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Based on the nature of standard level defeciency referenced to the Condition, it was determined the Condition of Participation §482.21, QUALITY ASSESSMENT AND PERFORMANCE IMPROVEMENT PROGRAM, was out of compliance.

A-0308 - Standard: QAPI Governing Body - The hospital's governing body must ensure that the program reflects the complexity of the hospital's organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement). The governing body failed to develop and implement a hospital-wide, data-driven quality assessment and performance improvement (QAPI) program. The facility failed to collect quality indicator data related to improved patient safety and health outcomes, identify opportunities for improvement, take action aimed at performance improvements, and measure and track the success of any actions taken.

Based on interviews and document review, the governing body failed to develop and implement a hospital-wide, data-driven quality assessment and performance improvement (QAPI) program. The facility failed to collect quality indicator data related to improved patient safety and health outcomes, identify opportunities for improvement, take action aimed at performance improvements, and measure and track the success of any actions taken.

These failures resulted in incomplete quality management processes and missed opportunities to improve patient safety and health outcomes.

1. The facility failed to implement a hospital wide QAPI program that included data analysis and collection, identification of distinct quality indicators, and activities or projects to improve patient safety and health outcomes.

a) Review of the Department Head Meeting minutes dated 01/14/16, 02/11/16, 03/08/16, 04/14/16, and 05/19/16 showed no evidence the facility reviewed the department quality reports for trends, performed an analysis of trends and identified areas of weakness. There was no evidence the facility collected data, conducted comparisons, and established benchmarks to improve patient safety and health outcomes.

Review of the governing body District Bylaws adopted 11/25/14 and the monthly meeting minutes from 2016 showed no evidence of a QAPI program was in place or implemented.

b) On 06/08/16 at 3:20 p.m., an interview was conducted with the Infection Control Nurse (ICN #9) who stated s/he thought the facility had a quality program, but was not involved in any meetings. Review of the 2016 Infection Control Risk Assessment showed hand hygiene as one of the goals the facility should focus on. ICN #9 was unable to provide evidence of performance improvement projects in place to improve or focus on hand hygiene compliance.

c) On 06/09/16 at 9:59 a.m., an interview was conducted with the Director of Health Information Management (Director #6) who was responsible for the QAPI program, and the Chief Executive Officer (CEO #8). Director #6 stated the facility did not have a quality policy or program. Director #6 stated the facility was in the process of developing a program. Director #6 further stated each department submitted their quality improvement reports quarterly for review by him/her; however s/he did not track or trend the results of each departments' reports. Director #6 stated a quality program had not been the facility's priority in the past.

CEO #8 stated his/her main focus in the prior years had been financial; and a quality program was not on top of his/her priority list until recently. CEO #8 stated if a quality program was not in place, the facility could not assess if the facility was providing safe patient care. CEO # 8 stated the facility had been working with an organization since March, 2016 to develop a quality program.

Based on observation and interviews, the facility failed to ensure outdated medications were removed from stock according to manufacturer's expiration date.

This failure created the potential for patients to receive expired medications.
FINDINGS:

POLICY

According to policy, Outdated Supplies, all outdated supplies, either by expiration date or by manufacturer recommended use by date will be removed from service and placed in CSR so that new supplies may be ordered. On a monthly basis all areas will be checked for any outdated equipment, medications, and supplies. If found they will be taken to CSR for proper disposal and reorder so as to not leave the hospital short supplies.

1. The facility failed to ensure outdated IV fluids were removed from the Central Supply and not available for patient use.

a) On 06/06/16 at 3:22 p.m., a tour of the Central Supply Room was conducted with Purchasing Agent (PA #2) and the Director of Nursing (DON #1). During the tour it was revealed:

-1 bag of Hospira 1 liter D5 0.9 Normal Saline bags was found with an expiration date of March 1 2015.

-4 bags of Hospira 1 liter D5 0.9 Normal Saline bags were found with expiration date of June 1 2016.

-3 bags of Baxter 3% Sodium Chloride (500 milliliters) were found with expiration date of May 2016.

b) On 06/08/16 at 5:15 p.m., an interview was conducted with DON #1 who stated all staff were responsible for monitoring supplies and medications for their expiration dates. DON #1 stated staff were expected to discard outdated medications and supplies.

c) On 06/09/16 at 9:00 a.m., an interview was conducted with PA #2 who stated s/he was responsible for the monitoring of outdated IV fluids on a monthly basis. PA #2 stated, per pharmacy, staff should follow the manufacture expiration date printed on the IV fluid bags. PA #2 was aware of facility policy and stated s/he missed the expired IV fluids. PA #2 stated s/he realized s/he should have asked for help.

