HospitalInspections.org

Based on staff interview and administrative document review, the hospital failed to have an effective governing body legally responsible for the conduct of the hospital as an institution when:

1. The Quality Assessment and Performance Improvement (QAPI) program was not implemented. The hospital QAPI projects that were identified failed to provide data documenting a comprehensive on-going program of quality improvement which failed to ensure patient safety programs and systems were in place. (Refer A 309)

2. The hospital did not have an Infection Control Program that was capable of preventing, controlling and investigating infections and communicable diseases. (Refer to A747)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.












22711

Based on staff interview and administrative document review, the hospital's governing body failed to be responsible and accountable for ensuring an ongoing, hospital wide, date-driven Quality Assessment and Performance Improvement (QAPI) program was established when:

1. The hospital's governing body failed to ensure a QAPI program for quality improvement and patient safety was implemented and maintained. The hospital did not provide evidence of on-going and current QAPI projects that reflected the complexity of the hospital's services and were aimed at quality improvement and patient safety. (Refer to A 309)

2. The hospital did not have an Infection Control Program that was capable of performing QAPI functions. (Refer to A747)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.










22711

Based on staff interview and administrative document review, the hospital's governing body failed to be responsible and accountable for ensuring that an ongoing, hospital wide, date-driven Quality Assessment and Performance Improvement (QAPI) program was established when:

1. The hospital's governing body failed to ensure a QAPI program for quality improvement and patient safety was implemented and maintained and failed to ensure distinct improvement projects that reflected the complexity of the hospital's services that were conducted and documented annually. This failure resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Findings:

On 11/18/13 at 1:52 p.m., an interview with the Director of Clinical Services (Admin 1) and a staff nurse (Admin 2) was conducted. Admin 2 indicated she worked in the Infection Control and Quality Departments. She stated her role in the Infection Control Department was to do basic tasks as assigned and the Quality Department was to assist the Director of Clinical Services. Admin 1 agreed, and stated, "There was no Director of Quality Assurance and Performance Improvement, and Admin 2 only completed tasks as assigned by her and the CEO. Admin 1 stated, "The beginnings have been put in place." They stated the Performance Improvement Management Program policy and procedures had been put in place by the Performance Improvement/Risk Management Committee on 9/23/13, but had not been fully implemented.

On 11/19/13 at 9:00 a.m., the hospital Medical Staff Bylaws were reviewed. The Bylaws indicated on page 52 "10.5 PERFORMANCE IMPROVEMENT/RISK MANAGEMENT COMMITTEE 10.5-1 COMPOSITION The Performance Improvement/Risk Management Committee shall consist of at least one representative from each clinical service, the Director of Nursing, the Infection control Nurse, Director of Quality, Lab Director, Pharmacist, representation from hospital administration and management. 10.5-2 DUTIES The duties of the Performance Improvement/Risk Management Committee shall include: (y) Recommend for approval of the Medical Executive Committee plans for maintaining quality patient care within the hospital. These may include mechanisms to: (1) establish systems to identify potential problems in patient care; (2) set priorities for action on problem correction; (3) refer priority problems for assessment and corrective action to appropriate departments of committees; (4) monitor the results of quality assessment and improvement activities throughout the hospital; and (5) Coordinate quality assessment and improvement activities. (6) Submit regular confidential reports to the Medical Executive Committee on the quality of medical care provided and on quality assessment and improvement activities conducted."

On 11/21/13 at 2:30 p.m. an interview with the Chief Executive Officer (CEO) and the Director of Clinical Services (Admin 1) was conducted. They agreed that not enough had been put in place to have an adequate quality program as follows: 1. Priorities for action on problem corrections had not been set or documented. 2. Problem priorities had not been referred for assessment and corrective action to committees in a timely manner. 3. Results of quality assessment and improvement activities throughout the hospital had not been comprehensively monitored. 4. A determination and list of distinct improvement projects was not conducted annually. 5. There was no director of Quality Assurance and Performance Improvement to coordinate activities. The CEO stated Admin 2 completed tasks as assigned by himself and the Director of Clinical Services on an "as needed basis". The CNO also stated that he had not been able to hire a full time person to be in charge of the quality program. He stated he was responsible for the lack of personnel and resources required to implement and maintain a QAPI program.


