3] was asked by [the APD #1] to

change the clients ' records (deceased clients)

saying we had tried to contact the clients, but they

were already dead. They wanted us to make it



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look like we did not know they had died. We saw

one client ' s death (Deceased Client #2 (DC #2))

on the news ... "

Further interview on 5/21/13 with Counselor #15

revealed:

- " It is my understanding that deaths must be

reported immediately. [The PD #1] is responsible

for that. "

- " I have some text messages (dated 5/8/13)

between me and [the APD #1] about them lying

about the deaths of clients. "

Review on 5/21/13 of texts, dated 5/8/13,

between Counselor #15 and the APD #1

regarding the patients deaths revealed:

- Counselor #15 was concerned because " I

knew [the PD #1] was lying to us (about not

having to report deaths), which he was ...if he had

done what he was legally obligated to do, this

wouldn ' t be an issue ...he ' s not protecting us by

lying ... [the PD #1 ' s] choices have affected us

all ...you really thought it was a good idea (to lie to

the State)? All of our careers are on the line ...I

answered [the State Opioid Treatment Authority '

s Coordinator (SOTA)] truthfully when she

interviewed me ...I know right from wrong ...lying

is wrong ...you can ' t sit there and say what was

going on here was ethical ...I answered truthfully

bc (because) it was the right thing to do ...YOU

put your career and license on the line when you

lied when you and [the PD #1] were asked about

this (client deaths) in the beginning ... "

- The APD #1 ' s responses to Counselor #15 ' s

concerns: " ...you should have clue me on the

fact that you put my job and my license on the

line ...supervisors lie all the time to protect their

employees ...that was a shitty selfish move on

your part (to tell the State about deaths not being

reported) ...I don ' t know what you ' ll try to use



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against me if this goes to court ...[the PD #1] has

never lied to me ...you may have gotten us shut

down and I may not have a job ...if you have a

problem with your place of employment you quit

...you threw us (the facility) under the bus ... "

Interview on 5/15/13 with Counselor #3 revealed:

- " I learned of [DC #2] ' s death the day that it

happened (3/18/13), on the news. I was his

counselor. The next morning, I got to work and

pulled his chart. I took his chart to [APD #1] ' s

office and [the PD #1] was in there. They said '

yeah, we know it was him (DC #2) ...I was told to

make sure the file was in order and I took the file

into [the PD #1] ' s office and never saw it again

...then I was instructed to go back into the notes

(by the PD #1) to change what I had put in there. I

was documenting the client was deceased every

day for 7 days. I had to change the

documentation to show that he was absent for 7

consecutive days so he could be shown as

discharged and a death report would not have to

be reported ...I was told to change it

(documentation) by [the APD #1] also ...it was

unethical and wrong ...they did this intentionally

...all the staff here knew there was more than one

deceased client ... After you (the State) left the

first time, we had several staff meetings to go

over the criteria for reporting deaths and it had

changed ...we knew it was a lie ...He (the PD #1)

told us the death reporting (requirements)

changed daily ... "


revealed:

- " I was at home the night it (DC #2 ' s death)

was aired on [a local television station]. I knew it

was [Counselor #3 ' s] client ...we were highly

instructed by all 3 (the PD #1, the APD #1 and

the CD) not to have a clue about any other deaths



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except [Deceased Client #1] ' s ...[The CD] went

to each counselor ' s office, whether it was

through [the PD #1] ' s advice or on her own

doing, to tell us we were to tell the State there

was only one death ...we (the counselors) were

all wondering why the deaths were not reported

...we were concerned with the legality of it (not

reporting the deaths) ...[the PD #1] was in

[Counselor #3 ' s] office as she was documenting

in [DC #2] ' s that he was deceased. [The APD

#1] instructed her to change her documentation to

make it look like he was still alive and that he was

absent from the program ...if anytime [the PD #1 '

s] mouth is moving, he is lying ... "

Interview on 5/15/13 with the Senior Counselor #1

revealed:

- " I was on vacation and recently returned. I just

recently learned (about the deaths) due to other

counselors talking. I understand people have died

and things weren ' t done right (unreported

deaths). Some of it (not reporting the deaths) is

disturbing. They are just trying to cover

themselves when the State comes in. It should

have been a process. There is chaos here.

Reporting them (the deaths) would be the ethical

thing to do. "

Interview on 5/16/13 with the CD revealed:

- " Deaths are reported to [the PD #1], [the APD

#1] and now me. [The PD #1] does them (the

IRIS report). I don ' t know the requirements to

report a death. I have not had anyone

(counselors) report deaths on their caseloads.

The deaths have been mentioned in staff

meetings and we do talk about it. I am not sure

who would make a note (document) about the

debriefing with the counselors ... "

Interview on 5/17/13 with the APD #1 revealed:



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- " [The PD #1] filled out the report in IRIS (for

patient deaths). We were under the impression

we had to confirm a death through family

members, hospitals and the death report (from

the Medical Examiner) before we reported it. Now

we have to report it if we have a suspicion it

occurred. We don ' t have a lot of deaths. I have

not had any deaths. I don ' t think I have ever

done a death report. My guess is that the

counselors do the death reports. Sometimes [the

PD #1] will do it (IRIS reports) because he has

the death report or death certificate. All the death

reports go to [the PD #1] and he does IRIS then. "

- When asked about the recent deaths of clients,

the APD #1 stated, " Gosh, I don ' t know exactly

(when the clients died). Probably some time,

gosh, I hate to say, February or January (2013)? I

don ' t remember the patients ' names. A couple

of clients dosed a few times. The counselor could

not reach or get in touch with their emergency

contact. A few days later we found an obituary. It

was not a confirmed death. We did not find out

about the deaths until after discharge. We would

use an obituary as unconfirmed, unless we had

contact with the family ...with [DC #2]; I know his

counselor was [Counselor #3]. She wrote

deceased in her notes. I told her to put patient

discharged. She was told to put that she tried to

have contact. We had not confirmed his death.

The protocol was to call the client or the family.

We could not get a hold of them. We don ' t

typically use a news article (to confirm a death)

...People can have the same first and last name.

We would call their emergency contact. We just

happened to check and see if we could find the

deaths. It was something we just stumbled upon

(clients ' deaths). It could have been in March

(when we learned of the death). I know it was in

the first quarter of the year ... [DC #1] is the one I

am talking about ...with [DC #2], we could never



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confirm it. A couple of employees saw a news

article about his death. The counselor (Counselor

#3) would not verify it (his death) with the family.

It was not my patient. I heard it through the

grapevine. They told me and then I assume they

called [the PD #1] as well. We really like to have it

(a death) confirmed with family. I know IRIS asks

for a cause of death. We cannot list it without an

autopsy. I don ' t report deaths, so no, I ' ve never

been told not to report them. "

- Regarding DC #3 ' s death: " I don ' t remember

if we talked about it in a staff meeting. I spoke

with his mother weeks after his death. She

wanted a refund ($200.00) on his account. I know

Corporate cut her a check. His (DC #3 ' s) mom

called to speak with someone in charge. The call

was transferred to me. It was one of those

random things ... "

Interview on 5/16/13 with the PD #1 revealed:

- " If a counselor is out for any reason and there

is a death (of a patient), I have to investigate the

death. If it is by another patient ' s report or we

hear that a patient has died, it is not a confirmed

death. After the last visit by [the SOTA

Coordinator], I was told to contact the patient ' s

emergency contact, contact the local police

department and complete an IRIS report. I was

cited for this because I did not know I had to

report deaths to the State Opioid Treatment

Authority ...If it is a confirmed death, I call the

police, the Office of the Chief Medical Examiner

(OCME) and try to get the death certificates ...I

was not aware unconfirmed deaths had to be

reported ...it is my responsibility to report (the

deaths). If I contact family (of a deceased patient)

and they confirm the death, that is confirmation of

a death. If I have an obituary, that would be

confirmed (death). That is while they are an

active patient ...if 3 or 4 weeks later and the



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patient is discharged and died, I was under the

assumption our responsibility ends at the date of

discharge ...I only reported one death ...I am

aware of the 4 other deaths ...those 4 clients

were discharged and we went through the

process of trying to contact the patient, contacting

local police and just got confirmation (Medical

Examiner ' s Report) on 2 of the patients ...[DC

#2] and what ' s the other name (of the deceased

client)?...ummm, oh crap. I just got the report this

week ...since they were discharged, I won ' t

report those (discharged patients deaths) ...With

[DC #2], I don ' t know the exact date of his

death. It was a patient I think that came in and

reported it. I tried to contact his emergency

contact and tried the Sheriff ' s Department. I

could not get in touch with them. I am not sure if

the counselor (Counselor #3) did ...I have to

contact the family if they are an active patient ...if

a counselor tells me they thought a patient died,

then I start the process (of trying to confirm the

death). I was made aware of [DC #2] ' s death

after his discharge. I was not made aware of all 4

deaths until after their discharge. I don ' t know

why [Counselor #3] did not tell me about [DC #2] '

s death ...with [DC #4] and [DC #5] ' s deaths, I

learned after their discharge. I cannot remember

when [Counselor #6] started. I did not want her in

the position, on her first day, to be involved in that

(contacting family or emergency contact on a

patient that had died) ... "

- " I made the contacts daily, numerous contacts,

daily (to try to get in touch with the deceased

clients). I do that as part of my job. I feel

responsible to do that. We (me and the

counselors) work together, unless the counselor

contacts a family member. I am not aware if any

of the counselors contacted the deceased clients

' family members. None of the family members

(of the deceased clients) have contacted me. The



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counselor for the clients (deceased) should have

contacted me ...I would complete an IRIS report

on active clients that have died ...I don ' t know if

a patient is discharged, do I report to IRIS if they

are discharged and died afterwards? [The SOTA

Coordinator] did not interview me (when she was

out in April 2013). That would be a question I ' d

like answered ...I have not covered up a death. I

will be glad to do that (report submitted in IRIS).

When is a patient not a patient? I can ' t find an

answer to that. So, do I go ahead and complete

IRIS (on the deaths)? Am I liable for these (the

deaths)? Is it IRIS ' fault? I did not know I had to

file them (the deaths). If a patient dies 6 months

later, do we still do an IRIS report? To be honest

with you, I don ' t know (if the IRIS reporting

criteria has changed) ...I have only done one

(death report in IRIS). We haven ' t had that many

deaths until now. I did not know they (the deaths)

had to be reported. I apologize for that. "


(MD) revealed:

- " Regarding patients ' deaths, there really is not

a protocol. My understanding is when there ' s

actual verification, [the CD] does a report. In

general practice, I sign off on it. That is pretty

much the extent of it. I just get a phone call from

Nursing or [the PD #1]. Sometimes they call with

a suspicion of a death. Death certificates are the

legal way we find out about deaths. We don ' t

check obituaries. If we saw an obituary, we can ' t

discuss it with just anyone. I was made aware of

the deaths, three of which were confirmed (DC

#1, DC #2 and DC #4). I guess that was about

three weeks ago. There have only been 4 deaths

since I have been here. "

Interview on 5/17/13 with the Corporate Director

of Clinical Practices revealed:



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- " [The PD #1] has been suspended last night

(5/16/13) as the Program Director. We are

becoming aware of incidents that needed to be

reported immediately. I am sure it will result in

termination ...I arrived at the facility on Tuesday,

(5/14/13). I had not had a lot of contact with [the

PD #1]. [The PD #1] said the State investigators

were here. He was very specific it was a

complaint (the State investigators were looking

into). What he said was that a patient had died

after discharge. How can we (Corporate Office)

know? He said why report it if they are not a client

anymore. In the course of my record audits, I

noticed he did not do something correctly. I found

I was not able to account for 12 charts. The

counselors said 4 of them (charts) were with the

State (surveyors) because they died. I spoke with

[the Chief Executive Officer/Program Sponsor

(CEO/PS)] and he said he had a conversation

with [the PD #1] over the phone. There were

patients that were discharged and had died. He

[CEO/PS] pressed [the PD #1]. When did they

(the 4 clients) die? Near their discharge date?

[The Program Director from Atlanta] and I sat at a

table and took the 4 deceased clients ' name and

went on the Internet to see the obituaries. I

looked their names up on Methasoft (the facility '

s computer program). I looked at the dates of

death versus the dates of discharge. Oh hell,

every one of these patients was discharged after

they died. That was not communicated to us by

[the PD #1]. I was not aware of [DC #1] ' s death

either. I spoke with [the CEO/PS] again. There is

no way 4 patients die and you don ' t report it. It is

appalling. It just can ' t happen. He (the PD #1)

was called and told he was suspended. There is

no way for it not to be communicated. You ' ve

got to know. It is doing your job. It all ends the

same way, termination. We are looking at

processes that need to change. About 3 weeks



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ago, I sent out a binder/template for critical

incident reports, very easy to track. I included the

manual which tells you how to report and to who.

We sent it out. In this situation, it clearly did not

get done. The first thing that had to happen was

[the PD #1] being suspended. Documentation

being deleted or added is beyond troubling. Why

not report a death? A death is a death. Trying to

hide it (deaths), I just don ' t understand it. "

This deficiency is cross referenced into 10A

NCAC 27D .0304 Protection from Harm, Abuse,

Neglect or Exploitation (V512) for a Type A1 rule

violation and must be corrected within 23 days.

V 110 27G .0204 Training/Supervision

Paraprofessionals

10A NCAC 27G .0204 COMPETENCIES AND

SUPERVISION OF PARAPROFESSIONALS

(a) There shall be no privileging requirements for

paraprofessionals.

(b) Paraprofessionals shall be supervised by an

associate professional or by a qualified

professional as specified in Rule .0104 of this

Subchapter.

(c) Paraprofessionals shall demonstrate

knowledge, skills and abilities required by the

population served.

(d) At such time as a competency-based

employment system is established by rulemaking,

then qualified professionals and associate

professionals shall demonstrate competence.

(e) Competence shall be demonstrated by

exhibiting core skills including:

(1) technical knowledge;

(2) cultural awareness;

(3) analytical skills;

(4) decision-making;

V 110



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(5) interpersonal skills;

(6) communication skills; and

(7) clinical skills.

(f) The governing body for each facility shall

develop and implement policies and procedures

for the initiation of the individualized supervision

plan upon hiring each paraprofessional.



facility failed to develop and initiate individualized

supervision plans for 5 of 13 audited

paraprofessional staff (Clinical Director (CD),

Counselors #3, #4, #6, and #16) and the CD

failed to demonstrate the knowledge, skills and

abilities required by the population served

affecting 1 of 13 audited paraprofessional staff

(the Clinical Director (CD)). The findings are:

Finding #1

Review on 5/13/13 of the facility ' s policy on

supervision of Paraprofessionals revealed:

- " All clinical staff members must receive

individual supervision. The goal of clinical

supervision is to ensure that client-centered

clinical care if provided to all purposes served

that works toward the goals identified in the client

' s individual treatment plan ... "

Review on 5/13/13 of the Program Director #1 ' s

(PD #1 ' s) Supervisory Notes Binder revealed:

- No documentation of supervision with audited

staff.

Review on 5/16/13 of Counselor #3 ' s record



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revealed:


- A job description of Substance Abuse Counselor

- Intern (SAC - I)


revealed:



- Registered (SAC-R)


revealed:


- A job description of Substance Abuse

Counselor-Registered (SAC-R)


revealed:



-Registered (SAC-R)

Review on 4/10/13 of the CD ' s record revealed:


- A job description of Clinical Director

Interview on 7/23/13 with the Vice President of

Operations revealed:

- Couselor #16 was terminated on 7/9/13

- The CD was terminated on 7/11/13


- " [The PD #1] is old school. I have had no

recent supervision, just a meeting (staff). You just

have to go and grab him (for supervision). I have

never done 1:1 supervision with [the PD #1] ... "


- Regarding supervision, " It is supposed to be



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[the PD #1] ...staff meetings are to be considered

supervision ... "


- " ...I go in and demand my supervision ...I

demand my supervision ...I am fairly new to this

field ... "


- Regarding supervision: " ...supervision with [the

PD #1] .... When I was hired, I was told he did

supervision differently ...group counseling ...can

have 1:1 if we have questions ...it was quite

different (supervision) where I worked previously

...it (supervision) was a little off to me ... "


revealed:

- Regarding supervision, " I plead the fifth on that

one. Anything I say about supervision would be

detrimental to my own program ... "


-No information regarding the supervision

provided to her by the PD #1.

Interview on 4/10/13 with the Assistant Program

Director #1 (APD #1) revealed:

- Regarding supervision, " ...it is through [the PD

#1] ...we don ' t have a scheduled time but spend

at least an hour a day with [the PD #1] or if

something comes up ... "


- " Supervision for a registered person is 4 hours

per week. We do this (supervision) individually,

group and patients ' staffing. I do group

differently ...if one of the counselors has a

question; I turn it back on them. We don ' t have a

set time for one hour per week for supervision.



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Most of the counselors don ' t learn that way

(meeting one hour per week for supervision). I

keep my supervisory notes in a binder. We have

many staff meetings (used for supervision). "

Finding #2

Review on 4/10/13 of the CD ' s record revealed:

- A job description of Clinical Director

- A client case load of 48


Deaths are reported to [the PD #1], [the APD #1]

and now me. [The PD #1] does them (the IRIS)

report). I don ' t know the requirements to report a

death. I have not had anyone (counselors) report

deaths on their caseloads. The deaths have been

mentioned in staff meetings and we do talk about

it. I am not sure who would make a note

(document) about the debriefing with the

counselors ... "

- Regarding DC #2: " I don ' t know when he

passed. I don ' t know why his name is on there

(deceased clients list). I don ' t know. Why would

they put a note in there if the person is

deceased? I don ' t know. I haven ' t messed with

that (case notes). I see what you are seeing (list

of deceased clients), but I don ' t know about that.

I would not go around telling people (counselors)

to do that (only talk about 1 death). I would not go

around telling people not to say that. These

deaths (5) were discussed in a staff meeting. I

am assuming the right things were done (deaths

being reported). I was a counselor then. I was not

the Clinical Director when the clients died. I would

think that the right procedures were followed

(regarding deaths being reported). "


- "[The CD] was telling us to tell the State there

was only one client death."



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revealed:

- " The day the State came out (on 4/8/13), they

(the PD #1, the APD #1 and the CD) came

around and told us, ' there ' s only one death that

has occurred at the facility, I was surprised to

hear that ...she knew everything [the PD #1] was

doing ...she blessed me out for telling the truth

(revealing other clients had died)... "


revealed:

-The [CD] went to each counselor ' s office,

whether it was through [the PD #1] ' s advice or

on her own doing, to tell us we were to tell the

State there was only one death ...we (the

counselors) were all wondering why the deaths

were not reported ...we were concerned with the

legality of it (not reporting the deaths) ..."

V 116 27G .0209 (A) Medication Requirements

10A NCAC 27G .0209 MEDICATION

REQUIREMENTS

(a) Medication dispensing:

(1) Medications shall be dispensed only on the

written order of a physician or other practitioner

licensed to prescribe.

(2) Dispensing shall be restricted to registered

pharmacists, physicians, or other health care

practitioners authorized by law and registered

with the North Carolina Board of Pharmacy. If a

permit to operate a pharmacy is Not required, a

nurse or other designated person may assist a

physician or other health care practitioner with

dispensing so long as the final label, Container,

and its contents are physically checked and

approved by the authorized person prior to

V 116



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dispensing.

(3) Methadone For take-home purposes may be

supplied to a client of a methadone treatment

service in a properly labeled container by a

registered nurse employed by the service,

pursuant to the requirements of 10 NCAC 45G

.0306 SUPPLYING OF METHADONE IN

TREATMENT PROGRAMS BY RN. Supplying of

methadone is not considered dispensing.

(4) Other than for emergency use, facilities shall

not possess a stock of prescription legend drugs

for the purpose of dispensing without hiring a

pharmacist and obtaining a permit from the NC

Board of Pharmacy. Physicians may keep a small

locked supply of prescription drug samples.

Samples shall be dispensed, packaged, and

labeled in accordance with state law and this

Rule.


Based on observation, record reviews and

interviews, the facility failed to ensure prescription

drugs were dispensed with the final label,

container and its contents being physically

checked and approved by the authorized person

prior to dispensing affecting 4 of 10 clients dosed

(Former Client #1 (FC #1), Client #s 16, 17 and

18). The findings are:

Review on 4/11/13 and 4/12/13 of Former Client

#1 (FC #1) ' s record revealed:



- A discharge date of 1/9/13

- No physician ' s order noting FC #1 ' s

Methadone disks could be dispensed in any other

manner than in an approved container.



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Review on 5/17/13 of client #16 ' s record

revealed:



- No physician ' s order noting client #16 ' s




revealed:


- A diagnosis of Opioid Dependence, Anxiety and

Hepatitis C





revealed:






Interview on 4/11/13 with client #16 revealed:

- " ...It is just that certain nurse (Registered

Nurse #2 (RN #2)) that leaves them (pills) there

(in the bowl) ...it was a Styrofoam bowl ... "

Interview on 5/17/13 with client #17 revealed:

- " I remember seeing [RN #2] pour the bottle (of

Methadone 40mg disks) into a bowl ...I have not

seen that in awhile ...It would not surprise me if

someone tried to grab those pills ...I know she did

shut the window (dosing) when she was finished,

but I don ' t think she ever locked it (dosing

window) ... "



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Interview 5/17/13 with client #18 revealed:

- He had seen the Methadone 40mg disks in the

bowl during his dosing on 1/5/13

- He could not remember if they were within arm '

s reach, but stated " they (the Methadone 40mg

disks) were visible to anyone that dosed that day

... "

Attempted interview on 5/17/13 with FC #1 was

unsuccessful.

