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12 NORTH 7TH AVENUE

MOUNT VERNON, NY 10550

COMPLIANCE WITH LAWS

Tag No.: A0021

Based on a review of personnel records, staff interview and medical records, the hospital did not assure that personnel are properly licensed and qualified for their title and position.

Findings include:

Mt. Vernon hospital has a psychiatric unit, which is required to meet both the general criteria for hospital units and the specific criteria for psychiatric units. The psychiatric unit must furnish, through the use of qualified personnel, psychological, social work, psychiatric nursing, occupational and recreational services.

A review of the hospital's job description for a Social Worker Counselor/Discharge Planner requires that the person have the minimum requirements of a Bachelor's degree in Social Work. Review of the hospital's job description for a Psychiatric Clinical Social Worker requires that the person have the minimum requirements of a Master's degree in Social Work. Review of the personnel record of Staff #28, who was recently promoted to a social worker position, revealed that the undergraduate degree was not in Social Work. According to the resume, Staff #28, is currently enrolled in a Masters Program in Clinical Social Work and will be graduating in May 2011.

Review of Medical Records #32, #40, and #41, revealed that Staff #28 wrote social worker progress notes in these medical records, dated 5/26/10 through 6/17/10.

Therefore, Social Work services are not furnished by a qualified social worker in accordance with accepted standards of practice and established policies and procedures.

LICENSURE OF HOSPITAL

Tag No.: A0022

Based on document reviews, interviews and observations, it was determined that the hospital did not obtain approval from New York State Department of Health, licensing agency, to provide or discontinue services as listed on the facility's Operating Certificate. Specifically, the facility did not obtain approval to provide services at onsite locations, or to discontinue 4 onsite services and 2 offsite premises.

Findings include:

1. The facility failed to provide an up-to-date operating certificate that lists current services at its main campus and its offsite locations. During an interview conducted June 14, 2010 at approximately 10:30AM with the administrative staff, it was determined that the hospital no longer has the following services listed on the Operating Certificate dated 1/5/09: AIDS Center, Primary Medical Care O/P, Dental, Maternity.

2. The off site, hospital extension clinics' services (Infectious Disease Center, 16 Guion Pl, New Rochelle, NY and the MVH Partial Hospitalization Program, 105 Stevens Avenue, Mt. Vernon, NY) are no longer being provided.

3. The hospital currently provides Hyperbaric and Acute Care Dialysis services which are not on the Operating Certificate.

4. Certified beds for the facility are listed at 196, including ten beds designated for AIDS. Administrative staff, during an interview, indicated that there no longer are designated AIDS beds and that the 124 Medical/ Surgical beds have been reduced to 25. Therefore, the average daily census is now 80. There has been no documentation to indicate the facility requested to reduce the total number of certified beds, or specifically designated unit beds.

GOVERNING BODY

Tag No.: A0043

Based on observation, staff interviews, medical record reviews, and document reviews conducted during the Federal Validation Survey on June 14 through June 18, 2010, the Governing Body failed to meet its responsibility of providing and maintaining a safe, sanitary, and comfortable environment for its patients and staff and ensure that medical, nursing, and dietary services are provided consistent with prevailing standards of practice.
Findings include:
1) The Governing Body was not effective in its oversight of the Condition of Physical Environment as evidenced by the hospital not being constructed, arranged and maintained to ensure the safety of its patients and staff. The hospital's premises, facilities, equipment, and environment were not maintained in a safe, sanitary, and comfortable condition. Dietary standards of practice were not being followed to ensure the safety and well-being of patients and staff. See A620 Director of Dietary Services, A700 Physical Environment, A709 Life Safety from Fire.
2) The Governing Body was not effective in its oversight of the Condition of Infection Control as evidenced by the hospital not being maintained in a sanitary manner. Prevailing standards of practice for infection control were not being followed. See A726 Ventilation, Light, Temperature Controls; A747 Infection Control; A749 Infection Control Officer Responsibilities.
3) The Governing Body was not effective in its oversight of the medical and nursing care provided in the hospital's emergency department. See A049 Medical Staff- Accountability; A392 Staffing and Delivery of Care; A1111 Supervision of Emergency Services.

MEDICAL STAFF - ACCOUNTABILITY

Tag No.: A0049

Based on medical record reviews, the Governing Body failed to ensure that the medical staff provided care consistent with prevailing standards of practice for 3 patients reviewed. ( MR #7, #16, #29).

Findings include:

1. For MR #16, an EKG and a cardiology consultation were not done in a timely manner. Nor did the patient receive continuous cardiac monitoring.

MR #16 presented to the emergency department (ED) on June 11, 2010 at 6:37PM with complaints of chest pain radiating down to the left arm, nausea and vomiting for 3 days. The patient was found on the floor at his home after he had fallen and could not get up and had a history of shortness of breath on exertion for 1 week.

Previous medical history included PCI stent placements x 4, Diabetes Mellitus, Hypertension and high cholesterol. The patient required administration of Aspirin (ASA), Nitropaste (NTP) 1" to chest wall and oxygen 2L per minute via a nasal cannula.

An electrocardiogram (EKG) was done at 8:16PM, approximately 1+ 1/2 hours later, which showed that the EKG was abnormal and that the patient had an Acute MI (Myocardial Infarction). Cardiac enzymes were elevated. A cardiology consultation was done at approximately 9:00PM, more than 2 hours after the patient arrived at the facility.

There was no evidence that continuous cardiac monitoring was done throughout the patient's 4 hour stay in the ED. The patient was transferred to another facility at approximately 11:00PM, for further management of his Acute Myocardial Infarction. Given the patient's symptoms, adequate medical care was not provided.


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2. MR #29 was triaged by the nurse at 14:37 in the Emergency Room (ER) on 7/24/09. The patient complained of pain in both arms and chest area for 3 days. The patient was seen by the physician at 15:26. EKG: RSR 94/min, T inversion in III, F (+) ST-T changes" (reviewed by MD at 3:30PM). There was no indication that the physician acted on the abnormal EKG.

The physician documented that the patient's condition was stable on cardiac monitoring and that the clinical impression was chest pain, rule out acute coronary syndrome. However, blood was not drawn for testing until 4:30PM, more than 2 hours later since being triaged. The blood work report came back positive for elevated Troponin 0.43 at 4:51PM.

There was no indication the physician acknowledged or took action on the elevated Troponin level or the abnormal EKG until 7PM, when the physician wrote that she went to speak with the patient and was informed that the patient left the ER with Heplock in place. There was no documentation to indicate the patient was seen by a physician before that time. The patient was on cardiac monitoring and was able to leave the facility without staff knowledge.

According to the medical record, the patient eloped from the ER at 6:50PM and was found 2 blocks away at 7:00PM in cardiac arrest. The police department was notified. The patient was returned and readmitted to the facility on 7/24/09 at 19:30 in cardiac arrest. CPR was in progress. The patient was intubated and in ventricular fibrillation. A CT scan of the head performed on 7/25/09 showed " diffuse cerebral edema compatible with anoxic insult "

According to the discharge summary of 8/3/09, the patient developed multi-organ failure, was extubated and transferred to a hospice hospital in a coma on 8/3/09 at 3:30PM.

3. The patient (MR #7) was admitted from the ER on 4/11/10 with the diagnosis of Arterial fibrillation, and exacerbation of CHFand HTN. Blood was drawn at 5PM and the patient was being monitored on telemetry which showed evidence of Atrial Fibrillation.

At 8PM, the ER physician wrote an order to admit the patient to the Telemetry unit. The PGYI (Intern) saw the patient at 9:30AM on 4/12/10, and indicated that the patient looks better, no recommendations were made. The nurse documented on 4/12/10 at 1:30PM that the patient was transferred to a telemetry room. There is no documentation to indicate that the attending physician or cardiologist evaluated the patient anytime before 8:45PM.

At 9:30PM, the attending physician documented that he came to see the patient at 8:45PM and he indicated that the patient was being coded for an unresponsive episode and ventricular fibrillation. The efforts to resuscitate the patient were unsuccessful and the patient was pronounced at 9:21PM.

Although the patient had a diagnosis of Atrial fibrillation and a Troponin I blood level of 0.18 ng/ml (0.0- 0.04) reported at 1757 hours (just before 6PM) on 4/11/10, the patient was not seen by an attending or a cardiologist to be re- evaluated until 8:45PM on 4/12/10. Therefore, a period of over 26 hours passed before an attending saw the patient after the report of the elevated cardiac enzymes.

PATIENT RIGHTS: REVIEW OF GRIEVANCES

Tag No.: A0119

Based on staff interviews, document and policy and procedure review, the hospital failed to implement fully the patient grievance process since investigations were not complete and the individual departments did not report back to QAPI on issues for follow-up or to evaluate corrective actions.
This was evident in 8 out of 8 grievances reviewed. Hospital Grievance #'s 54, 55, 56, 57, 58, 59, 60, and Grievance #1 in 2010.

