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The hospital failed to ensure that its definition of restraint included a physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely; or prevent functional use of hands. Findings include:

1. Hospital policy titled Restraint Policy for Patient Care Areas (410-HPP-D-6) was reviewed. Review reveals that the policy does not consider the use of hand mitts restraint when "using hand mitts that still allow the patient patient freedom of hand movement."

2. On 3/17/10 the surveyor was provided sample hand mitts that are available for use in the hospital. The hand mitts used by the hospital are "Posey Double Security Mitts". The mitts were tried on and it was determined that even if the mitts were not secured with wrist straps to a bed frame, a patient restrained in these mitts would not have functional use of his/her hands, would not be able to complete activities of daily living such as toileting, handling eating utensils, brushing ones hair or teeth, etc..

Based on document review and interview, the hospital failed to ensure that it established a policy/procedure to be followed if a patient was secluded on one of the hospital's medical units. Findings include:

Quality analyst #1, interviewed 3/18/10, stated that:

1. The hospital does not have a policy/procedure that applies to the hospital's medical units that defines seclusion or provides guidance regarding the procedures that must be followed if a patient were to be secluded on a medical unit. The hospital does have seclusion policies for the psychiatric unit and the hospital Emergency Department.

2. The hospital does not have a policy that prohibits the seclusion of a patient on a hospital medical unit.

The hospital failed to ensure in 2 of 7 cases where restraint was utilized that the use of restraint was in accordance with the order of a physician or other licensed independent practitioner who was responsible for the care of the patient as specified under §482.12(c) and authorized to order restraint or seclusion by hospital policy in accordance with State law. Findings include:

1. On 3/17/10 review of patient #66 medical record revealed that on 12/14/09 at 2300 hours a physician's assistant ordered the application of a vest restraint to ensure patient safety and to protect the patient from injury. Hospital Restraint Policy for Patient Care Areas (410-HPP-D-6) states that "For purposes of restraint, the Licensed Independent Practitioner (LIP) is a physician, and will be referred to as such in this policy." Hospital policy does not allow a physician's assistant to order restraint. Under Michigan Statute, a physician's assistant is not a LIP.

2. On 3/17/10 review of patient #51's medical record revealed a physician's order for restraint that expired on 11/22/09 at 3:18 p.m. There were no Restraint notes (" Restraint Med/Post Surg Non Violent Form") documented on 11/23/09. On 11/23/09 the Nursing Progress Note states, "3 point soft restraints on." The Physician Liaison RN verified these findings. Policy 410-HPP-D-6, titled "Restraint Policy for Patient Care Areas" states that the RN assesses the need for restraint by performing a comprehensive assessment and obtains a physician's order prior to or concurrently with application.

The hospital failed to ensure in 1 of 2 restrained patients that that the order for restraint used to ensure the physical safety of the non-violent or non-self-destructive patient was renewed as authorized by hospital policy. Findings include:

<1> Review of hospital policy titled Restraint Policy for Patient Care Areas (410-HPP-D-6) revealed that the policy states that a face to face assessment by a LIP (physician) must be performed every calendar day during restraint use and a progress note/order must be written that states the reason for the restraint when a patient is restrained for medical/post-surgical purposes.

<2> Review of patient # 65 medical records revealed that in the following instances physician progress note documentation was not noted that referenced assessment findings regarding patient behaviors requiring restraint use for medical/post surgical non-violent purposes when restraint was re-ordered on 11/26/09 @ 15:52 hours, 11/27/09 @2000 hours, 11/28/09 @1745 hours.

Based on interview and record review it was determined that facility physicians and nurses ordering and applying restraints had not been trained per facility policy. Findings include:

On 3/18/10 at approximately 10 a.m., review of the facility ' s policy 410-HPP-D-6 titled "Restraint Policy for Patient Care Areas" revealed, "Physicians or other LIP ' s (Licensed Independent Practitioners) involved in restraint and seclusion activities have completed a restraint education module, as evidenced in the medical staff credentialing and privileging files." Files for 2 (#11 and #12) of the physicians who ordered patient #51 ' s restraints were reviewed. Neither physician file contained documentation of restraint education.

Facility policy 410-HPP-D-6 states that "all staff who have direct patient contact have education and training in the proper and safe use of restraints." Files for 3 nurses (employees # 13, 14, 15) who applied or monitored patient #51's restraints were reviewed. Two nurses (#13 and 14) did not have documentation of training in safe application and use of restraints. These findings were verified with the Physician Liaison RN.

Based on observation and interview, the hospital failed to keep current and accurate records of controlled drugs. Findings include:

During tour and observations of the pharmacy on 3/16/10 at approximately 1000, selected medication counts of controlled drugs were validated in the controlled drug room. A count of midazolam 2mg/2ml revealed that the actual count was 553 and the computer tracking count was 552. The discrepancy could not be accounted for by pharmacy manager #7, pharmacy tech #5 or pharmacy tech #6. Further review of expired controlled drugs revealed that approximately 30 caps of Morphine SR 10mg were in the expired controlled drug box. A request for tracking of this expired medication from the above staff revealed no documented record of this medication. Further inquiry revealed that the medication was non-formulary and that it was not set up to be tracked in the Pyxis medication system (no manual count was maintained either). A count of Ketamine 10mg/ml in the expired narcotics box revealed a count of three (3). The narcotic record revealed that the count was to be four (4). Interview with pharmacy techs #5 and #6 revealed that one syringe must have broken and was wasted, but no one documented or witnessed this waste in the narcotic record. A review of the Department of Pharmacy Controlled Substances policy and procedure A5.1 documented "A pharmacist must witness any Controlled Substance, which is wasted or destroyed within the pharmacy, with proper notation on the Controlled Substances record".

