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Based on observation, interview and record review, the facility failed to ensure the necessary supplies and equipment for patient care were safe, maintained, and readily available for a universe of 12 patients presented to the Emergency Department (ED) from September 2, 2023, through September 5, 2023, when there were 20 vacutainers (blood collection tubes with colored rubber stoppers creating a vacuum seal inside of the tubes allowing predetermined amount of liquid to be drawn) and one (1) feeding tube (a medical device to assist in providing nourishment by bypassing oral intake) found to be expired in the ED.

This failure had the potential to result in unsafe care provided to patients with beyond the use date (expired) supplies, which could potentially cause infection, injuries, an unnecessary prolonged hospitalization, or death to medically compromised patients.

Findings:

During a concurrent observation and interview on September 5, 2023, at 1:10 PM, in the ED, with Registered Nurse 1 (RN 1), there were three (3) red/black top vacutainers found with an expiration of August 31, 2023. RN 1 verified and confirmed the expiration date of the vacutainers. RN 1 stated, all expired supplies should have been removed from the patient's care area.

A follow-up concurrent observation and interview on September 5, 2023, at 1:25 PM, in the ED, with RN 1, there were 17 vacutainers found as followed:

One (1) grey/black top vacutainer with an expiration date of February 28, 2023
Eight (8) grey/black top vacutainers with an expiration date of April 30, 2023
Two (2) grey/black top vacutainers with an expiration date of July 31, 2023
One (1) grey/black top vacutainer with an expiration date of August 31, 2023
Five (5) lavender top vacutainers with an expiration date of June 9, 2023

RN 1 verified and confirmed the expiration date of the vacutainers.

A follow-up concurrent observation and interview on September 5, 2023, at 1:30 PM, in the ED, with RN 1, there was one (1) feeding tube found with an expiration date of January 10, 2023. RN 1 verified and confirmed the expiration date of the feeding tube. RN 1 stated, it should have been removed from the patient's care area.

During an interview on September 5, 2023, at 3:10 PM, in the conference room, with the Chief Nursing Officer (CNO), the CNO stated, the facility did not have any specific person assigned to check for expired supplies. The CNO further stated, he was not aware of any expired supplies prior to the survey. The CNO confirmed, all expired items should have been removed and they should not be readily available to be used in the patient's care area.

During a concurrent interview and record on September 6, 2023, at 1:10 PM, with the CNO, the facility's policies and procedures (P&P) titled, "Outdated Supplies," dated April 2016, was reviewed. The P&P indicated, "Policy: It is the policy of [Hospital Name] Emergency Room that all equipment instruments and supplies are checked and re-ordered on a regular basis by the ER personnel. Purpose: To ensure that adequate supplies with current dates are available at all times. Procedure: Supplies are checked for outdated monthly. Sterile instruments are checked for outdated monthly ..." The CNO verified and stated, the supplies should have been checked monthly and removed any expired items as necessary.

Based on interview and record review, the facility failed to ensure an adequate and effective oversight by the Governing Body (GB) that carried out the functions to provide a safe and effective patient care when:

1. The facility was unable to provide the documentation to show the quality assurance program was established, implemented, and monitoring of inventory, sterile supply, competency training and infection prevention policies to ensure the quality health care for a universe of 15 patients admitted to the facility from April 25, 2023, through September 7, 2023 (Refer to C-0962).

The cumulative effect of these systemic problems resulted in the facility's failure to deliver care in compliance with the Condition of Participation for Governing Board and failure to provide a safe and secure environment for patients.

Based on interview and record review, the facility failed to provide the adequate and effective oversight by the Governing Body (GB) when the facility was unable to show that the GB oversaw the facility's quality of care provided including monitoring of inventory, sterile supply, competency training for new staff and infection control program policy to ensure a safe and effective patient care for a universe of 15 patients admitted to the facility from April 25, 2023, through September 7, 2023.

This failure had resulted in the facility's failure to oversee the operation to monitor and ensure a safe environment and improve or sustain quality of care for patients.

Findings:

During an interview on September 5, 2023, at 3:10 PM, in the conference room, with the Chief Nursing Officer (CNO), the CNO stated, the facility did not have any specific person assigned to check for expired supplies.

A follow-up interview on September 6, 2023, at 9:25 AM, with the CNO, the CNO stated, he was not aware of the damaged sterile package in the Emergency Department (ED). The CNO further stated, the facility did not have a system, or anyone assigned to keep track of sterile supplies.