Findings include:

1. Complaint #55 regarding a dirty room (6/15/09):
The facility did not receive a response to this complaint from the housekeeping department. Although a response letter was written to the complainant, housekeeping did not investigate why the room was not cleaned. The lack of a full investigation and response from housekeeping shows that the facility does not have an effective process in place to resolve grievances.

2. Complaint #56 regarding the Receptionist (7/1/09):
According to the grievance log documentation, this complaint remains unresolved. Although the facility identified the receptionist involved, no statement has been taken from the staff. No corrective action has been taken to ensure that staff respond appropriately to patients and relatives presenting at the receptionist desk.

3. Complaint #59 regarding MD rudeness to a patient (12/2/09):
According to the complaint log, the complaint has not been resolved to date. No input was received from the ED Director and no response has been sent to the complainant.

On 6/17/10 at 10:20AM - 10:30AM, an interview was conducted with Staff #1 who stated that the grievance policy and procedure require updating. Staff #1 also stated the policy as written is not functioning well with regard to input from other departments which does not always reach her department for coordination.

PATIENT RIGHTS: CONFIDENTIALITY OF RECORDS

Tag No.: A0147

Based on observation and interview, the facility failed to ensure patients the right to confidentiality of their medical records.

Findings include:

On 6/14/10 at 2:30PM, during observation of the basement, an unidentified room adjacent to the boiler room had numerous open boxes of medical records. This room was not secured from unauthorized access.

Staff #21 did not understand the breach of security and confidentiality issue as demonstrated by her statement, "that these medical records were probably being stored in the particular room before being shipped out to file and store at an offsite facility."

The room's location and its lack of security make it accessible to any individual in the facility.

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0160

Based on medical record reviews and interviews, it was determined that the facility did not have policies relating to the use of Medications used as Restraints.

Findings include:

When medications were used to address violent behavior, the facility failed to distinguish when a drug is considered a Restraint in the ED or inpatient unit. Medications were not considered Restraints when they were used as Prn or Stat orders or used during a "Code Gray" (Pt or visitor becomes agitated and is a 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 (blood pressure, pulse, and respirations) were not established.

In addition, since medications used to address violent behavior are not considered Medications used as Restraints, vital signs, face-to-face assessments by the physician, debriefing by the treatment team following the restraint, review and/or revision of the Care Plan, monitoring as to the effectiveness of the restraint, and documentation on the Restraint/Seclusion form, were not required to be completed.

Examples include:
1. MR # 28 revealed that the standard medications for the patient were Risperdal 3mg, Abilify 30mg, Cogentin 1 mg and Ativan 1mg. The patient was admitted 8/7/09 for Paranoid Schizophrenia and Psychosis. When there were increased psychotic symptoms with associated inappropriate behavior, stat doses were given on 8/11/09 for Haldol 5 mg IM, Ativan 2 mg IM, Cogentin 1 mg IM; 8/23/09 for Haldol 5 mg IM, Ativan 2 mg IM, Benadryl 50mg IM; 9/1/09 Geodon 20mg IM, Ativan 2mg IM, Benadryl 50 mg IM. In all cases, the medications were not considered Restraints and did not include monitoring of vital signs, face-to-face assessments by the physician within one hour, debriefing and review of the care plan and other required documentation for patients with psychiatric conditions.


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2. MR #26 was reviewed and indicated that the patient was brought to the ER on 6/11/2010 by police after eloping from the ER the day before. The patient was admitted as an Involuntary Admission with a diagnosis of Schizoaffective disorder, presenting with verbal threats, irritability, and angry affect. The physician ordered Haldol 5mg IM stat x1, Ativan 2mg IM stat x1 at 3:15PM.

On 6/15/2010, medical record review revealed that the patient became angry, threatening, and tried to enter the nursing station. A Code Gray was called and the patient received Haldol 10mg IM stat x1, Ativan 2mg IM stat x1, and Benadryl 25mg IM stat x1 at 1:45PM. He was placed on 1:1 observation. On 6/15/2010 at 2:30PM, orders were given for "Geodon 20mg IM now for agitation, Ativan 2mg IM now for agitation". According to the Nursing notes, the patient's behavior was described as angry, hostile, cursing, banging, and delusional.

According to the MVH Department of Psychiatry Policy/Procedure "All IM Psychotropic medications should be written as stat, after a face-to-face assessment by the MD and should be documented in the MD's progress note." However, the Stat medications that were given were not considered Medications Used as Restraints. As a consequence, the facility failed to require monitoring of patients for vital signs, face-to-face assessments of patients by the physician within one hour, a debriefing and review of the care plan, as well as the required documentation of restraint use.

This was confirmed for MR #26 since his vital signs were only recorded once daily on 6/15/2010, and 6/16/2010. According to Staff #10, vital signs were monitored daily after stat medication was given and vital signs were monitored every 2 hrs after physical restraints were used.

It should be noted that the frequency and time frames for monitoring patients after receiving stat medications were inadequate as they are not the standard of care. The patient should be monitored every 15 minutes the first hour and every 30 minutes the next hour to properly evaluate the effects of the Medications Used as Restraints.

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0162

Based on a review of policy and procedures and from interview, the seclusion room is also being used as a quiet room.

Findings include:

A review of Policy G18, Quiet Room for Therapeutic Reasons, and G19, Seclusion, indicates "an unlocked seclusion room ...may be utilized as a quiet room." The intent of a quiet room is not being met when the seclusion room is used for this purpose. The quiet room should be used to foster a calming environment versus the environment of padded walls and floor. The seclusion room is only to be used for the management of violent, self-destructive behavior.

Interview with the Director of Nursing on 6/17/2010 at 2:00PM revealed that the seclusion room is being used as a quiet room for patients who need to vent their frustrations or just be quiet. The seclusion room does not provide a calming environment or the feeling a quiet room should foster as a patient's bedroom, sensory stimulation room, or lounge area.

No Description Available

Tag No.: A0285

Based on medical record review, facility document review, and staff interview, the hospital failed to set priorities for its performance improvement activities that focus on high-risk, high-volume, or problem-prone areas namely the Emergency Room, Environment, Infection Control, Complaints, and Adverse Events, nor did it consider the incidence, prevalence, and severity of problems in these areas as they affect health outcomes, patient safety, and quality of care.

Findings include:

1. The patient MR #29 was seen in the Emergency Room (ER) on 7/24/09, eloped from the ER at 6:50PM and was found 2 blocks away from the facility at 7:00PM in cardiac arrest. The patient was on cardiac monitoring and was able to leave the facility without staff 's knowledge.

A review of the incident report by the facility showed that the facility failed to ensure that staff took the appropriate follow-up actions, as follows:

i) An investigative statement was not obtained from the ER department where the elopement occurred.
ii) There was no statement from the staff assigned to the patient, providing evidence of process review.
iii) There was no investigation into possible equipment failure to explain why the monitoring alarm was not attended to by staff.
iv) Patient exit/discharge from the ER was not investigated to examine how the patient left the ER without staff' s knowledge.
v) The incident was not reported to the facility Quality Assurance and Improvement Committee for review.
vi) The physician did not carry out appropriate medical follow-up for lab values.

2. The hospital failed to fully implement the patient grievance process since investigations were incomplete and the individual departments did not report back to QAPI on issues requiring follow-up, to ensure evaluation of corrective actions. As a result, some complaints were not resolved. (See 119)

3. An interview on 6/14/10 with Staff #1 at 11:00AM, revealed that individual department heads report to QI (Quality Improvement Committee) monthly. Action that is taken is reported back to QI at the next quarterly meeting. However, QI does not follow-up monthly with the individual departments. Therefore, it could be 3 months before the action plan is reviewed to determine if further action is needed. Staff #1 agreed that follow-up to monthly issues should be addressed the month following the month the issue was identified.

STAFFING AND DELIVERY OF CARE

Tag No.: A0392

Based on medical record review, environmental observation, staff interviews, and policy and procedure reviews, the facility did not ensure that nursing care was provided to all patients as needed. This was evident in 1 of 39 medical records reviewed. MR #29.

Findings include:

The patient MR #29 seen in the Emergency Room (ER) on 7/24/09 complained of having pain in both arms and chest area for 3 days.
Blood was not drawn for testing until 4:30PM, more than 2 hours later.

The patient eloped from the ER at 6:50PM and was found missing 2 blocks away from the facility at 7:00PM in cardiac arrest. Security staff who are stationed at the ED were pulled to provide 1:1 observation for another patient during the time of the patient's elopement.

