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Based on observation and interview, it was determined that eggs were not stored under conditions to prevent the potential contamination of other foods and soy sauce was not stored refrigerated according to manufacturer's instructions after opening. The failed practice for storage of eggs and refrigeration of soy sauce created the likelihood for a foodborne illness. The failed practices could affect any patient receiving those foods.

Findings:

A. Review of the Infection Prevention Plan stated departments would collaborate to, "Ensure safe techniques for food sanitation including food storage, preparation, serving and dish sanitation."

B. During a tour of the kitchen on 05/20/14 at 1330, the following was observed:

1) In the walk-in refrigerator, raw eggs were observed to be stored on a shelf directly above baked potatoes.

2) In the production area, a one-gallon jug of Soy Sauce with an opened date of 05/01/14 was observed on a shelf. The instructions on the jug said "refrigerate after opening."

C. Findings were confirmed by the Certified Dietary Manager at the time of the tour.

Based on interview, it was determined that the facility did not ensure regular inspections were done by the local fire department. The failed practice had the potential to affect the health and safety of all patients, staff and visitors because the fire department familiarity of the potential hazards and physical layout of the facility was not assured. The facility had a census of six on 05/20/14.

In an interview on 05/21/14 at 0840, the Director of Plant Operations verified there was no documentation of fire department inspection available for review.

Based on record review, review of Medication Administration Record (MAR) and interview, it was determined that the pharmacy responsible for processing orders written after pharmacy hours failed to assure the physician's order for digoxin included the frequency of administration for one (Patient #3) of four (Patient #1-4) inpatients. By not assuring the physician's order was complete, Patient #3 did not receive the prescribed medication. The failed practice had the potential to affect all patients who have prescriptions ordered after pharmacy hours. The findings follow:

A. Review of Patient #3's clinical record and MAR on 05/23/14 revealed a prescription for Digoxin 0.125 micrograms (heart medication- used for mild to moderate heart failure and/or heart rate control) was ordered on 05/19/14 at 2102. The frequency was listed as: See administration instructions. The start date was listed as 05/19/14. There was no evidence on the MAR that the drug Digoxin 0.125 was dispensed on 05/19/14, 05/20/14 or 05/21/14.

B. During an interview on 05/23/14 at 0905, Relief Pharmacist #1was asked why Patient #3 did not receive the important heart medicine that was ordered on 05/19/14. Relief Pharmacist #1 looked into the matter and answered she did not know why. She stated there were no notes in the Administration Instructions portion of that order. When asked what the pharmacy should do if they received an order like the above described order, the Pharmacist answered "I would call the Doctor to get the instructions." When Relief Pharmacist #1 was asked if she would expect the Pharmacy that covers them after hours to call a doctor if they received an order with incomplete dispensing instructions, the pharmacist answered "Yes".

Based on observation, review of manufacturer information on Rocuronium Bromide and Succinylcholine and interview, it was determined that the facility failed to ensure a method was instituted to reflect how long Rocuronium Bromide and Succinylcholine had been stored at room temperature on two of two (Cart #1 and Cart #2) Anesthesia carts. The potential existed for the medications to be stored at room temperature in excess of manufacturer guidelines leading to a decrease in potency of the medications upon administration to patients. The practice had the likelihood to affect all patients who received the medications during surgery. Findings follow:

A. A tour of Surgical Services was conducted on 05/20/14 from 1010 to 1135. The following observations were made:

1. Anesthesia Cart #1

a) 3 Succinylcholine 10 ml (milliliter) vials were not dated when removed from refrigerated storage; and

b) 7 Rocuronium Bromide 10 ml vials were not dated when removed from refrigerated storage.

2. Anesthesia Cart #2
a) 3 Succinylcholine 10 ml (milliliter) vials were not dated when removed from refrigerated storage; and

b) 1 Rocuronium Bromide 10 ml vial was not dated when removed from refrigerated storage.

B. Review of package insert for Succinylcholine stated "The multi-dose vials are stable for up to 14 days at room temperature without significant loss of potency".

C. Review of packaging for the Rocuronium Bromide stated "Upon removing from refrigerator to room temperature, use within 60 days".

D. Findings were verified, through interview, on 05/21/14 at 1037 with the Regional Director of Quality and Accreditation.


