HospitalInspections.org

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §485.608 Compliance with Federal, State, and Local Laws, was out of compliance.

C-0814 - All patient care services are furnished in accordance with applicable State and local laws and regulations. Based on record review and interviews, the facility failed to ensure compliance with State regulations. Specifically, the facility failed to ensure regulatory compliance with the use of restraints in one of one medical records reviewed (Patient #14).

Based on record review and interviews, the facility failed to ensure compliance with State regulations. Specifically, the facility failed to ensure regulatory compliance with the use of restraints in one of one medical records reviewed (Patient #14).

Findings include:

Facility policies:

The Restraint policy read, An order for restraint or seclusion is obtained from the attending physician responsible for patient's care. The order Must NEVER be written as a standing or PRN order. In an emergency, restraints may be utilized prior to obtaining an order if either during the emergency or immediately following the emergency, a restraint order is obtained from the ordering physician.

Monitoring and assessing during the restraint: The condition of the patient will be monitored by a registered nurse (RN) or trained staff. Assessing the patient will be conducted by an RN. Information obtained from trained staff during the monitoring of the patient during restraint is incorporated into the RN assessment and formulation of the patient care and readiness for discontinuation.

For non-violent restraints, staff is to monitor the patient every two hours unless more frequent monitoring of the patient is determined to be necessary. Based on clinical judgment, the frequency of assessment and monitoring may be individualized based on the patient's condition, cognitive state, medications, and type of restraints used. Observe and monitor the patient at least every two hours or more often if necessary based on the patient's medical needs, for physical and emotional well-being, patient safety (body positioning, adequacy of circulation/respirations, condition of skin and point of contact with the restraint device), and correct application of restraints, whether less restrictive methods are possible, and continued need for restraints.

Release the restraints every two hours for five minutes except when the patient is sleeping or restraint removal is deemed unsafe. Provide/offer interventions at least every two hours in the following areas: Toileting, ROM/repositioning/ambulation, skincare, food/fluid intake. Monitor closely the patient whose medical condition places them at high risk for potential complications from being restrained.

The Verbal or Telephone Orders policy read, the verbal order must be written in the Physician Orders section of the chart upon receiving the order by the nurse taking the order. The verbal order must include the following: the date, the time, the order, the name of the patient, the age and weight of the patient, when applicable for medication orders, indication when applicable, specific instructions for use when applicable, the name of the ordering prescriber and the electronic signature of the receiving nurse. The entire verbal/telephone order must be read back to the prescriber and documented as read back. The prescriber/ on-call prescriber must sign a verbal order as soon as possible. The order should be signed the next time the prescriber sees the patient or within 24 hours of giving the verbal order in the paper or in the electronic chart. Verbal orders should be used infrequently. They should only be used in emergent situations or when it is not feasible for the prescriber to write a written order or place the order within the electronic health record.

References:

According to the Standards for Hospitals and Health Facilities Chapter 2 - General Licensure Standards 6 CCR 1011-1 Chapter 2, Part 8.4.1 A facility or agency that uses restraint shall ensure that: (A) At least every fifteen (15) minutes, staff shall monitor any client held in mechanical restraints to assure that the client is properly positioned, that the client's blood circulation is not restricted, that the client's airway is not obstructed, and that the client's other physical needs are met; (B) No physical or mechanical restraint of a client shall place excess pressure on the chest or back of that client or inhibit or impede the client's ability to breathe; (C) During physical restraint of a client, an agent or employee of the facility or agency shall check to ensure that the breathing of the client in such physical restraint is not compromised.

1. The facility failed to ensure orders for restraints were signed and active when used on a patient.

A. Medical Record Review

i. On 12/8/23 Patient #14 was admitted to the facility for disorientation after being found laying on their floor for two days. A nurse note on 12/10/23 at 2:06 p.m. read, the patient was pulling at medical equipment. The provider was notified and provided a verbal/telephone order for the patient to be placed in bilateral wrist restraints.

A review of provider orders on 1/24/24 revealed an order for restraints was entered on 12/10/23 at 2:18 p.m. by registered nurse (RN) #2. The status of the order read as pending. There was no indication the provider order had been signed by the provider.

This was in contrast to the verbal or telephone order policy which read the prescriber must sign a verbal order as soon as possible. The order should be signed the next time the prescriber sees the patient or within 24 hours of giving the verbal order.

B. Interviews

i. On 1/25/24 at 11:50 a.m., an interview was conducted with the inpatient nurse manager (Manager) #3. Manager #3 stated a verbal order could be taken by a registered nurse, however should only be used in an emergency. Manager #3 explained they were unsure of the timeframe for which a provider needed to sign the order. Manager #3 stated it was important for an order to be signed by the provider to verify the provider had determined the course of treatment for the patient. They stated there was a risk to the patient being improperly restrained if the order was not verified and signed by a provider.


2. The facility failed to ensure a patients placed in restraints were monitored according to state regulations.

A. A review of the facility's restraint policy revealed staff were to monitor a patient in restraints every two hours unless more frequent monitoring was determined to be necessary.

The policy was in contrast to the Standards for Hospitals and Health Facilities Chapter 2 - General Licensure Standards 6 CCR 1011-1 Chapter 2, Part 8.4.1(A) which read, at least every fifteen (15) minutes, staff shall monitor any client held in mechanical restraints to assure that the client was properly positioned, that the client's blood circulation is not restricted, that the client's airway was not obstructed, and that the client's other physical needs were met.

B. A review of Patient #14's medical record revealed gaps in monitoring while the patient was in restraints.

i. On 12/8/23 Patient #14 was admitted for treatment of sepsis (a severe infection) and dementia. A review of Patient #14's provider orders revealed an order for restraints was entered on 12/10/23 at 2:18 p.m. by RN #2. A comment entered with the order read, place bilateral wrist restraints to maintain critical lines and for patient safety. Check circulation every 15 minutes.

a. A review of the nurse notes revealed a note was written every hour from 12/10/23 at 1:00 p.m. until 12/11/23 at 7:52 a.m. The notes revealed the patient's circulation was checked. There was no evidence the patient's circulation was checked every 15 minutes as ordered by the provider.

