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Based on record review, observation and interview, the facility failed to ensure the physician orders were obtained and included the type of restraint to be used prior to ongoing application for 2 of 5 patients with restraints (#3 & 4).

Findings:

Review of policy-Restraints (COP.R.1), revision date 1/10/2010 showed: #5 An order for restraint must be obtained from an LIP/physician who is responsible for the care of the patient prior to the application of restraint. The order must specify clinical justification for the restraint, the date and time ordered, the duration of use, the type of restraint to be used and behavior-based criteria for release.

During a tour and observation of the second floor intensive care unit on 11/07/2011 at 11:33 a.m., patient #3 is observed in bed, at rest, intubated (a tube into the lung for breathing) with mechanical ventilation, and restrained with bilateral soft wrist restraints.

Medical record review for patient #3, age 56, admitted on 11/02/2011 with a diagnosis of respiratory failure/exacerbation of asthma, showed the patient was in wrist restraints from 11/02/2011 to present. There are physician orders; however, the type of restraint is not specified for the use of the restraints on 11/02/2011, 11/04/2011, 11/05/2011 and 11/06/2011.

During an interview on 11/07/2011 at 11:45 a.m. the nursing manager (staff I) confirmed the physician orders only stated to restrain the right and left upper extremity, but does not state the type of restraint to be used.

During a tour and observation of the second floor cardiovascular intensive care unit on 11/07/2011 at 12:05 p.m., patient #4 is observed in bed and at rest.

Medical record review for patient #4, age 64, admitted on 10/16/2011 with a diagnosis of chest pain, showed the patient was in wrist restraints from 10/21/2011 to 10/24/2011. There is no type of restraint specified in the physician order for the use of the restraints on 10/21/2011, 10/22/2011, and 10/24/2011.

During an interview on 11/07/2011 at 12:45 p.m. registered charge nurse (staff L) confirmed the patient was in restraints from 10/21/2011 to 10/24/2011 and confirmed the physician orders only states to restrain the right and left upper extremity, but does not state the type of restraint to be used.

Based on record review, observation, and interview, the facility failed to ensure signed physician orders were obtained prior to ongoing application for 2 of 5 patients with restraints (#3 & 4).

Findings:

Review of policy-Restraints (COP.R.1), revision date 1/10/2010 showed: #5 An order for restraint must be obtained from an LIP/physician who is responsible for the care of the patient prior to the application of restraint. The order must specify clinical justification for the restraint, the date and time ordered, the duration of use, the type of restraint to be used and behavior-based criteria for release.

During a tour and observation of the second floor intensive care unit on 11/07/2011 at 11:33 a.m., patient #3 was observed in bed, at rest, intubated (a tube into the lung for breathing) with mechanical ventilation, and restrained with bilateral soft wrist restraints.

Medical record review for patient # 3, age 56, admitted on 11/02/2011 with a diagnosis of respiratory failure/exacerbation of asthma, showed the patient was in wrist restraints from 11/02/2011 to present. There were no signed physician orders for the use of the restraints on 11/02/2011 and 11/06/2011.
On 11/07/2011 at 11:45 a.m. the nursing manager (staff I) and the RN order specialist (staff G) both confirmed the physician orders are not signed on 11/02/2011 and the order for 11/06/2011 was missing entirely.

During a tour and observation of the second floor cardiovascular intensive care unit on 11/07/2011 at 12:05 p.m., patient #4 is observed in bed and at rest. Registered charge nurse (staff L) said patient #4 was in restraint earlier in his stay, but is not in restraints at this time.

Medical record review for patient #4, age 64, admitted on 10/16/2011 with a diagnosis of chest pain, showed the patient was in wrist restraints from 10/21/2011 to 10/24/2011. There were no signed physician orders for the use of the restraints on 110/21/2011 and 10/22/2011.

