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Based on observation interview, and record review, the facility failed to ensure care and treatment were provided in a safe environment, for one of 30 sampled patients (Patient 5), when:

1. Medical staff was not held accountable to the governing body for the quality of care provided patients (Refer to A-0049); and

2. Services were not provided in a safe and effective manner (Refer to A-0083).

The cumulative effect of these systemic failures resulted in the patients to not be provided safe and quality care to meet the patient needs and had the potential to delay the provision of care and treatment of the patients.

Based on interview and record review, the facility failed to ensure the medical staff is accountable to the governing body for the quality of care provided patients, for one of 30 patients (Patient 5).

This failure had the potential to result in patient harm or death.

Findings:

On April 11, 2024, at 9 a.m., a concurrent interview and record review with the Chief Quality Officer (CQO) and the Patient Safety Coordinator PSC were conducted. The facility document titled, "History and Physical," dated March 22, 2024, indicated Patient 5 was admitted to the facility on March 22, 2024, for low blood pressure.

The facility document titled, "Consent to Surgery Or Special Procedure," dated April 2, 2024, was reviewed. The document indicated Patient 5 was to have a percutaneous endoscopic gastrostomy (PEG, a procedure in which a tube is passed into a patient's stomach though a small incision on the abdominal wall for feeding) and a surgical tracheostomy (surgically created hole in a windpipe that provides an alternative way of breathing) on April 2, 2024.

The facility document titled, "IntraOperative Case Report," dated April 3, 2024, at 1:02 a.m., indicated, "...Emergent: No...Anes [Anesthesia] Start 04/02/2024 [April 2, 2024] 16:57 [4:57 p.m.]...Anesthesia: General anesthesia...Anes Stop 04/02/2024 23:10 [11:10 p.m.]...Case Note: Tracheostomy And Percutaneous Endoscopic Gastrostomy Insertion Turned Into Open Gastrostomy..."

The CQO stated there was an incident in the operating room (OR) where the surgeon requested Registered Nurse (RN) 2 to administer local anesthesia and to make an incision into Patient 5.

On April 16, 2024, at 5:05 p.m., an interview was conducted with the Governing Board Member (GBM) 2. She stated there are only three members on the governing board. She stated the members were GBM 1, GBM 2, and GBM 3. She stated she was not aware why there were no members of the community in the governing board. GBM 1 stated she did not know how she was appointed to the board. She stated she was not informed about the unusual event for Patient 5.

The facility document titled, "AMENDED AND RESTATED BYLAWS OF (NAME OF FACILITY) INCLUDES GOVERNING BODY BYLAWS," dated March 31, 2021, were reviewed. The documented indicated, "...The approved Medical Staff Bylaws and rules and regulations...shall create an effective administrative unit to discharge the functions and responsibilities assigned to the Medical Staff by the BOARD, and shall be upheld by Board...Board Responsibility. The Medical Staff shall be responsible to the Board for the general quality of medical care provided in the hospital and the ethical and professional standards of the members of the Medical Staff. The Board shall assure that specific review and evaluation activities are undertaken in order to assess, preserve and improve the overall quality and efficiency of patient care in the hospital...(c) Accountability to the Board. The Medical Staff and the other health care personnel providing patient care services at the hospital shall conduct and be accountable to the Board for conducting acitivities that contribute to the preservation and improvement of the quality and efficacy of patient care provided in the hospital...Documentation. The Board shall require, receive, consider and act upon the findings and recommendations emanating from the activities required by sub-section (c) above..."

Based on interview and record review, the facility failed to ensure the facility provided services in a safe and effective manner, for one of 30 sampled patients (Patient 5).

This failure could have resulted in patient harm or death.

Findings:

On April 8, 2024, at 1 p.m., an unannounced visit was conducted at the facility to investigate a complaint.

On April 9, 2024, at 4:10 p.m., an interview was conducted with the Director of Surgical Services (DSS). She stated she was called by the Certified Registered Nurse Anesthetist (CRNA, an RN who specialized in the administration of anesthesia [medications for sedation and pain]) who told her a "bad event" occurred in the operating room (OR). She stated the CRNA told her the surgeon had told RN 2 to administer a local anesthesia on Patient 5's abdominal skin and to make an incision (surgical cut) on the patient's skin. She further stated the Surgical Tech (ST) 1 was asked by the surgeon to pull the guidewire harder and this caused the PEG tube to come out of Patient 5's abdomen. The DSS stated this incident caused the patient to then have an open gastrostomy (placement of a tube placement into the stomach using a surgical procedure where the abdomen is cut open duirng the surgery). The DSS stated she received a call from RN 2 who told her, "I know I shouldn't have done it, I was stressed, the surgeon was yelling and cussing, I felt pressured."

On April 10, 2024, at 3 p.m., an interview was conducted with Surgical Tech (ST) 2. She stated the Surgical Charge Nurse (SCN) assigned her to this case. ST 2 stated she told the SCN she did not know how to assist in a PEG surgery. ST 2 stated S 1 instructed RN 2 and ST 1 to put on sterile gloves. ST 2 states S 1 then told RN 2 to administer local anesthesia to Patient 5's abdomen and then to insert the needle into Patient 5's abdomen into the stomach. ST 2 stated S 1 then instructed ST 1 to pull the guide wire out of Patient 5's stomach, and when ST 1 felt resistance S 1 told her to keep pulling. ST 1 stated the PEG tube then came out of Patient 5's abdomen. ST 2 stated S 1 became angry and started cursing and told them they needed to convert to an open surgery.

On April 10, 2024, at 3:38 p.m., an interview with the SCN was conducted. The SCN stated she assigned ST 1 and ST 2 to Patient 5's PEG procedure. She stated ST 1 and ST 2 stated they were unfamiliar with the PEG part of the case. She stated a practice kit was pulled out and ST 1 was inserviced (trained) using the practice kit. SCN stated the in-service only instructed ST 1 on the procedures she could do, which was hold the scope for the surgeon and hand him instruments. She further stated ST 2 was not in-serviced. The SCN stated the expectation of the charge nurse is to find staff that is comfortable with the procedure. The SCN stated she did not find anyone else because they were not available. She further stated she did not reach out to the Director of Surgical Services for help.

On April 11, 2024, at 9 a.m., a concurrent interview and record review were conducted with the Chief Quality Officer (CQO) and the Patient Safety Coordinator (PSC). The facility document titled, "History and Physical," dated March 22, 2024, indicated Patient 5 was admitted to the facility on March 22, 2024, for low blood pressure.

The facility document titled, "Consent to Surgery Or Special Procedure," dated April 2, 2024, was reviewed. The document indicated Patient 5 was to have a percutaneous endoscopic gastrostomy (PEG, a procedure in which a tube is passed into a patient's stomach though a small incision on an abdominal wall for feeding) and a surgical tracheostomy (surgically created hole in a windpipe that provides an alternative way of breathing) on April 2, 2024.

The facility document titled, "IntraOperative Case Report," dated April 3, 2024, at 1:02 a.m., indicated, "...Emergent: No...Anes [Anesthesia] Start 04/02/2024 [April 2, 2024] 16:57 [4:57 p.m.]...Anesthesia: General anesthesia...Anes Stop 04/02/2024 23:10 [11:10 p.m., 6 hours and 13 minutes]...Case Note: Tracheostomy And Percutaneous Endoscopic Gastrostomy Insertion Turned Into Open Gastrostomy..."

The CQO stated there was an incident in the operating room (OR) where the surgeon requested Registered Nurse (RN) 2 to administer local anesthesia and to make an incision into Patient 5.

On April 11, 2024, at 10 a.m., an interview with ST 1 was conducted. ST 1 stated, at the start of Patient 5's PEG procedure, the staff could not get the scope to work properly. She stated S 1 had said, "Who is going to do the peg since I'm going to run the scope," in which she (ST 1) responded that they were there to help S 1. ST 1 stated S 1 then told RN 2 to administer the local anesthesia to Patient 5's abdomen. ST 1 stated S 1 had said, "Anyone can do the local, just grab it and do the local!" ST 1 stated S 1 then instructed RN 2 to do the incision into Patient 5's abdomen then instructed ST 1 to pull the guidewire back through the abdomen. ST 1 stated she felt resistance and stopped pulling but S1 became angry and told her to keep pulling. ST 1 stated when she pulled a second time per S 1 instructions, the PEG tube came out of Patient 5's abdomen. ST 1 stated S 1 became very angry and yelled, "What the [expletive] happened," and she (ST 1) responded that she told him (S 1) she was in, but he insisted on her pulling more. ST 1 stated S 1 then told the staff that he would have to open the patient up. ST 1 stated S 1 apologized to her and said he should have never asked her to pull the wire and that it was his (S 1's) fault.

On April 11, 2024, at 11 a.m., an interview was conducted with the CRNA. The CRNA stated S 1 didn't seem like he was experienced in this type of case. The CRNA stated at the beginning of Patient 5's PEG procedure, the staff could not get the scope to work. He states S 1 was yelling at all the staff being condescending and belittling them. The CRNA stated the PEG tube placement was not an emergent case and could have waited till the next day when the proper equipment and knowledgeable staff was available. The CRNA stated both RN 2 and ST 1 had sterile gloves on during the procedure. The CRNA stated the surgeon performing a PEG procedure usually hands the scope over to the OR technician then scrubs in and administers local anesthesia, inserts the needle into the abdomen, and makes the abdominal cut. The CRNA stated a surgical tech had to assist S 1 place the peg tube onto the guidewire as S 1 was not doing it right. The CRNA stated S 1 then instructed ST 1 to pull the guidewire through the stomach and when ST 1 felt it was in place, S 1 very sarcastically told ST 1 to keep pulling and this was when the PEG tube came out of Patient 5's abdomen.

On April 11, 2024, at 12:30 p.m., an interview with Surgeon (S 2) was conducted. S 2 stated, during a PEG procedure, the nurses take care of monitoring the patient and the surgical techs are in charge of handing him instruments and hold the scope once it is in place. S 2 stated it is not in the scope of the RN's or the ST's practice to administer local anesthesia, insert a needle into the abdomen, or make any surgical cuts. S 2 stated he would not ask an RN to do any of those things.