Therefore, a patient who was on cardiac monitoring was able to disconnect from the monitor and elope from the facility without staff knowledge or nursing staff awareness.

CONTENT OF RECORD: ORDERS,NOTES,REPORTS

Tag No.: A0467

Based on medical record reviews, staff interviews, and observations, the facility did not ensure that the medical record was complete. Reports of treatments and other information necessary to monitor the patients' condition were not documented in the record.

Findings include:

A. Turning and positioning every 2 hours was not provided and not recorded in the medical record in 6 of 39 records reviewed:
MR #35, 34, 22, 36, 37 and 38.
1. Observations of the 2 Tower Unit on 6/15/10 with Staff #2, revealed:
a) On 6/15/10 at 10:40AM, patient MR #34 was observed lying on her left side in bed. The turning and positioning form was not completed for 8:00AM and 10:00AM.
b) On 6/15/10 at 11:55AM, patient MR #22 was observed lying on her back in bed. The turning and position form was not completed for 8:00AM and 10:00AM.
On 6/17/10 at 10:30AM to 10:46AM, Staff #4 was interviewed about the incomplete "Turning and Position Document." Staff #4 stated that the documentation process will be reviewed.

2. Observations of the 2 Tower Unit on 6/17/10 between 3:00PM and 3:35PM with Staff #10 revealed:

a) On 6/17/10 at 3:10PM, patient MR #37 was observed lying on his back in his room. The turning and position documentation was not completed at 8:00AM, 10:00AM, 12:00PM and 2:00PM. The patient's Braden score was also not completed.
b) On 6/17/10 at 3:30PM, patient MR #38 was observed lying on his back in room 225B. The turning and position documentation was not completed at 8:00AM, 10:00AM, 12:00PM and 2:00PM. The patient's Braden score was also not completed on 6/17/10.
c) A review of the Turning and Reposition Rounds form for the unit at 3:30PM showed that the 6 patients listed on the form were not positioned at 2:00PM when due.

B. Conductivity results for dialysis water testing were not accurately documented in 2 of 39 medical records reviewed: MR #22 and 39.

1. On 6/15/10, the medical record for patient MR #22 was reviewed which revealed that only one conductivity reading was recorded on the treatment form. Staff #2 was not able to explain whether this reading was for the machine conductivity or the manual conductivity. At 11:40AM on 6/15/10, an observation of the dialysis unit was conducted and a manual conductivity meter was not observed in the department. When the nurse was interviewed at that time, the nurse said the last conductivity meter has been missing for about a week.

2. On 6/18/10 at 10:30AM, patient MR #39 was being dialyzed. Staff #7 was interviewed about the conductivity result recorded on the form and stated "the recorded conductivity of 14 was from the test that she performed that morning, using a brand new Myron meter," now available in the department. Staff # 7 was asked for the machine conductivity and stated, "I read it off the machine and it was 13.9." Staff #7 further stated, "the acceptable range for the Fresenius 2008H machine conductivity is 13.7- 14.3." Staff #7 also stated that "the result is always the same, we don't write that down."

A review of the recording form "H2O Testing/ACDR Record" showed that Staff #7 did not record the test performed on 6/18/10 on the form.
At 10:45AM, Staff #16 explained that all tests performed, including manual conductivity, are recorded on the H2O Testing/ACDR Record and it is the machine conductivity result, that is recorded on the patient's treatment form. Staff #16 was informed that Staff #7's statement did not corroborate her statement. Staff #16 stated that in the future both conductivity results will be recorded on the patient's treatment form. Therefore, the facility failed to record the manual conductivity result for patient MR #39, on 6/18/10, before the patient was dialyzed.

C. Medical records did not document the date, time and signature of the provider for MRs #4, #6, #9, #11, #26. During observation and review of medical record, 6/14/2010-6/18/2010, the following findings were noted:

1. On 6/14/2010 in the CCU/ICU, MR #4 revealed that the Attending Physician's Permission for Operative and/or Diagnostic Procedure and/or Treatment for "Permanent Pacemaker Placement and related Procedures" was signed by the MD, but the Printed Name and Date were not recorded.

2. On the Psychiatric Unit, a review of MR #6 revealed that on the Doctor's order sheet on 6/12/2010, Haldol 5mg P.O. stat, Depakote 500mg P.O. stat, Benadryl 50mg P.O. stat, Seroquel 100mg P.O. stat were ordered and signed by the MD on 6/14/2010. The reason for ordering the stat medication was not indicated. No time was indicated on the following orders: 6/12/2010 orders above; 6/14/2010, Haldol 5mg IM and Ativan 2mg IM stat orders were signed by MD on 6/14/2010, but no time was indicated; 6/14/2010, CBC, Chemistry-7, urine drug screen, blood alcohol level was ordered, signed and dated, but no time was indicated.

3. Review of medical record, MR #9 revealed that the AMA form was not completed. It was signed by the patient and by physician as of 4/14/2010, but there was no time recorded.

4. On 6/18/2010 during medical record review, MR #11 revealed that the Certification (To support an Application for Involuntary Admission) was signed as of 4/13/2010, but it was not completed. A physician signed the form, but the Printed Name, Title, and Time were not recorded.

5. On the Psychiatric Unit on 6/16/2010 at 11:00AM-12:30PM, a review of
MR# 26 revealed that on 6/15/2010 between 1:40PM and 1:43PM, the Psychiatrist wrote stat orders as follows; Haldol 10mg IM stat x1, Ativan 2mg IM stat x1, Benadryl 25mg IM stat x1. These orders were not completed because the reason for the stat medication orders was not documented in the medical record.

6. The facility did not ensure that the medical record is complete since the discharge summary was missing for MR# 13. On June 18, 2010 at 11:00AM, it was noted that the discharge summary was missing from the chart.

PHARMACIST SUPERVISION OF SERVICES

Tag No.: A0501

Based on observations, interview, and document review, the provision of pharmacy services was not adequately supervised by Staff #29 to ensure compliance with state and federal regulations.

Findings include:

1. Staff #29 failed to ensure oversight of the Methadone program, including a review of policies and procedures. The Administration of Methadone Policy #5034, indicates that for the administration of Methadone, "only tablet methadone is used." The Diversion Control plan Policy #5034, also refers to Methadone tablet count accuracy. However, since the clinic only uses liquid Methadone, the policies are not accurate.

An observation on 6/16/2010 at 10:30AM revealed that only liquid Methadone is used via the Digispen 10 IVAC machine. The policy has not been revised to reflect this change, which would include the procedure to use the machine, and monitor the accuracy of liquid Methadone administered and in stock.

2. An observation in the Pharmacy on 6/14/10, at 11:00AM, revealed that liquid medications of EpiVir 10mg/ ml and Ibuprofen 10ml were repackaged from stock to 1ml and 10ml syringes, labelled with the lot number and expiration date of the manufacturer, and the name and strength of the drug. However, these items were not included in the repackaging log. Interview with Staff #29 on 6/14/10, at 11:00AM, revealed that only tablets and capsules that are repackaged are recorded in the repackaging log book. Liquids are not recorded in the log as they should be.

3. Interview with Staff #29 on 6/14/10, at 11:20AM, revealed that there are no pharmacy policies regarding the disposal of used Duragesic patches after they are removed from the patient. A policy is needed to ensure that there is accountability and no diversion of the used patches. Staff #29 indicated that discarded Duragesic patches are not monitored by pharmacy.

4. Observations made on 6/14/10 at 2:30PM, on the Mental Health Unit on the 2nd floor, revealed that the medication room contained an emergency supply of medications (Navane, Cogentin, Risperdal, Decanoate) to be used in a medical emergency, according to interview with Staff #2 at that time. A review of the April 2007 policy on Floor Stock revealed that this unit was not identified as being permitted to keep floor stock. Therefore, there is no listing of the drugs kept, no par levels, and no evidence this supply was approved by the Pharmacy and Therapeutics Committee.

UNUSABLE DRUGS NOT USED

Tag No.: A0505

A. Based on observations and staff interviews, the hospital failed to ensure that drugs and biologicals that are outdated or inappropriately labeled are removed from storage areas where they could be used for patient care.

Findings include:

1. The following outdated medications and biologicals were found in the outpatient clinic in the main hospital on June 14, 2010 between 3:43PM and 4:00PM.
a. Two containers of Mirapex, Pramipeole Dihydrochloride with expiration dates of 10/09 were found in examination room #2 in the clinic.
b. Six Placebo tablets with an expiration date of 3/10 were found in exam room #2.
c. In clinic's exam room #6, there was a bottle of Acetic acid which had expired 6/1/10.
d. Two bottles of alcohol were opened but not dated. All findings were verified by Staff #15 at that time.