22711

Based on observation, interview, and record review, the pharmacy failed to ensure the implementation of policy and procedures as evidenced by:

1. The pharmacy failed to ensure the implementation of a policy and procedure for multi-dose medication vials (MDV, more than one dose can be removed from a vial). Two MDVs were taken into patient treatment areas. The two MDVs were placed back into the medication storage areas. These failures resulted in the potential for patients to be exposed to avoidable infections.

2. The pharmacy failed to ensure the implementation of a policy and procedure for storing medications at the required temperatures. The hospital stored two medications outside of the manufacturers' temperature storage range. These failures resulted in the potential for patients to be exposed to medications at other than labeled strength and quality.

Findings:

1. During a concurrent observation and record review, on 11/18/13 at 1:25 p.m., in pre-op (area to prepare a patient for surgery), a 50 milliliter (ml) MDV of 1% lidocaine (drug), NDC 0409-4276-02, was identified. The lidocaine vial was in a yellow plastic basket on the top of a counter. Inspection of the vial showed it was opened and labeled with an expiration date of 12/13/13. Registered Nurse (RN 1), at 1:35 pm, was observed taking the lidocaine to the bedside of Patient 1 in Bay 4. RN 1, at 1:45 pm, was observed returning the vial of lidocaine to the yellow basket.

During a concurrent tour and interview, on 11/19/13 at 3 p.m., in the operating suite hallway, Registered Nurse (RN 3) identified a medication storage cart. Inspection of the cart showed it contained a MDV of betamethasone (drug) 30 milligram/5 ml. Further inspection of the vial showed that approximately 40% of the contents were removed. RN 3 acknowledged the betamethasone vial was opened.

During an interview, on 11/20/13 at 12:45 pm, with Administrator (Admin 2), the above MDV observations were described. Admin 2 acknowledged she was aware of the observations. Admin 2 stated that it was the hospital' s expectation that a MDV, if opened and in a treatment area (bedside, operating room), was not to be used for treatment of additional patients.

During an interview, on 11/21/13 at 10:00 am, RN 3 stated the betamethasone vial was removed from the medication storage cart, taken into the operating room, a dose of medication was withdrawn, and the vial returned to the medication storage cart.

During an administrative record review, of the hospital 's policy and procedure for Standard Precautions (IC.028, Approved: 28-June-2012) showed, Policy:, Safe Injection Practices, "The following recommendations apply to the use of needles, cannulas that replace needles, and where applicable intravenous delivery systems: ...7 Do not keep multi-dose vials in the immediate patient treatment area and store in accordance with the manufacturer 's recommendations; discard if sterility is compromised or questionable."

2. During a concurrent tour and interview, on 11/18/13 at 1:25 p.m., in pre-op (area to prepare a patient for surgery), a yellow basket, on a countertop, was identified. Inspection of the basket showed that it contained Baxter 1 gram cefazolin (antibiotic) in 50 milliliter (ml), NDC 0338-3503-41. Further inspection showed the cefazolin was labeled with an expiration date of 12/11/13 (23 days). The cefazolin was stored at room temperature. Registered Nurse (RN 1) acknowledged the cefazolin was stored at room temperature. The hospital was requested to provide the package insert for the cefazolin.

During a concurrent tour and interview, on 11/18/13 at 1:50 pm, in pre-op, RN 1 identified the medication refrigerator. Inspection of the refrigerator showed that it contained 9 doses of Baxter 20 milligram famotidine (drug), NDC 0338-5197-41. Inspection of the famotidine label showed "Recommended storage: Room temperature (25 degrees C (Celsius)/77 degrees F (Fahrenheit)." RN 1 acknowledged the famotidine was stored in the refrigerator.