On April 11, 2024, at 2 p.m., an interview was conducted with RN 2 and S1. RN 2 stated Surgeon 1(S 1) was having difficulty with the scope that would be used for Patient 5's PEG procedure. RN 2 stated he did not have much experience using PEG scopes at all. RN 2 stated S 1 was very upset and was yelling that he needed to do this case. RN 2 stated S 1 explained that S 1 would be doing the camera part of the procedure, and ST 1 would have to do the rest. RN 2 stated S 1 told RN 2 and ST 1 to don sterile gloves. RN 2 stated S 1 instructed him to administer topical anesthesia and insert the needle into Patient 5's abdomen. RN 2 stated he didn't feel comfortable doing it but with S 1 being angry, yelling, and cussing he felt pressured. RN 2 further stated S 1 told him to make a small incision into Patient 5's abdomen and unfortunately he did make that small incision. RN 2 stated S 1 then instructed ST 1 to pull the guidewire out of Patient 5's abdomen and ST 1 pulled the guidewire until ST 1 felt resistance but S 1 told ST 1 to continue pulling. RN 2 stated ST 1 pulled like instructed by S1 and the PEG tube completely came out of Patient 5's abdominal wall. RN 2 stated S 1 then became very angry and yelled at ST 1 while saying he now had to do an open surgery on Patient 5's abdomen. RN 2 stated he had never been trained to administer local anesthesia, to insert a needle into a patient stomach, or to make incision (cut) on a patient's skin and S 1 did not ask him (RN 2) if he was trained in these procedures.


S 1 stated he was not an employee of the facility. He stated he was contracted through (name of Company). S 1 stated he had only performed 10 endoscopic PEG tube placements in the past six years. S 1 stated there was a scope in the OR but it was not working, and that he did not know how to fix it. S 1 stated this surgery is a two-person procedure, one person has to do the scope and one person has to do the sterile portion. S 1 stated he asked the RN 2 to create a skin wheel with the dermal injection because the RN 2 was scrubbed and sterile. S 1 stated he asked RN 2 to advance a needle through the skin into the stomach and advance the guidewire through the needle into the stomach. S 1 stated he asked RN 2 to make a cut in the abdomen so the PEG tube could come out. S 1 stated ST 1 pulled the guide wire back out of the abdomen, guiding the PEG tube through. S 1 stated the PEG tube was seeded (in the right place) but it just popped out. S 1 stated he was not aware of RN 2's and ST 1's scopes of practice in (name of state). S 1 stated the local anesthesia administration, needle insertion, and the abdominal incision should be done by someone who is trained. S 1 stated he asked ST 1 to pull the guide wire even after she stated she met resistance. S 1 stated if he knew RN 2 was not supposed to do those procedures, he would not have asked RN 2 to do them. S 1 stated he supervised the staff the entire time and they did what he asked.

On April 12, 2024, at 1:45 p.m., an interview was conducted with the Chief of Surgery (COS). The COS stated it is not normal for a surgeon to ask a nurse to make an incision on a patient. The COS stated during a surgical residency, everyone's scope of practice is reviewed. The COS stated, "Why would a surgeon give a scalpel to someone who is not a surgeon?"

On April 12, 2024, at 2:10 p.m., an interview was conducted with the Medical Staff Director (MSD). The MSD stated this would be considered an unusual event. She further stated S 1 did not report the incident to the MSD and a written statement was not requested from S 1. MSD stated it was unusual for S 1 not to need to make a statement.

On April 16, 2024, at 4 p.m., an interview was conducted with the Chief Medical Officer and Chief of Clinical Operations (CMOCCO). The CMOCCO stated this event was an unusual event. The CMOCCO stated the surgeon should not have asked the OR staff "To do anesthesia, needle into the abdomen, cut." The CMOCCO stated a statement outside of the operative report was not obtained from S 1. The CMOCCO stated S 1 has completed his stay and will not be coming back. The CMOCCO stated, "There is a reason why he isn't coming back." The CMOCCO stated this event had not been reported to the state agency. The CMOCCO stated the responsibility is with the surgeon. The CMOCCO stated, "Clearly the RN practiced outside his scope. I have looked at competencies of our department staff and being asked to work outside of the scope is the person's responsibility." The CMOCCO stated it is not a normal practice to have anyone other than the surgeon cut into the patient. He further stated the surgeon should not have asked the staff to do what he did.

A review of the facility document titled, "Staff Registered Nurse- OR [operating room]," dated October 2023, was reviewed. The document indicated, "...Position Description...Under the supervision...to perform professional nursing duties in the care and services to patients and their families in an acute care...to assist physicians and carry out their orders...Knowledge & [and] Abilities...Federal, State, and local laws and regulations governing professional aspects of nursing...requires judgement/action which could result in undesirable patient outcome..."

A review of the policy and procedure (P&P) titled, "Scope of Services- Surgical Services," dated April 2021, was conducted. The P&P indicated, "...The Surgical Services Department...provides a safe and comfortable environment for both patients and staff in order to provide optimum assistance to the surgeon...The basic staffing plan for each Operating Room Suite is 1RN(s) and 1 scrub tech(s)...Qualifications Of Staff...An ongoing program of inservice education and periodic clinical skills evaluation for all staff members is maintained...Standards Of Practice and Methods UsedTo Meet Patient Care Needs...AORN [Association of periOperative Registered Nurses, a nationally recognized organization], ASPAN [American Society of PeriAnesthesia Nurses, a nationally recognized organization], Association of the Advancement of Medical Instrumentation (AAMI, a nationally recognized organization), the Center for Disease Control (CDC, a nationally recognized agency) and Public Health Department standards are references used in the formulation and review of policies, procedures and standards of practice in the Surgical Services Department, as well as collaborative input from the knowledgeable and expertise of the surgical staff...To assist in meeting patient care needs, support is readily available from all equipment and instrument manufactures..."

Based on interview and record review, the facility failed to develop, implement, and maintain an effective, ongoing, hospital-wide data driven quality program for the use of restraints (Refer to A0286).

This failure had the potential to cause harm or death to the patients.

The cumulative effect of these systemic failures resulted in the patients to not be provided safe and quality care to meet the patient needs and had the potential to delay provision of care and treatment.

Based on interview and record review, the facility failed to develop, implement, and maintain an effective, ongoing, hospital-wide data driven quality program for the use of restraints.

This failure had the potential to cause harm or death to the patients.

Findings:

On April 8, 2024, at 2 p.m., during the facility tour, an observation and concurrent interview was conducted with the Unit Supervisor (US). Patient 1 was observed to have bilateral (both left and right) soft wrist restraints and bilateral oversized mittens on his hands. The US stated the restraints were placed due to the patient attempting to pull out his intravenous catheter (IV, a long thin flexible tube that enters the body through a vein) and his Foley catheter (a device that drains urine from the bladder into a collection bag).

On April 9, 2024, at 3:30 p.m., a review of Patient 1's record was conducted. The "History and Physical," dated April 6, 2024, indicated Patient 1 was admitted to the facility on April 6, 2024, at 2:13 p.m., with diagnoses of low blood pressure of 50/47, atrial fibrillation (abnormal heart rhythm), and dementia (condition with confusion).

The facility document titled, "Order Inquiry," dated April 8, 2024, at 1:10 a.m., was reviewed. The document indicated, "...Restraint Soft Limb Wrist - Bilateral [both wrists]...Frequency q 24h (every 24 hours)..."

There was no documented evidence a physician's order was obtained for Patient 1's mitten restraints on April 8, 2024.

The facility document titled, "Assessment Type Daily," dated April 8, 2024, through April 9, 2024, was reviewed. The document indicated Patient 1 had mittens on from 12 a.m. through 6 a.m., and from 8 p.m. through 10 p.m. on April 8, 2024. The document further indicated Patient 1 had mittens on from 12 a.m., through 5 a.m. on April 9, 2024.

On April 9, 2024, at 2:27 p.m., an interview was conducted with the Chief Quality Officer (CQO). The CQO stated bulky hand mittens are considered a form of restraint and there should be a separate physician order for the mitten restraints. She further stated Patient 1 should not have mitten restraints without a physician's order for them.

On April 9, 2024, at 4:24 p.m., an interview was conducted with Registered Nurse (RN) 3. She stated she did not know mittens were a form of restraint. She stated Patient 1 did have bilateral mittens on April 8, 2024. RN 3 stated she did not document mittens under the assessment because she didn't know they were considered restraints.

On April 9, 2024, at 4:30 p.m., an interview was conducted with the US. She stated she was not aware that mittens were a form of restraint. She stated she did not know a physician's order was needed for mittens.

On April 16, 2024, at 10 a.m., the Quality Assurance and Performance Improvement (QAPI) minutes for January 2024, were reviewed. The QAPI minutes indicated the facility did not meet the measured goals for documentation and necessary physician orders for mitten restraints.

On April 16, 2024, at 4:50 p.m., an interview was conducted with the Deputy Regional Director of Quality (DRDQ). The DRDQ stated she did not know mittens were a form of restraint and that a physician's order for its application was needed.

A review of the facility P&P titled, "Restraints and Seclusion," dated April 2021, was conducted. The P&P indicated, "...Restraint...any manual method, physical or mechanical device...that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely...Each episode of restraint shall be initiated...Upon the order of a licensed independent practitioner who is responsible for the patient..."

A review of the facility P&P titled, "Restraint and Seclusion - Documentation Standards," dated April, 2021, was conducted. The P&P indicated, "...Examples of Physical Restraint...Mittens...Patient cannot flex fingers or does not have access to his/her body..."

A review of the facility's document titled, "AMENDED AND RESTATED BYLAWS OF (NAME OF THE FACILITY) INCLUDES GOVERNING BODY BYLAWS," dated March
31, 2021, was conducted. The document indicated, "...The QM (Quality Management) Committees shall receive reports from all quality improvement/management activities throughout the Hospitals, as applicable, and shall annually assess the effectiveness of the existing quality improvement programs. The QM Committees shall objectively and systematically monitor and evaluate the quality and appropriateness of patient care, pursue opportunities to improve patient care, and resolve identified problems. The QM Committees shall meet as necessary and no less than quarterly, and shall make recommendations to the full Board with respect to improving the quality of care throughout the Hospitals, as applicable...Report regularly to the Board on the performance of the Hospitals' functions such as financial matters, staffing and employment issues, quality of care issues and risk management issues. Cooperation and liaison with the Medical Staffs of the Hospitals, and with all other individuals rendering professional services to patients, with the objective of assuring a high quality of services rendered to patients...Assure that the requirements of the Hospitals', as applicable, Quality Improvement and Management System are carried out on a regular and ongoing basis, and implement such collective actions and preventive activities as are deemed necessary..."

Based on interview and record review the hospital failed to ensure the Medical Staff Bylaws and Rules and Regulations were received and reviewed by a medical staff (Surgeon 1).

This failure had the potential to cause harm to the patients.

Findings:

An interview was conducted on April 11, 2024, at 2 p.m., with Surgeon 1 (S 1.) S 1 stated, "I do not know if I received the Rules, Regs [regulations] and Bylaws when I was onboarding. S 1 further stated, "No, I can't say that I did."

An interview was conducted on April 11, 2024, at 4 p.m., with the Chief Medical Officer and Chief of Clinical Operations (CMOCCO). The CMOCCO stated the contracted surgeons are onboarded and the Medical Staff (MS) plays a large role in this piece and provides the Rules, Regs, and the Bylaws at onboarding.

