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Based on review of medical records, policies and procedures and interview, it was determined the facility failed to ensure patients' rights were respected and enforced for the right not to be restrained.

Based on record review and interview with Employee Identifier (EI) # 4, the Certified Psych Nurse (Acting Director of the Geri-Psych unit), it was determined the facility failed to follow its' policy for 2 of 2 patients with restraints. This affected Patient Identifier (PI) # 7208594 and # 7204907.

Findings include:

Facility Policy

Nursing Services Policy & Procedure
Title: Use of Restraints and Seclusion
Number: 2-R405
Effective date: 2/80

Policy: It is the policy of Medical Center Barbour, in accordance with its mission and core values, to respect the rights of our patients and thereby strive to provide them with the safest possible environment ...

Behavior Management Guidelines for Utilization of Restraint and Seclusion

1. Seclusion or restraint for behavior management can only be used in emergency situations if needed to ensure the patient's physical safety and less restrictive interventions have been determined to be ineffective ...

4. Orders for utilization of restraint and/or seclusion for patients with BEHAVIOR MANAGEMENT NEEDS should be limited to: Four (4) hours for adults age 18 and older ...

7. If restraints or seclusion are discontinued prior to the expiration of the original order, a new order must be obtained prior to the re-application of the restraint and/or seclusion ... When the original order is about to expire, the registered nurse should telephone the physician; report the results of his/her most recent assessment, and request that the original order be renewed for another period of time (appropriate to the age of the patient as stated previously) ...

18. Early release from restraint may be attempted if the patient demonstrates improvement in the behavior that led to the application of the restraint. The registered nurse is responsible for patient assessment and should make the determination to release the restraints when applicable.



1. PI # 7208594 was admitted to the facility on 6/17/11 with diagnosis including Dementia Disorder. Review of the Physician's Restraint Order dated 6/17/11 revealed bilateral soft wrist and ankle restraints were ordered at 15:50.

Review of the Patient Record/Patient Progress Notes dated 6/17/11 revealed the nurse documented, " @ (at) 19:50 ... (patient) was admitted to Geri Psych from ER (Emergency Room). Pt (patient) is in 4 point restraints, restless and combative transferred from ER was diagnosed with Dementia with aggression ... Restraint flow sheet below done ... " There was no documentation in the medical record of a physician's order for the continued use of restraints.

Review of the medical record revealed a Restraint Flowsheet was in the medical record, there was no date on this document. There was no documentation of a physician's order for the continued used of restraints.

Review of the Patient Record/Patient Progress Notes dated 6/17/11 and 6/18/11 revealed the Licensed Practical Nurse (LPN) documented the following:

21:15 to 23:45 the patient either appeared to be sleeping or was resting comfortably with the restraints in place. There were 11 entries documented by the LPN during this time frame.

From 00:00 to 00:45 the LPN documented the patient had some increased restlessness with the restraints in place. There were 4 entries documented by the LPN during this time frame.


01:00 - " Decreased restlessness noted, Pt appears to be sleeping ... skin dry & intact at restraint sites ... "


From 01:15 to 02:15 the LPN documented the patient had some increased restlessness with the restraints in place. There were 5 entries documented by the LPN during this time frame.


02:30 to 06:30 the patient either appeared to be sleeping or was resting comfortably with the restraints in place. There were 24 entries documented by the LPN during this time frame.


Review of the Patient Record/Patient Progress Notes dated 6/18/11 at 07:15 revealed the RN documented the patient was resting quietly with eyes closed and on 6/18/11 at 07:30 the RN documented the patient's restraints were released one at a time with all restraints removed by 0745.


The patient had bilateral wrists and ankle restraints in place in the Geri-Psych unit from 19:50 on 6/17/11 to 07:30 on 6/18/11, which was 11 hours and 40 minutes. There was no documentation of a physician's order for the continued used of restraints. There was no documentation an early release was attempted during the time the patient appeared to be sleeping or resting quietly.


An interview was conducted on 7/14/11 at 11:30 AM with EI # 4, who verified there was no documentation of a physician's order for the use of restraints.



2. PI # 7204907 was admitted to the facility on 4/30/11 with diagnosis including Dementia with Behavioral Disturbances. Review of the Physician's Orders dated 5/28/11 at 11:30 AM, revealed orders for a soft Posey vest for up to 4 hours for severe agitation.


Review of the Restraint Flowsheet dated 052811 (5/28/11) revealed the nurse documented at the 11:00 hour the patient was in restraints. There was no documentation on this form of the type of restraint used.


