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Based on interview, record review and policy review, the hospital failed to ensure that physicians' professional and clinical performance was appraised prior to reappointment to the medical staff, and that the Governing Body and Medical Staff bylaws and rules and regulations were updated. These failed practices had the potential to harm all patients in the hospital when medical staff professional and clinical performance was not assessed and when bylaws, rules and regulations were not updated to current standards of practice. The hospital census was six, including swing beds.

The cumulative effect of these failures resulted in non-compliance with 42 CFR 485.627 Condition of Participation: Organizational Structure. The hospital census was six, including swingbeds.

Based on interview, record review and policy review, the hospital failed to ensure that physicians' professional and clinical performance appraised prior to reappointment to the medical staff for five physicians and one certified registered nurse anesthetist (CRNA) of six medical staff credentialing files reviewed, and that the Governing Body and Medical Staff bylaws and rules and regulations were updated. These failed practices had the potential to harm all patients in the hospital when medical staff professional and clinical performance was not assessed and when bylaws, rules and regulations were not updated to current standards of practice. The hospital census was six, including swing beds.

Findings included:

Review of the hospital's document titled, "Medical Staff Bylaws Rules and Regulations," revised 07/2001, showed that in the reappointment process, the review of each member of the medical staff should consist of an appraisal of the member's professional and clinical performance, including his patterns of practice, based at least in part on the findings of quality assurance measures, such as medical audit, utilization review, infection control activities, tissue review, medical record review, participation in relevant continuing education programs, timely completion of medical records, attendance at medical staff and clinical department or service meetings and compliance with applicable hospital policies and with medical staff bylaws, rules and regulations.

Review of the hospital's policy titled, "Board of Directors, Annual Review," last reviewed 08/2011, showed that the bylaws shall be reviewed as necessary, and reviewed at least annually by the Board of Directors.

Review of the hospital's policy titled, "Board of Directors, Medical Staff Organization," dated 03/25/91 and last reviewed 08/2011, showed that the medical staff shall be organized under bylaws that are consistent with all statutory and regulatory requirements and that have governing board approval and any change in those bylaws must be approved by the board to be valid. The medical staff bylaws will include the qualifications and procedures for staff membership, including application, appointment and reappointment, periodic appraisal and provisional status.

Review of the hospital's policy titled, "Board of Directors, Medical Staff Responsibility," dated 03/25/91 and last reviewed 08/2011, showed that the medical staff will be responsible to the board for the quality of all medical care provided for patients in the hospital. The medical staff shall review their patient care through the use of quality assurance/peer review monitoring and reports of the quality assurance/peer review will be presented to the board along with any recommendations or plans of correction of deficiencies.

Review of the credentialing file for five physicians and one CRNA, showed the following:
- Staff E, Physician, Emergency Department and Rehabilitation Medical Director, had no documented quality assurance (QA) evaluations of clinical practice since 2015 and no current education/continuing medical education (CME) pertinent to his current position.
- Staff II, Physician, Laboratory Director, had no documented QA evaluations of clinical practice.
- Staff JJ, Physician, Surgery and Anesthesia Medical Director, had no documented QA evaluations of clinical practice since 2016 and no current education/CME pertinent to his current position.
- Staff KK, Physician, Radiology Medical Director, had no documented QA evaluations of clinical practice.
- Staff LL, Physician, Telemedicine Psychiatry Provider, had no documented QA evaluations of clinical performance.
- Staff Y, CRNA, had no documented QA evaluations of clinical performance.

During an interview on 12/07/22 at 1:30 PM, Staff G, Chief Executive Officer (CEO), stated that he was not aware until today that QA evaluation of the medical staff clinical practice had not been done for several years. His expectation of medical staff credentialing was that every provider would have an annual evaluation of performance to ensure the physician was meeting the hospital's expectations of acceptable standards of care. The board of director and medical staff bylaws, rules and regulations were "ancient" and in the process of being revised.