An interview was conducted on April 16, 2024, at 2:20 p.m., with the Director of Medical Staff (DMS). The DMS stated part of the application packet goes out to the medical staff, and in an attempt to be quick, that is one of the items that she did not follow up on. The DMS further stated he would have received this in his initial onboarding application, but he did not receive it.

A review of the facility document titled, "[Name of the facility] Medical Staff Bylaws," dated February 20, 2024, was reviewed. The document indicated, "...An acknowledgement that the applicant has received and read the Medical Staff Bylaws, Rules and Regulations, and that the practitioners agrees to be bound by the term thereof, as they may be amended from time to time, if the practitioner is granted membership or clinical privileges and to be bound by the terms thereof without regard to whether or not the practitioner is granted membership and/or clinical privileges in all matters relating to consideration of the application..."

Based on observation, interview and record review, the facility failed to ensure the facility's policy and procedures were implemented, for 22 of 30 sampled patients (Patients 1, 2, 3, 5, 6, 7, 8, 9, 14, 15, 16, 17, 18, 19, 22, 23, 24, 25, 26, 27, 28 and 29), when:

1. The facility failed to ensure an individualized plan of care was completed, for four of 30 sampled patients (Patient 22, 25, 26, and 27) (Refer to A0396);

2. For Patient 1, a physician's order for the application of restraints (any manual or physical or mechanical device, material, or equipment attached or adjacent to the resident's body that the individual cannot remove easily which restricts freedom of movement or normal access to one's body) was not obtained. This failure had the potential to result in injury or unnecessary use of restraints (Refer to A0398);

3. For Patient 24, repositioning was not done every two hours, weekly photographs of the patient's wounds were not taken, and documentation of the wounds was not completed, in accordance with the facility's policy and procedure (Refer to A0398);

4. For Patients 16, 18, and 27, screening for Methicillin Resistant Staphylococcus Aureus (MRSA, a bacterial infection that is difficult to treat) was not completed (Refer to A 0398);

5. For Patients 3, 6, 7, 8, 9, 14, 15, 16, 17, 22, 23, 24, 25, 26, 27, and 28, Chlorhexidine Gluconate (CHG, bathing product that kills germs and reduces the spread infection in hospitals) baths were not provided (Refer to A0398);

6. For Patient 14, two intravenous (IV, administered through the veins) medications observed hanging by the bedside were not labeled (Refer to A0398);

7. For Patients 6, 7, 8, and 29, pain was not reassessed after pain medication administration (Refer to A0398);

8. For Patients 2, 7, 14, 22, 23, and 24, a 12 lead EKG (electrocardiogram, a procedure to record heart rate and rhythm) was not completed in accordance with the facility's policy and procedure (Refer to A0398);

9. For Patient 27, pain was not addressed (Refer to A0398);

10. For Patient 27, critical blood pressure was not reported to the physician (Refer to A0398);

11. For Patients 25 and 27, medication reconciliation was not completed on admission (Refer to A0398);

12. For Patients 22 and 23, the telemetry (recording or remotely monitored heart rate and rhythm) strips were not printed, analyzed, signed, and documented in the patients' record every four hours, in accordance with the facility's policy and procedure (Refer to A0398);

13. For Patient 5, the facility did not ensure time sensitive medications were given timely in accordance with physician order (Refer to A0405);

14. For Patient 27, the facility failed to ensure the informed consent was completed by the physician prior to the surgical procedure (Refer to A0466);

15. Two different types of medium contrast (an internally administered substance used in imaging procedures)were not stored in accordance with the manufacturer's recommendation and were readily available for use (Refer to A0505); and

16. Expired supplies were found in the respiratory supply cart, and preventative and maintenance per manufacture recommendations for the endoscope drying and storage cabinet were not performed timely (Refer to A0724).

The cumulative effect of these systemic failures resulted in the patients to not be provided safe and quality care to meet the patient needs and had the potential to delay provision of care and treatment.

Based on interview and record review, the facility failed to ensure an individualized plan of care was completed, for four of 30 sampled patients (Patient 22, 25, 26, and 27).

These failures had the potential to delay patient care and services or cause patient harm.

Findings:

1. A condurrent interview and review of Patient 22's record was conducted on April 12, 2024, at 11 a.m., with the Deputy Regional Director Quality (DRDQ). The facility document titled, "History and Physical [H&P]," indicated Patient 22 was admitted to the facility on March 27, 2024, for pain and swelling in the right knee after a fall with a diagnosis of right patella (kneecap) fracture (a break in the bone).

There was no documented evidence an individualized patient care plan was completed related to Patient 22's infection risk, and skin integrity.

The DRDQ stated there should have been more to the care plans based on the patient's needs. She stated that since the patient had a surgical procedure, infection risk and skin integrity should have been included in the patient's care plan.

2. On April 15, 2024, at 3:30 p.m., a concurrent interview and review of Patient 25's record were conducted with the Nurse Educator Special Projects Administrator (NESPA).

The facility document titled, "History and Physical [H&P]," indicated Patient 25 was admitted to the facility on April 3, 2024, for pain in the left knee leading to a left knee total arthroplasty (left knee replacement).

There was no documented evidence an individualized patient care plan related to Patient 25's risk for infection and impaired skin integrity was completed.

The NESPA stated there should have been more to the care plans based on the patient's needs. The NESPA stated Patient 25's care plan is not complete and should have included the high risk for infection and skin integrity based on the patient's needs after having had a surgical procedure.

3. On April 16, 2024, at 10:05 a.m., a concurrent interview and review of Patient 26's record were conducted with DRDQ. The facility document titled, "History and Physical [H&P]," indicated Patient 26 was admitted to the facility on May 27, 2024, for wounds on both feet. Patient 26's record indicated Patient 26 had lower extremity cellulitis (deep infection of the skin) and had a right foot irrigation (procedure of flushing the wound with a solution) with debridement (procedure to remove the damaged tissue) and partial second toe amputation to the proximal phalanax (toe bone closest to the foot), and the infectious disease specialist was consulted on the wounds. The records indicated Patient 26 was identified as a fall risk.

There was no documented evidence an individualized patient care plan completed for impaired skin integrity and risk for fall.

The CQO stated a care plan based on the assessment was not completed. The CQO stated Patient 26 should have a care plan for skin integrity based on the surgical procedure and a fall risk care plan should have been completed.

4. On April 16, 2024, at 10:18 a.m., a review of Patient 27's record was conducted with the CQO. The facility document titled, "History and Physical [H&P]," indicated Patient 27 was admitted to the facility on April 3, 2024, for hip discomfort after a fall at home. The record indicated Patient 27 had a diagnosis of hip fractured and underwent a right hip nailing (pin placement) surgical procedure.

There was no documented evidence an individualized patient care plan for risk for infection and impaired skin integrity was completed.

An interview was conducted with the CQO on April 16, 2024, at 11:33 a.m. The CQO stated a care plan based on the assessment of Patient 27's needs for high risk for infection and impaired skin integrity related to the surgical wound should have been completed.

The facility policy and procedure (P&P) titled, "Initial Patient Assessment And Reassessment and Plan of Care," dated April 12, 2024, was reviewed. The P&P indicated,"...Each patient...shall receive a completed head-to-toe assessment...so that a plan of care can de developed to best meet the needs of the patient...Upon completion of the initial admission assessment, an individualized prioritized plan of care will be developed..."

Based on observation, interview and record review, the facility failed to ensure, for 21 of 30 sampled patients (Patients 1, 2, 3, 6, 7, 8, 9, 14, 15, 16, 17, 18, 19, 22, 23, 24, 25, 26, 27, 28 and 29),

1. For Patient 1, a physician's order for the application of restraints (any manual or physical or mechanical device, material, or equipment attached or adjacent to the resident's body that the individual cannot remove easily which restricts freedom of movement or normal access to one's body) was obtained. This failure had the potential to result in injury or unnecessary use of restraints;

2. For Patient 24, repositioning was done every two hours, weekly photographs of the patient's wounds were taken and documentation of the wounds were completed, in accordance with the facility's policy and procedure (P&P);

3. For Patients 16, 18, and 27, screening for Methicillin Resistant Staphylococcus Aureus (MRSA, a bacterial infection that is difficult to treat) was completed;

4. For Patients 3, 6, 7, 8, 9, 14, 15, 16, 17, 19, 22, 23, 24, 25, 26, 27, and 28, Chlorhexidine Gluconate (CHG, bathing product that kills germs and reduces the spread infection in hospitals) bath was provided;

5. For Patient 14, two intravenous (IV, administered through the veins) medications found hanging by the bedside were labeled;

6. For Patients 6, 7, 8, and 29, pain was reassessed after medication administration;

7. For Patients 2, 7, 14, 22, 23, and 24, the 12 lead EKG (electrocardiogram, a procedure to record heart rate and rhythm) was completed in accordance with the facility's P&P;

8. For Patient 27, pain was addressed;

9. For Patient 27, critical blood pressure was reported to the physician

10. For Patients 25 and 27, medication reconciliation was completed on admission; and

11. For Patients 22 and 23, the telemetry (recording or remotely monitored heart rate and rhythm) strips were printed, analyzed, signed, and documented in the patients' record every four hours, in accordance with the facility's P&P.

These failures had the potential to delay patient care, increase the risk for infection, and/or cause harm to the patients.

Findings:

1. On April 8, 2024, at 2 p.m., during the facility tour, an observation and concurrent interview was made with the Unit Supervisor (US). Patient 1 was observed to have bilateral (both left and right) soft wrist restraints and bilateral oversized mittens on his hands. The US stated the restraints were placed due to the patient attempting to pull out his IV (intravenous catheter, a long thin flexible tube that enters the body through a vein) and his Foley catheter (a device that drains urine from the bladder into a collection bag).

On April 9, 2024, at 3:30 p.m., a review of Patient 1's record was conducted. The "History and Physical," dated April 6, 2024, indicated Patient 1 was admitted to the facility on April 6, 2024, at 2:13 p.m., with diagnoses of low blood pressure of 50/47, atrial fibrillation (abnormal heart rhythm), and dementia (condition with confusion).

The facility document titled, "Order Inquiry," dated April 8, 2024, at 1:10 a.m., was reviewed. The document indicated, "...Restraint Soft Limb Wrist - Bilateral...Frequency q 24h (every 24 hours)..." There was no documented evidence a physician's order was obtained for Patient 1's mitten restraints on April 8, 2024.

The facility document titled, "Assessment Type Daily," dated April 8, 2024, through April 9, 2024, was reviewed. The document indicated Patient 1 had mittens on from 12 a.m. through 6 a.m., and from 8 p.m. through 10 p.m. on April 8, 2024. The document further indicated Patient 1 had mittens on from 12 a.m., through 5 a.m. on April 9, 2024.

