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68 HARRIS BUSHVILLE ROAD, P O BOX 800

HARRIS, NY 12742

LICENSURE OF HOSPITAL

Tag No.: A0022

Based on document reviews, interviews and observations, it was determined that the hospital failed to notify and obtain approval from New York State Department of Health licensing agency to de-certify discontinued and non-existent services as licensed on the facility's Operating Certificate.

Findings include:

a. The following Outpatient services are licensed on the facility's Operating Certificate but they are no longer provided on the hospital's main campus:
Nutritional; Prenatal; Well Child Care; Pediatric; Primary Medical Care; Multiphasic Screening; Chemical Dependence-Rehabilitation; and Podiatry services.
These findings were confirmed during the tour of the premises from January 24 -25, 2011.

b. The following 2 facility offsite clinics are no longer in operation, but are still licensed on the facility's Operating Certificate:
i) Rockland Family Health Center, Roscoe NY, 12776- Has been closed more than 5 years.
ii) Liberty Medical Group, 111 Sullivan Avenue, Ferndale, NY 12734- The hospital's staff has not provided services at this site since December 31, 2010.

Staff #4 stated on January 24, 2011 at approximately 11:30 AM, that the facility no longer employs the staff of the Liberty Medical Group because the physicians have joined a private medical group. The services are still being provided at this location but not by the hospital's staff.
These findings were confirmed during an interview with Staff #4 at 3:00 PM on January 27, 2011.

c. The following information was obtained regarding never-provided and discontinued services at another offsite location:

CRMC-Jefferson Extension Clinic, Jefferson Plaza, Jefferson Street, Monticello, NY 12701-
Has never provided Well Child Care services. In addition, Nutritional and Primary Medical Care services are not provided at this location.
This was confirmed during a tour of the center on January 23, 2011 at approximately 3:00 PM.

PATIENT RIGHTS

Tag No.: A0115

Based on medical record reviews, staff interviews and policy and procedure review, the Condition of Patients Rights is not met due to multiple deficiencies cited for Restraint and Seclusion.

Findings include:

The facility failed to monitor patient's as required when the facility is using "drugs as restraints". Physicians ordered PRN and STAT psychotropic medications to manage the patient's behavior when those medications are different from the patient's standard treatment orders or dosages.

See Restraint / Seclusion citations at A160, A164, A165, A167, A169, A175, A179, A187, A188 and A194.

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0160

Based on medical records reviews and staff interviews, facility staff untrained in the use of "drugs used as restraints", used PRN and STAT psychotropic medications to manage the patients' behaviors when they were not a part of the standard treatment for the patients' conditions. This is evident in 5 of 37 medical records reviewed. MR #s 12, 18, 19, 36, and 37.

Findings include:

1. MR #12 is a 61 year old patient admitted 1/09/11 with the primary complaint of Sepsis and Small bowel obstruction. The patient also has a history of depression and cerebral palsy. Home medication history includes Geodon and Depakote ER.

The patient's medical record was reviewed on 1/25/11 at 3:00 PM witnessed by Staff #3. On 1/20/11 (time illegible in medical record), the physician ordered Ativan 2 mgs IM q12hrs PRN and Haldol 5mgs IM q8h PRN for no documented reason. The orders were transcribed on the Medication Administration Record and on 1/20/11 at 11:30 PM, 1/21/11 at 10:00 PM and 1/23/11 at 9:15 PM, the Ativan 2mg IM doses were administered to the patient. In addition, the patient was ordered to receive on 1/20/11 at 1:40 PM " Ativan 1mg IV now " for no documented reason. The STAT dose was administered at 1:45 PM on 1/20/11.

The facility failed to monitor the vital signs of the patient in relation to the administered doses. In addition, the responses of the patient to the administered doses of Ativan given IV and IM were not documented.

On 1/25/11 at 3:00 PM, Staff #3 was interviewed about the facility's knowledge of "drugs used as restraints" and the monitoring requirements. Staff #3 stated the facility staff is not aware of the requirements; a facility policy is not in existence; she recognizes the physician orders as incomplete and the nurse should have questioned the orders.

2. MR #18 revealed that the patient was admitted on 1/25/2010 with a diagnosis of Schizophrenia. According to the Physician's orders on 1/25/10 at 8:00 PM, admit the patient to MHU with current diagnosis of Schizophrenia, PRN order box was checked for: Ativan 2mg po with Haldol 5mg po every 4 hours PRN agitation. Maximum daily dose of 4 in 24 hours and Vistaril 50mg po q 6 hours PRN for agitation/anxiety. Maximum dose of 4 in 24 HRS.

On 1/27/10 at 9:30 AM, Ativan 2mg IM and Haldol 5mg IM Stat was ordered. This order was not a complete order because the purpose for this medication was not documented. In addition, these medications were used as "drugs used as restraints", as they were not a part of the standard treatment for the patient.

According to the Single Orders-Stats, the patient received Ativan 2mg with Haldol 5mg IM Stat on 1/27/10 at 9:33 AM. There was no monitoring of vital signs after this Stat medication, no face-to-face assessments by the physician after the Stat order and no monitoring of the effectiveness of the medications was documented.

Although, in the Multidisciplinary Progress Note, the RN documented on 1/27/10 at 11:10 AM that "the patient was agitated, threatening, PRN of Ativan 2mg with 5mg IM given (missing the name of the second IM medication), the patient was cooperative. The patient was still with agitation" and the MD note at 11:10 AM documented: "the patient was physically aggressive, labile, received IM Haldol and Ativan."

According to the RN progress notes documented on 2/1/2010 at 5:10 PM, the patient was offered PRN Ativan 2mg with Haldol 5mg po, but the patient refused, MD was notified, T.O orders were received at 5:00 PM for Ativan 2mg with Haldol 5mg IM. The RN note on 2/1/10 at 5:10 PM did not indicate why the PRN dose was offered to the patient. According to the MAR (Medication Administration Record), the patient received PRN Ativan 2mg with Haldol 5mg IM q 4 hr for severe agitation on 2/1/10 at 5:00 PM and 2/2/10 at 9:30 PM. There was no face-to-face assessments by the physician after the PRN. The facility also failed to monitor the patient's vital signs after the administration of the PRN medications and no monitoring of the effectiveness of the medication was documented.

