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Based on observation, interview, and record review, the Governing body failed to:


A. ensure contracted services were provided in a safe manner. The facility failed to ensure there was a system in place to evaluate 10 of 27 contracted services that were reviewed (organ procurement, blood, lithotripsy, wound, anesthesia, radiology, head and spine, environmental, management and dialysis).

Refer to A tag 0084 for additional information.




B. ensure patients on ventilators (equipment used to assist patients with breathing) received care in a safe setting. The facility failed to:

Ensure physicians wrote ventilation setting orders for 5 of 8 patients that were identified as being on ventilators in the Adult intensive care unit (Patient #'s 57, 59, 61, 63 and 64). There were no orders for nursing to use as guides for monitoring the care of the patients and for respiratory staff to use to set up the desired settings the patients needed.

Physicians were giving verbal orders to staff which were not being written. Nursing and respiratory staff were depending on critical care notes and history and physical notes for their ventilation setting orders.

According to interview with staff this practice of not writing the physician orders for the ventilator settings had been going on for 2-3 years.

Refer to A tag 144 for additional information.



C. ensure data collected was used to identify opportunities for improvement. The facility failed to track and measure success on performance improvement projects for the timeframe of January 2018 to July 2019.

The facility failed to:

Ensure the Quality Improvement Program was organized in a manner and had the responsibility of effectively coordinating, implementing, and monitoring Performance improvement(PI).

Ensure PIs that were currently in place were being tracked and trended.

Ensure that high risk and problem-prone areas were focused on, identified, data collected, PIs developed and PIs reported timely in contracted services, infection control, nursing services, pharmacy services, and laboratory services.

Refer to A tag 0283 for additional information.



D. ensure that nursing services provided care and services that met the needs of patients in accordance with accepted standards of practice. The facility failed to:

Have adequate numbers of nurses and other personnel. The facility failed to staff per their established staffing grid.

A review of the staffing for the Progressive Care Unit (PCU) (50 beds) in the facility was completed for the dates 08/25/19 through 8/28/2019 and 09/01/19 through 09/3/19. The PCU was found to not be staffed per the staffing grid on 8 out of 11 shifts reviewed.


The facility failed to ensure Registered nurses (RN) supervised and evaluated care of each patient. The RNs failed to report abnormal vital signs to the physician. The review revealed that 5 patients (#13, #14, #22, #23, and #24) out of 6 reviewed had elevated vital signs (blood pressure, pulse and/or temperature) that were not reported to the physician.

They failed to notify the physician when medications were not administered in a timely manner, and/or failed to notify the physician when medications were not administered due to patient refusal of medications; Failed to see clarification of an order for medication that the patient was documented to have an allergy to.

The review revealed that 3 patients (#13, #22, and # 23) out of 6 had medications not given or patient refused and no documentation present that showed the physician was notified of the missed medication or the patient's refusal.

They failed to report critical lab values. The review revealed that 1 patient (#24) out of 6 reviewed had critical lab values. There was no documentation that the physician was notified of the critical lab values.

Refer to tags A 0392 and A0395 for additional information.


C. ensure medications were reconciled appropriately, accurate orders were obtained, and administered safely in 1 of 6 patients (Patient #1) reviewed for medication reconciliation.

Patient #1 received an overdose of medications because they were not reconciled on presentation into the Emergency department (ED). The facility implemented medication reconciliation training for all staff, but failed to ensure the staff who initially put the medications in incorrectly was trained as of 09/06/2019.

Nursing staff failed to administer medication as prescribed by the physician.


Refer to A tag 0405 for additional information.



D. To administer blood products and intravenous fluids were in accordance with written policy and procedures.

The facility failed to ensure blood transfusions were completed, physician orders for blood transfusions were complete, and vital signs were done per their policy during blood administration, in 8 of 8 patients (Patient #3, #13, #14, #19, #20, # 24, #35, and #92)

The facility failed to ensure physician orders for IV medications were complete and administered as ordered by the physician in 9 of 9 Patients (Patient #'s 2, 10,11,35, 36, 66, 89, 90, and 91) records reviewed. Also, the facility failed to ensure post-operative anesthesia orders were well defined and clear to nursing staff in the post-operative areas on Patient #40.


Refer to tag A0409 for additional information.



E. ensure that the pharmacy and drug storage areas were maintained according to acceptable United States Pharmacopeia (USP) standards for 14 out of 14 medication storage and preparation areas/units (ICU, Maternal / Child, Neonatal ICU, Labor and Delivery, Hemodialysis work area for med prep, Progressive Care Unit, Surgical Unit, Heart Vascular Unit, Same Day Surgery, Post Anesthesia Care Unit, Horseshoe/Medical medication room, Emergency Room, Cath Lab and Interventional Radiology, and the main Pharmacy). The facility failed to:

Ensure that all activities of pharmacy services fell under the supervision, control, and coordination of the Pharmacy Director. The facility allowed other departments to order, store, transport, and distribute medications [bulk Intravenous (IV) fluids] without following proper pharmacy oversight.

Ensure that processes were developed to minimize the risk of drug diversion, ensuring the accurate record of use when scheduled drugs/controlled medications were dispensed in Intravenous (IV) bag form for use with standard IV pumps rather than Patient Controlled Analgesia (PCA) pumps.


Ensure that safe and complete orders for titrating Intravenous (IV) medications (increasing or decreasing the amount of medication given to the patient based on the patient's response to the medication) were established and followed. This deficient practice required nurses to use their own judgement when decreasing medication due to patient response or reducing the medication for the purpose of discontinuing it. This type of judgement required the medical decision-making of a physician and was beyond the scope of practice for nursing.

Ensure a pharmacy process was developed for monitoring the nursing changes made in titrated medications to ensure medications were being delivered to the patient safely as ordered by the physician and were accurately recording the medication administration in 2 out 2 patient charts reviewed (Patient #57 and Patient #58).

Refer To A tags 0491, 0492, 0494 and 0500 for additional information.



F. ensure a sanitary environment in 34 of 34 area's ( Central Supply/ Warehouse, Surgical floor patient care area, Emergency Room, NICU supply room, L&D Nursery, L&D C- Section Room, L&D sterile instrument storage area, Post-partum patient room 349, ASC OR3, ASC OR4, ASC Equipment storage room, ASC sterile storage room, ASC GI room 3, Cath Lab 1, Cath Lab 3, Cath Lab housekeeping room, Cath Lab sterile storage room, Cove in hallway outside Autoclave 8, Sterile Processing Instrument Storage room, Main OR Room 3,4,9,10, &16, L&D Room 311, Main hallway store room post-partum floor, Bronchoscopy room, Cath Lab Pre-Post storage area, Radiology, Nuclear Medicine Departments, Laboratory,The Breast Center, The Wound Center, Second Floor Patient Care Area, Third Floor Patient Care Area, and Dietary.)


Ensure patient medical supplies were being stored in a clean, monitored temperature and humidity-controlled storage area in Central Supply warehouse. ensure sterile supplies and sterile instruments that were readily available for patient use was protected from extreme temperature and humidity and sterile supplies and instruments were not contaminated at The Center for Wound Healing and Hyperbaric Medicine.


Ensure staff removed Personal protective equipment (PPE) prior to leaving rooms of patients who were on Isolation precaution. The facility failed to ensure equipment and supplies that were used in rooms of patients on Isolation precaution was properly sanitized or discarded before removing it from the room. The facility failed to ensure housekeeping staff that were cleaning rooms for patients on Isolation precautions were properly trained on what PPE they needed to use and what precautions to take.


Ensure education was provided to patients, visitors, caregivers, and staff, as appropriate, about infections and communicable diseases and methods to reduce transmission in the hospital and in the community.

Ensure infection control officer maintained and monitored pest control.


Ensure the Emergency Room had sterile packets appropriately covered and ensure all patient were offered clean medical supplies and equipment.

Ensure a surgical instrument set was sterilized according to ANSI (American National Standards Institute)/ AAMI (The Association for Advancement of Medical Instrumentation) sterilization standards.

Ensure the I-Stat machine cartridges (portable clinical analyzer is a point of care analyzer to be used at the patient's bedside to measure critical care tests such as blood gases, electrolytes, metabolites and coagulation) were stored at temperatures recommended by the manufacturer.

Ensure the temperature in the Operating room (OR) was within acceptable standards to inhibit microbial growth, reduce the risk of infection, promote patient comfort and assure the physical safety of all patients. The temperature and Humidity was out of range for the months of August and September 2019. There was no documentation on the log to indicate corrective action taken and the temperature on follow up after corrective action was done. The facility failed to follow their own policy.

Ensure an infection control program that evaluated services areas and maintain a sanitary environment in temporary dietary kitchen, second and third floors of the nursing services units.


Refer To A tags 0749 for additional information.

Based on interview and record review, the Governing body failed to ensure contracted services were provided in a safe manner. The facility failed to ensure there was a system in place to evaluate 10 of 27 contracted services that were reviewed (organ procurement, blood, lithotripsy, wound, anesthesia, radiology, head and spine, environmental, management and dialysis).


This deficient practice had the likelihood to cause harm to all patients.



Findings include:



Review of a facility's contracted service list revealed there were 28 services. Ten (10) of the contracts involving organ procurement, blood, lithotripsy, wound, anesthesia, radiology, head and spine, environmental, management and dialysis were reviewed. No evaluations of the services were found.


During an interview on 09/04/2019 after 9:13 a.m., Staff #115 said that they had a company take over reviewing contracts last year. About 2 weeks ago all contracts and servicers were assigned to a reviewer because they discovered the contracts were not being reviewed. The only thing that had been done with contracts is that they were assigned to different departments. They had not had a meeting yet to determine what would be done.


During an interview on 09/06/2019 after 10:30 a.m., Staff #2 confirmed that contracted services were not being evaluated and brought to Governing body.

Based on observation, interview and record review, the facility failed to protect and promote patient's rights. The facility failed to:

A. ensure patients on ventilators (equipment used to assist patients with breathing) received care in a safe setting. The facility failed to:

Ensure physicians wrote ventilation setting orders for 5 of 8 patients that were identified as being on ventilators in the Adult intensive care unit (Patient #'s 57, 59, 61, 63 and 64). There were no orders for nursing to use as guides for monitoring the care of the patients and for respiratory staff to use to set up the desired settings the patients needed.

Physicians were giving verbal orders to staff which were not being written. Nursing and respiratory staff were depending on critical care notes and history and physical notes for their ventilation setting orders.

According to interview with staff this practice of not writing the physician orders for the ventilator settings had been going on for 2-3 years.


It was determined that these deficient practices posed an Immediate Jeopardy to patient health and safety, and placed all patients in the facility at risk for the likelihood of harm, serious injury, and possibly subsequent death.


B. The facility failed to ensure the security of the dialysis supplies and products in the acute dialysis unit.

The facility failed to ensure emergency hand cranks were present for each dialysis machine.

The facility failed to ensure dialysis staff were maintaining a clean and sanitary environment for the acute dialysis patient.

The facility failed to ensure acid and bicarb wands were secured to acid and bicarb jugs.

The facility failed to ensure that 1 of 6 dialysis machines (#123199) was disinfected every 7 days for the months of June 2019.

The facility failed to ensure staff was performing proper hand hygiene during CVC(central venous catheter) care.

The facility failed to ensure staff was not placing supplies on the bed while performing cannulation of the graft site.

The facility failed to ensure staff followed the physicians order for the length of the treatment for the dialysis treatment.


Refer to A tag 144 for additional information.



C. The facility failed to have a policy and procedures to address the administration of chemical restraints, ensure that systems and processes were developed, implemented, and evaluated that supported the patients' rights. Have a policy and procedure that would guide the nurse in appropriate patient assessment and reassessment after a chemical restraint was administered in 1of 3 (#56, 77, and 78) patient charts reviewed.

The facility failed to have documentation of law enforcement detainment, custody, or direct supervision in order to handcuff a patient to the stretcher in the Emergency Department (ED) in 1(#56) of 3(#56, 77, and 78) patient charts reviewed.

The facility failed to protect a patient from chemical restraints for staff convenience in 1(#56) of 3(#56, 77, and 78) patient charts reviewed.

The facility failed to follow their policy and procedures for observation when a patient was restrained and secluded in 1(#56) of 3(#56, 77, and 78) charts reviewed.

The facility failed to ensure the physician assessed a patient and documented a face to face before chemical restraints were administered in 1(#56, 77, and 78) of 3 patient charts reviewed.

The facility failed to have any monitoring of chemical restraints, education of staff, and Quality Assurance Performance Improvement (QAPI).

Refer to A tag 154 for additional information.

Based on observation, review of documents, and interview, the facility failed to develop a process to ensure that staff explained patient rights to the patient and provided the patient with required copies of those rights prior to furnishing services.


Findings included:

On the morning of 9-4-2019 registration Staff #111 was observed during the registration of Patient #79. The Director of Registration, Staff #110, was present during the observation. Patient #79 was registering for a pre-operative appointment to occur on the day of registration, 9-4-2019. He was also pre-registering for an inpatient admission to occur post-surgery on 9-11-2019, 7 days from the pre-registration date.

Two registration packets were prepared by Staff #111. Staff #111 placed an X next to the lines that required patient signatures, circled items that required the patient to initial, and put the current date and time on forms next to the patient signature blocks. Staff #111 explained to the patient that one packet was for the visit that day. The other packet was being filled out so that the patient would not have to do all of the same paperwork on the day of admission. After the patient had signed all of the documents, one packet was sent to pre-operative appointment staff for their files. The other packet was placed into a file box under the date the admission was to take place, 9-11-2019. The patient was not given a copy of either packet of forms he had signed.

Interview with Staff #110 confirmed that the process observed was the process used for all patient registrations that were not through the emergency department. Staff #110 was asked why patients were not given copies of the forms that had been signed. Staff #110 explained that if the patient requests a copy, they can have one, but one is not offered or given unless the patient asks. Staff #110 stated that they used to give patients a copy, but because it had Protected Health Information (PHI) on it there were privacy concerns when patient through them in public trashcans or left them laying in public areas of the hospital. Staff #110 was asked why the patients did not receive a copy of the same information without PHI on it. Staff #110 stated that the hospital could do that. This process of requiring the patient to ask for required notices shifted the burden of providing patients with their rights from the hospital to the patient. It required patients to understand the importance of the patient rights information being presented along with the knowledge that the important contact information and instructions on how to exercise their rights were contained on those forms and could be necessary for future reference.

During the registration process, Staff #111 was observed to present the first form for signature. Staff #111 told the patient that this form was the Hospital Disclosure for insurance filing. After the patient left the area, the signed form was reviewed and was found to contain the following statement:

"EXHIBIT B
Your name and signature below indicate that you have received a copy of the Longview Regional Medical Center Billing Disclosure on the date and time indicated"

The patient had never been given a copy of the Disclosure. A copy of the actual disclosure referenced in Exhibit B was not in the packet. When asked for the patient's copy of the form, Staff #110 stated the registration clerk had not prepared it, "She must have been nervous." Staff #110 provided a blank copy of Exhibit A, Longview Regional Medical Center Billing Disclosure form. The form contained the following information:

"Important Notice: Please Read Carefully

You are receiving the above services at Longview Regional Medical Center on the date(s) listed above.

Based on the health plan information you provided at the time you completed registration for these Longview Regional Medical Center services and the date(s) of service listed above, LRMC [is] [is not] a participating provider under your health plan.

Regardless of whether Longview Regional Medical Center is a participating provider under your health plan, including deductible, copayment and coinsurance amounts, depends on the exact terms of your health plan coverage. For example, the amount you owe may vary depending on whether the physician referring you for surgical services is a participating provider in your health plan. You should contact your health plan for more information.

During your stay at Longview Regional Medical Center for these Hospital Services, various physicians and providers will also provide services to you. Some examples of this would include anesthesiologist, pathologist or radiologists. Please be aware that these physicians or providers may not be participating providers under your health plan.

You should contact your health plan for accurate information regarding the plan structure and costs, including deductibles, copayments, and coinsurance requirements, that might apply to services provided by non-participating providers during your stay for Hospital Services."

The patient was not given the opportunity to read this notice as it was not in the package. The facility however, had him sign a statement saying he had received a copy. By not providing the patient this information, the patient was not allowed to exercise his right to make an informed decision about the care he was receiving based on his insurance coverage and ability to pay out-of-pocket expenses. The patient could potentially be placed in unnecessary financial hardship because this information had not been adequately explained to him, nor did he receive a copy to read.

The second form presented to Patient #79 was an "Inpatient/Outpatient Conditions of Admission and Consent to Medical Treatment - TX". This was a 3-page form requiring the patient to initial three times, check whether or not he was participating in any research study or projects and sign the bottom statement that read, "The undersigned certifies that s/he has read (or have had read to me) the forgoing, understand it, accepts its terms, and received a copy of. I hereby agree to all terms and conditions set forth above and understand that any sections of this consent that I do not consent to, I have struck through and initialed the section that does not have my consent or permission."

Staff #111 told the patient that the form was the consent for treatment, the consent to bill insurance, the consent for the procedure and for the pre-operative appointment. Staff #111 did explain the section about participating in research study or projects and answered questions the patient and spouse had.

Review of the form showed that the form also contained information about consenting to being photographed and videotaped; about the use of virtual health/telemedicine services; about how to file a complaint concerning physicians; about actions that could be taken against the patient if the patient failed to pay his bill; about access to private nursing and releasing the facility from any and all liability arising from not being provided private nursing; consent to release health information; a statement saying the patient had received a copy of the Facility's notice of Privacy Practices; that his cell phone number could be released to collection agencies so he could be contacted by phone call, automated telephone dialing system or an artificial or prerecorded voice, text, or email; and that he nor his visitors were allowed to photograph, video record, audio record, or otherwise capture imaging or sound on any device; as well as other important information.

The third form given to the patient to sign was the Notice of Patient Rights and Responsibilities. This form contained all of the required notifications of patient right information to include instructions with contact information on how to file a complaint. The statement above the patient signature stated, "The undersigned certifies that s/he has read the foregoing, understands it, accepts its terms, has received a copy of it and is the patient or is duly authorized by the patient as their agent to execute the above."

The last form in the packet was "An Important Message From Medicare About Your Rights". Staff #111 did not date and/or time this form as she had done on previous forms. The patient signed the form below a statement that said, "Please sign and date here to show that you received this notice and understand your rights."

None of this information was explained to the patient and the patient was not provided copies of the notices that the facility had him sign saying he had received copies. The patient was not encouraged to read these forms. Staff didn't explain the scope and importance of the information. Staff didn't explain the patient rights information contained on the forms or provide a copy of the information on these forms for future reference. While some of the information from these forms were included in a patient handbook that is in the patient rooms upon admission, this information was not fully provided in advance of services in order to allow the patient to make informed decisions and exercise his rights.

Review of Medicare Claims Processing Manual; Chapter 30 - Financial Liability Protections; did show that the Important Message from Medicare (IM Letter) could be completed up to 7 days in advance of admission. However, the specific instructions for presenting the IM Letter were not followed to include:
Staff did not allow or encourage the patient to read the IM Letter prior to asking the patient to sign.
Staff did not offer to explain the patient the rights contained in the IM Letter and/or verify that the patient understood those rights.
Staff did not provide the patient with the opportunity to ask questions and have them answered after those rights were explained.
Staff did not provide the patient with the original signed copy.

The IM Letter was for inpatient Medicare admissions only. The patient was also asked to sign an IM Letter for his outpatient pre-operative appointment.

Instructions for the manual include:

Medicare Claims Processing Manual
Chapter 30 - Financial Liability Protections
200 - Expedited Review Process for Hospital Inpatients in Original Medicare
200.3.1 - Delivery of the Important Message from Medicare

"Delivery Timeframe. Hospitals must deliver the original copy of the IM at or near admission, but no later than 2 calendar days following the date of the beneficiary's admission to the hospital. Hospitals may deliver the initial copy of the notice if the beneficiary is seen during a preadmission visit, but not more than 7 calendar days in advance of admission. If a beneficiary receives and signs the initial copy of the IM as part of the preadmission process, the follow-up copy of the notice must be delivered if delivery of the initial copy occurred more than 2 calendar days prior.

...

Ensuring Beneficiary Comprehension.

Hospitals must make every effort to ensure the beneficiary comprehends the contents of the notice before obtaining the beneficiary's signature. This includes explaining the notice to the beneficiary if necessary and providing an opportunity for the beneficiary to ask questions. The hospital should answer all the beneficiary's questions orally to the best of its ability. The beneficiary should be able to understand that he or she may appeal a discharge decision without financial risk, but may have to pay for any services received after the discharge date if he or she stays in the hospital and does not appeal. Notices should not be delivered during an emergency, but should be delivered once the beneficiary is stable.

These instructions do not preclude the use of assistive devices, witnesses, or interpreters for notice delivery. Thus, if a beneficiary is able to comprehend the notice, but either is physically unable to sign it or needs the assistance of an interpreter to translate it or an assistive device to read or sign it, valid delivery may be achieved by documenting use of such assistance.

Beneficiary Signature and Date.

The IM must be signed and dated by the beneficiary to indicate that he or she has received the notice and can comprehend its contents, unless an appropriate reason for the lack of signature is recorded on the IM, such as a properly annotated signature refusal (see below).

...

Notice Delivery and Retention. Hospitals must give the original copy of the signed or annotated notice to the patient. Hospitals must retain a copy of the signed notice and may determine the method of storage that works within their existing processes, for example, storing a copy in the medical record or electronically."

Based on record review and interview, the facility failed to ensure that patients or their representatives were provided with risks and benefits as related to their medical prognosis prior to procedures or treatments in 4 (Patient #'s 9,10,11 &12) of 5 Labor & Delivery patients reviewed. The facility also failed to provide informed consent to Patient #3.

The facility failed to follow their own policy and procedures.

The facility failed to ensure the patient's representative signed consent for treatments and services in the absence of the patient's ability to sign for herself in 1 of 5 patients reviewed, (Patient #3).


This deficient practice had the likelihood to cause harm to all patients.


Findings include:


PATIENT #9

Review of Patient #9's medical record on September 3, 2019 after 11:00 a.m. revealed the following:

Review of the facility document titled, "Disclosure and consent Medical and Surgical Procedures" revealed three consents. The procedures/treatments listed on the consent were Pitocin for Induction, Vaginal Delivery, and Anesthesia consent.

The Pitocin consent was signed by Patient #9 on 9-3-2019 at 5:40a.m. The witness was signed by Staff #123 on 9-3-2019 at 5:40 a.m. The physician signature was signed by Staff #10 on 9-3-2019 at 7:26 a.m.; almost 2 hours after the patient signed the consent.

The Vaginal delivery consent was signed by Patient #9 on 9-3-2019 at 5:40 a.m. The witness was signed by Staff #123 on 9-3-2019 at 5:40 a.m. The physician signature was signed by Staff #10 on 9-3-2019 at 7:27 a.m.; almost 2 hours after the patient signed the consent.

The anesthesia consent was signed by Patient #9 on 9-3-2019 at 5:40 a.m. The witness was signed by Staff #123 on 9-3-2019 at 5:40 a.m. The physician signature was signed by Staff #8 on 9-3-2019 at 9:00 a.m.; almost 3 ½ hours after the patient signed the consent.

There was no documentation in the medical record to ensure the physician/practitioner discussed the risks and benefits with the patient prior to the staff having the consents signed.


PATIENT #10

Review of Patient #10's medical record on September 3, 2019 after 11:00 a.m. revealed the following:

Review of the facility document titled, "Disclosure and consent Medical and Surgical Procedures" revealed three consents. The procedures/treatments listed on the consent were Pitocin Administration, Vaginal Delivery, and Anesthesia consent.

The Pitocin consent was signed by Patient #10 on 9-3-2019 at 7:02 a.m. The witness signature was signed by Staff # 11 on 9-3-2019 at 7:02 a.m. There was no physician signature.

The Vaginal Delivery consent was signed by Patient #10 on 9-3-2019 at 7:02 a.m. The witness signature was signed by Staff #11 on 9-3-2019 at 7:02 a.m. There was no physician signature.

The anesthesia consent was signed by Patient #10 on 9-3-2019 at 7:02 a.m. The witness signature was signed by Staff #11 on 9-3-2019 at 7:02 a.m. Staff #8 signed the consent on 9-3-2019 at 8:50 a.m.; almost 2 hours after the patient signed the consent.

There was no documentation in the medical record to ensure the physician/practitioner discussed the risks and benefits with the patient prior to the staff having the consents signed.