Based on observation, review of policy and interview, it was determined the facility could not ensure medications from MDVs (Multiple Dose Vials) were not made available for patient use when expired or beyond 28 days once opened (per policy); and a Single Dose Vial (SDV) was not used on multiple patients. The practice was observed in two (Operating Room (OR) #3 and Post Anesthesia Care Unit (PACU)) of three (OR #3, OR #2 and PACU) areas in Surgical Services toured. By not disposing of expired medication or SDV after single use, the facility could not ensure the safety or efficacy of the medication past the expiration date. The failed practice had the potential to affect any patient who received these medications. Findings follow:

A. A tour of Surgical Service on 05/21/14 between 1010 and 1135 revealed the following observations:

1. OR #3

a) #1 SDV of Sensorcaine 0.5% 10 ml (milliliter ) vial for injection was labeled "open 05/20/14; exp (expired) 06/17/14". SDVs do not have preservatives and therefore should only be used for a single dose and then disposed of.

b) #1 Flumazenil 0.5 mg (milligram)/ml 5 ml MDV for injection was labeled "Opened 04/03/14;exp 05/01/14"; and

c) #2 Hydralazine 20 mg/ ml 1 ml vial for injection expired 04/14.

2. PACU

a) #1 Novolin R insulin 10 ml MDV for injection opened, used and was not labeled indicating when it was opened or when it expired; and

b) #1 Novolin R insulin 10 ml MDV for injection opened 12/30/13; and still available for patient use past 28 days after opening.

B. Review of Policy titled "Compounding IV (intravenous) Solutions outside of Pharmacy" stated "All multi-dose vials (MDVs) shall be dated when opened for use. Once opened, all multi-dose vials expire 28 days after first opened." Also "Single dose vials without a preservative are only used once, then discarded."

C. Findings were verified, through interview with the Regional Director of Quality and Accreditation on 05/21/14 at 1047.

Based on interview, it was determined that the facility failed to have a process in place for the Infection Control Preventionist to obtain reports of employee illnesses. Failure to have a mechanism in place for the Infection Control Preventionist to be knowledgeable of employee illnesses did not allow the facility to be proactive in identifying, investigating and mitigating potential communicable diseases and illnesses. The failed practice affected all employees, patients and visitors on 05/20/14. Findings follow:

During an interview with the Infection Control Nurse at 1540 on 05/20/14, she stated all employee illnesses were reported to the Human Resources Department and there was no process for reporting those on to the Infection Control Nurse.


Based on interview and policy and procedure review, it was determined that the Respiratory Therapy Department did not have a policy and procedure in place addressing the cleaning of patient care equipment. The failed practice did not ensure a mechanism was in place to guide staff in the cleaning and disinfecting of patient care equipment. The failed practice affected all patients who received respiratory therapy services on 05/20/14. Findings follow:

A. During review of the Respiratory Therapy Policy and Procedure Manual at 1515 on 05/21/14, it was noted the manual did not contain a policy and procedure for the cleaning of patient care equipment.

B. During an interview with the Respiratory Manager at 1115 on 05/22/14, she stated there was not a policy and procedure in place which outlined the cleaning process of the patient care equipment.

Based on review of the Diet Manual, Medical Staff Meeting Minutes for June 2013 through March 2014, and interview, it was determined that the facility failed to ensure the Diet Manual had been approved by the Medical Staff and the Registered Dietitian. The failed practice did not allow the Medical Staff to ensure the diet manual was updated and reflected current practices, and had the potential to affect all patients in the facility. Findings follow.

A. Review of the Diet Manual and Medical Staff Meeting Minutes for June 2013 through March 2014 revealed no evidence the Diet Manual had been approved by Medical Staff or the Registered Dietitian.

B. Findings were confirmed by the Risk Manager on 05/21/14 at 1405.

Based on clinical record review and interview, it was determined that the facility failed to ensure operative reports included the time of surgery for five of five (#15 and #17-#20) surgical patients. The failed practice did not allow knowledge of which surgery happened first in the event of multiple surgeries in one day, and created the potential to affect any patient receiving an operation in the facility. Findings follow.

A. Review of the operative reports revealed the time of the surgery was not documented for Patient #15 and #17-#20.

B. Findings were confirmed by the Risk Manager on 05/22/14 at 0835.

Based on interview, it was determined that surgical services were not provided in a safe manner in that there was no tracheotomy kit in the operating suite. Failure to ensure a tracheotomy kit was available in the operating suite did not allow the facility to be prepared to meet the patient ' s medical needs in the event of an emergency. The failed practice affected all patients who have undergone procedures in the operating rooms of the facility. Findings follow:

During the facility tour conducted at 1030 on 05/21/14, the Surgery Manager stated a tracheotomy kit was not located in the operating suite and the nearest one available was located in the Emergency Room.