3. Review of MR #19 revealed a 25 year old patient was admitted on 11/24/2010 at 11:26 AM with current diagnosis of Schizophrenia. On 11/27/10 at (time not specified), the physician ordered that Ativan 2mg IM with Haldol 10mg IM q 4 hrs for agitation maximum dose 4 doses in 24hrs be administered to the patient.

The patient received Ativan 2mg IM with Haldol 10mg IM q 4 hrs for agitation at 4:00 PM on 11/27/10. These medications were used as "drugs used as restraints", as they were not a part of the standard treatment, (as the physician did not check the po order set on admission) or dosage for the patient. However, it was noted that there was no face-to-face assessment by the physician after the PRN medications were administered, no monitoring of the patient's vital signs after the PRN medication, and the monitoring of the effectiveness of the medications was not documented.

4. MR #36 revealed that the patient was a 29 year old female, admitted on 11/3/2010 with diagnoses of Depression with Suicidal Ideation and PTSD. On 11/3/2010, the PRN order was checked for Ativan 2mg po with Haldol 5mg po, every 4 hours PRN for agitation. Maximum daily dose of 4 in 24 hours; for Vistaril 50mg po 6 hours PRN for agitation/anxiety. Maximum dose of 4 in 24 HRS.

On 11/4/2010 at 9:20 PM, the patient was yelling and banging on the wall. A physician made a T/O for Abilify 9.75mg IM with Ativan 2mg IM q 4 hr PRN for severe agitation; the patient received PRN Abilify 9.75mg IM with Ativan 2mg IM at 9:30 PM. At 9:35 PM, MD T/O was noted by RN "place the patient on Mechanical Restraint up to 4 hours, 4 point restraints for assaultive, self abusive behavior." The patient was placed on restraint from 9:35 PM to 10:05 PM.
These medications were used as "drugs used as restraints", as they were not a part of the standard treatment, or treatment format for the patient.
The facility failed to monitor the vital signs of the patient after the administered doses of "drugs used as restraints" to control the patient's violent behavior.

5. MR #37 revealed that the patient was a 20-year old male admitted voluntarily to MHU on 10/05/2010 with a diagnosis of Schizophreniform disorder, unspecified state.
On 10/05/2010 at 12 noon, orders were checked for Ativan 2mg po with Haldol 5mg po every 4 hours PRN agitation. Maximum daily dose of 4 in 24 hrs. Vistaril 100mg po q 6 hrs PRN for agitation/anxiety.

On 10/5/10 at 1:45 PM, the RN documented in the Multidisciplinary Progress Notes that the patient was very disorganized, talking about throwing lit cigarette in oil gas. According to the MAR (Medication Administration Record), the patient received Ativan 2mg po with Haldol 5mg po q 4 hr PRN for agitation.

MD's progress notes on 10/9/10 at 8:30 AM documented "the patient was "intrusive and demanding to see MD, hit staff with fist, Manpower was called, and PRN medication of Ativan 2mg po with Haldol 5mg po were given." On 10/9/10, Physician;s Orders for Restraint documented "the MD T/O was written as "place the patient on Mechanical Restraint up to 4 hours, Ativan 2mg po with Haldol 5mg po as Emergency Medication for banging head against wall, punching the staff."
The patient was placed on 4 point restraints from 8:20 AM to 9:10 AM on 10/9/10.

According to the MAR, the patient received Ativan with Haldol PRN order 8 times as follows: 10/5/10 at 1:45 PM, 10/6/10 at 11:45 AM, 9:30 PM, 10/9/10 at 8:15 AM and 9:00 PM, 10/10/10 at 3:45 PM, and 10/11/10 at 12:15 AM and 9:00 AM. Vistaril 100 mg po PRN order was also given on 10/6/2010 at 7:15 AM.

Note:There was no evidence that the physician reviewed the patient's standing treatment orders, to titrate them in order to better manage the patient's condition and avoid repeated use of PRNs.

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0164

Based on medical record reviews and staff interviews, the facility failed to assess the patients in the facility for "least restrictive" interventions to address violent patient behavior. This is evident in 5 of 37 medical records reviewed, MR #s 12, 18, 19, 36, and 37.

Findings include:

SEE CITATIONS AT A160.

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0165

Based on medical record review and staff interview, the facility failed to use the least restrictive option in the treatment of a patient. This was found in 2 of 2 patients on physical restraints, MR #s 36 and 37, in 5 of 11 patients on "drugs used as restraints", MR #s 12, 18, 19, 36, and 37.
Findings include:

1. SEE CITATIONS AT A160.

2. The facility failed to provide different treatment modalities to ensure the patient's right to least restrictive intervention in addressing patient behavior that is violent or destructive to self or others.

During interviews conducted on 1/25/2011 at 2:15 PM with Staff #2 and #7, both staff members confirmed that they did not have a Quiet/ Comfort Room in the facility. The facility has a Patient Care Policy and Procedure Manual for Restraint, but no policy and procedure for use of a Quiet/ Comfort Room as part of the continuum of patient care.

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0167

Based on review of facility policy, the facility failed to address the use of "drugs used as restraints" in accordance with safe, appropriate restraint techniques to ensure patient safety and wellbeing, as determined by hospital policy in accordance with State Law.

Findings include:

1. A review of the facility's "Restraint Policy and Procedure", revised on 6/10, revealed that the Policy and Procedure:
Defined "Chemical Restraint" as "the use of a drug as a restraint to control behavior or to restrict the patient's freedom of movement and is not a standard treatment for the patient's medical or psychiatric condition".

Defined "Restraint" as "any manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body or head freely";

Stated that "The following restraints are approved for CRMC use:
Soft Wrist / Mechanical support
Tied limb restraints (limb restraints)
Vests
4 point restraints

The facility failed to identify "drugs used as restraints" in the policy as an approved means of controlling patients displaying behaviors harmful to self and others.
When medications were used to address violent behavior, the facility failed to distinguish when a drug is considered a restraint in the facility. Medications were not considered Restraints when they were used as PRN or Stat orders or used during placement of restraint on the patient for agitation or danger to himself or others. This resulted in a failure to protect the patient from harm since parameters for monitoring the patient's medical status (e.g.blood pressure, pulse, and respirations) were not established after the use of the drugs.