This was in contrast to the Standards for Hospitals and Health Facilities Chapter 2 - General Licensure Standards 6 CCR 1011-1 Chapter 2, Part 8.4.1(A) which read, at least every fifteen (15) minutes, staff shall monitor any client held in mechanical restraints to assure that the client is properly positioned, that the client's blood circulation is not restricted, that the client's airway is not obstructed, and that the client's other physical needs are met.

b. On 1/25/24 at 11:50 a.m., an interview was conducted with Manager #3. Manager #3 stated they would have to review the restraint policy if they had a patient in restraints. Manager #3 stated they assumed the policy met the state guidelines for the use of restraints.

The interview was in contrast to the review of the facility policy and state regulations which revealed conflicting timeframes for patient restraint monitoring.

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §485.618 Compliance with Federal, State, and Local Laws, was out of compliance.

C-0886 - Drugs and biologicals commonly used in life-saving procedures, including analgesics, local anesthetics, antibiotics, anticonvulsants, antidotes and emetics, serums and toxoids, antiarrhythmics, cardiac glycosides, antihypertensives, diuretics, and electrolytes and replacement solutions. Based on observations, interviews, and document review, the facility failed to ensure expired medications were not readily available for patient use. Specifically, the facility failed to ensure medications used to treat cardiac conditions were accessible to staff for use on patients in two of two crash carts (a cart stocked with supplies to be used in a medical emergency) observed.

Based on observations, interviews, and document review, the facility failed to ensure expired medications were not readily available for patient use. Specifically, the facility failed to ensure medications used to treat cardiac conditions were accessible to staff for use on patients in two of two crash carts (a cart stocked with supplies to be used in a medical emergency) observed.

Findings include:

Facility policy:

The Emergency Medications policy read, it is the policy of the hospital to have emergency medications available on notice of an emergent situation or a Code Blue. The Director of Pharmacy is responsible to keep the emergency kits and the crash carts with up-to-date medications that may be useful in an emergency situation.

1. The facility failed to ensure emergency medications were removed from use after the supplies had expired.

A. Observations revealed expired medications and supplies in two of two crash carts observed.

i. On 1/22/24 at 1:05 p.m., observations were conducted in the inpatient care unit. Observations of the crash cart revealed two IV bags of dobutamine (a cardiac medication used in emergencies) with an expiration date of 1/1/24. Emergency Department and Inpatient Nurse Manager (Manager) #3 removed the expired medication from the crash cart during the observation.

ii. On 1/22/24 at 1:24 p.m., observations were conducted in the emergency department. Observations revealed two IV bags of dobutamine with an expiration date of 1/1/24. Manager #3 removed the expired medication from the crash cart during the observation.

B. Interviews

i. On 1/25/24 at 12:35 p.m., an interview was conducted with registered nurse (RN) #4. RN #4 stated the pharmacy technician was responsible for checking the expiration dates of the medications in the crash carts. RN #4 stated the charge nurse would check the crash carts daily for expired supplies and required equipment that was present; however, they would not check the medication expiration dates. RN #4 stated it was important to check for expiration dates for patient safety. RN #4 stated medications given after the expiration date may not work and could have caused the patient to have a reaction.

ii. On 1/25/24 at 11:49 a.m., an interview was conducted with Manager #3. Manager #3 stated the pharmacist was responsible for checking the expiration dates of the medications in the crash carts on a monthly basis. Manager #3 stated the charge nurse would check the crash carts daily for expired supplies, validate the oxygen tank was full, and check the automated external defibrillator (AED). Manager #3 stated medications given after the expiration date may not work and could have caused harm to the patient.

iii. On 1/25/24 at 11:51 a.m., an interview was conducted with chief nursing officer (CNO) #9. CNO #9 stated the pharmacy technician, pharmacist, and ultimately, the CNO was responsible for checking the crash carts for expired medications. CNO #9 stated medications administered after the expiration date may not have the intended effect and may not work. CNO #9 stated that expired cardiac medications could lose their potency, not correct a lethal cardiac rhythm, and could result in death.

The interview with CNO #9 was in contrast to the Emergency Medications policy, which stated the director of pharmacy was responsible for maintaining the emergency kits and the crash carts with up-to-date medications that may be useful in an emergency.

Furthermore, the facility was unable to provide evidence the crash carts were maintained with unexpired medications for the purpose of responding to a Code Blue (a code to alert staff of respiratory or cardiac arrest)

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §485.635 Provision of Services was out of compliance.

C-1016 - Rules for the storage, handling, dispensation, and administration of drugs and biologicals. These rules must provide that there is a drug storage area that is administered in accordance with accepted professional principles, that current and accurate records are kept of the receipt and disposition of all scheduled drugs, and that outdated, mislabeled, or otherwise unusable drugs are not available for patient use. Based on observations, interviews, and document review, the facility failed to ensure oversight of pharmacy services regarding the implementation of mechanisms to prevent and detect the diversion of providers' prescription pads in one of one clinics observed.

C-1030 - Radiology services. Radiology services furnished by the CAH are provided by personnel qualified under State law, and do not expose CAH patients or personnel to radiation hazards. Based on observations, interviews and document review, the facility failed to ensure lead aprons used to prevent radiation exposure at the off-campus clinic were maintained according to the manufacturer's instructions for use in one of one observations of the clinic.