During an administrative record review, of Cefazolin Injection, USP in GALAXY Container (package insert) showed, Thawing of Plastic Container, "The thawed solution is stable for 30 days under refrigeration (5 degrees C/41 degrees F) and 48 hours at 25 degrees C/77 degrees F (room temperature)."

During an administrative record review, of the hospital 's policy and procedure for Pharmacy General Operations (PH.002, Approved: 28-June-2012), showed Policy:, Scope of Services:, 3. Drug Storage:, "Medications and blood products are stored under proper conditions of sanitation, temperature, light, moisture, ventilation, segregation, and security and comply with current USP established standards."

Based on observation, interview, and administrative record review, the pharmacy failed to implement a policy and procedure for drug shortages. Aminophylline (drug) was not stocked in the latex (part of natural rubber) allergy cart. Hospital management was not informed that aminophylline was not available and was not in the allergy cart. This failure resulted in the potential for patients to be exposed to a delay in receiving medications in a latex allergic reaction.

Findings:

During a concurrent tour, interview, and administrative record review, on 11/18/13 at 2:30 p.m., in the recovery room (area to recover from surgery), Registered Nurse (RN 1), identified the latex allergy cart. Inspection of the cart showed the drug contents were sealed with lock #8559691. Inspection of the drug contents did not show the cart contained aminophylline. Inspection of the PostAnesthesia Care Unit latex Allergy Cart (November 2013) (list of medications in the cart) showed, Drawer 1: Medications, 7. " Aminophylline, 500 mg (milligram)/20 ml (milliliter) (2)."

During an interview, on 11/21/13 at 11:07 a.m., Administrator (Admin 1) stated that she was the hospital administrator responsible for pharmacy services. Admin 1 acknowledged that aminophylline was not stocked in the latex allergy cart. Admin 1 stated that pharmacy did not inform her that aminophylline was not available and was not stocked in the allergy cart. Admin 1 stated that it was her expectation that pharmacy notify administration when aminophylline was not available and was not stocked in the latex allergy cart.

During an administrative record review of the hospital 's policy and procedure for Managing Drug Shortages (PH.060, approved 28-June-2012), showed Policy:, " The Drug Information Service (DIS), under the auspices of the Pharmacy Therapeutic Committee is responsible for investigating and providing information about potential drug shortages that may affect patents at (The Hospital). "

Based on observations, interview, and administrative record review, the pharmacy failed to ensure the implementation of a policy and procedure for labeling intravenous (IV, directly into a vein) medications. The hospital did not label a clindamycin (antibiotic) IV medication with an expiration date and time. This failure resulted in the potential for patients to be exposed to medications at other than labeled strength and quality.

Findings:

During a concurrent tour and interview, on 11/18/13 at 1:40 pm, in pre-op (area to prepare a patient for surgery), Registered Nurse (RN 1) identified a medication storage cabinet. Inspection of the cabinet showed that it contained an IV medication. Inspection of the medication showed that it was 900 milligrams of clindamycin in an ADD-Vantage system (vial of medication attached to an IV bag). Further inspection of the system showed the stopper was removed from the vial of clindamycin and the drug was mixed with the IV solution. Continued inspection did not show a hospital label on the clindamycin (no expiration date and time).

During an administrative record review, of the hospital ' s policy and procedure for Intravenous Admixtures Order Processing (PN.030, Approved: 28-June-2012) showed, Procedure:, 1. Nursing, D. "The expiration date and time on all IV labels indicates the chemical stability of the compounded product. Complete infusions by the expiration date and time on the label."