Based on observation, interview, record review, policy review and review of the United States Pharmacopeia (USP) Chapter 797, the hospital failed to:
- Conduct reviews and make recommendations concerning patient care policies on a biennial basis. (C-1008)
- Ensure pharmacy staff followed the hospital's policy and the infection prevention standards for compounded sterile preparations. (C-1016)
- Ensure staff performed vital signs per physician orders for three patients (#3, #8, and #10) of three patient records reviewed. (C-1048)
- Ensure staff confirmed the identification of patients prior to administering medications for four patients (#3, #8, #10 and #13) of five patients observed. (C-1049)

The cumulative effect of these failures resulted in non-compliance with 42 CFR 485.635 Condition of Participation (CoP): Provision of Services. The hospital census was six, including swingbeds.

Based on interview and policy review, the hospital failed to conduct reviews and make recommendations concerning patient care policies on a biennial basis. This deficient practice had the potential to adversely affect all emergency department, inpatient and swing bed (Medicare program in which a patient can receive acute care, then if needed, Skilled Nursing care in the same facility) patients treated or admitted to the facility, by failing to direct appropriate care and services. The hospital census was six, including swing beds.

Findings included:

1. Review of the following departmental policies showed that:
- "Surgery Department Policies and Procedures Annual Review" was last reviewed on 01/25/17.
- "Acute Care Nursing Policy and Procedures Annual Review" was last reviewed on 02/10/17.
- "Pharmacy Policy and Procedures Annual Review" was last reviewed on 01/31/2018.
- "Rehabilitation Services Policy and Procedures Annual Review" was last reviewed on 01/08/19.
- "Human Resources Policy and Procedures Annual Review" was last reviewed on 02/08/19.
- "Emergency Department Policy and Procedures Annual Review" was last reviewed on 08/17/20.
- "Time Critical Diagnosis Policy and Procedures Annual Review" was last reviewed on 09/22/20.
- "Cardiopulmonary Policy and Procedures Annual Review" was last reviewed on 11/02/20.

During an interview on 12/07/22 at 3:15 PM, Staff F, Chief Nursing Officer (CNO), confirmed that hospital policies had not been reviewed biennially.

During an interview on 12/07/22 at 1:30 PM, Staff G, Chief Executive Officer (CEO), stated that hospital policies should be reviewed every two years.

Based on observation, interview, policy review and review of the United States Pharmacopoeia (USP) Chapter 797 for compounded sterile preparations (CSP, drug and drug products prepared by mixing, in an area that minimizes possible contamination), the hospital failed to ensure that staff followed the hospital's policy and the infection prevention standards when they failed to:
- Ensure the work area (buffer area, sterile zone in the pharmacy where CSPs were prepared) was kept uncluttered and free from particle-generating (potential contaminants) materials.
- Document and clean the buffer area on days that medications were compounded.
- Document and clean the primary engineering control (PEC, a device that provides an environment for compounding medications) daily, and/or before processing CSPs.
- Have documented growth media (test to ensure proper cleaning technique) sampling.
- Have documented staff competency completion of proper hand hygiene/garbing.
- Have a documented successful glove fingertip test (test to ensure staff who process CSPs were able to prevent contamination of the CSP).
- Clean a pill counter tray after each use.

These failed practices had the potential to increase the risk of cross contamination (germs that are spread from one person or surface to another) in CSPs that could result in patient harm and/or death, which placed all patients who received CSPs at risk. The hospital census was six, including swingbeds.

Findings included:

Review of the hospital's policy titled, "Medication Management: Dispensing," revised 03/10/20, showed the following:
- Medications administered intravenously, intrathecally, intramuscularly, or other non-oral or topical routes expose the patient to greater risk of infection. In order to promote safe medication usage, products intended for these routes of administration will be prepared aseptically and according to good manufacturing practices whenever possible, by individuals qualified and trained to do so.
- Before compounding, all personnel will demonstrate competency maintaining product sterility, a media fill test will be performed and passed, evaluation of hand hygiene and garbing procedures, and glove-fingertip testing.
- Competency will be reassessed at least annually with written testing and demonstration of skills (media fill, glove-fingertip test, hand hygiene and garbing procedure, or as per the Director of Pharmacy)
- The segregated compounding area (SCA) will be cleaned: countertops - daily, floors - daily, walls - monthly, ceilings - monthly, shelving - monthly.