C-1038 - Laboratory Services The CAH provides basic laboratory services essential to the immediate diagnosis and treatment of the patient that meet the standards imposed under section 353 of the Public Health Service Act (42 U.S.C. 236a). (See the laboratory requirements specified in part 493 of this chapter.) The services provided include the following: (i) Chemical examination of urine by stick or tablet method or both (including urine ketones). (ii) Hemoglobin or hematocrit. (iii) Blood glucose. (iv) Examination of stool specimens for occult blood. (v) Pregnancy tests. (vi) Primary culturing for transmittal to a certified laboratory. Based on observations, interviews and document review, the facility failed to ensure lab equipment was maintained to provide the immediate diagnosis and treatment of patients in one of one observations of the off-campus clinic location.

C-1046 - Standard: Nursing Services Nursing services must meet the needs of patients. (1) A registered nurse must provide (or assign to other personnel) the nursing care of each patient, including patients at a SNF level of care in a swing-bed CAH. The care must be provided in accordance with the patient's needs and the specialized qualifications and competence of the staff available. Based on medical record review and interviews, the facility failed to ensure patients received assistance or were offered assistance with activities of daily living (ADLs) in 21 of 26 inpatient, swing bed or observation status patient medical records reviewed.(Patients #1, #2, #3, #4, #5, #7, #8, #9, #10, #11, #13, #14, #15, #16, #17, #18, #20, #22, #24, #25, and #26).

C-1049 - All drugs, biologicals, and intravenous medications must be administered by or under the supervision of a registered nurse, a doctor of medicine or osteopathy, or, where permitted by State law, a physician assistant, in accordance with written and signed orders, accepted standards of practice, and Federal and State laws. Based on medical record review and interviews, the facility failed to ensure medications were administered to patients at the time scheduled by the provider in 13 of 26 inpatient, swing bed or observation status patient medical records reviewed. (Patient #3, #4, #5, #6, #8, #12, #13, #17, #18, #19, #20, #24, and #25).

Based on observations, interviews, and document review, the facility failed to ensure oversight of pharmacy services regarding the implementation of mechanisms to prevent and detect the diversion of providers' prescription pads in one of one clinics observed.

Findings include:

Facility policy:

The facility's Drugs and Biologicals policy read, all drugs and biologicals will be kept under a single lock, and all controlled drugs will be stored under a double lock. Extra prescription pads will be kept under lock in the Pharmacy Room. Providers will keep prescription pads on their person and not in patients' rooms or offices at any time. No one other than providers shall have access to prescription pads.

1. The facility failed to ensure staff and patients' access to providers' prescription pads (tamper-resistant prescription paper used to order medications) was limited to prevent and detect diversion.

A. Observations

i. On 1/24/24 at 11:05 a.m., observations in the rural health clinic office revealed admission supervisor (Supervisor) #6 opened the top drawer of the provider's desk. Supervisor #6 stated they were looking for extra paper to take notes. Further observations revealed a prescription pad and multiple detached blank prescriptions. When questioned, Supervisor #6 stated the prescription pad was not supposed to be unlocked and closed the desk drawer. Further observations revealed the prescription pad remained unsecured throughout the observation.

B. Interviews

i. On 1/24/24 at 12:05 p.m., an interview was conducted with Supervisor #6. Supervisor #6 stated the providers' prescription pads should have been stored and securely locked in the pharmacy room. Supervisor #6 stated the providers were responsible to safeguard their prescription pads. Supervisor #6 stated it was important to keep the prescription pads secured to prevent access to patients and staff members. Supervisor #6 stated unsecured prescription pads could have been taken by staff or patients and used to forge prescriptions, leading to potential overdose and even death.

ii. On 1/24/24 at 4:28 p.m., an interview was conducted with clinic manager (Manager) #12. Manager #12 stated prescription pads should have been kept on the provider's person or locked in the pharmacy room. Manager #12 stated the providers were responsible for securing their prescription pads. Manager #12 stated it was possible for an individual to unlawfully obtain and create fraudulent prescriptions, which could have resulted in harm to patients.

iii. On 1/24/24 at 4:28 p.m., an interview was conducted with chief executive officer (CEO) #13. CEO #13 stated the facility had an incident of diversion with prescription pads in the past. CEO #13 stated the facility's policy was for the provider to lock their prescription pads in the pharmacy room, and the providers were solely responsible for securing their prescription pads. CEO #13 stated only the providers should have access to the prescription pads. CEO #13 stated providers not securing their prescription pads puts the facility at risk for drug diversion.

Based on observations, interviews, and document review, the facility failed to ensure lab equipment was maintained to provide the immediate diagnosis and treatment of patients in one of one observation of the off-campus clinic location.

Findings include:

Facility policy:

The iSTAT Chem8+ policy read, for quality control, run an external quality control (QC) simulator each day of patient testing. Quality controls were to be completed. Run an external QC simulator each day of patient testing. An external liquid QC is to be performed once per month of patient testing.

References:

Bayer Contour Meter System read, use only Bayer's Contour control solutions to practice on the system or to run a check to make sure the meter and the test strips are working properly. Remove a strip from the bottle. Tightly close the lid immediately after you have removed the test strip. Note: Check the expiration and discarded dates. Make sure the test strip does not appear torn or damaged.

Bayer's Contour Control IFUs read, Contour controls are aqueous glucose solutions intended for self-testing by people with diabetes and healthcare professionals as a quality control check. It is important not to use the control if the expiry date printed on the bottle label and the carton has passed or it has been six months since you first opened the bottle. It will help to write the six-month discard date on the label in the area provided when you first open.

1. The facility failed to ensure quality checks (QC) were done on lab equipment to ensure accurate patient results.

A. Observations

i. On 1/24/24 at 9:00 a.m., observation of an off-campus clinic location was conducted. The observation revealed a glucometer (a machine used to measure a patient's blood sugar level) and the solutions to test the quality controls of the glucometer. The glucometer's QC solution vials were noted to have been opened, however, the date of when they were opened was not noted on the vial.

This was in contrast to the Contour control IFUs which read, it was important not to use the control if the expiry date printed on the bottle label and the carton has passed or it has been six months since the bottle was first opened. It would help to write the six-month discard date on the label in the area provided when first opened.