During an interview on 11/07/2011 at 12:45 p.m. registered charge nurse and the RN order specialist both confirmed the physician orders were not signed on 10/21/2011 and the order for 10/22/2011 was missing entirely.

Based on interview and record review, the facility failed to credential one Advanced Registered Nurse Practitioner (ARNP staff CC) through the medical staff credentialing process prior to allowing access to patient care areas.

Findings:

File review for Advanced Registered Nurse Practitioner (ARNP staff CC) showed a hire date of 09/23/2011 with no documentation of temporary privileges or approval by medical staff. Review of time recording record for staff cc showed she worked on 09/21, 09/22, 09/23, 09/26, 09/27, 09/30, 10/03, 10/04, 10/05, 10/10, 10/11, 10/12, 10/13, 10/14, 10/17, 10/24, 10/25, 10/26, 10/31, 11/01, 11/02, 11/07, and 11/08/2011 (8 hour shifts).

During an interview on 11/08/2011 at 11:57 a.m., the director of the medical staff office (staff P) said staff CC is in the credentialing process, however, since she is a facility employee approval by the medical staff is not required. When asked about other ARNP privilege requirements, staff P said if an ARNP was privately employed by a physician, the ARNP would not be permitted to work until the credentialing process was completed. Staff P said ARNP staff CC is currently in orientation with another ARNP and on the patient care units.

Review of the Medical Staff Bylaws, dated revised in 11/2010, defines ARNP as an advanced practice professional in Article I, section 2, and defines the appointment process for an advanced practice professional in Article V, section 10 as The advanced practice professional, as defined in Article I, section 2, shall include but not be limited to Physicists, Psychologists, Physician Assistants, Nurse Practitioners, Midwives, and Nurse Anesthetists, who shall be deemed to meet a specific service within the hospital, and physicians who are seeking limited clinical privileges.

During an interview on 11/09/2011 at 2:45 p.m., both the director of Human Resources and Vice President of Quality and Risk confirmed there were two different processes for credentialing employed and non-employed ARNPs.

Based on observation, interview and record review, the facility failed to ensure expired, opened, and unlabeled medications were not readily available for patient use in the surgical department.

Findings:

The facility has a total of 9 operating rooms, 1 cysto room, and 2 endoscopy rooms.

Review of the policy Medication Shelf Life, revision date of 7/10, read Policy #1-All medications at ORMC shall be monitored for expiration dates. #3-It is the responsibility of all personnel who dispense, handle, or otherwise work with medications at ORMC to remove the deteriorated, discolored, inappropriately labeled, and/or expired drugs from their respective areas and return them to Pharmacy for proper disposition. #5-All opened vials will be given no greater than a 28 day expiration

During a tour of the surgical department on 11/07/2011 beginning at 2:10 p.m., the following medications were found:
1. Endoscopy room #2-Anesthesia cart, drawer #1- 1-10 milliliter (ml.) vial Esmolol 100 milligrams (mg.) (a medication used to slow the heart) unknown amount with no open date. The vial did not state if it is single or multi-use. 2- 5 ml. single dose vials of Metroprolol 5 mg. with no open date. 1-container, single dose, of Original nasal spray with an expiration date of 08/2011. 1-100 ml. bag of Normal Saline 0.9 % mixed with phenylephrine 100 mg. undated as to the date and time of mixing. 1-10 ml. syringe with Ephedrine 5 mg./ml. mixed on 11/02/2011. 1-10 ml. syringe labeled with 100 mg. of Phenylephrine dated as 11/01/2011. Endoscopy room anesthesia cart #2 was last used on 11/07/2011.

2. Endoscopy room #1 anesthesia cart was found in the storage room and drawer #1 had 1-multidose 5 ml vial of glycopyrrolate found opened and unlabeled with date. 1-single dose Ventolin inhaler opened and unlabeled for date. Endoscopy room anesthesia cart #1 was last used on 11/03/2011.