-Further attempted interviews on 4/12/13 and

4/16/13, with FC #1, were unsuccessful due to

her statement " I don ' t want to answer any

questions ...I have something to do. "

Observation on 4/12/13, at approximately 6:52

am, of the bowl used by RN #2 to dispense

Methadone 40mg disks revealed:

- The bowl was made of heavy duty paper

- The bowl had no final medication label

Review on 5/16/13 of the facility ' s dosing roster

from 1/5/13 by RN #2 revealed:

- Ten clients had dosed at the handicapped

accessible (dosing) window on 1/5/13

Interview on 4/12/13 with RN #2 revealed:

- She poured 100 40mg Methadone disks into a

bowl on 1/5/13.

- She poured the disks into the bowl due to " that

is the way I was trained. "

- There was no label on the bowl

- No one had authorized her to dispense the

Methadone disks into the bowl.

Further interview on 5/15/13 with the RN #2

revealed:

- " I poured the whole bottle into the bowl. That '

s how I was trained ...all in one place (putting the

disks in the bowl). Now we hand count them.



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Some disks/bottles had too little or too much

methadone in them. I now put the bottle under the

counter. "

Interview on 4/11/13 with the Registered Nurse

#1/Director of Nursing (RN #1/DON) revealed:

- " ...I administer my pills (Methadone 40mg

disks) from the bottle. All of us do except [RN #2]

...when I administer the disks (pills), I keep them

under the counter (at the dosing window). "

Interview on 4/11/13 with the Licensed Practical

Nurse #1/Lead Dosing Nurse (LPN #1/LDN)

revealed:

- " ...We (nurses) all use the bottles for our

dosing and [RN #2] still uses the bowls. I don ' t

know why she (RN #2) can ' t keep her

medications (Methadone 40mg disks) in a bottle

like everyone else. "


Director #1 revealed:

- " ...I know she (RN #2) uses a bowl to keep her

pill count ... "


revealed:

- " That (RN #2) dispensing Methadone from a

bowl would not be an authorized or proper

method to dispense Methadone ... "

Interview on 4/17/13 with the Program Director #1

revealed:

- He was not sure why RN #2 poured the

Methadone disks into a bowl, " that is something

you will have to ask her. "

V 117 27G .0209 (B) Medication Requirements V 117



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REQUIREMENTS

(b) Medication packaging and labeling:

(1) Non-prescription drug containers not

dispensed by a pharmacist shall retain the

manufacturer's label with expiration dates clearly

visible;

(2) Prescription medications, whether purchased

or obtained as samples, shall be dispensed in

tamper-resistant packaging that will minimize the

risk of accidental ingestion by children. Such

packaging includes plastic or glass bottles/vials

with tamper-resistant caps, or in the case of

unit-of-use packaged drugs, a zip-lock plastic bag

may be adequate;

(3) The packaging label of each prescription

drug dispensed must include the following:

(A) the client's name;

(B) the prescriber's name;

(C) the current dispensing date;

(D) clear directions for self-administration;

(E) the name, strength, quantity, and expiration

date of the prescribed drug; and

(F) the name, address, and phone number of the

pharmacy or dispensing location (e.g., mh/dd/sa

center), and the name of the dispensing

practitioner.


Based on observations, record reviews and

interviews, the facility failed to ensure all

prescription medications were administered in

tamper-resistant packaging and labeled with clear

directions, expiration date of the drug and the

name and address of the dispensing location



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affecting 1 of 10 clients dosed (Former Client #1

(FC #1)). The findings are:

Observation on 4/12/13, at approximately

6:52am, of the bowl used by Registered Nurse #2

(RN #2) to dispense Methadone 40mg disks on

1/5/13 revealed:

- The bowl was made of heavy duty paper

- The bowl was not in a tamper-resistant package

- There was no expiration date of the drug

- There was no name and address of the

dispensing location

Review on 5/16/13 of the facility ' s dosing roster

from 1/5/13 by RN #2 revealed:

- Ten clients had dosed at the handicapped

accessible window on 1/5/13

Review on 4/11/13 and 4/12/13 of FC #1 ' s

record revealed:





revealed:




revealed:


- A diagnosis of Opioid Dependence, Anxiety and

Hepatitis C


revealed:





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Interview on 4/12/13 with RN #2 revealed:

- " ...I keep my bowl of pills (Methadone 40mg

disks) to my right side on the counter ... "

-When asked why the bowl, filled with pills was on

the counter, RN #2 stated, " The bowl was on the

counter because I was getting ready to count

them ... "

- She stated the bowl was not in a

tamper-resistant package

- She stated there was no expiration date of the

drug

- She stated there was no name and address of

the dispensing location



- " ...She (RN #2) kept hers (Methadone 40mg

disks) in a bowl off to the side. "

- The RN#1/DON stated the bowl was not in a

tamper-resistant package

- The RN #1/DON stated there was no expiration

date of the drug

- The RN#1/DON stated there was no name and

address of the dispensing location


Nurse #1/Lead Dosing Nurse (LPN #1/LDN))

revealed:

- The LPN #1/LDN stated the bowl used by RN#1

was not in a tamper-resistant package

- The LPN #1/LDN stated there was no expiration

date of the drug

- The LPN #1/LDN stated there was no name and

address of the dispensing location


revealed:

- " That (RN #2 dispensing Methadone from a

bowl) would not be an authorized or proper

method to dispense Methadone ... "



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revealed:

- He was not sure why RN #2 poured the

Methadone disks into a bowl, " that is something

you will have to ask her. "

- He did not think the bowl was a tamper-resistant

package because there was no locking top to the

bowl

- He was not sure what was required to be

labeled on a prescription medication bottle

V 118 27G .0209 (C) Medication Requirements


REQUIREMENTS

(c) Medication administration:

(1) Prescription or non-prescription drugs shall

only be administered to a client on the written

order of a person authorized by law to prescribe

drugs.

(2) Medications shall be self-administered by

clients only when authorized in writing by the

client's physician.

(3) Medications, including injections, shall be

administered only by licensed persons, or by

unlicensed persons trained by a registered nurse,

pharmacist or other legally qualified person and

privileged to prepare and administer medications.

(4) A Medication Administration Record (MAR) of

all drugs administered to each client must be kept

current. Medications administered shall be

recorded immediately after administration. The

MAR is to include the following:

(A) client's name;

(B) name, strength, and quantity of the drug;

(C) instructions for administering the drug;

(D) date and time the drug is administered; and

(E) name or initials of person administering the

V 118



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drug.

(5) Client requests for medication changes or

checks shall be recorded and kept with the MAR

file followed up by appointment or consultation

with a physician.


Based on record reviews and interviews the

facility failed to administer medication on the

written order of a physician affecting 1 of 7

Deceased Clients (Deceased Client #3) (DC #3)).

The findings are:

Review on 5/13/13 of DC #3 ' s record revealed:


-A discharge date of 3/8/2013

-Client died on 3/1/13

-He was 21 years old

-Diagnoses of Generalized Anxiety, Panic

Disorder, Post Traumatic Stress Disorder, Mood

Disorder and Depressive Disorder

-Screening Assessment dated 12/28/12 which

reflected: history of IV (Intravenous) with opiates,

history of arrest, history of rehabilitation and

history of domestic violence.

-Treatment plan dated 12/18/12 which reflected

goals of: stabilize treatment in an outpatient

treatment program setting, Continue abstinence

of illicit substance use, Reduce burden of client

attendance

-Signed doctors order written 2/11/13 for 100 mg

Methadone

-No documentation of a signed physician ' s order

for 110 mg Methadone

-No SOWS (Subjective Opiate Withdrawal Scale)

or OOWS (Objective Opiate Withdrawal Scale) to

support the increased dose up to 110 mg



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Methadone


procedures for Dispensing Methadone revealed:

- " ...9. If the doctor has approved a change in

the patient ' s dosage level over the phone, two

important rules must be followed:

a. The order over the phone must be received

by the nurse;

b. An order must be written up by the nurse

and signed by the doctor within 72 hours (in NC

(North Carolina) only). "

Review on 5/13/13 of the facility ' s dosing report

record from 2/19-2/28/13 revealed:

-DC #3 received 110 mg Methadone on 2/19/13












-She had been employed at the facility since

September 2012

- " To increase over 100mg (of Methadone) need

doctor ' s order and need SOWS and OOWS on

every increase. "



- " Things were never quite clear before. "

-When asked to look through the file and find the

signed doctors order and the SOWS and OOWS

she could not locate any of these in DC #3 ' s file.



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- " If doc (the Medical Director (MD)) gave me a

verbal order would not need the SOWS and

OOWS to be honest we probably don ' t have the

SOWS and OOWS because we would print an

order and counselor would grab it before doc (the

MD) would sign it and then that ' s what could

have happened. "


revealed:

-When asked why DC #3 ' s increase up to

110mg of Methadone did not have a signed

physician order or SOWS and OOWS he replied:

" shouldn ' t be a reason but a lot of times SOWS

and OOWs are in a big stack nurses have to go

through it and give it to counselors to file. "

Interview on 5/16/13 with the MD revealed:

-He had been employed at the facility for five

years

-When asked about the missing order for DC #3 '

s increase of Methadone to 110mg on 2/19/13 he

replied: " They call me on every increase so

there must have been one. Now they are faxing

me orders every day. "

-When asked if he would have approved the

increase to 110mg for DC #3 ' s Methadone on

2/19/13 without the SOWS and OOWS he

replied: " No. "

V 131 G.S. 131E-256 (D2) HCPR - Prior Employment

Verification

G.S. §131E-256 HEALTH CARE PERSONNEL

REGISTRY

(d2) Before hiring health care personnel into a

health care facility or service, every employer at a

health care facility shall access the Health Care

Personnel Registry and shall note each incident

V 131



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of access in the appropriate business files.



facility failed to access the Health Care Personnel

Registry (HCPR) prior to hire for 3 of 22 audited

staff (Counselors #2, #3, and #16). The findings

are:


revealed:



- No HCPR check was completed


revealed:



Counselor 1

- No HCPR check was completed


revealed:



-Intern

- A HCPR was completed on 4/10/13





(PD #1) revealed:



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- It was the Corporate Office ' s responsibility to

ensure HCPR checks were conducted prior to

hire.



- " [The PD #1] was not consistent with getting

the HCPR checks done. He was responsible for

that. "

V 133 G.S. 122C-80 Criminal History Record Check

G.S. §122C-80 CRIMINAL HISTORY RECORD

CHECK REQUIRED FOR CERTAIN

APPLICANTS FOR EMPLOYMENT.

(a) Definition. - As used in this section, the term

"provider" applies to an area authority/county

program and any provider of mental health,

developmental disability, and substance abuse

services that is licensable under Article 2 of this

Chapter.

(b) Requirement. - An offer of employment by a

provider licensed under this Chapter to an

applicant to fill a position that does not require the

applicant to have an occupational license is

conditioned on consent to a State and national

criminal history record check of the applicant. If

the applicant has been a resident of this State for

less than five years, then the offer of employment

is conditioned on consent to a State and national

criminal history record check of the applicant. The

national criminal history record check shall

include a check of the applicant's fingerprints. If

the applicant has been a resident of this State for

five years or more, then the offer is conditioned

on consent to a State criminal history record

check of the applicant. A provider shall not

employ an applicant who refuses to consent to a

criminal history record check required by this

V 133



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section. Except as otherwise provided in this

subsection, within five business days of making

the conditional offer of employment, a provider

shall submit a request to the Department of

Justice under G.S. 114-19.10 to conduct a


section or shall submit a request to a private

entity to conduct a State criminal history record

check required by this section. Notwithstanding

G.S. 114-19.10, the Department of Justice shall

return the results of national criminal history

record checks for employment positions not

covered by Public Law 105-277 to the

Department of Health and Human Services,

Criminal Records Check Unit. Within five

business days of receipt of the national criminal

history of the person, the Department of Health

and Human Services, Criminal Records Check

Unit, shall notify the provider as to whether the

information received may affect the employability

of the applicant. In no case shall the results of the

national criminal history record check be shared

with the provider. Providers shall make available

upon request verification that a criminal history

check has been completed on any staff covered

by this section. A county that has adopted an

appropriate local ordinance and has access to

the Division of Criminal Information data bank

may conduct on behalf of a provider a State


section without the provider having to submit a

request to the Department of Justice. In such a

case, the county shall commence with the State


section within five business days of the

conditional offer of employment by the provider.

All criminal history information received by the

provider is confidential and may not be disclosed,

except to the applicant as provided in subsection



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(c) of this section. For purposes of this

subsection, the term "private entity" means a

business regularly engaged in conducting

criminal history record checks utilizing public

records obtained from a State agency.

(c) Action. - If an applicant's criminal history

record check reveals one or more convictions of

a relevant offense, the provider shall consider all

of the following factors in determining whether to

hire the applicant:

(1) The level and seriousness of the crime.

(2) The date of the crime.

(3) The age of the person at the time of the

conviction.

(4) The circumstances surrounding the

commission of the crime, if known.

(5) The nexus between the criminal conduct of

the person and the job duties of the position to be

filled.

(6) The prison, jail, probation, parole,

rehabilitation, and employment records of the

person since the date the crime was committed.

(7) The subsequent commission by the person of

a relevant offense.

The fact of conviction of a relevant offense alone

shall not be a bar to employment; however, the

listed factors shall be considered by the provider.

If the provider disqualifies an applicant after

consideration of the relevant factors, then the

provider may disclose information contained in

the criminal history record check that is relevant

to the disqualification, but may not provide a copy

of the criminal history record check to the

applicant.

(d) Limited Immunity. - A provider and an officer

or employee of a provider that, in good faith,

complies with this section shall be immune from

civil liability for:

(1) The failure of the provider to employ an



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individual on the basis of information provided in

the criminal history record check of the individual.

(2) Failure to check an employee's history of

criminal offenses if the employee's criminal

history record check is requested and received in

compliance with this section.

(e) Relevant Offense. - As used in this section,

"relevant offense" means a county, state, or

federal criminal history of conviction or pending

indictment of a crime, whether a misdemeanor or

felony, that bears upon an individual's fitness to

have responsibility for the safety and well-being of

persons needing mental health, developmental

disabilities, or substance abuse services. These

crimes include the criminal offenses set forth in

any of the following Articles of Chapter 14 of the

General Statutes: Article 5, Counterfeiting and

Issuing Monetary Substitutes; Article 5A,

Endangering Executive and Legislative Officers;

Article 6, Homicide; Article 7A, Rape and Other

Sex Offenses; Article 8, Assaults; Article 10,

Kidnapping and Abduction; Article 13, Malicious

Injury or Damage by Use of Explosive or

Incendiary Device or Material; Article 14, Burglary

and Other Housebreakings; Article 15, Arson and

Other Burnings; Article 16, Larceny; Article 17,

Robbery; Article 18, Embezzlement; Article 19,

False Pretenses and Cheats; Article 19A,

Obtaining Property or Services by False or

Fraudulent Use of Credit Device or Other Means;

Article 19B, Financial Transaction Card Crime

Act; Article 20, Frauds; Article 21, Forgery; Article

26, Offenses Against Public Morality and

Decency; Article 26A, Adult Establishments;

Article 27, Prostitution; Article 28, Perjury; Article

29, Bribery; Article 31, Misconduct in Public

Office; Article 35, Offenses Against the Public

Peace; Article 36A, Riots and Civil Disorders;

Article 39, Protection of Minors; Article 40,



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Protection of the Family; Article 59, Public

Intoxication; and Article 60, Computer-Related

Crime. These crimes also include possession or

sale of drugs in violation of the North Carolina

Controlled Substances Act, Article 5 of Chapter

90 of the General Statutes, and alcohol-related

offenses such as sale to underage persons in

violation of G.S. 18B-302 or driving while

impaired in violation of G.S. 20-138.1 through

G.S. 20-138.5.

(f) Penalty for Furnishing False Information. - Any

applicant for employment who willfully furnishes,

supplies, or otherwise gives false information on

an employment application that is the basis for a

criminal history record check under this section

shall be guilty of a Class A1 misdemeanor.

(g) Conditional Employment. - A provider may

employ an applicant conditionally prior to

obtaining the results of a criminal history record

check regarding the applicant if both of the

following requirements are met:

(1) The provider shall not employ an applicant

prior to obtaining the applicant's consent for

criminal history record check as required in

subsection (b) of this section or the completed

fingerprint cards as required in G.S. 114-19.10.

(2) The provider shall submit the request for a

criminal history record check not later than five

business days after the individual begins

conditional employment. (2000-154, s. 4;

2001-155, s. 1; 2004-124, ss. 10.19D(c), (h);

2005-4, ss. 1, 2, 3, 4, 5(a); 2007-444, s. 3.)



facility failed to request the required state and/or



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nationwide criminal record checks within 5

business days of offering employment for 4 of 22

audited staff (Counselors #2, #3, #16 and the

Assistant Program Director #1 (APD #1). The

findings are:


revealed:



- A criminal record check was completed on

2/19/13


revealed:




11/9/12


revealed:



Counselor-Intern


4/10/13




Review on 7/23/13 of the APD #1 ' s record

revealed:


- A job description of Assistant Program Director


11/9/12




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- APD #1 was transferred to another role within

the agency outside of Greensboro on 6/3/13


(PD #1) revealed:

- It was the Corporate Office ' s responsibility to

ensure criminal record checks were requested

within 5 business days of offering employment



- " Regarding the criminal record checks. Those

are done at the home office. "

V 235 27G .3603 (A-C) Outpt. Opiod Tx. - Staff

10A NCAC 27G .3603 STAFF

(a) A minimum of one certified drug abuse

counselor or certified substance abuse counselor

to each 50 clients and increment thereof shall be

on the staff of the facility. If the facility falls below

this prescribed ratio, and is unable to employ an

individual who is certified because of the

unavailability of certified persons in the facility's

hiring area, then it may employ an uncertified

person, provided that this employee meets the

certification requirements within a maximum of 26

months from the date of employment.

(b) Each facility shall have at least one staff

member on duty trained in the following areas:

(1) drug abuse withdrawal symptoms; and

(2) symptoms of secondary complications

to drug addiction.

(c) Each direct care staff member shall receive

V 235



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continuing education to include understanding of

the following:

(1) nature of addiction;

(2) the withdrawal syndrome;

(3) group and family therapy; and

(4) infectious diseases including HIV,

sexually transmitted diseases and TB.



facility failed to ensure a minimum of one certified

drug abuse counselor or certified substance

abuse counselor shall be on staff for each 50

clients for 6 out of 22 audited staff (Counselors

#2, #3, #6, #15, #16, & Senior Counselor #1).

The findings are:


procedure manual, on Ensuring Adequate

Staffing, revealed:

- " ...It is the policy of CTC (Crossroads

Treatment Center) to have sufficient amount of

qualified staff members on duty during the

program ' s hours of operation. Sufficient qualified

staff is defined as the minimum number of

employees necessary to carry out the policies

and provide the services offered by the program

...Full-time substance abuse counselors shall

carry a caseload not exceeding fifty (50) OTP

(Opioid Treatment Program) patients. This will

help ensure that each counselor has adequate

capacity to provide all relevant services for

persons served ... "


revealed:

-A hire date of 2/4/13



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revealed:



revealed:



revealed:



revealed:




- Counselor #15 was terminated on 7/10/13


Review on 4/11/13 of Senior Counselor #1 ' s

record revealed:



-His caseload was 52.

- " I have been trying to keep up with my

caseloads ...at first I really struggled with it...

$1 a day we are taking in more clients than we

can handle, are equipped for. The patients aren '

t getting what they need (services) if spread too

thin, can ' t do treatment for clients. "


-She had 52 patients on her caseload.

- " I was told I wouldn ' t get a caseload. [The PD

#1] assigned cases to me. I was to have

transition patients (new patients)



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-She was employed on 3/18/13 and reported "the

dollar per day was already going on when I got

here but will end on 6/1/13."


- The facility offered a fee reduction program

which allowed clients to pay a dollar per day for

their methadone for the first 30 days in treatment

-There was an increase in client intakes as a

result of this fee reduction


- " I was up to 55 clients. "


- She had a current caseload of 51

- She was not a certified drug abuse counselor or

certified substance abuse counselor but was

working towards it

- The Program Director #1 (PD #1) was aware

that her caseload exceeded 50


revealed:

- " I have a caseload of 53 right now. It ' s not

manageable to provide care. It ' s good for case

management. If someone came in and needed

more I wouldn ' t have time. I got 4 new patients

while I was out on vacation "

-When asked who monitors patients while you ' re

on vacation she replied: " I don ' t know. "

-When asked what the policy was on getting a

new client when you ' re out on vacation she

replied: " I don ' t know. We would complain

about the caseloads and [The PD #1] would say '

Fifty thousand years ago I had 300 plus clients

and I did the paperwork and got all his stuff done '

. He didn ' t say fifty thousand but said a lot of

years ago had 300 plus clients and got all my

stuff done. "



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revealed:

-She had worked at the facility since 11/21/11

- " I have 55 patients. Been like that past two

years ...We ' re not adequately staffed, we have

sent emails to Corporate. There ' s no way

possible to do all that you ' re asking us to do and

be in compliance. We have asked and asked for

more staff. No training Manual. We ' ve always

been understaffed. Should be no more than 50

patients. I don ' t think we should have any more

patients until we are adequately staffed. Eleven

presented for intake yesterday and then no

training provided. The operational policies that

should happen don ' t. I learned all of that by

myself. No training provided here. It ' s all about

the money. "

Interview on 4/11/13 with Senior Counselor #1

revealed:

- " Current caseload is 52. It was 53, discharged

1. This $1 a day we ' re offering, the treatment is

not effective been going on since we ' ve been

here ...I am not able to get all the intake

paperwork, doctor may leave, then they can ' t

dose ...It is not feasible to get it all done in the

time we have ...I understand people have died

and things weren ' t done right ...Some patients

want to see their counselor, it is hard to turn them

away ... "

Interview on 5/16/13 with The Program Director

#1 revealed:

-When asked if he was aware that all of his

counselors had over the 50 minimum clients on

their caseloads he replied: " Yes. I interviewed

three (perspective employees) this week but I

wouldn ' t hire any of them.