The facility was unable to provide evidence of when the QC controls were opened. Additionally, the facility failed to provide evidence of when the QC checks were completed on the glucometer.

ii. On 1/24/24, observation of the off-campus clinic was continued. Observations of the lab area revealed the iSTAT machine ( a machine used to obtain chemistries, electrolytes, hematocrit, and hemoglobin levels in a patient's blood) was missing the monthly liquid QC checks.

This was in contrast to the iSTAT Chem8+ policy which read, an external liquid QC was to be performed once per month of patient testing.

B. Interviews

i. On 1/24/24 at 9:36 a.m., x-ray and lab technician (Tech) #1 was interviewed. Tech #1 stated she was unaware of when the glucometer QC solution was opened and was unaware whether the solutions needed to be labeled when opened. Tech #1 stated it was important for the QC checks to be performed to ensure the machine was working properly and to ensure the correct lab results were provided.

During the interview, the iStat machine was discussed with Tech #1. Tech #1 stated they were unaware if a monthly QC check needed to be performed on the machine. Tech #1 stated if the QC checks were not completed on the lab equipment, there was a risk for inaccurate results.

The facility was unable to provide a log indicating the iStat machine had received the monthly QC checks.

ii. On 1/24/24 at 12:33 p.m., an interview was conducted with registered nurse (RN) #5. RN #5 stated it was important to ensure the QC checks outlined in the equipment IFUs were important to follow to ensure the machine was working and the results were valid. RN #5 stated if invalid results resulted, there was a risk a patient could receive improper care.

iii. On 1/24/24 at 12:05 p.m., an interview was conducted with clinic admission supervisor (Supervisor) #6. Supervisor #6 stated it was the lab tech's responsibility to perform QC checks on the lab equipment. Supervisor #6 stated it was important to perform the QC checks to ensure the equipment was working properly. Supervisor #6 stated if lab results were inaccurate, there was a risk of patients being treated improperly.

Based on observations, interviews and document review, the facility failed to ensure lead aprons used to prevent radiation exposure at the off-campus clinic were maintained according to the manufacturer's instructions for use in one of one observations of the clinic.

Findings include:

Facility policy:

The Lead Apron and Glove and Other Radiation Protective Equipment Check for Damage, Cracks or Tear Causing Transmittent Radiation Exposure read, the purpose is to perform checks of all protective lead aprons and gloves and other radiation protective shielding annually to prevent undue radiation exposure to hospital personnel. All aprons, gloves and other radiation protective shielding preventing undue radiation exposure to hospital personnel will be x-rayed. The equipment will be x-rayed individually and is to be performed by the radiologic technologist. Document the results of all protective equipment yearly.

Reference:

The Infab X-ray Protection Apron IFUs read, the infab's lead and bi-layer garments will give safe x-radiation protection for several years if properly used and maintained. Recommendations and use limitations are provided below. The following file pertains to the labeling, use, fit, maintenance, protection, ergonomics, manufacturing, and design of Infab's lightweight apparel.

Care, Maintenance, and Inspection: The warranty of the garments is 2 years from the date of manufacture. Infab core material is guaranteed for 2 years against cracking, stiffening, or pinholes; with careful use and proper storage, the useful life should be several years. When not in use, garments should be placed on a hanger. Regular inspections of the garment, at least annually, are recommended, using radiographic or fluoro operating at 70-90kV. Lines may indicate cracks.

1. The facility failed to ensure the lead apron at the off-campus location clinic was maintained according to the IFUs.

A. Observations

i. On 1/24/24 at 9:46 a.m., an observation of the clinic was conducted. The observation revealed two burgundy lead aprons hanging from the rack on the wall of the radiology room. The aprons appeared to have no visible cracks or holes upon observation.

B. Interviews

i. On 1/24/24 at 9:36 a.m., an interview was conducted with x-ray and lab technician (Tech) #1. Tech #1 stated the facility did not have a preventative maintenance (PM) log for the lead aprons. They stated the lead aprons had been purchased in 2008, however the facility had never x-rayed the lead aprons to ensure its integrity. Tech #1 was unable to state the frequency for how often the lead aprons were to be checked for integrity according to the IFUs. Tech #1 stated if the lead aprons had holes or damage, there was a potential of overexposure of radiation to patients or staff which could lead to serious adverse effects such as an increased risk for developing cancer.

The interview was in contrast to the lead apron IFUs and facility policy which read, lead aprons were to be checked for integrity every year.

ii. On 1/24/24 at 12:33 p.m., an interview was conducted with registered nurse (RN) #5. RN #5 stated they would assist the radiology department with positioning patients and holding the x-ray plate (a device used to obtain an x-ray image). RN #5 stated they wore the lead apron to prevent over-exposure to radiation. They further explained, over-exposure to radiation had the potential to put the staff member at risk of developing cancer.

iii. On 1/24/24 at 12:05 p.m., an interview was conducted with the clinic admission supervisor (Supervisor) #6. Supervisor #5 stated staff members at the clinic were to wear lead aprons before performing x-rays. Supervisor #5 stated they were unaware of the frequency of when the lead aprons should be checked for integrity. They further stated that it was important to ensure the integrity of the lead apron in order to prevent overexposure of radiation to the patients and staff.

iv. On 1/25/24 at 10:57 a.m., an interview was conducted with radiology manager (Manager) #10. Manager #10 stated the radiology technicians were responsible for performing preventative maintenance checks on the lead aprons to ensure integrity and that a log should be maintained to document the checks. Manager #10 stated the aprons were to be checked for integrity every year or two years. Manager #10 explained if there was damage to a lead apron there was a risk of increased radiation exposure which could lead to damaged tissue. Manager #10 stated they believed the personnel at the clinic were responsible for checking the lead aprons for integrity.