3. Operating room #4 anesthesia cart, drawer #1-1-container of Original nasal spray with no open date. 1-single dose Ventolin inhaler opened and unlabeled for date. 1-240 ml bottle (with an unknown quantity remaining) of Suprane (an inhaled anesthesia) with no opened date.

During an interview on 11/07/2011 at about 2:30 p.m., the anesthesia technician stated the entire bottle of Suprane is usually emptied in one day, but confirmed the bottle found was not labeled.

4. Operating room #8 anesthesia cart, drawer #1-1-240 ml. bottle (with an unknown quantity remaining) of Suprane (an inhaled anesthesia) with no opened date.

5. Sub sterile room between operating rooms #8 and #9 has a refrigerator containing Bacitracin 50,000 units for intra-muscular injection, one with an expiration date of 6/2011, and one with an expiration date of 9/11/2011. The interim chief nursing officer confirmed the dates of expiration.

During an interview on 11/08/2011 at 10:30 a.m., MD anesthesiologist said single dose medications are to be disposed of after each case, and the anesthesia technician was responsible for checking for expired medications when stocking the carts.

Based on observation, interview and record review, the facility failed to maintain operating room floors, failed to maintain operating room equipment, failed to ensure outdated supplies are not available for immediate patient use, and failed to maintain furniture in the obstetrical department to promote a sanitary environment.

Findings:

The facility has a total of 9 operating rooms and 1 cysto room.

Review of the policy Environmental Cleaning, revision date of 9/11, read #19 OR rooms are terminally cleaned on a rotating schedule-a. OR table is taken apart (pads and radio-lucent supports), cleaned and inspected for debris. i. Entire floor space shall be mopped. #20 All other areas and equipment shall be cleaned according to an established schedule to include: a. ducts and filters and c. ventilation and heating grills.

1. During a tour of the surgical department on 11/07/2011 at 2:45 p.m., the table and arm board pad in operating room #1 had several dime size areas with the outer covering of the pad worn away exposing the inner core mesh area of the foam. Also, there was adhesive tape left over from a prior surgical case on several areas of the mattress. This prohibits the cleaning of the pad because the inner foam of the mattress absorbs fluids and the leftover tape may have prior case body fluids adhering under or on the tape surfaces.

2. Operating room #3 is found to have a large area approximately 12 inches by 12 inches, covered with small quarter size areas split with the outer covering of the pad worn away exposing the inner core mesh area of the foam. Also, there was adhesive tape left over from a prior surgical case on several areas of the mattress. This prohibits the cleaning of the pad because the inner foam of the mattress absorbs fluids and the leftover tape may have prior case body fluids under or on the tape surfaces. The air return was dusty and in need of cleaning. The floor had tape stuck to ii and was black in color as if someone has repeatedly walked on the tape.

During an interview on 11/07/2011 at 2:50 p.m., the operating room nurse manager confirmed the hole in the mattress pads and the dirty tape on the floor. She stated room #3 was terminally cleaned last on 11/04/2011 and room #3 was last used on 11/07/2011 for two laparoscopic (a scope into the abdomen) gall bladder removals.

3. Operating room #4 had tape stuck to the floor and was black in color as if someone has repeatedly walked on the tape. The air return was dusty and in need of cleaning. The interim chief nursing officer stated room #4 was terminally cleaned last on 11/04/2011.

During an interview on 11/07/2011 at 2:55 p.m., the operating room housekeeper said his regular flooring cleaning machine has been broken the past few weeks. The housekeeper also said maintenance is responsible for cleaning the air ducts. The interim chief nursing officer stated a new floor machine is on order.

4. Operating room #8 had adhesive tape left over from a prior surgical case on several areas of the mattress. This prohibits the cleaning of the pad because the leftover tape may have prior case body fluids under or on the tape surfaces.

Review of the form 2011 Hazard Surveillance Survey last conducted on 08/2011 for the operating rooms did not show any survey activity specifically related to individual operating rooms.