- I am aware staff is over the 50:1 ratio. Our plan



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or goal is to be 45:1. We are actively recruiting

(counselors) ...It is hard to find people ...more

counselors are leaving the field than coming. "

This deficiency is cross referenced into 10A

NCAC 27D .0304 Protection from Harm, Abuse,

Neglect or Exploitation (V512) for a Type A1 rule


V 237 27G .3604 (A-D) Outpt. Opiod - Operations

10A NCAC 27G .3604 OPERATIONS

(a) Hours. Each facility shall operate at least six

days per week, 12 months per year. Daily,

weekend and holiday medication dispensing

hours shall be scheduled to meet the needs of

the client.

(b) Compliance with The Substance Abuse and

Mental Health Services Administration (SAMHSA)

or The Center for Substance Abuse Treatment

(CSAT) Regulations. Each facility shall be

certified by a private non-profit entity or a State

agency, that has been approved by the SAMHSA

of the United State Department of Health and

Human Services and shall be in compliance with

all SAMHSA Opioid Drugs in Maintenance and

Detoxification Treatment of Opioid Addiction

regulations in 42 CFR Part 8, which are

incorporated by reference to include subsequent

amendments and editions. These regulations are

available from the CSAT, SAMHSA, Rockwall II,

5600 Fishers Lane, Rockville, Maryland 20857 at

no cost.

(c) Compliance With DEA Regulations. Each

facility shall be currently registered with the

Federal Drug Enforcement Administration and

shall be in compliance with all Drug Enforcement

Administration regulations pertaining to opioid

treatment programs codified in 21 C.F.R., Food

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and Drugs, Part 1300 to end, which are

incorporated by reference to include subsequent

amendments and editions. These regulations are

available from the United States Government

Printing Office, Washington, D.C. 20402 at the

published rate.

(d) Compliance With State Authority Regulations.

Each facility shall be approved by the North

Carolina State Authority for Opioid Treatment,

DMH/DD/SAS, which is the person designated by

the Secretary of Health and Human Services to

exercise the responsibility and authority within the

state for governing the treatment of addiction with

an opioid drug, including program approval, for

monitoring compliance with the regulations

related to scope, staff, and operations, and for

monitoring compliance with Section 1923 of P.L.

102-321. The referenced material may be

obtained from the Substance Abuse Services

Section of DMH/DD/SAS.


Based on observations, record reviews and

interviews, the facility failed to comply with the

federal guidelines to diversion of medication

administration affecting 1 of 10 clients dosed

(Former Client #1 (FC #1). The findings are:

Observation on 4/17/13, at approximately

12:27pm, of the facility ' s American Disability Act

(ADA) dosing window, revealed:

- The ADA dosing window was 34 inches high

compared to the three other windows which were

41 inches high.

Review on 4/17/13 of the Federal Regulations

pertaining to Security Provisions revealed:

- " 21 CFR part 1300, specifically 21 CFR



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1301.71 (a) states ' all applicants and registrants

shall provide effective controls and procedures to

guard against theft and diversion of controlled

substances. "


procedure manual revealed:

- " Accounting for Lost or Stolen Controlled

Substances - Local law enforcement agency, the

Bureau of Drug Control and the Drug

Enforcement Agency (DEA) will be notified within

five days of the discovery of the loss/theft of

controlled substances used by [The Crossroads

Treatment Center of Greensboro PC] as required

by regulations. "

Review on 4/11/13 and 4/12/13 of FC #1 ' s

record revealed:




- In a urinalysis report, dated 1/4/13, she tested

positive for Cocaine, TetraHydroCannabinol

(THC) and Benzodiazepines (Benzos).

Review on 4/11/13 of the Registered Nurse #2 ' s

(RN #2) record revealed:


- A job description of Registered Nurse

Review on 4/10/13 of the facility ' s Inventory Bulk

Reconciliation form, dated 1/5/13, revealed:

- " Transaction Type/Transaction Detail:

Reconcile - Discrepancy Bottle Shortage -

Comment: Patient (pt.) (FC #1) attempted to

steal Methadone by reaching into the dosing

window when told [the Medical Director] ordered

a no dose due to (d/t) obvious impairment and a

positive drug screen for Cocaine, THC and

Benzos. She ran from the building chased by



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security guard. Five tablets were removed from

her possession but one is missing. "

Review on 4/16/13 of the facility ' s Supervisory

Meeting, dated 1/7/13, revealed:

- " 1) 1/5/13 incident (theft of 40mgs methadone

disk) - [Registered Nurse #2] was dosing - [FC

#1] became very upset when she was told she

would not be dosing due to a positive Urine

Analysis (U/A) for Benzos, THC and Cocaine per

[the Medical Director (MD)]. [FC #1] jumped into

the dosing window, grabbed several 40mg disks

and ran out of the clinic. [The Security Guard

(SG)] stopped [FC #1] from entering her vehicle.

All disks were recovered with the exception of

one 40mg. [The SG] searched the parking lot and

[FC #1]. The disk could not be located. According

to [the Security Guard], [FC #1] didn ' t have time

to swallow the disk ...Elimination of problem: 1)

Assure all medications are kept out of reach of all

patients (pts); 2) When a nurse leaves his/her

dosing window, make sure the window is locked

and medication is relocated to a place that can ' t

be accessed by patients (pts).. 3) Agitated

patients (pts) - have the security guard escort the

patient (pt) to the dosing window, observe dosing,

escort the patient (pt) to his/her vehicle ... "

Interview on 4/11/13 with FC #1 revealed:

- " ...There was a whole big bowl of them

(Methadone 40mg disks) sitting there (on the

counter at the dosing window). I was standing

there a long time ...anyone (clients) could have

grabbed the bowl ...it is just that certain nurse

(RN #2) that leaves them (pills) there (in the bowl)

...it was a Styrofoam bowl ...I grabbed 4 or 5

(pills) and I took (ingested) one of them ...I just

wanted my medication ...I lied saying I did not

take it (pill), but I did ...I gave [the SG] the pills I

had in my hand ... "



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- Further attempts to gain information from FC #1

were unsuccessful due to her statement " I don '

t want to answer any questions ...I have

something to do. "

Interview on 4/12/13 with the RN #2 revealed:

- " ...This was on a Saturday (1/5/13). I keep my

bowl of pills (Methadone 40mg disks) to my right

side on the counter. They (the pills) were pretty

close to the window. It is a lower window

(handicap accessible) than the other dosing

windows. When she came to the window, she

was acting silly and was slurring her words. I

informed her we would have to take a urine

analysis (u/a). It came back positive for Cocaine,

THC and Methadone. I called [the MD] and we

were told we could not dose her. I called her to

the window and told her. I was prepared for her

temper tantrum. She said ' I can ' t believe this

shit. ' She reached into the window where the

bowl was (on the counter) and grabbed the pills.

One nurse [Registered Nurse #1/Director of

Nursing (RN #1/DON)] chased after her and

yelled for [the SG]. Five (pills) were missing. We

recovered all but one. We are pretty sure she

popped (ingested) it. I am pretty sure I told [the

Program Director #1 (PD #1)] she took one. It

was a white 40mg Methadone pill. "

- When asked how the incident (on 1/5/13)

occurred, the RN # 2 stated, " It is easy for

clients to reach through the window. They could

see the pills when they were dosing. "

Interview on 4/11/13 with the RN #1/DON

revealed:

- " I was sitting two stations over ...I saw her (FC

#1) run towards the door to leave. I heard the

sound of the pills in the bowl and the reaching in.

I heard [RN #2] yell for [the SG] ...She (FC #1)

was impaired and was not getting her dose for



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the day, so she probably thought ' Here it (the

Methadone disk) is. I am just going to take it. ' I

think it was 5 pills taken and 1 was unaccounted

for. I know they searched her body. She did not

have anything in her mouth, but could have

swallowed them ...there is no way to know what

could have happened. It could have been lethal

(for her to swallow the pills) with what she had in

her system ...[RN #2] was using the handicapped

accessible window that day (1/5/13) and the shelf

under the dosing window is not high enough to

store medications under it, so she kept hers (pills)

in a bowl off to the side. [RN #2] ' s pills were not

out of sight (of the patients) ... "


Nurse #2 (LPN #2) revealed:

- " I saw [RN #2] sitting at the handicapped

accessible window (dosing) that day (1/5/13)

...the handicapped accessible window (dosing)

does not have a cabinet shelf. [FC #1] came to

dose and when she was told she would not be

able to, she said ' what am I going to do over the

weekend? I will be sick. ' She ran out with a

handful of pills. I was not aware of how much she

had taken. We counted and ended up losing 1

pill. It was never accounted for ... [The SG]

frisked her and looked in her pocket which she

flipped inside out. She could have put them

anywhere. One option could be that she could

have hidden the one that was unaccounted for. It

is a possibility she could have taken the missing

pill or all of them. She could have gotten away

with all the pills in the bowl ...she could have

overdosed ...that window (the handicapped

accessible) did not lock. "


revealed:

- When asked about the incident of FC #1



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stealing Methadone pills on 1/5/13, Counselor

#15 stated, " I was told she would not be

returning because she grabbed a handful (5 pills)

of Methadone (pill form). [The SG] stopped her

and one of the pills was unaccounted for. It is

possible she could have swallowed them. I am

surprised she did not take them all (five pills). She

could have overdosed. "


Director #1 (APD #1) revealed:

- " ... [FC #1] came in and appeared to be

impaired (on 1/5/13). She tested positive for

Benzos, Cocaine and THC. When they spoke

with [the MD], they were told they could not dose

her. She got very upset and said ' I am not

leaving here without my meds. ' That is when she

leaned over, reached in the window and grabbed

some tablets, maybe 4 or 5. I don ' t recall. [The

SG] was called and detained her. She gave all

but 1 pill back ...it is possible she could have

taken (ingested) the pill that was not recovered. If

she had overdosed, she could have died or had

health complications. "

Interview on 4/10/13 with the State Opioid

Treatment Authority Coordinator (SOTA)

revealed:

- " This is major (FC #1 grabbing Methadone pills

from the dosing window) ...this is a significant

event, very concerning because someone could

have died ... "

Interview on 4/10/13 with the Administrator/Co

Director for SOTA revealed:

- " ...How did the physical barrier (dosing

window) allow her (FC #1) to reach in? Had she

(FC #1) not been caught (with the Methadone 40

mg disks), it could have been lethal ... "



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- " [FC #1], if ingested a 40mg disk of

Methadone, in addition to testing positive for

Benzos, THC and Cocaine, she could have

respiratory distress (failure), she could have

overdosed on Methadone or had a heart attack. "

Interviews on 4/11/13 and 4/12/13 with the PD #1

revealed:

- " With one pill (40 mg) missing, I did not do an

investigation. The pill was reconciled as a theft. I

left a message for [the Drug Enforcement Agency

(DEA) representative] and never heard back. He

is usually good about returning calls. He never

got back to me. "

- When asked if he followed up with the DEA

representative, the PD #1 stated, " no. "

- When asked if he contacted the Bureau of Drug

Control or the local law enforcement agency, the

PD #1 stated " no. "

- When asked if he contacted the

Administrator/Co Director for the SOTA, the PD

stated " no. "

- When asked if he contacted the Division of

MH/DD/MA/SAS Community Policy Management

Section or the State Opioid Treatment

Coordinator, the PD #1 stated " no. "

- " ...I was the only one that observed the video

on that date (1/5/13). I saw her (FC #1) reach

through the window to the left and grab the pills

...the reach into the bowl was about 4 feet. If

anyone (clients) wanted to get the pills, they could

have. "

Review on 4/17/13 of the facility ' s Plan of

Protection, dated 4/17/13 and completed by the

PD #1 revealed:

- What immediate action will the facility take to

ensure the safety of the consumers in your care?

" The ADA (American Disability Act) dosing



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window has not been in use since the theft of a

40mg disk. All nurses have been instructed to

keep the window closed and locked at all times.

When dosing, all nurses keep all disks and 5mg

tablets under the counter and out of the patients

sight. The methadone pump is kept on the

opposite side of the open dosing window. The

security guard has been instructed to patrol the

lobby and dosing area more frequently. "

- Describe your plans to make sure the above

happens.

" The Program Director, Asst (Assistant)

Program Director, Clinical Director and RN

(Registered Nurse) monitor the pharmacy during

the dosing hours. The Clinical Director also

monitors the outside portion of the pharmacy.

The security guard also monitors the outside of

the pharmacy. To assure compliance with all

Federal, State, local rules and regulations, the

Administrative staff will be required to: complete

all IRIS (Incident Response Improvement

System) reports as soon as an incident occurs,

complete an incident report for the Program

Director, Asst Program Director and Clinical

Director to review, review all

SAMHSA/CARF/DEA (Substance Abuse and

Mental Health Services

Administration/Commission on Accreditation of

Rehabilitation Facilities/Drug Enforcement

Authority) rules and regulations regarding OTP ' s

(Opioid Treatment Program ' s). All reviews will

be documented and the documentation will be

kept in the Program Director ' s office. "

Describe the preventive measures in place prior

to the violation.

" The ADA dosing window has not been in use

since the theft of a 40mg disk. All nurses have

been instructed to keep the window closed and

locked at all times. When dosing, all nurses keep

all disks and 5mg tablets under the counter and



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out of the patients sight. The methadone pump is

kept on the opposite side of the open dosing

window. The security guard has been instructed

to patrol the lobby and dosing area more

frequently. Also, the PD, Asst PD, Clinical

Director have been reviewing the security

cameras on a random basis to assure the ADA

window is not used. "

- Describe how and when the violation was

corrected.

" The incident occurred on 1/5/13. On 1/7/13, this

Director contacted [the landlord] to repair the

broken dosing window. The window was repaired

on 1/7/13. "

- Describe the corrective measures the facility

implemented to achieve and maintain

compliance.

" The ADA dosing window has not been in use

since the theft of a 40mg disk. All nurses have

been instructed to keep the window closed and

locked at all times. When dosing, all nurses keep

all disks and 5mg tablets under the counter and

out of the patients sight. The methadone pump is

kept on the opposite side of the open dosing

window. The security guard has been instructed

to patrol the lobby and dosing area more

frequently. [Registered Nurse #2] and all other

nurses completed a course on Medication

Management in Essential Learning. All nurses

have been instructed to not pour any medication

in bowls and re-dispense medication from the

bowl. "

Describe the facility ' s system to ensure

compliance is maintained and how the system will

continue to be implemented.

" The incident occurred on 1/5/13. On 1/7/13, this

Director contacted [the landlord] to repair the

broken dosing window. The window was repaired

on 1/7/13. All nurses will continue Medication

Management Training in Essential Learning on an



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annual basis. Security cameras will continue to be

monitored on a random basis. "


7/25/13 written by the Director of Nursing, (RN

#1/DON) Assistant Program Director, (APD #2)

Program Director (PD #2) and Vice President of


" ... " 27G.0209

In regard to medication requirements:

1. Methadone disks are no longer dispensed out

of the handicap accessible window.

2. All medications are dispensed from the

original tamper-resistant manufacture ' s bottles.

3. When Methadone bottles are not being used

for dosing, they are kept under shelving and

therefore out of sight and inaccessible to patients

... "

This deficiency constitutes a Past Corrected Type

A2 rule violation. An administrative penalty of

$1000.00 is imposed. A plan of correction is

optional but not required for this violation.

V 238 27G .3604 (E-K) Outpt. Opiod - Operations

10A NCAC 27G .3604 OUTPATIENT OPIOD

TREATMENT. OPERATIONS.

(e) The State Authority shall base program

approval on the following criteria:

(1) compliance with all state and federal

law and regulations;

(2) compliance with all applicable

standards of practice;

(3) program structure for successful

service delivery; and

(4) impact on the delivery of opioid

treatment services in the applicable population.

(f) Take-Home Eligibility. Any client in

V 238



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comprehensive maintenance treatment who

requests unsupervised or take-home use of

methadone or other medications approved for

treatment of opioid addiction must meet the

specified requirements for time in continuous

treatment. The client must also meet all the

requirements for continuous program compliance

and must demonstrate such compliance during

the specified time periods immediately preceding

any level increase. In addition, during the first

year of continuous treatment a patient must

attend a minimum of two counseling sessions per

month. After the first year and in all subsequent

years of continuous treatment a patient must

attend a minimum of one counseling session per

month.

(1) Levels of Eligibility are subject to the

following conditions:

(A) Level 1. During the first 90 days of

continuous treatment, the take-home supply is

limited to a single dose each week and the client

shall ingest all other doses under supervision at

the clinic;

(B) Level 2. After a minimum of 90 days of

continuous program compliance, a client may be

granted for a maximum of three take-home doses

and shall ingest all other doses under supervision

at the clinic each week;

(C) Level 3. After 180 days of continuous

treatment and a minimum of 90 days of

continuous program compliance at level 2, a

client may be granted for a maximum of four

take-home doses and shall ingest all other doses

under supervision at the clinic each week;

(D) Level 4. After 270 days of continuous



client may be granted for a maximum of five

take-home doses and shall ingest all other doses



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under supervision at the clinic each week;

(E) Level 5. After 364 days of continuous



granted for a maximum of six take-home doses

and shall ingest at least one dose under

supervision at the clinic each week;

(F) Level 6. After two years of continuous

treatment and a minimum of one year of


client may be granted for a maximum of 13

take-home doses and shall ingest at least one

dose under supervision at the clinic every 14

days; and

(G) Level 7. After four years of continuous

treatment and a minimum of three years of


granted for a maximum of 30 take-home doses

and shall ingest at least one dose under

supervision at the clinic every month.

(2) Criteria for Reducing, Losing and

Reinstatement of Take-Home Eligibility:

(A) A client's take-home eligibility is reduced

or suspended for evidence of recent drug abuse.

A client who tests positive on two drug screens

within a 90-day period shall have an immediate

reduction of eligibility by one level of eligibility;

(B) A client who tests positive on three drug

screens within the same 90-day period shall have

all take-home eligibility suspended; and

(C) The reinstatement of take-home

eligibility shall be determined by each Outpatient

Opioid Treatment Program.

(3) Exceptions to Take-Home Eligibility:

(A) A client in the first two years of

continuous treatment who is unable to conform to

the applicable mandatory schedule because of

exceptional circumstances such as illness,

personal or family crisis, travel or other hardship



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may be permitted a temporarily reduced schedule

by the State authority, provided she or he is also

found to be responsible in handling opioid drugs.

Except in instances involving a client with a

verifiable physical disability, there is a maximum

of 13 take-home doses allowable in any two-week

period during the first two years of continuous

treatment.

(B) A client who is unable to conform to the

applicable mandatory schedule because of a

verifiable physical disability may be permitted

additional take-home eligibility by the State

authority. Clients who are granted additional

take-home eligibility due to a verifiable physical

disability may be granted up to a maximum

30-day supply of take-home medication and shall

make monthly clinic visits.

(4) Take-Home Dosages For Holidays:

Take-home dosages of methadone or other

medications approved for the treatment of opioid

addiction shall be authorized by the facility

physician on an individual client basis according

to the following:

(A) An additional one-day supply of

methadone or other medications approved for the

treatment of opioid addiction may be dispensed

to each eligible client (regardless of time in

treatment) for each state holiday.

(B) No more than a three-day supply of

methadone or other medications approved for the

treatment of opioid addiction may be dispensed

to any eligible client because of holidays. This

restriction shall not apply to clients who are

receiving take-home medications at Level 4 or

above.

(g) Withdrawal From Medications For Use In

Opioid Treatment. The risks and benefits of

withdrawal from methadone or other medications

approved for use in opioid treatment shall be



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discussed with each client at the initiation of

treatment and annually thereafter.

(h) Random Testing. Random testing for alcohol

and other drugs shall be conducted on each

active opioid treatment client with a minimum of

one random drug test each month of continuous

treatment. Additionally, in two out of each

three-month period of a client's continuous

treatment episode, at least one random drug test

will be observed by program staff. Drug testing is

to include at least the following: opioids,

methadone, cocaine, barbiturates,

amphetamines, THC, benzodiazepines and

alcohol. Alcohol testing results can be gathered

by either urinalysis, breathalyzer or other

alternate scientifically valid method.

(i) Client Discharge Restrictions. No client shall

be discharged from the facility while physically

dependent upon methadone or other medications

approved for use in opioid treatment unless the

client is provided the opportunity to detoxify from

the drug.

(j) Dual Enrollment Prevention. All licensed

outpatient opioid addiction treatment facilities

which dispense Methadone,

Levo-Alpha-Acetyl-Methadol (LAAM) or any other

pharmacological agent approved by the Food and

Drug Administration for the treatment of opioid

addiction subsequent to November 1, 1998, are

required to participate in a computerized Central

Registry or ensure that clients are not dually

enrolled by means of direct contact or a list

exchange with all opioid treatment programs

within at least a 75-mile radius of the admitting

program. Programs are also required to

participate in a computerized Capacity

Management and Waiting List Management

System as established by the North Carolina

State Authority for Opioid Treatment.