A follow-up interview and record review on September 7, 2023, at 11:15 AM, with the CNO, the facility's document title, "Medication Vials Single Use Only Inservice Sign-in Sheet," dated November 2022, was reviewed. Registered Nurse 3 (RN 3) was not listed on the sheet. The CNO verified and confirmed, RN 3 did not receive the provided education regarding using a multiple dose vial on a single patient in the ED. The CNO stated, he did not provide other formal education session to the ED nursing staff after November 2022, so all new hires did not receive the training.

A follow-up concurrent interview and record review on September 7, 2023, at 11:20 AM, with the CNO, the facility's policies and procedures (P&P) titled, "Infection Prevention and Control Plan," was reviewed. There was no approval date from the GB committee. The CNO stated, this policy was recently developed after the last survey in 2022 and had not been presented to the GB for the approval.

A follow-up interview on September 7, 2023, at 11:35 AM, with the CNO, the CNO stated, the GB committee usually meets once a month to discuss any quality issues and reviewing the facility's P&P. The CNO further stated, the P&P for "Infection Prevention and Control Plan" needs to be presented to the GB for approval before implementation and the GB is responsible to oversee the operation. The CNO stated, there was no current or active policy for infection control that was approved by the GB.

A review of the facility's bylaws, "Adoption. These Bylaws, Rules and Regulations are adopted by the Active Medical Staff of [Hospital Name]," approved February 28, 2015, which indicated, "Article IX Committees. 9.01 Joint Conference Committee ... 9.01-2 Purpose, Responsibilities and Authority: This committee shall serve as a focal point for furthering an understanding of roles, relationships, and responsibilities of the Governing Body, administration, and the Medical Staff. It may also serve as a forum for discussion of any Hospital matters regarding the provision of patient care ... 9.02-2 Purpose: The purpose of the Medical Executive Committee is to assure the development and implementation of policies, procedures, programs, rules, and regulations that accomplish the purposes and functions of the Medical Staff organization. The Committee shall also serve as the primary forum by which the Medical Staff formally participates in the Hospital's budget, planning, and policy making processes ..."

Based on observation, interview and record review, the facility failed to follow the manufacturer's guideline and ensure the medication was not available and beyond the use date (expired) after opened for a universe of 12 patients presented to the Emergency Department (ED) from September 2, 2023, through September 5, 2023, when a multiple dose insulin (medication to treat high blood sugar) vial was opened and stored where without any indication of expiration date on the vial.

This failure had the potential to result in patients receiving unusable outdated medications which could cause infection from cross-contamination (the transfer of harmful bacteria), injuries, or death to medically compromised patients.

Findings:

During a concurrent observation and interview on September 5, 2023, at 1:40 PM, in the ED medication refrigerator, with Registered Nurse 1 (RN 1), a vial of multiple dose insulin was observed without a protective cap on top of the bottle. RN 1 verified and confirmed, there was no expiration date written on the vial. RN 1 stated, the bottle considered as "opened" without a protective cap and it should have an expiration date written on the vial.

A follow-up concurrent interview and record review on September 5, 2023, at 1:42 PM, with RN 1, the manufacturer guideline for "Instruction for Use [Brand Name] Insulin," undated, as reviewed. The manufacturer guideline indicated, "After vials have been opened: Store opened vials in the refrigerator ... for up to 31 days ... Throw away all opened vials after 31 days, even if there is still insulin left in the vial ..." RN 1 verified and confirmed, the opened vial of multiple dose insulin should not have been kept more than 31 days. RN 1 stated, she was unable to tell when the vial was opened without a label or expiration date. RN 1 further stated, the vial should have been discarded since the opened date could not be identified.

During a concurrent interview and record review on September 6, 2022, at 9:20 AM, in the conference room, with the Chief Nursing Office (CNO), the facility's policies and procedures (P&P) titled, "Use of Multiple Dose Vials (MDVs)," revised February 2016, was reviewed. The P&P indicated as followed: "Policy: The beyond-use date (BUD) for an opened or entered (i.e., needle-punctured) multiple dose container with antimicrobial preservatives shall be 28 days, unless otherwise specified by the manufacturer. The healthcare provider shall write the expiration date on the vial, when it is opened. This revised expiration date replaces the manufacturer's original expiration date unless the original expiration date occurs earlier than the 28-day date ..." The CNO verified and confirmed, the facility had not developed or implemented the new policy for single used of multiple dose vial of insulin. The CNO stated, the multiple dose vial could still be used for multiple patients if it was used before the expiration date after the vial was opened. The CNO further stated, the opened vial should have been discarded if it did not have an expiration date written on the vial.

