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Based on review of the list of contracted services, staff interview, and review of the facility's performance improvement (PI) program and meeting minutes, the governing body failed to ensure contracted services were provided in a safe and effective manner. The findings were:

Review of the list provided by the facility revealed laundry services, occupational therapy, and speech therapy were contracted services. Refer to A0267 for details regarding the facility's failure to include these contracted services in the facility-wide PI program to ensure the services were provided in a safe and effective manner.

Based on staff interview and review of the facility's performance improvement (PI) program and minutes of the meetings, the facility failed to include the contracted services of laundry, occupational therapy and speech therapy in their performance improvement program. The findings were:

During an interview on 8/11/10 at 1:30 PM, the director of the PI program stated she received no PI data from the facility's contracted laundry service or occupational and speech therapies. However, she thought data from the laundry service might be reported to the ICP and the therapy services might report under physical therapy. At 3:08 PM that day, the ICP reported she did not receive written PI data from the laundry services; in fact, she stated it was difficult to get any information at all from them. Furthermore, at 3:22 PM the PI director reported that physical therapy did not report PI data for the other two therapy services. Review of the program and the minutes from the monthly meetings confirmed these contracted services were not included.

Based on observation, staff interview, and review of policies and procedures, the facility failed to ensure all medications were stored in a secure manner during two random observations. The findings were:

Interview with the pharmacy director on 8/10/10 at 1 PM revealed IV medication was ordered by, and stored in, the materials management department. Observation on 8/11/10 at 9:38 AM revealed the area for materials management was separate from pharmacy in a room labeled "General Stores." The door to this room was open, and no one was present in the front area when the surveyor entered. Various sized bags of IV solutions (including, but not limited to, Lactated Ringers, 0.9 % Normal Saline, Dextrose 5 % in Normal Saline, Dextrose 5% and 10 % in Water, and those solutions containing potassium) were stored in boxes on shelves. The manager came into the front area two minutes later, but she did not see the surveyor until the surveyor spoke. At that time the manager confirmed she did hear, but did not see, the surveyor. The manager stated she thought she heard another employee returning with the supply cart. The manager further stated there was no one in the front area as they were currently short-staffed. She confirmed the IV bags could have been taken or altered.
Observation throughout the survey showed the door to the hallway containing the General Stores room was labeled "Authorized Personnel Only," but the door was not always shut. Even when it was shut, other departments such as mechanical, clean linen, telephone equipment, and engineering were housed in that corridor, and their doors were open. A door to the outside also allowed entrance and exit into the corridor. At 3:40 PM on 8/11/10 three employees were observed in the corridor; the General Stores room was open with no staff visible in the front area. According to the facility's policy and procedure entitled "Drug Storage," last reviewed on 4/14/09, "...All drugs for use in the hospital shall be stored in the Pharmacy..." At 3:33 PM that day, the pharmacy director stated she did not know why the IVs were stored in the materials management department.
In addition, observation of the emergency department with the manager on 8/10/10 at 3:05 PM revealed the two trauma bays each contained a box holding numerous 10 milliliter syringes of Normal Saline for IV flushes; the manager confirmed the syringes were not secure. Review of the policy and procedure entitled "Floor Stock", last revised 5/21/10, showed floor stock was to "be maintained in locked cabinets in the nursing department..."

Based on observation, review of facility documentation, and staff interview, the facility failed to ensure expired medications were not available for patient use in 2 of 5 patient care areas. The findings were:

1. Observation on 8/9/10 at 3:42 PM of the medication refrigerator in the surgical suite area revealed an open multidose vial of Novolin Regular insulin. A date of "6/29" [June 29, 2010] was observed to be marked on the vial box. Interview with the surgical services nurse manager at that time confirmed the date was the date the vial box was opened. The nurse also stated that it exceeded the hospital corporation's standard to discard multidose vials 30 days after opening. Interview with the pharmacy director on 8/11/10 at 11:26 AM and review of corporation standards confirmed employees were to discard open multidose vials after 28 days. She stated both pharmacy and nursing departments were responsible to ensure outdated medications were not available for use.


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2. During a tour with the manager of the obstetrical department on 8/10/10 at 3:40 PM, the CRNA's cart, located in the delivery area, was observed to contain two syringes of Lidocaine 2%, which had expired on 8/1/10. The manager also stated the cart was stocked by the CRNAs and had been used that morning during the delivery of a newborn infant. She confirmed the expired medications were available for patient use. Review of the facility's policy and procedure "Medication Use," last revised 5/21/09, showed the pharmacy "...shall maintain Procedure Kits for OB which shall contain that departments [sic] medication exchange floor stock..." On 8/11/10 at 10:50 AM the pharmacy director stated she did not know why the CRNAs were maintaining the cart in the obstetrical department. Furthermore, according to the facility's policy and procedure last reviewed on 4/9/09 for Outdated and Unusable Drugs, "...There shall be no outdated or unusable drugs in the hospital in areas where they can be administered to a patient..."

Based on observation, staff interview, and review of product label information, the facility failed to ensure expired laboratory supplies were removed from 1 of 2 surgical suites. The findings were:

On 8/9/10 at 4:19 PM a tour of surgical suite #1 was conducted with the surgical services nurse manager. The observation revealed ten anaerobic culture tubes in a supply cabinet, readily available for use, with an expiration date of July 2010 stamped on each label. At the time of the finding, interview with the nurse manager confirmed the culture tubes were expired and should have been removed from use. When interviewed on 8/11/10 at 3:51 PM, the laboratory director stated the anaerobic culture tube medium can deteriorate. She acknowledged the tubes should be discarded upon expiration.