Review of the Restraint Flowsheet dated 052811 (5/28/11) revealed the nurse documented from 12:00 to 14:00 hours the patient was out of restraints, from 15:00 to 18:00 the nurse documented the patient was in restraints and then at 19:00 the nurse documented the patient was out of restraints. There was no documentation of a physician's order for the reapplication of restraints.


Review of the Restraint Flowsheet dated 052811 (5/28/11) revealed the nurse documented the following:
11:00 hours the patient was in restraints, " ordered and applied at 1045 "
12:00 hours the patient was out of restraints
13:00 hours the patient was in restraints
14:00 hours the patient was out of restraints
15:00 hours the patient was in restraints
16:00 hours the patient was out of restraints
17:00 hours the patient was in restraints
18:00 hours and 19:00 hours the patient was out of restraints


There was no documentation of a physician's order for the restraints.


An interview was conducted on 7/14/11 at 11:45 AM with EI # 4, who verified there was no documentation of a physician's order for the restraints.

Based on review of the medical records and nursing educational information, observation of the medication room and Operating Room # 2 and interview with the staff, it was determined the facility failed to ensure:

1. The nursing staff provided wound assessments and wound care as ordered in 2 of 2 medical records reviewed with wounds.

2. The nursing staff prepared and administered patients' medications in accordance to the facility's policy and Comprehensive Accreditation Manual for Hospitals: The Official Handbook (referenced in the facility's policy).

Based on review of the medical records and nursing educational information and interview with the staff, it was determined the facility failed to ensure the nursing staff provided wound assessments and wound care as ordered in 2 of 2 medical records reviewed with wounds. This affected Patient Identifiers (PI) # 7199938 and 7210009 and had the potential to affect all patients with wounds.

Findings include:

On 7/13/11 at 2:00 PM the surveyor asked Employee Identifier (EI) # 1, the Chief Clinical Officer for the facility's policy on wound assessment and none could be provided.

On 7/14/11 at 9:00 AM the surveyor asked EI # 2, the Director of Surgery/Outpatient, what the facility used to inform the nursing staff of the process to be used for wound assessments and wound care. EI # 2 submitted educational material used for the nursing staffs' orientation.

Educational Information Titled: Skin Care/Prevention
...Documentation of Skin Ulcers:
It is imperative to do a thorough skin assessment on admission of EVERY patient!
Be sure to document any abnormalities
Describe:
Skin color surrounding the wound
Color of wound bed
Size (measure)
Depth (with a sterile Q-tip
Consistency of drainage
Erythema
Dressing used.

Always check your orders to make sure you are performing the wound care that is ordered for the patient!

1. PI # 7199938 was admitted to the facility on 2/24/11 with diagnoses including Urinary Tract Infection, Dehydration and Decubitus Ulcers.

Review of the physician's Admission Orders dated 2/24/11 at 16:20 revealed,"Wound Care Daily" .

Review of the physician orders dated 2/24/11 at 17:59 revealed orders, "wound care - wash with soap and water".

Review of the Initial Nurse's Assessment documentation dated 2/24/11 revealed the following:
The wound to the Buttocks measured 1 inch deep and 2 inches wide with pink; reddened open edges and bloody drainage.
The Right Upper Quadrant wound on the abdomen had no measurement of the opened wound with serosanguinous drainage.
There was no documentation of either wounds bed or dressing used.

Review of the Patient Care Activities dated 2/24/11 at 22:00 revealed the nurse provided the following wound care to the lower right buttock wound and to the center abd. (abdomen) wounds: Washed with soap and water, flushed with normal saline, wet packing gauze, covered with gauze and taped.

The documentation for the wound assessment times and the wound care times did not correlate.

Review of the nurse's documentation dated 2/25/11 at 03:15 revealed the following:
The wound to the sacrum (buttocks) measured 1 inch deep and 2 inches wide with pink; reddened open edges and bloody drainage.
The Right Upper Quadrant wound on the abdomen had no measurement of the opened wound and had serosanguinous drainage.

Review of the nurse's documentation dated 2/25/11 at 05:09 revealed the following:
The wound to the sacrum measured 1 inch deep and 2 inches wide with pink; reddened open edges and bloody drainage.
The Right Upper Quadrant wound on the abdomen had no measurement of the opened wound and had serosanguinous drainage.

Review of the Patient Care Activities dated 2/25/11 at 08:15 revealed the nurse provided the following wound care to the lower right buttock wound and to the center abd. wounds: cleansed with normal saline, packed with packing strips, covered with gauze and taped. The nurse documented the old drsg that was removed was saturated with bloody drainage. There was no documentation of a physician's order for the saline, packing strips or covering with a gauze.