Review of the USP, Chapter 797, dated 2008, showed that:
- Particle shedding objects (pencils, corrugated cardboard, paper, and cotton items) were prohibited in the buffer area.
- The buffer area floors should be cleaned daily, walls monthly, ceilings monthly, storage shelving monthly and documented on a cleaning log.
- Sampling plans that included surface disinfection sampling (growth media requirements) should be performed on a periodic basis, at a minimum, annually.
- Low risk compounding required a successful glove fingertip test prior to performing CSPs, and annually.

Observation on 12/05/22 at 3:00 PM in the pharmacy and the pharmacy buffer room, showed the following:
- The entrance to the pharmacy was the office area, with metal cabinets and computers.
- The main pharmacy area housed medications, a refrigerator and freezer.
- The hospital's PEC was a Compounding Aseptic Isolator (CAI, an enclosed cabinet system which maintains a contaminate free environment for mixing non-hazardous drugs and drug components) and was in the back of the main pharmacy; there was no line of demarcation (a visual line on the floor that separates the room, typically where hair covers, masks, gloves, etc., must be worn).
- In the buffer area, in close proximity of the CAI, were opened cardboard boxes (particle shedding material) and a coffee machine with boxes of coffee (particle shedding material).
- A pill counter tray with white residue on the surface.

Record review showed there was no log that demonstrated when the buffer area and the CAI had been cleaned, and there was no documented successful glove-fingertip test, hand hygiene or surface sampling of staff that performed CSPs.

During an interview on 12/05/22 at 3:15 PM, Staff K, Pharmacy Director, stated the following:
- She followed 797 guidelines.
- She was the only pharmacist in the hospital and the only person that made CSPs in the hospital.
- She had worked at the hospital since 11/2021.
- She was not aware that gloved fingertip testing and media fill testing should be completed and documented and had never done that at this hospital.
- There was no cleaning log for the buffer area.
- There was no cleaning log for the CAI.
- The pill counter tray should be cleaned after each use and it appeared that it had not been cleaned lately.

Based on interview, record review, and policy review, the hospital failed to ensure that staff performed vital signs per physician orders for three patients (#3, #8, and #10) of three patient records reviewed. This failure placed all patients at risk for abnormal VS to not be identified and interventions not be performed. The hospital census was six including swing beds (Medicare program in which a patient can receive acute care, then if needed, skilled nursing care in the same facility).

Findings included:

Review of the hospital's policy titled, "Monitored Beds," dated 05/19/88, showed VS included blood pressure, pulse, and respirations, and were taken every two hours on all monitored bed patients, unless otherwise ordered by the attending physician or at the discretion of the Registered Nurse (RN). Oral temperatures were taken every four hours, unless otherwise ordered by physicians.

Review of the hospital's policy titled, "Patient Care," revised 03/01/14, showed blood pressure was taken as ordered by the physician, every four hours on telemetry (remote observation of a person's heart rhythm, using signals that are transmitted from the patient to a computer screen) patients, once daily on Skilled Nursing Facility (SNF, a facility which primarily provides inpatient skilled nursing care and related services to patients who require medical, nursing, or rehabilitative services but does not provide the level of care or treatment available in a hospital) status patients, every eight hours on all other patients, or as requested by the nurse.

Review of Patient #8's medical record showed that he was a 73-year-old male with a past medical history of low blood pressure, heart failure, and emphysema (a condition in which the air sacs of the lungs are damaged and enlarged, causing breathlessness). He was admitted on 11/12/22 for pneumonia (infection in the lungs) and a lung mass. A physician order, dated 11/12/22 at 5:33 PM, showed an order for VS to be performed daily at 12:00 AM, 4:00 AM, 8:00 AM, 12:00 PM, 4:00 PM, and 8:00 PM. A physician order on 11/23/22 at 8:17 AM showed telemetry was ordered for Patient #8. VS review showed that for 28 out of 28 days, from 11/12/22 through 12/05/22, no VS were documented at 12:00 PM. For four out of 28 days, no VS were documented at 4:00 AM.