2. In addition, since facility policy does not approve the use of "drugs used as restraints" to address violent patient behavior, and thus staff are not trained how to safely use these drugs, are not required to complete monitoring of vital signs, face-to-face assessments, review and/or revise of the patient Care Plan, monitoring effectiveness of the restraint, and documentation in the medical record, including the Restraint/Seclusion form.

SEE CITATIONS AT A160, MRs # 12, 18, 19, 36 and 37.

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0169

Based on medical record reviews and interviews, it was determined that physicians incorrectly wrote orders for "drugs used as restraints"on an as needed (PRN) basis when the drugs were not part of the standard treatment for the patient.

Findings include:

SEE CITATIONS AT A160, MR #s 12, 18, 19, 36, and 37.

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0175

Based on medical record reviews and staff interviews, the facility failed to monitor the patients' condition, including vital signs, as required to ensure patient safety during the use of PRN and STAT medications that were not part of the standard treatment for the patient, due to facility staff not having completed training on "drugs used as restraint" specified in 482.13(f) (A-194).

Findings include:

Five out of eleven medical records revealed PRN orders for "drugs used as restraints"

(MR #s 12, 18, 19, 36, and 37) See CITATIONS A160.

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0179

Based on medical record review and staff interviews, the facility failed to do a face-to-face (FTF) patient evaluation within 1 hour of initiation of "drugs used as restraint" interventions in the facility, in order to evaluate the patient's immediate situation; reaction to intervention; medical and behavioral condition; and need for termination or continuation of the restraint.

Findings include:

In 4 of 11 medical records reviewed, there was no face-to-face evaluation within one hour of initiation of the "drugs used as restraint" interventions. (MR #s 12, 18, 19, and 37).

SEE CITATIONS AT A160, and A187 .

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0187

Based on medical record reviews and staff interviews, the facility failed to document the patient's condition or symptom(s) that warranted use of "drugs used as restraint" interventions.

Findings include:

In one of 11 medical records reviewed, there was no documentation of the patient's condition or symptoms that required the use of "drugs used as restraint" as an intervention. (MR # 12)

SEE CITATIONS AT A160.

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0188

Based on medical record reviews and staff interviews, the facility failed to document in patient's medical record the patient's response to "drugs used as restraint" intervention.

Findings include:

In 5 of 11 medical records, the facility failed to document in the patient's record, the patient's response to the "drugs as restraint" intervention. (MR #12, 18, 19, 35, and 37).

SEE CITATIONS AT A160.

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0194

Based on medical record reviews and staff interviews, the facility failed to ensure the patient's right to safe implementation of "drugs used as restraint" interventions by staff who are trained.


Findings include:
No staff were trained in the implementation of "drugs used as restraint."

SEE CITATIONS AT A175.

QAPI

Tag No.: A0263

The Condition of QAPI is not met based on deficiencies cited below for Quality Assurance and Performance Improvement (QAPI). The hospital did not develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program (QAPI) that reflects the entire operation of the facility.

Findings include:

See A 267 Quality Indicators; A 274 Program Data; A 277 Program Data Frequency; A 285 Patient Safety; and A 312 Executive Responsibilities.

No Description Available

Tag No.: A0267

Based on facility document reviews and staff interviews, the hospital failed to measure, analyze, and track quality indicators and other aspects of performance that assess processes of care, hospital services, and operations.

Findings include:

On 1/28/11 the hospital's Performance Improvement (PI) Program Plan (unsigned and undated) was reviewed.
According to the scope of the program "All Hospital/ Medical Staff Programs and Departments are required to be involved in organization wide integrated Performance Improvement activities " .
During interview and review of facility documents with Staff #1 on 1/28/11 at 10:00 AM, Staff #1 stated that only 4 departments, Laboratory, Radiology, Cardiology and Medical Records, submitted PI reports to PI.

On 1/28/11 at 10:00 AM, a request was made to Staff #1 to submit a list of the indicators being studied by each department at the facility. Staff #1 stated that such a list does not exist and it will take her time to put it together. At 11:45 AM on 1/28/11, Staff #1 submitted the facility document "Report Responsibility Grid". The document listed topics and staff who are responsible to report on the listed topics. Staff #1 was asked to submit copies of the last report from the responsible staff. During the review, it was revealed that not all the departments at the hospital submitted PI reports to Quality Assurance and Performance Improvement (QAPI) Department. It was revealed that the following departments did not submit data/reports to QAPI on a regular basis: Food Services, Environmental Services, Human Resources, Patient Access, Customer Relations, Fiscal Services, Central Supply, and Staff Development.

During interview, Staff #22 stated that the Housekeeping department conducts audits on a regular basis which are submitted to the corporate managers of the contracted company. Staff #22 was not able to confirm if PI department at the hospital ever received a copy of the reports. Staff #1 stated that a copy was not provided to PI program for review.

No Description Available

Tag No.: A0274

Based on facility document review and staff interviews, the facility failed to ensure that all quality indicator data from high risk areas are incorporated in the program.

Findings include:

A review of the reports submitted to the facility Performance Improvement Analysis Committee (PAC) failed to demonstrate that high risk area departments, e.g. Dietary and Housekeeping, regularly submitted quality indicator data to the Committee. During interview on 1/28/11 at 11:45 AM, Staff #1 stated that only 4 departments at the facility namely, Laboratory, Radiology, Cardiology and Medical Record, report regularly to the PAC. Staff #1 also stated that there is a lot of resistance from the departments to submitting data.

At 2:45 PM to 3:15 PM, Staff #1 presented additional reports from other departments in the facility. Staff #1 stated that an e-mail was sent that day to the departments to submit the data they had collected. It was verified that the Dietary Department (a potential area of high risk) did not submit any data even with the e-mail reminder.

A one page Survey Summary report was presented for review from the Housekeeping Department. The report covered the period 12/1/10 to 12/31/10. The report summarized percentage scores for the risk areas studied by the Department. The report failed to establish goals for achievement, did not analyze the data collected, and did not present corrective actions when the score achieved was less than 100%.