The documentation of a wound assessment time did not correlate with the time of the wound care.

Review of the nurse's documentation dated 2/25/11 at 22:00 revealed the following:
The wound to the sacrum measured 1 inch deep and 2 inches wide with pink; reddened open edges and bloody drainage.
The Right Upper Quadrant wound on the abdomen had no measurement of the opened wound and had serosanguinous drainage.

Review of the nurse's documentation dated 2/26/11 at 05:30 revealed the following:
The wound to the right buttocks fold measured 1 inch deep and 2 inches wide with pink; reddened open edges with tunneling and bloody drainage.
The Right Upper Quadrant wound on the abdomen had no measurement of the opened wound with tunneling and bloody serosanguinous drainage.
There was no documentation of a measurement or location of the tunneling.

Review of the Patient Care Activities dated 2/26/11 at 08:50 revealed the nurse provided the following wound care to the lower right buttock wound and to the center abd. wounds: Washed with soap and water, cleansed with normal saline, wet packing gauze, covered with gauze and taped. There was no documentation of a physician's order for the saline, wet packing or gauze.

The times of the documentation for the wound assessment and the wound care did not correlate.

Review of the nurse's documentation dated 2/26/11 at 22:00 revealed the following:
The buttocks wound measured 1 inch deep and 2 inches wide with pink; reddened open edges with tunneling and bloody drainage.
The Right Upper Quadrant wound on the abdomen had no measurement of the opened wound with tunneling and bloody serosanguinous drainage.
There was no documentation of a measurement or location of the tunneling.

Review of the nurse's documentation dated 2/27/11 at 08:00 revealed the following:
The wound to the right buttocks fold measured 1 inch deep and 2 inches wide with pink; reddened open edges with tunneling and bloody drainage.
The Right Upper Quadrant wound on the abdomen had no measurement of the opened wound with tunneling and bloody serosanguinous drainage.
There was no documentation of a measurement or location of the tunneling.

Review of the nurse's documentation dated 2/27/11 at 18:00 revealed the following:
The wound to the right buttocks fold measured 1 inch deep and 2 inches wide with pink; reddened open edges with tunneling and bloody drainage.
The Right Upper Quadrant wound on the abdomen had no measurement of the opened wound with tunneling and bloody serosanguinous drainage.
There was no documentation of a measurement or location of the tunneling.

Review of the nurse's documentation dated 2/28/11 at 06:09 revealed the following:
The wound to the right buttocks fold measured 1 inch deep and 2 inches wide with pink; reddened open edges with tunneling and bloody drainage.
The Right Upper Quadrant wound on the abdomen had no measurement of the opened wound with tunneling and bloody serosanguinous drainage.
There was no documentation of a measurement or location of the tunneling.

Review of the Patient Care Activities dated 2/28/11 at 17:44 revealed the nurse provided wound care to the lower right buttock wound and to the center abd. wounds. There was no documentation of what wound care the nurse provided.

The times of the documentation for the wound assessment and the wound care did not correlate.

Review of the nurse's documentation dated 2/28/11 at 20:00 revealed the following:
The wound to the right buttocks fold measured 1 inch deep and 2 inches wide with pink; reddened open edges with tunneling and bloody drainage.
The Right Upper Quadrant wound on the abdomen had no measurement of the opened wound with tunneling and bloody serosanguinous drainage.
There was no documentation of a measurement or location of the tunneling.

Review of the nurse's documentation dated 3/01/11 at 07:09 revealed the following:
The wound to the right buttocks fold measured 1 inch deep and 2 inches wide with pink; reddened open edges with tunneling and bloody drainage.
The Right Upper Quadrant wound on the abdomen had no measurement of the opened wound with tunneling and bloody serosanguinous drainage.
There was no documentation of a measurement or location of the tunneling.

An interview was conducted on 7/14/11 at 12:00 PM with Employee Identifier (EI) # 3 , the Director of Medical/Surgical and Intensive Care who verified the nurse did not have orders for the wet to dry dressings or packing strips nor did the wound care and the wound assessments documentation correlate.

2. PI # 7210009 was admitted to the facility on 7/8/11 with diagnoses including Small Bowel Obstruction and Decubitus.

Review of the Initial Admission Assessment dated 7/08/11 at 19:05 revealed the patient had a wound to the buttocks with a wound vac.