PATIENT #11

Review of the facility document titled, "Disclosure and consent Medical and Surgical Procedures" revealed two consents. The procedures/treatments listed on the consent were Pitocin and Vaginal Delivery.

The Pitocin consent was signed by Patient #11 on 9-3-2019 at 6:31 a.m. The witness signature was signed by Staff #9 on 9-3-2019 at 6:31 a.m. The physician signed the consent at 07:30 a.m.; almost 1 hour after the patient signed the consent.

The Vaginal Delivery consent was signed by Patient #11 on 9-3-2019 at 6:31 a.m. The witness signature was signed by Staff #9 on 9-3-2019 at 6:31 a.m. Physician #125 signed the consent on 9-3-2019 at 7:30 a.m.; almost 1 hour after the patient signed the consent.

There was no documentation in the medical record to ensure the physician/practitioner discussed the risks and benefits with the patient prior to the staff having the consents signed.


PATIENT #12

Review of the facility document titled, "Disclosure and consent Medical and Surgical Procedures" revealed five consents. The procedures/treatments listed on the consent were Pitocin Administration, Vaginal Delivery, Cytotec administration, Anesthesia consent and Bilateral Tubal Ligation consent.

The Pitocin consent was signed by Patient #12 on 9-2-2019 at 7:50 p.m. The witness signature was signed by Staff #124 on 9-2-2019 at 7:50 p.m. There was no physician signature.

The Vaginal Delivery consent was signed by Patient #12 on 9-2-2019 at 7:50 p.m. The witness signature was signed by Staff #124 on 9-2-2019 at 7:50 p.m. There was no physician signature.

The Cytotec administration consent was signed by Patient #12 on 9-2-2019 at 7:50 p.m. The witness signature was signed by Staff #124 on 9-2-2019 at 7:50 p.m. There was no physician signature.

The anesthesia consent was signed by Patient #12 on 9-2-2019 at 7:50 p.m. The witness signature was signed by Staff #124 on 9-2-2019 at 7:50 p.m. The anesthesia provider signature was illegible. The signature was dated 9-2-2019 at 11:00 p.m.; over 3 hours after the patient signed the consent.

The Bilateral Tubal consent was signed by Patient #12 on 9-2-2019 at 7:50 p.m. The witness signature was signed by Staff #124 on 9-2-2019 at 7:50 p.m. The physician signature was illegible. The signature was dated 9-3-2019, the day after the patient signed the consent. There was no time on the physician signature.


There was no documentation in the medical record to ensure the physician/practitioner discussed the risks and benefits with the patient prior to the staff having the consents signed.





28659


PATIENT #3

On 9/6/2019 a review of the medical record (MR) for Patinet (Pt) #3 was conducted in the conference room.

Pt #3's MR indicated on the admission face page that her, "In case of emergency" contact, was her mother.

Review of the admission consent indicated the patient may have signed by initial only but used a "G" rather than a "J" to initial her name.

Admission information indicated the patient's last name began with a "J". However the patient name was signed with a "G". This is the only time the full name of the patient is found signed in the MR.

Pt #3 underwent a cardiac catheterization and a surgery. Both of these consents were initialed by her daughter. Identified as "MR" on the signature line.

Interview with staff #87 confirmed the facility did not have a Power of Attorney in the MR.

Documentation identified in the discharge planning of pt #3 indicated her mother was fearful to challenge the daughter. Also discharge planning notes indicated "Red flags observed by the nursing staff indicated Adult Protective Services (APS) might need to be contacted related to adult neglect situation".

Confirmed with discharge planning staff, APS was not contacted on behalf of pt #3.

Daughter refused home health, skilled nursing care and insisted pt #3 be discharge home with provider care only.





Review of the facility policy titled, "Functional Manual - Informed Consent with an effective date of 6-1995 and the last approval date of 9-2010 revealed the following:

"Medical Records shall contain written evidence of the patients informed consent prior to performance of any procedure or treatment ...

Disclosure and Consent for Medical and Surgical Procedures. The consent for Medical and Surgical procedures OR-1701 should be used for the following procedures:

1.Major and minor surgery involving the entry into the body, either through an incision or through a natural body opening.

2. Procedures in which general, regional block or spinal anesthesia is used, regardless of whether an entry into the body is involved.

3. The administration of medicine, dye, and other material that involves more than slight risk of harm to the patient or that may cause a change in the patient's body structure ....

Surgical/Procedural Consent
The attending physician and/or surgeon are responsible for informing the patient of all alternative options, all potential complications and risks, and benefits or surgery. The physician, or designee, is also responsible for obtaining the proper signature indicating consent.

Disclosure of Risks
It is the physician's or surgeon's responsibility to give the patient sufficient information regarding the planned procedures so that the patient gives an informed consent ..."

Ventilator Patients

Based on observation, interview and record review, the facility failed to ensure patients on ventilators (equipment used to assist patients with breathing) received care in a safe setting. The facility failed to:

Ensure physicians wrote ventilation setting orders for 5 of 8 patients that were identified as being on ventilators in the Adult intensive care unit (Patient #'s 57, 59, 61, 63 and 64). There were no orders for nursing to use as guides for monitoring the care of the patients and for respiratory staff to use to set up the desired settings the patients needed.

Physicians were giving verbal orders to staff which were not being written. Nursing and respiratory staff were depending on critical care notes and history and physical notes for their ventilation setting orders.

According to interview with staff this practice of not writing the physician orders for the ventilator settings had been going on for 2-3 years.


It was determined that these deficient practices posed an Immediate Jeopardy to patient health and safety, and placed all patients in the facility at risk for the likelihood of harm, serious injury, and possibly subsequent death.


Findings include:



During an interview on 09/06/2019 after 2:02 p.m., Staff #78 (Informatics Registered nurse) revealed not knowing where respiratory staff got their setting orders for ventilator and Bipap patients. Staff #78 said there had been a problem with the physician ordering system. Staff #78 said the computerized ordering system would not allow for a drop down box so the physicians could just select the desired ventilation settings. Right now the physicians would have to free text their orders in, but that was not being done.


During an interview on 09/06/2019 after 2:30 p.m., Staff #89 (Respiratory therapist) said the doctors were giving verbal orders for the ventilator and Bipap patients. The computerized system would not let them add the settings.


During an interview on 09/06/2019 after 3:40 p.m., Staff#89 said they had met with someone from corporate and they were working on order sets for the physicians. After that person left the facility, staff were told that the doctors could write their setting orders in the comments section in the computer. The area they would use is limited as to how much text it will allow. There is not enough room to put the setting ranges in the system. The doctors tell us what they want verbally and we set the patient's up on the ventilator. Staff #89 said we can write verbal orders, but we do not do it. We want the providers to write their own orders. We brought it up 2-3 years ago, but after being told the doctors could type in the comments we let it go. We have told Administration staff about it. We talked to "Med Host" (health information technology company) about the problems and they said you get what you pay for.


During an observation and interview on 09/06/2019 after 3:40 p.m., Staff #25 (Respiratory staff) showed the surveyor where she went to look for physician's orders for ventilator setting orders for patients. Staff #25 consistently went to critical care notes.


During an observation and interview on 09/06/2019 after 4:20 p.m., Staff #127 (Nurse practitioner) said she could put her ventilator orders in the system. Staff #127 sat at a computer and preceded to pull up orders and then turned to Staff #89 (Respiratory therapist) and asked where are the settings. Staff #89 replied you don't have them over here. Staff #127 had to free text settings.


During interview on 09/06/2019 after 4:40 p.m., Staff #109 (Registered nurse) said the critical notes are not considered as physician orders.




Patient #64


Review of the clinical record of Patient #64 revealed was a 65-year-old female who presented to the Emergency room on 09/06/2019 and the chief complaint was cardiac arrest.

The vent settings on the physician's history and physical that was signed off 09/06/19 at 6:44 a.m., were as follows:

FiO2(100)- oxygen percentage in inspired air. This should be determined by arterial blood gas measurement. Ideally, this should be measured prior to being placed on the ventilator and repeated 30 minutes after ventilator support is initiated.

A/C (Assist/control) which was a ventilator mode in which the machine delivered the same tidal volume during every inspiration, whether initiated by the ventilator or by the patient.

Rate (25) the number of breaths every minute.

Tidal volume (500=>450) the lung volume representing the normal volume of air displaced between normal inhalation and exhalation when extra effort is not applied.

PEEP (6) Positive end expiratory pressure which was a method used to increase the functional residual capacity. Functional residual capacity being the volume of air present in the lungs at the end of passive expiration.


Review of the ventilator flow sheets dated 09/06/2019 at 6:53 a.m., revealed the initial setup of the ventilator and settings documented.

Review of the ventilator flow sheets dated 09/06/2019 at 9:27 a.m.- 2:04 p.m. revealed the FiO2 was set at 50.

Review of the chart revealed no documentation of a physician's order for the settings.



During an interview on 09/06/2019 after 3:40 p.m., Staff #89 (Respiratory therapist) and Staff #78 (Informatics Registered nurse) confirmed there were no written physician's order for the settings. Staff #89 (Respiratory therapist) was asked how did respiratory know what the orders were and he said by the history and physical.





Patient #61


Review of the clinical record of Patient #61 revealed she was a 69-year-old female had an admission date of 08/21/2019. According to critical care notes the following was documented:

Patient #61 had a history of aspiration pneumonia and presented to the emergency room with chief complaints of worsening shortness of breath/hypoxia. Some of the following ventilator settings were listed on the critical care notes:


FiO2(50)
Rate (15)
Tidal volume (550)
PEEP (7)


Review of the critical care notes revealed that on 08/30/2019 that Patient #61 had significant respiratory alkalosis (breathing to deep or too fast causing carbon dioxide levels to drop too low) and the tidal volume was decreased to 400.


Review of the chart revealed no documentation of physician's orders for the settings for the ventilator nor the change in the settings.


During an interview on 09/06/2019 after 3:40 p.m., Staff #89 (Respiratory therapist) and Staff #78 (Informatics Registered nurse) confirmed there were no written physician's order for the settings.






Patient #63


Review of the clinical record on Patient #63 revealed he presented to the Emergency room on 09/03/2019 with complaints of nausea and vomiting.

Review of physician notes dated 09/05/2019 revealed Patient #63 was in hemodialysis, coded and was intubated.

Review of respiratory flowsheets dated 09/05/2019 revealed documentation of ventilator settings.

Review of physician's orders dated 09/05/2019 revealed an order for a ventilator, but there was no documentation of what the settings were supposed to be.

During an interview on 09/06/2019 after 3:40 p.m., Staff #89 (Respiratory therapist) and Staff #78 (Informatics Registered nurse) confirmed there were no written physician's order for the settings.








39801

Patient #57


During a chart review for Patient #57 on 9-6-2019 at 3:45 P.M. with Staff #86, the following was revealed:

Patient #57 was a 64-year-old male admitted on 8/23/2019 post MI. Patient #57 underwent stents in the Left Anterior Descending Artery and Right Coronary Artery. Patient #57 was on an Impella (temporary ventricular support device used in patients with depressed heart function) and was on a vent when admitted to the ICU.

Staff #86 was asked to show surveyor the initial vent setting orders. Staff #86 looked in several areas to include respiratory, nurse orders, and physician orders and was not able to find vent orders. There was an initial vent set up request order form, however; the form was greyed out and could not be documented in. Staff #86 was asked how the physician vent settings were determined. Staff #86 stated, "I will just go into the room and look at the vent." Staff #86 was asked how she was notified if there was a change in the vent settings. Staff #86 stated, "Well the doctor or respiratory therapist will usually tell us. Staff #86 said for instance, this morning Patient #57 had a change in condition and the nurse practitioner changed the settings. I was in the room, so I knew they had been changed." Staff #86 was asked to show the surveyor the change in orders from that event. Staff #86 could not find any order for vent parameters for 9-6-2019 or any other day since Patient #86 was admitted.

An interview with Staff #85 revealed the following:

Staff #85 was asked to show the surveyor where the vent order for parameters were in the computer. Staff #85 stated well sometimes the doctors type in their notes and sometimes we type in our notes. Staff #85 was asked to show the surveyor where the order was for the change in vent settings that changed today. Staff #85 stated, "well the physician gave me the order and I have not had time to put the order in yet."






29191

Patient #59

During a chart review for Patient #59 on 09/06/2019 at 4:00 P.M. with Staff #78, the following was revealed:

Patient #59 was a 71-year-old male admitted on 09/05/2019 at 11:00 AM for Septic shock and acute kidney injury due to sepsis. Also, persistent rapid atrial fibrillation, hypertension essential, asthma. chronic kidney disease, hyperlipidemia, and obesity. Further review shows an admission for right renal mass s/p radical nephrectomy.

There was a critical care assessment completed on Patient #59 at 19:15 (7:15 PM) by the Staff #129. Patient was not oriented but will follow some commands with full range of motion.

A central line was placed on 09/05/2019 at 19:29 (7:29 PM) per the Physician # 128.

The next critical care assessment was completed at 00:15 (12:15 AM) by Staff #129 and patient was now intubated and the assessment shows ventilator settings.

Settings:
Ventilator Mode:
PRVC (Pressure Regulated Volume Control)
Respirations:
18
FIO2 Percent:
80
VT- set (ml)
500
PEEP _CPAP-EPAP(cmH2O)
8

There was an "Initial Vent set Up request" ventilator set up request order form. The only documentation on the form was "Mode PRVC" dated 09/05/2019 at 22:05 (10:05 PM).
This order form was found in the computer system called "MedHost" and dated 09/05/2019 at 22:05 (10:05 PM).

There was no documentation by a physician during the time patient was intubated and the next note by a physician was a nephrology note by the nephrologist on 09/06/2019 at 7:49 (7:49AM). At this time there was no documentation by the intensivist.

Staff #78 was assisting the surveyor with the computer to find Ventilator orders on Patient #59.
Staff #78 looked in several areas to include respiratory, nurse orders, and physician orders and was not able to find ventilator orders.

An interview with Staff #78 on 09/06/2019 at 4:00 P.M confirmed there were no ventilator orders found in the computer for Patient #59.



Review of a facility's policy updated 07/2017 and named "Respiratory-Mechanical Ventilation Policy" revealed the following:

PURPOSE

Establish acceptable parameters for installation and monitoring of ventilators.

I. At no time will the setting of ventilator parameters be the responsibility of the RCP (Respiratory care practitioner). These settings must be ordered by the physician before any patient will be placed on a mechanical ventilator. However, the therapist can make suggestions regarding standard guidelines to the physician.

II. The physician, nurse and RCP should be very familiar with the following techniques and parameters- their definitions, applications and standard guidelines ....

III. Goals of Mechanical Ventilation
A. Provide ventilation
B. Reverse and prevent tissue hypoxia
C.Treat arterial hypoxemia
D. Decrease the work of breathing
E. Decrease the myocardia

IV.Complications and Hazards
A. Mechanical Failure
B. Alarm Failure
C.Improper humidification
D. Improper heating
E. Patient disconnect
F. Self extubation
G. Alveolar hypoventilation
H. Alveolar hyperventilation
I. Gastric distention
J. Atelectasis
K. Pneumonia
L. Hypotension
M. Renal Impairment
N. Tension Pneumothorax
O. Infection."




40990






Dialysis Unit


Based on observation, record review, and interview the facility failed to:

A. ensure the security of the dialysis supplies and products in the acute dialysis unit.

B. ensure emergency hand cranks were present for each dialysis machine.

C. ensure dialysis staff were maintaining a clean and sanitary environment for the acute dialysis patient.

D. ensure acid and bicarb wands were secured to acid and bicarb jugs.

E. ensure that 1 of 6 dialysis machines (#123199) was disinfected every 7 days for the months of June 2019.

F. ensure staff was performing proper hand hygiene during CVC(central venous catheter) care.

G. ensure staff was not placing supplies on the bed while performing cannulation of the graft site.

H. ensure staff followed the physicians order for the length of the treatment for the dialysis treatment.


This deficient practice had the likelihood to cause harm to all dialysis patients.



Findings included:

A. During a tour of the Dialysis unit on 9/03/2019 at 10:45 AM, observed the dialysis unit was storing powdered potassium chloride and calcium additives in the supply storage room located in the dialysis unit. The door had a lock, but other staff besides dialysis staff had keys to enter the supply closet, such as housekeeping, which would allow access to the additives when dialysis staff were not present.

The policy titled, "Calcium and/or Potassium Chloride Storage and Administration" revealed:

"2. All electrolyte additives (potassium chloride and calcium chloride) are stored in a safe
and locked place that is not accessible to persons other than the authorized acute dialysis
teammates."

This deficient practice allowed access to the jugs and allowing potassium chloride additives to be added to the open jugs or tampering with the jugs.

An interview with Staff #3 and Staff #4 on 9/03/2019 at 11:25 AM confirmed the above findings.


B. During a tour and observation of the Dialysis unit on 9/03/2019, observed emergency hand cranks were not present on 2(#170797 and #123799) of 6 dialysis machines. Emergency hand cranks are to remain on each machine in the event of power outage, so that blood may be returned to the dialysis patient in the event of power outage or disaster.

An interview with Staff #3 and Staff #4 on 9/03/2019 at 11:15 AM confirmed the above findings.

C. The facility failed to ensure a clean and sanitary environment for the acute dialysis patient based on during observation in the dialysis unit on 9/03/2019, the dirty sink had a water leak under the cabinet with corroded fittings and a bucket under the pipe to catch the water. The cabinet was also heavily soiled with rust and dirt.

An interview with Staff #3 and Staff #4 on 9/03/2019 at 11:00 AM confirmed the above findings.

D. During a tour of the dialysis unit on 9/03/19 at 3:35 PM, observed a patient receiving a dialysis treatment. The pick-up tubes (wands) were hanging out of the acid and bicarbonate jugs. There was no secure connection from the pick-up tube to the opening of the acid or bicarbonate jug. This deficient practice allowed for cross contamination, acid spills, and bacterial growth in the bicarbonate jug. Acid concentrate is not susceptible to bacteria contamination, but every effort should be made to keep the system closed to prevent nonbacterial contamination and evaporation per the ANSI/AAMI standards. Also, the facility failed to ensure that after the cleaning and disinfection of acid and bicarb wands, the wands were being placed in a container labeled as "clean".

An interview with Staff #3 and Staff #4 on 9/03/2019 at 3:40 PM confirmed the above findings.

E. Ensure that 1(#123199) of 6 dialysis machines was bleached every 7 days in the month of June 2019. Review of disinfection records on 9/04/2019 revealed: machine #123199 was bleached on 6/14/2019, the machine was taken out of service on 6/20/2019 for repair and returned to service on 6/25/2019 and was heat disinfected by the biomed technician. Machine #123199 was not bleached until 7/01/2019.

The policy titled "Fresenius Dialysis Delivery System Cleaning and Disinfection Policy", revealed:

"Cleaning and Disinfection Procedures and Intervals-
Heat Disinfection and Citric acid or Vinegar-each treatment day (unless chemical disinfectant day)
Bleach or Peracetic Acid Disinfection-weekly
Peracetic Acid or Integrated Heat End to End Disinfection-monthly"

An interview with Staff #3 on 9/04/2019 at 10:30 AM confirmed the above findings and stated the machine should have been bleached by the biomed technician when it was returned to service.

F. Ensure infection control and hand hygiene policies were being followed by staff while performing CVC (central venous catheter) care. On 9/04/2019 at 11:15 AM, observed Staff #40 performing CVC care on Patient #25. Staff #40 was observed touching the CVC line then touching his facemask and then returning to CVC care without changing gloves. Also, the heparin syringe was lying on the bed prior to flushing the CVC. Staff #40 did not change gloves during the process of discontinuing the dialysis treatment and flushing the catheter.

The policy titled "Infection Control in the Hospital Dialysis Setting", revealed:

"3. Medication vials, syringes, tape, alcohol swabs, dressings, gloves or other supplies will
not be carried in pockets or placed on the patient's bed. Medical supplies and medications
provided by the hospital are not to be taken from the hospital.

o Going from a "dirty" area or task to a "clean" area or task
o Moving from a contaminated body site to a clean body site of the same patient
o After touching one patient or their dialysis delivery system and before arriving to
care for another patient or touch another patient's dialysis delivery system"

An interview with Staff #40 on 9/04/2019 at 11:30 PM confirmed the above findings. He stated, "I guess I was nervous".

G. Ensure staff does not place equipment on bed prior to cannulating patients graft sites. On 9/03/2019 at 3:45 PM, Staff #7 was observed placing alcohol swabs and opened cannulation needles directly onto the bed linens prior to cannulation of Patient #27 graft site.

The policy titled "Infection Control in the Hospital Dialysis Setting", revealed:

"3. Medication vials, syringes, tape, alcohol swabs, dressings, gloves or other supplies will
not be carried in pockets or placed on the patient's bed. Medical supplies and medications
provided by the hospital are not to be taken from the hospital".

An interview with Staff #3 and Staff #4 on 9/03/2019 at 3:55 PM, confirmed the above findings.

H. Ensure staff followed the physicians order for the length of the treatment prescribed for the dialysis treatment. During a review of patient treatment records for Patient #26 on 9/04/2019 at 3:00 PM, observed the physician's hemodialysis order was for the treatment to run 4 hours. The dialysis nurse Staff #41, ran the dialysis treatment for 3 hours, there was no physicians order to decrease the treatment time and no documentation by the nurse why the treatment time was cut short.

An interview with Staff #4 on 9/04/2019 at 3:00 PM, confirmed the above findings.

Based on review of documents and interview, the facility failed to:

A. ensure all staff had effective training on abuse and neglect to prevent staff abuse and neglect and allowed all hospital staff to identify allegations of abuse and neglect of patients by hospital staff to include the Risk Manager and Patient Advocate in 5 (Patients #85, # 95, #97, #98, and #99) out of 7 patients.

B. develop policies and procedures that clearly define abuse and neglect of a patient by hospital staff or to follow the steps for conducting an abuse and neglect investigation as outlined in the current policy for in 7 (Patients #2, #4, #85, # 95, #97, #98, and #99) out of 7 patients.

C. develop processes to ensure that vulnerable patients to include children who were known victims of abuse were not discharged until it was determined through investigation and contact with appropriate agencies that the patient was being discharge into a safe environment and not discharged to the perpetrator of the abuse in 1 (Patient # 100 )out of 1 case of known sexual assault reviewed.

Findings included:

Review of the requirements for this regulation show that the definition of neglect was, "failure to provide goods and services necessary to avoid physical harm, mental anguish, or mental illness"

On 9-4-2019 a review was made of a document titled, "Event Log for Regulators" that listed the complaints and grievances that had been filed. A sample of complaints and grievances investigations for the month of March were requested and reviewed. Investigations were documented on a form titled, "Event Reports".

The documents titled, Event Reports, had a column titled "Investigation Findings". Upon reviewing the investigations, it was noted that only 2 out of the 5 complaints and grievances reviewed that contained potential allegations of patient abuse and neglect by hospital staff had been processed appropriately as grievances. Five (5) of them (Patients # 85, #95, #97, #98, and #99) had been processed as complaints.

Patient #85

The Patient Advocate had met with Patient #85 and treated the patient's allegations as a complaint. The "Description of Event" was as follows:

"PtAdv received called from charge nurse ______ (staff name) asking her to visit with patient. PtAdv went to patient's bedside. Patient stated that because she had soiled herself and had to clean herself up due to no one coming to help her. She stated each time she calls for a nurse, it is an extremely long time before they come. Patient states that all her nurses have terrible attitudes. She states that she does not want Charge nurse ________ (staff name) to come into her room anymore. Patient was unable to tell me specifics as to why she doesn't want to see her anymore-just that she had a really bad attitude. PtAdv told patient the ______ (staff name) would not be back until Monday, but that she would let her know the patient does not want to see her. Patient states her bedside toilet was full and "stinking" and not emptied it until she asked them to. She also says she asked for 24 hours for a cup of ice before it was finally brought to her.

PtAdv did talk to Charge Nurse _____ (staff name) about the patient's complaints and will notify Director of Medical, as well. PtAdv will speak to RN _______ (staff name) on Monday and if patient is still here will instruct ______ (staff name) not to see her. Patient was satisfied when PtAdv left and stated she would call back if things got worse."

Per the allegations, staff neglected the patient's toileting needs forcing the patient to clean herself up, were not emptying her bedside commode causing the patient to have to sit in a room that was "stinking" until she had to ask staff to perform their duties, was not given a cup of ice for 24 hours after the original request, and endured staff with bad attitudes.