During interview on 1/28/11 at 3:00 PM, Staff #22 stated that the Housekeeping Department submitted its data to the corporate management of the contracted company. Staff #1 stated the reports were never shared with the PAC prior to the date of the survey.

No Description Available

Tag No.: A0277

Based on facility documents reviews and staff interviews, the facility's Governing Body did not specify the frequency and detail of data collection by hospital departments as required.

Findings include:

On 1/28/11 the facility Performance Improvement Program Plan was reviewed. Under Section III Aggregate and Analyze section, the facility stated: " Collected data will be systematically aggregated on an on going basis. Frequency with which data is aggregated will be appropriate to the activity or area being studied. "

During a review of the facility document "2010 PI Project by Unit/Department" it was revealed that not all the departments were submitting data or aggregating data on a specified frequency. Some departments did not submit data in the last quarter of 2010, while other departments were regularly collecting and aggregating data.

Examples of departments that have not submitted or aggregated data in the past 6 months were: Food Services, Environmental Services, Human Resources, Patient Access, Customer Relations, Fiscal Services, Central Supply and Staff Development.

It is pertinent to note that the most current aggregated report from Nursing, Organ Procurement, and Environment of Care Committee was for August of 2010, and the Case Management Department aggregated data, for June 2010.

It was stated in the PI plan that infection control data analysis is reported to Performance Improvement Council quarterly. During interview with Staff #1 on 1/28/11 at 2:45 PM to 3:15 PM, and Staff #21 on 1/28/11 between 12:50 PM to 1:10 PM, the last aggregated report from Infection Control was completed for September 2010.

No Description Available

Tag No.: A0285

Based on facility documents review and staff interviews, the hospital did not ensure that priorities are set for performance improvement activities that focus on high risk, high volume, or problem prone areas which impact on patient safety and quality of care.

Findings include:

SEE CITATIONS AT: A620, A701 AND A749.

No Description Available

Tag No.: A0312

Based on facility document review and staff interviews, the hospital-wide quality assessment and performance improvement efforts did not address priorities for improved quality of care and all improvement actions were not evaluated.

Findings include:

SEE CITATIONS AT A0267 AND A0277.

CONTENT OF RECORD: ORDERS,NOTES,REPORTS

Tag No.: A0467

Based on reviews of medical record, policies and procedures and staff interviews the facility did not ensure that reports of treatments (positioning records) necessary to monitor treatment of the patients' conditions, are documented in the medical record. This is evident in 3 of 37 medical records reviewed. MR #s 13, 16 and 17.

Findings include:

1. MR #13 is a 76-year old patient admitted from a Skilled Nursing Facility on 1/23/11. On 1/23/11 at 8:16 PM the physician orders included: "Position change Q2hr to prevent Decubitus ulcer".

During the review of the medical record on 1/26/11 at 10:45 AM witnessed by Staff #10 and 13, it was stated by Staff #13 that there was no individual record of positioning in the patient's medical record. Consequently, the facility did not have any recorded evidence in the patient's medical record that the physician's order to reposition the patient every 2 hours was carried out.

2. MR #16 is a 52-year old patient admitted from a Skilled Nursing Facility on 1/09/11. On 1/15/11 the Braden score was 12 and on 1/19/11 the Braden score was 11 (high risk for the development of pressure sores). On 1/12/11 at 9:46 AM, the physician ordered the following treatment for the patient: "Turn and position every 2 hrs to prevent bedsore". On 1/19/11 at 8 AM, the physician orders included "decubitus prevention". On 1/25/11, the facility formulated a care plan for impaired skin integrity related to pressure ulcer. This care plan failed to identify the location of the ulcer or the size of the pressure ulcer. On 1/26/11 at 10:35 AM, the physician orders included: "Decubitus Protocol". During the medical record review witnessed by Staff #13, 10 and 14 at 3:30 PM, it was recorded in the medical record that the patient was restrained to prevent self dislodgement of the Tracheostomy tube and self extubation at various times during the admission. It was also verified that the facility did not have recorded evidence in the medical record that the physicians' orders to reposition the patient every 2 hours were carried out. Consequently, the patient developed a pressure ulcer during the patient's stay.

3. MR #17 is an 86-year old patient admitted from a Skilled Nursing Facility on 1/18/11. On admission, the patient was noted with stage I sacral ulcer and a Braden assessment score of 10 (high risk for skin impairment).
On 1/21/11 the physician's orders included: "Change pt's position frequently Q 2 hrs" . During the review of the medical record on 1/26/11 at 3:45 PM witnessed by Staff #10,15 and 13, the patient was observed lying supine on her back. According to the facility's (untitled) color coded position diagram, the patient should be on the left side at the noted time. On interview, Staff #15 stated that the patient was just placed in the observed position.

During further interview, Staff #10 stated that the facility follows the color-coded positioning diagram but does not maintain an individual positioning record on patients. A review of the facility policies and procedures: 1) Policy # PC 2103 "Pressure Ulcer Prevention Low, Medium and High". 2) Policy # PC 2104 "Pressure Ulcer Treatment: Stage 1-4" and 3) Policy # PC 2109 "Skin Risk Assessment", did not identify how the facility will individually document the position for patients who are not able to be repositioned according to the diagram. The policies did not mention the color-coded diagram positioning tool as an adopted means of verifying the patients' positions at any given time. The facility was also unable to verify that the physicians' orders to reposition the patients every 2 hours were carried out.

UNUSABLE DRUGS NOT USED

Tag No.: A0505

Based on observations and staff interviews the facility did not ensure that outdated, mislabeled, or otherwise unusable drugs and biologicals, would not be available for patient use.

Findings include:

On 1/24/11 at 12:30 PM to 1:30 PM an observation of the 2nd Floor medical surgical unit was performed, witnessed by Staff #10, 11 and 12. The following were observed:
1) 2 Ross enteral size 8 feeding tubes with the expiration dates of 7/2009.
2) Baby food (squash) with the expiration date of 01/7/11.
3) Baby food (banana peach, granola) with the expiration date of 12/21/10.