Based on observation, staff interview, and review of product label information, the facility failed to remove expired hand hygiene product from 4 of 9 clinical departments and services. In addition, one random observation showed the facility failed to separate clean and dirty linen. The findings were:

1. Observation on the initial tour of the facility on 8/9/10 showed wall-mounted, alcohol-based hand rub (ABHR) dispensers were located throughout the hospital in both clinical and support areas. Review of the product labels on ABHR products currently in use revealed four areas in the hospital with expired product: surgical services (3M Avagard surgical hand sanitizer, expiration March 2010), ultrasound room (Alcare Plus, expiration June 2010), housekeeping cart (Alcare Plus, expiration May 2010), and the administration conference room (Alcare Plus, expiration June 2010). Multiple observations on 8/9/10 and 8/10/10 showed these products were used by staff, patients, and visitors.

The ICP stated in an interview on 8/10/10 at 4:25 PM she was not aware expired hand hygiene product was in use. She stated each department and service was responsible for ensuring hand sanitizers were available and in-dated (not expired).

Telephone interview on 8/16/10 at 11:10 AM with a company representative for the Alcare Plus ABHR product revealed the antiseptic properties of the alcohol-based product diminished over time and the product was not intended for use in healthcare settings beyond the expiration date.

2. Observation during a tour of the facility on 8/11/10 at 2:48 PM showed a yellow plastic bag sitting on the floor of the sleep lab clean linen closet. When opened, the bag contained dirty bedding. Interview with the Director of Plant Operations at the time revealed the bedding was used by a previous night's patient. The Director also stated that on other occasions dirty laundry was observed in the clean linen closet.

Based on review of medical staff bylaws, medical record review, and staff interview, the facility failed to ensure post-anesthesia evaluations occurred for 2 of 2 surgical outpatients (OP #1, OP #2). The findings were:

Medical record review with the chief CRNA on 8/10/10 at 12:10 PM was done for two outpatient surgeries, OP #1 and OP #2. Each record lacked a post-anesthesia evaluation. While reviewing the records, the CRNA verified that OP #1 and OP #2 each received general anesthesia. She stated CRNAs do not typically do a post-anesthesia visit, as the outpatients have usually been discharged by the time the CRNA gets out of his/her next case. She further stated when a post-anesthesia visit occurred, it was typically not documented. She stated current practice was for nursing to include assessment information regarding recovery from anesthesia during their post-hospitalization phone calls. Nursing then notified anesthesia if problems were discovered.

Review of Medical Staff Bylaws, section 4.9, documented the need for staff that were qualified to give anesthesia to perform a post-anesthesia evaluation. The bylaws instructed that the post-anesthesia evaluation occur prior to the patient's discharge and it further instructed that the evaluation be documented.

Based on staff interview and review of personnel files, the facility failed to ensure the director of rehabilitation services was qualified to supervise the department. The findings were:

During the entrance conference on 8/9/10 at 2:40 PM, the director of quality identified employee #1, who was the previous lab manager, as the director of the rehabilitation (therapy) department. The following concerns were identified:
a. On 8/11/10 at 11:30 AM, the human resources director verified employee #1 was the previous lab manager, and was also the director of therapy. However, upon reviewing the personnel file, she further stated that the job description for the employee did not include supervising the therapy department.
b. Review of the personnel file for PT #1 revealed his annual competency evaluation of skills dated 12/31/09 was completed by a physical therapy assistant (PTA), and then signed by the director of therapy. On 8/11/10 at 11:20 AM, the human resources manager agreed that a PTA could not assess the competency of a PT. She stated another PT should have completed the competency evaluation.
c. During an interview on 8/11/10 at 1:30 PM, the director of therapy stated she was the previous lab manager and did not have a background or education in therapy. She stated as director of the therapy department, she was responsible for budget and billing issues. She further stated with regard to technical/therapy issues "...they were on their own to supervise themselves." When asked about therapy policies, such as timelines for completing a patient evaluation, she stated she had no knowledge of those policies and suggested talking to one of the therapists. The director of therapy also stated she only supervised the physical therapists, but not speech or occupational therapists because those services were provided under contract. However, when asked who would supervise the contracted speech or occupational therapists on 8/11/10 at 3:25 PM, the director of quality stated it would be the director of therapy.

Based on observation, staff interview, and review of personnel training records and proficiency test documents, the facility failed to document technical competency for 4 of 4 respiratory technicians who performed blood gas analysis on patient specimens. The findings were:

A blood gas analyzer was observed in the respiratory therapy department on 8/11/10 at 2:30 PM. According to respiratory technician #1, she and three other technicians routinely performed blood gas analysis on patient specimens. She further stated she had received training that qualified her to perform lab testing.

Review of personnel training records with the lab medical director showed a checklist had been prepared to document initial orientation and assessment for testing personnel in the respiratory therapy department. These documents were not signed to show training was completed or that technical competency had been established. Interview with the lab medical director on 8/11/10 at 2:50 PM revealed she had not reviewed the training program, nor had she approved the competency assessment for the respiratory technicians.

Establishing competency for testing personnel through orientation, training, and assessment is required by the Clinical Laboratory Improvement Amendment (CLIA), Code of Federal Regulations 42, Part 493, requirements for laboratories.