Based on medical record review and interviews, the facility failed to ensure patients received assistance or were offered assistance with activities of daily living (ADLs) in 21 of 26 inpatient, swing bed or observation status patient medical records reviewed.(Patients #1, #2, #3, #4, #5, #7, #8, #9, #10, #11, #13, #14, #15, #16, #17, #18, #20, #22, #24, #25, and #26).

Findings include:

Facility policies:

The Oral Hygiene policy read, patients shall be offered oral hygiene and assisted as necessary to perform oral hygiene routinely as a part of an hour of sleep care and morning care to promote oral cleanliness and comfort. Document the procedure on the nurse's notes.

The Range of Motion (ROM) and ADL's policy read, all patients will be offered assistance with activities of daily living at regular intervals throughout the day. Document all ADL's on the certified nurse assistant (CNA) flow sheet.

1. The facility failed to ensure assistance with ADLs were offered or provided to patients.

A. Medical Record Review

i. On 4/13/23 until 5/4/23, Patient #6 received care at the facility for atrial fibrillation with a rapid ventricular rate (when the rapid contractions of the atria make the ventricles of the heart beat too quickly).

a. A review of Patient #6's flowsheets revealed the patient was offered a shower or bath or refused a shower or bath 8 out of the 21 days they were at the facility. There was no evidence in the medical record Patient #6 was offered or provided oral care throughout their entire stay.

ii. On 12/14/23 Patient #12 was admitted for treatment of septic arthritis (an infection in the joint fluid and joint tissues). Patient #12 was a current patient at the time of the survey.

a. A review of Patient #12's flowsheets at the time of the survey revealed the patient was offered a bath or shower or refused a bath or shower 9 out of 41 days they were at the facility. There was no evidence in the medical record Patient #12 was offered or provided oral care throughout their stay.

iii. On 12/1/23 Patient #19 was admitted to the facility for treatment of cellulitis (an infection of the skin). Patient #19 was discharged from the facility on 12/5/23.

a. A review of Patient #19's flowsheets at the time of the survey revealed the patient was not offered a bath or shower or refused a bath or shower during their stay. Additionally, there was no evidence in the medical record Patient #19 was offered or provided oral care throughout their stay.

iv. Similar findings of the lack of daily oral care and daily ADL assistance offered to patients were noted in Patients #1, #2, #3, #4, #5, #7, #8, #9, #10, #11, #13, #14, #15, #16, #17, #18, #20, #22, #24, #25, and #26.

This was in contrast to the ADL policy which read, all patients would be offered assistance with activities of daily living at regular intervals throughout the day. This was also in contrast to the Oral Hygiene policy which read, Patients shall be offered oral hygiene and assisted as necessary to perform oral hygiene routinely to promote oral cleanliness and comfort.

B. Interviews

i. On 1/25/24 at 12:35 p.m., an interview was conducted with registered nurse (RN) #4. RN #4 stated oral care and other ADLs were offered to patients depending on their condition. She stated when completed, ADLs were documented in the patient's medical record. RN #4 stated bathing and oral care were important to provide to patients in order to prevent infection and skin breakdown.

ii. On 1/25/24 at 11:49 a.m., an interview was conducted with the inpatient nurse manager (Manager) #3. Manager #3 stated, ADLs were completed by both RNs and CNAs. Manager #3 stated it was expected for staff to offer assistance with oral care three times a day to patients and to offer a bath or shower to patients once a day. They further explained if a patient refused oral care or a shower or bath, the staff member was to document the refusal in the patient's chart.

Manager #3 explained it was important to offer or assist with bathing and oral care in order to preserve and respect patients dignity. Manager #3 stated if patients were not bathed often, there was a risk for patient harm to their skin. Additionally, they explained if oral care was not offered or provided to patients, there was a risk of the patient developing cavities or infections of the mouth.

Based on medical record review and interviews, the facility failed to ensure medications were administered to patients at the time scheduled by the provider in 13 of 26 inpatient, swing bed or observation status patient medical records reviewed. (Patient #3, #4, #5, #6, #8, #12, #13, #17, #18, #19, #20, #24, and #25).

Findings include:

Facility policies:

The Medication Administration policy read, routine scheduled medications will be administered in a timely fashion within 60 minutes before or after the scheduled time. Administration times: Medications are administered via physician orders in concert with the definition and time frame established by nursing and Pharmacy in collaboration with the medical staff members. While STAT drugs are given immediately (within 15 minutes of the order), As Soon As Possible (ASAP) drugs (within 45 minutes of the order), and routine drug times are determined in such a way as to promote optimum blood levels but interfere as little as possible with patient rest and change of shift routines.

The Standardized Times policy read, the use of standard times shall be used only for the delivery of drugs that are deemed safe to do so by the Medical Staff.

1. The facility failed to ensure medications were administered when scheduled and/or 60 minutes after the scheduled time according to facility policy.

A. Medical Record Review

i. On 2/8/23 Patient #3 was admitted to the facility for treatment of a diabetic foot ulcer. A review of Patient #3's medication administration record (MAR) revealed medications were administered beyond the scheduled time.

a. On 2/10/23 at 8:00 p.m., Insulin Lispro (a fast-acting medication to lower a patient's blood glucose level) was scheduled to be administered. The MAR revealed the medication was not administered until 2/11/23 at 2:26 a.m., 6 hours and 26 minutes after the scheduled time.

There was no evidence why the medication was administered beyond the scheduled time.

ii. On 4/13/23 until 5/4/23, Patient #6 received care at the facility for atrial fibrillation with a rapid ventricular rate (when the rapid contractions of the atria make the ventricles of the heart beat too quickly). A review of Patient #3's MAR revealed medications were administered beyond the scheduled time.

a. On 4/16/23 at 9:00 a.m., Insulin Lispro was scheduled to be administered. The MAR revealed the medication was not administered until 12:38 p.m., three hours and 38 minutes after the scheduled time.

b. On 4/21/23 at 11:00 a.m., Insulin Lispro was scheduled to be administered. The MAR revealed the medication was not administered until 1:37 p.m., two hours and 37 minutes after the scheduled time.

c. On 4/27/23 at 8:00 p.m., Insulin Lispro was scheduled to be administered. The MAR revealed the medication was not administered until 4/28/23 at 12:15 a.m., four hours and 15 minutes after the scheduled time.

d. On 5/1/23 at 4:30 p.m., Insulin Lispro was scheduled to be administered. The MAR revealed the medication was not administered until 9:19 p.m., four hours and 49 minutes after the scheduled time.