On April 9, 2024, at 2:27 p.m., an interview was conducted with the Chief Quality Officer (CQO). The CQO stated bulky hand mittens are considered a form of restraint and there should be a separate physician order for the mitten restraints. She further stated Patient 1 should not have mitten restraints without a physician's order for them.

On April 9, 2024, at 4:24 p.m., an interview was conducted with Registered Nurse (RN) 3. She stated she did not know mittens were a form of restraint. She stated Patient 1 did have bilateral mittens on April 8, 2024. RN 3 stated she did not document mittens under the assessment because she didn't know they were considered restraints.

On April 9, 2024, at 4:30 p.m., an interview was conducted with the US. She states she was not aware that mittens were a form of restraint. She stated she did not know a physician's order was needed for mittens.

A review of the facility P&P titled, "Restraints and Seclusion," dated April 2021, was conducted. The P&P indicated, "...Restraint...any manual method, physical or mechanical device...that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely...Each episode of restraint shall be initiated...Upon the order of a licensed independent practitioner who is responsible for the patient..."

A review of the facility P&P titled, "Restraint and Seclusion - Documentation Standards," dated April, 2021, was conducted. The P&P indicated, "...Examples of Physical Restraint...Mittens...Patient cannot flex fingers or does not have access to his/her body..."

2a. On April 15, 2024, at 10 a.m., a review of Patient 24's record was conducted with the CQO and the US.

The facility document titled, "History and Physical," indicated Patient 24 was admitted to the facility on March 19, 2024, with diagnoses which included chronic ventilatory insufficiency (inefficient breathing) due to anoxic brain injury (caused by a complete lack of oxygen to the brain) for a scheduled tracheostomy (a procedure to help air and oxygen reach the lungs by creating an opening into the trachea [windpipe] from outside the neck).

The facility document titled, "Flow Sheet," was reviewed. There was no documented evidence Patient 24 was turned or repositioned every two hours on the following dates and times:

- On March 20, 2024, from 8 a.m., to 6 p.m. (10 hours);
- On March 21, 2024, from 8 a.m., to 4 p.m. (8 hours);
- On March 22, 2024, from 9 a.m., to 3 p.m. (6 hours);
- On March 24, 2024, from 2 a.m., to 6 a.m. (4 hours);
- On March 24, 2024, from 6 p.m., to 10 p.m. (4 hours);
- On March 25, 2024, from 12 a.m., to 6 a.m. (6 hours);
- On March 25, 2024, from 6 p.m., to 10 p.m. (4 hours);
- On March 26, 2024, from 10 a.m., to 6 p.m. (8 hours);
- On March 29, 2024, from at 10 p.m., to March 30, 2024, at 6 p.m. (11 hours);
- On March 31, 2024, from 10 a.m., to April 1, 2024, at 6 a.m. (20 hours);
- On April 5, 2024, from 8 a.m., to 6 p.m. (10 hours);
- On April 6, 2024, from 12 a.m., to 4 a.m. (4 hours);
- On April 6, 2024, from 12 p.m., to 8 p.m. (8 hours);
- On April 9, 2024, from 8 a.m., to 2 p.m. ( 6 hours);
- On April 10, 2024, from 6 a.m., to 2 p.m. (8 hours); and
- On April 11, 2024, from 8 a.m., to 8 p.m. (12 hours).

An interview and record review was conducted with the US on April 12, 2024, at 3:05 p.m. The US stated the expectation was the patient should be turned every two hours and the RN should have documented the turning every two hours. The US stated the RN did not turn Patient 24 every two hours in accordance with the facility's policy.

2b. The facility documents titled, "Wound Progress Notes," were reviewed. There is no documented evidence Patient 24's wounds on the left upper extremity, the left elbow, the left extremity, the right shoulder and clavicle, and on the right extremity with dimpling of the skin and dark brown patches on the right extremity, on the neck and chin, and the sacrum (tailbone) were photographed, dated, and signed, on March 23, 2024, April 4, 2024, and April 11, 2024, in accordance with the facility P&P.

A concurrent interview and record review were conducted with the US on April 15, 2024, at 12:15 p.m. The US stated photos of the patient's wounds are to be taken weekly and the wound assessment should be completed, dated, and signed.

The facility P&P titled, "SKIN AND WOUND CARE," dated April 21, was reviewed. The P&P indicated, "...Photographs ... For wounds present on admission and/or discovery, and on the day of discharge...Additional photos will be retaken on Thursday, during any scheduled dressing changes and with any change of condition...Photographs include the patient's last name and first initial, measuring device, anatomical location, and head/toe reference guide (Stickman). The photograph is placed on the photograph form and includes patient identification sticker, time date, identification of site, wound measurements, and printed name of the...Measurements taken on admission or whenever a wound is identified, and weekly thereafter or when there is significant change in the wound. Measure the wounds using the longest length (head to toe direction) by the longest width (side to side). Depth is measured by gentle insertion of a cotton-tipped applicator to the point that it meets skin level, then removed and held alongside a ruler to determine depth measurement in centimeters...Regular repositioning. Avoid direct pressure to at-risk body surfaces. Off-load heels with off-loading boots or pillows for patients at high risk for potential injury to heels..."

3. The records of Patients 16, 18, and 27 were reviewed with the US on April 15, 2024, at 9:25 a.m.

a. For Patient 16, the facility document titled, "History and Physical," indicated Patient 16 was admitted to the facility on April 2, 2024, for sepsis (a serious infection), fracture of the right ulna (broken arm bone).

The facility document, titled, "...Order Report," indicated, "...Decision to Admit...Start Date...4/2/2024 [April 2, 2024]..."

The facility document titled, "...Orders Report," was reviewed. The document indicated, "...MRSA Screen....Start Date...4/3/2024 [April 3, 2024]..."

An untitled facility document indicated the order for MRSA screening for Patient 16 was placed on April 3, 2024, at 9:54 a.m. and the MRSA screening was collected on April 4, 2024, at 7:36 p.m.

The facility document titled, "[Name of facility] Operative Report," dated April 8, 2024, indicated, "...right hand dog bites; ulnar styloid fracture [break in the wrist bone]..."

There was no documented evidence Patient 16 MRSA screening was done within 24 hours of being admitted to the facility.

An interview and record review were conducted on April 15, 2024, at 10:11 a.m., with the US. The US stated the patient was admitted April 2, 20224, and the MRSA screening was ordered April 3, 2024, but was not collected until April 4, 2024. The US stated the screening was collected 48 hours after the patient was admitted. The US further stated the facility policy indicates a patient needs to be screened for MRSA within 24 hours of being admitted.

b. For Patient 18, the facility document titled, "History and Physical," indicated Patient 18 was admitted to the facility on April 5, 2024, for an infected sacral decubitus (infection to wound on the tailbone which was due to pressure over a bony area). Patient 18's record indicate he was admitted from a skilled nursing facility (a facility which provides nursing care).

The facility document titled, "[Name of facility] Operative Report," dated April 7, 2024, at 2:53 p.m., indicated, "...Preoperative diagnosis: sacral decubitus ulceration with underlying abscess [infection] extending over the left gluteus [thigh] complex and left perianal [area in the buttocks] region...Postoperative diagnosis: same...Procedure: normal saline lavage and VAC [vacuum assisted closure, a device for wound treatment] wound dressing drainage..."

There was no documented evidence MRSA screening was done for Patient 18 within 24 hours of being admitted to the facility.

There was no documented evidence MRSA screening was done for Patient 18 during his hospitalization, despite meeting the criteria for MRSA screening.

An interview and record review were conducted on April 15, 2024, at 9:54 a.m., with the US. The US stated MRSA screening should have been done for Patient 18 within 24 hours of admission due to the patient coming from a skilled nursing facility and having had a surgery. The US further stated there was no documented evidence a MRSA screening order was placed and completed.

c. For Patient 27, the facility document titled, "History and Physical," indicated Patient 27 was admitted to the facility on April 3, 2024, for hip discomfort after a fall. Patient 27's record indicated he had a right hip nailing (pin placed in the hip).

The facility document titled, "[Name of Facility] Discharge Assessment/Summary Report," dated April 5, 2024, at 6:23 p.m., indicated, "...If patient did not meet the above indication, do not perform MRSA screening, culture not indicated..."

There was no documented evidence MRSA screening was done on Patient 27 within 24 hours of being admitted to the facility.

An interview with was conducted with Chief Quality Officer (CQO) on April 15, 2024, at 10:36 a.m. The CQO stated Patient 27 had a surgical procedure and what the patient had is considered an implant. The CQO stated Patient 27 should not have been excluded from the MRSA screening.

The facility's P&P titled, "Active Surveillance Cultures (ASC) - MRSA," dated September 2021, was reviewed and indicated, "...MRSA screening is performed as outlined by SB 1058 in accordance with the policy...Nursing staff are responsible for carrying out all pertinent orders and for initiation and daily implementation of proper precautions as indicated by clinical and laboratory findings...The following patients must be screened within 24 hours of admission...The patient being admitted/transferred to the intensive care unit (ICU, CCU)...The patient is being transferred from a skilled nursing facility...Patients with scheduled orthopedic..."

4. The review of the records of Patients 3, 6, 7, 8, 9, 14, 15, 16, 17, 19, 22, 23, 24, 25, 26, 27, and 28, and concurrent interview were conducted with the Patient Safety Coordinator (PSC) on April 10, 2024, at 9 a.m.

a. For Patient 3, the facility document titled, "History and Physical," indicated Patient 3 was admitted to the facility on April 2, 2024, for respiratory failure (inefficient breathing).

There was no documented evidence Patient 3 was provided a CHG bath while admitted to the facility.

The PSC stated Patient 3 had a PICC (peripherally inserted central catheter, when a type of catheter is inserted to access large veins in the chest) line placed on April 3, 2024. The PSC stated Patient 3 should have had a daily CHG bath while hospitalized.

b. For Patient 6, the facility document titled, "History and Physical," indicated Patient 6 was admitted to the facility on March 31, 2024, for abdominal pain.

There was no documented evidence Patient 6 received a CHG bath while admitted to the hospital.

The PSC stated Patient 6 had a hernia repair surgery on April 4, 2024. The PSC stated Patient 6 should have had a CHG bath prior to surgery.

c. For Patient 7, the facility document titled, "History and Physical," indicated Patient 7 was admitted to the facility on April 1, 2024, for abdominal pain, associated nausea, and two episodes of vomiting with small dots of suspected blood.

There was no documented evidence Patient 7 received a CHG bath while admitted to the facility.

The PSC stated Patient 7 had a Magnetic Resonance Cholangiopancreatography (MRCP, an imaging procedure) on April 4, 2024. The PSC stated Patient 7 should have had a CHG bath prior to the MRCP.

d. For Patient 8, the facility document titled, "History and Physical," indicated Patient 8 was admitted to the facility on April 3, 2024, for a mechanical fall and injury to the left leg.