Based on observation, interview and administrative record review, the hospital failed to develop and implement a policy and procedure for removal of drugs from drug room A and B. The hospital had two drug rooms. Each drug room had a log for signing out medications. Each log entry had space for two registered nurses to sign. Eight out of ten log entries were not signed by two registered nurses. These failures resulted in the potential for patients to be exposed to avoidable medication errors.

Findings:

During a concurrent tour, interview, and administrative record review, on 11/18/13 at 2:55 p.m., Registered Nurse (RN 1) identified pharmacy drug room B. Inspection of the room showed that it contained medications and a pharmacy drug room medication log (document to track medications removed from the room). Inspection of the log showed, from 5/22/13 to 10/29/13, 14 lines were completed for drugs removed from the room. Of the 14 lines completed, 4 lines were signed by a second RN. 10 lines were not signed by a second RN.

During an interview, on 11/19/13 at 10:30 am, Administrator (Admin 1) acknowledged Drug Room B 's Pharmacy Drug Room Medication Log did not document a second RN signed each entry. Admin 1 stated that it was her expectation that each log entry was to be signed by two RN's. The facility was requested to provide the policy and procedure for RN's removing medications from the drug storage rooms A and B. The policy and procedure was not provided before the end of the survey.

Based on staff interviews and administrative document review, the facility failed to ensure there was an active infection control program when:
1. The facility failed to have a designated infection control officer or officers to develop and implement an ongoing infection control program. (refer to A 748)
2. The facility failed to ensure the development and implementation of an active infection control and prevention program. (refer to A 749)
3. The facility failed to have an infection control program that could identify potential issues for review by a quality assessment and performance improvement program. (refer to A 756)

The cumulative effects of these systemic problems resulted in the hospital's inability to provide care in a safe and effective manner in accordance with the statutorily-mandated Conditions of Participation for Infection Control.


29643

Based on staff interview and administrative document review, the facility failed to designate an infection control officer or officers to maintain an active ongoing program. This failure resulted in the potential for the hospital to be unable to track or prevent infections.
Findings:
On 11/21/13 at 2:30 p.m., the Chief Executive Officer (CEO) and the Director of Nursing (Admin 1) were interviewed. They stated that, "Not enough had been put in place." The hospital had developed a policy and procedure, titled "Infection Prevention and Control Program: Authority, Accountability and Functions", but it had not been signed as approved by the Performance Improvement/Risk Management (PR/IM) committee. They stated they had not been able to hire an Infection Preventionist to direct the program. They stated that Admin 2 gave her resignation as Infection Control Nurse in November 2012, but had been helping the hospital out on an as needed basis. They agreed there had not been an Infection Control (IC) Nurse to direct the Infection Control Program since the retirement of Admin 2. They stated that Admin 2 had been directed to perform certain basic tasks for Infection Control on an as needed basis while they were looking for a new Director of Infection Control.

On 11/21/13 at 3:00 p.m., administrative documentation titled "Quality Nurse Recruitment/Infection Preventionist Recruitment 2013 and copies of attempted contacts and postings were reviewed. Documentation verified five contacts were made between 8/22/13 and 11/18/13 without any results.