Review of the Medical/Surgical Shift assessment dated 7/9/11 at 08:00 revealed an opened wound to the sacrum with moderened purulent drainage and measured 5 cm (centimeters) in diameter and a blistered area to the right hip. There was no documentation how or when the wound vac was discontinued.

Review of the Patient Care Note dated 7/9/11 at 17:00 revealed the following wound care to the sacrum - cleansed with NS (normal Saline), packed with sterile water gauze, and covered with an abd pad and paper tape and the wound to the right hip was covered with telfa and tape.

The times of the documentation for the wound assessment and the wound care did not correlate.

Review of the Medical/Surgical Shift assessment dated 7/9/11 at 19:33 revealed an opened wound to the sacrum with moderate purulent drainage and measured 5 cm (centimeters) in diameter and a blistered area to the right hip.

The times of the documentation for the wound assessment and the wound care did not correlate.

Review of the Medical/Surgical Shift assessment dated 7/10/11 at 08:00, 18:00, 18:10, and 22:32 revealed an opened wound to the sacrum with moderate purulent drainage and measured 5 cm (centimeters) in diameter and a blistered area to the right hip.

There was no documentation that wound care was provided for 7/10/11.

Review of the Medical/Surgical Shift assessment dated 7/11/11 at 2:17, 6:26, 8:01, 11:55, 15:35, and 19:39 revealed an opened wound to the sacrum with moderate purulent drainage and measured 5 cm (centimeters) in diameter and a blistered area to the right hip.

There was no documentation of wound care for 7/11/11.

Review of the Medical/Surgical Shift assessment dated 7/12/11 at 02:29, 04:12, 08:00 and 12:00 revealed an opened wound to the sacrum with moderate purulent drainage and measured 5 cm (centimeters) in diameter and a blistered area to the right hip.

The times of the documentation for the wound assessment and the wound care did not correlate.

The surveyor completed an initial tour of the Intensive Care Unit on 7/12/11 at 14:00 and reviewed the patient's medical record. The surveyor requested a copy of the physician's order for the wound care and none could be provided.

Based on an observation of the medication room and Operating Room # 2 and interviews with administrative staff, it was determined the facility failed to ensure the nursing staff prepared and administered patients' medications in accordance to the facility's policy and Comprehensive Accreditation Manual for Hospitals: The Official Handbook (referenced in the facility's policy). This had the potential to affect all the patients served by this facility.


Findings include:

1. Facility Policy

Pharmacy Policy & Procedure
Title: Dispensing - Labels
Effective date: 01/01/2008

Policy: All drugs stocked in the pharmacy, supplied to floor stock, or dispensed to patients shall be clearly, accurately, appropriately, and safely labeled using a standardized method. Care should be taken to protect patient information from potential public disclosure for any discarded label.

Procedure: Drug labeling must be consistent among all preparation areas throughout the facility and comply with the applicable laws and regulations of the state Board of Pharmacy.

Label Contents:
All labels shall include at a minimum:
Patient name and location (if applicable)
The proprietary and/or nonproprietary name of the drug
Drug strength
Dosage form...

Reference: JCAHO (Joint Commission on Accreditation of Healthcare Organizations) Standards: MM.2.20 MM 4.30


2. Comprehensive Accreditation Manual for Hospitals: The Official Handbook (Referenced in the facility's policy above.)

Standard MM.2.20 Medications are properly and safely stored.

Rationale for MM.2.20 Appropriate medication storage increases patient safety. Medication storage is designed to assist in maintaining medication integrity, promote the availability of medications when needed, minimize the risk of medication diversion, and reduce potential dispensing errors.*

Note: The following elements of performance also apply to emergency medications. Additional requirements for emergency medications are addressed at standard MM.2.30.

Elements of Performance for MM.2.20

1. Only approved medications are routinely stocked or stored.
2. Medications are stored under conditions suitable for product stability.
3. There is a written policy addressing the storage of medication between receipt of a medication by an individual health care provider and medication administration. At a minimum, the policy addresses the following:
* Safe storage
* Safe handling
* Security
* Disposition of these medications (including return to the pharmacy medication storage area) at the end of the individual's shift.

4. The policy addressing the storage of medication between receipt of a medication by an individual health care provider and medication administration is implemented ...


9. Medications and chemicals used to prepare medications are accurately labeled with contents, expiration dates, and warnings ...

12. Medications in care areas are maintained in the most ready-to-administer forms available from the manufacturer or if feasible, in unit-doses that have been repackaged by the pharmacy or a licensed repackager.