All allegations of abuse and neglect require the facility to initiate an investigation. By definition, since an investigation should have occurred, this complaint should have been treated as a grievance and not a complaint.

The investigation portion of the Event Report did not contain any information on an investigation. On 9-9-2019, an interview was conducted with the Risk Manager. The Risk Manager stated the Patient Advocate worked under the Risk Manager, and at times, the Risk Manager also performed Patient Advocate duties. The Risk Manager stated that she reviewed all complaints and grievances that are logged. When asked why this had not been investigated as grievance as abuse and neglect, the Risk Manager stated the she and the Patient Advocate had failed to identify the allegations as neglect.

The Policy Title: Risk Management Abuse, Neglect, and Exploitation Policy was reviewed. The policy reference cited was "Medicare Condition for Coverage: (3/15/2013) 42 CFR: 416.50(d)(1)(2)(3) Standard: Submission and Investigation of Grievances." This reference cited was found to be the requirements for Medicare participation for Ambulatory Surgery Centers and not the required Conditions of Participation for an Acute Care Hospital.

The policy on page 3 of 8 stated the following:
"The following criteria may be used to assist in the identification of abuse:
...
Neglect - The failure to provide for one's self the goods or services necessary to avoid physical harm, mental anguish or mental illness or the failure of a caretaker to provide such goods or services, for example:
Malnourishment, dehydration
Over/under medication
Lack of heat and/or running water
Lack of medical care
Lack of personal hygiene and/or appropriate clothing"

The policy did not specify that this pertained to the patient's care outside of the facility, as well as the care inside the hospital provided by staff employed by the hospital. When asked about the vagueness of the definition along with other language in the policy that inferred the definitions given pertained to care provided outside of the facility, the Risk Manager stated, "This policy is geared more towards the screening of the patient for abuse and neglect outside of the hospital."

A section titled "Management of Suspected Abuse/Neglect was found on Page 5 of 8; and a section titled "Grievance Allegations Related to Verbal, Mental, Sexual, or Physical Abuse" were noted. These sections did not clearly differentiate between the actions taken to protect the patient and report/investigate incidences of abuse and neglect of a patient that occurred outside of the facility versus allegations of abuse and neglect that occurred inside of the facility and involved hospital staff.

Because the policy did not include the definitions from the appropriate reference source and did not clearly define the process for identifying, documenting, investigating and protecting the patient when allegations of abuse and neglect were made in different settings, (out of the facility by others versus in the facility by hospital staff), the potential for confusion among staff and missed investigations placed patients at risk of continued harm in both settings.

Other incidents of patient allegations either not being identified as potential neglect, adequately investigated as abuse/neglect, and/or adequate steps taken to protect the patient from being discharged back into an unsafe setting where known abuse and neglect had occurred included:

Patient #2:

A patient satisfaction survey had been sent to Patient #2 after services. The patient's spouse had returned a written complaint attached to the survey. The complaint was stamped as received on May 10, 2019, a response letter was typed up and sent out the same day. The letter included in part, "Thank you very much for taking the time to express your concerns and detail the interactions you had with the individual staff member on the 1st of May here in the facility. We will use this information to improve our processes, provide continuing education to our staff, and enhance the experience that patients have when they use Longview Regional for medical care.

The process includes an internal investigation, which is now concluded. Your concerns were reviewed with the Chief Nursing Officer, the Pharmacy Director, the Director of the Surgical Unit, the Chief Executive Officer, and the Chief Quality Officer. They will address with their teams and the hospital leadership, and implement corrective actions as appropriate."

Review of the Event Report did not include notes of the investigation of neglect allegations. The Risk Manager was asked if there was any evidence that the staff listed in the response letter had been involved. An email from the Risk Manager to the staff listed above was presented as evidence that the complaint was forwarded to the above mentioned staff and that an investigation was done. The e-mail read, "This letter was received in Admin today. I've drafted a response letter, but please review and make corrective actions as appropriate. _______ (Pharmacy Director name), is there any truth to the statement that we have "limited" IV Tylenol: or that it was withheld for any other reason?"

The letter that was drafted and sent to the complainant the same day, falsely claiming that the investigation was completed, everyone had reviewed the allegations and were taking action. This, in fact, had never been done. The grievance was marked that the parties involved were satisfied, all without evidence that the Risk Manager had spoken to the parties involved and without an investigation into the allegations of neglect being completed.

The facility failed to investigate allegations of neglect that included:
The patient was moved from the Post Anesthesia Care Unit after neck surgery to her room at 12:10 PM. Her family arrived to her room at 1:10 PM to find her lying flat on her back and too weak to get up and help herself. The patient had not been checked on by nursing staff she arrived in her room and had not been given a call button. For an hour she had been hitting the button to raise and lower the bed in an attempt to find the call button. The nurse assigned to her told the patient that didn't have time to find the equipment needed for patient care. The nurse assigned failed to administer the ordered medications needed to control pain after surgery until another nurse intervened and went to pharmacy to pick the medication up herself.

The Assistant Chief Nursing Officer (ACNO) was interviewed on 9-9-2019 regarding her role in the investigation of these allegations of neglect. The ACNO stated she did not have any documentation of an investigation. The ACNO stated that the assigned nurse mentioned in the complaint had been let go at the end of May for similar allegations by other patients. An email was provided that was dated 5-30-2019 that confirmed this.

Patient #4:

Allegations of possible neglect that were not identified and investigated as neglect included:

Procedure delayed due to no one contacting the physician and the physician was unaware of blood pressure and other information.

The complainant had taken pictures of the condition of the patient's room and tried to have a conversation with staff. When the situation escalated, she tried to record the conversation. Security was called and she was escorted off of the property. She alleged that this was in retaliation to previously filing a complaint.
Staff members were rude, didn't change his sheets and left him with bowel movement and urine on the bed.

The patient's arms and hands were swollen because the bandages were placed too tight and the site where intravenous medications were given was bad.

The patient suffered an unwitnessed fall and no precautions had been put in place despite patient having suffered several strokes.

The patient care technician (PCT) had asked the patient to say, "Yes ma'am" when he addressed her.

The complainant expressed fear that staff were mistreating the patient when the family was not around.

The complete investigation documentation on the Event Report was as follows:
"The RM answered _______ (complainant's name) questions and concerns throughout their conversations from the 14th through the 18. The RM made sure to let _______ (complainant's name) know that the events that took place involving security were not in any way a form of retaliation. The RM has provided __________ (complainant's name) with her contact information if any further issues should arise throughout the remainder of the pt's stay. It is likely that the pt will be continuing to HH (home health) or SNF (skilled nursing facility)".

No evidence was provided that the allegations above were thoroughly investigated. While it was noted in the descriptions of the event that the complainant did not have medical power of attorney and that the patient was his own decision maker, the events as described showed that the complainant was acting as the patient representative. The facility failed to confirm this and provide her with the information she requested as his representative. She had asked for policy that limited her right to record conversations that was not addressed and was not provided a written response to the allegations she made on behalf of her family member.

The patient records show that he was discharged to a SNF in Longview, TX. The written response to the grievance was sent to an address in Hallsville, TX that neither the complainant or the patient resided at. No effort had been made to verify that the address listed on the chart was still going to be the correct mailing address at time of discharge. The Risk Manager stated that the hospital does not do that. They send their letters to the address listed in the patient record. The Risk Manager did not provide evidence of the letter being sent or delivered, such as postal tracking with confirmation of delivery.

A telephone interview was conducted with the complainant at the onset of the survey. The complainant provided pictures of the patient and the patient's room that supported the allegations that the patient's sheets and gown were not changed, as well as his hands being swollen and bandages that appeared to be tight around his hand. The complainant stated that neither the patient or she, acting as the patient's representative, received a written response to her allegations of neglect.

Patient #95

Allegations of neglect were not investigated. These allegations were classified as a complaint that was resolved at that time. Allegations included:

Family alleged that the patient "was a victim of neglect due to him to being fed for 3 days, and they state he has become weaker and weaker with every day."

No evidence was alleged or provided of an investigation of the events that led up to the delay in the patient having a feeding tube placed or what action would be taken to improve the process so that other patients would not be negatively affected through repeated occurrences.

Patient #97

Allegations of neglect were not investigated. These allegations were classified as a complaint that was resolved at the time. Allegations included:

The wound care nurse found the patient in with his gown and bedding soaked in urine. A blue bed pad had been stuffed into the front of the patient's diaper to catch urine. However, blue pads were not absorbent and intended for that purpose. Instead, it held urine against the patient's skin, increasing his risk for skin breakdown. The patient's spouse told the wound care nurse that the patient urinates a lot and suspected the PCT of placing it there for that reason.

This was never investigated to find out why someone would neglect to change the patient's appropriate briefs when wet and stuff it with an inappropriate pad.

Patient #98

Allegations of neglect were not investigated. These allegations were classified as a complaint that was resolved at the time. Allegations included:

The patient's family member stated he had asked for the nurse to give the patient something for her headache and something for the anxiety she was experiencing due to breathing difficulties and having to be on a machine to assist with her breathing. The family member (who was a nurse) stated that the patient's assigned nurse had not completed an assessment of the patient yet and stated "it could be 24 hours before the doc/Hospitalist come to see her".

No investigation was conducted to determine if there were significant delays in care due to the physicians or hospitalists not seeing patients in a timely manner.

An interview was conducted with Staff #69, a nurse, who confirmed that patients arrive from the emergency department to the inpatient floors without any orders. Staff #69 stated that the Emergency Room physicians won't write orders to hold the patient over until the primary physician can see them. Staff #69 stated it has taken up to 12 hours at times to get orders for patients.

Patient #99

Allegations of neglect were not investigated. These allegations were classified as a complaint that was resolved at the time. Allegations included:

The wound care nurse reported that during the initial wound care visit on 3-30-2019 at 3:00 pm, the patient was found lying flat on his back and buttocks where he had a pressure ulcer. The patient had left the ER to go to the room at 11:13 am. The wound care nurse found that the patient had not been oriented to the call light/TV remote because he didn't have one. Staff had not placed his slip resistant socks on him because they were still in a bucket at the bedside. The patient had no water, skin protection (waffle mattress) and "no identifier of being a veteran. "

No investigation was conducted regarding the staff neglecting to provide initial care of the patient for almost 4 hours or why a patient with skin breakdown was left in that position for that length of time.

During interview with the Risk Manager and the ACNO, they were asked if the hospital had adequate staffing to take care of patients' needs. Both agreed that adequate staffing was an issue that was being addressed by trying to recruit more nursing staff. One problem identified was the lower pay offered to PCT than what they could get at Long Term Care facilities (nursing homes). No plan to increase pay in order to be competitive was presented.

On the morning of 9-3-2019, an interview was conducted with Staff #107 on the Progressive Care Unit (PCU). The patients on PCU did not require as much care as patients in the Intensive Care Unit (ICU), but were not stable enough to go to a regular medical or surgical care unit. Staff #107 explained that they were allowed to have 1 nurse assigned to 4 patients during the day. At night, the patient load increased to 1 nurse assigned to 5 patients. This was a 50 bed unit and was currently with 31 patients. Staff #107 stated that the unit was only allowed to have 1 Patient Care Technician (PCT) assigned to the floor. PCTs provided care that was not required to be provided by licensed nursing staff. This included assisting with bathing and toileting needs, feeding needs, linen changes, checking vital signs, providing supplies like water, and other tasks that would free up licensed staff to provide necessary patient care. On the day of interview, 1 PCT was responsible for providing all of those services for 31 patients (and potentially, up to 50 patients)

During interview with the Risk Manager and ACNO on 9-9-2019, they were asked about the staffing. They both agreed that it could be "challenging" at times and that nursing staff were expected to perform those duties a PCT could perform, potentially taking them away from other duties that must be performed by a licensed nurse. Neither could provide documented investigations of alleged neglect due to inadequate staffing even though the Complaint and Grievance log for Regulators listed 17 complaints/grievances between 5-24-2019 and 8-9-2019 that were listed as Event Type Sub-category of "Staff response to call light or request for assistance".

Patient # 100

Patient #100 was a minor seen in the emergency department with evidence that she had been sexually assaulted at some time prior to her arrival.

Review of Policy Title: Risk Management Abuse, Neglect, and Exploitation Policy, Page 6 of 8 was as follows:

"To protect the patient from a real or suspected mental, physical, sexual and verbal abuse, neglect and/or exploitation, staff will safeguard the patient from the offending individual(s). This "safeguarding" may be overt or covert, dependent upon the patient's mental and physical sense of wellbeing. If any type of abuse or exploitation is proven legitimate (witnessed and obvious), the offending individual will be restricted from access to the patient. If the abuse is suspected, however unproven, staff shall be present at all times when the patient receives visitors, staff may contact the House Supervisor for additional support if support is not immediately available, the House Supervisor or Security will stay with the patient until additional support arrives."

The policy did not address the need to ensure that a minor who had been abused would not be discharged until all reasonable efforts were made through investigation by the hospital and/or responsible authorities to ensure that the minor would be discharged to a safe environment rather than discharged to an environment with the potential perpetrator of the physical or sexual abuse.



32143

ED Findings:

Review of Patient #100's Emergency Department (ED) chart revealed she was a 10-year-old girl brought in for a sore throat and dysuria on 2/17/19 at 11:13AM.

Review of the nurse's notes dated 2/17/19 at 11:34 AM revealed the patient was accompanied by her mother, father and a sibling. "Parent/caregiver report the patient having burning upon urination."

Review of the physician notes dated 2/17/19 at 13:36(1:36 PM) revealed Patient #100 had "pustules noted to the post pharyngeal area." The patient was swabbed for the flu, strep, and a urinalysis was done. The patient was treated with antibiotics, Tylenol and Motrin. The patient was discharged to home at 13:29 (1:39 PM).

Review of Patient #100's chart revealed she was brought back into the ED on 2/18/19 at 10:58 AM. Review of the nurse's notes dated 2/18/19 at 10:57 AM revealed, "Father states: seen here yesterday treated for UTI, has taken 2 doses of antibiotics. Motrin given at 6am, dad brought patient back because she has been crying and also he was told that we were going to check her "private parts" but never did yesterday. 11:11 AM Complains of pain in pelvis appears uncomfortable."

Review of Patient #100's nurses note on 2/18/19 revealed the following:
12:19 PM-Pt visited by father.
13:06 Assist provider with pelvic exam: Pelvic tray set up. patient moved temporarily to room 25 for pelvic exam.
13:20 Assist provider with pelvic exam: Assisted ____ (Staff #134 NP) with assessing patient's vagina. Several ulcerations inside both labia's. Green discharge noted. Patient denies anyone touching her inappropriately but seems very scared and is crying. Police notified and Child Protective Services (CPS) notified.
13:40 Assist provider with pelvic exam: Specimens sent to lab. Performed by ____ (Staff #134) patient was assessed on the labia - visible blister and lesion, round and open, green discharge present.
13:42 Herpes Simplex HSV 1/2 DNA PCR Sent.
14:11 Patient Rounding: patient was in distress, did not want to say what has happened. Dr. ____ (Staff #133), MD, talked to the mother and step-dad that someone touched their daughter inappropriately. I gave her a piece of paper to write down the name who did that to her. She wrote down the name "____ (name of male cousin)." Her mother is talking to her, calmly. Will give them a moment.
14:16 Patient Rounding: ____, step-cousin, abused sexually the patient. it happened in Mexico, last year August 2018, patient's mother took her family to Mexico to visit them. They stayed for one month and returned to the States right before school started. Mother stated they don't come to the States. (There was documented evidence that the child had been interviewed by a trained investigator for a potential crime.)
17:10 Patient Rounding: called ____, RN, at Trinity Mother Frances ER in Tyler, Texas, to give report on the patient at 1709.
18:46 Patient is resting quietly. Pt visited by mother, father."

Review of the Case Management notes dated 2/18/19 at 14:26 stated, "Case Management:
02/18 14:26 Case Management Note: Contacted CPS at request of ____ (Staff #133). Initiated CPS report with _____ (CPS Worker) (ID #5049). Reference #71968911. Case was triaged as a Priority 1 per ____ (CPS Worker). Provided CM and ED phone numbers for call back.

02/18 16:57 Case Management Note: Discussed case with ER MD, NP, LPD, Charge RN, Primary Nurse and CPS. Per MD and LPD, pt will be transferred via Camp County EMS, under Institutional Authorization to Christus Mother Francis ER for SANE exam. Post exam, pt will be transferred via EMS back to LR ER for admission. CM contacted Christus Mother Francis ER and s/w ____ (RN) who, was agreeable to above plan. Report will be called to ___ (RN) @ 903-531-4262. Information provided to Primary RN, _____ (Staff 130)."

There was no found documentation in Patient #100's chart that revealed when the CPS worker arrived at the facility. Who the worker was and what the plan was with CPS.

Review of the nurse's notes revealed Patient #100 revealed the patient was discharged from the ED on 2/18/19 at 19:54. Patient #100 was transferred to CTMF ER by EMS for a SANE exam.
Review of Patient #100's chart revealed she was brought back to the ED by ambulance from Sane Exam on 2/19/19 at 2:18 AM. Patient #100 had been discharged but was readmitted to the ED with a new chart.
Review of the physician notes dated 2/19/19 at 2:46 AM stated, "Pt was here earlier and was determined to have been sexually assaulted by step dad's brother's son who lives in Mexico- Pt has written his name down and given it to her mother. Parents report they were in Mexico visiting family approx. 1 year ago.
2:43 AM- ED course: Pt just returned from Tyler where she had a SANE exam. Pt was brought back with the assumption she would be admitted for further IV Valtrex or transferred to Dallas CMC. Family did not want to go to Dallas. They would prefer to go home. D/W Dr. ____ (on call Pediatrician) on call for ____ (Patient 100's Pediatrician). _____ (on call Pediatrician) agrees with DC home as long as is safe to go home. Family indicates the person who assaulted the pt. is not in the area and pt. will be safe at home. Will DC home with Valtrex and is to FU with ____ (Pediatrician) later this week."

Patient #100 was ordered and administered IV Valtrex on 2/19/19 at 2:29AM for the diagnosis of Genital Herpes. Patient left the ED with her mother and step father on 2/19/19 at 3:46 AM. The ED Physician failed to verify a safety plan was in place before discharging the patient to home.

There was no police report, notes from CPS, or SANE report in the child's chart to determine if the child was properly interviewed away from her parents. There was no found documentation if the parents were allowed in the exam or had time to coach the child. There was no documentation that CPS or law enforcement was notified before the patient left the safety of the ED.

Review of Patient #100's chart for the 2/18/19 visit to the ED revealed a Nurses Note Addendum dated 2/19/19 at 10:40 AM. The note stated, "Spoke with Dr.____ (Patient 100's pediatrician) nurse regarding follow- up appointment. Mom had not made the appointment. Appointment is scheduled for Thursday at 9:20. I called mom to inform of the appointment no answer did leave message. 11:15 spoke with mom and informed about the appointment. Mom stated she would make sure the patient was there and the child was doing ok and resting at this time. I expressed to mom that if she or the patient needed anything don't hesitate to call us. 16:24 Positive IHS 1 DNA report received. Per ____ (Lab personnel) in the lab results were faxed to Dr.____ (patient 100's pediatrician) office, but report given to ____ (Staff #134) for follow up."

Review of the ERS (event reporting system) form dated 2/19/19 revealed nursing Staff #68 made a report concerning Patient #100. The report reflected the nurses concern for an improper discharge. Patient #100 was to stay at the hospital for IV antibiotics. The nurse stated on the report, "I'm not sure if I'm doing this right."

An interview was conducted with Staff #70 on 9/5/19 at 1:28 PM. Staff #70 was asked who reviews the ERS and how was this one processed? Staff #70 stated that she and Staff #115 would review the ERS. Staff #70 stated that she had reviewed Patient #100's chart and felt all the issues had been resolved. Staff #70 stated, "I talked to both Staff #68 and 69 they never said she was unsafe to go home. It seemed to me they were upset over the doctor not following the plan for the patient to stay overnight for antibiotics." Staff #70 reported that the plan was changed by the oncoming ED doctor and she was sent home. Staff #70 reported that Staff # 68 had called the patients mother and checked on them. "I felt it had been resolved." Staff #70 was asked if there were any further information documented on another system concerning CPS and the police involvement? Was there another system for Case management to document? Staff #70 stated, "No." Everything would be in the chart. Staff #70 was asked why CPS information was not in the chart and how were they sure the patient was sent home to a safe environment if there were notes from CPS? Staff #70 stated, "I spoke with Staff #68 and 69. They didn't seem upset about the child going home in danger. They just seemed upset that the doctor did not follow the plan to admit the patient." Staff #70 stated that she was not a clinician and referred the complaint to Staff #1."

An interview was conducted with Staff #1 on 9/5/19 at 1:40 PM with Staff #70. Staff #1 confirmed he was aware of the ERS for Patient #100 and had spoken with Staff #70. Staff #1 reported that he remembers discussing the SANE exam and his concern that the patient had to go to Tyler to receive the exam. Staff #1 reported that he had not reviewed the chart. Staff #1 and #70 failed to properly investigate the incident and protect the patient from potential harm.

An interview was conducted with Staff #69 on 9/6/19 and Staff #72 at 9:30 AM. Staff #69 confirmed she was the case manager for patient #100 on 2/18/19. Staff #69 reported that she had contacted CPS on 2/18/19 at 14:26 (2:26 PM). Staff #69 reported that CPS arrived along with the police department. CPS was told by the nurse that she had the patient to write down the name of her assailant. Staff #69 stated that a plan was made with CPS and ER physician Staff #133 would admit the patient for IV Acyclovir after Patient #100 returned from her SANE exam. CPS to follow up with the patient the next day and decide placement. Staff #69 stated that CPS had left, and the physician and charge nurse was aware and in agreement. Staff #69 stated that the ER physician was concerned because there was a story of a cousin molesting Patient #100 a year ago and then it turned into 6 months ago. Staff #69 stated Staff #133 had reservations about the story. The step-father stated that Patient #100's biological father had a step son living in his house and patient #100 goes to his house to visit. Step father insinuated that maybe it was that boy that molested the patient. Staff #69 stated that raised the awareness of the physician and staff and was worried about the child's safety at home. Staff #69 stated that she went home before Patient #100 went for her SANE exam and did not know the outcome till the next day. Staff #69 stated that she came in the next morning and realized the patient had discharged that night with the parents. Staff #69 stated that she spoke with the charge nurse (Staff #68) in the ED on the following morning. Staff #68 charted in the patient's chart and Staff #69 charted in her Case Management program "Morrisey." Staff #69 stated that her and Staff #68 spoke to Staff #70 concerning Patient #100. Staff #69 stated that she and Staff #68 was visibly upset and made concerns that due to the changing shift, the plan to admit the patient for safety, and IV acyclovir was not followed by the incoming ER physician. Staff #69 confirmed that she shared her concerns of the child's safety at home and potential for further abuse. Staff #69 stated that she called the CPS worker the next morning and reported that the child was discharged and had

Based on record reviews and interviews, the facility failed to:

a. have policy and procedures to address the administration of chemical restraints, ensure that systems and processes were developed, implemented, and evaluated that supported the patients' rights. Have a policy and procedure that would guide the nurse in appropriate patient assessment and reassessment after a chemical restraint was administered in 1(#56) of 3(#56, 77, and 78) patient charts reviewed.

b. have documentation of law enforcement detainment, custody, or direct supervision in order to handcuff a patient to the stretcher in the Emergency Department (ED) in 1(#56) of 3(#56, 77, and 78) patient charts reviewed.

c. protect the patient from chemical restraints for staff convenience in 1(#56) of 3(#56, 77, and 78) patient charts reviewed.

d. follow the policy and procedures for observation when a patient is restrained and secluded in 1(#56) of 3(#56, 77, and 78) charts reviewed.

e. ensure the physician assessed the patient and documented a face to face before chemical restraints were administered in 1(#56) of 3 (#56, 77, and 78) patient charts reviewed.

f. have any monitoring of chemical restraints, education of staff, and Quality Assurance Performance Improvement (QAPI).