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(k) Diversion Control Plan. Outpatient Addiction

Opioid Treatment Programs in North Carolina are

required to establish and maintain a diversion

control plan as part of program operations and

shall document the plan in their policies and

procedures. A diversion control plan shall include

the following elements:

(1) dual enrollment prevention measures

that consist of client consents, and either

program contacts, participation in the central

registry or list exchanges;

(2) call-in's for bottle checks, bottle returns

or solid dosage form call-in's;

(3) call-in's for drug testing;

(4) drug testing results that include a

review of the levels of methadone or other

medications approved for the treatment of opioid

addiction;

(5) client attendance minimums; and

(6) procedures to ensure that clients

properly ingest medication.



facility failed to ensure that patients who receive

take home medications (methadone) must meet

the specified requirements for levels of eligibility

affecting 1 of 7 Deceased Clients (Deceased

Client #1)(DC #1). The findings are:



-A discharge date of 3/26/13


-She was 37 years old

-Diagnoses of Opioid Dependence,

Polysubstance Abuse, Post Traumatic Stress



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Disorder, Anxiety Disorder, Major Depressive

Disorder, Recurrent, Moderate, Hearing Loss -

80% and History of Gastric Bypass

-A diagnosis of Substance Induced Psychotic

Disorder with Hallucinations added on 10/16/12

by clinician at a local mental health facility

-A treatment plan dated 3/4/13 and completed by

DC#1 ' s counselor (Counselor #16) which

documented the following goals: - " Patient will

continue to take methadone as prescribed and

not use illicit substances; to overcome feelings of

depression; and to monitor chronic illness signs

and symptoms. "

Review on 4/8/13 of DC #1 ' s drug screens from

3/27/12 - 3/5/13 revealed DC #1 was positive for

the following substances on these dates:

- 3/27/12 Benzodiazepines (BNZs) and

Opiates

- 7/12/12 BNZs and Alcohol (Etoh)

- 8/1/12 BNZs

- 8/28/12 Breathalyzer with a reading of

0.025

- 9/4/12 BNZs

- 10/5/12 Etoh - Breathalyzer reading of

0.029


0.026


0.011

- 2/5/13 Opiates

- 2/14/13 BNZs

- 2/23/13 BNZs

- 3/5/13 BNZs

Further review on 4/16/13 of DC #1 ' s record

revealed:

-A request for a take-home medication form was

completed on 1/22/13 and signed by the (The

Assistant Program Director #1 (APD #1) and



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Counselor #16 on 1/22/13

-The Medical Director signed the form also;

however, there was no date listed by the Medical

Director ' s signature

-A Patient Orders ' form dated 1/17/13 which

documented DC #1 was staffed and approved for

take-home medications to begin on 1/22/13

-The form documented that DC #1 would attend

the facility on Monday, Tuesday, Wednesday and

Thursday with take-homes for Friday, Saturday

and Sunday which indicated a change from Level

1 to Level 2

-This " Patient Orders " form was signed by

Counselor #16, the Registered Nurse #1/Director

of Nursing (RN #1/DON) and the Medical Director

(MD) with no dates listed by their signatures

-DC #1 continued on Level 2 until her death on

3/16/13 with her receiving three take home doses

of Methadone at 107 mg per bottle

Review on 4/8/13 of the facility ' s policy on Take

Home Medications revealed:

- " Requirements for Eligibility:

1. Absence of recent abuse of drugs (narcotic

and non-narcotic) including alcohol ...

Take-Home Eligibility. Any patient in


requests unsupervised or take-home use of


treatment of opioid addiction must meet the


treatment. The patient must also meet all the

requirements for continuous program compliance

and must demonstrate such compliance during

the specified time periods immediately preceding

any level increase.

1. Levels of Eligibility are subject to the following

conditions:

a. Level 1. During the first 90 days of continuous

treatment, the take home supply is limited to a



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single dose each week and the patient shall

ingest all other doses under supervision at the

clinic;

b. Level 2. After a minimum of 90 days of

continuous program compliance, a patient may

be granted for a maximum of three take home

doses and shall ingest all other doses under

supervision at the clinic each week... "


revealed:

- " I saw [DC #1] every day. Everyday was the

same as yesterday; she (DC #1) couldn ' t

remember anything ...

- [DC #1] was a high risk patient due to her dual

diagnoses ...

- Our facility (Crossroads Treatment Center)

(drug) tests do not show how much of the

substances she (DC #1) takes, only that it ' s

there (drugs in her system) ...

-We had discussed with the owners (of the

facility) whether we needed to MSW (Medically

Supervised Withdrawal) her out of the clinic (DC

#1), but she wasn ' t eligible for the Medically

Supervised Withdrawal because she was very

random with her drug use...She didn ' t hit

anything hard, no cocaine ...

-I don ' t see where she leveled down (in DC #1 '

s record), it could be in the computer because

she should have been (brought down to level 1).

We go to our supervisor (Program Director #1

(PD #1) to level down. There would be no reason

why she (DC #1) would not be leveled down (to

level 1) but what might have happened is at

minimum two failed because positive tests on

2/5/13 and 2/14/13 are only counted as one failed

drug test so there is a possibility that she could

still have been on level two when she passed.

[The PD #1] would have to look at that because

she (DC #1) has been discharged and I don ' t



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have access to that. "


revealed:

-DC# 1 was admitted to the facility in April of 2012

-DC #1 was " a sweet patient with a traumatic

brain injury and mental health issues. "

-DC #1 had issues with alcohol and breathalyzers

were administered to her and she was educated

on the dangers of alcohol use

-DC #1 had been diagnosed with Substance

Induced Psychotic Disorder

- " If a client has three positive urine analyses in a

row, the client ' s counselor will speak with the

client about the positive urine analyses and

discuss the client with the Medical Director if

necessary "

-There is a list in the copy room where counselors

put patients that need to be leveled up and

RN#1/DON gives the Medical Director the list and

he does the Central Registry. The APD #1, the

Clinical Director (the CD) and the RN

#1/DON]look at registry.

- " I speak to him (the Medical Director) everyday,

so he knows if someone is a repeat offender

(continues to test positive for drugs and alcohol)

and he makes the decision for MSW or to

decrease methadone and level changes ...2 clean

drug screens a week apart is what doc (The

Medical Director) wants now. Back then (3/27/12

-3/5/13) we used 1 clean drug screen (to decide

on making changes with methadone and level

changes). "

Interview on 4/12/13 and 4/17/13 with the PD #1

revealed:

- " There was not a day that went by " that he did

not speak with the MD

-His nurses spoke to the MD every day

-When asked how the facility decides on leveling



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a patient up and down he replied: " Prior to

about 2 months ago, we would staff individuals

(patient) in meetings and counselor involved

would bring medical record to staff meeting, we

would review all criteria to see if they should be

leveled up. Recently we met and we actually

leveled down some people who were leveled up

erroneously... "

-When asked what criteria is met for a patient to

be leveled down he replied: ' 2 positives in 90

days, including alcohol, down one level, 3

positives 90 days go all the way down regardless

of where they are at. ' "

-When asked in looking through the charts for

patients and seeing that some had been leveled

up erroneously what would be done he replied: "

I would do a coaching note for whoever had the

error. "

-When asked if he had the opportunity to look

through DC #1 ' s record to see what happened

with her level error he replied: " I have not. "

Interview on 4/16/13 with facility ' s MD revealed:

-He had been employed by the facility for five

years. " I ' m basically on call every day of the

week, including Saturdays and available to

nurses every day. "

-When asked how testing positive (on drug

screens) impacts his decisions the MD replied: "

It ' s a case by case basis. A lot of it has to do

with when I ' m making decisions about a dose; I

look at current dose, history of dose. On a day to

day basis it comes down to impairment. You want

to keep them (clients) stable, not a scientific

algorithm, comes down to talking to nurses. If

they are impaired I would have to lower doses. If

you drop them too much they will go out on

streets. It ' s a tricky balance. I put a great bit of

trust on the nurses and also the counselors. "

-Clients are moved from Level to Level when they



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produce three months of clean drug screens and

no illicit drug use. " [PD #1] calls me on that

(level changes) and we make a decision. "

-When asked if alcohol is considered an illicit

substance he replied: " Yes and no. Depends on

the situation. If it ' s constantly positive (for

alcohol) then it ' s definitely failing (would be

considered a positive drug screen). "

-As a result of the information shared with the MD

during the interview, he stated " I ' m going to talk

to [PD #1] and he (the PD #1) will get with the

counselors. We will probably come up with a

check list. We (the facility) need to have a red

flags test for the counselors. "

V 366 27G .0603 Incident Response Requirments

10A NCAC 27G .0603 INCIDENT

RESPONSE REQUIREMENTS FOR

CATEGORY A AND B PROVIDERS

(a) Category A and B providers shall develop

and implement written policies governing their

response to level I, II or III incidents. The policies

shall require the provider to respond by:

(1) attending to the health and safety needs

of individuals involved in the incident;

(2) determining the cause of the incident;

(3) developing and implementing corrective

measures according to provider specified

timeframes not to exceed 45 days;

(4) developing and implementing measures

to prevent similar incidents according to provider

specified timeframes not to exceed 45 days;

(5) assigning person(s) to be responsible

for implementation of the corrections and

preventive measures;

(6) adhering to confidentiality requirements

set forth in G.S. 75, Article 2A, 10A NCAC 26B,

42 CFR Parts 2 and 3 and 45 CFR Parts 160 and

V 366



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164; and

(7) maintaining documentation regarding

Subparagraphs (a)(1) through (a)(6) of this Rule.

(b) In addition to the requirements set forth in

Paragraph (a) of this Rule, ICF/MR providers

shall address incidents as required by the federal

regulations in 42 CFR Part 483 Subpart I.

(c) In addition to the requirements set forth in

Paragraph (a) of this Rule, Category A and B

providers, excluding ICF/MR providers, shall

develop and implement written policies governing

their response to a level III incident that occurs

while the provider is delivering a billable service

or while the client is on the provider's premises.

The policies shall require the provider to respond

by:

(1) immediately securing the client record

by:

(A) obtaining the client record;

(B) making a photocopy;

(C) certifying the copy's completeness; and

(D) transferring the copy to an internal

review team;

(2) convening a meeting of an internal

review team within 24 hours of the incident. The

internal review team shall consist of individuals

who were not involved in the incident and who

were not responsible for the client's direct care or

with direct professional oversight of the client's

services at the time of the incident. The internal

review team shall complete all of the activities as

follows:

(A) review the copy of the client record to

determine the facts and causes of the incident

and make recommendations for minimizing the

occurrence of future incidents;

(B) gather other information needed;

(C) issue written preliminary findings of fact

within five working days of the incident. The



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preliminary findings of fact shall be sent to the

LME in whose catchment area the provider is

located and to the LME where the client resides,

if different; and

(D) issue a final written report signed by the

owner within three months of the incident. The

final report shall be sent to the LME in whose

catchment area the provider is located and to the

LME where the client resides, if different. The

final written report shall address the issues

identified by the internal review team, shall

include all public documents pertinent to the

incident, and shall make recommendations for

minimizing the occurrence of future incidents. If

all documents needed for the report are not

available within three months of the incident, the

LME may give the provider an extension of up to

three months to submit the final report; and

(3) immediately notifying the following:

(A) the LME responsible for the catchment

area where the services are provided pursuant to

Rule .0604;

(B) the LME where the client resides, if

different;

(C) the provider agency with responsibility

for maintaining and updating the client's

treatment plan, if different from the reporting

provider;

(D) the Department;

(E) the client's legal guardian, as

applicable; and

(F) any other authorities required by law.


Based on record reviews and interview, the



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facility failed to implement written policies

governing their response to level I, level II, or

level III incidents. The findings are:

Review on 7/24/13 of "Policy 1031: Incident

Reporting & (and) Analysis" revealed:

- "Crossroads Treatment Center has a policy of

recording critical incidents that might occur in the

process of providing services. An annual review

and analysis (study) of all incident reports will be

conducted by The Program Director. Trends and

patterns will be evaluated and barriers to

treatment that might emerge will be recorded..."

Review on 5/13/13 of the facility ' s IRIS (Incident

Reporting Improvement System) reports from

10/1/12 to 5/13/13 revealed:

- No information on the deaths of Deceased

Client #2 (DC #2), Deceased Client #3 (DC #3),

Deceased Client #4 (DC #4) and Deceased Client

#5 (DC #5)

Review on 5/13/13 of the facility's Internal

Incident Reporting forms revealed:

- No documentation of the deaths of DC clients

#2, #3, #4 and #5

- No documentation to determine causal factors

- No documentation to analyze the facility's

system of care

- No documentation of corrective measures



- " Our policy is to file an incident report and write

it up. [The Program Director #1] is responsible for

the incident reports. "


- " After the last visit by [the State Opioid

Treatment Authority Coordinator (SOTA)], I was



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told to contact the patient ' s emergency contact,

contact the local police department and complete

an IRIS report. I was cited for this because I did

not know I had to report deaths to the SOTA...it is

my responsibility to report (the deaths) ...I only

reported one death ...I am aware of the 4 other

deaths ...since they were discharged, I won ' t

report those (discharged patients deaths) ...I

would complete an IRIS report on active clients

that have died ...I don ' t know if a patient is

discharged, do I report to IRIS if they are

discharged and died afterwards? [The SOTA



like answered ...I will be glad to do that (report

submitted in IRIS). When is a patient not a

patient? I can ' t find an answer to that. So, do I

go ahead and complete IRIS (on the deaths)? Am

I liable for these (the deaths)? Is it IRIS ' fault? I

did not know I had to file them (the deaths). If a

patient dies 6 months later, do we still do an IRIS

report? To be honest with you, I don ' t know (if

the IRIS reporting criteria has changed) ...I have

only done one (death report in IRIS). We haven ' t

had that many deaths until now. I did not know

they (the deaths) had to be reported. I apologize

for that. "

V 367 27G .0604 Incident Reporting Requirements

10A NCAC 27G .0604 INCIDENT

REPORTING REQUIREMENTS FOR

CATEGORY A AND B PROVIDERS

(a) Category A and B providers shall report all

level II incidents, except deaths, that occur during

the provision of billable services or while the

consumer is on the providers premises or level III

incidents and level II deaths involving the clients

to whom the provider rendered any service within

V 367



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90 days prior to the incident to the LME

responsible for the catchment area where

services are provided within 72 hours of

becoming aware of the incident. The report shall

be submitted on a form provided by the

Secretary. The report may be submitted via mail,

in person, facsimile or encrypted electronic

means. The report shall include the following

information:

(1) reporting provider contact and

identification information;

(2) client identification information;

(3) type of incident;

(4) description of incident;

(5) status of the effort to determine the

cause of the incident; and

(6) other individuals or authorities notified

or responding.

(b) Category A and B providers shall explain any

missing or incomplete information. The provider

shall submit an updated report to all required

report recipients by the end of the next business

day whenever:

(1) the provider has reason to believe that

information provided in the report may be

erroneous, misleading or otherwise unreliable; or

(2) the provider obtains information

required on the incident form that was previously

unavailable.

(c) Category A and B providers shall submit,

upon request by the LME, other information

obtained regarding the incident, including:

(1) hospital records including confidential

information;

(2) reports by other authorities; and

(3) the provider's response to the incident.

(d) Category A and B providers shall send a copy

of all level III incident reports to the Division of

Mental Health, Developmental Disabilities and



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Substance Abuse Services within 72 hours of

becoming aware of the incident. Category A

providers shall send a copy of all level III

incidents involving a client death to the Division of

Health Service Regulation within 72 hours of

becoming aware of the incident. In cases of

client death within seven days of use of seclusion

or restraint, the provider shall report the death

immediately, as required by 10A NCAC 26C

.0300 and 10A NCAC 27E .0104(e)(18).

(e) Category A and B providers shall send a

report quarterly to the LME responsible for the

catchment area where services are provided.

The report shall be submitted on a form provided

by the Secretary via electronic means and shall

include summary information as follows:

(1) medication errors that do not meet the

definition of a level II or level III incident;

(2) restrictive interventions that do not meet

the definition of a level II or level III incident;

(3) searches of a client or his living area;

(4) seizures of client property or property in

the possession of a client;

(5) the total number of level II and level III

incidents that occurred; and

(6) a statement indicating that there have

been no reportable incidents whenever no

incidents have occurred during the quarter that

meet any of the criteria as set forth in Paragraphs

(a) and (d) of this Rule and Subparagraphs (1)

through (4) of this Paragraph.



facility failed to ensure all level II and III incidents

were reported within 72 hours of the incident to

the Local Management Entity (LME) responsible

for the catchment area where services were



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provided. The findings are:

Finding #1:

Review on 5/13/13 of the facility ' s IRIS (Incident

Reporting Improvement System) reports from

10/1/12 to 5/13/13 revealed:

- No information on the deaths of Deceased

Client #2 (DC #2), Deceased Client #3 (DC #3),

Deceased Client #4 (DC #4) and Deceased Client

#5 (DC #5)




- He was 29 years old





- Diagnoses of Generalized Anxiety, Panic

Disorder, Post Traumatic Stress Disorder, Mood

Disorder, and Depressive Disorder













- She was 32 years old




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revealed:

- " It is my understanding that deaths must be

reported immediately. [The Program Director #1

(PD#1)] is responsible for that. "

Interview on 5/16/13 with the Clinical Director

(CD) revealed:

- " Deaths are reported to [the PD #1], [the

Assistant Program Director #1 (APD #1)] and now

me. [PD #1] does them (the IRIS report). I don ' t

know the requirements to report a death ... "


- " [The PD #1] filled out the report in IRIS (for

patient deaths) ...Sometimes [PD #1] will do it

(IRIS reports) because he has the death report or

death certificate. All the death reports go to [the

PD #1] and he does IRIS then. "


(MD) revealed:

- " Regarding patients ' deaths, there really is not

a protocol. My understanding is when there ' s

actual verification, [the CD] does a report. "


- " After the last visit by [the State Opioid

Treatment Authority Coordinator (SOTA)], I was

told to contact the patient ' s emergency contact,

contact the local police department and complete

an IRIS report. I was cited for this because I did

not know I had to report deaths to the SOTA...it is

my responsibility to report (the deaths) ...I only

reported one death ...I am aware of the 4 other

deaths ...since they were discharged, I won ' t

report those (discharged patients deaths) ...I

would complete an IRIS report on active clients



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that have died ...I don ' t know if a patient is

discharged, do I report to IRIS if they are

discharged and died afterwards? [The SOTA



like answered ...I will be glad to do that (report

submitted in IRIS). When is a patient not a

patient? I can ' t find an answer to that. So, do I

go ahead and complete IRIS (on the deaths)? Am

I liable for these (the deaths)? Is it IRIS ' fault? I

did not know I had to file them (the deaths). If a

patient dies 6 months later, do we still do an IRIS

report? To be honest with you, I don ' t know (if

the IRIS reporting criteria has changed) ...I have

only done one (death report in IRIS). We haven ' t

had that many deaths until now. I did not know

they (the deaths) had to be reported. I apologize

for that. "

Finding #2:

Review on 4/10/13 of FC #1 ' s record revealed:


- Diagnosis of Opioid Dependence


Review on 4/11/13 of the RN #2 ' s record

revealed:


- A job description of Registered Nurse

Review on 4/9/13 of the facility ' s Internal

Incident Reporting Form, dated 1/5/13 and

completed by Registered Nurse #2 (RN #2)

revealed:

- " Patient (Former Client #1 (FC #1)) appeared

at the dosing window impaired. A urine analysis

(u/a) was requested and after 3 attempts, she

said she couldn ' t urinate. [The Medical Director

(MD)] was notified. He ordered a no dose if she



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was positive for Benzodiazepines (Benzos).

When she did urinate, she was positive for

Cocaine, TetraHydroCannabinol (THC) and

Benzos. When told she would not be dosed, she

became very angry and accusatory. She then

reached into the window and grabbed a handful

of orange disks out of the dosing bowl and ran

out of the building. The Security Guard (SG)

chased her and when detained, 5 tablets were

confiscated and returned to the dosing nurse (RN

#2]. "

Review on 4/12/13 of a letter dated 4/10/13,

completed by the PD#1, to Administrator/Co

Director for State Opioid Treatment Authority

(SOTA) revealed:

" ...During this time, (when pills were stolen) I

failed to complete an IRIS and bear full

responsibility for the omission ... "

Reviews on 4/11/13, 4/12/13, 4/16/13 and 4/17/13

of the IRIS revealed:

- No documentation regarding FC #1 taking a

40mg tablet of Methadone from the dosing

window had been submitted.

Interview on 4/12/13 with the RN #2 revealed:

- She made the PD #1 aware of the incident on

1/5/13

- She worked part time at the facility, usually 1 or

2 days per month

- She gave the PD #1 her written statement


revealed:

- " I don ' t know who did the incident report or if

one was even done at all. That would not be a

surprise to me. "




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revealed:

- She spoke with the Assistant Program Director

#1 (APD #1) regarding the incident on 1/5/13

- She gave a written statement regarding the

incident on 1/5/13

- The staff (RN #2) involved is to write up the

incident and contact the PD #1

- "The [PD #1] was responsible for submitting

incident reports"


Nurse #1 /Lead Dosing Nurse (LPN #1/LDN)

revealed:

- It was the PD #1 ' s responsibility to submit

Incident Reports.