There was no documented evidence Patient 8 received a CHG bath while admitted to the hospital.

The PSC stated Patient 8 had a left tibial-fibular fracture (broken leg bones) and had left tibia intramedullary nailing (placement of pins on the bones) on April 5, 2024. The PSC stated Patient 8 should have had a CHG bath prior to the surgery.

e. For Patient 9, the facility document titled, "History and Physical," indicated Patient 9 was admitted to the facility on April 7, 2024, for a fall. The document indicated Patient 9 had a prior medical history of diabetes (abnormal blood sugar levels), high blood pressure, and frequent fractures (breaks in the bone).

There was no documented evidence Patient 9 received a CHG bath while admitted to the hospital.

The PSC stated Patient 9 had an open reduction internal fixation (ORIF, surgical procedure to fix broken bones) surgery on April 8, 2024. The PSC stated Patient 9 should have had a CHG bath prior to the surgery.

f. For Patient 14, the facility document titled, "History and Physical," indicated Patient 14 was admitted to the facility on April 6, 2024, for acute respiratory failure (inefficient breathing) and lung disease.

The facility document titled, "Genitourinary Assessment," dated April 6, 2024, indicated, "...Urinary catheter insertion...April 6, 2024, at 10:34 p.m..."

There was no documented evidence Patient 14 received a CHG bath on April 8, 9, 10, and 11, 2024, while a foley catheter was in place.

On April 12, 2024, at 9:45 a.m. a concurrent interview and record review were conducted with the US. The US stated there is no documentation Patient 14 was provided with a daily CHG bath on April 8, 9, 10, and 11, 2024. The US stated Patient 14 had a foley catheter and per the facility's policy, the patient was supposed to be provided a daily CHG bath.

g. For Patient 15, the facility document titled, "History and Physical," indicated Patient 15 was admitted to the facility on March 29, 2024, for hyperglycemia (high blood sugar) and osteomyelitis (bone infection).

There was no documented evidence Patient 15 received a CHG bath while admitted at the facility.

On April 12,2024, at 10:30 a.m, an interview and concurrent record review were conducted with the US. The US stated Patient 15 had a left foot irrigation (procedure to clean an infection) and debridement (by removing infected parts and dead tissues) treatment for wound down to the bone on April 2, 2024. The US further stated there is no documentation Patient 15 received a CHG before and on the day of his surgery. The US stated the patient should have had a CHG bath 24 hours before surgery which would have been April 1, 2024, and on day of surgery per the facility's policy.

h. For Patient 16, the facility document titled, "History and Physical," indicated Patient 16 was admitted to the facility on April 2, 2024, for sepsis (a serious infection), cellulitis (skin redness and irritation), and fracture of the right ulnar (broken bone in the arm).

There was no documented evidence Patient 16 received a CHG bath while admitted to the hospital.

On April 12, 2024, at 1:45 p.m., an interview and a concurrent record review were conducted with the US. The US stated the patient had a right-hand incision and drainage (procedure to treat an infection) on April 2, 2024. The US stated the patient should have had a CHG bath before the day of the surgery. The US further stated there is no documentation Patient 16 was provided a CHG bath before the day of the surgery.

i. For Patient 17, the facility document titled, "History and Physical," indicated Patient 17 was admitted to the facility on April 3, 2024, for a fall.

There was no documented evidence Patient 17 received a CHG bath while admitted to the hospital.

On April 15, 2024, at 11:07 a.m., a interview and a concurrent record review were conducted with the US. The US stated the patient had a right ankle ORIF surgery on April 4, 2024. The US further stated there is no documentation Patient17 was provided a CHG bath before and on the day of his surgery. The US stated Patient 17 should have had a CHG bath 24 hours before surgery which would have been April 3, 2024, and on day of surgery per the facility's policy.

j. For Patient 19, the facility document titled, "History and Physical," indicated Patient 19 was admitted to the facility on April 2, 2024, for an appendicitis (when the appendix becomes inflamed and painful).

There was no documented evidence Patient 19 received a CHG bath while admitted to the hospital.

On April 15, 2024, at 11:20 a.m., an interview and a concurrent record review were conducted with the US. The US stated the patient had an appendectomy (removal of the appendix) on April 3, 2024. The US stated there is no documentation Patient 19 was provided a CHG bath before and on the day of his surgery. The US stated the patient should have had a CHG bath 24 hours before surgery which would have been April 2, 2024, and on the day of the surgery per the facility policy.

k. For Patient 22, the facility document titled, "History and Physical," indicated Patient 22 was admitted to the facility on March 27, 2024, for right patella fracture (a break in the knee cap). Patient 22's record indicated the patient had an open reduction internal fixation (surgical procedure to fix fractures) of the right patella.

There was no documented evidence Patient 22 received a CHG bath while admitted to the hospital.

An interview and concurrent record review were conducted with Deputy Regional Director of Quality (DRDQ) on April 12, 2024, at 11:05 a.m. The DRDQ stated that she is not able to find any documentation that CHG baths have been given. The DRDQ stated Patient 22 should have had a CHG bath daily per the facility policy.

l. For Patient 23, the facility document titled, "History and Physical," indicated Patient 23 was admitted to the facility on April 2, 2024, for left radical nephrectomy (surgical removal of a kidney).

There was no documented evidence Patient 23 received a CHG bath while admitted to the hospital.

An interview and concurrent record review were conducted with DRDQ on April 12, 2024, at 1:30 p.m. The DRDQ stated the patient was in the ICU and should have had the baths daily.

m. For Patient 24, the facility document titled, "History and Physical," indicated Patient 24 was admitted to the facility on March 19, 2024, with diagnoses which included chronic ventilatory insufficiency (inefficient breathing) due to anoxic brain injury (caused by a complete lack of oxygen to the brain) for a scheduled tracheostomy (a procedure to help air and oxygen reach the lungs by creating an opening into the trachea [windpipe] from outside the neck).

There was no documented evidence Patient 24 was provided a CHG bath on the following dates: March 23, 2024, March 27, 2024, March 28, 2024, April 2, 2024, April 3, 2024, April 4, 2024, and April 6, 2024, while admitted to the facility.

An interview and concurrent record review were conducted with US on April 12, 2024, at 3:30 p.m. The US stated she cannot find that a CHG bath was documented on Patient 24's record. The US stated Patient 24 should have been given a CHG bath daily.

n. For Patient 25, the facility document titled, "History and Physical," indicated Patient 25 was admitted to the facility on April 3, 2024, with a diagnosis of left knee pain and had a left knee total arthroplasty (joint replacement).

There was no documented evidence Patient 25 received a CHG bath while admitted to the hospital.

An interview and concurrent record review were conducted with the DRDQ on April 15, 2024, at 12 p.m. The DRDQ stated there is no documentation Patient 25 was provided a CHG bath was daily. The DRDQ stated the nurse should have given the CHG bath daily per the facility policy.

o. For Patient 26, the facility document titled, "History and Physical," indicated Patient 26 was admitted to the facility on March 27, 2024, with a diagnosis of wounds on both feet. The record indicated Patient 26 had lower extremity cellulitis (deep infection of the skin) and had a right foot irrigation (solution to the wound to flush) with debridement (removal of damaged tissue) and partial second toe amputation to the proximal phalanx (surgical removal of the toe bone closest to the foot).

There was no documented evidence Patient 26 was provided a CHG bath 24 hours before the surgical procedure, on the day of the procedure, and while admitted to the hospital.

An interview and concurrent record review were conducted with the DRDQ on April 16, 2024, at 9:41 a.m. The DRDQ stated Patient 26 was not provided a CHG bath. DRDQ stated the nurse should have given the CHG bath daily per the facility policy.

p. For Patient 27, the facility document titled, "History and Physical," indicated Patient 27 was admitted to the facility on April 3, 2024, for hip discomfort after a fall. The record indicated Patient 27 had a right hip nailing.

There was no documented evidence CHG bath 24 hours before the surgical procedure, on the day of the procedure, and while admitted to the hospital.

An interview and concurrent record review were conducted with the Chief Quality Officer (CQO) on April 16, 2024, at 10:30 a.m. The CQO stated Patient 27 was not provided a CHG bath 24 hours prior to the surgical procedure and on the day of the procedure. The CQO stated the patient should have had the CHG baths while in the hospital and prior to the procedure.

q. For Patient 28, the facility document titled, "History and Physical," indicated Patient 28 was admitted to the facility on April 5, 2024, for a cystoscopy (examination of the lining of the bladder) with insertion of left ureteral (tubes that carry urine) doubled j-stent (tube to drain urine).

There was no documented evidence CHG bath 24 hours before the surgical procedure and on the day of the procedure.

An interview and concurrent record review were conducted with the CQO on April 16, 2024, at 11:46 a.m. The CQO stated the patient should have had a CHG bath because he was a surgical patient. The COO stated the nurse documented "NA [not applicable]" on the check list for CHG bath. The CQO stated the patient should have had the CHG bath the day of the procedure.

A review of the facility's P&P titled, "Bathing With Hospital Approved Skin Antiseptic," dated April 2021, was conducted and indicated, "...the steps for all healthcare workers assigned to provide bedside bathing to patients...Daily bathing with a hospital approved skin antiseptic will be performed upon admission and daily thereafter on the following patients...admitted to ICU [intensive care unit, unit for critically ill patients], CCU [cardiac critical unit, unit for critically ill patients with heart conditions], or DOU [definitive observaion unit, a step down unit for patients with conditions not necessitating critical care]...history of multi-drug resistant organism (MRDO) [a type of infection that is hard to treat] or Clostridium difficile infection (CDI) [a bacterial infection]...have a central line [insertion of a plactic tube in the large blood vessels] (CVC [central venous catheter], PICC, Hemodialysis [procedure of removal of toxin from the body using a machine] catheter)...Have an indwelling urinary catheter....all surgical patients...document the type of bathing performed in the patient's medical record...All surgical patients...Surgical patients will be bathed the evening before and the morning of surgery...."

5. A tour of the Intensive Care Unit (ICU) was conducted on April 8, 2024, at 3 p.m. with CQO. During an observation conducted in Patient 14's room, two IV bags were observed hanging on the IV pole. The IV bags were observed to not have the date and time it was hung documented on the label.

An interview was conducted on April 8, 2024, at 3:15 p.m., with Registered Nurse (RN) 1. RN 1 stated the two hanging IV bags in Patient 14's room were not dated, timed, or labeled per facility policy.

On April 8, 2024, at 3:37 p.m., Patient 14's record was reviewed with US. The facility document titled, "[Name of facility] History and Physical," dated April 6, 2024, at 10:06 p.m., indicated, Patient 14 had a diagnosis of "...AHRF 2/2 COPD [acute hypoxemic respiratory failure secondary to chronic obstructive pulmonary disease, a lung disease]...Sepsis [a serious infection]..."