Based on observation, interview and record review, the facility failed to ensure the nursing staff received a competency training before working in the assigned area for a universe of 12 patients presented to the Emergency Department (ED) from September 2, 2023, through September 5, 2023, when four (4) ED nursing staff did not receive a training regarding using a multiple dose vial for a single patient.

This failure had the potential to negatively affect patient's care due to incompetent or unqualified nursing staff such as preventable medication handling and administration error, which could harm patients' health and safety, causing prolonged hospitalization or lead up to death.

Findings:

During a concurrent observation and interview on September 5, 2023, at 1:40 PM, in the ED medication refrigerator, with Registered Nurse 1 (RN 1), a vial of multiple dose insulin was observed without a protective cap on top of the bottle. RN 1 verified and confirmed, there was no expiration date written on the vial. RN 1 stated the bottle was considered as "opened" without a protective cap and it should have an expiration date written on the vial.

During an interview on September 5, 2023, at 3:22 PM, in the medication storage room, with the Director of Pharmacy (DOP), the DOP stated, the facility provided an in-service training to all ED nursing staff after last survey in 2022 regarding using a multiple dose vial on a single patient. The DOP further stated, it was instructed to staff to throw away any opened multiple dose vial after patient discharged or transferred or sent the vial home with patient.

During an interview on September 6, 2023, at 8:45 AM, in the medication storage room, with RN 2, RN 2 stated, there was an education provided last year in 2022 regarding using a multiple dose vial on a single patient in the ED; however, the education was not provided to all new ED nursing staff during the new employee education.

During a concurrent interview and record review on September 6, 2022, at 9:20 AM, in the conference room, with the Chief Nursing Office (CNO), the facility's policies and procedures (P&P) titled, "Use of Multiple Dose Vials (MDVs)," revised February 2016, was reviewed. The P&P indicated as followed: "Policy: The beyond-use date (BUD) for an opened or entered (i.e., needle-punctured) multiple dose container with antimicrobial preservatives shall be 28 days, unless otherwise specified by the manufacturer. The healthcare provider shall write the expiration date on the vial when it is opened. This revised expiration date replaces the manufacturer's original expiration date unless the original expiration date occurs earlier than the 28-day date ..." The CNO verified and stated, the facility did not develop a new policy for multiple dose vial, but the ED nursing staff was trained and expected to use of a multiple dose vial on a single patient as a unit specific process.

During an interview on September 6, 2023, at 3:50 PM, in the ED, with RN 3, RN 3 stated, she was hired around July or August 2022. RN 3 stated, she did not receive the training regarding using a multiple dose vial on a single patient in the ED.

A review of the facility's current nursing staff roster and "Medication Vials Single Use Only Inservice Sign-in Sheet," dated November 2022, indicated, there were three (3) ED nursing staff hired in 2023 and were not listed on the sign-in sheet including:

RN 4, hired on April 19, 2023
RN 5, hired on March 1, 2023
RN 6, hired on April 27, 2023

A follow-up interview and record review on September 7, 2023, at 11:15 AM, with the CNO, the facility's document title, "Medication Vials Single Use Only Inservice Sign-in Sheet," dated November 2022, was reviewed. RN 3, RN 4, RN 5, and RN 6 were not listed on the sign-in sheet. The CNO verified and confirmed, all ED nursing staff did not receive the provided education regarding using a multiple dose vial on a single patient in the ED. The CNO stated, he did not provide other formal education session to the ED nursing staff after November 2022, so all new hires did not receive the training.

Based on interview, and record review, the facility failed to ensure the infection prevention control program demonstrate adherence and control the transmission of infectious diseases for a universe of 15 patients admitted to the facility from April 25, 2023, through September 7, 2023, when:

1. The facility did not ensure a system in place to track all infection surveillance, prevention and control, and antibiotic use activities to demonstrate the implementation and evaluation of the activities (Refer to C-1225).

2. The facility did not have an appropriate communication and discussion between the infection control program and the facility-wide quality assurance (QA) team to monitor and evaluate the program for sustained improvement (Refer to C-1237).

The cumulative effects of these systemic problems resulted in the hospital's inability to ensure safe and quality infection control program.