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2. An environmental observational tour of the facility was conducted on 6/14/10 between 11:40AM and 3:10PM. Staff #2 observed the findings.

6th Floor Tower Unit
a. At 11:40AM, 52 blue Vacutainer bottles with the expiration dates of 05/10 were observed on a storage rack in the medication room.
b. At 12:15PM, 3 Baxter Evacuated Containers with the expiration date of 12/09 were observed on the storage rack in the clean utility room.
c. At 12:20PM, a patient had a meal tray on the bedside table. A used urinal bottle was placed in close proximity on the same table. The patient was interviewed and he confirmed that the urinal was not new.
d. At 12:25PM, a patient was noted in room 617 receiving IV therapy; the IV lines were not dated.
e. At 12:30PM, a used face mask was observed hanging on the O2 pipe line, and was uncovered.
f. At 12:35PM, a patient was in room 619 receiving IV therapy; the IV lines were not dated.
g. At 12:45PM, the Crash Cart was observed with 1 Central Line Prep Kit with expiration date of 06/09 and another one with expiration date of 12/09.

Wound Care Clinic
a. At 2:45PM, 2 bottles of Sodium Chloride 250ml were observed opened on the treatment cart in room 539, with no date written on the bottles.
b. An Ultra Sound Transmission Gel, with an expiration date of 3/10, was observed on the treatment cart in room 539 at 2:47PM.
c. At 2:50PM, a bottle of opened sterile water 1000cc was observed on the treatment cart in room 538 without a date of opening. Staff #14 stated during interview that the bottle is discarded at the end of the day.
d. At 2:51PM, a bottle of Betadine with expiration date of 8/09 was observed on the treatment cart in room 538.
e. At 2:53PM, 3 Kendal Non Adhering Dressing packs with expiration dates of 3/08 and one Ultra Sound Gel with expiration date of 3/10, were observed on the treatment cart in room 537.
f. At 2:57PM, 3 Tegaderm Dressings with expiration dates of 08/05, were observed on the treatment cart in room 536.

Hyperbaric Chamber Clinic
At 3:10PM, 1 bottle of Betadine with expiration date of 4/06, was observed in the clinic storage cabinet.

3. An environmental observational tour of the facility was conducted on 6/15/10 between 10:30AM and 2:45PM. Staff #2 observed the findings.

a. At 10:30AM during the observation in room 217, the following items were observed on the bedside table for Podiatry: 2 bottles of opened Betadine solution, 5 syringes, one Dressing pack, 3 suture removal sets and one 250cc opened Normal Saline with no date on the bottle.

During interview, Staff #2 verified with nurse on the unit that this was a
set-up for the Podiatrist.

b. At 10:45AM, the patient in room 225A was observed to be receiving IV therapy. The IV line was not dated.
c. At 10:50AM, 1 bottle of sterile water for inhalation therapy was observed on the O2 port on the wall. The bottle of sterile water was not dated.

Dialysis Unit
a. At 11:40AM, Dimethicone Protectant cream with the expiration date of 3/10 was observed on the treatment cart in the unit.
b. At 11:45AM, 5 Tegaderm dressings 15cm by 20cm, with expiration date of 4/09, were observed in the storage cabinet.


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4. During an observational review of the patient care in the CCU/ICU, Critical Unit on June 14-15, 2010 between 11:00AM-12:30PM and 2:30PM-3:45PM, the following outdated medications and biologicals were found as follows:
a. Two BD Vacutainer-push button blood collection sets were found with expiration date of 10/2009.
b. Three Non-DEHP Catheter Extension sets (V-Link Luer Activated Device With vital shield protective coating) were found with expiration date of 1/2009.
c. One Lorazepam 0.5mg tab was found with expiration date of 10/2009.
d. Nine 5% Dextrose 50ml injection solutions were found with expiration date of 2/2010 (eight) and 5/2010 (one).
e. Fifteen 5% dextrose and 0.33% Nacl 500ml injection solutions were found with expiration of 10/2009 (seven), 11/2009 (one), 12/2009 (two), 2/2010 (one), 4/2010 (one), and 5/2010 (three).

The locks for the medication cabinet for the individual patient's medications, and for the Surgical supplies cabinet including IV fluids supplies, were not in a working condition. It was very difficult to open/lock the both cabinets.
This condition results in the patients not being able to receive the necessary care and treatment on a timely basis.

5. During an observational review of Central Supply to the CCU/ICU, Critical Unit on June 15, 2010 between 2:30PM and 3:45PM, the following outdated medications and biologicals were found as follows:
a. Three BD Insyte Autoguards (Angio Cath) 18GA had expiration date of 5/2010.
b. Six Urinary Drainage bags had expiration date of 11/2009.
c. Three Softsilks (coated, braided silk), 2-0, 3-0, 4-0 had expiration date of 9/2002, 5/2006, 9/2007.
d. Seven Petrolatum Gauzes had expiration date of 1/2009.
e. One Tracheostomy set package was broken and had expiration date of 12/15/2008.
f. One MVH Chest Tube Tray package was broken and had expiration date of 3/16/2010.
g. One Cut down set package was broken and had expiration date of 4/5/2009.
h. One Med H Plast Bag Decanter II had expiration date of 5/2010.
i. Two Large "Y" Connectors had expiration date of 2/2010.
j. One IV administration set had expiration date of 7/2008.
k. Two Suction catheters had expiration dates of 1/2009 and 2/2009.
l. Two Port-A-Cath 1 1/2inch needles had expiration date of 3/2010.
m. One Hundred BD vacutainers (blue color)-blood had expiration date of 5/2010.

ADEQUACY OF LABORATORY SERVICES

Tag No.: A0582

Based on observations and interviews, it was determined that the facility did not provide laboratory services in a safe manner.

Findings include:

Expired or undated reagents and chemical agents were noted in the histology laboratory on June 15, 2010 at 2:45 PM - 3:00 PM. These items may potentially impact on test results of specimens.

Examples include:

a. A bottle of Acetic acid had been opened on 8/5/03.

b. A bottle of Methylene Blue had expired on 5/9/05.

c. One bottle of 1% Alcohol was opened but not dated.

d. One bottle of 5% Oxalic Acid had expired on 12/05.

e. Two bottles of Krystalon solution had expired on 7/31/09.

f. Two bottles of 1% Sodium Bisulfite Solution were opened and were not dated.

g. A bottle of 37% Formalin had expired on 6/8/08.

h. There was a bottle of Trichrome stain that expired on 4/6/10.

i. There was an iron staining kit that had expired 12/09.

h. Three bottles of Cytoblock were opened but not dated.

All the above findings were verified by Staff #17at that time.

DIRECTOR OF DIETARY SERVICES

Tag No.: A0620

Based on observation, staff interview and review of the dietary policy and procedures, the facility failed to provide dietary and food services in a sanitary and safe manner:

Findings include:

During observation and inspection of the kitchen, cafeteria, and food service areas conducted on 6/14/10 and 6/15/10, staff interview and review of the dietary policies and procedures manual, the following items were noted:

1. During the tour of the kitchen on 6/14/10, two potentially hazardous cooked beef briskets were not cooled by an adequate method to ensure that every part of the beef brisket reached the required temperature within the mandated timeframe. According to Staff #18, the two beef briskets, weighing 12 to 14 pounds each, were cooked on 6/6/10 and cooled whole in the walk-in freezer. On 6/14/10 at 12:15 PM, the beef briskets, weighing 12 to 14 pounds, were observed in the walk-in freezer.

Review of the Hospital's Food and Nutrition Services policy entitled, "Chilling Potentially Hazardous Foods," states that "Potentially hazardous foods requiring refrigeration after preparation shall be rapidly cooled to an internal temperature of 45 degrees F or below." "The following procedures will be used as applicable to promote rapid cooling: Large cuts of meat (i.e. roast beef, pork roast, ham) will be divided into smaller portions prior to refrigeration." "Top Round: Remove from oven at 145 degrees internal temperature. Cut in half, place in clean pan with middles facing out. Place in freezer for two hours. After two hours, remove, cover, label and date. Place in refrigerator." "Meat temperatures will be monitored to assure the rate of cooling is acceptable."

The standard of practice for cooling of potentially hazardous foods requires that every part of the product must be cooled quickly from 140?F to 70?F within 2 hours and then to 41?F or below within 4 additional hours (total cooling time 6 hours).
The method for cooling of potentially hazardous foods includes cutting solid foods, such as roasts of meat, into portions of 6 pounds or less after cooking and prior to cooling.

There was no evidence that the temperatures of the beef briskets cooked on 6/6/10, were monitored to assure that the rate of cooling met the standard of practice. Interview with Staff #18, revealed that there was no temperature cooling log available to ensure that the beef briskets were cooled properly. Furthermore, the beef briskets were not divided into smaller portions prior to cooling, as per hospital's policy.