Review of Patient #3's medical record showed she was a 92-year-old female with a past medical history of back pain, urinary tract infection (UTI), and low heart rate. She was admitted on 11/22/22 for a UTI and a back abscess (collection or pocket of thick fluid caused by an infection). Physician orders, dated 11/22/22 at 1:11 PM, showed she was placed on SNF status and VS were ordered once per day. VS review showed that for three consecutive days out of 15 days, from 12/02/22 through 12/04/22, no blood pressure, pulse, respirations, or temperature were documented.

Review of Patient #10's medical record showed he was a 79-year-old male with a past medical history of dementia (a loss of thinking abilities and memory). He was admitted on 11/09/22 for sepsis (life threatening condition when the body's response to infection injures its own tissues and organs) and wounds on his tailbone and right heel. Physician orders, dated 11/09/22 at 12:13 PM, showed he was placed on SNF status and VS were ordered once per day. VS review showed that for four out of 28 days, on 11/09/22, 11/15/22, 11/22/22, and 12/01/22, no VS were documented.

During an interview on 12/07/22 at 1:19 PM, Staff J, RN, stated that VS were performed every four hours. Nurses were supposed to obtain the 11:00 AM VS, and the Certified Nurse Assistants (CNAs) were supposed to obtain the 7:00 AM and 3:00 PM VS. Night shift staff obtained VS for the SNF patients.

During an interview on 12/07/22 at 1:30 PM, Staff O, RN, stated that VS were performed every four hours on all inpatient and observation patients, and once per day on SNF patients. She stated that a temperature or oxygen reading was enough to satisfy the VS requirement.

During an interview on 12/07/22 at 4:30 PM, Staff HH, CNA, stated that VS were performed every four hours. The CNAs were supposed to obtain the 7:00 AM and 3:00 PM VS, and nurses were supposed to obtain the 11:00 AM VS. SNF patient VS were usually performed once per day at 3:00 AM.

During an interview on 12/08/22 at 3:15 PM, Staff F, Chief Nursing Officer, CNO, stated that there were several new employees, and that during the staff turnover, the previous protocols on obtaining vital signs were likely not addressed. However, she would expect staff to follow what the policy stated in regards to vital signs. She then stated she was unsure what the policy specified and she would need to look it up.



41865

Based on observation, interview and policy review, the hospital failed to ensure that staff confirmed the identification of patients prior to administering medications for four patients (#3, #8, #10 and #13) of five patients observed. This failure placed all patients at risk for improper identification and medication errors. The hospital census was six including swing bed patients.

Findings included:

1. Review of the hospital's policy titled, "Medication Administration," last revised 05/31/20, showed that positive identification of the patient would be ascertained by the medication nurse by reading the identification wrist band as well as obtaining the two additional patient identifiers prior to the administration of all medications.

Observation on 12/06/22 at 8:50 AM, showed Staff J, RN, did not ask Patient #13 to verify his name and date of birth prior to medication administration.

Observation on 12/06/22 at 9:40 AM showed Staff O, RN, did not ask patient #3 to verify her name and date of birth prior to medication administration.

Observation on 12/05/22 at 2:50 PM showed Staff H, RN, scanned a patient identification label at the end of Patient #8's bed and did not ask Patient #8 to verify his name and date of birth prior to medication administration. Patient #8 did not have a patient identification wristband on any part of his body.

Observation on 12/06/22 at 10:01 AM showed Staff O, RN, scanned a patient identification label at the end of Patient #10's bed and did not ask Patient #10 to verify his name and date of birth prior to medication administration. Patient #10 did not have a patient identification wristband on any part of his body.