Findings included:


Patient #56

Review of Patient #56's chart revealed he was brought into the ED on 8/30/19 at 19:39 (7:39 PM). Review of the physician notes revealed,"22:18 (10:18pm) _____ (Patient #56) is a 49 year old white male who presents with a chief complaint of altered mental status. The patient was brought in from a local nursing home after being aggressive with staff. He has a history of mental disabilities and was placed in a nursing home because his family wasn't able to care for him any longer. He has become more agitated and aggressive. On arrival he is trying to hit and spit on staff and is screaming curse words. Neuro: Orientation: to person, Mentation: unable to test, the patient is developmentally delayed, Gait: is steady, at a normal pace. Psych: Behavior/mood is aggressive, Patient has no thoughts /intents to harm self or others. Judgement/insight is impaired." (Pt was documented at 129 lbs.).

Review of the Nursing notes dated 8/30/19 at 19:53 (7:53pm) stated, "Triage Assessment: General: Appears slender, Behavior is combative, inappropriate for age, Neuro: Level of Consciousness is awake, alert, Patient is not oriented to time, place, person or situation.

08/30 19:39 (7:39 pm) Patient arrived in ED.

08/30 19:45 (7:45 pm) Patient Rounding: Pt kicking at nurses and calling people in the ER "you bitch." Pt trying to take off clothes and hit staff.

08/30 Patient placed in exam room.

08/30 19:49 (7:49 pm) One-on-one care: Initiated continuous observation, based on the suicide risk/behavioral disorder. Assessment. Pt combative with staff and police. Hitting, kicking, spitting, yelling profanities, exposing genitals to staff and visitors.

08/30 19:50 (7:50 pm) Patient Rounding: Pt became aggressive, cussing and hitting this nurse while walking from waiting room to stretcher. Pt continued to yell at patients and families in hallway and hit nursing staff, officer ____ RN, and ___ RN at bedside to assist. Pt pulled his pants and underwear down in hallway while continuing to swing at nursing staff. Officer placed pt in handcuffs.

08/30 19:54 (7:54 pm)Patient Rounding: While in hall bed pt removed pants and exposed himself to staff and visitors, attempted to cover with sheet on bed and pt became combative with staff, hitting and spitting at staff. LPD officer already in ER assisted with restraining pt.

08/30 20:05 (8:05) Patient Rounding: Pt originally with nurse aid for _____ NH, aid left to lobby stating, "I need to go get something I'll be right back." Aid asked not to leave but aid left anyway and stopped at registration to tell staff that pt was longer allowed at NH and that he would not be back. (SIC)

08/30 20:06 (8:06 pm) Patient Rounding: After striking this nurse, nurse _____Staff RN, _____ Staff RN and officer____ (Officer #1) restrained pt and called for another officer to assist with pts combative and aggressive behavior. Pt in handcuffs with LPD Officer #1 and Officer #2.

08/30 20:11 (8:11 pm) Patient Rounding: Pt continues to shout profanities and spit at staff while in police custody in handcuffs. Attempting to contact pt family at this time.

08/30 20:19 (8:19 pm)Patient Rounding: Pt in room with police at standby. Pt spitting and cursing at staff. Pt refusing any vital signs and attempts to kick when attempts are made.

08/30 20:40 (8:40 pm) Patient Rounding: Pt placed in bed and hand cuffed to bed, vitals obtained at this time. LPD will not pursue criminal charges against pt due to MHMR status. Handcuffs to be removed and replaced with Velcro wrist restraints per verbal order from _____ (ER Physician). While attempting to move pt from hand cuffs to full restraints during this time pt had enough range of motion with handcuffs to strike this nurse on the left side of the face near eye. Officer #1 assisted in further restraining pt in Velcro wrist restraints. See paper order form for further restraint documentation."

Review of the Restraint Physician Orders dated 8/30/19 revealed the nurse took a verbal order from the ED physician at 2020 (8:20 PM). The physician signed the order at 2045 (8:45 PM). The order was for four-point restraints and a sitter. The order stated the restraints are to be released when "Aggressive/violent behavior is not evident." There was no documentation from the physician or nurse practitioner that a face to face was performed.
Review of the physician notes and nursing notes for 8/30/19 revealed there was no sitter documented. Review of the nurse's notes revealed the nurse performed 15-minute checks but no documentation of a sitter.

An interview was conducted on 9/19/19 with Staff #65,71, and 72. Staff #65 stated he was called on the night of 9/19/19 when the patient came in to the ED. Staff #65 stated the patient was very combative and the police were in the ED for another reason. The police assisted the staff with handcuffing the patient. Staff #65 stated the staff in the ED will use the police when they need assistance with patient's behavioral outbursts. Staff #65 confirmed the staff had training in handling violent patients and so had the hospitals security. Staff #65 confirmed there was no documentation that trained security staff were involved with Patient #56. Staff #65 confirmed the LPD did not work for the hospital and did not have any training in handling a patient within the ED of the facility. Staff #65 confirmed he was not sure if the patient was placed under police custody or detainment. There was no police report on the chart to show the patient was in police custody or detention. There was no report from the officers on why the patient was apprehended and handcuffed by the Longview Police Department LPD.

Review of the physician orders for 8/30/19 at 20:34(8:34 pm) revealed the nurse practitioner ordered "Geodon 10mg IM once." There was no reason documented for the administration of a psychotropic medication. Review of the order sheet revealed the medication was not administered until 21:47 (9:47 PM); 1 hour and 13 minutes after it was ordered. The RN documented it was given in left deltoid. The nurses response was "first dose monitoring." There was no further documentation of the medication administered as a chemical restraint or the effectiveness of the drug. There was no face to face documented. Review of the chart revealed the order for the chemical restraint was not noted as a restraint and not written on a restraint order.

Review of the policy and procedure Restraint and Seclusion stated, "Restraint: A drug or medication when it used as a restriction to manage the patient's behavior or restrict the patient's freedom of movement and is not a standard treatment or dosage for the patient's condition. VII -When a drug or medication is used as a restriction to manage the patient's behavior or restrict the patient's freedom of movement, monitoring may be more frequent after administration such as every 15 minutes for first 2 hours, depending on the dose and type of drug or medication.

Procedures: Our facility educates and assesses the competence of staff in minimizing the use of restraint and seclusion prior to participation in any use of restraint or seclusion, as pert of orientation and on a periodic basis in order to use them safely, including:

IX- monitoring of physical and psychological well-being of a patient in restraint or seclusion including respiratory and circulatory status, skin integrity, vital signs and special requirements of the face to face evaluation."

The facility failed to have a policy and procedure that would guide the nurse in appropriate patient assessment and reassessment after a chemical restraint was administered. There was no documentation in the restraint policy on how, when, and who will perform the face to face on a violent chemical restraint administration (behavioral restraint).

Review of the Nursing documentation dated 08/30/19 at 20:40 (8:40 pm) Cardiac monitor on. NIBP on. Continuous pulse oximetry monitoring: via room air. 08/30 22:30(10:30 pm) "Patient Rounding: Pt trial out of one wrist restraint. Pt immediately attempted to deliberately hit this nurse in the face while also spitting and continuing to mutter profanities. Pt placed back in wrist restraint and provider notified of pts continued combative behavior. Orders received."

Review of the physician orders dated 8/30/19 at 2254 (10:54 pm)revealed the nurse practitioner wrote another order for "Geodon 10mg IM once." The RN documented it was given in the left deltoid at 2254(10:54 pm). Response was documented as, "No adverse reactions." There was no further documentation of the medication administered as a chemical restraint or the effectiveness of the drug. There was no face to face documented.

08/30 23:00 "Patient Rounding: When offered toileting pt states "yeah you stupid ass bitch." Attempted to assist pt with urinal but pt either was unwilling to void at this time or unable to understand directions, unclear which. 23:10 (11:10 pm) Straight cath inserted Specimen obtained. 15 Fr for specimen collection volume on insertion: 300 mls, returned clear yellow urine. Patient tolerated poorly. There was no further documentation in what "patient tolerated poorly" meant.

Review of the nurse's notes revealed Adult protection was called at 23:23(11:23pm). The nurse documented, "23:30
(11:30 pm) Patient Rounding: Pt trail out of left wrist restraint. Pt initially appeared that he would be able to have at least one limb free of restraints. Pt then began to yell at staff and attempted to hit this nurse in the face when giving him a blanket. Pt wrist placed back in restraint at this time. 08/31 00:30 (00:30 am) Patient Rounding: Pt again attempted to hit staff when right arm was released from wrist restraint. Pt shouting "You dumb ass bitch." Order received to renew restraint order. pt wrist placed back in restraint." The nurse documented under restraints section every 15 minutes from 8/30/19 21:00 to 8/31/19 00:30.

An interview was conducted on 9/19/19 with Staff #65 and 71. Staff #65 and #71 confirmed Patient #56 was placed in room #5 with 4-point restraints. Review of the room revealed the room had a door with a window. Staff #71 confirmed the door had an automatic closure. Staff #65 and 71 could not confirm that the patient had an assigned sitter when he was placed in restraints. The nursing assignment sheet revealed the nurse caring for Patient #56 still had other patients and was documenting on the patient every 15 minutes. The patient was placed in a room with a door that closes. Staff #65 was asked if the patient was restrained and now secluded where was the surveillance video or camera's? Staff 65 and 71 confirmed there was no video cameras in the ED.

Review of the policy and procedure Restraint and Seclusion stated, "Restraint AND Seclusion used at the same time is only permitted if the patient is continually monitored by trained staff via audio AND video monitoring equipment or face to face by competent staff."

Review of Patient #56's chart revealed the physician continued the orders for 4-point restraints for the following dates and times:
8/31/19 at 0040 (00:40 am)
8/31/19 at 0440 (4:40 am)
8/31/19 at 0840.(8:40 am)

Review of the nursing documentation on 8/31/19 at 10:30 AM, "Medical devices removed. Pt displays self control Pt is redirectable, sitter at bedside for pt safety.

08/31 04:20(4:20 am) Patient Rounding: Pt less verbally abusive toward staff at this time. Initially pt tolerated two arms out of restraints. Pt then became self destructive and violet (SIC), hitting himself and slapping this nurse in the arms and torso. Pt was able to be redirected to lay down and offered another blanket. Pt seemed agreeable, so legs were released. Pt immediately stripped naked and began to attempt to leave room while hitting this RN. Required assistance of two additional staff to keep pt in room and place back in bed. Dr. Taylor to bedside who ordered restraints be placed back on pt and ordered additional medications." There was no further documentation of what interventions the nurse tried before a chemical restraint was administered.

Review of the physician orders on 8/31/19 at 4:08 AM revealed the patient was ordered "Benadryl 50 mg IVP once and Haldol 10mg IVP once." There was no behavior or diagnosis documented on the physician order. There was no physician documentation of the patient behavior, an assessment, or a face to face.

Review of the nurse's notes revealed on 8/31/19 "Pt walked out of room after pooping all over the place in his room, escorted to the bathroom by sitter, room cleaned, pt bathed and placed in paper scrubs and disposable scrubs. ____ (Physician) notified and new orders received." There was no further documentation of what interventions the nurse tried before a chemical restraint was administered or what behavior constituted a chemical restraint.

Review of the physician orders on 8/31/19 at 13:16 (1:16 PM) revealed the patient was ordered. "Ativan 2 mg IVP once." There was no further documentation of the medication administered as a chemical restraint or the effectiveness of the drug. There was no face to face documented. The nurse administered the medication at 13:17 (1:17 pm) with no documentation on the effectiveness of the medication.

Review of the Nurses notes dated 9/1/19 revealed at 0200 (2:00 am), "Pt. given teddy bear. Pt excited and clapping hands. Continues to keep teddy bear with him. 0400 (4:00 am)- Pt. sleeping holding teddy bear. 0551 (5:51 am)- Pt. sleeping holding teddy bear. 0725(7:25 am)- Pt not agreeable to taking PO home medications by mouth at this time, Dr.______ (physician) notified and indicated he would order IM meds. Pt shakes his head in agreement to taking medications through a shot." There was no documentation of disruptive behavior.

Review of the physician orders dated 9/1/19 at 7:28 AM revealed an order for Ativan 2 mg IM once, Haldol 10mg IM once, Benadryl 50mg IM once. there was no behavior or diagnosis documented on the physician order. There was no physician documentation in the notes of the patient behaviors, an assessment, or a face to face. Review of the physician orders for 7:37 AM on 9/1/19 revealed there was an order for Narco 10mg-325mg 1 tablet po once. There was no physician documentation that the patient was in pain or required pain medication. The patient was able to take a Narco tablet. The RN documented Patient #56 would not take his regular medication and required IM psychotropic medications.

There was no documentation that the nurse attempted to administer medications with food, or any other intervention documented. The nurse documented the patient was unable to educate on the medications due to "intellectual disability" yet documented that the patient agreed to receiving the medication in a shot form. There was no assessment or documentation of the medication effectiveness. Patient #56 was administered psychotropic medications IM for staff convenience.

Review of the nurse's notes dated 9/2/19 at 14:24 (2:24 pm)revealed the patient was given po fluids, verbal reassurance and given a warm blanket. There was no other nursing documentation until 17:02 (5:02 pm). Nurse documented, "Patient is sleeping. Pt had an episode of being combative, slapping the RN's and being verbally abusive, pt medicated with Ativan and Haldol IM per orders. There was no documentation of any interventions attempted to calm patient. There was no assessment or reassessment of psychotropic medications.

Review of physician orders dated 9/2/19 at 16:37 (4:37 pm) revealed an order for "Haldol 6 mg IM once and Ativan 2 mg IM once". There was no documentation on the physician record that the patient was ever assessed by a physician on 9/2/19. There was no face to face documented.

Review of the nurses notes on 9/4/19 at 12:25 PM stated, "Patient with sudden onset of agitation and combative behavior. Patient attempting to hit staff with open hand. Patient also spitting. Attempted to redirect patient with calm voice and direct instruction. Patient continued attempting to hit and spit on staff. Patient placed on stretcher by 3 staff and calmly attempted to redirect patient. Staff began to read Dr. Seuss book to patient with therapeutic results." Nurse documented the patient was administered "Ativan 2 mg IM once at 12:22". The physician order was not written till 12:33 PM. There was no reassessment or effectiveness of the medication documented. No face to face documented.

An interview was conducted on 9/9/19 with Staff #65, #71 and #72. Staff #72 confirmed the facility did not have clear policy and procedures for the administration of chemical restraints. Staff #72 stated the problem had been identified and they have had meetings to discuss the issue about a "couple of months ago" but there has not been a plan put in place. Staff #72 confirmed that the current nursing staff and physicians have had no training concerning the administration of chemical restraints. Staff #71 stated the ED had started a monitoring tool and log for physical restraints but did not have a log or monitoring for chemical restraints. Staff #65 confirmed there was no QAPI concerning chemical restraints at this time.



Patient #78

Review of Patient #78's chart revealed he was brought into the ED on 9/6/19 at 23:27 (11:27 PM). Review of the physician's note at 23:53 (11:53 PM) stated, " 09/06 23:53 Pt presents to the ED with complaints of being hit by a moving vehicle that occurred today. Pt reports he was here in the ED today for a snake bite and states he left AMA. Pt reports while getting in a vehicle to go home he saw a snake and ran from the vehicle. Pt reports he was then hit by vehicle. Pt reports pain to the abdomen and low back. Longview PD reports pt's Hx of bi-polar and schizophrenia and has not been compliant with his medication. Longview PD also reports pt was hit by a vehicle and states damage was noted to the driver's side window. Pt is a poor historian and unable to provide accurate HPI details. Neuro: Orientation: to person, Mentation: able to follow commands, confused, Motor: moves all fours. Psych: Behavior/mood is manic, Affect is animated, Delusions/hallucinations are present and described as seeing snakes in the exam room."

Review of the nurse's notes dated 9/7/19 revealed the following:

23:50 (11:53AM) Patient pacing around in the room looking for snakes, no acute distress, no respiratory distress, resp even and unlabored.
00:06 (0:06 am)- Patient reporting visual hallucinations reporting he is seeing snakes in his room.
00:17(0:17 am)- Patient displaying psychotic symptoms, is agitated and anxious, attempting to leave the ER. Patient requiring constant verbal redirecting and constant encouragement to stay in the ER for treatment. Security in to see patient."

Review of the physician orders Patient #78 was ordered Ativan 2 mg IM once on 9/7/19 at 00:11 (12:11 AM) and Geodon 10mg IM once at 00:12 (12:12 AM). Review of the physician order revealed no reason for administering the chemical restraint. There was no face to face documented. Review of the physician notes revealed there was no documentation on why the chemical restraint was ordered.

Review of the nurses notes for 9/7/19 revealed there was no documentation on the effectiveness of the chemical restraint.




Patient #77

Review of Patient #77's chart revealed she was brought into the ED on 9/6/19 at 02:19 (2:19 AM). Review of the physician note at 2:53 AM stated, "Pt presents to the ED via EMS complaining of an insect bite that began today. Pt was picked up by the EMS at the gas station. She states she has "bug" crawling on her body. Pt reports she was seen at ____ (local hospital) for symptoms and was placed on permethrin cream and clindamycin. She reports the medications are not helping. Pt presents with bleeding from excessive scratching to extremities." Patient #77 had a past medical history of Bipolar disorder and Schizophrenia.

Review of the physician orders dated 9/6/19 revealed an order for "Haldol Lactate 8 mg IM once and Ativan 1 mg IM once at 2:42 AM" There was no documentation in the physician orders or notes to why Patient #77 was ordered a chemical restraint. No face to face was documented.

Review of the nurse's notes dated 9/6/19 at 2:30 AM stated, "pt. sitting up in bed scratching her arms and legs crying." There was no documentation of interventions performed to assist with patient behavior before medications administered. There was no documentation of the patient's response to the medications until 3:45 AM the nurse documented, "pt. not itching anymore." The patient was ordered a consult for the mental health authority to assess the patient.

Review of the drug information for Haldol on the FDA.com website revealed the following:
"HALDOL (haloperidol) Haloperidol is the first of the butyrophenone series of major antipsychotics that is indicated for use in the treatment of schizophrenia. HALDOL is indicated for the control of tics and vocal utterances of Tourette's Disorder.

HALDOL (haloperidol) should be administered cautiously to patients: with severe cardiovascular disorders, because of the possibility of transient hypotension and/or precipitation of anginal pain. Should hypotension occur and a vasopressor be required, epinephrine should not be used since HALDOL may block its vasopressor activity and paradoxical further lowering of the blood pressure may occur. Instead, metaraminol, phenylephrine or norepinephrine should be used. When HALDOL is used to control mania in cyclic disorders, there may be a rapid mood swing to depression.

Monitor for development of neuroleptic malignant syndrome (fever, respiratory distress, tachycardia, seizures, diaphoresis, hypertension or hypotension, pallor, tiredness, severe muscle stiffness, loss of bladder control). Report symptoms immediately. May also cause leukocytosis, elevated liver function tests, elevated CPK"

Based on observation, interview, and record review, the facility failed to ensure data collected was used to identify opportunities for improvement. The facility failed to track and measure success on performance improvement projects for the timeframe of January 2018 to July 2019.

The facility failed to:

A. ensure the Quality Improvement Program was organized in a manner and had the responsibility of effectively coordinating, implementing, and monitoring Performance improvement (PI).

B. ensure PIs that were currently in place were being tracked and trended.

C. ensure that high risk and problem-prone areas were focused on, identified, data collected, PIs developed and PIs reported timely in contracted services, infection control, nursing services, pharmacy services, and laboratory services.

Refer to A tag 0283 for additional information.

Based on observation, interview, and record review, the facility failed to ensure data collected was used to identify opportunities for improvement. The facility failed to track and measure success on performance improvement projects for the timeframe of January 2018 to July 2019.

The facility failed to:

A. ensure the Quality Improvement Program was organized in a manner and had the responsibility of effectively coordinating, implementing, and monitoring Performance improvement (PI).

B. ensure PI's that were currently in place were being tracked and trended.

C. ensure that high risk and problem-prone areas were focused on, identified, data collected, PIs developed and PIs reported timely in contracted services, infection control, nursing services, pharmacy services, and laboratory services.



This deficient practice had the likelihood to cause harm to all patients.


Findings include:


Quality Organization and Pharmacy


Review of an undated organization chart named "Reporting Structure- Performance Improvement" revealed the following:


The Quality council which was made up of all the department heads only branched off into the non-clinical branch of quality. There was no documentation on the chart of a clinical branch

During an interview on 09/04/2019 after 10:24 a.m., Staff #115 said there should be two branches on the organization chart. There should be a non-clinical and a clinical branch. Staff #115 confirmed that the clinical branch was not listed on the chart and it needed to be added. Staff #115 showed the surveyor a list of departments that reported to the clinical branch. Pharmacy and Therapeutics (P&T) was missing on the list. Staff #115 said the P&T committee needed to be added to the clinical branch. P&T was reporting to the non-clinical branch about 2 months ago, but the physicians under that branch that could not make efficient changes that were needed for pharmacy. The two examples given by Staff #115 were with antibiotics and the anti-coagulant therapy, heparin. Staff #115 said P & T had not reported for June, July or August 2019. Instead of going through the clinical branch of Quality, P&T information was going straight to the MEC.

The information was not being brought to the Quality council for discussion. The Quality council area was where all of the other departments met and who could potentially be affected by issues occurring in pharmacy.





Infection control


During an interview on 09/04/2019 after 10:24 a.m., Staff #115 said that infection control problems that were found in the central supply area during the survey with the storage of supplies had not been brought to quality. Staff #115 said she had not been over to central in about 9 months and did not know if any of her staff had been over there.





Lab/ Blood utilization

Review of MEC committee minutes dated 08/07/2019 revealed blood utilization information that was from the first quarter (January-March 2019) being reported.

The second quarter (April-June 2019) information was missing.

During an interview on 09/04/2019 after 10:24 a.m., Staff #115 confirmed the information was reported late. Staff #115 said she did not have the new data from lab because they had a new lab director. The director had only been there 2 months. Staff #115 said they had found another problem in lab with staff not being able to get their blood draws. They changed up the blood carts and re-trained staff on chain of command. When questioned about seeing the Performance improvement results. Staff #115 said they had not put a PI into place on this.





Performance Improvement Projects


Review of the facility's "Top Ten Problem List" for hospital wide problems revealed some of the following:





Nursing


Review of quality minutes dated 07/25/2019 revealed a problem with critical lab results not being called to the physician (blood cultures).

According to documentation on the quality form the performance improvement was implemented on 11/29/2018 (over 8 months ago). There was documentation on the form that there had been an improvement.

There was no documentation of what the initial goal was and what percent of compliance they were currently achieving.





Review of quality minutes dated 07/25/2019 revealed a problem with venous thromboembolism (VTE) documentation.

According to documentation on the quality form the performance improvement was implemented on 10/18/2018 (over 9 months ago). There was documentation on the form dated 06/13/2019 that there had been an improvement with physicians ordering the anticoagulant agent Lovenox more.

There was no documentation of what the initial goal was and what percent of compliance they were currently achieving.






Review of quality minutes dated 07/25/2019 revealed a problem with insulin not being given in a timely manner related to blood sugars.

According to documentation on the quality form the performance improvement was implemented on 09/30/2018 (over 11 months ago). There was documentation on the form that there had been an improvement.

There was no documentation of what the initial goal was and what percent of compliance they were currently achieving.




During an interview on 09/04/2019 after 10:24 a.m., Staff #115 confirmed that goals were not always being set nor the information being tracked like it needed to be.







Contracted services


Review of a facility's contracted service list revealed there were 28 services. Ten (10) of the contracts involving organ procurement, blood, lithotripsy, wound, anesthesia, radiology, head and spine, environmental, management and dialysis were reviewed. No evaluations of the services were found.

During an interview on 09/04/2019 after 9:13 a.m., Staff #115 said that they had a company take over reviewing contracts last year. About 2 weeks ago all contracts and servicers were assigned to a reviewer because they discovered the contracts were not being reviewed. The only thing that had been done with contracts is that they were assigned to different departments. They had not had a meeting yet to determine what would be done. Staff #115 said that none of the contracted services had been taken through the quality process. When they meet they will be working on performance improvements for them.

During an interview on 09/06/2019 after 10:30 a.m., Staff #2 confirmed that contracted services were not being evaluated and brought to Governing body.










Review of the facility's policy named "Quality Improvement Plan" with a review date of 02/2019 revealed the following:

"..The Quality Improvement Program is designed to provide a systematic and organized mechanism to promote safe and quality patient care and services. Through an integrated, interdisciplinary process, patient care services shall be continuously monitored and evaluated to promote optimum outcomes.

The organization has the responsibility to design, measure, assess, and improve performance and patient safety. Ultimate authority and accountability for the quality and safety of patient care and services lies with the Governing Board and is delegated through the Quality Improvement Program to the Medical Staff, Administration and staff of the hospital ..."