Based on observation, interview, and record review, the facility failed to develop a system to identify, report, and monitor the infection prevention control program for a universe of 15 patients admitted to the facility from April 25, 2023, through September 7, 2023, when the facility did not have a system in place to track all infection surveillance to demonstrate the implementation and evaluation of the program.

This failure had resulted in the facility's inability to track and evaluate the infection control program and had the potential to cause a preventable infection from the cross-contamination (the transfer of harmful bacteria) within the facility which can negatively impact patients' health and subject the patients to a prolonged hospitalization.

Findings:

During a concurrent observation and interview on September 5, 2023, at 1:20 PM, in the Emergency Department (ED), with Registered Nurse 1 (RN 1), one silver clamped equipment seal package with the label as "Sterile unless package opened or damaged" had a hole in the package. RN 1 verified and confirmed, the sterile package was damaged. RN 1 stated, the sterile equipment should be sealed and intact. RN 1 further stated, the damaged package should be removed from the patient's care area since it had a high risk for cross-contamination.

During an interview on September 6, 2023, at 9:25 AM, in the conference room, with the Chief Nursing Officer (CNO), the CNO stated, he was not aware of the damaged sterile package in the ED. The CNO further stated, the facility did not have a system, or anyone assigned to keep track of sterile supplies. The CNO confirmed, the outdated and damaged sterile product should have been removed from the patient's care area.

A follow-up interview on September 6, 2023, at 2:00 PM, with the CNO, the CNO stated, the facility was recently hired a new infection prevention and control professional (IPCP) who will oversee the infection control program. The CNO stated, he was unable to provide any documents to show the tracking of infection control rate, identification of any possible hospital acquired infection (HAI), and the antibiotic used activities.

A follow-up concurrent interview and record review on September 7, 2023, at 11:20 AM, with the CNO, the facility's policies and procedures (P&P) titled, "Infection Prevention and Control Plan," was reviewed. There was no approval date from the Governing Body (GB) committee. The CNO stated, this policy was recently developed after the last survey in 2022 and had not been presented to the GB for the approval. The CNO further stated, the Infection Control Committee was supposedly scheduled to meet quarterly (every four months); however, the last meeting was completed on March 8, 2023. The CNO stated, the facility did not have a meeting in July 2023. The CNO further stated, there was no current or active policy for infection control that was approved by the GB.

A review of the facility's bylaws, "Adoption. These Bylaws, Rules and Regulations are adopted by the Active Medical Staff of [Hospital Name]," approved February 28, 2015, which indicated, "Article IX Committees. 9.03 Other Medical Staff Committees-General Provision ... 9.03-3 Duties: (a) Each staff committee is responsible to: 1. Develop policies and procedures describing how it will carry out its purpose; and, upon approval by the Medical Executive Committee and the Governing Body implement those policies and procedures ... 3. Unless otherwise specified in these Bylaws, meet at least quarterly but as often as necessary to fulfill its purpose. 4. Unless otherwise provided by hospital policy, maintain permanent records of its activities ..."

Based on interview, and record review, the facility failed to ensure the infection prevention and control professional (IPCP) had the communication and collaboration to the quality assurance (QA) team on any potential infection control issues for a universe of 15 patients admitted to the facility from April 25, 2023, through September 7, 2023, when the facility did not have an appropriate communication and discussion to monitor and evaluate the infection prevention and control program for sustained improvement.

This failure had resulted in the facility's inability to work together as a whole to track and evaluate the IPCP to ensure the provision of care and improve or sustain quality of care for patients in the facility.

Findings:

During an interview on September 6, 2023, at 2:00 PM, in the conference room, with the Chief Nursing Officer (CNO), the CNO stated, the facility was recently hired a new IPCP who will oversee the infection control program. The CNO further stated, he was unable to provide any data collection to show the infection control plans were implemented and no documented evidence to show any communication or discussion with the QA team regarding the implementation and outcomes of the infection control and risk assessment plan.

A follow-up concurrent interview and record review on September 7, 2023, at 11:20 AM, with the CNO, the facility's policies and procedures (P&P) titled, "Infection Prevention and Control Plan," was reviewed. There was no approval date from the Governing Body (GB) committee. The CNO stated, this policy was recently developed after the last survey in 2022 and had not been presented to the GB for the approval. The CNO further stated, the Infection Control Committee was supposedly scheduled to meet quarterly (every four months); however, the last meeting was completed on March 8, 2023. The CNO stated, the facility did not have a meeting in July 2023. The CNO further stated, there was no current or active policy for infection control that was approved by the GB.