On 1/24/11 at 2:15 PM to 2:30 PM, an observation of the 5th Floor medical surgical unit was performed, witnessed by Staff #10, and 13. The following were observed:
4) Unwrapped 4 inches high supply of 4 by 4 gauze sponges were found lying exposed in the emergency crash cart.
5) 5 unwrapped airways were also found lying in the crash cart cabinet.
6) A Medivac tubing 3/8 connector with the expiration date of 03/2010 was also found in the supply storage area.

On 1/25/11 at 10:10 AM to 11:10 AM an observation of the Radiology Department was performed witnessed by Staff #3 and 16. The following were observed:
7) 1 pump IV set with the expiration date of 10/2010.
8) 1 Naso-pharyngeal airway with the expiration date of 10/2010.
9) 1 canister of Personal cleanser with the expiration date of 06/2010.
10) 4 containers of foam Antiseptic hand rub with the expiration dates of 5/2007.
11) 500cc bottle of Sodium Chloride opened with no posted date of opening.
12) 500cc bottle of Sodium Chloride opened with the posted date of opening of 12/11/10.

On 1/25/11 at 11:40 AM to 12:37 PM observations of the Cardiac and Surgical Clinics were performed witnessed by Staff #3, 4 and 17. The following were observed:
13) 1 Central venous catheter set with the expiration date of 09/2004.
14) 2 Accu-check test strips containers of 50 test strips with the expiration dates of 11/30/10.
15) 1 bottle of Hydrogen Peroxide with the expiration date of 09/2010.

On 1/26/11 at 2:10 PM to 3:35 PM, an observation of the Laboratory Department was performed witnessed by Staff #10 and #18. In attendance was also a consultant from the Clinical Laboratory Evaluation Program of the NYS DOH. The following were observed:
16) 1 Bottle of opened Sodium Chloride that was previously used and was no longer good.
17) 1 bottle of 1500cc of sterile water with no open date of expiration on the bottle.
18) 1 bottle of 1500cc of sterile water with opened date of 12/1/10 on the bottle.
Staff #20 confirmed that the opened bottles of solution do come into contact with the specimens tested in the department. It was explained to the staff that the solutions are not sterile after 24 hours of opening unless used in a closed system.

DIRECTOR OF DIETARY SERVICES

Tag No.: A0620

Based on observations noted during the tour of the kitchen with Staff #9 on 1/24/11 between 11:00 AM and 12:15 PM, the facility failed to maintain dietary services equipment in a sanitary and safe condition.

Findings include:

1. The pot washing sinks were observed without indirect drains.

2. The food preparation and handwashing sinks were observed with leaking faucets.

3. The rubber gasket on the door of the soda walk-in refrigerator was torn.

4. The Cook's preparation sink was missing a strainer.

5. The bottom of the walls in the walk-in meat refrigerator were damaged and in need of repair.

MAINTENANCE OF PHYSICAL PLANT

Tag No.: A0701

Based on observations, staff interviews and document reviews, it was determined that the facility failed to maintain a safe, sanitary and comfortable environment to ensure that the safety and well-being of patients are not compromised.

Findings include:

1. During observations of the patient floors/areas from 01/24/11 to 01/28/11 between 10:30 AM to 3:30 PM, it was noted that the grills/heating elements of some heating/air-conditioning units in patient rooms (such as room #531 and room #538 on fifth floor and some rooms in the Detox unit) exhibited an accumulation of dust, dirt, and excessive lint. Similar findings were also noted in the air-conditioning/heating unit in the Emergency Department by the nurse's station and in the Pre-op bay room of the Ambulatory Surgery unit.

All findings were verified with Staff #23 and Staff #24 at the time of observation.

2. During observations on 01/24/11 to 01/28/11 between 10:30 AM to 3:45 PM, it was noted that the exhaust ventilation vents in different areas of the facility were very dirty, which leads to environmental contamination. Examples include but are not limited to:
On 01/28/11 at 2:00 PM, during the tour of the Emergency Department (ED it was noted that the exhaust vent in the Ortho room (bed #10 and #11) was very dirty with a thick accumulation of dirt and dust.

The findings were verified with Staff #23, 24 and Staff #25 at the time of observation.

3. During observations made on 01/24/11 to 01/28/11 between 10:30 AM to 3:45 PM, it was observed that several patient and visitor bathrooms on different floors of the hospital did not have the appropriate emergency nursing call bell pull cords as required by AIA 7.32.G2. The emergency pull cords were either short in length, were tied to a grab bar, or were bunched together. This practice does not provide easy access for patient safety.
Also, it was noted that the emergency call bell cords were covered with an accumulation of dirt. Examples include but are not limited to:

a) On 01/25/11 at 11:15 AM, during survey of the Physical/Occupational Therapy unit, it was noted that the emergency nursing pull cord in the bathroom was wrapped around the grab bar, thus not providing easy access to a patient who might collapse on floor.
b) On 01/25/11 at 3:15 PM, during survey of the Detox unit on fourth floor, it was noted that the pull cords in rooms (such as room #406, #405) were very short, thus not providing easy access to a patient who might collapse on floor.
c) On 01/27/11 at 11:45 AM, during survey of the Med/Surge unit on fifth floor, it was noted that the emergency nursing pull cords in the bathrooms
(such as bathroom of patient room #531) were wrapped around the grab bar, thus not providing easy access to a patient who might collapse on floor.