There was no evidence why the medication was administered beyond the scheduled time.

iii. On 12/14/23 Patient #12 was admitted for treatment of septic arthritis (an infection in the joint fluid and joint tissues). A review of Patient #12's MAR revealed medications were administered beyond the scheduled time.

a. On 1/4/24 at 8:00 p.m., Cefazolin (a medication used to treat bacterial infections) was scheduled to be administered. The MAR revealed the medication was not administered until 10:07 p.m., two hours and seven minutes beyond the scheduled time.

b. On 1/16/24 at 1:00 p.m., Cefazolin was scheduled to be administered. The MAR revealed the medication was not administered until 4:06 p.m., three hours and six minutes beyond the scheduled time.

There was no evidence why the medication was administered beyond the scheduled time.

iv. On 1/9/24 Patient #13 was admitted to the facility for altered mental status (AMS). A review of Patient #13's MAR revealed medications were administered beyond the scheduled time.

a. On 1/10/24 at 6:30 a.m., Insulin Lispro was scheduled to be administered. The MAR revealed the medication was not administered until 10:08 a.m., three hours and 38 minutes beyond the scheduled time.

There was no evidence why the medication was administered beyond the scheduled time.

v. A review of Patient #4, #5, #8, #17, #18, #19, #20, #24 and #25's medical records revealed similar findings of medications being administered beyond the scheduled time.

B. Interviews revealed medications were to be administered at the time prescribed by the provider.

i. On 1/25/24 at 12:36 p.m., an interview was conducted with registered nurse (RN) #4. RN #4 explained the nurse was to adhere to the five patient rights of medication administration when medications were administered to patients to include, administration at the right time. RN #4 explained this was important to ensure a patient did not receive too much of a dose of medication.

ii. On 1/25/2024 11:50 a.m., an interview was conducted with the inpatient nurse manager (Manager) #3. Manager #3 stated if medications were not administered at the scheduled time, there was a risk for patient safety and concerns for the patient to receive too much of one medication.

Based on medical record review and interviews, the facility failed to ensure consent for treatment was provided to patients in six of 25 inpatient and swing bed status patient medical records reviewed. (Patient #1, #7, #11, #16, #17, and #22).

Findings include:

References:

The facility's patient rights read, the facility respects your rights as a patient and recognizes that you are an individual with unique healthcare needs. You have the right to: Be informed of your patient rights in advance of receiving or discontinuing care when possible. Give informed consent for all treatments/procedures and receive an explanation in layman's terms of recommended treatment or procedure; risks and benefits of the treatment or procedure; the likelihood of success, serious side effects, and risks including death; and alternatives and consequences if treatment is declined.

The facility's consent for treatment form read, Consent for health care services: I, suffering from a condition requiring inpatient or outpatient hospital medical care, hereby voluntarily consent to the rendering of care, which may include routine hospital services, diagnostic procedures, medical treatment, or other hospital care and services as the attending physician or others holding clinical privileges at the hospital consider necessary, and performed by the employees and staff of the hospital.

For Inpatient Only: a copy of patient rights/responsibility was given - yes or no.

I acknowledge that I have read this form and understand its contents and have received a copy hereof. I further acknowledge that I am the patient, or person duly authorized either by the patient or otherwise, to sign this agreement, consent to and accept its terms.

1. The facility failed to ensure all patients admitted for treatment were advised of their rights to treatment and failed to provide evidence of signed consent forms in the medical record.

A. Medical Record Review

i. On 1/4/23, Patient #1 was admitted to the facility for a pulmonary embolism (a blockage of the blood vessels that send blood to your lungs) and a deep vein thrombosis (a blood clot that develops within a deep vein in the body). A review of Patient #1's record revealed a lack of evidence Patient #1 was provided and signed a consent for treatment.

ii. On 5/9/23, Patient #7 was admitted for cellulitis (a bacterial skin infection). A review of Patient #7's medical record revealed a lack of evidence Patient #7 was provided and signed a consent for treatment.

iii. On 8/8/23, Patient #11 was admitted for bacterial pneumonia (an infection of the lungs caused by bacteria). Patient #11's medical record revealed a lack of evidence Patient #11 was provided and signed a consent for treatment.

iv. A review of Patient #16, #17, and #22's medical records review similar findings.

The medical record reviews were in contrast to the facility's patient rights which read, a patient had the right to be given informed consent for all treatments and procedures.

B. Interviews

i. On 1/25/24 at 12:35 p.m., an interview was conducted with registered nurse (RN) #4. RN #4 stated when patients presented to the emergency department, they were provided a consent for treatment. They further explained, if the patient was experiencing an emergency or was unable to sign a consent for treatment, staff would potentially accept verbal consent. RN #4 stated it was important for the consent form to be completed and signed to ensure the patient had been provided their consent for treatment.

ii. On 1/25/24 at 11:50 a.m., an interview was conducted with the inpatient nurse manager (Manager) #3. Manager #3 stated it was important for patients to provide their consent for treatment so the patient had a say in the treatment they were provided. They further explained, if a consent for treatment was not obtained, there was a potential to provide care to a patient against their will.

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §485.640 Infection Prevention and Control and Antibiotic Stewardship Programs was out of compliance.

C-1206 - The infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the CAH and between the CAH and other healthcare settings. Based on observations, interviews, and document review, the facility failed to ensure staff performed hand hygiene and glove use according to national standards and facility policy based on one of one patient care observations.