Based on review of Medical Staff Meeting Minutes, and review of Governing Board Meeting Minutes and interview, it was determined that the facility failed to ensure Quality Assurance was reported for Environmental Services, Laboratory, Respiratory, and Dietary on a quarterly basis as required by the Performance Improvement Plan. The failed practice did not ensure the Medical Staff and Governing Board were aware of any potential performance improvement issues that needed to be addressed; and had the likelihood to affect any patient admitted to the facility. Findings follow.

A. Review of the Performance Improvement Plan revealed findings of performance improvement activities would be reported to Medical Staff no less than quarterly. It also stated, "The dimensions of performance of patient care and quality control activities in the following services are monitored, assessed and evaluated"-Clinical Laboratory Services, Environmental Services, Food and Nutritional Care Services, and Respiratory Services were included.

B. Review of Medical Staff Meeting Minutes for June 2013 through March 2014, and review of Governing Board Meeting Minutes for July 2013 through May 2014 revealed the following:

1) QAPI (Quality Assessment/Performance Improvement) was not reported for Food and Nutritional Care Services for 2nd, 3rd, and 4th quarters for 2013.

2) QAPI was not reported for Environmental Services for 2nd, 3rd, and 4th quarters of 2013 and 1st quarter 2014.

3) QAPI was not reported for Clinical Laboratory Services for 3rd and 4th quarter of 2013 and 1st quarter of 2014.

4) QAPI was not reported for Respiratory Services for 2nd, 3rd, and 4th quarters of 2013.

C. Findings were confirmed by the Risk Manager on 05/21/14 at 1000.

Based on interview and review of the facility transfer/discharge notice for Swing Bed patients, it was determined that the facility failed to include in its transfer/discharge notice to the patient the following information: the reason for transfer or discharge, the location to which the patient was transferred or discharged, the name, address and telephone number of the State long term care ombudsman and the mailing addresses and telephone numbers of the agencies responsible for the protection and advocacy of the developmentally disabled and the mentally ill.

Failure to include the above information on the transfer/discharge form did not allow the patient and/or family to be knowledgeable regarding the reason and location of transfer/discharge as well as the contact information of the organizations who could assist the patient/family in appealing the transfer/discharge. The failed practice affected all patients admitted to Swing Bed Status. Findings follow:

A. Review of the transfer/discharge notice received from the Infection Control/Swing Bed Manager at 1310 on 05/22/14 revealed it did not contain the reason for transfer or discharge, the location to which the patient was transferred or discharged, the name, address and telephone number of the State long term care ombudsman and the mailing addresses and telephone numbers of the agencies responsible for the protection and advocacy of the developmentally disabled and the mentally ill.

B. The above findings were verified by the Infection Control/Swing Be Manager at 1330 on 05/22/14.

Based on interview and policy and procedure review, it was determined that the facility had no policy, process or mechanism in place that defined and identified actions in the event of resident maltreatment, abuse or neglect of patients admitted to Swing Bed status. The failed practice had the potential to allow resident maltreatment, abuse or neglect to go undetected and without action once discovered. The failed practice affected the one of one (#1) swing bed resident on 05/22/14 but had the potential to affect all patients admitted to Swing Bed status. Findings follow:

A. Review of the Swing Bed Policy and Procedure Manual revealed no process which defined and helped staff identify patient maltreatment, abuse and neglect as well as the action to take if maltreatment, abuse and neglect were discovered.

B. During a group interview with the Regional Director of Quality and Accreditation, the Executive Director for Clinical Excellence and Regulatory Compliance and the Director of Risk Management at 1115 on 05/22/14 they stated the facility did not have a policy or procedure for identifying and acting on patient abuse, neglect and maltreatment.

Based on interview and clinical record review, it was determined the activities calendar for swing bed patients had not been developed and placed on the unit or in patient rooms. Failure to develop an activities calendar did not allow the swing bed patient and/or family to be knowledgeable of available activities and choose which activities they would like to participate in. The failed practice affected the one (#1) swing bed patient on 05/22/14. Findings follow:

A. An activities calendar was requested from the Infection Control/Swing Bed Manager at 0915 on 05/22/14. The Infection Control/Swing Bed Manger stated there was not a calendar for swing bed activities.

B. During an interview with Swing Bed Patient #1 at 1330 on 05/22/14 she stated an activities calendar had been given to her ten minutes prior to this interview. Swing Bed Patient #1 was admitted on 05/16/17 and did not have an activities calender developed until 05/22/14.