Based on interview and record review, the facility failed to conduct a thorough appraisal of privileges on 1 of 4 Allied health practitioner credentialing files that were reviewed ( Staff #10 (mid-wife)).

Staff #10 was delivering babies at the facility with incomplete credentialing information on file.


This deficient practice had the likelihood to cause harm to all patients who had babies delivered by this practitioner.


Findings include:



Review of a clinical record on Patient #9 revealed she was a 21 year old female who was admitted into the hospital on 09/03/2019. According to documentation Staff #10 (nurse mid-wife) delivered Patient #9's baby on 09/03/2019.


Review of the credentialing file on Staff #10 (mid-wife) revealed the following request made on the "Allied Health Professional Delineation of Privileges" dated 06/01/2018;

Prepare suture- under degree of supervision the category for doctor needed to be present and doctor supervision were not required were both checked.

Labor 36 weeks or more gestation with no medical or OB (obstetric) complication was requested, but the degree of doctor supervision was not checked.

The category labeled "Delivery (as above)" was not requested nor was the degree of doctor supervision checked.

The privileges were signed off and approved by the MEC and Governing body on 06/2018.


During an interview on 09/05/2019 after 1:30 p.m., Staff #122 confirmed the information was inaccurate on the privilege sheets. The information needed to corrected and the privilege to deliver babies needed to be checked and signed off by a physician.





Review of the "Medical Staff Bylaws/Rules and Regulations" dated 2018 revealed the following:



"..AHP's shall be credentialed in the same manner as outlined in these bylaws for credentialing practitioners. Each AHP shall be assigned to one (1) of the clinical departments and shall be granted clinical privileges relevant to the care provided in that department. The Board of Trustees in consultation with the MEC shall determine the scope of activities which each AHP may undertake.."

Based on observation, interview and record review, the facility failed to ensure that nursing services provided care and services that met the needs of patients in accordance with accepted standards of practice. The facility failed to:


A. Have adequate numbers of nurses and other personnel. The facility failed to staff per their established staffing grid.

A review of the staffing for the Progressive Care Unit (PCU) (50 beds) in the facility was completed for the dates 08/25/19 through 8/28/2019 and 09/01/19 through 09/3/19. The PCU was found to not be staffed per the staffing grid on 8 out of 11 shifts reviewed.

Refer to tag A0392 for additional information.



B. Ensure Registered nurses (RN) supervised and evaluated care of each patient. The RNs failed to:

Report abnormal vital signs to the physician. The review revealed that 5 patients (#13, #14, #22, #23, and #24) out of 6 reviewed had elevated vital signs (blood pressure, pulse and/or temperature) that were not reported to the physician:

They failed to notify the physician when medications were not administered in a timely manner, and/or failed to notify the physician when medications were not administered due to patient refusal of medications; Failed to see clarification of an order for medication that the patient was documented to have an allergy to.

The review revealed that 3 patients (#13, #22, and # 23) out of 6 had medications not given or patient refused and no documentation present that showed the physician was notified of the missed medication or the patient's refusal.


They failed to report critical lab values. The review revealed that 1 patient (#24) out of 6 reviewed had critical lab values. There was no documentation that the physician was notified of the critical lab values.


Refer to tag A0395 for additional information.




C. Ensure medications were reconciled appropriately, accurate orders were obtained, and administered safely in 1 of 6 patients reviewed for medication reconciliation (Patient #1).

Patient #1 received an overdose of medications because the patient's medications were incorrectly reconciled on presentation into the Emergency department (ED). The facility implemented medication reconciliation training for all staff, but failed to ensure the staff who initially put the medications in incorrectly was trained as of 09/06/2019.

Nursing staff failed to administer medication as prescribed by the physician.


Refer to A tag 0405 for additional information.


D. administer blood products and intravenous fluids in accordance with written policy and procedures.

The facility failed to ensure blood transfusions were completed, physician orders for blood transfusions were complete, and vital signs were done per their policy during blood administration, in 8 of 8 patients (Pt #3, #13, #14, #19, #20, # 24, #35, and #92)

The facility failed to ensure physician orders for intravenous medications were complete and administered as ordered by the physician in 9 of 9 Patients (Patient #'s 2, 10,11,35, 36, 66, 89, 90, and 91) records reviewed. Also, the facility failed to ensure post-operative anesthesia orders were well defined and clear to nursing staff in the post-operative areas on Patient #40.


Refer to tag A0409 for additional information.

Based on interview and record review, the facility failed to have adequate numbers of nurses and other personnel. The facility failed to staff per their established staffing grid.

A review of the staffing for the Progressive Care Unit (PCU) (50 beds) in the facility was completed for the dates 08/25/19 through 8/28/2019 and 09/01/19 through 09/3/19. The PCU was found to not be staffed per the staffing grid on 8 out of 11 shifts reviewed.


This deficient practice had the likelihood to cause harm to all patients on the unit.


The findings were as follows:



An interview was conducted with Staff #18 on 09/03/2019 at 10:50 a.m. Staff #18 was asked about staffing on the unit, Staff #18 stated "we try to keep the nurse patient ratio at 4:1 (4 patients for 1 nurse), with a free charge, but that sometimes the charge nurse has to take patients." Staff #18 stated agency nurses are sometimes used on the unit. Staff # 18 was asked about the acuity of patients on the unit, staff # 18 stated, "they are sicker than other units I would think, some of the patients on this unit are on telemetry and very sick." Staff #18 stated they also get Intensive care unit (ICU) stepdown patients. Staff #18 stated "patient turnover was high on this unit and sometimes there are not enough people it seems to get everything done." Staff #18 was asked if unit leadership helped when the unit was busy, Staff #18 stated "yes, sometimes."


An interview was conducted with Staff #17 on 09/03/19 at 10:53 a.m. on the unit. Staff #17 was asked about staffing on the unit and the acuity of the patients on the unit. Staff #17 stated they have a "high turnover of patients on this unit and it is a 50-bed unit and some of the patients are pretty sick." Staff #17 stated that "sometimes we don't have enough staff on the unit, but they are in the process of trying to hire staff." Staff #17 was asked how short staffing was handled and Staff #17 reported the unit director works the floor sometimes to help when it is really busy.


An interview was conducted with Staff # 21 on 09/03/19 at 11:15a.m.. Staff #21 was asked if there was adequate staff to take care of the patients on the unit. Staff # 21 stated "most of the time," Staff #21 stated "we have a lot of agency nurses that work at the facility, and we admit and discharge a lot of patients during the day."


An interview was conducted with staff # 34 on 09/04/19 at 10:30 a.m. Staff #34 was asked about facility staffing. Staff #34 stated "we try to keep the unit staffed with a 5 patient for 1 nurse for a 25-bed unit, with 1 CNA for 25 patients." Staff #34 was asked if the unit was ever short staffed, and Staff #34 stated "it happens occasionally." Staff #34 was asked to give an example of when this happens, Staff #34 stated "sometimes if a patient needs to be admitted early in the morning, say around 3:00 a.m., they will admit a patient and they will be short staffed for a few hours meaning 1 nurse will have 6 patients instead of 5." Staff #34 was asked the acuity of the patients on the unit, staff # 34 stated the patients "are mostly medical and telemetry patients."

An interview was conducted with Staff #24 on 09/04/19 at 10:49 a.m. Staff #24 was asked about staffing on the unit, staff # 24 stated, we are short staffed CNAs most of the time. Staff #24 stated "there are usually only 2 CNAs on the unit, sometimes 3, but never 4 like it is supposed to be when the unit is full."

An interview was conducted on 09/05/19 at 9:30 a.m. with Staff #130. Staff #130 explained how the nursing units are staffed in the facility. Staff #130 stated they used the staffing grids and staffed all units in the hospital except for the women's unit, labor and delivery and NICU, she explained those units staffing is handled by the director/supervisors on the units. Staff # 130 was asked if there was always enough staff to cover the census on each unit, staff # 130 stated not always, and sometimes the units were short staffed. Staff #130 stated "we are really short on CNAs, and we have a lot of agency nursing staff that we use, but we are still short sometimes." Staff #130 was asked how the schedules were compiled and Staff #130 stated, the nurses on the units schedule themselves on the days they want, and then the unit director will go over the schedule before it is turned into the house supervisors office and 'even out' the schedule. Staff #130 was asked to explain what 'even out' the schedule meant and Staff # 130 stated, "sometimes certain days are over staffed and certain days are understaffed, they try to fill in the holes." Staff #130 stated the facility started losing staff when bonus shifts were eliminated.

An interview was conducted on 09/05/19 at 10:12 a.m. with staff #1. Staff #1 was asked about staffing in the facility. Staff # 1 was asked how many vacant positions were open, staff #1 stated, "I can't give you an exact number, but I know we have a lot of vacancies, and we currently have 35 contracted agency nurses." Staff #1 was asked what efforts were being made to hire full time staff, staff #1 stated "we go to the local nursing schools and job fairs, we have a video on Facebook, we have jobs posted on various websites."


Review of the facility's staffing schedules and staffing matrix revealed the following:

08/25/2019 7:00 a.m. to 7 p.m. shift
Census of 37 patients
Staffing per staffing grid called for
1 charge nurse
10 nurses
3 CNAs
1-unit clerk
Actual staffing per unit assignment sheet
1 charge nurse
9 nurses
1 CNA
1-unit clerk
The unit was understaffed by 1 nurse and 2 CNAs for 37 patients.


08/26/2019 7:00 a.m. to 7:00 p.m.
Census 40 patients
Staffing per staffing grid called for
1 charge nurse
10 nurses
3 CNAs
1.5-unit clerks
Actual Staffing per assignment sheet
1 charge nurse
8 nurses
2 CNAs
1-unit clerk
The unit was understaffed per staffing grid 2 nurses, 1 CNA, and 0.5-unit clerks for 40 patients

08/26/2019 7:00 p.m. - 7:00 a.m.
Census 50 patients
Staffing per staffing grid called for
1 charge nurse
10 nurses
4 CNAs
0.5 unit clerks
Actual Staffing per unit assignment sheet
1 charge nurse
10 nurses
2 CNAs
1-unit clerk
The unit was understaffed per staffing grid 2 CNAs for 50 patients

08/27/2019 7:00 a.m. to 7:00 p.m.
Census 45
Staffing per staffing grid called for
1 charge nurse
12 nurses
3.5 CNAs
1.5-unit clerks
Actual Staffing per assignment sheet
1 charge nurse
12 nurses
2.5 CNAs
1-unit clerk
The unit was understaffed per staffing grid 1.5 CNAs for 45 patients.

08/27/2019 7:00 p.m. to 7:00 a.m.
Census 45
Staffing per staffing grid called for
1 charge nurse
9 nurses
3.5 CNAs
0.5-unit clerk
Actual Staffing per assignment sheet
1 charge nurse
9 nurses
3 CNAs
1 unit clerk
The unit was understaffed per staffing grid 0.5 CNAs for 45 patients.

08/28/2019 7:00 a.m. - 7:00 p.m.
Census 42
Staffing per staffing grid called for
1 charge nurse
11 nurses
3 CNAs
1.5-unit clerks
Actual Staffing per assignment sheet
1 charge nurse
10 nurses
2 CNAs
1-unit clerk
The unit was understaffed per staffing grid 1 nurse and 1 CNA for 42 patients.

08/28/2019 7:00 p.m. to 7:00 a.m.
Census 45
Staffing per staffing grid called for
1 charge nurse
9 nurses
3.5 CNAs
0.5-unit clerks
Actual Staffing per assignment sheet
1 charge nurse
9 nurses
2 CNAs
1-unit clerk
The unit was understaffed per staffing grid 1 .5 CNAs for 45 patients.

09/01/19 7:00 a.m. to 7:00 p.m.
Census 38
Staffing per staffing grid called for
1 charge nurse
10 nurses
3 CNAs
1.5-unit clerks
Actual Staffing per assignment sheet
1 charge nurse
9 Nurses
2 CNAs
0-unit clerks
The unit was understaffed per staffing grid 1 nurse, 1 CNA and 1-unit clerk for 38 patients.

All findings were confirmed on 09/09/19 at 12:52 p.m. by staff # 26.

An interview was conducted with staff # 26 on 09/09/19 at 12:52 p.m. Staff #26 reviewed the staff assignment sheets from 08/25/19 through 08/28/19 and 09/01/19 through 09/03/19 and verified the findings of the 8 incidents the unit was short staffed. Staff #26 stated, "I am aware of the staffing issues and am currently trying to hire additional staff, however it is difficult to hire staff, we have a lower end pay scale." Staff #26 was asked how he has tried to prevent the staffing shortages, staff #26 stated, "again, trying to hire nurses and CNAs, and we have reached out to the local nursing agencies to see if we can cover some shifts, but they are not returning our calls now." Staff # 26 was asked what the expectation of unit leadership was if the unit was short staffed, staff #26 stated, "If or when the unit is short staffed, the unit supervisor will step in as charge nurse and the charge nurse will take patients." Staff # 26 was asked if he had the authority to close beds due to staffing and he stated, "not without approval, and that is difficult."

An interview was conducted with staff #1 on 09/09/19 at 10:45 a.m. Staff #1 was asked to review the staffing from 08/25/19 through 08/28/19 and 09/01/19 through 09/03/19 and staffing grid approved 07/19. Staff #1 stated, "The staffing grid is only used as a guideline for ideal staffing and that core staffing gives the nurses a nurse patient ratio of 5:1 instead of 4:1 as the grid indicates." Staff #1 was asked to show where a core staffing model was used on the staffing grid approved 07/19 and currently being used by the house supervisors for staffing the facility. Staff #1 could not produce anything in writing, that the house supervisors, those responsible for staffing daily, would know to use "core staffing" on days when the facility could not be staffed according to the grid. Staff #1 stated, "there is nothing in writing, it is just understood."


28659

On the morning of 9/9/19, in the office of the supervisor the second floor nursing unit, staff #26, the supervisor confirmed his awareness of the shortage of available Registered Nurses, Certified Nurses Aides and ward clerks to adequately staff his unit around the clock and on weekends. He further confirmed he was aware of present staff frustrations and fears of poor patient outcomes related to inadequate staffing ratios. He confirmed he was not surprised when staff, who asked not to be identified teared up when speaking of the shortage of RN and how tired they were. He confirmed a large portion of the RN's who were scheduled to work were agency however there were not enough agency RN's fill all vacancies.

This interview was witnessed by staff #19.

Based on observation, interview and record review, the RN failed to supervise and evaluate care of each patient. The RN failed to:

A. Report abnormal vital signs to the physician. The review revealed that 5 patients (#13, #14, #22, #23, and #24) out of 6 reviewed had elevated vital signs (blood pressure, pulse and/or temperature) that were not reported to the physician:

B. Notify the physician when medications were not administered in a timely manner, and/or failed to notify the physician when medications were not administered due to patient refusal of medications; Failed to see clarification of an order for medication that the patient was documented to have an allergy to. Further review revealed that 3 patients (#13, #22, and # 23) out of 6 had medications not given or patient refused and no documentation present that showed the physician was notified of the missed medication or the patient's refusal.

C. Report critical lab values. The review revealed that 1 patient (#24) out of 6 reviewed had critical lab values. There was no documentation that the physician was notified of the critical lab values.


The findings are as follows:





A. Failed to report abnormal vital signs to the physician:


A review of medical records was conducted on 09/05/2019, from 10:30 a.m. until 2:30 p.m. and on 09/06/2019, at approximately 10:30 in the physician dictation room attached to the medical records department.


Patient # 13

According to the history and physical dated 08/28/2019 in the patient's medical record, Patient # 13 was admitted to the hospital on 08/28/2019 with uncontrolled pain following spinal surgery related to breast cancer, opioid related constipation, and suspected surgical wound infection. A review of the medical record revealed the patient had five (5) episodes of elevated temperature greater than 100.5 and 14 episodes of pulse greater than 120 beats per minute. There was no documentation to show the nurse ever notified the physician of the elevated temperature or pulse. There were no orders for patient specific parameters for vital signs.

On 08/28/2019, there was documentation of an elevated pulse ranging from 121-132, six (6) times during the day.

On 08/29/2019 there was documentation of an elevated temperature of 100.6.

On 08/31/2019, there was documentation of elevated temperatures ranging from 100.5-102.3, two (2) times during the day.

On 09/01/2019, there was documentation of elevated pulse ranging from 122-127 three (3) times during the day and an elevated temperature of 100.7.

On 09/02/2019, there was documentation of elevated pulse of 122.

On 09/03/2019 there was documentation of elevated pulse ranging from 123-126 two (2) times during the day and elevated temperature of 101.3.

On 09/04/2019 there was documentation of an elevated pulse of 121 and elevated temperature of 100.4

On 09/05/2019 there was documentation of an elevated pulse of 122.

There was no documentation found that the physician was notified of the abnormal vital signs from 08/28/2019 through 09/05/2019.

The findings were confirmed by staff # 19 at the time of review.

Review of facility policies revealed no specific policy related to vital sign parameters and when to notify the physician for vital signs outside of range.


Patient # 14

According to the history and physical dated 08/30/2019 in the patient's medical record, patient # 14 was admitted on 08/30/2019 for a psychiatric issue. Patient had a past medical history of hypertension noted. The patient had two episodes of elevated blood pressures and there was no documentation to show the physician was notified by the nurse.

08/31/2019
4:50 a.m. blood pressure 169/98
7:32 a.m. blood pressure 177/101

There was a physician's order for blood pressure medication Labetalol 20 mg to be given intravenously (IV) every 6 hours as needed (PRN) for systolic blood pressure greater than 160 or diastolic blood pressure greater than 95 entered on 08/31/2019 at 11:29 a.m. The documentation showed the patient was given a dose of this medication on
08/31/2019 at 11:40 a.m. Further review of the documentation showed:

08/31/2019
4:30 p.m. blood pressure 169/104 - no intervention
6:32 p.m. blood pressure 177/11
7:13 p.m. the documentation shows 10 mg of Labetalol was given - order was for 20 mg (no documentation to show the nurse contacted the physician regarding giving one-half the dose.
7:59 p.m. the documentation shows 10 mg of Labetalol was given - order was for 20 mg.
A new physician order was entered on 09/01/2019 at 12:17 a.m. for Labetalol 20 mg to be given IV every 2 hours PRN for systolic blood pressure greater than 160 or diastolic blood pressure greater than 95.
09/01/2019 8:21 a.m. blood pressure 163/108 - morning medications given, no PRN blood pressure medications given, no physician notification
12:07 p.m. blood pressure 147/97 - no PRN medication given, no documentation of physician notification.


Patient # 22

According to the history and physical dated 09/03/2019 in the patient's medical record, Patient # 22 was admitted to the hospital on 09/03/2019 with a diagnosis of pneumonia. The patient was placed on telemetry for monitoring. Between 09/03/2019 at 4:00 p.m. and 09/14/2019 at 7:53 p.m. the patient had nine episodes of elevated pulse greater than 120 beats per minute based on review of telemetry strips, and 1 episode of temperature greater than 100.5 degrees Fahrenheit according to the vital signs section of the medical record. There was no documentation to show the physician was notified of the elevated pulse or elevated temperature.

On 09/03/2019 the documentation showed an elevated pulse ranging from 120-132 five times between 4:00 p.m. and 11:55 p.m.

On 09/04/2019 the documentation showed an elevated pulse ranging from 121-129 four times between 12:15 a.m. and 7:53 p.m. and an elevated temperature of 102.5.

The above findings were confirmed by staff # 19 at the time of review.


Patient # 23

According to the history and physical dated 09/03/2019 in the patient's medical record, Patient # 23 was admitted to the hospital on 09/03/2019 with a diagnosis of pneumonia. Review of the documentation revealed the patient had an elevated temperature of 103.2 degrees Fahrenheit on 09/04 at 12:00 a.m. There was no documentation to show the physician was notified of the elevated temperature.

The above finding was confirmed by staff # 19 at the time of review.


Patient # 24

According to the history and physical dated 08/22/2019 in the patient's medical record, Patient # 24 was admitted to the hospital with a fractured femur resulting from a fall at a local nursing home. The patient had a past medical history of COPD, CHF, Diabetes, Paraplegia, Chronic Kidney Failure. The patient was started on hemodialysis on 08/24/2019. The patient was initially found to be hypotensive, anemic and received 10 units of blood between 08/22/2019 and 09/03/2019. The patient had 17 episodes of elevated blood pressure with a systolic blood pressure over 150 and/or a diastolic blood pressure over 90. The patient also had two episodes of temperature greater than 100.5 degrees Fahrenheit. There was no documentation to show the nurse notified the physician of the elevated vital signs.

The vital signs below were documented when the patient was receiving blood while on hemodialysis on 08/24/2019.
5:15 p.m. blood pressure 155/104
5:30 p.m. blood pressure 185/92
5:45 p.m. blood pressure 207/104
6:00 p.m. blood pressure 189/83

08/26/2019
11:00 p.m. temperature 100.6

08/27/2019
12:00 a.m. temperature 100.6
1:00 a.m. blood pressure 185/102
2:14 a.m. blood pressure 164/102
3:00 a.m. blood pressure 146/110
5:00 a.m. blood pressure 168/102
6:00 a.m. blood pressure 193/88
7:00 a.m. blood pressure 168/86
8:00 a.m. blood pressure 167/80

09/01/2019
8:00 a.m. blood pressure 162/83

09/03/2019
7:30 p.m. blood pressure 162/91

09/04/2019
4:16 p.m. blood pressure 185/70

09/05/2019
5:40 a.m. blood pressure 167/73
The above findings were confirmed by staff # 19 at the time of review.


B. Failed to notify physician when medications were not administered in a timely manner, and/or failed to notify the physician when medications were not administered due to patient refusal of medications; Failed to seek clarification of an order for medication that the patient was documented to have an allergy to;

A review of medical records was conducted on 09/05/2019, from 10:30 a.m. until 2:30 pm and on 09/06/2019, at approximately 10:30 a.m. in the physician dictation room attached to medical records.

Patient #13

According to the history and physical dated 08/28/2019 in the patient's medical record, Patient # 13 was admitted to the hospital on 08/28/2019 with uncontrolled pain following spinal surgery related to breast cancer, opioid related constipation, and suspected surgical wound infection. A review of the medical record revealed the patient had an order for Lactulose 20 GM (grams) orally BID (two times daily) and Metoclopramide 10 mg orally with meals and at bedtime. The documentation showed the patient either missed these medications or refused these medications 10 times between 08/29/2019 and 09/05/2019.

08/29/2019 - 9:00 a.m. - Lactulose "other reason for missed dose"
08/29/2019 - 9:00 p.m. - Lactulose dose patient refused
08/31/2019 - 7:30 a.m. - Metoclopramide patient refused
08/31/2019 - 4:30 p.m. - Metoclopramide patient refused
08/31/2019 - 9:00 p.m. - Lactulose dose patient refused
09/01/2019 - 9:00 p.m. - Lactulose dose patient refused
09/02/2019 - 9:00 p.m. - Lactulose dose patient refused
09/03/2019 - 9:00 a.m. - Lactulose dose patient refused
09/03/2019 - 9:00 p.m. - Lactulose dose patient refused
09/04/2019 - 9:00 a.m.- Lactulose dose patient refused
09/04/2019 - 9:00 p.m. - Lactulose dose patient refused
09/05/2019 - 9:00 a.m.- Lactulose dose patient refused

Findings were confirmed by staff # 19 at the time of review.


Patient #22

According to the history and physical dated 09/03/2019 in the patient's medical record, Patient # 22 was admitted to the hospital on 09/03/2019 with a diagnosis of pneumonia. The patient was ordered Zosyn 3.375 GM IV (an antibiotic) every 8 hours. The dose was ordered to be given 09/03/2019 at 1:00 p.m. The medication was not documented as being given until 09/04/2019 at 2:00 a.m. There was no documentation found that the physician was notified regarding the late dosing of this medication and there was no reason given as to why the medication was given late.


Further review of the record revealed there were eight medications listed as "Not Administered.' The patient was ordered Albuterol Nebulizer (respiratory medication) treatments. There were four times (09/04/2019 1100, 09/04/2019 3:00 p.m., 09/04/2019 7:00 p.m., 09/05/2019 0700) documented that the patient's family refused this medication on behalf of the patient due to an allergy. Review of patient's allergies found the patient had a documented allergy to the Albuterol. There was no documentation to show the provider was contacted for clarification of the order for a medication the patient had a documented allergy to.