15. All medication storage areas are periodically inspected according to the hospital's policy to make sure medications are stored properly.

Standard MM.4.30
Medications are labeled.

Rationale for MM.4.30
A standardized method for labeling all medications will minimize errors.

Elements of Performance for MM.4.30
1. Medications are labeled in a standardized manner according to law or regulation and standards of practice.
2. Any time one or more medications or solutions are prepared but are not administered immediately, the medication container must be labeled.
3. At a minimum, all medications prepared in the hospital are labeled with the following:
* Drug name, strength, amount (if not apparent from the container)
* Expiration date when not used within 24 hours
* Expiration time when expiration occurs in less than 24 hours
* The date prepared and the diluent for all compounded IV admixtures and parenteral nutrition solutions

4. When preparing individualized medications for multiple specific patients, or when the person preparing the individualized medications is not the person administering the medication, the label also includes the following:
* Patient name
* Patient location
* Directions for use and any applicable cautionary statements either on the label or attached as an accessory label (for example, "requires refrigeration," "for IM use only")



On 7/12/11 at 11:30 AM, the surveyor observed the medication preparation room with Employee Identifier # 4, the Certified Psych Nurse. The surveyor observed a clear medication cup with a patient's name and room number #106 marked on the outside of the cup. In this medication cup were 7 pills/capsules which were exposed to the air. The pills/capsules were unlabeled.

An interview was conducted with EI # 4 on 7/12/11 at 11:30 AM. The surveyor asked EI # 4 what medications were in the medication cup above. The response was the medication cup contained the patient's (room # 106) morning medications and were not given because the patient was too groggy. EI # 4 looked at the patient's Medication Administration Record (MAR) and started naming the patient's 9:00 AM medications. EI # 4 was able to identify Aspirin 81 milligrams, Dulcolax and a Multivitamin located in the medication cup and unable to identify the 4 remaining medications.

During the initial tour of the Operating Room # 2 on 7/12/11 at 11:30 AM the surveyor observed 4 syringes prefilled on top of the anesthesia cart. None of the syringes had the patient's name, date or time drawn up, or dosage contained in the syringes.

An interview was conducted on 7/13/11 at 11:35 AM with EI # 2, the Director of Surgery who verified medications should be labeled with Drug name, strength, patient, amount and time.


An interview was conducted on 7/13/11 at 1:35 PM with EI # 1 who verified medications should be labeled with Drug name, strength, amount and time.

Based on interviews, review of the facility's policies and procedures, and review of standards of practice, it was determined the facility failed to ensure the pharmacy department filed all the actions taken for recall medications and failed to assure patients were taking only medication prescribed by the physician, verified by a pharmacist and supplied by the hospital. This had the potential to affect all patients being served by the hospital.

Findings include:

Facility Policy Titled: administration of Patient's Personal Drugs

Policy: A patient's personal drugs shall only be administered to the patient upon the order of the patient's physician...

Procedure:
Retention of Personal Drugs in the Facility

Unless administration of a patient's personal drugs is authorized by the responsible prescribing practitioner, these drugs shall be sent home with the family or others. If the drugs must be retained in the facility, they shall be packaged, sealed, labeled with the patient's name, and maintained in locked storage.

Identification of Patient's Personal Drugs

Drugs brought into the facility by patients shall not be administered unless the drugs have been absolutely identified, their quality and integrity is not questionable, and there is a written order from the responsible prescribing practitioner to administer the drugs.

Storage of Patient's Personal Drugs

Unless directed otherwise by the responsible practitioner, personal drugs to be administered shall be stored with other drugs supplied by the facility...

1. Patient Identifier (PI) # 7209326 was admitted to the facility on 6/28/11 with Abdominal Pain Right Upper Quadrant. The surveyor observed Employee Identifier # 7, the RN prepare this patient's medication which included Bactrim and Norvin. The Norvin was a drug out of the patient's personal stock and had been checked by the pharmacist with a label so the staff would know the medication had been verified and stored in the medication room.

At 9:00 AM EI # 7 entered the patient's room and handed him/her the cup with the Bactrim and Norvin. The patient then asked EI # 7 to hand him/her the pill planner on the cabinet. The patient took the pill planner and removed 4 tablets. The surveyor asked the patient what each tablet was and the patient responded, Norvin, Prezista, Vitamin D, and Fish Oil. The patient also had the cup of medication EI # 7 had handed to him/her which contained the Norvin. Before the patient took all the medication the nurse left the room. The surveyor asked the nurse if the pharmacist had verified the medication in the pill planner and the response was, "I don't think so."