2. During the tour of the kitchen on 6/14/10, the door of the dessert/juice walk-in refrigerator was in need of repair and the rubber gasket was soiled.

3. During the tour of the kitchen on 6/14/10, single service containers were observed in the freezers and refrigerators being reused to store soups and other leftover food items. According to the Hospital's policy and procedure entitled, "Disposable Containers and Utensils", "Disposable containers and utensils are discarded after one use."
a) In the walk-in freezer, single service containers were reused to store soups. The dates on the 6 single service containers with soup ranged from 10/14/09, 11/6/09 and 11/20/09.
b) In the chef's preparation refrigerator, single service containers were reused to store vegetable soup dated 6/6/10, and chili dated 6/10/10.
b) According to the hospital's policy and procedure entitled, "Food Handling/Food Storage," "To ensure proper handling and storage of food: "All food products and supplies are rotated so that "first in is first out."
According to the hospital's policy and procedure entitled, "Label and Dating of Food," "All opened or leftover foods are to be used within 48 hours."

Single service containers are to be discarded after using the item from the original container. Leftover soups and other food items were not being handled and stored as per the hospital's policy.

4. During the tour of the kitchen on 6/14/10 at 11:50 AM, the temperature of the puree beef on the steam table was 120 degrees F. According to the hospital's policy and procedure entitled, "Food Handling/Food Production," "To insure proper handling and preparation of food." "All steamable items are kept above 140 degrees F."

5. During the tour of the cafeteria on 6/15/10 at 2:04 PM, the temperature of the cooked, hard boiled eggs located on the salad bar was 55 degrees F. The temperature of the butter on the counter was 58 degrees F.

6. During the tour of the cafeteria on 6/15/10 at 2:06 PM, cracked floor tiles were observed.

7. During the tour of the cafeteria on 6/15/10 at 2:00 PM, raw, fresh eggs were observed on the shelf of a reach-in refrigerator in the cafeteria, above fresh salad items.

8. During the tour of the cafeteria on 6/15/10 at 2:02 PM, haphazard storage and display of eating utensils were observed. Utensils were not stored in the same direction.

9. During the tour of the kitchen areas on 6/14/10 and the cafeteria areas on 6/15/10, soiled and stained ceiling tiles and vents were observed throughout the kitchen and cafeteria areas. Also observed were broken floor tiles.

10. During the tour of the kitchen on 6/14/10 and the cafeteria on 6/15/10, observed were food preparation sinks without indirect drains.

11. During the tour of the kitchen on 6/14/10 and the cafeteria on 6/15/10, observed were food preparation and handwashing sinks with leaking faucets.

PHYSICAL ENVIRONMENT

Tag No.: A0700

The Condition of Physical Environment is not met since the hospital is not constructed, arranged and maintained to ensure the safety of its patients and staff.

Findings include:

1. The facility did not maintain its premises in a safe, sanitary and comfortable environment to ensure the safety and well-being of patients.
See 0701.

2. The facility did not ensure that all facilities/areas and equipment were maintained in such a way to ensure safety and quality for the patients and staff.
See A 0724.

3. The facility did not ensure that proper ventilation was provided and monitored in patient care areas and other areas of the building.
See A 0726.

4. The facility did not ensure that dietary and food services were provided in a sanitary manner, and that food preparation areas and related equipment and supplies were adequately maintained.
See A 0620, 0726.

5. Life Safety Code violations resulted in the provision of unsafe environment for the patients. See A709.

MAINTENANCE OF PHYSICAL PLANT

Tag No.: A0701

Based on observation, it was determined that the facility and its equipment were not kept in good repair and the housekeeping department did not maintain a clean, sanitary environment to ensure that the safety and well-being of patients are not compromised.

Findings include:

A. The facility and its equipment were not kept in good repair and the housekeeping department did not maintain a clean, sanitary environment. These observations were noted at the Methadone clinic at 3 South 6th Avenue, Mount Vernon, NY 10551.

1. The cover for the radiator in the lobby was missing on June 16, 2010 at 12:40PM.

2. The heating unit was also very dirty and dusty. This finding was verified by Staff #2 at that time.

3. There were at least 10 broken and missing sections of tiles in the corridor of the clinic on June 16, 2010 at approximately 12:25PM. This does not facilitate proper cleaning as the broken surface facilitates the accumulation of dirt and organisms.

4. Similarly, the base of the examination table and the cover of the radiator in the Physician's Assistant's office had an excessive amount of dust and dirt. This was observed on June 16, 2010 at approximately 12:20PM. This finding was witnessed by Staff #2 at that time.

B. The following findings were noted at the main campus.

1. On June 15, 2010 at 3:30PM, the refrigerator in the Hematology lab, used to store reagents, was noted to be dirty.

2. The base and inner aspect of the door of the specimen refrigerator in the Histology lab were covered with a large area of black substance on June 15, 2010. These findings were verified by Staff #17 at that time.

3. At 12:25PM on June 14, 2010 in the ED, the lock for the door to the clean utility room was not in working condition. Since this room is used to store IV needles and catheters, intravenous solutions and blood tubes, this is a security issue.

4. On June 14, 2010 at 2:35PM, it was noted that the roof at the door to the loading dock had an approximate 8" x 2" piece of ceiling that was missing and in need of repair. Clean and sterile supplies are received via this area. These findings were verified at that time by Staff #4 and 19.

5. A counter in the Central Supply Department was noted to be torn and in need of repair. The front edge of the counter, which was made of formica, was torn and had been been taped with an adhesive tape. This poses an infection control risk since the area cannot be cleaned thoroughly.


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6. During the survey from 06/14/10 to 06/18/10 between 10:30AM to 4:00PM, 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 06/14/10 at 10:30AM, during the tour of Physical and Occupational Rehab in the basement, four ceiling tiles were noted stained in the corridor of the suite and two ceiling tiles were noted stained by the Occupational Rehab area.
b) On 06/16/10 at 11:20AM, during the tour of the Post-Anesthesia Care Unit, a dirty ceiling tile with dust/dirt accumulation and water leak stain was noted above the bay/bed #5.
c) On 06/16/10 at 11:45AM, during tour of the ICU, a grossly dirty ceiling tile was noted with a large greenish/grey stain in the area/room across from the "Staff Only" bathroom. It is to be noted that in this area, clean supplies are also stored.
d) On 06/16/10 at 2:30PM, during the tour of the Ambulatory Surgery Suite, it was noted that in the patient holding room #1, a ceiling tile was stained orange with black growth in the middle. Upon removal of this tile it was noted that the black growth was extending above the ceiling tile (on both sides) and on the insulating material of the HVAC.
e) Two ceiling tiles were noted stained in the Respiratory unit on 06/16/10 at 3:15PM.
f) On June 14, 2010 at 12:00PM, 2 ceiling tiles in the trauma room in the ED were noted to have brown residue/stains indicative of leakage.

All findings were verified with Staff #21 and Staff #22 at the time of observation.

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

7. During the tour of the facility, it was noted that various exhaust vents had a thick accumulation of dust. Examples, including but not limited to, are:
a. On 06/14/10 at 11:15AM, it was noted that an exhaust vent above the exercise step ladder in the gym of PT/OT, had thick layer of black dust and dirt accumulation.
b. On 06/15/10 at 11:00AM, the exhaust vent in the autoclave room/sub sterile room between OR #5 and OR #6 was noted dirty with a very thick accumulation of dirt and dust. This condition may lead to environmental contamination and spread of infection.
c. Exhaust vent of the Cystoscopy OR was noted dirty and dusty.
d. Exhaust vent in the patient room #232 on Med/Surge floor was dirty.
e. Exhaust vents in the bathroom on the Behavior Health floor were dirty.

Findings were verified with Staff #21 and Staff #22 at the time of observation.

8. On 06/16/10 at 2:15PM, during tour of the Ambulatory Surgery suite, it was observed that in the two patient holding rooms, the heating units exhibited an accumulation of dirt and dust in the grills and around the floor perimeters beneath their edges.

Findings were verified with Staff #21, Staff #22 and Staff #23 at the time of observation.