The patient was ordered an oral medication Dextromethorph-Guaifenesin (cough medicine) ordered to be given two times a day at 9:00 a.m. and at 9:00 p.m. This medication was documented as missed due to patient unable to swallow on 09/04/2019 at 10:54 a.m. and at 10:23 p.m. Review of the record revealed the patient had a PEG Tube (percutaneous endoscopic gastrostomy tube) and medications were ordered to be administered per this tube. However, some medications were not able to be crushed and put through a PEG tube and were ordered to be given orally by the physician. The physician had also placed an order for the patient to have nothing by mouth (NPO). There was no documentation the physician was contacted for clarification regarding orders for medications to be given orally when patient had order for NPO and had a PEG tube.

These findings were confirmed by staff # 19 at the time of review.



Patient #23

According to the history and physical dated 09/03/2019 in the patient's medical record, Patient # 23 was admitted to the hospital on 09/03/2019 with a diagnosis of pneumonia. Review of the documentation revealed the patient had an order for Cefepime (antibiotic), an antibiotic used to treat respiratory infections. The order was for 2000 mg to be given IV now on 09/03/19 at 11:52 a.m. The medications were not documented as given. There was no documentation that the physician was notified that this medication was not given. An order for the medication to be discontinued was placed on 09/03/19 at 10:08 p.m., 9 hours after it was ordered to be given.

The above findings were confirmed by staff # 19 at the time of review.


C: Failed to report critical lab values

A review of medical records was conducted on 09/05/2019, from 10:30 a.m. until 2:30 pm and on 09/06/2019, at approximately 10:30 a.m. in the physician dictation room attached to medical records.

Patient #24

According to the history and physical dated 08/22/2019 in the patient's medical record, Patient # 24 was admitted to the hospital with a fractured femur resulting from a fall at a local nursing home. The patient had a past medical history of COPD, CHF, Diabetes, Paraplegia, Chronic Kidney Failure. A review of the medical record revealed 12 critical lab results from 08/28/19-09/02/19. There was no documentation to show the physician was notified of the critical lab values.

08/26/19 at 6:07 a.m.
BUN (blood urea nitrogen)-85 (normal 7-18)
Creatinine- 4.8 (normal 0.6-1.2)
A/G (total serum protein) - 8.1 (normal 2.5-4.9)

08/27/19 4:08 a.m.
BUN - 47

08/28/19 4:30 a.m.
BUN - 54

08/30/19 7:50 a.m.
Hgb (Hemoglobin) 7.5 (normal 9.9-15.9)
BUN - 45
Na (Sodium) 127 (normal 135-145)

08/31/19 6:31 a.m.
Hgb - 7.4
Hct (hematocrit) - 22.8 (normal 29.6-46.8)

09/01/19 3:38 a.m.
Hgb 7.3

09/02/19 5:27 a.m.
Na - 130
BUN - 49

The above findings were confirmed by staff # 19.

Review of the facility policy titled "Nursing-Critical Lab Values," most recent review date of 09/2018 stated "The nursing personnel, or other clinician will respond as described below:

"Patient type - Inpatient - The Laboratory tech must contact the patient's RN or other RN on same unit; This RN will then initiate contact with physician: If necessary, page physician, if no response within 5-10 minutes, re-page and continue to re-page every 5-10 minutes; if no response within 30 minutes initiate Chain of Command as detailed in the Functional Manual, Policy # C260."

The facility failed to follow its own policy regarding notification of physician of critical lab values.

Based on interview and record review, the facility failed to ensure medications were reconciled appropriately, accurate orders were obtained, and administered safely in 1 of 6 patients reviewed for medication reconciliation(Patient #1).

Patient #1 received an overdose of medications because they were reconciled incorrectly on presentation into the Emergency department (ED). The facility implemented medication reconciliation training for all staff, but failed to ensure the staff who initially put the medications in incorrectly was trained as of 09/06/2019.


This deficient practice had the likelihood to cause harm to all patients.



Findings include:



Review of the Emergency department (ED) record on Patient #1 revealed he was a 76- year- old male who presented on 08/08/2019 at 11:12 a.m., with complaints of chest pain. Patient #1 had diagnoses which included atrial fibrillation, coronary heart disease, congestive heart failure, chronic kidney disease, depression, diabetes, hypertension and chronic obstructive pulmonary disease.

The following home medications were listed on the ED assessment:

1. Glucovance (diabetic agent)
2. Levothyroxine (thyroid agent)
3. Mirapex (agent used for Parkinson/restless legs)
4. Toprol XL 100 milligrams (blood pressure agent)
5. Lipitor 40 milligrams one tablet daily (cholesterol agent)
6. Cymbalta (anti- depression agent)
7. Gabapentin (anti-convulsant/nerve pain agent)
8. Vaseretic (blood pressure agent)
9. Insulin aspart subcutaneous (diabetic agent)
10. Tresiba FlexTouch (diabetic agent)
11. Eliquis (anti-coagulant agent)
12. Pantoprazole (anti- acid agent)
13. Potassium chloride (potassium supplement)
14. Torsemide 100 milligrams 0.5 tablet twice a day (diuretic agent)
15. Torsemide 50 milligrams one tab daily(diuretic agent)
16. Toprol Xl 50 milligrams one daily(blood pressure agent)
17. Aspirin (anti-coagulant /anti-inflammatory agent)
18. Advair Diskus (bronchodilator agent)
19. Ipratropium-albuterol (bronchodilator agent)
20. Trazadone (anti-depressant agent)
21. Sertraline(anti-depressant agent)
22. Lipitor 80 mg one tablet at bedtime(cholesterol agent)

There was documentation on the assessment that all meds were verified by patient's bottles.

Review of an emergency medical technician's (EMT) trip report dated 08/08/2019 revealed "MED LIST LEFT WITH ER STAFF."

This was a discrepancy and some of the medications on the list had duplicate actions.



According to a physician's order dated 08/08/2019 at 1:57 p.m., revealed Patient #1 was being admitted for observation.

Two days later on 08/10/2019 at 2:30 p.m., a physician's order was received to discharge Patient #1 to home.

According to the discharge instructions Patient #1 was to continue taking the same list of home medication.


The same medications that was listed on the ED assessment dated 08/08/2019 were listed on the discharge assessment dated 08/10/2019.



Review of ED notes dated 08/10/2019 at 8:52 p.m., revealed that Patient #1 returned to the hospital. The following was documented:

"..Having problems with shaking, can't walk. turns out his med list was his caretakers that the home health nurse had sent with him so he wasn't being given the correct medications. Is wanting to talk to house supervisor immediately."


The following medication list was provided by the family as the ones Patient #1 was supposed to be taking:


Eliquis
Klor Con
Pantaprazole
Torsemide 100 milligrams 0..5 tablet daily
Tamsulosin
Trazedone
Metoprolol
Sertraline
Lipitor 80 milligrams at bedtime
Aspirin
Titropium bromide inhalation
ProAir HFA
Advair Diskus
Iron
Multiple vitamins


According to the physician's documentation dated 08/10/2019, Patient #1 presented to the ED with complaints of shaking and confusion. .."Daughter checked patient's medications and found that he was receiving the wrong meds during his inpatient treatment including Gabapentin, Tresiba, Mirapex, and Cymbalta among other medications. The physician wrote orders to admit Patient #1 for observation.

After a change in condition, a physician's order dated 08/11/2019 was written for Patient #1 was admitted to intensive care unit.

According to a Nurse practitioner note dated 08/12/2019 revealed the following :

"Toxic encephala secondary to accidental drug overdose-patient is improved as medications are metabolize out of his system. Will continue observing."

During an interview on 09/06/2019 after 2:30 p.m., Staff #70 said she had investigated the complaint about the medications and found that the nurse in the ED had called the family on 08/08/19, but had done a thorough check on the medication list she had received from the EMT's. Staff #70 said she found out from the family that the EMT's were given the wrong list of medications on 08/08/2019. The wrong list of medications was what was left with the ED nurses. When the family called the EMT to pick up Patient #1 the next visit to the ED on 08/10/2019 they noted on the discharge papers dated 08/08/2019 that Patient #1 had been given the wrong medications. The family member recognized that the medications listed belonged to her. Staff #70 said the ED nurse called the family on 08/08/2019 and had the family read off Patient #1's medication bottles to her, but failed to share the list of medications she already had. When both list of medications were placed in the computer system they all merged. Staff #70 said Patient #1 got wrong doses of medications on the 9th and 10th. Patient #1 got doses of his medications and the ones belonging to family members.


Staff #70 said as a result of the medication errors they implemented a training for the nurses and pharmacy staff on medication reconciliation. The nurse had been counseled and the case was sent to peer. As of today (09/06/2019) 54 percent of the staff had done the new education. The nurse who put the medications in the system incorrectly had not been trained yet and she had worked two times since the incident occurred that she knew of.

Based on record review and interview, the facility failed to administered blood products and intravenous fluids in accordance with written policy and procedures. The facility failed to:

A. ensure blood transfusions were completed, physician orders for blood transfusions were complete, and vital signs were done per their policy during blood administration, in 8 of 8 patients (Pt #3, #13, #14, #19, #20, # 24, #35, and #92)

B. ensure physician orders for intravenous medications were complete and administered as ordered by the physician in 9 of 9 Patients (Patient #'s 2, 10,11,35, 36, 66, 89, 90, and 91) records reviewed. Also, the facility failed to ensure post-operative anesthesia orders were well defined and clear to nursing staff in the post-operative areas on Patient #40.


This deficient practice had the likelihood to cause harm to all patients.

Findings include:



Patient #3

On 9/6/2019 in the Physician's dictation room the Medical Record (MR) for pt #3 was reviewed and revealed a blood transfusion was conducted on 4/8/2019. The transfusion began at 0100. Vital signs were recorded at 15 minutes after start of infusion, 1 hour, 2 hours and 3 hours after start of infusion. The vital signs for 1 hour post transfusion were not recorded.


Patient #19
Review of pt #19's MR a blood transfusion was initiated on 8/15/2019. Documentation for, vitals signs, is identified below.

Unit #1
Pre-transmission vitals signs were recorded at 2110
Start time of time of transfusion 2125
15 minutes after start 2140
1 hour after start 2225
2 hours after start no vitals signs documented
3 hours after start no vitals signs documented
one hour post transfusion documented a 2244

This unit ran in in 1 hour and 14 minutes.

Unit #2 was initiated 8/22/2019
Pre-transfusion vital signs were recorded at 2200
Start time for transfusion 2209
15 minute after start 2225
1 hour after start 2310 10 minute late
2 hours after start 0010
1 hour post completion 0200 50 minutes late

Unit #3 was initiated 8/22/2019. Only one nurse verified the correct unit of blood.
The pre-transfusion time had been marked through and was not legible
Start time for transfusion 1130
15 minute after start 1145
1 hours after start 1230
2 hours after start 1330
3 hours after start 1430
1 hour after completion 1530
Transfusion completed 1255 (sic)

The above documentation indicated the blood transfusion started at 1130 and was completed at 1255, 1.25 minutes.




Patient #20

On 9/7/2019 in the Physician's dictation room the MR for pt #20 was reviewed. Pt #20 came to the facility in sickle cell crisis and received 2 units of blood. The first unit was issued at 0140 on 8/30/2019. Documentation indicated the unit began on 8/30/2019 at 0215 and was documented as complete at 0420. Please review the following vitals signs documentation.
Unit #1
Pre-transfusion vitals signs 0130
start time of transfusion 0215
15 minutes after start original time 0300 rewritten time 0215
One hour after start original time 0330 rewritten time 0245
Two hours after start original time 0430 rewritten time 0300
Three hours after start original time 0530 rewritten time 0345
Post transfusion 1 hour original time 0615 rewritten time 0420

Transfusion completed at 0420

Unit #2
Issued on 8/30/2019 at 0430
Pre-transfusion vitals signs 0420
start time 0440
15 minute after start
One hour after start
Two hours after start
Three hours after start
one hour post transfusion
Completed 8/30/2019 at 0620. Vitals signs were recorded but no time was entered.

The above findings were confirmed by staff #22.


41831

Patient #14

Patient # 14 was admitted on 08/30/2019 for psychiatric issues. Review of the record revealed the patient had blood transfusion on 09/03/19.

Further review of the documentation revealed on 09/03/2019 the patient was to receive a second unit of blood and at 10:12 a.m. the pre- transfusion vital signs were as follows:

Blood pressure 123/85, pulse 83, temp 98.5, respirations 16.

The documented start time of the blood was 10:15 a.m. then "15 minutes after start" vital signs were as follows:

blood pressure 157/100, pulse 84, temp 98.6, respirations 18.

There was no documentation that the nurse notified the provider of the elevated blood pressure during the transfusion of the second unit of blood.


The above findings were confirmed by staff # 19.


Patient #24

Patient # 24 was admitted to the hospital on 08/22/2019 with a fractured femur resulting from a fall at a local nursing home. Further review of the record showed that patient received blood transfusions on 08/22/19, 08/23/19, 08/24/19, 08/25/19, 08/30/19, 08/31/19, and 09/01/19. The patient was given blood during hemodialysis on 08/24/2019, however there was no order found to transfuse blood during hemodialysis. During the blood transfusion on 08/24/19, the patient began having elevated blood pressures, there was no documentation to show the hemodialysis nurse administering the blood, ever contacted the physician regarding the elevated blood pressures.

The vital signs below were when the patient was receiving blood and hemodialysis on 08/24/2019.

08/24/2019
5:15 p.m. - blood pressure 155/104
5:30 p.m. - blood pressure 185/92
5:45 p.m. - blood pressure 207/104
6:00 p.m. - blood pressure 189/83

Review of the facility policy titled" Nursing-Blood and Blood Products Transfusion Policy," with current review date of 01/03/2019 section 3 - 'During Transfusion' subsection f - Signs or symptoms of a potential transfusion reaction may include the following: v. - Blood pressure changes, either hyper - or hypotension. Under the section "Management of Transfusion Complication," # 5. In the event of a possible transfusion complication, the nurse will do the following: a. "Immediate Transfusion Reaction Complication (see signs and symptoms above.)", i. - STOP TRANSFUSION, ii. - Remain with the patient, do not leave the patient alone, iii. Call for help (i.e., other nursing staff). This second person should notify the patient's physician for order and should provide assistance so that the
patient's nurse can remain with the patient at all times.



Patient #66

A review of medical records was conducted on 09/05/2019, from 10:30 a.m. until 2:30 pm and on 09/06/2019, at approximately 10:30 a.m. in the physician dictation room attached to medical records. The review revealed that 1 patient (patient #66) out of 6 patients reviewed had orders for Total Parental Nutrition (TPN)/Lipids (a fat emulsion used for added nutrition) intravenously. The review also revealed the 2 out of 4 doses were not administered according to facility policy. The findings are as follows:

09/01/2019
10:30 a.m. - physician hand wrote an order for TPN/Lipids
10:30 a.m. - RN signed the order
Order was received in the pharmacy - no time was documented as to what time the order was faxed by the nurse and what time the order was received by the pharmacy.

The pharmacist entered the order for TPN/Lipids into the EMR at 10:51 a.m. The pharmacist entered a start date and time as 09/02/19 4:00 p.m.

There was no time documented to show when the pharmacy delivered the TPN to the floor. There was no documentation to show when the nurse received the TPN

6:41 p.m.- Nurse documents TPN/Lipids as administered. There was no documentation to show the TPN was verified by a second nurse prior to being started on the patient.

09/02/2019
12:08 p.m. - physician hand wrote an order for TPN/Lipids

Nurse signed order on 09/02/19 however the time was illegible.

Order was received in the pharmacy - no time was documented as to what time the order was faxed by the nurse and what time the order was received by the pharmacy.

The pharmacist entered the order for TPN into the EMR at 12:39 p.m., and Lipids at 12:40 p.m. The pharmacist entered a start date and time as 09/02/19 4:00 p.m.

There was no time documented to show when the pharmacy delivered the TPN to the floor.
There was no documentation to show when the nurse received the TPN.

5:00 p.m. - Nurse documented TPN/Lipids as administered in the EMR. There was no documentation to show the TPN was verified by a second nurse prior to being started on the patient.

09/03/2019
11:32 a.m. - physician hand wrote an order for TPN/Lipids

Nurse signed order on 09/03/19 however the time was illegible

Order was received in the pharmacy - no time was documented as to what time the order was faxed by the nurse and what time the order was received by the pharmacy.

The pharmacist entered the order for TPN into the EMR at 12:10 p.m. and Lipids at 12:12 p.m. The pharmacist entered a start date and time as 09/03/19 4:00 p.m.

There was no time documented to show when the pharmacy delivered the TPN to the floor.
There was no documentation to show when the nurse received the TPN.

5:30 p.m.- Nurse documents TPN/Lipids as administered in the EMR (30 minutes after the "24-hour" limit.) There was no documentation the nurse notified the physician that the TPN was started late. There was no documentation to show the TPN was verified by a second nurse prior to being started on the patient.


09/04/2019
11:10 a.m. - physician hand wrote an order for TPN/Lipids

11:10 a.m. - RN signed the order

Order was received in the pharmacy - no time was documented as to what time the order was faxed by the nurse and what time the order was received by the pharmacy.

The pharmacist entered the order for TPN into the EMR at 11:56 a.m. and Lipids at 11:58 a.m. The pharmacist entered a start date and time as 09/04/19 4:00 p.m..

There was no time documented to show when the pharmacy delivered the TPN to the floor.
There was no documentation to show when the nurse received the TPN.

4:52 p.m. - Nurse documents TPN/Lipids as administered in the EMR. There was no documentation to show the TPN was verified by a second nurse prior to being started on the patient.

09/05/2019
11:19 a.m. - physician hand wrote an order for TPN/Lipids
11:30 a.m. - Nurse signed order

Order was received in the pharmacy - no time was documented as to what time the order was faxed by the nurse and what time the order was received by the pharmacy.

The pharmacist entered the order for TPN into the EMR at 12:22 p.m. and Lipids at 12:24 p.m. The pharmacist entered a start date and time as 09/05/19 4:00 p.m.

There was no time documented to show when the pharmacy delivered the TPN to the floor.
There was no documentation to show when the nurse received the TPN.

5:13 p.m. - Nurse documented TPN/Lipids as administered in the EMR (16 minutes after the previous days dose). There was no documentation the nurse notified the physician that the TPN was started late. There was no documentation to show the TPN was verified by a second nurse prior to being started on the patient.


An interview was conducted on 09/06/2019 at 10:15 a.m. in the Neonatal Intensive Care Unit (NICU) with staff # 126. Staff # 126 was asked to describe the procedure for hanging TPN in the NICU. Staff # 126 stated the physician writes the order for TPN. This order was then faxed to the pharmacy before 2:00 p.m. If the patient was starting on TPN the nurses use what was called a "Starter TPN" that was kept as stock on the floor. Staff #126 stated that for additional doses, the pharmacy prepares the TPN and delivers it to the floor. The TPN was then verified by two nurses and all tubing was replaced from the previous TPN using sterile technique with two nurses. When asked if TPN had a specific time it was to be administered, staff #126 stated it was not usually given at a specific time and it depends on the time the previous dose was started. When asked to verify in the medical record where the two-nurse verification was documented, staff # 126 stated, the two-nurse verification was not documented in the medical record or on the medication. Staff# 126 was asked if the TPN ever hung longer than 24 hours and if so what was the process, staff # 126 stated the TPN hangs until the next dose gets there and that sometimes pharmacy does not bring the TPN up to the floor until after 5:00 p.m.

An interview with staff # 56 was conducted in the conference room on 09/06/2019 at 12:50 p.m. Staff # 56 was asked to describe the process for TPN at the facility. Staff # 56 stated the physician writes the order for TPN and the order was to be faxed to the pharmacy before 2:00 p.m. The order was then verified by 2 pharmacists and APEX was used for TPN calculations. Staff # 56 stated that APEX was a computer compounding program used to verify calculations for compounding TPN at the facility. Staff # 56 stated the pharmacy technician then mixes the TPN, and then a two-person process check was performed in the pharmacy, the TPN was then labeled and delivered to the floor. Staff # 56 was asked if there was a specific time that TPN was to be administered in the facility, and staff # 56 stated there was no specific time, that the pharmacy tried to get the TPN to the floor by 1600 however that was not always possible. Staff # 56 was asked if there was a process in place for the nurses to sign for the receipt of the TPN on the floor, and or was the time the TPN was delivered to the floor logged in the pharmacy, staff # 56 stated there was no process currently in place for documenting the times the TPN was delivered to the floor. Staff # 56 stated the nurses do not sign when the TPN was received on the floor.

Staff # 56 explained that the "due by 4:00 p.m." which shows in the comment section of the computer entered order and was listed as the start time of the TPN in the medication administration screen, was a default time built into the order system for TPN, but there was no facility specific time that TPN was to be administered. Staff # 56 then stated that TPN was treated like a daily scheduled medication with a 2-hour window for administration.

Staff # 56 was then shown the facility specific policy related to TPN titled "Pharmacy-Total Parenteral Nutrition Solutions - TPN Policy," with the latest review date of 01/2017, and asked to read # 6 under "Procedure" which states "Once hung a single TPN solution should not run for more than 24 hours. If the physician orders a rate of 42ml/hr or less, the pharmacy will prepare the total solution, then divide the total volume into two equal portions to be hung consecutively by nursing personnel unless otherwise specified by the prescriber." Staff # 56 stated he was not very familiar with this policy. Staff # 56 was then asked what the procedure was if TPN had been administered for longer than 24 before the next dose arrived on the floor, and staff # 56 stated if the TPN was hung for longer than 24 hours the nursing staff were to hang D10 (Dextrose 10% IV (intravenous) solution) until the next dose has arrived.

Further review of the facility policy for TPN, under "Procedure" item # 9 states "Orders for TPN Solutions should be received by pharmacy by 1400 each day. Order written for TPN solutions after the pharmacy closes will be prepared as soon as the pharmacy opens until that time, Dextrose 10% will be hung at a rate of 50 ml/hr (subsequent TPN orders only).

Review of the facility's unit specific policy titled "Standards of Care in the NICU," section titled "Nutrition-C. Parenteral Nutrition and IV Fluids- 1. Total Parenteral Nutrition (TPN), Intralipids and clear IV fluids will be infused as ordered via infusion pump. i. - All TPN and intralipids must be verified by two RN's with the medical provider order prior to administration. Ii. - TPN solution and intralipid emulsion tubing must be changed every twenty-four hours. 1.- If a central line is in place, utilized two-person sterile technique to change tubing."


The facility failed to follow its own policy, by not administering TPN within the 24-hour time frame set in the policy.


40989


An observation tour was conducted after 10:00 AM on 9/04/2019 with Staff #34, #48, and #51 in the out-patient infusion clinic.


PATIENT #35

A review of Patient #35's medical record revealed a written order dated 8/8/2019 for weekly outpatient infusions for Magnesium Sulfate (an electrolyte replacement commonly used for cancer patients) and a Banana Bag (a bag of IV fluids with vitamins and minerals used to correct nutritional deficiencies).

A review of the document titled, "Longview Regional Medical Center Chemotherapy Orders" revealed the written order was as follows:

" ...Magnesium Sulfate 2gm at____ml per hour and Banana Bag Thiamine 100mg, Folic Acid 1mg, MVI ..." The written order from Staff #92 was as follows: "Q (every) Wednesday (weekly) X 6 months."


Staff #92 failed to document the rate of infusion for the Magnesium Sulfate and the Banana Bag.


Patient #35's medical record also revealed a written order for a blood transfusions and/or a platelet transfusions.

A review of the document titled, "Outpatient Blood & Blood Products Transfusion Order, Longview Regional Medical Center-Outpatient Infusion" for Patient #35 revealed:

" ...PRBC's
Type/crossmatch & Transfuse 2 units of PRBC's per Blood and Blood Products Transfusion Protocol Policy.

PLATELETS
Type for 6 units pooled platelets & transfuse per Blood and Blood Products
Transfusion Protocol Policy.

ADDITIONAL ORDERS:
Transfuse 2 units of irradiated PRBC if Hgb less than 8
Transfuse 1 unit of irradiated PLTS if less than 20 ..."

A review of the written order did not reveal a rate of infusion nor the duration of the ordered transfusions for the PRBC's (Packed red blood cells) or the PLT's (Platelets).


A review of Patient #35's medical record revealed the patient was transfused 2 units of PRBC's and 1 unit of Platelets on 8/28/2019.