The findings were verified with Staff #23, 24 and Staff #25 at the time of observation.
4. During survey of the handicap accessible patient (ADA) bathrooms in the facility, it was noted that:
a. The drain pipes underneath the handwashing sink were not protected/insulated to prevent patient leg contact against hot water pipes. (ADA 4.24.6);
b. The signage for the ADA bathrooms were not posted on the wall by the latch side of the door as required by ADA 4.30.6.
All findings were verified with Staff #23 and Staff #24 at the time of observation.
5. During the survey from 01/24/11 to 01/28/11 between 10:30 AM to 3: 45 PM, it was noted that the facility did not ensure that the environment around the premises, and the equipment used, were maintained in a sanitary condition and free of dust and dirt to prevent the transmission of infection and contamination.
Examples, including but not limited to, are:

a) On 01/24/11 at 3:00 PM, during tour of the Main bulk storage room it was noted that the closet/room within this room, used to store Alcohol and Formaldehyde, was grossly dirty with dust, dirt and cob-webs.

b) On 01/25/11 at 11:00 AM, during the tour of the Physical/Occupational Therapy department in the hospital, it was noted that two Hydrocollators installed in the room were dirty with rust all around and dirt inclusions floating in the water.

c) On 01/27/11 at 3:15 PM, during the tour of the Maternity Unit on second floor, it was noted that the gasket of the refrigerator used for patient juice was grossly dirty.

d) On 01/28/11 at 12:30 PM, during the tour of the In-patient Dialysis room on fifth floor, it was noted that the two chairs in the room were dirty with sticky, reddish, brown stain on the underside of the armrest. Furthermore, the upholstery of one of the chair was noted torn and the other chair had yellowish adhesives on the chair.

e) The use of adhesive tape was found in areas around the facility. Tape was found stuck on stretchers, refrigerators, chairs/stretchers and other items. If tape and its sticky residues are not cleaned properly, they are a means of environmental cross-contamination.

All findings were verified with Staff #23 and unit staffs present at the time of the observation.

6. During the survey from 01/24/11 to 01/28/11 between 11:00 AM to 3:45 PM, it was observed that several ceiling tiles on different floors of the hospital showed signs of old leaks. Examples include, but are not limited to:
a) On 01/24/11 at 12:15 PM, during tour observation of the Main boiler room in the basement, one ceiling tile was noted grossly stained dark brown outside the boiler room door.

b) On 01/24/11 at 12:45 PM, two ceiling tiles were noted stained in the Main clean linen/Laundry room.

c) On 01/24/11 at 2:30 PM, three ceiling tiles were noted very stained in the Central Sterile supply room. Furthermore, two ceiling tiles also were noted cracked.

d) On 01/24/11 at 3:00 PM, during survey of the Main bulk storage room in the basement, it was noted that there was one ceiling tile with a black-colored growth/stain. Furthermore, there were two ceiling tiles in the area stained dark brown.

e) On 01/25/11 at 11:45 AM, two ceiling tiles were noted stained in the Physical/Occupational therapy unit's waiting room.

f) On 01/25/11 at 12:45 PM, one ceiling tile was noted stained above the formaldehyde fume hood in the Histology lab.

All findings were verified with Staff #23 and Staff #25 at the time of observation.

g) On 01/27/11 at 12:45 PM, two ceiling tiles in the Dialysis room were noted grossly stained.

All findings were verified with Staff #23, 24 and Staff #25 at the time of observation.

NOTE: If ceiling tiles are not replaced and stay humid/wet, they may harbor the growth of mold/fungi and contribute to environmental contaminants. Also, stained ceiling tiles need to be investigated for potential leaks above, as it may be an indication of a problem with the plumbing/sprinkler system or of insufficient insulation around the steam pipes supplying heating to the facility.

7. During the survey from 01/24/11 to 01/28/11 between 11:00 AM to 3:45 PM, it was noted that the facility did not ensure that the physical plant was kept in good repair to ensure a sanitary environment. Examples include:

a. On 01/24/11 at 12:14 PM, during the tour of the Main boiler room in the basement, it was noted that there was a big hole near the door entrance of the boiler room.

b. On 01/24/11 at 12:30 PM, during the tour of the Main soiled linen room, it was noted that drains in the room had garbage and rag cloths in the drains. Furthermore, the room/area was noted dirty and in disrepair.

c. On 01/24/11 at 2:30 PM, during the tour of the Central Sterile supply room, it was noted that a big portion of wall was missing the vinyl coving thus revealing the structure beneath.

d. On 01/24/11 at 12:45 PM, during the tour of the Main clean linen room/laundry, it was noted that one of the ceiling exhaust grill/screen had a big hole which revealed that the HVAC duct above had a 3-4 inch in diameter hole made in the metal duct.

e. On 01/27/11 at 12:30 PM, during the tour of the Critical Care Unit, it was noted that the sink in room #505 was not working and had 'Sink Broken' sign posted.

f. On 01/27/10 at 2:30 PM, during the tour of the ORs it was noted that a portion of the wall in OR #5 was in disrepair.

g. On 01/27/10 at 2:40 PM, during the tour of the ORs it was noted that scrub sink #3 was not operational.

h. On 01/27/10 at 2:50 PM, during the tour of the ORs it was noted that the grill of the exhaust installed near the floor in OR #3 was broken.

All findings were verified with Staff #23 and Staff #25 at the time of observation.

8. On 01/27/11 at 11:30 AM during the survey of the Med/Surge unit on the fifth floor, it was noted that when a nurse call bell was elicited from a patient room, it did not register in the medication room, clean utility room, soiled utility room and other areas as required by AIA 7.32.G1.

The findings were verified with Staff #23 and Staff #25 at the time of observation.

9. On 01/25/11 at 2:15 PM during the tour of the Behavior unit on 4th floor, it was noted that the facility does not have any Seclusion room and Quiet room as required by AIA 7.6.D and 7.6.B7.

As per Staff #27, facility had a Seclusion room but now has discontinued the use of the room. During the survey an area which was previously used for seclusion room was shown to the surveyor. This area/alcove is now being used by the nursing staff as nursing station.

Findings were verified with Staff #23 and Staff #24 at the time of observation.

10. The ADA bathroom in the Behavior Health unit was noted having a protruded flush handle that may posses loopable hazard or patient may harm themselves by using the protrusion as an excuse to injure themselves.

Findings were verified with Staff #23 and Staff #24 at the time of observation.

LIFE SAFETY FROM FIRE

Tag No.: A0710

Based on observations, record reviews and staff interviews, it was determined that the facility failed to meet the applicable provisions of the Life Safety Code, NFPA 101, 2000 edition.