C-1208 - The infection prevention and control includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and that the program also addresses any infection control issues identified by public health authorities. Based on observations, interviews, and document review, the facility failed to follow the instructions for use (IFUs) for the reprocessing of surgical and procedural equipment. Specifically, the facility failed to ensure the endoscope pre-cleaning process was followed in one of one observation. Additionally, the facility failed to ensure equipment used during the instrument pre-cleaning process was maintained according to the IFUs.

Based on observations, interviews, and document review, the facility failed to ensure staff performed hand hygiene and glove use according to national standards and facility policy based on one of one patient care observations.

Findings include:

Facility policies:

The Hand Hygiene policy read, this policy applies to all healthcare personnel (HCP) and visitors. The purpose is to outline the process for appropriate hand hygiene. Hand Hygiene is the single most important process for interrupting the transmission of organisms from person-to-person, and preventing healthcare-acquired infections.

The following is the World Health Organization's outline for when you should sanitize your hands: before touching a patient; before clean or aseptic procedures; after body fluid exposure risk; after touching a patient; and after touching patient surroundings.

Additional situations in which your hands should be washed or sanitized include before putting on gloves and after removing your gloves; when moving hands from a contaminated body site to a clean body site during patient care; and before handling clean equipment such as patient charts, computer monitors, keyboards and mouse, and IV pumps.

1. The facility failed to ensure staff performed hand hygiene and glove use according to policy and national standards to reduce the risk of infection.

A. Observations

i. On 1/24/24 at 9:36 a.m., observations were conducted in the rural health clinic lab. Observations revealed technician (Tech) #1 performed a blood draw. Tech #1 did not remove their gloves or wash their hands after the procedure. Tech #1 walked the patient down the hall to the restroom for a urine sample with gloved hands. Tech #1 removed their gloves but did not perform hand hygiene and returned to the lab. Tech #1 with ungloved hands, labeled lab vials and used CaviWipes to wipe down hard surfaces. Tech #1 did not perform hand hygiene throughout the observation.

B. Interviews

i. On 1/24/24 at 9:36 a.m., an interview was conducted with Tech #1. Tech #1 stated they forgot to remove their gloves and wash their hands after the lab draw. Tech #1 stated gloves should not have been worn in the hallway since there was potential for cross-contamination to multiple surfaces. Tech #1 stated that gloves should be worn when labeling blood samples. Tech #1 stated to prevent the spread of infection; it was important to wash their hands and wear personal protective equipment (PPE). Tech #1 stated patients and staff were put at risk of contracting infections if the staff members did not wash their hands or wear PPE properly.

ii. On 1/24/24 at 12:33 p.m., an interview was conducted with registered nurse (RN) #5. RN #5 stated gloves worn while drawing labs should be removed directly after the procedure was performed. RN #5 further stated used gloves should not be worn in the hallway and patient care areas. RN #5 stated hand hygiene should be performed before and after patient care, after hands became soiled, and before and after gloves were applied and removed. RN #5 stated it was important to perform hand hygiene for infection control purposes. RN #5 stated improper hand hygiene could lead to cross-contamination and increase the risk of infection for the patients and staff.

iii. On 1/24/24 at 12:05 p.m., an interview was conducted with the clinic admission supervisor (Supervisor) #6. Supervisor #6 stated proper hand hygiene should be performed before and after patient care to prevent cross-contamination and prevent the spread of infections. Supervisor #6 stated patients and staff were at a higher risk of infection when staff did not perform hand hygiene correctly.

iv. On 1/24/24 at 12:04 p.m., an interview was conducted with infection control and chief quality officer (Officer) #8. Officer #8 stated health clinics associated with the hospital would follow the same policies and procedures. Officer #8 stated they used a web-based application to complete hand hygiene audits. Officer #8 stated the facility's hand hygiene compliance was at 42%. Officer #8 stated staff were educated on infection control and how and when to perform hand hygiene during new hire orientation and annual competencies training. Officer #8 stated hand hygiene was important to prevent the spread of infection.

v. On 1/25/24 at 11:52 a.m., an interview was conducted with chief nursing officer (CNO) #9. CNO #9 stated hand hygiene should be performed before and after entering a patient's room, anytime a staff member touched a patient, and when the hands became visibly soiled. CNO #9 stated Officer #8 performed the hand hygiene audits at the facility. CNO #9 stated the hand hygiene audits were discussed in the infection control meetings. CNO #9 stated the reported hand hygiene audit numbers were not up to their standards. However, CNO #9 was unable to provide evidence related to hand hygiene audits and current rates. CNO #9 stated proper hand hygiene was important to prevent the spread of infection. CNO #9 stated improper hand hygiene put the patients at risk of infection, especially patients who were already immunocompromised (weak immune system).

Based on observations, interviews, and document review, the facility failed to follow the instructions for use (IFUs) for the reprocessing of surgical and procedural equipment. Specifically, the facility failed to ensure the endoscope pre-cleaning process was followed in one of one observation. Additionally, the facility failed to ensure equipment used during the instrument pre-cleaning process was maintained according to the IFUs.

Findings include:

Facility policy:

The Endoscopy Processing policy read, the policy was to provide a safe patient environment when performing procedures utilizing endoscopes by reducing the risk of potential contamination equipment being used for procedures and to provide a safe environment for personnel when processing soiled endoscopes.

The following steps should be utilized when preparing the endoscope for processing. Immediately following the procedure, clean/wipe all debris from the insertion tube using an enzymatic cleaner and run brushes through channels. Aspirate detergent several times through the biopsy/suction channel. Remove all removable caps. Visually inspect the insertion tube as well as the outside of the entire scope for any possible signs of damage. Perform the leak test as follows:

For the dry test: secure the leakage tester connector to the air vent on the scope light guide. Be sure the PVE soaking cap is securely in place over the electrical contacts. The leakage tester connector and air vent on the scope light guide must be dry before connecting. To obtain proper connection, align the air vent pin and then clockwise rotation of the leakage tester connector. Turn the gauge faceplate to zero the pressure indicator. Pressurize the scope by pumping the hand bulb until the indicator on the gauge is in the green zone. Do not pressurize in the red zone as it may cause serious damage to the scope. During this leakage test flex the insertion tube in various directions as well as angulate the distal tip of the insertion tube to confirm the absence of a leak.