- " Our policy is to file an incident report and write

it up. [The PD #1] is responsible for the incident

reports. "

Finding #3:


revealed:


- Diagnosis of Opioid Dependence

Review on 5/17/13 of the Licensed Practical

Nurse #3 ' s (LPN #3 ' s) record revealed:

- A date of hire of 1/21/13

- LPN #3 was terminated immediately


- Licensed Practical Nurse #3 (LPN #3) was

terminated because she administered client #12

a 100 mg dose of Methadone instead of her

prescribed dose of 50 mg of Methadone

- Counselor #3 was unable to recall the date

the dosing mistake occurred

- The mistake was caught by another nurse



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(name of nurse not provided) and attempts were

made to contact client #12

- It was her understanding the mistake was

caused because another client ' s name came up

prior to client #12 ' s name in the dosing queue

and client #12 received the other ' s client ' s dose

- Client #12 returned to the facility on the

following day.

Review on 5/17/13 of client #12 ' s " Case Notes

" completed by the Licensed Practical Nurse

#1/Lead Dosing Nurse (LPN#1/LDN) on 4/23/13

and on 4/24/13 revealed:

- " Nurse (LPN#1/LDN) Patient was dosed at

100mg (on 4/23/13). Patient ' s normal dose is

50 mg, dosing error was noticed and attempted to

contact patient. Doctor (the Medical Director

(MD)) was on site and notified, but reported that

patient may be drowsy and that patient should be

okay since patient had been at a higher dose

before, Dr (the MD) ordered for patient to go and

be assessed at hospital or come back to clinic to

be checked out. Patient could not be contacted.

Notified patient emergency contact [client #12 ' s

mother] to get where about of patient. Contacted

patient boyfriend and was able to speak with

patient she states ' I have been throwing up for

30min. ' Patient was instructed to come back to

clinic for observation, patient refused. Then told

patient to go to the ER and call clinic upon arrival.

Nurse called [local hospitals] to see if the patient

was in the ER department. Patient did not go to

the ER as instructed. [Law enforcement in the

county client #12 was located] was notified and

was asked to go and perform a wellness check. "

- " Nurse - Patient did not come to clinic to

receive dose today. Called and followed up with

patient, she states I didn ' t think I needed to dose

today, I just slept all day yesterday and my

mother was here to check up on me. I will come



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in to dose tomorrow. "

Review on 5/17/13 and on 7/25/13 of the Incident

Response Improvement System (IRIS) revealed:

- No documentation of the medication error

which occurred when client #12 was administered

the incorrect dose of Methadone on 4/23/13

An attempt to interview LPN #3 on 5/17/13 was

unsuccessful as a request for a return phone call

was not met.


- " IRIS was not filed because I forgot ... "

- " Should I got ahead and put the report in

IRIS or is it too late? "

V 512 27D .0304 Client Rights - Harm, Abuse, Neglect

10A NCAC 27D .0304 PROTECTION FROM

HARM, ABUSE, NEGLECT OR EXPLOITATION

(a) Employees shall protect clients from harm,

abuse, neglect and exploitation in accordance

with G.S. 122C-66.

(b) Employees shall not subject a client to any

sort of abuse or neglect, as defined in 10A NCAC

27C .0102 of this Chapter.

(c) Goods or services shall not be sold to or

purchased from a client except through

established governing body policy.

(d) Employees shall use only that degree of force

necessary to repel or secure a violent and

aggressive client and which is permitted by

governing body policy. The degree of force that

is necessary depends upon the individual

characteristics of the client (such as age, size

and physical and mental health) and the degree

of aggressiveness displayed by the client. Use of

intervention procedures shall be compliance with

V 512



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Subchapter 10A NCAC 27E of this Chapter.

(e) Any violation by an employee of Paragraphs

(a) through (d) of this Rule shall be grounds for

dismissal of the employee.



facility staff failed to protect 1 of 37 audited clients

(#12) ,1 of 2 Former Clients (FC #2) and 3 of 7

Deceased Clients (DCs #1, #4 and #5) from harm

and neglect. The findings are:

Cross Reference: 10A NCAC 27G .0203

Competencies of Qualified Professionals and

Associate Professionals (V109)

Based on record reviews and interviews 2 of 9

Qualified Professionals (QPs) failed to

demonstrate knowledge, skills and abilities

required by the population served (the Program

Director #1 (PD #1) and Assistant Program

Director #1 (APD #1).

Cross Reference: 10A NCAC 27G .3603 Staff

(V235)


facility failed to ensure a minimum of one certified

drug abuse counselor or certified substance

abuse counselor shall be on staff for each 50

clients for 7 out of 16 audited staff (Counselors

#1, #2, #3, #6, #15, #16 and Senior Counselor

#1).

Finding #1:


- Licensed Practical Nurse #3 (LPN #3) was

terminated because she administered client #12

a 100 mg dose of Methadone instead of her

prescribed dose of 50 mg of Methadone



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- Counselor #3 was unable to recall the date

the dosing mistake occurred

- The mistake was caught by another nurse

(name of nurse not provided) and attempts were

made to contact client #12

- It was her understanding the mistake was

caused because another client ' s name came up

prior to client #12 ' s name in the dosing queue

and client #12 received the other client ' s dose

Review on 5/17/13 of Client #12 ' s record

revealed:



Review on 5/17/13 of LPN #3 ' s record revealed:

- A date of hire of 1/21/13

- LPN #3 was terminated " immediately. "

Review on 5/17/13 of Client #12 ' s " Patient

Medication Record " revealed:

- Client #12 ' s most recent written doctor ' s

order dated 4/12/13 indicated Client #12 was to

be administered 50 mg of Methadone

- On 4/23/13, LPN #3 administered Client #12

100 mg of Methadone instead of 50 mg of

Methadone

- On 4/24/13, Client #12 was absent from the

facility

- On 4/25/13, Client #12 returned to the facility

for dosing and resumed her regular dosing

regimen of 50 mg of Methadone

Review on 5/17/13 of Client #12 ' s " Case Notes

" completed by the Licensed Practical Nurse

#1/Lead Dosing Nurse (LPN#1/LDN) on 4/23/13

and on 4/24/13 revealed:

- " ...Patient was dosed at 100mg (on 4/23/13).

Patient ' s normal dose is 50 mg, dosing error

was noticed and attempted to contact patient.



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Doctor (the Medical Director (MD)) was on site

and notified, but reported that patient may be

drowsy and that patient should be okay since

patient had been at a higher dose before. Dr (the

MD) ordered for patient to go and be assessed at

hospital or come back to clinic to be checked out.

Patient could not be contacted. Notified patient

emergency contact [Client #12 ' s mother] to get

where about of patient. Contacted patient

boyfriend and was able to speak with patient she

states ' I have been throwing up for 30min. '

Patient was instructed to come back to clinic for

observation, patient refused. Then told patient to

go to the Emergency Room (ER) and call clinic

upon arrival. Nurse called [local hospitals] to see

if the patient was in the ER department. Patient

did not go to the ER as instructed. [Law

enforcement in the county Client #12 was

located] was notified and was asked to go and

perform a wellness check. "

- " Nurse - Patient did not come to clinic to

receive dose today. Called and followed up with

patient, she states I didn ' t think I needed to dose

today. I just slept all day yesterday and my

mother was here to check up on me. I will come

in to dose tomorrow. "


" completed by the Registered Nurse #1/Director

of Nursing (RN #1/DON) on 4/23/13 revealed:

- " Nurse (RN #1/DON) - Per (LPN #1/LDN), pt

(patient) was instructed to go to the ED

(Emergency Department) for evaluation as she

refused to return to clinic after an incorrect dose

of methadone was administered this morning. Pt.

is unable to be reached by phone. Calls made to

emergency departments at [local hospitals].

Each hospital emergency room stated there were

no admissions by pt name. "



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" completed by the Program Director #1 (PD #1)

on 4/23/13 revealed:

- " Program Director (PD #1) - This PD met

with [LPN #1/LDN], [RN #1/DON], and [the MD] in

regards to the dosing error of [Client #12]. [The

MD] was told [Client #12 ' s] current dose was 50

mg qd (every day) and that she had been

incorrectly dosed at 100 mgs. [The MD]

recommended that we continue to attempt to

contact [Client #12] via her cell phone, a landline,

her emergency contact, or 911 if needed. [Client

#12 ' s] primary counselor [Counselor #16] was

informed of the situation. [The MD]

recommended [Client #12] be referred to a local

hospital or to have someone drive her back to the

clinic for observation. [The MD] asked to be

advised of the situation on a regular basis. "

- " Program Director - This PD (PD #1) spoke

to [Client #12] at 10:10 AM on this date. She was

told she was given an incorrect dose of

methadone. Her regular dose is 50 mgs. She

was given 100 mgs. [Client #12] reported she

had been ' throwing up for about 10 minutes.

After I threw up, I felt a lot better. ' This PD (PD

#1) told [Client #12] she needed her boyfriend to

bring her back to the clinic for observation. [Client

#12] refused stating ' I live in [name of city] I ' ll

go to the Emergency Room because it ' s closer. '

[Client #12 ' s] boyfriend agreed to take her to the

ER. [Client #12] was asked to contact this PD

(PD #1), [LPN#1/LDN] or [Clinical Director (CD)]

upon arrival at the ER. She was also asked to

have the admitting MD (Medical Doctor) contact

this clinic to receive her dosing information. She

agreed. This PD (PD #1) asked [LPN#1/LDN] to

contact [Client #12] in approximately 30 minutes if

[cCient #12] hasn ' t contacted the clinic. "

- " Program Director - This PD (PD #1)

contacted the [law enforcement in the county



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Client #12 was located] in regards to this patient.

During an earlier telephone call with the

[LPN#1/LDN], the patient refused to go to the ER.

She had also refused to return to the clinic for

observation. The Police Department was given

this information. According to [name] (the

dispatcher for the law enforcement agency the

PD #1 had contacted], a patrolman would be

dispatched to [Client #12 ' s] residence for a

wellness check and to ask if [Client #12] would go

to the local hospital for observation. [The

dispatcher] agreed to contact this PD (PD #1) as

soon as the wellness check was completed. "

- " Program Director - This PD (PD #1) spoke

with [Deputy with the Sheriff ' s Department]. He

stated, ' I checked on [Client #12]. She was fine.

She told me she threw up some and felt better. I

asked her if she needed to go to the hospital.

She refused and stated, ' I feel fine, I ' m not

even sleepy. She appeared to be alert. She knew

what time it was. In my judgment, she was not

appropriate for hospitalization. ' This PD (PD #1)

thanked the deputy and contacted [the MD] to

inform him of the situation. "


revealed:

- She was made aware of Client #12 being

double dosed on 4/23/13

- " [The LPN #1/LDN] busted into my office

freaking out (about the double dose). "

- " We all tried to contact her and couldn ' t get

in touch with her; [the LPN#1/LDN] reached her

later that day through her boyfriend. "

- " I talked to her about it the next day. "

An attempt to interview the Licensed Practical

Nurse (LPN #3) on 5/17/13 was unsuccessful as

a request for a return phone call went unmet.



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Interview on 5/22/13 with Registered Nurse


- Client #12 was mistakenly dosed 100 mg of

Methadone instead of 50 mg by LPN #3 on

4/23/13

- The dosing error occurred as a result of LPN

#3 having administered Client #12 the dose of the

client who came before Client #12 in the dosing

line

- The nursing staff attempt to dose the clients

as quickly as possible because the clients

become irritable; however the clients must be

dosed safely

- Symptoms of a Methadone overdose include,

nausea, vomiting, diarrhea, lethargy and a

change in the mental status

- " Lying down or going to sleep is one of the

worst things to do. "

An attempt on 5/21/13 to interview the MD was

unsuccessful as the MD was out of the country

and could not be made available for interview.

-Review on 5/17/13 of the effect and the signs of

a methadone overdose on www.opiates.com

<http://www.opiates.com/> revealed:

- "Accidentally or intentionally ingesting too

much Methadone can lead to an overdose which

can be fatal ... "

- "Methadone is a powerful narcotic medication

that is most often used to treat addiction to heroin

or other opiates including Oxycontin, Percocet

and Vicodin. What ' s considered to be a normal

dose for one person could be deadly for another

... "

- " Signs of a Methadone overdose can vary

from person to person so it ' s essential to be

familiar with all potential symptoms. They include

slowed or labored breathing, loss of breath,

pinpoint pupils, weak pulse, low blood pressure,



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muscle or stomach spasms, blue lips, dizziness,

extreme drowsiness, confusion, fainting, cold and

clammy skin, seizures and coma... "

Finding #2:


revealed:



Counselor (SAC)

Review on 7/22/13 of Former Client #2 ' s (FC #2

' s) record revealed:


- Diagnoses of Opioid Dependence, Major

Depression and Anxiety Disorder


Review on 7/22/13 of a " Crossroads Treatment

Center Incident Reporting Form " revealed:

- Counselor #2 completed the Incident

Reporting Form on 6/20/13 and the Program

Director reviewed and signed the Incident

Reporting Form on 6/20/13

- " Description of the Incident: [FC #2 ' s]

girlfriend reported to counselor on 6/20/13 @ 9:30

am that [FC #2] had cut his wrist last night and

police were called and ambulance took client to

hospital. He was admitted. "

- " Was Physician Notified? Yes No via

_____________. " There was no documented

response to this question listed on the form


- " I was the counselor for [FC #2]. He was

discharged on 7/1/13. I made several attempts to

contact his psychiatrist at [a local behavioral

health facility]. I started contacting them right after

he was admitted in October (2012). "



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- " Originally, I tried to fax his consent several

times. One was sent back showing me he had a

prescription for Klonopin by his psychiatrist. "

- " On the day of his attempted suicide

(6/20/13), I talked to one of the nurses at [a local

behavioral health facility]. I don ' t know if [the

MD] had contact with his psychiatrist or not. I

have no clue to be honest with you. "

- " He was not really referred to [the MD] for his

withdrawal symptoms. He did sit in the office with

me and [the MD], after the fact (the suicide

attempt) on June 25, 2013. His withdrawal

symptoms started after he no longer had regular

employment and he could not dose on a regular

basis. "

- " I started seeing a pattern ...in March (2013)

he did not have the money to regularly dose. I felt

it would be best for him to have gone through

Medically Supervised Withdrawal (MSW). That

did not happen. Why? I don ' t know. I did talk to

[Registered Nurse #1/the Director of Nursing (RN

#1/DON)] about it, but I did not document it. "

- " I would probably say I just missed

documenting it and writing it down. I was up to 55

clients in my caseload at the time. I should have

written it down. "

- " Honestly, he was probably not assessed for

depression by [the MD]. I don ' t think that ever

took place. I cannot explain it. I did not talk with

nursing about having him assessed for

depression. "

- " I got [FC #2] on my caseload on February

18, 2013. I did not do a behavior contract with

him either. The only signs of depression I saw

was he just seemed frustrated because he could

not dose. "

- " After he attempted suicide, we did make a

referral to a higher level of care. He declined to

take us up on the offer. It would have been

important to get his medical records from [a local



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hospital] after he was released from attempting

suicide. "

- " I am not sure who was responsible for that

(obtaining the medical records). I did not see any

documentation by [RN #1/DON] regarding a

behavioral support plan. It would have been

important to do. The behavior support plan would

be a precursor to Medically Supervised

Withdrawal. "

- " Since I have been here, it should have been

done (referrals to the MD for MSW). "

- " Hell yea, that should have been done in [FC

#2 ' s] ' s case. I have dudes that are on

behavioral support plans that need to be

addressed for MSW. "

- " [FC #2] stated his depression started when

his father died several years ago. I sometimes

have issues when we accept people who need a

higher level of care. "

- " He was one of the clients that needed a

higher level of care (inpatient) because his drugs

of choice were Oxymorphine, Cocaine and

Intravenous Opiate user. "

- " He continued to test positive for

Benzodiapines. Our screening system is flawed

(for positive urine screens.) We keep admitting

patients for the money. "

- " We have trouble taking care of the clients

we have. We just roll them through ... "

Review on 7/24/13 of the faxes sent by Counselor

#2 to FC #1 ' s psychiatrist that requested a

completed Coordination of Care (COC) form

revealed:

- Faxes were sent to the psychiatrist on

10/29/12, 3/15/13, 4/22/13, 5/14/13 and 6/26/13

Review on 7/22/13 of FC #2 ' s " Case Notes " ,

from 10/2/12 to 7/1/13, written by Counselor #2

revealed:



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- " 10/29/12, Counselor had a scheduled

appointment (apt) with patient (pt) ...counselor

was informed by nurse that pt had a prescription

for Klonopin. Nurse indicated pt that he needed to

make an apt to see our doctor (the Medical

Director) to discuss the matter further. Counselor

communicated to pt that he would have to sign a

coordination of care form, so that prescribing

clinic can communicate with doctor [at the facility]

to monitor his use ...Plan: Pt will overcome

feelings of depression ... "

- " 10/30/12, pt will follow up with [a psychiatrist]

concerning his benzo (benzodiazepam) use ... "

- " 12/5/12, pt reported he takes medication for

depression and anxiety per his primary care

doctor. Counselor reminded pt to continue to be

careful with his prescriptions while on Methadone

and to only take them as indicated due to risk of

interaction ...Plan: Pt will continue care with his

primary care physician to continue to address and

treat his anxiety/depression ... "

- " 4/2/13, This patient visually looked ill, skin

being semi pale, his affect being a little flat and

he seemed very nervous ...this patient ' s

condition seems to be questionable at this time

...Plan: pt will overcome feelings of depression ...

"

- " 4/8/13, Patient and counselor met for 1:1

counseling session today ...counselor is

agreeable to monitor patient for possible referral

to higher level of care ...Assessment: this patient

continues to use illicit substances and may need

a higher level of care ... "

- " 4/22/13, This patient signed an updated

Coordination of Care (COC) form to coordinate

with [a psychiatrist] at [a local behavioral health

center] on his prescription for benzos ...it seems

that patient is using cocaine to overcome or self

medicate from the withdrawal symptoms of



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Methadone since he is not regularly dosing ... "

- " 5/3/13, This patient states he is struggling to

stay abstinent from needles. He reports that he

has been using cocaine to cope with withdrawal

symptoms ...pt expressed that he has been using

Intravenous (IV) cocaine about one a week ...pt

will continue to be monitored and possibly

referred to a higher level of care ... "

- " 5/14/13, pt reports many times he gets sick

while working ...he expressed that he started to

use illicit substances again to cope with the

withdrawal symptoms ...this patient may be put on

a behavioral contract if he continues to use illicit

substances ... "

- " 6/3/13, this patient presented to session in

somewhat of a sickly manner ... "

- " 6/19/13, pt expressed that he has been feeling

quite sick after not being able to dose for several

days (due to financial issues). Pt reports constant

cramping, vomiting, loose bowel movements and

looks (very sickly), visually. Pt reported that ' I

am so cold ' when it was about 75 degrees. Pt

reports that using is the only way that he copes

with his withdrawal symptoms ... "

- " 6/20/13, Case Manager: On this date, pt ' s

girlfriend came into counselor ' s office and

voluntarily informed him that [FC #2] had slit his

wrists (attempted suicide). This girlfriend

informed counselor that pt had gotten paid for

work and had spent it all on crack cocaine. The

girlfriend reported that [FC #2] had slit his wrists

(very deep) the night before (6/19/13) and she

had called 911. She said ' he said just let me

bleed out! ' , but the girlfriend was able to perform

first aid until Emergency Medical Services (EMS)

got to scene ...the girlfriend reported that [FC #2]

was in [a local hospital] Emergency Room and

scheduled to have a second surgery today

(6/20/13) ... "

" 6/25/13, this patient reluctantly presented to



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session after counselor approached pt in the

parking lot ...pt came into counselor ' s office and

reported significant withdrawals. Pt reported ' I

have been using crack, benzos and opiates for

the last few weeks to deal with the withdrawals

from not being able to regularly dose ...Pt and

counselor met/consulted with [the Medical

Director], [the Vice President of Operations], [the

Program Director] in order to discuss options for

referral. Pt signed a release of information to

consult with [a local behavioral health center] and

[the psychiatrist], who prescribes him with

benzos. Counselor called and spoke with [the

nurse] at [the behavioral health center] about the

situation regarding pt slitting wrists on suicide

attempt on 6/19/13. Pt reported getting out of [a

local hospital] on 6/22/13. This patient declined

an immediate referral to detox. This patient

seems agreeable to keep in daily contact with

counselor to assess his suicidality. Pt did report

to session with large cast on his arm and seemed

to be in pain. This patient will definitely need to be

monitored for suicidality risk assessment,

continued use and possible overdose.