2. The facility failed to ensure outdated medications were removed from the Pharmacy and not available for patient use.

a) On 06/07/16 at 11:45 a.m., a tour of the pharmacy was conducted with DON #1 and PA #2, who was also the Pharmacy Technician. During the tour, 3 syringes of Bicillin-LA 2,000,000 units were found in the medication refrigerator with a manufacturer expiration date of July 2015, a black widow spider anti venom (Latrodectus mactans) kit with a manufacturer expiration date of June 2009 and a cyanide kit with a manufacturer expiration date of February 2013. DON #1 stated any expired medications should be removed. DON #1 then proceeded to dispose of the expired Bicillin.

PA #2 stated it was the responsibility of the Pharmacy Department to monitor expiration dates on medications in the pharmacy. S/he stated replacements for both the black widow spider anti venom and the cyanide kits were not available and were kept beyond their expiration dates in case of an emergency.

b) On 06/09/16 at 9:35 a.m., a telephone interview was conducted with Pharmacist #5. Pharmacist #5 stated s/he was unaware the facility had a black widow spider and cyanide kit and was unable to explain how they had been overlooked during the last monthly inspection. Pharmacist #5 further stated all expired medications should be removed and not used.

Based on observation, document review and interviews, the facility failed to ensure emergency medications and supplies were readily available for use during an emergency.

This failure created the potential for negative patient outcomes during an emergency situation due to the lack of available emergency medications and supplies.

FINDINGS:

POLICY

According to the policy, Outdated Supplies, all outdated supplies, either by expiration date or by manufacturer recommended use by date will be removed from service and placed in CSR so that new supplies may be ordered. On a monthly basis all areas will be checked for any outdated equipment, medications, and supplies. If found they will be taken to CSR for proper disposal and reorder so as not to leave the hospital short supplies.

1. The facility's Emergency Department (ED) contained expired or missing emergency medications and supplies.

a) On 06/06/16 at 3:22 p.m. a tour of the Emergency Department was conducted with the Director of Nursing (DON #1) and revealed the following expired or missing medications and supplies in the adult emergency cart, the pediatric emergency cart, and in the trauma room.

Observation of the adult emergency cart revealed empty slots labeled for intravenous (IV) dopamine (used for blood pressure support during emergent situations). According to the Inventory Near Expiration List, the facility should have had a minimum of 2 vials of dopamine in inventory; however, there were none documented as available for use. Review of the ED emergency cart checklist revealed as of 06/02/16, there was no Dopamine stocked in the cart.

Expired items observed in the Trauma Room:

-1 Size 3 laryngeal mask airways Unique (LMA, a medical device used to keep a patient's airway open during anesthesia or unconsciousness) expired May 2007.

-1 Size 4 LMA Unique had expired January 2001.

-1 Size 5 LMA Unique had expired January 2009.

-1 Size 2 LMA had expired May 2008.

Expired items observed in the pediatric emergency cart:

- 1 Broselow/Hinkle Pediatric Emergency System Intraosseus Module expired November 2014.

- 1 Broselow/Hinkle Pediatric Emergency System IV Delivery Module expired September 2012.

- 2 Broselow/Hinkle Pediatric Emergency System Oxygen Delivery Module expired April 2016.

- 1 Broselow/Hinkle Pediatric Emergency System Intubation Module expired May 2013.

At the end of the tour, DON #1 stated s/he was not aware of the outdated LMAs and the missing Dopamine.

b) On 06/08/16 at 5:15 p.m., an interview was conducted with DON #1 who stated all staff were responsible for monitoring supplies for their expiration dates. DON #1 stated the facility did not have a tracking log to monitor outdated supplies in the ED. S/he assumed each department discarded and reordered the supplies as needed. DON #1 stated s/he was aware the pediatric cart contained outdated supplies; however due to financial concerns had not been able to order supplies needed.

c) On 06/09/16 at 9:30 a.m., an interview was conducted with Respiratory Therapist (RT #4) who was responsible for monitoring and restocking respiratory supplies, including LMAs. RT #4 stated s/he would monitor supplies for quantity, but did not check for outdates. RT #4 stated s/he was unaware the LMAs had expiration dates. RT #4 further stated s/he was unaware of a policy regarding outdated supplies.

d) On 06/09/16 at 10:30 a.m., a telephone interview was conducted with Pharmacist #5 who stated Dopamine should be in emergency carts as it was part of Advanced Cardiac Life Support. Pharmacist #5 was not aware the ED emergency cart was not stocked with Dopamine. Pharmacist #5 stated all of the emergency medications should be available and easy to access for patient emergencies.