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Based on record review and interview, the hospital did not ensure that the patient (or his representative) had the right to be notified and make informed decisions regarding his care and treatment, including being able to request or refuse treatment. This failure prevented the patient from exercising his right.

Finding includes:

Patient 11 was admitted to the emergency department (ED) of the hospital on 11/14/21 following a stab wound to the chest. Review of an ED note dated 11/14/21 at 2:33 a.m. revealed that the patient was alert, oriented times 3 (person, time, place) and had, approximately, a 3-cm wound to the left back below the scapula. Following a radiology report which noted several findings including a left pneumothorax (the presence of air or gas in the cavity between the lungs and the chest wall causing collapse of the lung), a decision was made for the placement of a chest tube which included administration of an anesthetic agent, dissecting tissue over the intercostal space (space between the ribs) with a scalpel, inserting the tube, and then securing the tube with silk sutures at the insertion site.

Further record review revealed that while documentation was made that Patient 11's verbal permission was received for repair of the stab wound site, there was no indication that informed consent was obtained from the patient for insertion of the chest tube.

Review the hospital's policy and procedure on Informed Consent (effective 7/06/21) revealed that "Informed consent or informed refusal must be obtained and recorded in compliance with the procedures stated in the policy." Medical procedures requiring informed consent, according to the policy, included chest tube placement, as well as administration of blood products. The same ED note (dated 11/14/21 at 2:33 a.m.) indicated that Patient 11 had also received 2 units of FFP (fresh frozen plasma) for which informed consent was not documented in the medical record as having been obtained.

The policy further noted that "In an emergency situation in which consent cannot be obtained, the clinician will document the circumstances in their clinical documentation within the patient's medical record."

A medical record review conducted concurrently with a licensed staff (LS20) on 11/17/21 at 1:40 p.m. revealed that while an inpatient admission consent was obtained and signed by the patient, LS20 stated that she could not find any documentation that informed consent was obtained for the chest tube placement and for administration of the FFP, a blood product.

Based on staff interview and review of documents, the facility failed to ensure pharmacy technician (PT) training and competencies for intravenous (IV) medication compounding (mixing) were supervised by a pharmacist for ten of ten PT personnel files reviewed (PT5, PT6, PT7, PT8, PT9, PT10, PT11, PT12, PT13, and PT14. Failure to ensure sterility of the IV end product had the potential to cause negative outcomes for patients receiving these medications.

Findings include:

During an interview with Staff 5, Pharmacy Technician, on 10/17/21 at 10:00 AM, he/she stated that he/she had worked in the facility for two years, had been trained in IV compounding by other technicians, and had never been competency checked by a pharmacist.

During an interview with Staff 4, Acting Chief Pharmacist, on 11/17/21 at 10:00 AM, Staff 4 stated that he/she did not know what qualifications the pharmacy technicians were required to maintain and did not know if the pharmacy technicians were evaluated for competency.

During a follow-up interview with Staff 4 on 11/18/21 at 9:35 AM, he/she was asked to provide documentation of training and evaluations of pharmacy technicians for proper infection control techniques for IV compounding. Staff 4 stated, "New staff shadow other technicians in each position," and stated the pharmacist had no input or oversight of the training program. Staff 4 was unable to locate documentation of pharmacy technician training or recent competency checks for current employees. During the interview, Staff 4 did show documents titled, "RL-2 (brand name of testing solutions) Validation Exercise Sterility Log" dated 2018, indicating that three of the current ten pharmacy technicians had been tested for competency in 2018. Staff 4 explained the testing demonstrated that the pharmacy technicians maintained sterile technique but was unable to explain why this testing was no longer conducted with the staff. Staff 4 stated, "Every tech. should be tested with the Validation Exercise at least once."

Review of the personnel files of the ten current pharmacy technicians (PTs), PT5, PT6, PT7, PT8, PT9, PT10, PT11, PT12, PT13, and PT14 showed all ten had current certification from the Pharmacy Technician Certification Board, but none of the files showed documentation of hospital training or competency evaluations.

Review of the position description titled, "Chief of Pharmacy," revised date 11/17/19, revealed, "Essential Duties, Functions and Responsibilities: Assumes responsibility for the professional actions of the pharmacy staff; Ensures orientation of staff to the functions of the Pharmacy Department."