9. The facility's environment and equipment were noted to be dusty, dirty, and in disrepair. Examples, including but not limited to, are:
a. During the tour of the Surgical Suite on 06/15/10 between 10:45AM to 12:15PM, it was noted that the floor and corners of the suite (pre-op holding area, corridors, areas where racks of supplies were stored) were very dirty with accumulation of dust and dirt. Furthermore, the floors were noted chipped/broken making it hard to thoroughly clean the areas as required to prevent spread of infection. The walls were also noted in disrepair with holes and base coving missing, exposing the structures underneath them in various areas.
b. The ceiling tiles of the Operating rooms (such as OR #6) were noted stained with dirt/rust.
c. A hole/gap was noted behind the clock in the autoclave room/sub-sterile room between OR #5 & OR #6.
d. On 06/14/10 at 11:00AM, it was noted that the treadmill in the gym of PT/OT had dirt all around its perimeter and on the floor. Furthermore, an equipment 'work simulator' near the treadmill was also noted to be dusty all around the unit.
e. The window sills in the patient holding rooms of the Ambulatory Surgery Suite were noted to be grossly dirty and dusty and had cobwebs around the sill.
f. The filters of the HVAC vents in the Mental Health Unit (Psych) were noted to be extremely dirty.
g. During the tour of the facility, it was noted that various electrical closets/Information Technology closets were dirty with dust on the floor and around the equipment.
h. The use of adhesive tape was found in many areas around the facility. Tapes were found stuck on stretchers, refrigerators, chairs/stretchers and other places. If tape and its sticky residues are not cleaned properly, they are a means of potential risk to infection control.
i. On 06/14/10 at 10:45AM during the tour of the PT/OT unit, it was noted that the wall behind the whirlpool tub in hydrotherapy room was in gross disrepair, such as broken wall, and wall paint peeling off revealing structure underneath .
j. The women's bathroom in the PT/OT suite had the wall paint chipping off revealing the structure underneath.
k. During the tour of the facility many wooden doors were noted to be in disrepair and had splinters. Examples are:
i) Main entrance door of the PT/OT suite.
ii) Door of the Clean sterilization workroom in the OR suite.
iii) Entrance door to the holding room #2 in Ambulatory surgery unit.
iv) Door to the Behavior Health room in the Emergency Room.

l. The walls of the outside room #421, #422 and #420 in the ICU were noted to be in disrepair with holes or missing base coving.

m. The wall in the autoclave room/sub-sterile room between OR #5 and OR #6 was noted to be in disrepair.

n. The Hydrotherapy room in PT/OT was noted to be in disrepair, had lots of supplies that were expired, and various pieces of equipment present which were very dirty/dusty. Also, the room had abundant amount of storage including two Hydrotherapy Whirlpool tubs. These storage items may contribute to fire hazard and risk to patient safety and infection control.

Findings were verified with Staff #21, Staff #22 and Staff #23 at the time of observation.

10. During the survey between 06/14/10 and 06/18/10, it was observed that several patient and visitor bathrooms on different floors of both hospital campuses, and bathrooms in outpatient areas, did not have appropriate emergency nursing call bell pull cords as required by AIA 7.32.G2. The emergency pull cords were either short in length, or were missing. This practice does not provide easy access for patient's safety. It was also noted that the emergency call bell cords had an accumulation of dirt.

Examples include but are not limited to:
a. The emergency nursing call bell cord in the patient bathrooms of PT/OT was short in length, thus not providing easy access to a patient who might collapse on floor. Furthermore, the pull cord in the female patient bathroom was a string of wool with a tape roll at the end, which may contribute to cross contamination since it is not cleanable.
b. No nursing call bell pull cord was provided for the emergency nursing call bell in the patient bathroom of the holding rooms in the Ambulatory surgery suite, thus not providing any access to a patient who might collapse.
c. Emergency nursing call bell cords were noted short in length in the patient bathrooms on Med/Surg Unit 2nd floor (such as room #230, room #232, etc).

Findings were verified with Staff #21, Staff #22 and Staff #23 at the time of observation.

11. During the tour of the Mental/Behavior Heath unit ( Psych unit) on 06/17/10 at 2:30PM, many looping hazards were noted in the patient bathroom/room and areas.
Examples, including but not limited to, are:
a. The toilet roll dispenser was not the recessed type and had a spindle hazard.
b. Pipes under the basin were not enclosed and were exposed, providing a looping hazard.
c. The lever/handle of the faucet on the wash basin was the protruding type that poses a safety hazard for patients who want to harm themselves.
d. Some door handles of the patient rooms and toilet/tub rooms in the unit were not the approved type, and are looping hazards.
e. The exhaust vents in the tub rooms were not protected by a mesh to prevent suicide or looping hazard.
f. The flush lever of the toilet bowl was protruding, posing a risk of harm to the patient.
g. The mixing valves in the tub rooms were not the approved type and pose a risk of looping hazard.
h. The cord of the public phone installed in the corridor was too long and could lead to staff or patients being harmed by strangulation.
i. The door hinges in the patients rooms were not the continuous type. The hinges had gaps. The hinges are supposed to be continuous with hospital cut tip to avoid any looping hazard

Findings were verified with Staff #21 and Staff #23 at the time of observation.

12. One of the electrical outlets outside the living/day room on the Behavior/Mental health unit was noted not to be tamper resistant. The facility could not verify if all electrical outlets in the Behavior/Mental Health unit were tamper resistant by providing any documentation or specification on them.

13. During the tour of the Mental/Behavior Health unit, it could not be verified if the window of the seclusion room opening to the ante-room/area was rated. As per AIA 1996-97 7.6.D, all the openings of the seclusion room should be protected by construction of not less than one hour.

Findings were verified with Staff #21 and Staff #22 at the time of observation.
14. During survey of the handicap accessible patient bathrooms (for example in the Physical and Occupational Rehab unit in the basement) 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 mirrors were mounted such that the bottom edge of the reflecting surface was more than 40 inches above the floor, and thus are not in compliance with ADA 4.19.6; and
c. Handicap accessible universal signage was not posted on the wall outside the handicap accessible bathrooms.

Findings were verified with Staff #21 and Staff #22 at the time of observation.

15. It was noted that many medicine/specimen and pantry refrigerators had ice/frost build-up/accumulation, which indicated that they had not been defrosted, or had broken/torn gaskets. Examples, including but not limited to, are:
a. On 06/16/10 at 11:45AM, during survey of the ICU, it was noted that the refrigerator in the nourishment area/pantry had a broken gasket.
b. During survey of the PT/OT unit on 06/14/10 at 11:30AM, it was noted that the cold pack in the unit had ice/frost build up/accumulation which indicated that it had not been defrosted.

Findings were verified with Staff #21 during the observation.

Note:
Frost buildup increases the amount of energy needed to keep the motor running and may put more load on the engine, which in turn decreases the efficiency of the unit. If the unit is frost free, then this build up indicates the possibility that the heater element has failed. Otherwise, it is a sign that the unit is not maintained and cleaned frequently to avoid contamination or infection control issues.

16. During the survey of the ICU on 06/16/10 at 11:45AM, it was noted that when a nurse call bell was elicited from a patient room, it did not register in the clean utility room, soiled utility room, and other areas as per AIA 7.32.G1.

The findings were verified with Staff #21 and Staff #22 at the time of observation.

17. During the tour of the PT/OT unit on 06/14/10 at 11:15AM, it could not be verified if the tall exercise mirror on the floor had shatter-proof glass.

Findings were verified with Staff #21, Staff #22 and Staff #25 at the time of observation.

18. During observations made in the pharmacy department on 6/14/10 at 11:00AM, two desks and a locked file cabinet were stored in the area in front of the medication pick up station windows.
In the pharmacy, storage racks containing clean supplies were on the same shelf as ink cartridges and other clerical supplies. Staff #29 indicated at that time that the items would be moved.

19. Expired supplies were available for patient use. On June 14, 2010 at approximately 2:50PM in the Central Supply Department in Cabinet #7, the following were observed: 16 packages of Allevyn Plus Cavity Dressing with expiration dates of 9/09; 1 dressing expired in 7/09; and another dressing expired 10/09.

LIFE SAFETY FROM FIRE

Tag No.: A0709

Based on observations, record reviews and staff interviews, it was determined that the facility did not meet the applicable provisions of the Life Safety Code, NFPA 101, 2000 edition.

Findings include:

During the survey of the facility from 06/14/10 to 06/18/10, Life Safety Code deficiencies were noted in multiple areas of the Code requirements and were cited under the following Fire/Life Safety Code tags:

? K-17 (Corridor walls not maintained as 1/2 hour fire resistive.)
? K-21(Corridor door protecting hazard area did not have approved closure.)
? K-25 (Smoke Barrier door was not maintained to resist passage of smoke.)
? K-29 (All hazardous areas were not safeguarded with proper protection or did not have self-closures/positive latching.)
? K-62 (Sprinkler system was not maintained and tested as per code.)
? K-64 (Portable fire extinguishers were installed above the required 5 feet/60 inches height.)
? K-67 (Fire dampers were not tested and maintained as per code.)
? K-76 (Bulk storage oxygen was not safeguarded per code.)
? K-77 (Medical gases were not maintained as per NFPA 99.)
? K-78 (Humidity was not monitored in anesthetizing areas.)
? K-130 (Remote annunciator for 2 generators was not provided.)
? K-140 (Two master alarm panels for Oxygen were not installed in the facility.)
? K-141 (No-smoking signs were not posted around the bulk oxygen storage.)

FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE

Tag No.: A0724

Based on observations and interviews, the facility failed to ensure that equipment was maintained to ensure patient safety.

Findings include:

1. Routine annual inspections of equipment were not performed to ensure safety during use in the OR.
a. On June 15, 2010 at approximately 10:40AM, it was noted that a monitor in OR #6 was overdue for its inspection since 11/09.

b. On June 15, 2010 at approximately 10:45AM in OR #6, the "Biomet" equipment's last inspection was 4/22/09.

c. The Valley Lab equipment was due for an inspection on 1/10.

All the above findings were verified by Staff #10 at time of observation.


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2. As per interview with Staff #6 on 06/17/10 and Staff #27 on 06/16/10, facility uses portable HEPA filters in any med/surg or ICU rooms to convert them to isolation rooms with negative pressure. Staff #21 was requested to provide preventive maintenance documents regarding how the HEPA filters are maintained/cleaned and how often the filters are changed to ensure that no contamination occurs between patients. Staff #21 stated on 06/18/10 that the facility did not maintain any documents to ensure safe handling of these units.

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 06/15/10 at 11:00AM, Staff #21 was interviewed regarding how the temperature and humidity are monitored for the ORs. Staff #21 stated that engineering does not have a mechanism to check or monitor the temperature and humidity. He stated that only two ORs out of 7 that are being used had equipment to measure temperature. Staff #10 was asked how nursing staff ensure that the temperature and humidity are within acceptable range before surgery or during surgery. Staff #10 did not know and stated that she needs to ask her other nursing staff. No answer was given nor any monitoring logs provided.

Therefore, it could not be determined how temperature and humidity values were maintained in the ORs, what the values were during surgery, and if they remained in compliance.

1.b. Staff #21 ordered humidity and temperature monitors for the ORs on 06/15/10. A policy and log was initiated, indicating that the facility will monitor the temperature and humidity 3 times daily and record/trend it. Also, if the ranges are not within limit, appropriate actions will be taken.

1.c. On 06/16/10 at 10:45AM, during a second/verification survey of the ORs, it was noted that OR #4 and Cystoscopy OR did not have the monitors installed as the facility had observed. At the time of survey, it was noted that a procedure had already taken place in the morning in OR #4. Findings were verified with Staff #21.

2. During the survey of the facility from 06/14/10 to 06/18/10, 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, including but not limited to, are:
2.a. The Bio-Hazard room in the Ambulatory Surgical suite did not have required negative pressure.
2.b. The soiled utility room in the Emergency Department exhibited positive pressure instead of the required negative pressure.
2.c. The soiled utility room in the OR suite had neutral pressure instead of the required negative pressure.
2.d. The clean workroom in the OR suite had neutral pressure instead of the required positive pressure.

3. During the survey of the facility, it was noted that most of the doors of the toilet/bathroom (used by patients, staff and public) were kept open. This practice compromises the per hour air-exchange of the toilet as required by AIA, Table 2.

INFECTION PREVENTION CONTROL ABX STEWARDSHIP

Tag No.: A0747

The Condition of Infection Control is not met based on a failure of the hospital to provide a sanitary environment and failure to prevent the transmission of infections and communicable diseases, as evidenced by the following:

1. The facility failed to provide a sanitary environment for its patients.
See A701.

2. The facility failed to implement proper infection control practices to avoid sources and transmission of infections and communicable diseases.
See A749 (1-6, 13-17).

3. The Operating Rooms were not maintained in a manner to prevent the transmission of infections and cross contamination.
See A749 (7-12).

4. The equipment in the Operating Rooms was not maintained properly to prevent the transmission of infection and cross contamination.
See A724 (1a-1b).

5. Proper Temperature, Humidity and Pressure were not maintained to prevent the transmission of Infection.
See A726.

6. Life Safety Code violations were potential sources of transmission of infections and cross contamination. See A709 (K 29, K 78).

INFECTION CONTROL PROGRAM

Tag No.: A0749

Based on observations and interviews, the facility did not ensure that proper infection control practices were implemented and that a clean and safe environment was provided to eliminate potential areas and situations that could result in infections.

Findings include:

1. A clean environment was not provided to prevent contamination and infections. The Pyxis machine in the ED had a dried pink substance measuring approximately 3'' x 2'' on the surface. Also, there was a dirty/black adhesive substance on the top surface on June 14, 2010 at approximately 12:10PM.

2. There was an excessive amount of dust accumulation in 2 storage brackets attached to the side of the adult code cart in the trauma room in the ED on June 14, 2010 at approximately 12:05PM. Stored in this area were clean items such as an ambu bag and oxygen tubing. This finding was verified by Staff #2 at that time.

3. Cabinet #7 in the Central Supply department was observed on June 14, 2010 at 2:35PM to have a heavy of accumulation of dust and dirt on the shelves that are used to store sterile supplies, including sterile dressings. These findings were also verified at that time by Staff #19.

4. Observed in the Central Supply Department were 3 armboards with an excessive accumulation of dust on June 14, 2010 at 3:00PM.

5. A container of Lysol disinfectant spray was stored with an open box of clean gloves in a cabinet on June 14, 2010 at 3:40PM in the clinic. Staff #15 verified this finding at that time.

6. On 6/18/10 at 11:00AM during an observation of the chemistry laboratory, several boxes of laboratory supplies were observed in their original cartons in the corner of the room, with two of these boxes directly on the floor in the same room where sterile lab work is done. Staff #30 did not follow the procedure for the storage of all boxes of supplies to prevent cross contamination.



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7.a. During observations of the operating room (OR) suite on 06/15/10 at 11:30 AM, it was noted that:
1. Air flow in OR #2, OR #3 and OR #4 was neutral rather than positive as required.
2. Air flow in the Soiled Utility Room was neutral rather than negative as required.
3. Air flow in the Clean Sterilization workroom was neutral rather than positive as required.

7.b. Staff #21 stated that the OR's were in compliance by having positive air-pressure as required. In order to achieve positive air pressure, the facility checked the HVAC belt and changed the filters of the HVAC.

Staff #21 stated at that time that the filters needed to be changed due to their condition. Staff #21 was asked how the facility ensures that positive air pressure is always provided in the OR. Staff #21 stated that apart from regular preventive maintenance there is no other way to ensure the positive air pressure.

Preventive maintenance record for the OR HVAC was provided to the surveyor on 06/18/10 at 12:00 PM. It was noted that last filter check request was made on 03/12/10 and was completed on 03/16/10 along with the monthly preventive maintenance. Semi-annual check was completed on 03/25/10 and annual check on 03/30/10.

Positive air pressure in the above mentioned ORs and Clean workroom was verified on 06/16/10 at 11:00 AM. However, the Soiled Utility Room still exhibited neutral pressure. Finding was verified with Staff #21.


8. During the survey of the Surgical suite on 06/15/10 and 06/16/10, it was noted that some doors of ORs (such as OR #5) 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. On 06/15/10, this condition was observed for OR #5 in which an operative procedure was being conducted at the time of survey.

Finding was verified with Staff #21 and Staff #22.

9. During survey of the surgical suite on 06/15/10, it was observed that between OR #1 and OR #4 there is a sub-sterile/autoclave room. The back of the autoclave/sterilizer was noted opening into a room/space. At the time of survey, this room/space housing the back of the sterilizer was noted to be dirty/dusty and in disrepair. It was further noted that the sterilizer/ autoclave is installed so there is a wide gap between the floor and the edge of the sterilizer. This gap creates a passage for air exchange between the clean sub-sterile room and dirty room/space at the back of the sterilizer, thus compromising the sterility/air exchanges of the sub-sterile room.

10. It was noted during survey of the surgical suite on 06/15/10 that, the scrub sink in the sub-sterile room between OR #5 and OR #6 has a button to operate the flow of water. As per AIA 7.31.E1 'Free standing scrub sinks and lavatories used for scrubbing in procedure rooms shall be trimmed with foot, knee, or ultrasonic controls (no single lever wrist blades)'.
At the time of survey on 06/15/10 at 11:30 AM, it was noted that a nursing staff came for scrubbing. She pushed the button labeled as 'short scrub', scrubbed herself with the flowing water and left for the procedure in OR #5. The water was noted running for 5-7 minutes after the staff left, since after scrubbing the staff could not push the button again or use any other method to stop the flowing water. Finding was noted with Staff #21 and Staff #22.