Interview with the pharmacy director, pharmacy manager #7, and pharmacy techs #5 and #6, on 3/16/10 at approximately 1100, regarding reconciliation of expired controlled drugs, revealed that no reconciliation occurred at the time of disposal of controlled drugs. Current and accurate records were not maintained on expired controlled drugs.

Based on observation and interview, the hospital failed to dispose of outdated medications, which were available for use in the main pharmacy. Findings include:

During tour of the pharmacy on 3/16/10 at approximately 1000, the main pharmacy refrigerator contained opened Procrit 10,000/ml. One vial was opened/uncapped, labeled single use with a small amount of medication in the vial, and one syringe was drawn up and available. Interview with the pharmacy director at that time revealed that Procrit was single dose and should have been disposed of when all medication was not used.

The facility failed to provide and maintain a safe environment for patients and staff.

This is evidenced by the Life Safety Code deficiencies identified. See A-710.

Based upon on-site observation and document review by Life Safety Code (LSC) surveyors on March 15-18, 2010, the facility does not comply with the applicable provisions of the 2000 Edition of the Life Safety Code.

See the K-tags on the CMS-2567 dated March 18, 2010, for Life Safety Code.

Based on observation and interview, the hospital failed to ensure that equipment was maintained to ensure an acceptable level of safety. Findings include:

1. During observations conducted on the psychiatric unit dinning room at 8:10 a.m. on 3/18/10 it was observed that a steam table was set up in the dinning room from which to disperse hot food. It was observed that the steam table did not have a sneeze guard.

2. The psychiatric program manager who was present during the 3/18/10 observation was asked whether a sneeze guard was ever in place on the steam table to minimize the opportunity for contamination of the food on the steam table by patients going through the serving line. The program manager stated that she did not recall seeing a sneeze guard on the steam table. Dietary staff person #1 present during the 3/18/10 observation stated that a sneeze guard was not available for installation on the steam table.

3. Several hours after the 3/18/10 observations on the psychiatric unit on the hospital provided to the surveyor a copy of confirmation order (#775467) initiated that morning to purchase from Hubert Company a FOLDING PORTABLE SNEEZEGUARD-4 FT GOLD.


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The facility did not maintain supplies in such a manner as to ensure the safety of stored supplies. This was evident based upon the following observations:

1. On 3/15/10 at approximately 11 AM the med room on 7 North and the med room on 3 North had significant accumulation of dust and debris under the Omnicell units in these rooms. This was also observed in a number of other areas throughout the facility on subsequent days of the survey including the 5th floor linen closet across from the nurses station observed on 3/17/10 at approximately 1:30 PM.

2. Numerous shelving units throughout the hospital had very little clearance under the bottom shelf to enable environmental services to properly clean under the shelves. Accumulation of dust and debris was observed under most of these shelves.

3. Clean supplies which were overstock items that had been retrieved from the patient floors were being stored in the main materials management area on open shelves. This rooom is not maintained under positive pressure ventilation and would not be considered a clean environment.

4. The main linen receiving storage room on 1st floor was observed to have gowns and other clean linen uncovered on open shelves without benefit of a positive pressure ventilated room. This was observed at approximately 10:30 Am on 3/16/10.

Based on observation, interview and record review, the hospital failed to develop and/or implement infection control policies and procedures. Findings include:

The facility staff failed to implement contact precautions. Observations on the 2G unit, on 3/16/10 at approximately 1400, revealed patient #23 in contact precautions. It was noted that visitors were in the room with the patient without observing contact precautions. Interview with nurse manager #2 and record review revealed that the patient was in contact precautions for c. difficile.

Observations on the Pediatric Unit on 3/15/10 at approximately 1200 revealed patients #6 and #7 in droplet precautions with visitors in the room. Interview with the pediatric nurse manager at that time revealed that parents were exempt from the droplet precautions. Record review revealed that both patients were under droplet precautions for RSV (respiratory syncytial virus). Review of the hospital policies and procedures, and interview with the infection control officers on 3/17/10 at 1300 revealed no documented exemptions in the droplet precautions policies and procedures.

During observations in the pharmacy on 3/16/10 at approximately 1000, a pharmacy tech was observed moving from the IV ante room to the IV admixture room with gloves on, cleansing gloved hands and proceeding to mix IVs. Interview with the pharmacy director revealed no concerns. Review of infection control policies and procedures and interview with the Infection Control Officers on 1/17/10 at 1300 revealed that staff are to remove gloves, practice hand hygiene then place another pair of gloves on as necessary.

Based on observation, interview and record review the facility failed to establish and maintain policies to promote consistent evaluation for emergency medical patients.

Findings include:
The hospital policy for triage is Hospital Policy #ERGN-NGL-106-3: Guidelines for Triage Practice, dated 10/08. Within this policy, a level range of 1 through 5 is to be documented. No instructions were given to indicate which level equates to the most severe acuity nor does it provide guidance for conducting the triage.

On 3/16/10 at 2:32 PM, surveyor observed patient triage completed by staff Advanced Emergency Medical Technician (AEMT #1) at which time Patient # 71 was triaged as level 3. Upon interview, AEMT #1 stated that she uses a 1-4 level system (which contradicts the policy) and does not classify any patients at level 2. When asked what criteria is used for triage, a binder entitled "Advanced Triage Guidelines" was provided from the reception triage desk. The stated guideline does not describe or identify a level system and does not refer to or include the hospital policy.

On 3/16/10 at 3:00 PM, surveyor interview with the Emergency Department Manager and RN Section Manager confirms that the hospital policy is not implemented as written and that there were no training records to demonstrate how staff had been instructed to implement a sytem for consistent acuity determinations for triage.