The facility document titled, "Medication Administration Record," dated April 7, 2024, indicated, "...IV D5W [dextrose 5% (percent) in water, a type of IV fluid] 0.45 % NACL [sodium chloride, a type of IV fluid]...SOLUTION 50 ML [milliliter, a measure of volume]/HR [per hour] Intravenously...1,000 ML..."

The facility document titled, "Medication Administration Record," with a start date of April 7, 2024, and a stop date of April 8, 2024, was reviewed. The document indicated, "...Vancomycin [an antibiotic] 500 MG [unit measurement] INJECTABLE IVPB [IV piggyback, administered with another IV medication] EVERY 8 [eight] HOURS...Additives: IV NACL 0.9% WATER [a type of IV fluid]..."

An interview was conducted on April 10, 2024, at 10 a.m., with the CQO. The CQO stated there were two IV bags of fluids in Patient 14's room which lacked the patient identifier, date, and time when the fluid was hung, which was not in accordance with the facility policy. The CQO stated any medication or fluid hung must have the patient identifier, date, and time. The CQO further stated if the fluid contains an additive the additive needs to be labeled as well. The CQO stated the IV medications that were found at Patient 14's bedside were not labeled correctly in accordance with the facility's policy.

A review of the facility's P&P titled, "MEDICATION MANAGEMENT," dated December 2018, indicated, "...Label Contents: At a minimum, medications will be labeled with the following...Inpatient...Drug name, strength and amount/concentration...Bar code label...Expiration Date and Lot number...Any applicable cautionary or auxiliary labels...IV/Irrigation/TPN solutions, in addition to the above...type, concentration and amount of additive(s)...type and volume of solution...Date prepared..."

6a. On April 15, 2024, at 9 a.m., a concurrent interview and record review with the Patient Safety Coordinator (PSC) was conducted.

- A review of Patient 6's record was conducted. The "History and Physical," dated March 31, 2024, indicated Patient 6 was admitted to the facility on March 31, 2024, for abdominal pain.

The facility document titled, "Order Inquiry," dated April 2, 2024, at 9 p.m., indicated, "...KETOROLAC [a medication for pain]...EVERY 8 [eight] HOURS...INTRAVENOUS [IV, administer through the vein]...DOSE...15MG[milligram, a unit of measurement]/0.5ML [millilitter, a unit of measurement]...STRENGTH...30MG/ML..."

The facility document titled, "Medical Administration Record," indicated Patient 6 was administered Ketorolac on the following dates:

-April 2, 2024, at 9:10 p.m.;
-April 3, 2024, at 3:14 a.m.; and
-April 3, 2024, at 8:40 a.m.

There was no documented evidence Patient 6's pain was reassessed after the pain medication Ketorolac was administered.

The PSC stated the registered nurses must assess pain after pain medication administration to assess if the pain medication was effective.

- A review of Patient 7's record was conducted. The facility document titled, "History and Physical," dated April 1, 2024, indicated Patient 7 was admitted to the facility on April 1, 2024, for abdominal pain.

The facility document titled, "Medication Administration Record," dated April 8, 2024, was reviewed. The documented indicated, "...HYDROmorphone 0.5 MG/0.5ML [a pain medication]...EVERY 4 [four] HOURS AS NEEDED...INTRAVENOUS..." The document indicated Patient 7 was administered hydromorphone on April 5, 2024, at 3:29 a.m.

There was no documented evidence Patient 7's pain was reassessed after hydromorphone was administered. The PSC stated the registered nurses must assess pain after medication administration to assess if the pain medication was effective.

- A review of Patient 8's record was conducted. The facility document titled, "History and Physical," dated April 3, 2024, indicated Patient 8 was admitted to the facility on April 3, 2024, for a fall with left tibial-fibular fracture (a break in the bones of the lower leg).

The facility document titled, "Medication Administration Record," dated April 7 2024, was reviewed. The documented indicated, "...HYDROmorphone (PF) 1MG/ML...EVERY 4 HOURS AS NEEDED...INTRAVENOUS..." The document indicated hydromorphone was administered to Patient 8 on the following dates:

- April 5, 2024, at 10:45 a.m.;
- April 5, 2024, at 2:43 p.m.;
- April 5, 2024, at 10:12 p.m.;
- April 6, 2024, at 2:27 a.m.; and
- April 6, 2024, at 1:37 p.m.

There was no documented evidence Patient 8's pain was reassessed after hydromorphone was administe

Based on interview and record review, the facility failed to ensure time sensitive medications were given timely, in accordance with physician order and the facility policy and procedure, for one of 30 patients reviewed (Patient 5).

This failure had the potential to adversely affect Patient 5's healing and medical outcome.

Findings:

On April 11, 2024, at 9:15 a.m., a concurrent interview and record review with the Patient Safety Coordinator (PSC) were conducted. The PSC stated antibiotics are considered timed medication (medications which should be administered within a certain time period). She stated all timed medications should be given on time. She further stated a timed medication could be given one hour prior or one hour after the scheduled time but anything outside of that parameter would be considered administered too early or too late.

The facility document titled, "CPOE Orders Report," dated March 27, 2024, was reviewed. The document indicated, "...Cefepime [an antibiotic] 2 [two] grams [unit of measurement] intravenously [administered theough the vein] every 8 [eight] hours...Start date 03/27/2024 [March 27, 2024] 14:00 [2 p.m.]...Stop date 04/03/2024 [April 3, 2024]..."

A review of Patient 5's medication administration record was reviewed with the PSC. Patient 5's medication record indicated Cefepime was administered on the following dates and times:

- March 28, 2024, at12:37 p.m., (1 hr 23 minutes early);
- March 28, 2024, at 8:47 p.m., (1 hour 13 minutes early);
- March 30, 2024, at 4:17 p.m., (2 hours 17 minutes late);
- March 31, 2024, at 11:39 a.m., (2 hours 21 minutes early) and;
- April 3, 2024, at 12:45 p.m., (1 hour 15 minutes early).

During a concurrent interview, the PSC stated the antibiotic was due at 6 a.m., 2 p.m., and at 10 p.m. She stated the registered nurses administered the antibiotic either too early or too late.

A review of the policy and procedure (P&P) titled, "Medication Management," dated December 2018, was conducted. The P&P indicated, "...Medication Management is a critical component in the safe treatment of patients...The organization is committed to the implementation of an effective program that addresses the critical process of...preparing/dispensing, administration, and monitoring...Staff who administers medications is responsible for...Administering medications in accordance with the regulations...Medications are safely and accurately administered...Accuracy In Medication Administration: All licensed personnel who administer medication will Follow...right time...Medication Schedules...Medications will be dosed on a scheduled dosing time...Time-critical scheduled medications - the following medications...are considered to be time-critical because delay in administration can have a negative affect or outcome. Thus, they must be administered within a 1 hour of the scheduled dosing time...Antibiotics..."

Based on interview and record review the facility failed to ensure the informed consent was completed by the physician prior to the surgical procedure, for one of 30 sampled patients (Patient 27), in accordance with the facility's policy and procedure (P&P).

This failure had the potential to delay patient care and services or cause harm to the patient.

Findings

On April 15, 2024, at 3:45 p.m. an interview and concurrent review of Patient 27's record were conducted with the Chief Quality Officer (CQO) and the Unit Supervisor (US).

The facility document titled, "History and Physical," dated April 3, 2024, indicated Patient 27 was admitted to the facility on April 3, 2024, for hip discomfort after a fall. The record indicated Patient 27 had a right hip nailing (placement of a pin in the bone).

A facility document titled, "CONSENT TO SURGERY OR SPECIAL PROCEDURE," dated April 4, 2024, was reviewed. The consent did not include the date and time Surgeon 6
(S 6) completed the consent..

The CQO stated the physician did not indicated date and time the surgical consent was completed prior to the surgical procedure. The CQO further stated the consent was incomplete and S 6 should have indicated the date and time on the consent form prior to Patient 27's surgery.

A review of the P&P titled, "INFORMED CONSENT," dated June 2021, was conducted. The P&P indicated, "...A procedural consent form, dated, timed, and signed...are required for surgical invasive procedures/complex prodedures...If the consent for is completed in the doctor's office prior to the patient's admission to the hospital for an elective procedure, a person other than the doctor shall serve as the witness and the original signed form shell be submitted to the hospital for inclusion in the patient's record...If the consent is form is completed in the hospital, a hospital staff member shall serve as the witness..."

Based on observation and interview, the facility failed to ensure two different types of medium contrast (an internally administered substance used in imaging procedures) were stored in accordance with the manufacturer's recommendation, readily available for use.

This failure placed the patient's medical safety at risk.

Findings:

A tour of the Radiology Department was conducted on April 9, 2024, at 1:15 p.m., with the Director of Surgical Services (DSS), and the Chief Quality Officer (CQO), and the Unit Supervisor (US). The following were observed inside the Pyxis (an automated dispensing cabinet for medications and supplies):

- Six 300 milliliter (ml, unit of measurement) bottles labeled, "Cystografin Diatrizoate Meglumine [a type of contrast medium], Injection USP 30% [percent]..." A green sticker labeled "PROTECT FROM LIGHT" was observed on the plastic container of the contrast which was not observed to have a dark pocket cover (used to keep a medication/contrast from direct light exposure);

- Seven bottles of "Optiray 350 Loversol Injection 74%) 350 mg/ml Organically Bound Iodine..." A green sticker labeled "PROTECT FROM LIGHT" was observed on the plastic container of the contrast which was not observed to have a dark pocket cover.

The two contrast media were observed stored in the Pyxis and exposed to direct light.

An interview was conducted om April 9, 2024, at 1:47 p.m., with the Director of Radiology (DOR) who stated she did not know they were supposed to be protected from the light.

An interview was conducted on April 10, 2024, at 10:30 a.m., with the CQO. The CQO stated the contrasts should have been protected from direct light and the contrasts were not. The CQO further stated for the two different contrast media, the manufacture instruction instructions indicated the items should be protected from light. The CQO stated the contrast media were not stored properly and the manufacturer's instructions for storing and the facility policy were not followed.

An interview was conducted on April 16, 2024, at 3: 28 p.m., with the Director of Pharmacy (DOP). The DOP stated the contrast media were not stored per the manufacturer's recommendations. The DOP further stated this medium contrast should have been stored in a dark plastic cover to protect them from light.

A review of the facility's policy and procedure titled, "STORAGE OF MEDICATIONS," dated September 2023, indicated, "...The medications will be stored according to the manufacturing's recommendations or in the absence of such recommendations, according to a pharmacist instructions...Prepackaging...Prepackaged medications will be in light-resistant containers to ensure their stability..."