For the wet test: after it has been determined there are no major leaks from the dry test, the scope may be immersed to test for loss of integrity in the watertight construction of the scope. Before immersing, remove the red ETO gas sterilization venting cap and make certain the PVE soaking cap is securely on covering the electrical contacts. With the leakage tester securely attached to the scope and the scope pressurized into the green zone, the PVE soaking cap securely attached over the electrical contacts, all valves and inlet seals removed, the entire scope may be immersed in clean water. Do not immerse the leakage tester, only the connector and a small portion of the tubing may be immersed. Observe the scope closely. Flex the scope as above in the dry test as well as angulate the distal end of the insertion tip. A few bubbles may be noted at first. This is normal. If a continuous stream of bubbles is noted from the same spot, this indicates a leak. Immediately removed from the water. Do not use the scope.

The Surgical Instrument Decontamination policy read, the policy's purpose is to minimize the potential risk for surgical site infections by providing instruments, supplies, and other items free of contamination at the point of use. A handle brush should be used with friction in cleaning all surfaces of each instrument and device. The cleaning brushes will also be cleaned after use according to the IFU for each different brush.

References:

The Fujifilm Reprocessing Summary and Guide for Flexible GI Endoscopes read, flexible endoscopes are reusable medical devices which require special handling after each clinical use to render them safer for subsequent patient procedures.

Leak testing: the endoscope should first be leak tested per the manufacturer's recommendations. Instruments should be fully immersed in a basin containing clean water during the wet leak test. Ensure that all removable scope components are detached from the endoscope prior to leak testing. Attach a dry waterproof/soaking cap to the endoscope prior to immersion in any fluid. Inspect the leak tester before use and connect it to the scope out of water. Dry leak test the scope before immersion. Ensure the leak tester has no fluid/moisture inside the tubing, connector or bulb. Perform a dry leak test by pressurizing the scope, letting it stand for 30 seconds and checking if the indicator needle on the Fujifilm tester gauge drops 10 gradations. Perform a wet leak test in clean water while manipulating the bending section and remote/video switches; confirm that no leak exists by looking for a continuous stream of air bubbles.

The Batrik Medical Manufacturing Reusable Brushes IFUs read, the reusable brushes are intended to assist in the cleaning of medical devices in conjunction with a suitable cleaning solution. All components used in the manufacturing of our reusable brushes are made of commonly used materials and do not require special sterilization handling outside your facility's standard sterilization protocol. Between usages, inspect for wear, fraying or damaged bristles. If observed, the brush should be discarded in compliance with your facility disposal instructions.

Cleaning and sterilization: These products have been manufactured using materials that withstand repeated steam sterilization cycles achieving 273?. Although the product is designed for considerable re-use, variables such as frequency of sterilization, cleaning application and handling can impact the product's useful life.

1. The facility failed to ensure endoscopes were reprocessed according to the manufacturer's IFUs.

a. On 1/24/24 at 7:50 a.m., an observation of certified surgical technician (Tech) #11 reprocessing an endoscope was conducted. During the observation, Tech #11 did not retroflex the tip of the endoscope during both the dry leak test and the wet leak test.
The observation was in contrast to the manufacturer IFUs which read, leak testing should be conducted per the manufacturer's recommendations. Perform a wet leak test in clean water while manipulating the bending section and remote/video switches; confirm that no leak exists by looking for a continuous stream of air bubbles.

The observation was also in contrast to the endoscope reprocessing policy which read,
during the leakage test, flex the insertion tube in various directions as well as angulate the distal tip of the insertion tube to confirm the absence of a leak. During the wet leak test, flex the scope as above in the dry test as well as angulate the distal end of the insertion tip.

b. On 1/24/24 at 10:35 a.m., an interview was conducted with Tech #11. Tech #11 stated when he performed the leak test on the endoscopes, they did not move the tip around. Tech #11 further stated if they had a question about how to reprocess an endoscope, they would refer to the manufacturer's IFUs.

This interview was in contrast to the manufacturer IFUs and the endoscope reprocessing policy which read, flex the insertion tip to check for leaks.

c. On 1/25/24 at 11:52 a.m., an interview was conducted with chief nursing officer (CNO) #9. CNO #9 stated it was important for manufacturer IFUs to be followed to ensure equipment was cleaned appropriately to prevent the spread of infection.

2. The facility failed to ensure IFUs for equipment used to clean surgical instruments were followed.

a. On 1/23/24, an observation was conducted of the sterile processing area. During the observation, Tech #11 was observed reprocessing instruments from an orthopedic total knee casket. Tech #11 was observed cleaning the surgical instruments with a scrub brush. In addition to the brush utilized by Tech #11, numerous other brushes were identified stored in a plastic bin on the sink. The brushes in the plastic bin appeared to be worn and had been used.

b. On 1/23/24 at 8:20 a.m., an interview was conducted with Tech #11. Tech #11 stated the scrub brushes used on the instruments were reused and did not need to be sterilized in between use. They stated the brush typically could be used for four months or until the bristles of the brush began to fall out.

The interview was in contrast to the manufacturer IFUs which read, the products have been manufactured using materials that withstand repeated steam sterilization cycles achieving 273?. Although the product is designed for considerable re-use, variables such as frequency of sterilization, cleaning application, and handling can impact the product's useful life.

c. On 1/25/24 at 11:52 a.m., an interview was conducted with CNO #9. CNO #9 stated it was important for staff to follow the manufacturer IFUs to ensure surgical instruments were cleaned in order to prevent the spread of infection between patients.