The surveyor asked the nurse how many Norvin the patient had taken and the response was '"the one I gave him". The surveyor asked if EI # 7 heard the patient state what medications were in the pill planner and the response was," yes."

2. PI # 9102187 was admitted to the facility on 7/12/11 with cellulitis. The surveyor observed EI # 7 prepare the patient's AM medication which included Singular 10 mg (milligrams), Prilosec 20 mg, Celebrex 200 mg, and Celexa 40 mg. EI # 7 took the cup of medication to the patient's bedside. The patient then asked what all the medication was and EI # 7 told the patient what each tablet was. The patient then said, "I have already taken my Celexa." EI # 7 asked the patient where did you get it from and the patient showed her the pill bottles which were on the patient's night stand and included Singulair, Ketorolac, Celexa, Cetirizine, Zetia, Flonase the patient had brought from home. The medication had not been verified by the pharmacist.

Guidance on How to Handle Drug Recall in a Pharmacy:

Recall Procedures for Hospital Pharmacy

All hospital staff is to be notified of the recalled drug.

This information should be immediately entered into the hospital's medication management system as an alert and immediately removed from the hospital's formulary...

Pharmacy staff should inspect all possible storage areas, i.e. stock, patient care areas, medication stations, emergency supplies, patient cassettes, patient storage units within hospital rooms and floor stock.

Depending on the instruction outlined on the recall notice, the recall medication should be disposed of or quarantined in a designated area until further instructions from the FDA (Food and Drug Administration) or manufacturer are received.

The pharmacy should document and file all actions taken to remove the recalled medication.

Referenced from www.ehow.com

A tour of the pharmacy was conducted on 7/13/11 at 12:15 PM with the Employee Identified (EI) # 6, Director of the Pharmacy. The surveyor asked for the process on recalls. EI # 6 stated the recalls were looked at, steps were taken to remove the recalls and then the recall information was thrown away. The surveyor asked EI # 6 how he/she would know at a later date what steps were taken to remove the recalls. EI # 6 stated there was no record keeping for recalls.

Based on observations during facility tour with hospital staff by the Fire Safety Compliance Officer and staff interviews, it was determined that the facility was not constructed, arranged and maintained to ensure patient safety.

Findings include:

Refer to Life Safety Code violations.

Based on observations, review of the facility's policies and procedures and interviews, it was determined the facility failed to ensure the staff followed infection control standards in anesthesia administration and cleaning Endoscopes. This had the potential to negatively affect all patients being served by this facility surgery department.

Findings include:

Facility Policy Titled: Disposal of Sharps

Purpose: To ensure proper disposal of all sharp objects and to reduce accidental needle sticks.

Procedure:

1. All needles and syringes (including suture needles, I.V. (intravenous) needles, spinal needles, and any other contaminated sharp object is to be placed in and disposed of these receptacles immediately after use.

During an observation of putting a patient to sleep on 7/12/11 at 12:00 PM the surveyor observed the Employee Identifier (EI) # 8, the CRNA (Certified Registered Nurse Anesthetist) used 4 syringes (removed the needle first) to administer medication to the patient thru the needles system. EI # 8 replaced the needles on to the syringe and placed the syringes back on the anesthesia cart and did not dispose of them in the sharpes container.

An observation of endoscope cleaning by EI # 9, the Scrub Nurse was conducted 7/13/11 at 10:20 AM. EI # 9 stated that they use one cleaning brush a day and let it soak in the high level disinfection solution and then reuse it. The surveyor then requested the Manufactures Guidelines for the cleaning brush.

EI # 9 submitted the following on 7/13/11 at 10:40 AM

Manufacture: US endoscopy

Warnings and Precautions:

...Dispose of the cleaning brush after initial use. The mechanical attachment of the brush(es) to the plastic sheath cannot be guaranteed to be reliable or secure following initial use...

Never transfer a used cleaning brush from one endoscope to another endoscope, since cross-contamination could occur and result in patient complications. Disposable cleaning brushes are designed to safely remove debris, some of which can be retained in the bristle structure.

These products are intended for single patient use only. Any institution, practitioner, or third party who reprocesses, refurbishes, remanufactures, resterilizes, and/or reuses these disposable devices must bear full responsibility for their safety and effectiveness.

An interview was conducted with EI # 2, the Director of Surgery/Outpatient on 7/13/11 at 10:55 AM. The surveyor asked EI # 2 if the cleaning brushes were multiple use and the response was, "no the brushes are single use".