The documentation on the blood transfusion flow sheet on 8/28/2019 was as follows:

Platelets:
Transfusion started at 2:10 PM and was complete at 2:50 PM. This is 20 minutes faster than the Blood and Blood Products Transfusion policy allows if the provider fails to document the rate or duration on the order for transfusion.

Packed Red Blood Cells:
Transfusion #2 was started at 3:15 PM and completed at 5:30 PM. This is 15 minutes longer than the Blood and Blood Products Transfusion policy allows if the provider fails to document the rate or duration on the order for the transfusion.

There was no further documentation as to why the Platelet transfusion was faster than what the policy allowed or why the PRBC's was slower than what the policy allowed.


A review of the policy titled, "Nursing-Blood and Blood Products Transfusion Protocol Policy" revealed:

" ...PRIOR TO TRANSFUSION

1. The nurse will perform the following before initiation the blood transfusion:

a. Validate physician (or licensed healthcare provider) for transfusion. Order to specify type and amount of blood product to be transfused. Unless flow rate or length of transfusion duration is otherwise specified in the order, blood components will be transfused as follows:

i. Red Blood Cells: given over one to two hours (at approx. 120-240 ml/hr).

ii. FFP/Platelets: given over one hour (at approx..300 ml/hr) ..."


Staff #34 and #51 confirmed the above findings.



PATIENT #36

A review of Patient #36's medical record revealed a written medication order dated 4/09/2019 by Staff #94. The written order was as follows:

" ...KCL (Potassium) infusion parameters
2-2.5- 80 meq IV X 1 dose
2.6-3- 60 meq IV X 1 dose
3.1-3.5- 40 meq IV X 1 dose ..."

Further review revealed there was no route, (IV push or infusion), no rate, no duration, no start or stop time of the continuous order.

During an interview after 10:00 AM on 9/4/2019 with Staff #34 and #51, Staff #51 was asked how she knows what rate or route to use for this medication. Staff #51 replied, "Patient #36 comes in weekly and the pharmacists puts the rate on the IV bag." Staff #51 was asked if there was ever a call made to the ordering provider to get clarification on the medication order. Staff #51 stated, "No." Staff #51 was asked if this was a standard practice of not calling the provider for order clarification. Staff #51 replied, "It is based on the hospital protocol for electrolyte replacement and the pharmacists sets the rate. We should be calling the provider so that they will have to write a complete and accurate order."

During an interview after 10:00 AM on 9/5/2019 with Staff #56, Staff #56 was asked how he determined the rate of infusion for IV medications. Staff #56 replied, "We have protocols for most all medications and if there are not set protocols we use the infusion guidelines from the manufacturer or other pharmaceutical companies like GlobalRXPH. They set infusion guidelines with maximum infusion rates and we have the authority to override a physician order if it is safest for the patient."

A review of the document titled, "Electrolyte Replacement, Adult", revealed no specific protocol guidelines for the dose of Potassium ordered by Staff #94 for Patient #36.







PATIENT #89


A review of Patient #89's medical record revealed a medication order was written for Venofor (a medication used to treat iron deficiency) by Staff #117. The medication order was as follows:

"8/27/2019 Venofor IV Infusion 200 mg with sono if needed, most likely
Dx: Anemia." No duration or rate was documented by Staff #117 on the medication order.



PATIENT #90


A review of the medical record for Patient #90 revealed a medication order for Ertapenem (an antibiotic used to prevent and treat infections) was written by Staff #119 on 8/26/2019. The medication order was as follows:

" ...Medication--Ertapenem 1-gram solution for injection
Quantity--7 (seven) g
SIG--Take 1 g by IV every day for 7 days ..."

Further review of the medication order revealed there was no route, no rate, and no start date ordered by Staff #119. Staff #119 failed to document the time the order was written.






PATIENT #91

A review of Patient #91's medical record revealed Staff #118 had written a medication order for Entyvio (a medication used to treat Ulcerative Colitis or Chrons Disease) dated 5/30/2019 that read, "Entyvio infusion 300 mg q (every) 4 wks X 1 yr." Staff #118 failed to document the time the order was written, the start date for the medication, and the rate of infusion.



A review of the policy titled, "Pharmacy-Prescribing and Ordering- General Practices Policy" was as follows:

" ...To be considered complete, all medication orders shall include the name of the drug, the dosage and strength, the quantity or duration (as appropriate), the route and frequency of administration, the reason the drug is ordered/indications for usage (as appropriate) and the time and date the order is written. The patients name must be documented on the order sheet or written on a prescription (from Rx pad) ..."


Staff #51 confirmed the above findings.


PATIENT #92

A review of the medical record for Patient #92 revealed a blood transfusion was given on 8/30/2019. The blood transfusion flow sheet revealed the transfusion was started at 9:25 PM by Staff #54 and completed at 10:04 PM. Further review revealed the blood was checked out of the blood bank at 7:41 AM on 8/30/2019 with no documentation of the personnel it was released to.


A review of the transfusion flow sheet revealed the following:

" ...Transfusion Information

Transfusion MUST begin within 30 minutes of removal from Blood Blank. Blood Products EXPIRE 4 hours after removal from Blood Blank ..."




During an interview after 7:30 AM on 9/5/2019 with Staff #54, Staff #54 was asked why was there a delay in starting the blood transfusion when the transfusion flow sheet clearly states, "Transfusion MUST begin within 30 minutes of removal from the Blood Bank." Staff #54 replied, "I can't remember this specific patient but what probably happened was the patient was a surgical patient and the blood cooler came with the patient from surgery, so the blood was already in the cooler when he was admitted to the unit. So, I'm sure the blood was taken from the cooler for the transfusion. The coolers are supposed to keep the blood at the right temperature and if we do not use it, then we return it to the lab." Staff #54 was then asked how the blood temperature was monitored to ensure the blood was safe to transfuse. Staff #54 replied, "As long as it's in the cooler it should stay at the right temperature." Staff #54 was asked if there was a temperature sticker on the back of the blood before the start of the transfusion. Staff #54 replied, "I don't know about the temperature sticker or how to read the sticker. I don't look for that before I give the blood out of the cooler." Staff #54 was asked if he documented on the transfusion flow sheet that the blood was removed from the cooler prior to transfusion. Staff #54 replied, "No, because there is no place to document that on the flow sheet."

During an interview after 8:00 AM on 9/5/2019 with Staff #55, Staff #55 was asked how she ensured the blood stored in the cooler did not reach an unsafe temperature before the start of the blood transfusion. Staff #55 said, "If it is in the cooler it should be safe. The cooler comes with the patient from surgery and if we don't use the blood then we return it to the lab but, we never take it out of the cooler unless we are going to transfuse it." Staff #55 was asked if she had any education on the temperature sticker on the blood bag and if she checked to make sure there was one on the bag before she started a blood transfusion. Staff #55 stated, "No I have not, and I don't look for a sticker when I take it out of the cooler."

An interview with Staff #23 was conducted on 9/5/2019 after 8:00 AM. Staff #23 was asked if the nursing staff in ICU had been educated regarding the HemoTemp II temperature sticker that was placed on the back of the blood bags that were stored in the cooler. Staff #23 replied, "I would like to say they were but, I am really not sure that they have."



A review of the policy titled, "Nursing-Blood and Blood Products Transfusion Protocol Policy" revealed:

" ...l. After obtaining the blood or blood component from Blood Bank, begin the transfusion as soon as possible. Transfusion MUST be started within 4 (4) hours of product issue or removal from temperature controlled storage.
Document the time of the removal of the blood product from the controlled storage cooler on the transfusion record. Blood products may be returned to the Blood Bank for storage components. Transfusion must occur within 4 hours of the time of the product issue or removal from the temperature controlled storage device. PRODUCT MUST NOT BE REFRIGERATED ON THE NURSING UNIT..."



A review of the policy titled, Blood Bag Temperature Indicator (HemoTemp II) was as follows:

" ...Principle:
Blood bag temperature indicators are to be used when multiple units of blood are issued to Surgery or Emergency Department and use is uncertain. The blood bags will be tagged with a temperature indicator and placed in a cooler with previously REFRIGERATED ice packs. NEVER USE FROZEN ICE PACKS ON PRBC UNITS. Unused units are to remain in cooler and returned to the Laboratory ..."

An interview was conducted after 10:00 AM on 9/6/2019 with Staff #49. Staff #49 was asked if there was a facility policy on the coolers and/or the validation of the coolers that were used for storage of multiple units outside the blood bank. Staff #49 replied, "No there is not a policy on the coolers and how they should be used or validated. We are working on a policy, but we do not have one that has been approved by the Medical Staff or Governing Body."

Staff #1, #48 and #49 confirmed the above findings.









39801


PATIENT # 10
Review of the medical record for Patient #10 revealed the following:

The nursing documentation on 9-3-2019 at 6:57 a.m. showed the nurse started Pitocin at 4 milliunits per hour at 12:16 a.m.

The physician order on 9-3-2019 at 6:57 a.m. showed an order for Pitocin infusion to begin at 2 ml/hr. There was no order to begin at 4 ml/hr.


PATIENT #11
Review of the medical record for Patient #11 revealed the following:

The nursing documentation on 9-3-2019 at 6:49 a.m. showed the nurse started Pitocin at 4 milliunits per hour at 6:49 a.m.

The physician order on 9-3-2019 at 7:04 a.m. showed an order for Pitocin infusion to begin at 2 ml/hr. There was no order to begin at 4 ml/hr.

An interview with Staff #13 on 9-3-2019 after 11:00 a.m. revealed the following:

Staff #13 was asked if there was a protocol for nursing to follow physician orders on Pitocin. Staff #13 stated there was a standard order; however, several physicians preferred the high dose Pitocin when initiating the orders. Staff #13 was asked if the physicians put an order in the computer system if their preference was different than the standard order set. Staff # 13 stated, "yes, they are supposed to but if they do not then the nurse should put a verbal order in."


PATIENT #2

Review of the physician orders for Patient #2 revealed the following:

An order for IV Tylenol was entered on 5-1-2019 at 10:25 a.m., prior to the patient leaving the PACU area.

The order read as follows:
Acetaminophen INJ 1000 mg/100 ml SOLN, Route: Intravenously, Frequency: Every 6 hours.

Patient #2 was moved to the Surgical floor at 11:45 a.m. The order was not acknowledged until 2:22 p.m. by Staff #83.

Review of the Medication Administration Record revealed the following:

Ofirmev (IV Tylenol) was administered on 5-1-2019 at 2:22 p.m. There was no pain scale recorded. The scheduled time to give the medication was 12:00 p.m. There was a late dose reason documented as other, no other explanation was given.

During an interview on 9-6-2019 after 10:50 a.m., Staff #84 confirmed the findings for Patient #2 on the IV Tylenol. Staff #84 stated there is sometimes a delay from pharmacy if the order does not get entered in. Staff #84 was asked to confirm the time the physician entered the orders. Staff #84 confirmed they were entered at 10:25 a.m. and did not see any reason there was a delay.




PATIENT #40

During a chart review for Patient #40 on 1:50 P.M. with Staff #61 the following was revealed:

Medications administered were as follows:

Dilaudid - 0.25 mg at 10:35 a.m., 10:40 a.m., 10:45 a.m., 10:50a.m., and 10:55 a.m.
Fentanyl - 25 mcg at 10:15 a.m., 10:20 a.m., 10:25 a.m., and 10:30 a.m.

Staff #61 was asked to explain the parameters for giving the above listed pain medications. Staff #61 stated pain meds were given to try and keep FLACC pain scale or verbal pain scale under 5. Staff #61 was asked to provide the order on Patient #40 for review.

Review of the order revealed the following:

"1. Fentanyl 25 mcg every 5 minutes prn pain not exceed 100 mcg in one hour.
2. Hydromorphone (Dilaudid) 0.25 mg every 5 minutes prn pain not to exceed 8 mg in one hour."

There was also an order written in at the bottom of the order set for Ofirmen (IV Tylenol) 1 gram in PACU for pain control. There was no parameter listed for how often the medication should be given or maximum doses. There was an illegible initial next to the order. Threre was no way to determine who wrote the order or what time it was written.

Staff #81 was asked what the pain parameter was for the orders. Staff #81 stated she did not see one listed.
During an interview with Staff #115 after 3:30 p.m. the following was revealed. Staff #115 showed documentation on the anesthesia orders for the following:

"Medications - Pain Control -Titrate to maintain pain score less than 5 (0-10) scale, maintaining oxygen greater that 92% and responsiveness or patient states acceptable pain level of pain. Medications are to be given in sequence of order if desired effect is not met with maximum dose given of prior medication."

The information provided regarding orders was on the top of the order sheet and separate from the actual medication orders. Staff #61 & #82 in the PACU were not able to answer questions about the medication orders when asked.

The anesthesia order was unclear and posed a risk of medication errors for patients.

Staff #59 confirmed the above findings on anesthesia orders.

Based on observation, review of documents, and interview, the facility failed to:

A. ensure that the pharmacy and drug storage areas were maintained according to acceptable United States Pharmacopeia (USP) standards for 14 out of 14 medication storage and preparation areas/units (ICU, Maternal / Child, Neonatal ICU, Labor and Delivery, Hemodialysis work area for med prep, Progressive Care Unit, Surgical Unit, Heart Vascular Unit, Same Day Surgery, Post Anesthesia Care Unit, Horseshoe/Medical medication room, Emergency Room, Cath Lab and Interventional Radiology, and the main Pharmacy)

Cross Refer to Tag A0491

B. ensure that all activities of pharmacy services fell under the supervision, control, and coordination of the Pharmacy Director. The facility allowed other departments to order, store, transport, and distribute medications [bulk Intravenous (IV) fluids] without following proper pharmacy oversight.

Cross Refer to Tag A0492


C. ensure that processes were developed to minimize the risk of drug diversion, ensuring the accurate record of use when scheduled drugs/controlled medications were dispensed in Intravenous (IV) bag form for use with standard IV pumps rather than Patient Controlled Analgesia (PCA) pumps.

Cross Refer to Tag A0494

D. ensure that safe and complete orders for titrating Intravenous (IV) medications (increasing or decreasing the amount of medication given to the patient based on the patient's response to the medication) were established and followed. This deficient practice required nurses to use their own judgement when decreasing medication due to patient response or reducing the medication for the purpose of discontinuing it. This type of judgement required the medical decision-making of a physician and was beyond the scope of practice for nursing.

E. ensure a pharmacy process was developed for monitoring the nursing changes made in titrated medications to ensure medications were being delivered to the patient safely as ordered by the physician and were accurately recording the medication administration in 2 out 2 patient charts reviewed (Patient #57 and Patient #58).

Cross Refer to Tag A0500

Based on observation, interview, and review of documents, the facility failed to ensure that the pharmacy and drug storage areas were maintained according to acceptable United States Pharmacopeia (USP) standards for 14 out of 14 medication storage and preparation areas/units (ICU, Maternal / Child, Neonatal ICU, Labor and Delivery, Hemodialysis work area for med prep, Progressive Care Unit, Surgical Unit, Heart Vascular Unit, Same Day Surgery, Post Anesthesia Care Unit, Horseshoe/Medical medication room, Emergency Room, Cath Lab and Interventional Radiology, and the main Pharmacy)

Findings included:

A tour of the main Pharmacy area was conducted on 9-3-2019. During the tour, the following observations were made.

The area was observed to be carpeted. The carpeting was worn and heavily stained in areas. Carpeting is not a material that is easily cleaned and sanitized. The porous carpet fibers trap dirt, dust, and moisture, providing an environment for dangerous bacteria, fungus, and viruses to grow.

Shelving and countertops were observed to be covered with a laminate surface material that was cracked, broken, missing, and lifted in areas. This left the porous counter material underneath the laminate exposed to absorb moisture, trap dirt, and provide an environment for dangerous bacteria, fungus, and viruses to grow. Porous materials were not able to be properly sanitized.

A sink was observed to be located next to the door leading to the sterile compounding room. There was a white plastic drain tray like the type used for drying dishes located on the countertop next to the sink. The drain tray had bags of Intravenous (IV) fluid in it. The area surrounding the sink had evidence of water and what appeared to be soap residue splashed and dried along the back of the sink and around the sink. The white drain tray was visibly soiled with dust.

Staff #56 was interviewed as to the observations made. Staff #56 explained that the bags of IV fluids had been frozen and were being thawed for use. That was why they were in a drain tray next to the sink. When asked about them being in such close proximity to the sink without any protection from splashing as evidences by the dried splash droplets in the sink area, Staff #56 stated that the problem had been identified and splashguards had been requested. Staff #56 was asked to provide evidence of this.

Review of emails between Staff #56, Staff #67, Staff #115, and Staff #50 showed that splash guards by sinks in all medication preparation areas throughout the hospital were missing. The Infection Control Nurse had brought it to the attention of the Pharmacy Director and had reported it to the Quality Director as a "huge concern for an HAI risk" (HAI - Healthcare Associated Infection). This was first identified a year prior on 8-16-2018. E-mails showed that Staff # 56 and Staff #67 continued to follow-up on this matters into 2019. Staff #56 confirmed that splash guards had not been installed in the locations previously identified.

During a review of air quality testing reports for the Sterile Compounding room, it was noted that the Buffer Area air sample had been positive for colonies of harmful bacteria, yeast, and other fungi. While the Primary Engineering Controls (PEC - compounding hoods/workbenches) did not test positive and passed inspection, colonies of harmful bacteria, yeast, and other fungi in the air of the Buffer represent a potential risk for possible contamination of Compounded Sterile Preparations (CSP). CSPs that have unknowingly become contaminated can cause harm and death in patients. The first positive air sample was from January 2019. The second positive sample was from July 2019. The third positive sample was from August 2019.

Staff #56 was asked about the actions taken to correct this condition. Staff #56 provided a timeline to show that issues with sink and eyewash station in the Ante Room area had been addressed. A pass through refrigerator was removed and a new pass through door was installed. However, the new pass through installed by plant operations did not meet the cleanable surface requirements. A new pass through placed on order that met USP guidelines.

Staff #56 was also asked about the carpeting in the pharmacy and the potential for contamination. Even though there is positive airflow between the Sterile Compounding room and the general pharmacy area, every time the door to the room is pushed open and staff member walks into the room, airflow is disrupted. The potential existed to carry airborne particles with them. Staff walking on the visibly soiled carpet kick up dust, dirt, fibers and airborne contaminates that have the potential to be carried into the Sterile Compounding area every time a staff member entered the room. A blue tack mat that collected large contaminates from the bottom of staff shoes was observed to be placed in front of the door to the sterile compounding room. However, this did not eliminate the potential for airborne contaminants from the carpeting from entering the room when the positive airflow is interrupted by the opening of the door and a person entering the room. Staff #56 stated that he had requested the carpeting be removed from the pharmacy. Staff #56 stated that this was delayed because USP 800 standards would not become enforceable until December. This standard required other remodeling work to be done. When asked if the work was going to be completed by December 2019 when USP 800 becomes enforceable, Staff #56 stated it would not.

This delay in removing the carpets from pharmacy places the medications being stored in pharmacy at risk of contamination and provides a potential source of contamination to the Sterile Compounding room.

Review of USP 36 Good Storage and Shipping Practices <1079>

"Scope

Good storage and distribution practices apply to all organizations and individuals in any aspect of the storage and distribution of all drug product, including but not limited to the following:
...
Pharmacies including but not limited to retail, compounding, specialty, mail order, hospital, and nursing home pharmacies


Storage in Buildings and Facilities

Drug product storage areas are required to maintain the product temperature between the limits as defined on the product label. Buildings and facilities used for the warehousing, storage, and/or holding of drug products should be of adequate size for their intended use. These facilities should be adequate to prevent overcrowding. The building and facility should be designed to control environmental conditions where necessary and should be made of readily or easily cleanable materials. Sanitation and pest control procedures should be written, indicating frequency of cleaning and the materials and methods used. The pest-control program should ensure the prevention of contamination as well as the safe use of pesticides. Records of all cleaning and pest-control activities should be maintained."

Based on observation and interview, the facility failed to ensure that all activities of pharmacy services fell under the supervision, control, and coordination of the Pharmacy Director. The facility allowed other departments to order, store, transport, and distribute medications [bulk Intravenous (IV) fluids] without following proper pharmacy oversight.

Findings included:

A tour of an off-site central supply storage building on 9-4-2019 found that IV fluids were being stored improperly. The building was observed to be unlocked with access to anyone from the street. IV fluids were observed to be stored on the floor in opened cardboard boxes next to dirty pallets of other types of hospital supplies. The building was climate controlled, but no temperature logs were kept as a record of the medications being stored at the appropriate manufacturer's requirements.

An interview was conducted with the Pharmacy Director, Staff #56, on the afternoon of 9-4-2019. Staff #56 stated that he had not been to the off-site storage area. He stated he was aware that other departments were ordering IV fluids and had requested that all ordering of medications (IV fluids) be moved to the Pharmacy for proper control. Staff #56 stated that due to the lack of immediate pharmacy space and medication dispense towers, his request was denied at that time. Staff #56 confirmed that the department staff ordering and managing the IV fluids for use throughout the hospital were not trained pharmacy staff.

IV fluids are medications that fall under the United States Pharmacopeia USP standards. A review of USP 36 Good Storage and Shipping Practices <1079> was as follows:

"Scope

Good storage and distribution practices apply to all organizations and individuals in any aspect of the storage and distribution of all drug product, including but not limited to the following:
...
Pharmacies including but not limited to retail, compounding, specialty, mail order, hospital, and nursing home pharmacies

...


Storage in Buildings and Facilities

Drug product storage areas are required to maintain the product temperature between the limits as defined on the product label. Buildings and facilities used for the warehousing, storage, and/or holding of drug products should be of adequate size for their intended use. These facilities should be adequate to prevent overcrowding. The building and facility should be designed to control environmental conditions where necessary and should be made of readily or easily cleanable materials. Sanitation and pest control procedures should be written, indicating frequency of cleaning and the materials and methods used. The pest-control program should ensure the prevention of contamination as well as the safe use of pesticides. Records of all cleaning and pest-control activities should be maintained."

Based on observation, review of documents, and interview, the facility failed to ensure that processes were developed to minimize the risk of drug diversion, ensuring the accurate record of use when scheduled drugs/controlled medications were dispensed in Intravenous (IV) bag form for use with standard IV pumps rather than Patient Controlled Analgesia (PCA) pumps.

Findings included:

On the morning of 9-4-2019, a tour of the Intensive Care Unit (ICU) was made. Nursing interviews were conducted with Staff #108, Staff #109, and Staff #131 concerning titration of medications and managing/documenting controlled medications that were administered using a standard IV pump rather than a PCA pump.

Staff #109 stated that scheduled drugs/controlled medications administered through a standard IV pump were documented on the same forms as scheduled drugs administered through a PCA pump. Staff #109 stated that the volume of medication delivered to the patient was cleared when the initial bag was hung and then recorded on the PCA flow sheet during the administrations. Staff #109 was asked how the medications were secured. Staff #109 explained that the extra port on the medication bag that would allow someone to insert a needle and syringe to add or withdraw medication from the bag had been capped with a locking cap to prevent anyone from taking scheduled medications from the bag and replacing them with a compatible fluid. Staff #109 was asked what type of tubing was used. Staff #109 explained that the standard tubing that was used for all medications was also used for the IV administration of scheduled drugs/controlled medications. Staff #108 and Staff #131 confirmed this was the IV tubing setup that was used. The standard tubing was used to connect the medication bag to the IV pump; and then connected from the IV pump to the patient. The tubing was observed to have an access port between the IV bag and the IV pump that could be used to remove scheduled medications and replace them with compatible fluids without detection. There was also an access port on the tubing located between the pump and the patient. This port also allowed unauthorized access to controlled medications. Staff #108, Staff #109, and Staff #131 confirmed that this was possible with the tubing that was being routinely used.

A review of the Pharmacy Policy and Procedure Table of Content was reviewed. All policies that referenced controlled substances were requested and reviewed. None were found to address the security of the IV bag and the use of port-less tubing during the continuous infusion IV administration of scheduled drugs.

Based on review of documents and interview, the facility failed to ensure:

A. that safe and complete orders for titrating Intravenous (IV) medications (increasing or decreasing the amount of medication given to the patient based on the patient's response to the medication) were established and followed. This deficient practice required nurses to use their own judgement when decreasing medication due to patient response or reducing the medication for the purpose of discontinuing it. This type of judgement required the medical decision-making of a physician and was beyond the scope of practice for nursing.