Review of the facility's policy titled, "Intravenous Medication Preparation and Administration," revision date 09/18/14, revealed, "Custom made IV medications by their nature are inherently high in potential risk due to contamination and/or complications ...IVs prepared in the pharmacy will be prepared either by a registered pharmacist or a pharmacy technician under the supervision of a pharmacist. All pharmacy personnel will be trained, and their competency certified prior to making IV solutions without direct supervision."

Based on observation, interview and record review, the Governing Body (GB) failed to recognize the need to ensure coverage of infection control prevention, monitoring, education and surveillance while recruiting for a new infection control officer. This failure had the potential to cause infections or outbreaks within the hospital

On 11/17/2021 at 3:03 PM, an interview and record review were conducted with VP 1 and VP 2. They stated the IC offsite contractor (ICOC) was responsible for mandatory reporting of infections to the surrounding state's health departments and to the National Health Safety Network (a federal government reporting system), not the infection control program. They stated ICO 2 was only responsible for the same reporting as the ICOC, not the infection control program, and ICO 2 had left on November 6, 2021. They stated infection control oversight was the responsibility of VP 2, who was not a medical or clinical staff. They reviewed the hospital document, titled "Infection prevention and Control Survey Report," dated April 1-June 30 2021, and stated there were no further reports since June 30, 2021.

On 11/18/2021 at 8:51 AM, an interview and record review was conducted. Per the document titled "Personnel Orders," ICO1's last day providing IC services in the hospital was 4/2/21. Per the Quality Assurance Manager (QAM), ICO 2's last day was 11/7/21.

On 11/18/2021 at 2:06 PM, during an interview, the QAM stated the hospital was unable to provide documentation of a Health Care Associated infection monitoring system, an infection control events monitoring system, hand hygiene compliance tracking, infectious disease reporting or targeted surveillance data for infections of employees or patients.

On 11/18/2021 at approximately 1 PM, an interview was conducted with the GB. The GB stated without an ICO, there was a potential for infections or outbreaks within the hospital because there was no IC system in place to recognize a problem quickly. The GB stated there had been lack of communication with the units and departments in the hospital because there was no ICO. The GB stated the hospital staff had no ICO, had not known who to contact, how to get assistance or who to report infections to. The GB stated they had not considered delegating ICO duties to medical or nursing staff to ensure coverage of the IC program, and should have.

On 11/18/2021 at 2:47 PM, a record review was conducted. Per the document titled "Services Rendered," dated 8/23/21, ICO 3's final date of work was 8/19/21. There had been no infection control program hospital-wide for three months.

Based on interview and record review, the Antibiotic Stewardship Committee did not follow their policy when they failed to provide training to pharmacy staff to analyze the use of antibiotics hospital-wide. In addition, not all pharmacists were trained in the antibiotic stewardship program guidelines. As a result, there was a potential to miss opportunities to optimize the use of antibiotics for patient care, which could lead to harm caused by unnecessary antibiotic use, and antibiotic resistance.

Findings include:

On 11/17/2021 at 2:44 PM, an interview was conducted with the Surgical Director (SD). The SD stated "I don't get [updates] about the surgical site infection control protocol (SCIP). No one has given me any updates or data regarding SCIP ...We aren't getting the data back telling me how things are going- nothing since June 30, 2021 has been provided to me ... It would be helpful to have the data to determine if we are compliant."

On 11/18/2021 at 8:58 AM, an interview and record review were conducted with the Acting Chief of Pharmacy (ACP) and Antibiotic Stewardship Committee Leader (ASC). They stated the Antibiotic Stewardship Committee had developed practice guidelines for the administration of antibiotics, but there had been no program put in place to ensure the pharmacists had been trained in the guidelines. They stated some pharmacists had been trained, but not all. They further stated they were unable to retrieve data from the pharmacy computer system to analyze the use of antibiotics within the hospital, including those used for SCIP. Per the ACP and ASC, the potential outcome of failure to analyze the use of antibiotics hospital-wide included possible missed opportunities to optimize patient care.

On 11/18/21, the hospital policy, titled "Antibiotic Stewardship Program," dated May 2021, was reviewed. The policy read, in pertinent part, "Purpose: To optimize the use of antibiotics to effectively treat infections, protect patients from harms caused by unnecessary antibiotic use, and combat antibiotic resistance ...5. Tracking- monitor antibiotic prescribing, impact of interventions and other important outcomes ...6. Reporting- Regularly report on antibiotic use ...to prescribers, pharmacists, nurses and hospital leadership ...7. Education- educate prescribers, pharmacists ...about ...optimal prescribing ...."