During an interview on 12/05/22 at 3:00 PM, Staff H, RN, stated that she was unsure why Patient #8 had a wristband taped to the end of his bed and not applied to his wrist. She stated that she did not confirm his identification because she had cared for him before and knew who he was.

During an interview on 12/06/22 at 10:30 AM, Staff O, RN, stated that having the patient identification label on the end of a patient's bed was okay. Patient #10 was "out of it" and did not have a wristband on because "he eats everything" and she was concerned that if a wristband was put on Patient #10's arm, he would "pull it off and eat it."

During an interview on 12/08/22 at 3:15 PM, Staff F, Chief Nursing Officer (CNO), stated that it was her expectation that prior to administering medications the nurse would confirm the patient's identity and scan their wristband. She stated it was not acceptable for a patient to not have an identifying wristband. She stated that she was aware that some patient's wristbands were taped to the end of their bed and stated that "probably should not happen."


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Based on observation, interview, record review, and policy review the hospital failed to:
- Perform hand hygiene during the care of patients;
- Ensure that intravenous (IV, in the vein) dressings and tubing were properly labeled;
- Ensure the cleanliness of vital sign carts;
- Ensure that expired milk was removed from a patient refrigerator on the inpatient unit; and
- Ensure that dry bulk foods were labeled with open date and use by date.

The cumulative effect of these failures resulted in non-compliance with 42 CFR Condition of Participation: Infection Prevention and Antibiotic Stewardship. The hospital census was six, including swingbeds.

Based on observation, interview, and policy review, the hospital failed to:
- Ensure that staff performed hand hygiene during the care of five patients (#3, #8, #10, #12 and #13) of five patients observed;
- Properly label intravenous (IV, in the vein) dressings and tubing for five patients (#1, #3, #8, #10, and #12) of five patients observed;
- Ensure cleanliness of a vital sign cart and contents between each patient use;
- Ensure two expired milks were removed from patient refrigerators; and
- Ensure that dry bulk foods were labeled for an open and use by date.

Findings included:

Review of the hospital's policy titled, "Hand Hygiene," dated 11/19/20, showed that hand hygiene was performed between all patient contact, before medication preparation, before donning and after removing gloves and after contact with inanimate objects in the immediate vicinity of the patient such as medical equipment, furniture, linens.

Review of the hospital's policy titled, "Standard and Transmission-Based Precautions," dated 02/09/21, showed staff were to clean and disinfect patient care equipment and surfaces that were likely to be contaminated with infectious agents, including those that were in close proximity to the patient (e.g., bed rails, over bed tables) and frequently-touched surfaces in the patient care environment (e.g. doorknobs, surfaces in and surrounding toilets in patients' rooms).

Review of the hospital's policy titled, "Intravenous Infusion," revised 01/17/19, showed that after an IV was inserted it would be covered with a transparent dressing and labeled with the date and the nurse's initials. IV tubing would be changed every 96 hours. When tubing was changed it would be labeled with date and time changed.

Observation on 12/06/22 at 8:50 AM, on the Medical Unit, showed Staff J, Registered Nurse (RN), did not perform hand hygiene before administering medications to Patient #13. A sign on Patient #13's door showed he was on isolation precautions (techniques used to prevent the spread of highly contagious or high risk infections). Staff J took a VS cart into Patient #13's room without removing unneeded equipment from the VS cart, and did not wipe down the equipment when she removed the cart from Patient #13's room.

During an interview on 12/07/22 at 4:30 PM, Staff HH, Certified Nurse Assistant (CNA), stated that there were only three VS carts available on the Medical Unit and staff would try to leave a VS cart in any Transmission-based Precautions patient rooms. If there were more than two patients with Transmission-based Precautions, staff would sanitize the entire VS cart between patients use. Staff HH would minimize what was in the VS cart to keep only what was necessary for patient care. She would clean extra equipment in the VS cart if it was taken into a patient room.

During an interview on 12/07/22 at 4:15 PM, Staff O, RN, stated that any equipment taken into a patient room should be wiped down before it was used for another patient. She normally only wiped down whatever equipment touched a patient, but stated that everything should be wiped down.