Assessment: this patient seems to be at elevated

risk to harm self as evidenced by recent suicide

attempt. Plan: Pt will be referred to a higher level

of care ... "

Review on 7/22/13 of Former Client #2 ' s (FC #2

' s) record revealed FC #2 was positive for the

following substances on these dates:

- 1/10/13 Benzodiazepines (BNZs)

- 2/8/13 BNZs, Cocaine and Opiates

- 3/13/13 BNZs, Cocaine and Opiates

- 4/15/13 BNZs and Cocaine

- 5/13/13 BNZs

- 6/19/13 Cocaine and Opiates

An attempt to interview FC #2 on 7/23/13 was not



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successful as a request for a return telephone

call was not met.


revealed:

- " I remember [FC #2] was taking Klonopin for

anxiety. The counselor would have been

responsible for completing the Coordination of

Care (COC) paperwork. "

- " If the counselor tried 3 or 4 times to contact

them [a local behavioral health center], then they

should have conveyed that to me and he

(Counselor #2) did not do that. "

- " There would be a nursing note if a

counselor came to me to assist them and I do not

remember [Counselor #2] coming to me. I would

have followed up on that. We like to have a

Coordination of Care form and be able to make

the outside doctor [psychiatrist] aware that a

client is in Methadone treatment since they are

prescribing other medications. "

- " We like to make informed decisions when

other medications are prescribed. With all the

other drugs [FC #2] was testing positive for, he

would be at high risk for overdose, respiratory

depressors. It would magnify the intensity (of an

overdose). "

- " I was made aware of his suicide attempt the

day we met with him on June 25, 2013. I know

[Counselor #2] did not come to me regarding [FC

#2 ' s] signs and symptoms of withdrawal. "

- " We would like to keep the lines of

communication open. I would have staffed this

case with [the Medical Director]. "


(PD #2) revealed:

- " I don ' t recall much about [FC #2]. I do

know that [Counselor #2] came into my office

because [FC #2 ' s] girlfriend revealed he tried to



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cut his wrist. I did ask [Counselor #2] to try and

contact [FC #2]. "

- " The next day we learned he had cut his

tendons. He came to the facility with his arm

bandaged. We talked to him about a higher level

of care, but he declined. We even talked to him

about MSW. "

- " He was willing to be hooked back up with [a

local behavioral health center]. I asked

[Counselor #2] to coordinate that. We also talked

with [the MD]. I also talked with [RN #1/DON] and

she contacted [the MD]. "

- " He [the MD] was ambivalent as to whether

he was an actual patient at [a local behavioral

health center]. We needed to have talked to his

psychiatrist there and I am not sure if he was

even involved with [a local behavioral health

center]. "

- " I do not even know it [FC #2 ' s] psychiatrist

was even notified. I don ' t know if this fell

through. I am finding that a Coordination of Care

form was faxed several times, but I don ' t know if

[Counselor #2] was able to speak with the

psychiatrist or not. I don ' t think there was any

follow through. "

- " I don ' t know if [the PD #1] gave them (the

counselors) the mentality not to follow through. I

don ' t even know if the counselors are getting it

or not (their job and client care). "

- " I have requested the counselors to bring

their cases for a treatment team meeting if the

client has tested positive for 2 urine analyses. [FC

#2 ' s] ' s case would have been perfect to staff in

a treatment team meeting. "

- " I don ' t remember if we discussed a

behavioral contract with [FC #2] specifically. We

usually do that within the first 30 days. That is the

first step into shaping them back into reality. "

- " I was not aware [FC #2] was having signs

and symptoms of withdrawals. That is where the



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miscommunication came in. We don ' t like cases

like [FC #2 ' s]. "

- " I remember when his [FC #2 ' s] girlfriend

came into my office; she said his tendons were

showing when he cut his wrists. I know we never

got his hospital records. That should have been

the responsibility of his counselor. "

- " From what you are describing to me from

the counselor ' s notes, he was having withdrawal

symptoms. To me, that (FC #2 ' s withdrawal

symptoms) would have been brought to our

attention by the counselor. "

- " We needed to have had a Subjective Opiate

Withdrawal Scale (SOWS) and Objective Opiate

Withdrawal Scale (OOWS) updated on him. The

counselor should have filled that out. "

- " It becomes much more severe when a client

is using illicit drugs and having to deal with

withdrawal. Was his [Counselor #2 ' s] judgment

impaired? Good judgment would have been to

bring this to nursing ' s attention. "


- In reviewing FC #2 ' s record, the MD stated

" I am not sure if I was made aware of this suicide

attempt or not. I don ' t remember this and that is

not okay. I did not hear about this until you (the

surveyor) pointed out the progress notes written

by [Counselor #2] on June 25, 2013. "

- " I don ' t remember hearing the word

suicidal, but here (in the progress notes) it looks

like I was consulted by telephone regarding

seeking a higher level of care for him. "

- " This is strange because I always remember

the scenarios with clients, but I do not remember

this one. I was not even here that day. "

- " It was appropriate that they wanted to seek

a higher level of care for him. I did not know he

had slit his wrists until after the fact. "

- " I was not aware he was exhibiting any signs



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and symptoms of [FC #2] going through

withdrawal. That is concerning that he was self

medicating with cocaine to deal with the

withdrawal. "

- " I would have liked to have been contacted

about that. This is a medical condition. He should

have immediately been evaluated by a nurse. If

not, then he should have been sent to the hospital

immediately. "

- " He needed to be careful as to not have

overdosed with all of his positive urinalyses. I am

also concerned because he was taking

Oxymorphene in pill form. That is also an Opioid.

"

- FC #2 being placed on a behavior contract

was a possibility because " with a behavioral

contract, we would have started MSW after 30

days of non compliance with our 8 point criteria. "

- " The counselor should have informed

nursing staff about his symptoms and continued

illicit drug use. That would have been clinical

judgment by our nurses as well, the more

information in the chart of a client; the better. "

- " I know I never had any contact with [FC #2 '

s] psychiatrist. I know him personally. The

counselor should have come to me with his

concerns. I also know [the psychiatrist] ' s Nurse

Practioner. "

- " It would have been very easy for me to

contact them and get confirmation if [FC #2] was

a patient of theirs and if he did indeed have a

prescription for Klonopin. "

- " I know if the counselor was having trouble

getting a COC result, then he [Counselor #2]

should have talked with the nursing staff. "

- " The signs of withdrawals are very well

known to our counselors. It would have been

ideal for the counselors to have gone to nursing

and then nursing come to me. "



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Operations (VPO) revealed:

- On 6/25/13, " [Counselor #2] brought him

(FC #2) into [the Program Director #2 ' s] office. I

just happened to be in her office working on the

computer. "

- " [Counselor #2] told us he (FC #2) had

attempted suicide and wanted to know what to

do. [The MD] was here that day, but didn ' t do

much because [FC #2] walked back into the

office within 10 minutes. We were trying to make

referrals for him (FC #2). "

- " It was [the MD ' s] mentality to just follow

our protocol and try to get him help (higher level

of care). "

- " We asked [Counselor #2] to follow up with

[FC #2] the next day. Really, [Counselor #2]

should have done a behavioral contract with him

right away for testing positive for illicits. That way,

we would be able to address a higher level of

dose to see if it was warranted especially if he

was showing all the signs and symptoms of

withdrawals. "

- " If he (FC #2) was a poly substance user and

not stopping, perhaps inpatient would have been

best for him. "

- " It would have also been a good case to staff

in a treatment team meeting. After hearing and

watching what was not done, it would have been

an incompetent counselor not to have brought

this to someone ' s attention. "

- " The assessment for depression for [FC #2]

probably did not happen with [the MD]. "

- " It is the counselor ' s job to follow up with

the COC paperwork. If you are not successful

with it (COC form), then you need to be talking to

nursing, especially [RN #1/DON]. Also, [the MD]

is also very approachable. He has an open door

policy. "



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procedures manual revealed:

- " ...If a patient received a prescription from

any doctor, the case manager (Counselor) may

ask for a release signed by the patient and

contact said doctor and complete documentation

to coordinate care. At this time information

concerning reason for medication, length of

treatment, and prior knowledge of methadone

treatment is discussed ... "

Finding # 3:

Review on 4/8/13 of Deceased Client #1 ' s (DC

#1 ' s) record revealed


- Diagnoses of Opioid Dependence,

Polysubstance Abuse, Post Traumatic Stress

Disorder, Anxiety Disorder, Major Depressive

Disorder, Recurrent, Moderate, Hearing Loss -

80% and History of Gastric Bypass

- A diagnosis of Substance Induced Psychotic

Disorder with Hallucinations added on 10/16/12

by clinician at a local mental health facility

- DC #1 was found dead in her home on

3/16/13 and transported to a local hospital and

declared deceased by the Medical Examiner on

3/16/13

- She was 37 years of age


- A treatment plan dated 6/26/12 and

completed by DC #1 ' s counselor (Counselor

#16) which documented the following goals and

interventions: " Goal: The Patient (Pt.) reports

feelings of depression. Intervention: Pt will be

referred to [The MD] for assessment for

depression. Goal: The patient will continue to

take methadone as prescribed and not use illicit

substances. Intervention: Counselor will meet

with Pt a minimum of 2xs (times) a month to offer



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supportive counseling



#16) documented the same goals and

interventions as listed in the treatment plan dated

6/26/12



#16) documented the same goals and

interventions as listed in the treatment plan dated

6/26/12. One additional goal and intervention was

added - " Goal: To monitor chronic illness signs

and symptoms. Intervention: Counselor will have

Pt sign a coordination of care form to allow

effective communication between medical

facilities. "

Review on 4/8/13 of DC #1 ' s drug screens from

3/27/12 - 3/5/13 and nurses notes completed by

RN #1/DON from 8/28/12 -1/8/13 revealed DC #1

was positive for the following substances on

these dates:

- 3/27/12 Benzodiazepines (BNZs) and

Opiates

- 7/12/12 BNZs and Alcohol (Etoh)

- 8/1/12 BNZs


0.025

- 9/4/12 BNZs

- 10/5/12 Etoh - Breathalyzer reading of

0.029


0.026


0.011

- 2/5/13 Opiates

- 2/14/13 BNZs

- 2/23/13 BNZs

- 3/5/13 BNZs



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Review on 4/8/13 of " Case Notes " completed

by the RN #1/DON revealed:

- 8/14/12 - " Pt presented with significant

non-pitting edema in Rt (Right) leg. Swelling in Lt

(Left) leg was minimal. Instructed pt to go to PCP

(Primary Care Physician) or urgent care to be

evaluated for thrombus. Pt verbalized

understanding and stated she would go

immediately. "

- 8/28/12 - " Pt came to speak with RN

#1/DON about MD (doctor) appt. Pt breath

smelled of alcohol. Gave pt breathalyzer. Pt blew

0.025. Explained to pt she would be unable to

dose today and could return tomorrow to dose as

normal. Reviewed zero alcohol tolerance policy

with her. Pt. verbalized understanding. "

- 10/5/12 - " Pt. ' s breath smelled of alcohol

this morning. Pt. given a breathalyzer with results

of 0.029. Explained to pt. that she would not be

dosed today due to positive breathalizer and

breath smelling of alcohol. Pt. denies use of

alcohol and states that ' it must be my cough

syrup. ' "

- 11/23/12 - " Pt breath smelled of alcohol. Pt

given breathalizer and blew a 0.026. Pt states

she did drink yesterday evening and early this

morning with family. Explained to pt that we

would be unable to dose her today and dangers

of drinking alcohol while taking methadone. Pt

verbalizes understanding. Requested pt return to

clinic tomorrow to dose. "

- 1/8/13 - " Breathalyzer today reads 0.011.

Pt. admits to having strawberry daiquiris

yesterday at her sister ' s birthday party.

Explained again to pt dangers of mixing alcohol

with methadone and due to her positive

breathalyzer test, we would not be able to dose

her today. Pt. verbalized her understanding. "

- 3/15/13 - " Instructed pt today as well as

yesterday to go to ED (Emergency Department)



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to be evaluated for falls and gait imbalance. Pt is

unable to get out of the seated position without

assistance or falling. Pt has fallen in clinic or in

parking lot 3 times in the past two weeks. Pt has

also informed staff of having a " seizure " at

home and falling at home. At each of these

instances, pt was instructed to go to ED to be

evaluated but pt did not go. "

Review on 4/17/13 of " Case Notes " completed

by Counselor #16 revealed:

- 7/19/12 - " This Pt. reported to her Counselor

' s office this morning as a result of being flagged

for missing time her Counseling session; she said

that she still struggles terribly with the fact of not

being stable on her dose and with constant

[nagging] thoughts of using. This Counselor

reminded this Pt. that it would be of benefit for her

to attend the clinic daily, keep all scheduled

Counseling sessions, and discontinue all use of

illicit substances. This Pt agreed; however she

said that she has been going through so many

stressful situations at home that it is the only thing

she knows how to do in order to maintain her

sanity. This Pt. reports she has been feeling so

terribly sick on her stomach all the time and

vomiting almost every day. She said, ' I believe it

' s my nerves, I ' ve always had a bad nerve

problem. ' This Pt. reports she is in the process

of seeing her Primary Care Physician or

psychologist regarding her history with anxiety

and panic disorder. "

- " Assessment - Assessment Here: Dimension

1: This Pt. is addicted to opiates; she is alert and

oriented 3x ' s. Dimension 5: This Pt. is at med

(medium) to high risk for relapse or continued use

potential due to her recent relapse on BNZ ' s

(Benzodiazepines) and Ethol. "

- " Plan - Plan Here: This Pt. will remain on

MMT (Methadone Maintenance Treatment) at



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their current dose (120 mg) and level (Level 2)

until otherwise indicated by Medical Staff. This

Pt. will meet with their Counselor 2x (times)

monthly, provide 1 negative UA (Urine Analysis)

and continue working on building new life

management skills and relapse prevention skills

moving forward in treatment. "

- 7/26/12 - " This Pt. presented for their 1:1

Counseling appt. this morning; this Pt. firstly

indicated that they are doing well on MMT and

has positive plans for their family ' s future without

the use of drugs and/or alcohol she said that

since she and her counselor spoke about the

dangers of mixing methadone, alcohol, and BNZ '

s she hasn ' t drank or taken another Xanax.

However she did indicate not being stable on her

current dose and will be scheduling an upcoming

peak and trough. She did make this Counselor

aware that she is scheduled for upcoming MH

(Mental Health) appt. ' s and has been addresses

multiple biomedical/medical conditions including

stomach ulcers, dental, chronic low back issues

that make for an unhealthy recovery/environment.

This Counselor and Pt. agreed that until her

medical issues are resolved it will make the

recovery process more of a challenge. "

- " Plan - Plan Here: The Plan remained the

same plan as noted in the 7/19/12 case note;

however, with the following addition " This Pt. will

loose any take-home privileged if the following

drug screen is evident of alcohol or

non-prescribed BNZ ' s. "

- 8/2/12 - " This Pt. reported to her scheduled

appt. this morning; she told her Counselor that

her family has told her that if she is leveled back

down to a Level 1 and she has to start coming

back to clinic daily (from [a local county]) they will

discontinue finances and transportation

necessary for this Pt. to remain in treatment.

This Pt. said, ' I really didn ' t know that I wasn ' t



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allowed to drink; I mean I ' ve been drinking a lot

everyday! ' This Counselor reviewed the 8 pt

(point) criteria [again] with this PT, and was clear

she understood that she wouldn ' t be allowed to

remain a Level 2 Pt with 1 more failed UA for any

illicit substance . Additionally, this Counselor

reviewed the dangers associated with

self-medicating particularly BNZ ' s and alcohol in

combination with MMT. She agreed to

discontinue use immediately and seek additional

services with [local mental health facility.] A

referral was given [again] to this Pt. for [a local

mental health facility] and further treatment was

discussed as this Pt. needs additional care at a

higher level for issues revolving around a history

of abuse, anxiety, & depression. "


MMT at her current dose (120 mg) and level

(Level 2) until otherwise indicated by Medical

Staff ... " " She agrees with her Counselor that

she will discontinue use of BNZ ' s (unprescribed)

and alcohol. This Counselor reiterated the 8 pt.

criteria for level patients in the clinic and

reminded this Pt. that alcohol is a drug and there

is a zero tolerance for alcohol while on MMT.

She agreed to discontinue use. This Pt.

understands that another failed UA (Urine

Analysis) for any illicit substance will result in her

being leveled back down from a Level to a Level.

" (There is no documentation of which Levels

the Counselor is speaking about.)


' s office this morning for her scheduled session;

she told her Counselor she is having a lot of

difficulty with cravings and thoughts of using due

to the recent passing of her grandfather and now

with her grandmother being in the Intensive Care

Unit at the hospital. She admits to taking BNZ ' s

without a prescription, but she says she has

always been on BNZ ' s due to a history with



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Anxiety and depression. She will follow up with [a

local mental health] facility on 8/27/2012 to be

further evaluated ... "




Staff. This Pt. will meet with her Counselor ' s 2x

' s monthly, provide 1 negative UA and continue

working on building new life management skills

and relapse prevention skills moving forward in

treatment. This Counselor will speak with RN

[RN #1/DON] in regards to this Pt. ' s MH issues

and coordinate a follow up apt. with [a local

mental health center]. This Pt. agrees to attend a

Therapy session at [a local mental health center]

on 8/27/2012 to address issues revolving around

MH. She will report back to her Counselor on her

follow up appt. to make her aware of the changes

in medications and therapy. "


' s office this morning as a result of being flagged

for not passing her breathalyzer on 8/29/12. This

Pt. was staffed on yesterday and the staff agreed

this Pt. should not be allowed to handle her own

methadone; as she has been positive for BNZ

and alcohol for two consecutive UA ' s (July and

August). She said that she still struggles terribly

with the fact of not being stable on her dose and

with constant [nagging] thoughts of using. Plus,

she admits that her home life isn ' t stable, she

doesn ' t work, and has no transportation of her

own to clinic, and they are still in the middle of

court proceedings regarding her teenage

daughter that was kidnapped and raped. This

Counselor spent time explaining the 8 pt. criteria

in detail to this Pt. she agreed that she should

loose her take-home medications. This Pt. said,

' I can promise you one thing; this has really been

an eye opener for me! I don ' t want to stop

coming to the clinic and now I see why I have



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been feeling so sick (and throwing up daily) it was

from the alcohol not the methadone. I didn ' t

drink a drop yesterday and I don ' t plan on

drinking anymore. ' This Counselor explained

there is a 0 tolerance for alcohol in this clinic

[again] and to this Pt. and explained that drinking

and methadone can produce fatal results. This

Pt was referred [again] to [a local mental health

facility] and a [community medical facility]. This

Pt. will be observed and re-evaluated in the next

30 days. "

- " Plan - Plan Here: This Pt. will return to a

Level 1 pt due to her failure of the past 2 UA ' s

(for July and August). In addition, this Pt.

presented to clinic yesterday after drinking in the

AM (morning); this Pt. didn ' t pass the

breathalyzer administered by the RN (RN

#1/DON). This Pt will come to the clinic daily,

meet with her counselor 2x monthly, provide 1

negative UA per month and be re-evaluated for

level up in the next 30-days per she comply wit

the 8 pt. criteria for take-home medications . "

- 9/7/12 - " ...She (DC #1) indicated that since

she was leveled down and stopped using alcohol

completely she is feeling so much better: she

doesn ' t throw up daily, has been feeling more

stable on MMT, and is able to eat ... "

- " Plan - Plan Here: ...This Counselor will

speak with RN (RN #1/DON) in regards to this Pt.

' s MH issues and coordinate a follow up apt. with

[the Medical Director] for this Pt. she will

additionally meet with Medical Staff daily/weekly

in order to keep a check on her vitals as well as

her alcohol intake moving forward. "

- 9/25/12 - This Pt. presented for her 1:1

Counseling Re-assessment appt. this morning;

she firstly indicated that she is doing well on her

MMT; however she continues to struggle

financially with issues revolving around her MH.

This Pt. didn ' t follow up with [a local mental



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health agency] as had been discussed and she

said she wouldn ' t be able to anytime soon

seeing as her mother-in-law was violently

attacked by her [own] son and she would now be

caring for her during the day. This Pt. was

referred to [health care facility in another county]

as another option for addressing MH issues .... "

- " Plan - Plan Here: ...This Counselor will

speak with RN [RN #1/DON] in regards to this Pt.