A review of the facility's bylaws, "Adoption. These Bylaws, Rules and Regulations are adopted by the Active Medical Staff of [Hospital Name]," approved February 28, 2015, which indicated, "Article IX Committees. 9.03 Other Medical Staff Committees-General Provision ... 9.03-3 Duties: (a) Each staff committee is responsible to: 1. Develop policies and procedures describing how it will carry out its purpose; and, upon approval by the Medical Executive Committee and the Governing Body implement those policies and procedures ... 3. Unless otherwise specified in these Bylaws, meet at least quarterly but as often as necessary to fulfill its purpose. 4. Unless otherwise provided by hospital policy, maintain permanent records of its activities ..."

Based on interview and record review, the facility failed to ensure the Periodic Evaluation and Quality Assurance (QA) Review was met when:

1. The facility was unable to provide the documentation to show an effective QA program to monitor, analyze, and evaluate the quality and maintenance of an effective, ongoing, hospital wide, data driven QA of overall provision of care for a universe of 15 patients admitted to the facility from April 25, 2023, through September 7, 2023 (Refer to C-1306).

The cumulative effect of the facility's failure to have a quality assurance system in place to ensure oversight of the hospital's QA program resulted in the facility's failure to deliver care in compliance with the Condition of Participation for QAPI and failure to provide care to their patients in a safe environment.

Based on interview and record review, the facility failed to ensure and maintain an effective, ongoing, hospital-wide, data driven quality assurance (QA) program when the facility was unable to provide the monitoring of inventory, sterile supply, competency training for new staff, and the collection of data and analysis of the risk assessment issues to evaluate the quality and appropriateness of the treatment and outcomes for a universe of 15 patients admitted to the facility from April 25, 2023, through September 7, 2023.

This failure had resulted in the facility's inability to focus on the high-risk assessment and problem prone areas to ensure the provision of care and improve or sustain quality of care for patients to go unrecognized and unresolved for all patients who received services within the facility.

Findings:

During an interview on September 5, 2023, at 3:10 PM, in the conference room, with the Chief Nursing Officer (CNO), the CNO stated, the facility did not have any specific person assigned to check for expired supplies.

A follow-up interview on September 6, 2023, at 9:25 AM, with the CNO, the CNO stated, he was not aware of the damaged sterile package in the Emergency Department (ED). The CNO further stated, the facility did not have a system, or anyone assigned to keep track of sterile supplies.

During a concurrent interview and record review on September 6, 2023, at 2:00 PM, in the conference room, with the Chief Nursing Officer (CNO), the facility's "Performance Improvement Monitoring and Evaluation Plan," dated February 1, 2023, was reviewed. The CNO stated, the facility had developed plans to evaluate on identified areas such as patient safety and infection control. The CNO further stated, he was unable to provide any data collection to show the tracking of all identified focus areas such as pain assessment, effectiveness of pain medication, patient safety, infection control rate, identification of any possible hospital acquired infection (HAI), and the antibiotic used activities. The CNO confirmed, the facility did not have a system in place or an effective QA program to monitor and evaluate the quality of care.

A follow-up interview and record review on September 7, 2023, at 11:15 AM, with the CNO, the facility's document title, "Medication Vials Single Use Only Inservice Sign-in Sheet," dated November 2022, was reviewed. Registered Nurse 3 (RN 3) was not listed on the sheet. The CNO verified and confirmed, RN 3 did not receive the provided education regarding using a multiple dose vial on a single patient in the ED. The CNO stated, he did not provide other formal education session to the ED nursing staff after November 2022, so all new hires did not receive the training.

A review of the facility's policies and procedures (P&P) titled, "Quality Assurance Performance Improvement Plan," dated January 2023, indicated, "Purpose: The purpose of this policy is to establish a program and matching department with the responsibility of ensuring high quality patient care and consistent improvement on metrics that are meaningful to our district and community ... 1. Establish, maintain, and implement written policies and procedures which serve as the roadmap for all quality monitoring and improvement activities within the district, providing standardized workflows but allowing implementation flexibility in each department. These policies should centralize ancillary care delivery and essential business process monitoring within the quality department as appropriate, providing the necessary data collection and management tools (and P&P), training, and project management infrastructure that empower staff to implement Continuous Quality Monitoring and Improvement throughout the healthcare district ..."