During an interview on 11/09/2011 at 1:45 p.m., the infection control officer said she tries to round in areas on a quarterly basis, but did not always go in to all of the operating rooms, because they may be in use. The infection control officer said she was not aware of the broken floor cleaning machine. She also said she depends on other staff to keep of informed of any infection control issues in their areas.

Review of the policy In-House Sterilization Shelf Life, Sterile Storage and Handling, last revision date of 02/03, states in Procedure: 1. Shelf Life of Sterile Products. A. Shelf Life is event related with regard to packaging manufacturer's recommendation. B. Products that degrade over time and have a manufacturer expiration date will be adhered to.

5. During a tour on 11/07/2011 at 10:30 a.m., the crash cart on the second floor intermediate care unit had a CVP dressing tray on the top of the cart with an expiration date of 04/2008. The cart was last checked on 11/06/2011.


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6. During a tour of the facility obstetrical department on 11/07/11 at about 2:15 p.m., a chair was observed in a patient room 349 which had multiple tears in the seat cushion. During an interview with the Nurse Manager for the floor at that time, she agreed the cushion was in need of repair.

Based on observation, interview and record review, the facility failed to enforce the infection control policy related to contact isolation, affecting 1 sampled patient (#2).

Findings:

Review of the policy-Isolation Policy, last revision date of 3/07, read Contact Precautions: Don gown and gloves upon entry into the patient room and After personal protective equipment (PPE) removal ensure that clothing and skin do not contact potentially contaminated environmental surfaces that could result in possible transfer of micro-organisms to other patients or environmental surfaces.

1. During a tour of the second floor intermediate care unit on 11/07/2011 at 10:30 a.m., a visitor was observed in a room with a sign designating the room to be a contact isolation patient. The visitor had gloves on, but no gown. The visitor handled patient items, assisted the patient (#2) with a drink, and touched the patient's environment with his clothing.

The charge nurse spoke with the visitor and said the visitor said this was the first time he has not put a gown on when entering the room. The charge nurse confirmed the visitor should have put a gown on.

Review of the medical record showed patient #2 had a positive nasal culture on 10/29/2011 for Methicillin Resistant Staphylococcus Aureus (MRSA) resistant to most antibiotics.

2. During a tour of the second floor intensive care unit on 11/07/2011 at 11:25 a.m., a staff registered nurse (RN) was observed in a room with a sign designating the room to be a contact isolation patient. The staff nurse caring for the patient and did not wear a gown or gloves. The charge nurse present during the observation, confirmed the staff should be wearing a gown and gloves.

The charge nurse said the patient had a prior positive culture and was being cultured again, but the culture is not back yet. She also said the staff should have worn the gown and gloves until the culture results were returned.

Based on record review and interview, the facility failed to credential 4 registered nurse first assistants (RNFAs) (staff Y, Z, AA, & BB) through the medical staff credentialing process prior to allowing their services assisting with patient surgical procedures in the operating rooms.

Findings:

The facility had four RNFAs recorded as employed and providing services at the facility, two (AA & BB) were employed by the facility and two were physician employed.

During an interview on 11/08/2011 at 2:25 p.m., the director of the medical staff office said all of the RNFAs go through a process by an outside source for the collection of the items required for credentialing. The outside source then turns the data over to the medical staff office; however, the RNFAs were not appointed or granted privileges through the medical staff office.

Review of the Medical Staff Bylaws, dated revised in 11/2010, did not define a RNFA as an advanced practice professional in Article I, section 2, and did not define the appointment process for a RNFA.

Review of the two employed RNFA who worked during the month of October 2011, showed RNFA staff AA and BB each worked 20 days in October 2011.

Review of the Medical Staff Bylaws, dated 11/2010, showed no requirement for RNFA to be credentialed by the medical staff.

During an interview on 11/09/2011 at 2:45 p.m., both the director of Human Resources and Vice President of Quality and Risk confirmed there were two different processes for credentialing employed and non-employed RNFAs.