' s MH issues and coordinate a follow up apt. with

[the Medical Director] for this Pt. This Pt. has not

been followed up with the referral given for [a

local mental health facility] even though she

clearly has severe issues with MH ... "

- 10/5/12 - " ...She (DC #1) had been flagged

by the dosing LPN (Licensed Practical Nurse

#1/Lead Dosing Nurse) [LPN #1/LDN] as

presenting with symptoms of intoxication. The

RN [RN #1/DON] administered the breathalyzer

and this Pt. and the results were conclusive she

did in fact have alcohol in her system. This Pt. ' s

breathalyzer presented with 0.029 EtOH in her

system prior to being denied dosing today. This

Pt. explained to her Counselor she had been sick

and has been taking ' NightTime ' cough

medicine which does contain alcohol. This Pt.

provided a UA for her Counselor; the specimen

was dipped and proved positive for methadone

only; however the results of alcohol will be

reported by the Clinical Lab at which time this

Counselor will send a confirmation report in order

to determine if the presence of Etoh was a result

of over-the-counter cough medicines or whether

this Pt. continues to abuse the zero tolerance to

alcohol policy in this clinic. " Further review of the

10/5/12 " case note " revealed " This Pt. told her

counselor she had been back to [a local mental

health facility] for a follow up appt. in regards to

her [overwhelming] MH issues; she says, ' I will

go back to [a local mental health agency] on



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Tuesday 10/9/12 and attempt to get myself the

MH care I need. ' "

- " Plan - Plan Here: This Pt will remain on



Staff. This Pt. will met with her Counselor 2x ' s

monthly, provide 1 negative UA and continue



treatment. She will be continually observed for

difficulties presenting as a result of alcohol; this

Counselor will speak with this Pt. about a possible

higher level of care and/or detox program that

can more effectively address the issues revolving

around her MH and continue use of EtOH... " "

This Counselor will speak with RN [RN #1/DON]

in regards to this Pt. ' s MH issues and coordinate

treatment that is in the best interest and needs of

this particular Pt. "

- 11/8/12 - " This Pt. presented for her 1:1

Counseling session this morning; firstly she made

this Counselor aware of her most recent accident

with the stove. This Pt. received 3rd degree

burns on her arm and is being treated at the

Health Department in [the county the DC #1

resided]; she denies any opioid being prescribed

for pain and said ' They treat my arm bi-daily, put

pain ointment on my burn, and don ' t give me

anything to take at home as a result of my

injuries. ' This Pt. did admit to continuing to drink

from time to time and says she is taking her

Zoloft as prescribed by [a local mental health

facility.] She says that things have gotten so bad

in the home that her husband has asked her to

leave; she was upset that after 21 years of

marriage he wants to end the relationship. This

Pt. says she doesn ' t know how much more she

can handle and has even thought most recently

of suicide and this Pt. confirmed that she didn ' t

have a plan or the means to kill herself. She has



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a follow up appointment at [a local mental health

facility] on 11/16/2012; however this Counselor

will flag her on 11/13/12 in order to see where she

is with her SI (Suicidal Ideation). This Pt. provided

a UA on 11/2/12 which was negative of any illicit

substances. "

- " Plan - Plan Here: This Counselor will speak

with RN [RN #1/DON] in regards to this Pt. ' s MH

issues and coordinate a follow up apt. with [the

Medical Director] for this Pt. She is currently

receiving MH treatment through [a local mental

health facility]; however she isn ' t stable and

functioning at her current dose. A Peak and

Trough may be in order for this Pt. to get her

where she needs to be in treatment. "

- 11/9/12 - " This Pt. was observed in the

lobby ' appearing impaired ' prior to dosing; the

dosing LPN [LPN/LDN] called this Counselor and

requested a session to determine her level of

intoxication. This Counselor and Pt. met,

discussed [again] the importance of NOT taking

illicit medications and/or drinking alcohol in this

clinic as neither are tolerated. This Counselor

explained to this Pt. that this would [in fact] be her

final warning and moving forward if she presented

to the clinic after drinking or taking unprescribed

BNZ she would be placed on a ' Behavior

Contract. ' This Pt. admitted to taking one 0.5

Xanax last night and one 0.5 Xanax this AM

(morning) combined with ½ a beer. This Pt. was

able to carry on a normal conversation and

provided urine for this Counselor the dipped

provide positive for BNZ and Methadone. "

- " This Pt. was further encouraged to keep her

up-coming appt. with [a local mental health

facility] and her Counselor on 11/16/2012; she

was walked to the dosing window where this

Counselor spoke briefly with the LPN [LPN/LDN]

to make her aware of the UA results and the Pt. '

s confession of illicit use. "



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- " Plan - Plan Here: This Pt. ' s dose will be

reduced today per [the Medical Director]; Medical

Staff will continue to keep a close observance on

this Pt. she will be staffed on 11/14/2012 as a

potential Pt. requiring ' In-patient ' detox care or

at the very least a higher level of care than that of

an OTP (Opioid Treatment Program) setting.

This Pt. will meet with her Counselor 4x ' s

monthly, provide 1 negative UA (more if asked for

or required) and continue working on building new

life management skills and relapse prevention

skills moving forward in treatment. "

- " ... " This Counselor will speak with RN [RN

#1/DON] in regards to this Pt. ' s MH issues and

coordinate a follow up apt. with [the Medical

Director] for this Pt. "

- 12/3/12 - " This Pt. attended her scheduled

1:1 Counseling session this morning; she firstly

talked about not being stable in areas revolving

around her MH and that the voices guide her

throughout the night to get up and begin doing

about the house, redecorating rooms, cooking

meals, and having detailed conversations. The

voices and hallucinations are becoming

frightening to the Pt. and to her family and this

Counselor encouraged this Pt to speak with her

Therapists at [a local mental health facility]

regarding the changes she has been

experiencing on an auditory and hallucinatory

level. She agreed she would. She said, ' They

are treating me for the wrong things at [a local

mental health facility], even though I like it over

there they seem to believe my problem is related

to my drug use and it is not! The whole reason I

started taking the drugs was to try to quiet the

voices. "

- " This Pt. says the Zoloft make her condition

worse and she would really like to be placed on

the appropriate medication to become more

stable in her cognitions. She said ' I ' m afraid



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they will put me in a place for ' crazy people '

and I don ' t want that. I do just fine once I ' m on

the right meds. ' "




Staff. This Pt. will meet with her Counselor 2x ' s




treatment. "

- 12/17/12 - " ...This Pt. discussed the issues

revolving around her MH and stated, ' The voices

are getting much worse; in fact they are now

becoming violent and causing me to fall, pushing

me around, and insisting I take them '

somewhere/anywhere ' for a drive. I don ' t drive,

so this is very frightening to me. ' This Counselor

suggested this Pt. contact [a local mental health

facility] today and make them aware of the

urgency with the voices and see if there is

anyway they could work her in on today or

tomorrow. She agreed she would call [a local

mental health facility] today. "




Staff. The remainder of the plan remained the

same as the plan documented on 12/3/12.

- 1/3/13 - " ...Her (DC #1 ' s) primary concern

was when she would be able to begin '

taking-home. ' " This Pt. explained that the

transportation to the clinic daily is borrowed from

a family member and it would make her recovery

a lot easier if she didn ' t have to attend clinic 6x

weekly. This Counselor advised this Pt. she had

[again] earned take-home status and she would

be staffed on 1/9/2013 in order to request

take-home status. The Pt. said ' I ' m attending

to all my appt. ' s at [a local mental health facility]



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as we talked about, my Medicaid card should be

here soon and I will start scheduling other needed

medical appt. and I am taking my medication for

MH issues as prescribed. ' "

- " The Pt. provided a UA today which was

negative for any illicit substance (90-days

consecutive). "

- 1/8/13 - " This Pt. presented to her

Counselor ' s office this morning as a result of

being flagged for missing her scheduled appt. on

1/7/2013. This Pt. signed a consent to release

information from [a local mental health facility]

and a new COC (Coordination of Care) form was

signed and faxed in lieu of this Pt. ' s new

prescriptions for MH. This Pt. met with the RN

(RN#1/DON) on staff this morning and a result of

being flagged for a breathalyzer. She did present

with an alcohol count of .0011 and was unable to

dose today as a result. This Pt. presented with a

negative UA on 1/3/13 ... "

- Assessment - Assessment Here: Dimension

I: This Pt. is addicted to opiates; she is alert and

oriented 3x ' s; however she admits to drinking

one alcoholic beverage on 1/7/2013 due to her

sister ' s 40th birthday party. She describes this

as a ' special occasion ' and that she hasn ' t

drank in more than 90 days prior. "








treatment. "

- 2/6/13 - " This Pt. presented to her

Counselor ' s office this morning in a mode of

panic. She told her Counselor, ' I had such a

terrible seizure last night that I felt like I was going

to die! ' This Pt. was assessed by this Counselor



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regarding Axis I diagnoses and a determination

was concluded: this Pt. rates highly on Dimension

3 criterion as suffering from current psychiatric,

psychological, and emotional needs that need

addressing. She was immediately taken to the

RN (no indication as to who this was) on duty for

further evaluation. She was also instructed to

contact her MH provider as she has yet to stable

on her psychotropic medications yet continues to

drink alcohol and partake of additional illicit drugs.

The RN on staff asked this Pt. to go straight from

the clinic to the ER (Emergency Room) whereas

she could gain further Medical care. This Pt.

provided a UA: 2/5/13 which presented positive

for illicit opiates. "

- " Assessment - Assessment Here: Dimension

1: this Pt. appeared to be extremely agitated and

stressed regarding last nights seizure; she fails to

realize she is putting herself in imminent danger

by continuing to combine methadone, BNZ,

alcohol and opiates, She spoke about the trauma

incurred due to the seizure and her condition has

greatly worsened since her last session. "








treatment. "

Review on 4/8/13 of DC #1 ' s " Patient

Medication Record " revealed:

- On 12/4/12, DC #1 ' s Methadone dosage

was increased from 110 mg of Methadone to 120

mg of Methadone

- On 1/3/13, DC #1 ' s Methadone dosage was

increased from 120 mg to 130 mg of Methadone

- On 2/12/13, DC #1 ' s Methadone dosage



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was decreased from 130 mg to 97 mg of

Methadone

- No documentation a " Peak and Trough "

had been completed on behalf of DC #1 which

was discussed in Counselor #16 " case note "

for 11/8/12 " in order for to get her where she

needs to be in treatment. "


- A request for a take-home medication form

was completed on 1/22/13 and signed by the

(Assistant Program Director #1 (APD #1) and

Counselor #16 on 1/22/13

- The MD signed the form also; however, there

was no date listed by the MD ' s signature

- A " Patient Orders " form dated 1/17/13

which documented DC #1 was staffed and

approved for take-home medications to begin on

1/22/13

- The form documented that DC #1 would

attend the facility on Monday, Tuesday,

Wednesday and Thursday with take-homes for

Friday, Saturday and Sunday which indicated a

change from Level 1 to Level 2

- This " Patient Orders " form was signed by

Staff 16, the RN #1/DON and the Medical

Director with no dates listed by their signatures

- DC #1 continued on Level 2 until her death

on 3/16/13 with her receiving three take home

doses of Methadone at 107 mg per bottle


- No documentation of a staffing held on

11/14/12 on behalf of DC #1 to discuss the need

for a possible higher level of care than that of an

OTP (Opioid Treatment Program)

- No documentation any appointments were

scheduled on behalf of DC #1 with the facility ' s

Medical Director prior to 3/7/13, when DC #1 ' s

yearly physical was completed



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Review on 4/9/13 of a " case note " written by

the Program Director #1 (PD #1) and dated

3/26/13 revealed:

- " This PD (PD #1) met with [DC #1 ' s]

husband on this date. He was able to verify that

[DC #1] had passed away on 3/16/2013. He

reported ' for the last several months, she had

trouble keeping her balance. She would be

walking and then just fall. I tried and tried to get

her to go to the doctor be she didn ' t want to.

She wanted to help me because I had just had

hernia surgery. ' This PD (PD #1) asked if he

was aware of the cause of [DC #1 ' s] death. He

reported ' she told me she was tired and she was

going to take a nap. I went to the other bedroom

so I wouldn ' t wake her up. I went to sleep and

woke up a couple of hours later. I got up and

went into the other bedroom and saw blood on

her face. It looked like she had been bleeding

from her nose and her mouth. I called 911. They

took her to the hospital and said it looked like she

had a brain aneurysm. They sent her for an

autopsy. ' This PD (PD #1) asked if a copy of the

death certificate was available. [DC #1 ' s

husband] reported the certificate ' would be

ready ' in about 2-3 weeks. ' He agreed to bring

a copy to this clinic. This PD (PD #1) referred [DC

#1 ' s husband] to grief counseling at [a local

counseling facility.] "

Review on 4/15/13 of DC #1 ' s death certificate

revealed:

- DC #1 was " found dead in bed " at

approximately 5:39 pm on 3/16/13

- DC #1 ' s immediate cause of death was "

Pending OCME (Office of Chief Medical

Examiner) Autopsy Findings "

Interview on 4/23/13 with a Detective with the



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Sheriff ' s Department who investigated

(Deceased Client #1 ' s (DC #1 ' s) death

revealed:

- DC #1 was found dead in her home on

3/16/13 and transported to a local hospital and

declared deceased by the Medical Examiner on

3/16/13

- While at DC #1 ' s home, he observed a lock

box in the client ' s purse with three bottles of

methadone still intact

- He also observed an empty pill bottle near

the DC #1 with DC #1 ' s name on the bottle;

however, he could not determine what if any type

of medication may have been in the bottle

- The bottles of methadone and the one empty

pill bottle were sent with the DC #1 ' s body to the

state Medical Examiner ' s office as DC #1 was to

be autopsied

- In speaking with a member of DC #1 ' s

family, he learned that DC #1 had " quite a

history of drug use. "

- The family member also reported DC #1 had

been falling quite often, especially when she

attempted to go up steps

- The family member reported that on one

occasion, while he was present, he observed DC

#1 fall in the parking lot of the facility and had to

be attended to by the medical staff

- The family member stated while DC #1 did

not experience any bleeding from her injury, she

did sustain a " knot on her head. "

Review on 7/19/13 of DC #1 ' s " Report of

Autopsy Examination " completed by a physician

with the Office of the Chief Medical Examiner ' s

(OCME ' s) on 3/18/13 and signed by the same

physician on 7/18/13 revealed:

- DC #1 ' s cause of death was " Methadone

and dextromethorphan toxicity. "

- Additional diagnoses included Obesity (BMI



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(Body Mass Index) = 45, Microvesicular hepatic

steatosis and Myocardial fibrosis. "

- " ...Received with the body are three full

bottles of liquid methadone and one bottle of

citalopram (containing approximately 20 pills). "

Review on 7/22/13 of DC #1 ' s toxicology report

from the OCME ' s office revealed:

- Based on the analysis of DC #1 ' s liver

tissue, it was determined " 41 mg/kg of

Dextromethorphan, 7.7 mg/kg of Doxylamine and

24 mg/kg of Methadone " were present in DC #1

' s system

- Based on the analysis of a 8.0 ml blood

specimen from DC #1 ' s vena cava, it was

determined " 0.055 mg/L of Alprazolam, 2.3

mg/L of Dextromethorphan, 0.83 mg/L of

Doxylamine and 1.9 mg/L of Methadone " were

present in DC #1 ' s blood were present in DC #1

' s blood

-Review on 7/22/13 of the following medications

on www. <http://www.drugs.com/> revealed:

- " Alprazolam belongs to a group of drugs

called benzodiazepines

(ben-zoe-dye-AZE-eh-peens). It works by slowing

down the movement of chemicals in the brain that

may become unbalanced. This results in a

reduction in nervous tension (anxiety).

Alprazolam is used to treat anxiety disorders,

panic disorders... "

- Dextromethorphan is an ingredient in cough

suppressant medication

- " The nervous system side effects of

dextromethorphan have included drowsiness and

dizziness. Other side effects such as excitation,

mental confusion, and opioid like respiratory

depression have been rare and occurred at

higher dosages. In some cases of abuse, patients

experienced euphoria, hyperactivity, mania, and



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auditory and visual hallucinations. "

- "Doxylamine is an antihistamine that reduces

the effects of natural chemical histamine in the

body. Histamine can produce symptoms of

sneezing, itching, watery eyes, and runny nose.

Doxylamine is used to treat sneezing, itching,

watery eyes, and runny nose caused by allergies

or the common cold. "

Interview on 4/11/13 with Counselor #16 and DC

#1 ' s primary counselor revealed:

- " I saw [DC #1] every day. Everyday was the

same as yesterday; she (DC #1) couldn ' t

remember anything. "

- " [DC #1] was a high risk patient due to her

duel diagnosis.

- She was a client of [local mental health

agency] and they had diagnosed her with

Substance Induced Psychotic Disorder with

Hallucinations. "

- " It ' s bull crap, (the diagnosis of Substance

Induced Psychosis) because her family had

schizophrenia and she (DC #1) said she had

been diagnosed with schizophrenia " ; however

she could not remember what physician had

given her the diagnosis

- " I don ' t see how she (DC #1) was on

enough substances for the Substance Induced

Psychosis Diagnosis. Our facility (Crossroads

Treatment Center) (drug) tests do not show how

much of the substances she (DC #1) takes, only

that its there (drugs in her system). "

- " They (the local mental health agency) had

been changing her medications and DC #1 had

started falling. "

- DC #1 went to the emergency room for a

variety of physical complaints.

- DC #1 was illiterate; she could not read or

write, " Post It " notes were given to her to

provide to her parents to assist her with



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remembering what she had been told while she

was at the facility and to remind her of her

appointments

- " We (Counselor #16 and unnamed others)

think there might have been some domestic

violence with her husband. We had discussed

with the owners (of the facility) whether we

needed to MSW (Medically Supervised

Withdrawal) her out of the clinic, but she wasn ' t

eligible for the Medically Supervised Withdrawal

because she was very random with her drug use.

"

- " She did have paranoia depending on

whether she was manic or not. "

- " She didn ' t hit anything hard, no cocaine. "

- " I know that she (DC #1) was not good on

that last day (3/15/13); not only her cognitions but

her gait. We really came down on her, me and

the nurse (RN #1/DON) because we realized how

unstable she was. "

- DC #1 would not allow someone from the

facility to contact Emergency Medical Services

(EMS) on her behalf

- It was DC #1 ' s choice to not have EMS

called on her behalf

- DC #1 stated " I ' m going to the house (DC

#1 ' s home) because I ' m not going to leave my

husband by himself. "

- DC #1 ' s husband had recently had hernia

surgery and was recovering at their home.

Interview on 4/10/13 with the facility ' s Registered

Nurse #1/Director of Nursing (RN #1/DON)

revealed:

- DC# 1 was admitted to the facility in April of

2012

- DC #1 was " a sweet patient with a traumatic

brain injury and mental health issues. "

- Counselor #16 worked hard to getting her to

a local mental health agency for treatment as DC



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#1 had difficulty with her memory and the

memory issues may have been related to her

traumatic brain injury

- DC #1 had issues with alcohol and

breathalyzers were administered to her and she

was educated on the dangers of alcohol use

- DC #1 had been diagnosed with Substance

Induced Psychotic Disorder

- DC #1 had reported that she had been

diagnosed with Schizophrenia while in her 20 ' s;

however she could not remember the doctor who

diagnosed with Schizophrenia

- " We were trying to get her back to [the local

mental health facility] to look at the Substance

Induced Psychotic Disorder. "

- If a client has three positive urine analyses in

a row, the client ' s counselor will speak with the

client about the positive urine analyses and

discuss the client with the Medical Director if

necessary

- Counselors can talk with their clients,

determine what their stressors are and assist

them with addressing their stressors

- If there are concerns regarding the clients '

doses, the Medical Director would be contacted

- Based on a review of DC # 1 ' s record, it did

not appear a Peak and Trough test was

administered to DC #1

- " Sometimes he (the Medical Director) will go

up to 130 milligrams (of Methadone) without a

Peak and Trough. " If the client does not have

the income for the Peak and Trough and there is

no positive urine analysis an increase may be

ordered with the Peak and Trough

- A client can receive a Medical Supervised

Withdrawal (MSW), if there are health problems

which are interfering with their treatment.

- The client ' s counselor and the RN #1/DON

discuss the client ' s progress and if there is still a

problem; the client could be put on a " behavior



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contract " and the Medical Director could reduce

the client ' s dose

- " I speak to him (the Medical Director)

everyday, so he knows if someone is a repeat

offender and he makes the decision for MSW or

to decrease. "

- It was difficult at times to determine if DC #1 '

s mental health issues were affecting what DC #1

was reporting

- DC #1 did mention that she was falling and

she was advised to go to the Emergency Room

(ER); however, DC #1 would refuse to go

- DC #1 would state that she could not go to

the ER and leave her husband alone.

Interview on 4/9/13 with Licensed Practical

Nurse/Lead Dosing Nurse (LPN/LDN) revealed:

- If clients have health issues, the facility staff

would refer the client to their primary care

physician, if clients did not have health insurance,

facility staff referred the client to a local heath

care

- If clients have health issues the facility refers

them to their primary doctors. If clients have no

health insurance the facility refers them to a

health care facility. If clients refuse to follow up

with an outside physician then the facility ' s

Medical Director would see the client.

Interview on 4/16/13 with the facility ' s Medical

Director (MD) revealed:

- He had been employed by the facility for five

years. " I ' m basically on call every day of the

week, including Saturdays and available to

nurses every day. "

- " I do all of the annuals (yearly physical

exams) ...If people want to set up appointments

to come in to discuss methadone or other issues

(non methadone issues) they go to the RN (RN

#1/DON) if they (the clients) need to set up an



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appointment to see me. "

- " [RN#1/DON] handles most of the medical

issues when it comes to methadone issues. Any

of the nurses can call me but [RN#1/DON] is

usually the one to call me unless she ' s close to

overtime then [the LPN #1/LDN] calls. "

- With regard to clients with dual diagnoses,

the MD stated, " Honestly it ' s hard to

differentiate because we are not a dual diagnosis

clinic. We recommend clients going to Primary

Care Physician or Emergency Room. "

- " If it ' s an acute situation here when they ' re

unstable and you think they are in danger, call the

EMS (Emergency Medical Services). "

- " The problem comes in when we don ' t

know if it ' s Benzos (Benzodiazepines) or

something else then we recommend they follow

up. It ' s difficult to know. "

- " When I saw her (DC #1) for her yearly,

(annual physical exam) she did not tell me she

was falling down, her main concern was [a local

mental health facility]. She was not unstable in

my medical opinion; she was walking around,

looked fine. "

- " Sounds like she had an aneurysm, with an

aneurysm it goes like that. You could be stable

and then just go. "

- " It wasn ' t her mental status as to why she

wasn ' t going to follow up. These folks have so

much going on in their life they ' re just trying to

become stable. It seemed like whatever you told

her she didn ' t take it that seriously. "

- It was initially the understanding of the MD

that DC #1 had not been on any psychotropic

medications

- After reviewing DC #1 ' s record, he realized

that DC #1 had been put on Zoloft in October of

2012.

- When asked how testing positive (on urine

analysis) impacts his decisions, the Medical



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Director replied: " It ' s a case by case basis ...I

look at current dose, history of dose. "

- " On a day to day basis it comes down to

impairment. You want to keep them (the clients)

stable ...if they are impaired I would have to lower

doses. If you drop them too much they will go out

on the streets. It ' s a tricky balance. I put a great

bit of trust on the nurses and also the counselors.

"

- " Psychosocial is important as to why we

think they need a higher level of care. No support

at home and relapse we would have to look at

higher level. Sometimes we can ' t get them a

higher level they don ' t meet criteria etc. so it ' s a

tricky situation. "

- " I ' m not sure if [PD #1] talked to [Counselor

#16] about the higher level. "

- He did not attend treatment team meetings;

however, he had the option of reviewing the

clients ' case notes

- He was not aware of DC #1 ' s diagnosis of a

Substance Induced Psychotic Disorder

- He had about five conversations about DC #1

via the phone with RN #1/DON. Some of the

conversations were about DC #1 ' s complaining

about falls; however, most were about her

positive drug screens and how she should be

dosed.