11.a. During survey of the OR from 06/15/10 to 06/16/10, many pieces of equipment, such as stretchers and portable x-ray equipment, were noted stored in the corridor. As per AIA 7.7.C18, one of the requirements of Surgical Suite is provision of 'Storage areas for portable X-ray equipment, stretchers, fracture tables, warming devices, auxiliary lamps, etc. These areas shall be out of corridors and traffic'.
11.b. On 06/15/10, it was noted that a janitorial bucket was stored right next to the C-arm machine. This poses a risk of cross contamination.

12. During survey on 06/16/10, it was noted that a procedure was being performed in OR room #6, and the door from the OR opening into the sub-sterile/autoclave room was open. Such an arrangement not only compromises the per hour air exchange of the rooms, but also may contribute to cross contamination.
Similar finding was noted for OR#2 which had its door open to the sub-sterile/autoclave room, and the sub-sterile/autoclave room's door was open to the corridor. Thus, the air from corridor was being circulated to the OR #2.

12. On 06/14/10 at 2:40 PM, it was noted that one ceiling tile in a storage room (in the basement near Boiler room) was missing/removed from its place. Structure and elements above the drop ceiling were exposed since this storage room is used to store clean supplies, there is a definite potential for dust and dirt contamination from above the ceilings.

Furthermore, this storage room was also noted to have miscellaneous items of clean, dirty and used items stored together. A storage room has to be designated as clean or dirty storage room with no mingling of items so that cross contamination does not occur.

13. On 06/17/10 during observation of the main clean linen storage area, it was noted that the clean linens were stored directly beneath the sprinkler pipes and water/chiller pipes going along the ceiling. There was no barrier between the pipes and the clean linens. This condition may lead to contamination since water condensation or dust fall out from the holes in the walls through which these pipes are passing and may contaminate the clean linens stored beneath the sprinkler and chiller/water pipes.
Furthermore, the base of the wall in this room was also noted in disrepair.

Finding verified with Staff #21, Staff #22, Staff #23 and Staff #24.

14. On 06/17/10 during the survey of the laundry/washing room on 2nd floor, it was noted that in this room dirty items such as mops and surgical scrubs are being washed in washing machines. Some dry surgical scrubs were noted neatly folded and stored on a table in this room.

As per the cleaning staff present there, the scrubs are washed in the laundry room, folded and stored for some time until somebody takes them on the floors where they are put in a dispensing machine. It was determined that these folded scrubs were cleaned and ready to wear and did not require any more cleaning.

Therefore, it is to be noted that:
a. Surgical scrubs after being washed were being kept/stored in the same room where other dirty items/linen/mops were brought in. Thus leading to poor infection control practices because of possibility of cross contamination.
b. A dirty oscillating fan was also noted blowing air and contaminating the air/environment in this room where washed and cleaned surgical scrubs were kept.

15. On 06/16/10 at 2:30 PM, it was noted that the upholstery of a stretcher/bed in holding room #2 of the Ambulatory Surgical unit was torn, thus imposing a risk of cross contamination due to difficulty in cleaning.

16.a. On 06/18/10 at 2:00 PM, it was noted that the isolation room in the Emergency Department (room #E) did not have self-closure installed on the door. As per AIA 7.9.D22, at least one airborne infection isolation room should be provided complying with the requirements of Section 7.2 in the emergency department. Section 7.2.C4 states that 'air borne infection isolation room shall have self-closing devices on all room exit doors'.

Note:
By not having a self-closure at the door, the room will not to be able to maintain optimum negative pressure as required and may contribute to contamination of the corridor outside the isolation room.

16.b. Furthermore, as per AIA 96-97 7.2C1 and 7.3.A14, at least one isolation room is required for the Nursing/Surgical unit and Intensive Care Unit (and more may be required as per the Infection Control Committee). The facility has Med/Surg unit/beds on the second floor and sixth floor, and ICU on fourth.

As per interview with Staff #6 on 06/17/10 and Staff #27 on 06/16/10, any room may be converted to negative isolation pressure room by putting in a portable HEPA filter. As per the staffs, room #s 214, 614, 419 and 419 were the ones primarily used for air-borne patients if required.

During observation of the above referenced units from 06/16/10 to 06/18/10, none of the rooms in the units complied with all requirements of Section 7.2 for isolation room. The ceiling tiles of all rooms (including the ones mentioned above) 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 the doors did not have self-closure installed on them.

SUPERVISION OF EMERGENCY SERVICES

Tag No.: A1111

Based on medical record review, the facility failed to ensure that medical care provided by physicians in the Emergency Room, was adequately supervised. This is evident in 2 of 39 medical records reviewed. (MR #16 and 29).

Findings include:

1. For MR #16, an EKG and a cardiology consultation were not done in a timely manner. Nor did the patient receive continuous cardiac monitoring.

MR #16 presented to the emergency department (ED) on June 11, 2010 at 6:37PM with complaints of chest pain radiating down to the left arm, nausea and vomiting for 3 days. Previous medical history included PCI stent placements x 4, Diabetes Mellitus, Hypertension and high cholesterol. The patient required administration of Aspirin (ASA), Nitropaste (NTP) 1" to chest wall and oxygen 2L per minute via a nasal canula.

An electrocardiogram (EKG) was done at 8:16PM, approximately 1+ 1/2 hours later, which showed that the EKG was abnormal and that the patient had an Acute MI (Myocardial Infarction). Cardiac enzymes were elevated. A cardiology consultation was done at approximately 9:00PM, more than 2 hours after the patient arrived at the facility.

There was no evidence that continuous cardiac monitoring was done throughout the patient's 4 hour stay in the ED. The patient was transferred to another facility at approximately 11:00PM, for further management of his Acute Myocardial Infarction. Given the patient's symptoms, adequate medical care was not provided in the ED.

2. MR #29 was triaged by the nurse at 14:37 in the Emergency Room (ER) on 7/24/09. The patient complained of pain in both arms and chest areas of 3 days. The patient was seen by the physician at 15:26 in the ED. EKG: RSR 94/min, T inversion in III, F (+) ST-T changes" (reviewed by MD at 3:30PM). There was no indication that the physician acted on the abnormal EKG.

The physician documented that the patient's condition was stable on cardiac monitoring and that the clinical impression was chest pain, rule out acute coronary syndrome. However, blood was not drawn for testing until 4:30PM, more than 2 hours later since being triaged. The blood work report came back positive for elevated Troponin 0.43 at 4:51PM. There was no indication the physician acknowledged or took action on the elevated Troponin level, or the abnormal EKG until 7:00PM when the physician wrote that she went to speak with the patient and was informed that the patient left the ER with Heplock in place. There's no documentation to indicate the patient was seen by a physician before that time.

3. During an observation in the ED on 6/18/10 at 11:30AM, ED staff was interviewed in the presence of Staff #6. Staff #8 stated at that time, that if 2 cardiac monitor alarms went off at the same time, it is possible for a patient to leave the ED, while staff were investigating one alarm, if security did not stop the patient from leaving. Upon further observation of the department at 11:32AM, it was observed that there was no security staff at the security desk immediately outside the ER. According to Staff #2, the security officer was assigned to monitor a patient on 1-1 observation. A review of the security staffs assignment showed that he had been on the 1-1 observation since 8:00AM. At 11:40AM, a security replacement staff was posted at the station. Staff # 9 was present during these observations and stated that keeping the patient from eloping is a challenge but he will work on ensuring that patients do not discharge themselves from ER without staff's knowledge.

A review of the facility policy and procedures reveal that there is no specific policy written for the ED for high risk patients and elopement. Per the department of nursing policy on 1 to 1 observations, two CNA's are needed to alternate sitting with the patient.

A review of the Psych Holding Area policy and procedure from the ER indicates that, "the security officer will remain outside the holding room but in close proximity". The holding room is located at the end of the hallway from the ER entrance. It was determined that one security officer cannot monitor the holding area and the ER entrance at the same time.

RESPIRATORY CARE SERVICES POLICIES

Tag No.: A1160

Based on observation and medical record review, Respiratory Services delivered to a patient were not in accordance with medical staff directives.

Findings include:

On 6/15/10 at 11:30AM, an environmental observation of the 2 Tower Unit was performed. Patient MR #33 was observed in room 231, receiving Oxygen therapy via nasal canula tubing connected directly to the wall O2 port. It was noted that the rate of the O2 delivery was set at 15 liters/min. This observation was shown to Staff #2 to verify the finding.

On 6/16/10 at 3:25PM and 6/17/10 at 4:00PM, the patient's medical record was reviewed and it was noted that the order for O2 therapy was written by the physician on 6/11/10 and that the patient was ordered to have 50% Ventimask #2 for the delivery of the oxygen and not the nasal cannula.