Observation on 12/06/22 at 9:11 AM, on the Medical Unit, showed Staff O, RN, did not perform hand hygiene before administering medications to Patient #8.

Observation on 12/06/22 at 10:30 AM, on the Medical Unit, showed Staff BB, Physical Therapist, Certified Wound Specialist, performed a wound dressing change to Patient #10's right heel and sacrum. Staff BB used the windowsill in the patient's room to set up her supplies and did not clean the workspace prior to set up. Observation also showed that Patient #10 had a right lower leg IV site that was not dated or initialed.

During an interview on 12/06/22 at 11:00 AM, Staff BB stated that she should have cleaned and used the bedside table to set up her supplies and was not sure why she didn't do that.

Observation on 12/06/22 at 12:20 PM, on the Medical Unit, showed Staff Z, RN, performed an unsuccessful attempt to start an intravenous catheter (IVC, small flexible tube inserted into a vein through the skin to deliver medications or fluids into the bloodstream) on Patient #10. Staff Z did not clean his workspace prior to IVC insertion, placed a bloody needle and IVC on the windowsill, and did not clean the windowsill after he had disposed of his supplies and equipment.

Observation on 12/05/22 at 2:50 PM, on the Medical Unit, showed Patient #8's left forearm IV site was not dated or initialed.

Observation on 12/06/22 at 9:04 AM, on the Medical Unit, showed Patient #3's right forearm IV was not dated or initialed. Staff O, RN, did not perform hand hygiene before administering medications to Patient #3.

Observation on 12/06/22 at 9:31 AM, on the Medical Unit, showed Patient #12's left forearm IV was not dated or initialed. Staff J, RN, did not perform hand hygiene before administering medications to Patient #12.

Observation on 12/05/22 at 2:55 PM, on the Medical Unit, showed Patient #1 had a peripherally inserted central catheter (PICC line, a flexible tube inserted into an arm, leg or neck vein to infuse fluids, blood products, and medications, or to withdraw blood for testing) that had no disinfecting caps (cap placed on the end of a PICC line to reduce the risk of infection). There was no date or time on the intravenous (IV, in the vein) tubing.

Observation on 12/06/22 at 8:20 AM on the Medical Unit, showed disinfecting caps available in a bin at the nurse's station.

During an interview on 12/17/22 at 2:45 PM, Staff FF, Infection Prevention, stated that her expectations of staff were that they perform hand hygiene before and after medication administration. PICC lines should always have disinfecting caps on as the risk of infection increased with no disinfection caps on PICC lines. Staff should label IV tubing, IVC dressings with the date, time, and the staff's initials. VS carts should never go into an isolation room unless it was left in the room. Staff were to wipe down everything in the cart before leaving the room and clean it again after removing the VS cart from the room.

2. Review of the hospital policy titled, "Food Storage," dated 01/2006, showed the following:
- All food would have proper dates and labels.
- All food would be used by expired dates, written or manufactured.
- All bulk item food stored in bins would be changed monthly.
- If there was any question about a product's storage or expiration, the product would be discarded.

Observation on 12/05/22 at 2:43 PM, showed the patient nourishment refrigerator on the inpatient care unit contained two milk containers with expiration dates of 12/01/22.

Observation on 12/06/22 at 9:00 AM, in the dietary department, showed three large storage containers for bulk food such as beans and rice, which did not have an open or expiration date.

During an interview on 12/06/22 at 8:25 AM, Staff I, Medical Surgical Manager, stated that he would expect all foods in the patient refrigerator to be labeled with an open date and use by date. He expected all expired food and drink to be removed from refrigerators and freezers. He stated he was unaware that there were expired items in the refrigerator as those checks were the responsibility of the dietary staff.

During an interview on 12/06/22 at 9:17 AM, Staff Q, Dietary Manager, stated that the dietary department was responsible for stocking and managing the contents of patient nourishment refrigerators on the units. He stated all food items within the hospital's kitchen, including dry bulk goods, should be marked with either an open date or an expiration date.




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