The findings include:

During the survey of the facility from January 24-28, 2011, Life Safety Code deficiencies were noted in multiple areas of the Code requirements and were cited under the following Fire/Life Safety Code K-Tags:

· K-21 (Fire/smoke doors not maintained to close automatically in case of fire);
· K29 (Hazardous area not safeguarded by smoke/fire one hour construction);
· K-47 (Exit signs not maintained to illuminate continuously);
· K-52 (Fire alarm system not inspected as per NFPA 72);
· K-62 (Sprinkler system not tested as per NFPA 25);
· K-64 (Portable fire extinguishers installed above the required 5 feet/60 inches height);
· K-73 (Interior decorations not flame resistive)
· K-75 (Soiled linen/Garbage can greater than 32 gallons not stored in a one hour constructed space);
· K-104 (Penetrations in smoke/fire barrier not completely sealed/protected);
· K-160 (Fire fighter recall feature installation could not be verified for all elevators serving the patients).

FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE

Tag No.: A0724

A. Based on observations and interviews, it was determined that the facility failed to maintain equipment in good repair and to ensure that a safe environment was maintained.

Findings include:

1. The agitator for the whirlpool in the rehabilitation department was noted to be leaking water on January 24, 2011 at 12:31 PM .
This finding was verified with Staff #6 at that time.

2. Items were inappropriately stored in the boiler room at the CRMC-Jefferson Extension Clinic. On January 27, 2011 at 2:55 PM a roll of carpet was noted leaning against the wall, 2 stacked vinyl covered chairs and a 1" foot cardboard box with tiles were seen stored in the boiler room. These items are combustible, hence a safe environment was not maintained.

These findings were witnessed by Staff #4 at that time.


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B. Based on observation, it was determined that the facility did not ensure that all facilities/areas and equipment were maintained in such a way to ensure safety and quality for the patient and staff.

Findings include:

1. On 01/24/11 at 12:45 PM, it was noted that storage supplies, such as file cabinets, old refrigerator and other items were stored in one of the Transformer/Electrical room in the basement. Such arrangement not just hinders the easy accessibility to the electrical panels but also fire hazard.
A similar finding was noted in another electrical room in the basement, which had combustible items (such as cardboards and paint buckets) stored in the room.

2. On 01/25/11 at 12:30 PM, during the tour of the Physical/Occupational Therapy department, it could not be verified by observation, staff interview or any documentation that electrical receptacles were hospital grade.

3. On 01/25/11 at 12:45 PM, during the tour of the Cardio-Pulmonary unit, it was noted that the medical gas outlet in the treatment room was blocked by the presence of books and other items on the counter/sink.

4. On 01/27/11 at 12:30 PM, during the tour of the Surgical Suite it was noted that a big linen cart was stored in front of the Medical Gas Alarm panel. This condition compromises easy accessibility to the staff in case of an emergency.

5. On 01/28/11 at 3:00 PM, during tour of the Emergency Department it was noted that electrical panels near Exam room/bay #7 and #8 were not kept secured and were open. Furthermore, a Clean supply cart was noted stored in front of these panels, thus limiting the access of the panel to the engineering staff in case of emergency

6. On 01/25/11 at 12:30 PM, the shatter-proof status of the tall exercise mirror in the PT/OT unit could not be verified.

All findings were verified with Staff #23, 24 and Staff #25 at the time of observation.

7. The kitchen and dietary area were not maintained to ensure an acceptable level of safety and quality for the patient and staff.
See A 620.

VENTILATION, LIGHT, TEMPERATURE CONTROLS

Tag No.: A0726

Based on observation and staff interviews, it was determined that the facility did not ensure that proper humidity levels were provided and monitored in the ORs and that proper ventilation was provided to other areas of the building.

Findings include:

1.a. During observations of the ORs on 01/27/11 at 2:40 PM, Staff #28 was interviewed regarding how the temperature and humidity are monitored. Staff #28 stated that the engineering department was responsible for central monitoring and no monitoring was done in the OR itself before or during an operation.
Staff #29 on 01/28/11 at 12:15 PM stated that the system of monitoring temperature and humidity is such that no logging or trending is done for the values. Engineering staff is responsible to check on the computer and notify the surgical department if any discrepancies occur. However as per observation and interview with Staff #29 it was noted that there are no alarms or alarm limits in the system to ensure that the staff is aware of the proper range of temperature and humidity.

b. On 01/28/11 at 12:45 PM, Staff #29 provided the surveyor with a log indicating the humidity level below 20% on several days from November 2010 to January 2011 in the ORs #5, 3, 1 and 6. The values were not in the range of 20-60% as per AIA Table 2 and CDC guidelines. For OR #6, the humidity has been between 9% to 13% for the whole month of November 2010 and January 2011 (except for 4-5 days when it was in 20s).

Staff #29 stated that since he is new in the facility he was not aware of these low humidity values and will look into bringing these values in compliance.
Therefore, it could not be determined how the facility ensured compliance with the range of humidity, if the values fluctuated during the day/surgery, and how often they fall out of compliance.

c. On 01/24/11 at 2:55 PM during the tour of the Central Sterile Supply (CSSR) room it was noted that the humidity of the CSSR was 68% and the humidity of the sterile storage room was 62 %. As per AIA Table 2 these room should have maximum 60% humidity.

2. On 01/27/11 at 12:00 PM during the survey of the Med/Surg unit on fifth floor, it was noted that the two isolation rooms did not have negative pressure. As per Staff #23, the rooms are not reversible and are always on negative air pressure.
On 01/28/11 at 1:00 PM, Staff #23 provided the latest preventive maintenance work order dated 12/01/10 for these two isolation rooms. The work orders indicated that the room had negative air-pressure but at the time of survey no negative air-pressure was noted in these rooms.

3. During the survey from 01/24/10 to 01/28/10 between 10:30 AM to 4:00 PM, it was noted that non-patient areas that may contribute to infection control/contamination, did not have the required ventilation/air-pressure as per AIA 1996-97 Table 2.
Examples include, but are not limited to the following:
a) On 01/24/11 at 3:00 PM, during observation of the Central Sterile Supply room, it was noted that the room did not have positive air pressure.
b) On 01/25/11 at 12:30 PM, soiled utility room in the Physical/Occupational Therapy department was noted to have positive air pressure and the clean utility room had negative air pressure.
c) On 01/25/11 at 2:45 PM it was noted that the housekeeping closet on the Behavior Health unit 4th floor did not have an exhaust thus did not have the required negative air-pressure.
d) On 01/25/11 at 3:30 PM, soiled utility room in the Wound Care unit had neutral air-pressure.
e) On 01/27/11 at 3:00 PM, during observation of the OR suite, it was noted that the soiled utility room had neutral air-pressure.