Based on observation, interview, and record review, the hospital failed to ensure available supplies and equipment were ready for patient use, when:

1. Expired supplies were found in the respiratory supply cart; and

2. Preventative maintenance per manufacture recommendations for the endoscope drying and storage cabinet were not performed timely.

These failures had the potential to delay patient care and services or cause patient harm.

Findings:

1. A tour of the Emergency Department was conducted on April 8, 2024, at 2:23 p.m., with the Chief Quality Officer (CQO), the Deputy Regional Director of Quality (DRDQ), and the Emergency Department Manager (EDM). During the tour an observation was made of the respiratory supply cart and the following expired supplies were observed inside the cart:

- Aircare Endotracheal Tube, labeled with an expiration date of March 28, 2024; and
- GlideScope Single Use Stylets, labeled with an expiration date of April 2, 2023..

An interview was conducted on April 8, 2024, at 2:32 p.m., with the Respiratory Therapist (RT). The RT stated the items found in the respiratory cart were expired. The RT stated the cart is checked weekly but there is no log to document it. The RT further stated the items should have been discarded.

An interview was conducted on April 10, 2024, at 10:24 a.m., with the CQO. The CQO stated it is against hospital policy to have expired items in patient care areas and the respiratory cart in the Emergency Department is a care area. The CQO verified the above items were expired and should have been discarded.

A review of the facility's policy and procedure (P&P) titled, "STOCK ROTATION AND EXPIRATION," dated April 2024, was conducted and indicated, "...Expired products and devices shall not be made available for patient use. All stock will be rotated and expiration dates on products should be checked...Expiration dates must be monitored on a regular basis so those items nearing expiration date can be identified and used properly if possible...Expired stock is not to be used under any circumstances..."

2. A tour of the Radiology Department was conducted on April 9, 2024, at 11:40 a.m., with the Director of Surgical Services (DSS) and the CQO. A sticker was observed on the endoscope drying and storage cabinet which indicated the last preventative maintenance was performed in March of 2022.

An interview was conducted on April 10, 2024, at 10:04 a.m., with Director of Facilities (DOF). The DOF stated the preventative maintenance for the endoscope drying and storage cabinet was missed. The DOF further stated the preventative maintenance should be done every six months according to the facility's policy and this was not done for the endoscope drying and storage cabinet.

An interview was conducted on April 10, 2024, at 2:09 p.m., with the CQO. The CQO stated this endoscope cabinet was last serviced in March of 2022. The CQO stated preventative maintenance should have been done on the cabinet every six months, and this was not done.

A review of the facility's policy and procedure (P&P) titled, "Preventative Maintenance Program -Ensuring Operation Ability," dated April 2021, was conducted and indicated, "...Each component within a system must be evaluated to determine the content and frequently of testing procedures, inspections, calibrations, and the services and replacement of parts. In the development of preventive maintenance programs, a review is made from various sources of information, such as manufactures' recommendations, codes, standards, and federal, state, and local laws and regulations. The basic sources of information are invaluable as start-up aids, however, over time it is essential that local operating experience be factored in to modify the program. Though this process, initial levels of risk are maintained or reduced..."

A review of the facility's P&P titled, "Medical Equipment Management Plan, "dated January 2023, was conducted and indicated, "...Maintaining, Inspecting, and Testing Activities...The Biomedical Manager identifies in writing the activities used for maintaining, inspecting, and testing all of the medical equipment in the inventory used for the diagnosis, care, treatment, and monitoring, of patients thus assuring safety and maximum useful life...Predictive maintenance based on manufacture's recommendations...Reliability-centered maintenance based on equipment history, Interval-based inspections based on specific intervals between tests, inspections, or maintenance activity...Corrective maintenance based on a request for service or failure of the equipment to pass internal self-tests (Such equipment is subject to an initial test on receipt, and asset management)..."

Based on interview and record review, the hospital failed to ensure the facility's policy and procedures were implemented, for 15 of 30 sampled patients (Patients 6, 7, 8, 9, 15, 16, 17, 18, 21, 24, 25, 26, 27, 28, and 29), when:

1. For Patients 6, 7, 8, 9, 16, 18, 24, and 27, a pre-surgery (before the surgery) checklist (a list of items that need to be completed prior to surgery) was not completed (Refer to A-0951);

2. For Patients 25 and 29, the necessary documentations were not completed prior to surgery (Refer to A-0952); and

3. For Patients 15, 16, 17, 26, 28, and 29, a comprehensive operative report was not completed immediately after a surgery (Refer to A-0959).

The cumulative effect of these systemic failures resulted in the patients to not be provided safe and quality care to meet the patient needs and had the potential to delay provision of care and treatment.

Based on interview and record review, the hospital failed to ensure a pre-surgery (before the surgery) checklist (a list of items that need to be completed prior to surgery) was completed, for eight of 30 sampled patients (Patients 6, 7, 8, 9, 16, 18, 24, and 27) in accordance with the facility's policy and procedure (P&P).

This failure had the potential to cause harm or death to these patients.

Findings:

1. On April 15, 2024, at 9 a.m., an interview and concurrent record review was conducted with the Patient Safety Coordinator (PSC).

a. A review of Patient 6's record was conducted. The facility document titled, "History and Physical," dated March 31, 2024, indicated Patient 6 was admitted to the facility on March 31, 2024, for abdominal pain. The record indicated Patient 6 had surgery for hernia repair on April 2, 2024.

There was no documented evidence the facility completed the pre-surgery checklist prior to Patient 6's surgery. The PSC stated the pre-surgery checklist was missing from Patient 6's Electronic Medical Record (EMR). She further stated if its not in the EMR then the pre-surgery check list was not done. The PSC stated a pre-surgery check list should have been completed prior to any patient who had surgery.

b. A review of Patient 7's record was conducted. The facility document titled, "History and Physical," dated April 1, 2024, indicated Patient 7 was admitted to the facility on April 1, 2024, for abdominal pain. The record indicated Patient 7 had surgery for a laparoscopic cholecystectomy (surgical removal of gall stones with the use of a camera) on April 4, 2024.

There was no documented evidence the facility completed the pre-surgery check list prior to Patient 7's surgery.

The PSC stated the pre-surgery check list was missing from Patient 7's EMR. She further stated if it's not in the EMR, then the pre-surgery check list was not done. The PSC stated a pre-surgery check list should have been completed prior to any patient who had surgery.

c. A review of Patient 8's record was conducted. The facility document titled, "History and Physical," dated April 3, 2024, indicated Patient 8 was admitted to the facility on April 3, 2024, for a left tibia fracture (a break in a leg bone). The record indicated Patient 8 had surgery to repair the left tibia fracture on April 5, 2024.

There was no documented evidence the facility completed the pre-surgery check list prior to Patient 8's surgery.

The PSC stated the pre-surgery check list was missing from the EMR. She further stated if it's not in the EMR then the pre-surgery check list was not done. The PSC stated a pre-surgery checklist should have been completed prior to any patient who had surgery.

d. A review of Patient 9's record was conducted. The facility document titled, "History and Physical," dated April 7, 2024, indicated Patient 9 was admitted to the facility on April 7, 2024, for a left ankle fracture due to a fall. The record indicated Patient 9 had surgery to repair the left ankle fracture on April 8, 2024.

There was no documented evidence the facility completed the pre-surgery check list prior to Patient 9's surgery. The PSC stated the pre-surgery check list was missing from Patient 9's EMR. She further stated if it's not in the EMR, then the pre-surgery check list was not done. The PSC stated a pre-surgery check list should have been completed prior to the surgery for any patient who had surgery.

2. On April 15, 2024, at 9:07 a.m. an interview and concurrent review Patients 16's and 18's records were conducted the Unit Supervisor (US).

a. A review of Patient 16's record was conducted with the US. The facility document titled, "History and Physical," dated April 2, 2024, indicated Patient 16 was admitted to the facility on April 2, 2024, for sepsis (a serious infection), cellulitis (skin redness and irritation), and fracture to the right ulnar (a break in a bone of the arm). The record indicated Patient 16 had an incision and drainage procedure (procedure to drain an infection) to his right hand on April 2, 2024.

There was no documented evidence the facility completed the pre-surgical checklist prior to Patient 16's surgery.

The US stated the pre-surgery checklist was not found in Patient 16's EMR. The US further stated it does not look like a pre-surgery checklist was completed for Patient 16. The US stated the presurgery checklist is required before the patient is sent down to surgery per the facility policy.

b. A review of Patient 18's record was conducted with the US. The facility document titled, "History and Physical," dated April 5, 2024, indicated Patient 18 was admitted to the facility on April 5, 2024, for septic sacral decubitus (infection to a wound caused by pressure on an area). The record indicated Patient 18 had surgery to his sacral (tailbone) area, normal saline lavage (flushing of the wound area with a salt solution), and wound vac (vacuum assisted closure, a device for wound treatment) dressing application on April 7, 2024.

There was no documented evidence the facility completed the pre-surgical checklist prior to Patient 18's surgery. The US stated the pre-surgery checklist was not found in Patient 18's EMR. The US further stated it does not look like the pre-surgery checklist was completed for Patient 18, and this check list is required before the patient is sent down to surgery per the facility's policy.

3. A concurrent interview and record review was conducted with Deputy Regional Director Quality (DRDQ) on April 15, 2024, at 10 a.m.

Patient 24's record was reviewed. The facility document titled, "History and Physical," indicated Patient 24 was admitted to the facility on March 19, 2024, with diagnoses which included chronic ventilatory insufficiency (inefficient breathing) due to anoxic brain injury (caused by a complete lack of oxygen to the brain) for a scheduled tracheostomy (a procedure to help air and oxygen reach the lungs by creating an opening into the trachea [windpipe] from outside the neck). The record indicated Patient 24 had surgery procedure for tracheostomy.

There was no documented evidence the facility completed the pre-surgical checklist prior to Patient 24's surgery.

The DRDQ stated the pre-surgery checklist was not found in Patient 24's EMR. The DRDQ stated the checklist is a requirement prior to a surgical procedure per the policy.

4. A concurrent interview and review of Patient 27's record were conducted with the CQO on April 15, 2024, at 10:30 a.m. The facility document titled, "History and Physical," indicated Patient 27 was admitted to the facility on April 3, 2024, for hip discomfort after a fall. The record indicated Patient 27 had a right hip nailing (surgery for placement of a pin in the bone).

There was no documented evidence the facility completed the pre-surgical checklist prior to Patient 27's surgery. The CQO stated the pre-surgery check list was not found in Patient 27's EMR. The CQO stated it is the facility's responsibility to ensure the checklist is completed before surgery.