29643

Based on interview and administrative document review, the hospital failed to ensure an infection control officer developed an active infection control and prevention program when the hospital did not have an infection control officer and a system was not implemented for identifying, reporting, investigating, and controlling infections. This failure resulted in the hospital's inability to provide care in a safe and effective manner.
Findings:
On 11/21/13 at 2:30 p.m., the Chief Executive Officer (CEO) and the Director of Nursing (Admin 1) were interviewed consecutively. They stated that, "Not enough had been put in place." The hospital had developed new policies and procedures, titled "Infection Prevention and Control Program: Authority, Accountability and Functions", but it had not been signed as approved by the Performance Improvement/Risk Management (PR/IM) committee. They agreed they had not been able to hire an Infection Preventionist to direct the program. They stated that Admin 2 gave her resignation as Infection Control Nurse in November 2012, but had been helping the hospital out on an as needed basis since. They agreed there had not been an Infection Control (IC) Nurse to direct the Infection Control Program since her retirement. They stated that Admin 2 had been directed to perform certain basic tasks for Infection Control on an as needed basis while they were looking for someone to direct the Quality Program.
On 11/21/13 at 2:40 p.m., an interview with the Chief Executive Officer (CEO) was conducted. The CEO stated he had not been able to hire a full time person to be in charge of the Infection Control Program. He stated he was responsible for the lack of personnel and resources required to implement and maintain an Infection Control Program.
On 11/21/13 at 3:00 p.m., administrative documentation was provided and reviewed which contained a list of contacts and postings the hospital had used in their attempts to locate an Infection Control staff person. The document was titled "Quality Nurse Recruitment/Infection Preventionist Recruitment 2013. The contents verified five contacts were made between 8/22/13 and 11/18/13 which resulted in no offers for a Infection Preventionist.
On 11/21/13 upon request the hospital staff supplied a review of the hospital's infection control study reports. The reports indicated a study on Surgical Site Infections and studies for the National Healthcare Network were the only current studies provided for 2013.


29643

Based on staff interview and administrative document review, the hospital failed to ensure a quality assessment and performance improvement program addressed problems identified by the infection control officer when there was not a designated infection control officer and a comprehensive infection control program was not in place to identify problems. These failures resulted in the hospital's inability to provide care in a safe and effective manner.
Findings:
On 11/18/13 at 1:52 p.m., a concurrent interview with the Director of Clinical Services (Admin 1) and staff nurse (Admin 2) was conducted. Admin 2 indicated she worked in the Infection Control and Quality Departments. She stated her role in the Infection Control Department was to do basic tasks as assigned. In the Quality Department Admin 2 was to assist the Director of Clinical Services. Admin 1 agreed, and stated, "There was no Director of Quality Assurance and Performance Improvement, and (Admin 2) only completed tasks as assigned to her by the CEO or Admin 1." Admin 1 and Admin 2 stated there were some basic problems identified and some basic performance Improvement Projects were being conducted in each department.

On 11/21/13 at 2:30 p.m., the Chief Executive Officer (CEO) and the Director of Nursing (Admin 1) were interviewed concurrently. They stated that, "Not enough had been put in place." The hospital had developed a policy and procedure, titled "Infection Prevention and Control Program: Authority, Accountability and Functions", but it had not been signed as approved by the Performance Improvement/Risk Management (PR/IM) committee. The CEO and Admin 1 stated they had not been able to hire an Infection Preventionist to direct the program. They stated that Admin 2 gave her resignation as Infection Control Nurse in November 2012, but had been helping the hospital out on an as needed basis. They agreed there had not been an Infection Control (IC) Nurse to direct the Infection Control Program since Admin 2 had retired. The CEO stated he assigned Admin 2 to perform tasks in infection control on an as needed basis. The CEO and Admin 1 stated basic problems had been identified and some basic performance Improvement Projects were being conducted in each department. They stated the hospital was drafting a list of these projects but it had not been completed yet. They agreed there were some audits being done but there was no implementation of successful corrective action plans in the identified problem areas.

On 11/21/13 at 2:40 p.m. an interview with the Chief Executive Officer (CEO) was conducted. The CEO stated he had not been able to hire a full time person to be in charge of the Infection Control Program. He stated he was responsible for the lack of personnel and resources required to implement and maintain an Infection Control Program.

On 11/21/13 at 3:00 p.m., administrative documentation titled "Quality Nurse Recruitment/Infection Preventionist Recruitment 2013 and copies of attempted contacts and postings were reviewed. Documentation verified five contacts were made between 8/22/13 and 11/18/13 without any results.

On 11/21/13 a review of the hospital's infection control study reports indicated a study on Surgical Site Infections and studies for the National Healthcare Network were the only current studies provided as requested for 2013.



29643