All findings were verified with Staff #23, 24 and Staff #25 at the time of observation.

INFECTION CONTROL PROGRAM

Tag No.: A0749

Based on observations, policy reviews and interviews, the facility failed to maintain an environment to prevent the spread of infections.

Findings include:

1. A wheelchair was found stored in the patient's bathroom at the Wurtsboro Extension Clinic on January 27, 2011 at 3:38 PM. This finding was verified by Staff #4 at that time.

2. A circulating nurse was observed not following proper infection control practices in the operating room on January 25, 2011 between 12:50 PM and 1:20 PM. Staff #8 was observed in operating room 3 touching the garbage can but she did not perform hand hygiene afterwards.

Staff 8 was also observed on 2 occasions during the above timeframe removing gloves from her hands but she did not practice hand hygiene.

The facility's hand hygiene policy states hand hygiene must be followed after removing gloves.

3. Debris was noted on the floor in the operating room at approximately 1:00 PM on January 25, 2011.

4. The ends of the tubings to connect to the Venodyne boots were observed touching the floor prior to the procedure. The tubes without being cleaned, were connected to the boots which were on the patient's legs.

The facility's policy is that the operating room is to be cleaned after each procedure.

These findings were witnessed by Staff #1 at that time.




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5. On 01/24/11 at 2:35 PM, during survey of the Central Sterile supply room, it was noted that the ceiling tiles in the room were porous/had holes that may retain dirt (they were not monolithic) and thus were not as per AIA 7.28.B8. Such porous ceiling tiles compromise thorough cleaning of the ceiling which is required to keep the environment of Central Sterile as clean/sterile as possible.

Findings were verified with Staff #23, 24 and Staff #25 at the time of observation.

6. As per AIA 7.2C1, at least one isolation room is required for the nursing/surgical unit (and more may be required as per the infection control committee). The facility has 2 isolation rooms on med/surg unit of the fifth floor. During observation of med/surge unit of 5th floor on 01/27/11 at 12:30 PM, it was noted that the two isolation rooms did not comply with all requirements of Section 7.2 for isolation room (such as self-closure at the door). The ceiling tiles were porous and were of such material, that they would not minimize the retention of dirt as required by 7.28.B8 and would not be thoroughly washable/cleanable.

Also it was noted that there is no room/arrangement for patients who are immunocompromised and require Protective environment/positive air-pressure room. As per Staff #13, the facility does treat to such patients/community and the procedure was to use a regular room.

It is to be noted that as per AIA 7.2.D, the infection department needs to assess the need of such room based on the community need and if treats to such patients should at least provide one such room.

All findings were verified with Staff #23 and Staff #25 at the time of observation.

7. On 01/24/11 at 12:45 PM, during the survey of the Main Clean linen room/laundry in the basement, it was noted that the floor and ceiling of this room was very dirty with an accumulation of dust and dirt all around its perimeters. This may lead to cross contamination of the clean linens that are washed and stored here and are ready to be used by the patients

All findings were verified with Staff #23, 24 and Staff #25 at the time of observation.

8. During the survey of the Surgical suite on 01/27/11 at 2:40 PM, it was noted that:
a. Some doors of ORs (such as OR #6, OR #4 and others) did not completely shut/positively latch during operative procedures to ensure that the ORs maintain their positive air pressure and that cross contamination from the corridor does not take place.
b. Footrest of the stretcher in OR #3 was noted stored on the floor.
c. The seam of the floor in OR #4 was noted broken/not continuous. This may result in improper cleaning of the floor in case of blood/body fluid splatter.
d. The upholstery of the stool in OR #5 and Endoscopy room was noted torn, thus imposing a risk of cross contamination due to difficulty in cleaning. Similarly the Upholstery of the stretcher in OR #6 was noted torn and had tape patching it.

All findings were verified with Staff #23 and Staff #25 at the time of observation.

7. During survey of the Decontamination room of the Central Sterile supply on 01/24/11 at 12:45 PM, it was observed that the door from the Decontamination side leading to the Clean sterile side was wide open. This arrangement contributes to cross contamination by allowing the mix of clean and dirty area's environment.

Finding was verified with Staff #23 at the time of observation.

Similarly at 2:40 PM during the tour of the clean side of Central Sterile supply it was noted that the pass-through window of the washer from decontamination side to the clean side was left wide open thus again allowing the mixing of air and environmental contamination.

Finding was verified with Staff #23 and Staff #26 at the time of observation.

8. It was noted that one ceiling tile in the room/closet housing the back of the sterilizer, was missing/removed from its place. Structure and elements above the drop ceiling were exposed. Since this room had gaps under the door and under the sterilizer and communicates with the clean sterile
room, there is a potential for dust and dirt contaminates falling from above the ceilings and contaminating the clean environment. Similar situation of missing tile was found in the Fluorsoscopy room on 01/28/11 at 3:30 PM.

9. Also it was noted the in there were dust, dirt and cob-webs around the perimeters/corners of the Steam Sterilizer in the Clean Sterile room.

All findings were verified with Staff #23 and Staff #25 at the time of observation.

OPERATING ROOM POLICIES

Tag No.: A0951

Based on observations and interviews, it was determined the facility failed to follow its policy to ensure that procedures are conducted according to current standards of practice and according to its policies.

Findings include:

Surgical procedures were not conducted in a safe manner. The initial timeout was conducted with the patient's participation after the patient had received medication to assist with sedation and intubation and it did not include checking the patient's name band. This was noted on January 25, 2011 at approximately 1:10 PM. Similarly, in the second timeout, none of the staff confirmed the patient's identity with a check of the identification band.

The facility's timeout policy revealed confirmation of the patient's name includes a check of the patient's ID band.

These findings were confirmed with Staff #1 at that time.