A review of the policy and procedure (P&P) titled, "UNIVERSAL PROTOCOL FOR PREVENTING WRONG PERSON, WRONG SITE, WRONG PROCEDURE, WRONG SURGERY," dated June 2021, was conducted. The P&P indicated, "...This protocol is an organization-wide policy. It applies to all medical staff and hospital personnel performing applicable operative or invasive procedures...to ensure patient safety by...PROCEDURE FOR PRE-OPERATIVE SCHEDULINE/INVASIVE PROCESURE VERIFICATION...Start pre-procedure check list [sic] in EHR [electronic health record]..."

Based on interview and record review the facility failed to ensure the necessary documentations were completed prior to surgery, for two of 30 sampled patients (Patients 25 and 29).

This failure had the potential to delay patient care and services or cause harm to the patient.

Findings

1. On April 15, 2024, at 3:45 p.m., an interview and concurrent record review was conducted with the Chief Quality Officer (CQO) and the Unit Supervisor (US).

A review of Patient 25's record was conducted. The facesheet indicated Patient 25 was admitted to the facility on April 3, 2024, for pain in the left knee for which Patient 25 underwent a left knee total arthroplasty (a surgical procedure to resurface a knee damaged by arthritis).

A review of the facility document titled, "[Name of facility] Orthopedics," completed by Surgeon 5 on April 2, 2024, in the orthopedics office was conducted. The document indicated the facility document titled, "History and Physical (H&P)," was completed by Surgeon 5 on April 2, 2024, in the orthopedics office.

There was no documented evidence the H&P was updated prior to Patient 25's surgical procedure.

The CQO stated the H&P for Patient 25 was completed on April 3, 2024, and needed to have had an update prior to the procedure. The CQO stated there was no documentation the up-date was completed as required by the facility's policy.

2. On April 16, 2024, at 3:45 p.m., an interview and concurrent record review was conducted with the CQO and the US.

A review of Patient 29's was conducted. The "History and Physical," dated April 2, 2024, indicated Patient 29 was admitted to the facility on April 8, 2024, for a left knee replacement.

A review of the facility document titled, "SHORT STAY RECORD CHART SUMMARY [Name of facility]," was conducted. The document indicated the H&P for Patient 29 was started by Surgeon 6 on April 3, 2024, but was not completed.

An interview and record review were conducted with the CQO. The CQO stated the H&P for Patient 29 started on April 3, 2024, needed to have had an update prior to the procedure. The CQO stated there was no documentation the update was completed as required by policy nor is there documentation staff contacted the surgeon to complete the document prior to Patient 29's surgery.

The facility policy and procedure (P&P) titled, "History and Physical," dated February 2024, was reviewed. The document indicated, "...When an H&P is performed prior to admission, an updated H&P, including any changes in the patient's condition, must be completed and documented by a licensed practitioner who is credentialed and privileged by the hospital's medical staff to perform an H&P, within 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services, when the medical history and physical examination are completed within 30 days before admission or registration...If the licensed practitioner finds no change in the patient's condition since the H&P was completed, he/she shall indicate in the patient's medical record that the H&P was reviewed, the patient was examined, and that "no change" has occurred in the H&P was completed...history and physical examination includes indications for procedures, pertinent medical history, medications being taken, allergies and vital signs. Additionally, evaluation of heart and lungs is to be recorded prior to any outpatient procedure..."

Based on interview and record review the facility failed to ensure a comprehensive operative report was completed immediately after a surgery in accordance with the facility's policy and procedure (P&P), for six of 30 sampled patients (15, 16, 17, 26, 28, 29).

This failure had the potential for delay of treatment for patients.

Findings:

1. On April 12, 2024, at 8:40 a.m., an interview and concurrent record review was conducted with the Chief Quality Officer (CQO) and the Unit Supervisor (US).

a. A review of Patient 15's record was conducted. The facility document titled, "History and Physical," indicated Patient 15 was admitted to the facility on March 29, 2024, for hyperglycemia (high blood sugar) and osteomyelitis (bone infection). The record indicated Patient 15 had incision and drainage (procedure to drain an infection) to the first toe of his left foot on April 2, 2024.

A facility document titled, "[Name of facility] Brief Post-Operative Progress Note," dated April 2, 2024, was reviewed. There was no entry on the sections under Findings and Specimen Disposition.

There was no documented evidence a comprehensive operative report was completed immediately after Patient 15's surgery on April 2, 2024.

A facility document titled, "[Name of facility] Operative Report," dated April 8, 2024 (six days after Patient 15's surgery on April 2, 2024), was reviewed. There was no entry on the sections under Findings, Specimen Removed, and Specimen Disposition.

An interview and record review were conducted with the US. The US stated the surgeon (Surgeon 3) completed the operative report on April 8, 2024, at 2:27 p.m. The US stated this should have been done immediately per the facility's policy. The US further stated the brief note was completed on April 2, 2024, but the brief note was incomplete, and the operative note written on April 8, 2024, was also incomplete.

An interview and record review were conducted with the CQO. The CQO stated the April 2, 2024, note for Patient 15 was incomplete and was missing the Findings and Specimen disposition. The CQO further stated the note written on April 8, 2024, was also incomplete and was missing entries for the Findings, Specimen Removed, and Specimen Disposition.

b. A review of Patient 16's record was conducted. The facility document titled, "History and Physical," indicated Patient 16 was admitted to the facility on April 2, 2024, for sepsis (a serious infection) and fracture of the right ulna (a break in the arm bone). The record indicated Patient 16 had incision and drainage (procedure to drain the infection) to his right hand with the application of ulnar gutter splint (a type of an arm splint for immobilization) on April 2, 2024.

A review of the facility document titled, "[Name of facility] Brief Post-Operative Progress Note," dated April 2, 2024, was conducted. There was no entry on the sections under Findings, Anesthesia, Specimen Removed, and Specimen Disposition.

A review of the facility document titled, "[Name of facility] Operative Report," dated April 8, 2024 (six days after Patient 15's surgery on April 2, 2024), was reviewed. There was no entry on the sections under Findings, Specimen Removed, Specimen Disposition, and Post operative diagnosis.

During a concurrent interview, the CQO stated the operative reports for Patient 16, dated April 2, 2024, and April 8, 2024, were both incomplete and missing many required items.

c. A review of Patient 17's record was conducted. The facility document titled, "History and Physical," indicated Patient 17 was admitted to the facility on April 3, 2024, for a fall. The record indicated Patient 17 had an open reduction and internal fixation (ORIF, type of surgery to fix broken bones) surgery to her right ankle on April 4, 2024.

A review of the facility document titled, "[Name of facility] Brief Post-Operative Progress Note," dated April 2, 2024, was conducted. There was no entry on the sections under Findings, Descriptions of the Procedure, Specimen Removed, and Specimen.

A review of the facility document titled, "[Name of facility] Operative Report," dated April 10, 2024, was conducted (eight days after Patient 17's surgery on April 4, 2024). There was no entry on the sections under Specimen Removed and Specimen Disposition.

During a concurrent interview, the CQO stated the operative reports for Patient 17, dated April 2, 2024, and April 10, 2024, were both incomplete and missing many required items.

2. On April 15, 2024, at 3:45 p.m., an interview and concurrent record review was conducted with the CQO, the Unit Supervisor (US), and Nurse Educator Special Projects Administrator (NESPA).

A review of Patient 26's record was conducted. The facility document titled, "History and Physical," indicated Patient 26 was admitted to the facility on March 27, 2024, with a diagnosis of wounds on both feet. The document indicated Patient 26 had lower extremity (legs) cellulitis (deep infection of the skin) and underwent a right foot irrigation (procedure of flushing the wound with a solution) with debridement (removal of damaged tissue) and partial second toe amputation to the proximal phalanx (surgical removal of the toe bone closest to the foot) on April 4, 2024.

A review of the facility document titled, "[Name of facility] Brief Post-Operative Progress Note," dated April 4, 2024, was conducted. There was no entry on the sections under Post-operative diagnosis, Urine output, IV (intravenous, through the vein) fluids, Findings, Anesthesia, Specimen removed, and Specimen Disposition.

A review of the facility document titled, "[Name of facility] Operative Report," dated April 6, 2024 (two days after Patient 26's surgery on April 4, 2024), was conducted. There was no entry on the sections under the Specimens removed and Specimen Disposition, Estimated blood loss, and Findings.

During a concurrent interview, the CQO stated the operative reports for Patient 26, dated April 4, 2024, and April 6, 2024, were both incomplete and missing many required items.

3. On April 16, 2024, at 11:45 a.m., an interview and concurrent record review was conducted with the CQO, US, and NESPA.

a. A review of Patient 28's record was conducted. The facility document titled, "History and Physical," indicated Patients 28 was admitted to the facility on April 5, 2024, for a cystoscopy (examination of the lining of the bladder) with insertion of left ureteral (tubes that carry urine) doubled j-stent (a type of tube to drain urine) on April 5, 2024.

A review of the facility document titled, "[Name of facility] Operative Report," dated April 5, 2024, was conducted. There was no entry on the sections under Specimens Removed, Specimen Disposition, and Estimated blood loss.

During a concurrent interview, the CQO stated the operative report written for Patient 28's surgery on April 5, 2024, was incomplete and missing many of the required items.

b. A review of Patient 29's record was conducted. The facility document titled, "History and Physical," dated April 2, 2024, indicated Patient 29 was admitted to the facility on April 8, 2024, for a left knee replacement (procedure to replace parts of an injured knee) which was completed on April 8, 2024.

A review of the facility document titled, "[Name of facility] Operative Report," dated April 8, 2024, was conducted. There was no entry on the sections under Specimens Removed and Specimen Disposition.

An interview and record review were conducted with the CQO. The CQO stated the operative report written for Patient 29's surgery on April 8, 2024, was incomplete and missing the required items.

A review of an undated facility document titled, "[Name of the facility] GENERAL RULES AND REGULATIONS," was conducted. The document indicated, "...A post-operative note must be written immediately following surgery to provide information to those caring for the patient in the immediate post-operative phase. The note must include: date/time; surgeon; assistant; procedure performed; post operative diagnosis; findings; description of procedure; estimated blood loss and specimen(s) removed...Operative reports shall include a detailed account of the findings at surgery as well as detailed of the surgical technique. Operative reports shall be written (or dictated) immediately following surgery for outpatients as well as in patients, the report promptly signed by the surgeon and made part of the patient's current medical record..."

A review of the facility's policy and procedure (P&P) titled, "DOCUMENTATION OF OPERATIVE AND OTHER HIGH-RISK PROCEDURES," dated February 2024, indicated, "...Reports of operative and other high-risk procedures will be written or dictated for inclusion in the medical record immediately after the operative or other high-risk procedure and before the patient is transferred to the next level of care. The comprehensive operative report must contain: Preoperative diagnosis...Procedure(s) performed; Description of the procedure(s); Clinical findings; Any specimens removed; Disposition of the specimen, Estimated blood loss, Postoperative diagnosis; Name of the primary surgeon, assistants and the anesthesist, if anesthesia was provided..."