- " Even if I knew about the Substance Induced

Psychotic Disorder, I would not have changed the

doses. There were no signs of any neurological

symptoms at the time I saw her on 3/5/13. The

aneurysm wasn ' t related to the behaviors. "

- As for a client who continues to use alcohol

or illicit drugs and continued Methadone

treatment, " It is a case by case basis. If we see

9 months to year and still dirty (positive drug

screens), then we will consider dosing an MSW. "

- The MD was not aware of DC #1 having had

hallucinations



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- Clients are moved from one level to the next

when they produce three months of clean drug

screens and are not engaged in any illicit drug

use

- Alcohol may or may not be considered as an

illicit drug as it depends on the situation. If a

client is constantly positive for alcohol, then it

could be considered a positive drug screen

- The danger of mixing Benzodiazepines with

Methadone was that both drugs could cause "

respiratory distress ...you stop breathing. "

- As a result of the information shared with the

MD during the interview, he stated " I ' m going to

talk to [PD #1] and he (PD #1) will get with the

counselors. We will probably come up with a

check list. We (the facility) need to have a red

flags test for the counselors. "

Interview on 4/12/13 and 4/17/13 with facility ' s

PD #1 revealed:

- " There was not a day that went by " that he

did not speak with the Medical Director (MD)

- His nurses spoke to the MD every day

- My guess is [DC #1] was having a lot of

financial difficulties; he (the MD) will override his

standing order if patient is doing well. For [the

MD], this would be the exception, not the norm to

increase dose without " peak and trough. "

- Since DC #1 ' s death he had come up with a

new system to ensure all information was shared

with him and the MD

- He was not sure if the facility had staffed DC

#1 for a higher level of care

- The facility had not done an internal review

regarding DC# 1 ' s death

Review on 4/16/13 of the facilities policy and

procedures regarding " Medical Director ' s

Standing Orders " revealed:

- " When Patient appears to be intoxicated:



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The patient will not be dosed. The patient shall

be referred to the nurse or to a counselor for

observation and evaluation.

If in doubt, alert the Program Director and the

patient ' s counselor. Discuss any concerns

before dosing the patient. You may opt to

observe and monitor the patient ' s condition

before deciding whether or not to dose the

patient.

The patient is not to be dosed on that day without

both the nurse and the counselor agreeing that

the patient can safely be dosed. If there are

questions remaining about safety, then the

patient should not be dosed unless the case is

reviewed with the Medical Director.

The decision to dose or not to dose should be

clearly documented in the patient ' s record. If

patient is dosed, the patient should be observed

after dosing for at least 30 minutes to document

the patient is safe to leave the clinic. "

Further review on 4/17/13 of facility ' s policy and

procedures manual regarding levels and take

home criteria revealed:

- " Take Home Eligibility: Any patient in


requests unsupervised or take home use of


treatment of Opioid addiction must meet the


treatment. The patient must also meet the

specified requirements for continuous program

compliance and must demonstrate such

compliance during the specified time periods

immediately preceding any level increase. In

addition, during the first year of continuous

treatment a patient must attend a minimum of two

counseling sessions per month. After the first

year and in all subsequent years of continuous

treatment a patient must attend a minimum of



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one counseling session per month.

- 1. Levels of Eligibility are subject to the

following conditions:

a. Level 1. During the first 90 days of continuous

treatment, the take home supply is limited to a

single dose each week and the patient shall

ingest all other doses under supervision at the

clinic;

b. Level 2. After a minimum of 90 days of

continuous program compliance, a patient may

be granted for a maximum of three take home

doses and shall ingest all other dose under the

supervision at the clinic each week. "

Finding #4:


#4 ' s) record revealed:



- Two obituary listings which documented DC

#4 died on Monday, March 18, 2013

- He was 35 years of age


- An intake assessment completed on 3/15/13

which documented DC #4 had entered treatment

with his girlfriend (DC #5) on the same date

- DC #4 reported no depressive thoughts in the

previous 30 days

- " The Physician ' s Initial Orders For A New

Patient " completed and dated by the MD on

3/15/13 documented DC #4 would be receive a

30 mg dose of Methadone on 3/15/13

- " A Patient Medication Record " which

documented that DC #4 received a 30 mg dose

of Methadone on 3/16/13 and a take-home dose

of 30 mgs for 3/17/13

- A " Patient Medication Record " which

documented that DC #4 was absent from the

facility from 3/18/13-3/26/13



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- The " Patient Medication Record " indicated

staff (no staff listed) " attempted to contact pt

(DC #4) - couldn ' t connect to telephone " from

3/18/-3/22/13

- On 3/25/13 staff (no staff listed) " attempted

to contact emergency contact - no vm

(voicemail). "

- A " Patient Discharge " form with a

discharge date of 3/26/13 for DC #4. The form

was not dated and did not indicate who

completed the form

- The " Patient Discharge " form documented

" Patient ' s Current Condition/Gains: Unknown;

Treatment Summary: Did not complete treatment;

Reason for Discharge: Left against staff advice -

missed 7 consecutive days after being contacted.

Could not contact pt (patient). Follow up Plans:

None. "

- A " Report of Investigation By Medical

Examiner " dated 3/19/13 and completed by the

Medical Examiner for the county in which DC #4

resided included a " Narrative Summary of

Circumstances Surrounding Death " which

documented " ...He (DC #4) and his girlfriend

were living together at [address of DCs #4 and

#5]. His girlfriend (DC #5) had apparently been

taking some Methadone and inhaling air

freshener. When he woke up, he found her lying

beside him. She was unresponsive and

apparently dead. He then called his mother and

told her that his girlfriend was dead. He then

hung up and wrote a suicide note and got back

into bed next to her. She was on her right side

and he got up on his right side up close to her.

He then used a 9mm (millimeter) handgun and

shot himself in the left side of the head. The

bullet went through his head and then into his

right upper arm which was above his head.

There were also rose petals on him as well as

her. We do not know if he put the rose petals in



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the bed after he found her dead or if they had

rose petals in the bed from the night before. In

examining the body, there was an odor of alcohol

on the body. "

- No autopsy was completed on DC #4




specimen from DC #4 ' s subclavian vessel, it

was determined DC #4 had 30 mg/dL of Ethanol

in his blood

Review on 5/15/13 of the facility ' s " Patient List

By Counselor " revealed:

- DC #4 was assigned to Counselor #6 on

3/15/13


revealed:





- The PD #1 and the APD #1 learned of DCs

(#4 ' s) death during the late afternoon of 3/22/13

- They learned of DCs (#4 ' s) death via the

internet

- " No one contacted the client because no

counselor had been assigned "

Finding #5:


#5 ' s) record revealed:



- An obituary listed by a funeral home in a



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newspaper documented DC #5 " passed

Monday, March 18, 2013 at her home. "

- She was 32 years of age


- A screening completed by Counselor #3 on

3/15/13 which documented that DC #5 ' s primary

drug of use was " pain pills of any kind. "

- She had used opiates for ten years with a

cost of $200.00 per day

- Her last opiate use was on 3/15/13 as she

had had a prescription for five Oxycodone pills

filled the morning of 3/15/13

- She had taken all five Oxycodone pills prior to

her arrival at the facility for her intake

- No evidence a History and Physical Exam

was completed by nursing staff

- A urine analysis (UA) conducted via " intake

dip " on 3/15/13 indicated DC #5 was positive for

Benzodiazepines, Opiates, Oxycodone and THC

(TetraHydroCannabinol)

- " A Physician ' s Exam " completed by the

facility ' s Medical Director (MD) on 3/15/13 which

documented the MD ' s " assessment " of DC #5

indicated diagnoses of " Opioid Dependence,

Epilepsy, Kidney Stones. "

- DC #5 ' s " Plan " included "

Methadone/Counseling and Dilantin. "

- An " Addiction Verification Form " completed

and signed by the MD on 3/15/13 on behalf of DC

#5 documented " The above named patient (DC

#5) has applied to Crossroads Treatment Center

for treatment. The following items, which are

checked and have been documented, are used to

verify addiction to opiate drugs and to warrant

admission into our program. "

- Further review on 3/151/3 of the " Addiction

Verification Form " revealed: " The patient has

been assessed with regards to signs and

symptoms of opiate withdrawal (See Physical

Assessment). "



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- " The patient ' s initial urine test was positive

for opiates. "

- The patient has submitted testimonies

regarding at least a one year history of addiction

to opiate drugs. "

- " The patient has tried unsuccessfully to stop

using drugs. "

- An initial note completed by the MD indicated

the " Patient Is A Good Candidate for treatment.

"

- " The Physician ' s Initial Orders For A New

Patient " completed and dated by the MD on

3/15/13 documented DC #5 would receive a 30

mg dose of Methadone on 3/15/13

- " A Patient Medication Record " which

documented that DC #5 received a 30 mg dose

of Methadone on 3/16/13 and a take-home dose

of 30 mgs for 3/17/13

- A " Patient Medication Record " which

documented that DC #5 was absent from the

facility from 3/18/13-3/26/13

- The " Patient Medication Record " indicated

staff (no staff listed) " attempted to contact pt

(DC #5) - couldn ' t connect to telephone " from

3/18/-3/22/13

- On 3/25/13 staff (no staff listed) " attempted

to contact emergency contact - no vm

(voicemail). "

- A discharge date of 3/26/13 with the reason

for discharge entered by the PD #1 as " Left



- A " Patient Discharge " form with a

discharge date of 3/26/13 for DC #5. The form

was not dated and did not indicate who

completed the form

- The " Patient Discharge " form documented

" Patient ' s Current Condition/Gains: Unknown;

Treatment Summary: Pt did not complete

treatment; Reason for Discharge: Left against



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staff advice - missed 7 consecutive days after

being contacted. Follow up Plans: None. "

Review on 7/22/13 of DC #5 ' s " Report of

Autopsy Examination " completed by a physician

with the Office of the Chief Medical Examiner ' s

(OCME ' s) office on 3/19/13 and signed by the

same physician on 7/18/13 revealed:

- DC #5 ' s cause of death was " Cocaine,

methadone and morphine toxicity. "

- " Personal effects received with the body

include one Glade air freshener aerosol bottle,

one empty liquid methadone container, and one

short plastic straw. "




specimen from DC #5 ' s aorta, it was determined

Benzodiazepines, Cocaine metabolite,

Levamisole, and Opiates/Opioids were present in

DC #5 ' s blood

- Based on the analysis of a 8.0 mg/L blood

specimen from DC #5 ' s vena cava, it was

determined " 0.37 mg/L of 7-Aminoclonazepam;

0.43 Benzoylecgonine mg/L; 0.039 mg/L Cocaine;

0.38 Methadone mg/L; and 0.17 mg/L Morphine "

were present in DC #5 ' s blood

- Based on the analysis of a 15.0 ml sample of

urine from DC #5 ' s bladder, it was determined "

6.8 ml of Morphine " was present in DC #5 ' s

urine

-Review on 7/22/13 of the following medications

on www. <http://www.drugs.com/> revealed:

- " Aminoclonazepam is used to monitor the

use of the parent drug Clonazepam which is a

benzodiazepine that is used to treat seizures and

sometimes panic disorders. It is a muscle

relaxant, sedative and has hypnotic properties. "



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- Benzoylecgonine is a metabolite of Cocaine

which serves as a marker for Cocaine ingestion

- Levamisole is a cancer medication used to

treat colon cancer

- Morphine is and opioid pain medication used

to treat moderate to severe pain

Review on 5/15/13 of the facility ' s " Patient List

By Counselor " revealed:

- DC #4 was assigned to Counselor #6 on

3/15/13


revealed:





-She was hired on 3/18/13

-"Got my caseload almost 2 weeks later."

-"There are 2 (DC #s 4 and 5) on my caseload

that passed away."

-"I never put in notes in, never met them, never

talked to them."


- The PD #1 and the APD #1 learned of DCs

(#5 ' s) death during the late afternoon of 3/22/13

- They learned of DCs (#5 ' s) death via the

internet

- " No one contacted the client because no

counselor had been assigned "

Interview on 5/17/13 with Assistant Program

Director #1 (APD#1) revealed:

- DCs #4 & 5 were transition clients (clients

awaiting assignment of a counselor)

-"They had not been assigned a counselor.

[PD#1] may have been contacting clients."



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- The facility does not admit clients on Fridays

any longer

- There had been a standing order for clients to

receive take-homes for Sundays; however, the

facility has now become a Level Zero facility with

all new clients beginning in the induction phase

and required to attend the clinic seven days per

week

- Five Hydrocodone is not unusual for these

clients; Dilantin also lowers blood levels and 30

mgs of Methadone would feel more like 20 mgs

- If a History and Physical were not completed

by the RN #1/DON, it would not impact the MD ' s

evaluation of the client ' s need for services as he

completes his own physical examination.

- " My evaluations are more than enough to

determine what levels to start dosing "







" ...26G .0203

Specific actions taken to date to address issues

related to the competencies of qualified

professionals and associate professionals

include:

Former Program Director, [Program Director #1],

was terminated on May 25, 2013.

Former Assistant Program Director, [Assistant

Program Director #1] is no longer employed by

Crossroads Treatment Center of Greensboro

effective June 3, 2013. She has since been

transferred to another role within Crossroads

outside of Greensboro.



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New Program Director, [Program Director #2],

was hired on 6/20/2013.

New Assistant Program Director, [Assistant

Program Director #2] was promoted to that

position on 7/16/2013.

New Senior Counselors, [Senior Counselor #1]

and [Senior Counselor #2], were promoted to

their positions on 7/19/2013. "

" 27G.3603

Concerning treatment center staffing:

1. All current caseloads are equal to or under 50

per counselor.

2. Current hiring of qualified counselors will

continue to keep up with demand. "

" 27D.0304

Patient protection is addressed through the

following measures:

1. An improved intake process was

implemented on May 27, 2013.

2. A new Intake Coordinator, [Counselor #6]

was promoted to this position on May 24, 2013 to

ensure the new intake process provides the

desired quality improvements.

3. We became a " Level 0 " clinic (dosing 7

days per week) on April 29, 2013 to provide a

higher level of monitoring for induction patients.

Therefore, patients in this higher risk phase of

treatment no longer receive take-home

medication. Should we again decide to conduct

intakes on Friday at some point in the future,

induction patients will be doubly protected by the

absence of take-home medications for Sundays

and the restriction prohibiting dose increased

over the weekend.

4. As stated above, a High Risk Binder was

created in May 2013 for patients identified as "

high risk " due to pregnancy, co-occurring

disorders or medical fragility. This binder was



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created and is maintained by the Director of

Nursing and presented to the program physician

bi-weekly for review. Further, the Director of

Nursing meets weekly with these patients and

completes an individual health status update.

5. A Medication list is completed for each

patient upon intake and placed in the chart for

review by medical staff. All medications are then

checked against the Epocrates database to

identify potential adverse reactions with

Methadone. This check is conducted by the

Intake Coordinator prior to each patient meeting

with the program physician. All medications are

reviewed by the program physician and must

receive physician approval.

6. The two Senior Counselors (#1 and #2)

provide immediate quality clinical supervision of

all staff. The counseling staff has been divided

into two groups to be managed by the Senior

Counselors (there are currently 5 counselors per

Senior counselor).

7. The Senior Counselors meet with their team

weekly for Mini-Treatment Team meetings to

discuss treatment decisions, patient record

issues, patient behavior, treatment planning,

coordination of care issues and quality of

counseling.

8. As of June 25, 2013, counselors are able to

staff patients with the center ' s Medical Director

at a weekly meeting specifically designated for

this purpose.

9. All Staff Treatment Team Meetings will be

held bi-weekly and chaired by [Program Director

(Program Director #2 (PD #2)], LCAS (Licensed

Clinical Addiction Specialist) to discuss cases

from the Mini-Treatment Teams that need further

clinical care and decisions. Patients will be

eligible to attend these meetings (as needed) for

treatment decisions such as discussion of

eligibility for continued treatment or MSW



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(Medically Supervised Withdrawal).

10. Coordination of Care documentation that is

not received back from health care providers

within seven business days will be followed up

directly by the Lead Nurse or Director of Nursing

to ensure documentation was received and is

being acted upon.

11. On or before August 2, 2013, the Director of

Nursing (Registered Nurse #1/Director of Nursing

(RN #1/DON) will re-train all staff that work on

Saturdays and/or Sundays on the procedures

associated with screening patients prior to dosing

for signs of impairment and the proper steps to

take if impairment is suspected. "

This deficiency constitutes a Type A1 rule


An administrative penalty of $20,000.00 is

imposed. If the violation is not corrected within 23

days, an additional administrative penalty of

$500.00 per day will be imposed for each day the

facility is out of compliance beyond the 23rd day.

V 536 27E .0107 Client Rights - Training on Alt to Rest.

Int.

10A NCAC 27E .0107 TRAINING ON

ALTERNATIVES TO RESTRICTIVE

INTERVENTIONS

(a) Facilities shall implement policies and

practices that emphasize the use of alternatives

to restrictive interventions.

(b) Prior to providing services to people with

disabilities, staff including service providers,

employees, students or volunteers, shall

demonstrate competence by successfully

completing training in communication skills and

other strategies for creating an environment in

which the likelihood of imminent danger of abuse

V 536



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or injury to a person with disabilities or others or

property damage is prevented.

(c) Provider agencies shall establish training

based on state competencies, monitor for internal

compliance and demonstrate they acted on data

gathered.

(d) The training shall be competency-based,

include measurable learning objectives,

measurable testing (written and by observation of

behavior) on those objectives and measurable

methods to determine passing or failing the

course.

(e) Formal refresher training must be completed

by each service provider periodically (minimum

annually).

(f) Content of the training that the service

provider wishes to employ must be approved by

the Division of MH/DD/SAS pursuant to

Paragraph (g) of this Rule.

(g) Staff shall demonstrate competence in the

following core areas:

(1) knowledge and understanding of the

people being served;

(2) recognizing and interpreting human

behavior;

(3) recognizing the effect of internal and

external stressors that may affect people with

disabilities;

(4) strategies for building positive

relationships with persons with disabilities;

(5) recognizing cultural, environmental and

organizational factors that may affect people with

disabilities;

(6) recognizing the importance of and

assisting in the person's involvement in making

decisions about their life;

(7) skills in assessing individual risk for

escalating behavior;

(8) communication strategies for defusing



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and de-escalating potentially dangerous behavior;

and

(9) positive behavioral supports (providing

means for people with disabilities to choose

activities which directly oppose or replace

behaviors which are unsafe).

(h) Service providers shall maintain

documentation of initial and refresher training for

at least three years.

(1) Documentation shall include:

(A) who participated in the training and the

outcomes (pass/fail);

(B) when and where they attended; and

(C) instructor's name;

(2) The Division of MH/DD/SAS may

review/request this documentation at any time.

(i) Instructor Qualifications and Training

Requirements:

(1) Trainers shall demonstrate competence

by scoring 100% on testing in a training program

aimed at preventing, reducing and eliminating the

need for restrictive interventions.

(2) Trainers shall demonstrate competence

by scoring a passing grade on testing in an

instructor training program.

(3) The training shall be

competency-based, include measurable learning

objectives, measurable testing (written and by

observation of behavior) on those objectives and

measurable methods to determine passing or

failing the course.

(4) The content of the instructor training the

service provider plans to employ shall be

approved by the Division of MH/DD/SAS pursuant

to Subparagraph (i)(5) of this Rule.

(5) Acceptable instructor training programs

shall include but are not limited to presentation of:

(A) understanding the adult learner;

(B) methods for teaching content of the



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course;

(C) methods for evaluating trainee

performance; and

(D) documentation procedures.

(6) Trainers shall have coached experience

teaching a training program aimed at preventing,

reducing and eliminating the need for restrictive

interventions at least one time, with positive

review by the coach.

(7) Trainers shall teach a training program

aimed at preventing, reducing and eliminating the

need for restrictive interventions at least once

annually.

(8) Trainers shall complete a refresher

instructor training at least every two years.

(j) Service providers shall maintain

documentation of initial and refresher instructor

training for at least three years.

(1) Documentation shall include:

(A) who participated in the training and the

outcomes (pass/fail);

(B) when and where attended; and

(C) instructor's name.

(2) The Division of MH/DD/SAS may

request and review this documentation any time.

(k) Qualifications of Coaches:

(1) Coaches shall meet all preparation

requirements as a trainer.

(2) Coaches shall teach at least three times

the course which is being coached.

(3) Coaches shall demonstrate

competence by completion of coaching or

train-the-trainer instruction.

(l) Documentation shall be the same preparation

as for trainers.



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facility failed to have initial and updated annual

training in alternatives to restrictive interventions

for 2 of 22 audited staff (Counselor #2 and the

Medical Director (MD)). The findings are:


revealed:



- No documentation of a training certificate for

North Carolina Interventions (NCI) Part A.

Review on 4/10/13 of the MD ' s record revealed:


- A job description of Medical Director

- No documentation of a training certificate for

North Carolina Interventions (NCI) Part A.


- He was not aware NCI Part A training was

required


(PD #1) revealed:

- He was not sure why some staff had training

and some did not.



Documents

STATEMENT OF DEFICIENCIES (X2) MULTIPLE ...EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (X5) COMPLETE DATE ID PREFIX TAG (X4) ID TAG SUMMARY STATEMENT