B. a pharmacy process was developed for monitoring the nursing changes made in titrated medications to ensure medications were being delivered to the patient safely as ordered by the physician and were accurately recording the medication administration in 2 out 2 patient charts reviewed (Patient #57 and Patient #58).

Findings included:

On the morning of 9-4-2019, a tour of the Intensive Care Unit (ICU) was made. Nursing interviews were conducted with Staff #108, Staff #109, and Staff #131 concerning titration of medications. Patient #57 was receiving a medication, norepinephrine bitartrate, that was being titrated to support his blood pressure (BP). The order #5921952 was as follows:

"Titration Detail: Titrate for A line BP Mean MAP 65-75 (an average pressure calculated through monitoring line in an artery)
Begin Infusion at 10 mcg/minute (micrograms per minute)
Increase by 2.5 mcg/minute every 3 min for A line BP mean maintained MAP between 65-75 to a maximum of 70 mcg/min.

Notify Physician if: Monitor Blood Pressure, Fluid Status, IV vein infiltration, - use large vein or central line for infusion minimum rate of 0.5 mcg/min"

While the order gave instructions for increasing the medication, it did not give instructions for decreasing or stopping the medication.

The titration record on the electronic Medication Administration Record (eMAR) detailed report showed that nursing staff initiated the medication at 30 mcg/min for A Line BP mean = 92 on 8-23-2019 at 14:15 (2:15 pm).

The next adjustment documentation showed it was decreased from 30mcg/min to 8mcg/min for a mean = 97 on 8-24-2019 at 07:00 (7:00 am). This was a decrease of 22mcg/min rather that the 2.5 mcg/min every 3 minutes that had been ordered.

The next adjustment documentation showed it was decreased from 8 mcg/min to 4 mcg/min for a mean = 86 on 8-25-2019 at 20:02 (8:02 pm)

Of the 15 documented adjustments for titration between 8-23-2019 and 9-3-2019, none followed the parameters set by the order for initiation, increase rate, or BP mean. No orders were found for rates of decrease of medication or parameters for stopping the medication. The medication was stopped on 8-28-2019 at 07:02 (7:02 am) for a mean of 75. However, the order was to keep the mean between 65-75.

The next titration showed the medication to be at 5.5 mcg/min for mean = 86. This mean was above the range ordered and the rate it was started at was less than the rate ordered to initiate the medication.

No nursing documentation was found to explain why nursing was not documenting the titrations adjustments within the parameters set by the physician orders or why nursing was stopping and re-initiating the orders outside the parameters set by the physician orders.



Patient #58 titration orders for Fentanyl, a powerful drug used for pain relief, were reviewed. The order referenced three different pain scales based on the patient's level of consciousness and ability to report pain. The scales that were referenced were the FLACC (faces, legs, activity, crying, and consolability), the BPS (behavioral pain scale rates facial expression, facial expression, and compliance with mechanical ventilation), and NPS (numeric pain scale allows the patient to rate their pain on a scale of 1 to 10). The order written on 8-18-2019 at 10:03 am was as follows:

"Titration Detail: Titrate for Fentanyl FLACC Scale 0-2 or BSP (sic) <5 or NPS 0-2
Begin infusion at 25 mcg/hour
Increase by 12.5 mcg /hour every 60 min for Fentanyl Uncontrolled Pain to a Maximum of 400 mcg/hour

Notify Physician if: Monitor for Pain Relief, BP, HR, Cont EKG Pulse Ox, ENT-Tidal CO2 - Communicative Pt use NPS for target 0-2 - Noncommunicative Pt use FLACC Scale Target 0-2 or BPS
The bags of Fentanyl contained medication in a concentration of 12.5 mcg in 1 milliliter (ml) of fluid. That meant that the Fentanyl could be increased by 1 ml every hour with a beginning infusion rate of 2 ml per hour.

No PCA flow sheet for 8-18-2019 was provided by the facility. The first record provided showed that a bag was emptied (wasted) and a replacement bag started on 8-19-2019 at 13:46 (1:46 pm) at a continuous rate of 22.5 ml per hours (22.5 ml x 12.5 mcg = 281.25 mcg per hour). This meant at some point between initiation and the first documented rate received, the titration rate had been adjusted by 6.25 mcg when the order was to increase by 12.5 mcg.

The next documented rate change was on 8-19-2019 at 23:12 (11:12 pm) when the rate was again increased by 6.25 mcg to 23 ml per hour instead of the ordered rate change 12.5 mcg.

The next documented rate change was on 8-20-2019 at 21:15 (9:15 pm) when the rate was decreased by 6.25 mcg to a rate of 22.5 ml per hour. The physician's titration orders did not specify the rate that the Fentanyl could be decreased. No order clarification or new order to decrease the rate was found; indicating that nursing staff made the decision to decrease the rate using their own judgement.

The next documented rate change was on 8-22-2019 at 09:36 am. The rate was increased by 25 mcg instead of the ordered 12.5 to a rate of 24.5 ml per hour.

The next documented rate change was on 8-23-2019 at 11:13 am for ordered amount of 12.5 mcg to a rate of 25.5 ml per hour.

The next documented rate change was on 8-23-2019 at 21:00 (9:00 pm) to a rate of 10 ml per hour, a decrease in rate of 15.5 ml per hour. No order for decreasing the rate was found.

The next documented rate change was on 8-24-2019 at 17:16 (5:16 pm). The rate was increased from 10 ml per hour to 13.8 ml per hour. This was an increase of 47.5 mcg instead of the ordered 12.5 mcg. No new order was found to increase the rate by that amount.

The next documented rate change was on 8-25-2019 when it was decreased back to 10 ml per hour.

Between 8-25-2019 and 8-30-2019, nursing staff did not document the continuous rate of infusion the pump was set at. This meant that there was no way for pharmacy to verify rate changes for medication safety or accurately reconcile the amount that should have been administered within the time frame versus what the pump was set at and what was actually given during the time frame between hanging a new bag of medication and the medication running out. This did not allow for the verification of appropriate rate changes that were within the parameters of the physician orders.

On 8-30-2019 at 23:36 (11:36 pm) the nurse documented the rate at 10 ml per hour.

Many of the PCA flow sheets documented by nursing, nursing staff showed the Fentanyl concentrations to be 10 mcg per 1 ml of fluid when the pharmacy record for the order showed the concentration to be 12.5 mcg per ml of fluid. The concentration of 10 mcg per 1 ml of fluid would make it difficult and confusing for nursing to adjust the rate as ordered, 12.5 mcg per hour. In a concentration of 12.5 mcg per ml, nursing simply had to increase the rate by 1 ml per hour to titrate per physician orders.
Staff #108 and Staff #109 were asked if they could find any documentation as to why the nurses had made adjustments outside of the ordered parameters for titration. Neither staff member could find such documentation.

Interview was conducted with Staff #56 concerning incomplete titration orders and nursing staff not following the titration orders or documenting the titration orders. Staff #56 stated he was aware of the need to revise the titration order sets but had been having difficulty coordinating the changes with the medical staff. Staff #56 did not provide any evidence of order sets being under revision or of a monitoring process to ensure that medications were being titrated and appropriately documented for patient safety.

Based on observation and interview, the facility failed to follow its own policy regarding storage of CT (cat scan) contrast and other contrast media. Contrast materials were left unlocked and accessible to patients and staff in the CT and radiology rooms. Also, keys to a locked cabinet where contrast was stored were in an unsecured drawer beneath the locked cabinet. Furthermore, a drawer in ultrasound room 1 where medications were kept had a broken lock.


This deficient practice had the likelihood to put all patients at risk for harm due to the accessibility of the contrast.

Findings included:

On a tour of the Radiology department on 9/05/2019 at 9:30 AM the following observations were noted:

CT Room #2

2 cases of Isovue contrast media were in an unlocked metal cabinet.
1 bottle of Cysto-Conray II contrast was also in the unlocked metal cabinet.

Radiology Room #1

6 bottles of Gastrogafin contrast media and 1 bottle of Barium Sulfate suspension were found in an unlocked cabinet.
6 bottles of Gastrogafin contrast media and 1 bottle of Barium Sulfate suspension were found in an unlocked refrigerator that had not had an electrical inspection since 8/27/2014.

Radiology Room #4

12 bottles of Gastrogafin contrast media and 2 bottles of Barium Sulfate suspension were found in an unlocked cabinet.


The facility policy titled, "Contrast Media Injection/Reaction" states:

"Contrast material is stored in a secured closet within the radiology department. Requests for
contrast replacement is made to the pharmacy who orders the contrast material and restocks
the supply closet."

CT Room #1

Upon observation in CT room #1 the cabinet which contained contrast media was locked and when the surveyor asked the CT technician to open the cabinet she opened the drawer beneath the locked cabinet which contained the keys to the locked cabinet and said, "this is where we always keep them".

Ultrasound Room #1

The drawer in ultrasound room #1 which contained medications had a broken lock and the security of the medications could not be guaranteed to prevent other staff or patients from tampering with the medications.


Staff #74 observed and confirmed the above findings on 9/05/2019.

Based on observation and interview, the facility failed to have a policy and procedure for the cleaning and disinfection of lead aprons being used during radiological procedures.

This deficient practice had the liklihood to expose patients and staff to harmful bacteria by not having policy and procedure in place to clean and disinfect lead aprons.


Findings include:

During a tour of the radiology department on 9/05/2019 at 10:00AM , Staff #77 was asked by the surveyor, "How do you clean the lead aprons in the Radiology Department?". Staff #77 stated," I just wipe them with Sani Wipes". Staff #79 contacted the hospital's vendor for the lead aprons, which is AADCO Medical Inc., and requested information on what was recommended to clean the aprons. AADCO Medical sent written information to the facility which stated:

AADCO Medical Inc. Care and Use information as labeled in all x-ray protective wear.

"Cleaning -never immerse in any fluids. Clean with soap and water, disinfect with isopropyl alcohol."

In an interview in the afternoon on 9/5/19, Staff #74 and Staff #77 confirmed the facility had no policy or procedure on cleaning and disinfecting lead aprons.

Based on review of documents and interview, the facility failed to ensure that there was a functioning Utilization Review Program and the Utilization Review (UR) Plan was current and being followed.


Findings included:

On 9-3-2019 a Policy Titles: Case Management Utilization Management Plan Template was provided for review. Review of the document showed that the template had not been completed and lacked the following elements:
Audience:
Policy Approvals:
Original Effective Date:
Acceptance and Approval signatures of the UR Committee Chairman, Quality Improvement Council Chairman, Medical Executive Committee Chairman, Chief Executive Office, and Board of Trustees Chairman.

The element for Reviews/Revisions had a Revised column with the "Date:" of 2/20/2018 but no information in the block for who it was revised "By:".

Staff #115 was advised that the plan provided was incomplete and dated for 2018. Staff #115 was asked for the currently approved plan that was in effect and was currently being used. Staff #115 provided the Policy Title: Case Management- 2016 Utilization Management Plan Policy. This plan also lacked the Acceptance and Approval signatures. The element for Reviews/Revisions had a Revised column with the "Date:" of 2/17/2016 but no information in the block for who it was revised "By:". Staff #115 confirmed that it was the most current plan and was in effect.

Review of section II. Authority was as follows:
"The Board of Trustees (Directors) has the ultimate responsibility for review of the quality, appropriateness, and medical necessity of admissions, continued stays, and support services. It delegates specific functions to the Medical Staff to develop and implement a comprehensive Utilization Manage Plan. Acknowledgement of this responsibility is verified by the Medical Staff's and Board of Trustees' (Directors') approval of the Plan. The Utilization Management Plan is under the Direction of the Utilization Management Committee. The Committee will review the Plan annually for its scope and objectives."

Review of section IV. Definitions was as follows:
"Physician Advisor:
A physician member of the Medical Staff and Utilization Management Committee who is assigned responsibility for performing certain review functions as described in this Utilization Management Plan. Such physician must have interest and awareness about the utilization management process.

Each Physician Advisor will be responsible for review of cases referred the case manager/reviewer, making appropriate determination regarding the patient's need for medically necessary hospital services, and contacting the attending physician if a negative determination is considered. In addition, Physician Advisors shall serve as liaison between the Utilization Management Committee and the Medical Staff. In the event a Physician Advisor is unable to review a case referred by the case manager/reviewer due to conflict of interest or for other reasons, the Chairperson must assign an alternate Physician Advisor."

Review of section V. Utilization Review Committee was as follows:
"A. Organization:
The Committee will be composed of two (2) or more physicians of the Active Staff, at least two (2) of which must be doctors of medicine or osteopathy. The remaining members will represent the admitting services of the medical staff, and assisted by other professional personnel. The Physician Advisor will be a member of the Committee. All medical staff committee members shall be appointed by the Chief of Staff. Appointment shall be for a period of time no greater than two years.

No less than four non-physician members, appointed by Administration, will serve on the Committee. Representatives may include Nursing Services, Medical Records, Case Management, Patient Accounts, Quality Improvement, and Administration.

Upon invitation from the Chairman, other representatives of the hospital or medical staff may attend meetings. The Chairman and other designated medical staff members of the Committee shall serve as Physician Advisor if there is not an appointed advisor, available. (sic)

...

C. Meetings
The Committee shall meet, at a minimum, quarterly. More frequent meetings shall be held, when needed, to complete agenda business in a timely manner. The attendance of two physicians or 50% of the Committee, whichever is greater, shall constitute a quorum.

D. Committee Reports and Records
The Committee shall maintain the minutes and records of each Committee meeting and will the actions taken regarding the admission or continued stay of any patient reviewed, and the reasons for such actions. The Committee will report on identified trends associated with over-utilization, under-utilization, and inefficient scheduling of its resources. Copies of such reports and records shall be made available to the Committee members, the Hospital CEO, and the Medical Executive Committee. The Utilization Review Committee shall make a summary report to the Quality Improvement Council, Medical Executive Committee, and Governing Board quarterly.

The Director of Case Management shall be responsible for maintaining individual and aggregate data with respect to the reviews of acute care patients. He/she shall be responsible for distribution of the reports to the appropriate individuals. The Utilization Review process is conducted as part of the Quality Improvement/Quality Assurance program of the Medical Staff and Hospital. The Case Management Department will maintain copies of all worksheets, and other data. All utilization review findings shall be considered confidential."

An interview was conducted with Staff #112 on the morning of 9-4-2019. Staff #112 stated that the Case Management Department had been operating under an Interim Director for a while and was currently without a director. Staff #112 advised that she was not functioning as the Interim Director, but was considered the lead Case Manager since she had been in the department the longest. Staff #112 stated she had been told there was a Utilization Review Committee but none of the Case Managers were members of the Committee or were ever invited to attend UR Committee meetings. Staff #112 was not able to say who the UR Committee members were. Staff #112 stated the only physician she was aware of that was involved with UR was physician Staff #120 who was the Physician Advisor. Staff #112 stated that when the previous Physician Advisor left the position, she had been tasked to recruit physician Staff #120 who agreed to fulfill the role as Physician Advisor. Staff #112 was not aware of anyone else who was acting as Physician Advisor. This was contrary to what the 2016 UR Plan required; that all medical staff appointed to the committee shall be appointed by the Chief of Staff for a time period of no more than two years, including the Physician Advisor.

Staff #115 was asked to provide a list of members of the UR Committee and UR Committee meeting minutes. Staff #115 stated that the previous Interim Director of Case Management stated that they did have committee meetings, however, no minutes were kept of those meetings.

On the morning of 9-9-2019, follow-up interviews were conducted with Case Management, the Chief Financial Officer (CFO) and Quality after no evidence of a UR Committee or organized UR program was provided.

Staff #112 stated the Medical Quality Resource Committee (MQRC) was where Utilization Review was discussed. A sign-in sheet and agenda for the August 15, 2019 meeting was provided. Attached were the meeting minutes for the MQRC meeting of May 16, 2019. In May, Case Management presented data on the 30-day readmission rate with no committee discussion. The agenda for the August 15, 2019 meeting showed that Item 3.8 Utilization Case Management Review Q2 2019 was scheduled to present the 30-day readmission rate again.

During interview with the CFO, the CFO stated that the Hospitalist meeting was where UR issues were discussed and the Peer Review was where they looked at Medical Necessity. A sign-in sheet for the Hospitalist Meeting on June 12, 2019 was provided with an Agenda, along with 4 separate sheets of data that was presented at the meeting. No meeting minutes were provided. The agenda included the following topics:

Length of Stay
Medicare Top DRGs (DRGs - Diagnostic Related Groups are codes that are assigned to diagnosis and linked with a Medicare payment for that diagnosis)
Discharge Dispositions
__________ (Staff #112s name listed as an agenda item)
Director of Case Management search
Medicare/Medicaid Time Studies 6/3/2019 through 6/9/2019, and 6/20/2019 through 6/16/2019
Open Discussion

The attached data that was to be presented at the Hospitalist meeting included a graph showing the Length of Stay (LOS) for the hospitalist group as compared to non-hospitalists for the years of 2017 and 2018, along with 2019 broken down by month; a table of the LOS broken down by individual physicians in the Hospitalist group by month for 2019; a breakdown of the Medicare Top DRGs LOS by Volume for 2018 and 2019; a breakdown of the LOS by DRG for the individual physicians in the Hospitalist group; and a breakdown of patient discharge dispositions (where patients discharged from the hospital to) by location for each individual physician in the Hospitalist group.

Staff #115 was interviewed later in the afternoon when she asked if there were any more questions concerning discharge planning and UR. Staff #115 asserted that the MQRC and Hospitalist group were functioning as the Utilization Review Committee.

Review of documentation provided showed that, while information presented at the MQRC and Hospitalist Meetings fell into the category of Utilization Review, these groups did not fulfill the purpose and duties of a functioning Utilization Review Committee and no authority statement was ever alleged or provided that designated those groups as taking on the role and responsibilities of the UR Committee or how those groups would fulfill the requirements of the UR Committee as outlined in the UR plan. The UR plan in operation was over 3 years old with no evidence of a committee reviewing, revising, or approving an annual plan since 2016. No evidence of a functional UR program or current plan was found.

Based on observation, interview and record review, the facility failed to ensure that routine and preventative maintenance (PM) and testing of the electrical safety checks were performed in a manner that ensured the safety and well-being of patients.

The facility failed to:

A. ensure that PM (Preventative Maintenance) checks were performed prior to the expiration date for 7 of 7 pieces equipment reviewed.

B. ensure that three pacemaker Interrogation generator machines had electrical safety checks prior to using the equipment in patient pacemaker procedures.

C. ensure a Bronchoscopy Covidien Navigator machine was calibrated prior to use on 36 patients.

D. ensure there was an emergency pull cord in the patient bathroom located in the main radiology hallway behind the main desk.


This deficient practice had the likelihood to cause harm in all patients.


ASC

During a tour of the ASC on September 4, 2019 after 9:00 a.m., the following observations were made:

There was an Abbott PHACO machine (Used in cataract surgeries) that had a PM sticker which showed next PM due 3/2019; over 6 months ago. On 9-4-19, the machine was used on a patient for a cataract surgery. The facility provided a company inspection later; however, there was no way for the staff to determine the machine was safe for the patient at the time of use.

There was an Arthrocare Quantum machine used in arthroscopic orthopedic cases. The PM showed next PM due on 12/2018; over 9 months ago. Staff #42 stated the machine was no longer in use. The machine was stored in an equipment room and ready for patient use.

CATH LAB

During a tour on September 5, 2019 after 8:30 a.m., the following observations were made:

There were three pacemaker Interrogation generators stored in the Cath Lab sterile storage room. There was no sticker or label from the Biomedical department to show the machines had an electrical safety check when brought into the facility.

An interview with Staff #47 on September 4, 2019 after 9:00 a.m. revealed the following:

Staff #47 was asked how long the pacemaker Interrogation generators had been in the facility. Staff #47 stated, "I really don't know the exact time, but as long as I can remember they have been here." Review of pacemaker log for August 2019 revealed there had been 69 patient pacemaker procedures performed with the generators.

Staff #47 confirmed the findings on the pacemaker generators.


29191


C-SECTION ROOM

During a tour of the C-section room #1 on 09/03/2019 at 2:34 PM observed a Valley lab Bovie that needed preventive maintenance and was due 04/2019.

LABOR & DELIVERY

On the same tour in a clean utility room of the Labor and Delivery at 2:47 PM observed that the preventive maintenance was due 01/2019 for a Data scope monitor.

Staff #13 confirmed the above findings.

OPERATING ROOM 8

During a tour of the operating room on 09/05/2019 at 11:13 AM observed a Luxtec headlight that had preventive maintenance that was due 03/2019.

SAME DAY SURGERY

A tour of the "Same Day Surgery Unit" on 09/05/2019 at 2:07 PM observed two (2) transport monitors that had preventive maintenance that was due 05/2019.

BRONCHOSCOPY ROOM

A tour of the Bronchoscopy room on 09/06/2019 at 2:02 PM revealed the "Covidien superDimension Navigation system" had preventive maintenance that was due March 2016. The Navigation System with Fluoroscopic Navigation Technology, Pulmonary and Biopsy Tools, Navigation Catheters assist with airway pathways to the nodal in the lungs for biopsy during Bronchoscopy procedures. The facility had used the machine on 36 patients, before the sales representative from the company informed the facility the machine needed to be calibrated. At this time, the facility had stopped using the machine about one month ago per Staff #89. The Respiratory Director #89 has been sending emails to the upper management since January 3, 2019 trying to get a preventive maintenance agreement signed, so the facility can use the navigation system.


40990


RADIOLOGY

During observation of the Radiology Department on 9/05/2019 at 10:30 AM surveyor noted the patient bathroom located in the main radiology hallway behind the main desk area did not have an emergency pull cord.

This deficient practice had the likelihood to put all patients at risk for serious harm due to not having access to an emergency pull cord in the event of an emergency.

An interview with Staff #74 on 9/05/2019 at 10:30 AM confirmed the above findings.


40989


An interview was conducted on 9/6/2019 after 10:30 AM with Staff #90. Staff #90 was asked who ensured all Preventive Maintenance (PM) was completed and up to date. Staff #90 replied, "We do most of the PM's except for those that are serviced by outside vendors. We have a schedule set for each department. Some departments are scheduled more than annually, it just depends on the equipment." Staff #90 was asked if the Bio Medical Department was also responsible for the electrical safety checks on all equipment. Staff #90 said, "Yes we do all electrical safety inspections (ESI) on all equipment unless it is battery powered only. We also perform ESI's on any equipment brought in from outside prior to use even if it is not our inventory. Sometimes the equipment that does not require a PM is removed from our list of equipment to perform PM's on by the corporate office. This is the same list we use for ESI's. When this happens, it doesn't show up on our inventory sheet to PM and therefore it doesn't get an ESI performed on it either. That's because out of all the equipment that is on the list, we don't know if one piece of equipment has been removed and corporate never tells us if something is removed."

Based on observation, record review, and interview the facility failed to:

A. ensure a sanitary environment in 34 of 34 area's ( Central Supply/ Warehouse, Surgical floor patient care area, Emergency Room, NICU supply room, L&D Nursery, L&D C- Section Room, L&D sterile instrument storage area, Post-partum patient room 349, ASC OR3, ASC OR4, ASC Equipment storage room, ASC sterile storage room, ASC GI room 3, Cath Lab 1, Cath Lab 3, Cath Lab housekeeping room, Cath Lab sterile storage room, Cove in hallway outside Autoclave 8, Sterile Processing Instrument Storage room, Main OR Room 3,4,9,10, &16, L&D Room 311, Main hallway store room post-partum floor, Bronchoscopy room, Cath Lab Pre-Post storage area, Radiology, Nuclear Medicine Departments, Laboratory,The Breast Center, The Wound Center, Second Floor Patient Care Area, Third Floor Patient Care Area, and Dietary.)


B. Ensure patient medical supplies were being stored in a clean, monitored temperature and humidity-controlled storage area in Central Supply warehouse; ensure sterile supplies and sterile instruments that were readily available for patient use was protected from extreme temperature and humidity and sterile supplies and instruments were not contaminated at The Center for Wound Healing and Hyperbaric Medicine.

C. ensure staff removed Personal Protective Equipment (PPE) prior to leaving rooms of patients who were on isolation precaution. Failed to ensure equipment and supplies that were used in rooms of patients on isolation precaution was properly sanitized or discarded before removing it from the room. Failed to ensure housekeeping staff that were cleaning rooms for patients on isolation precautions were properly trained on what PPE they needed to use and what precautions to take.

D. ensure education was provided to patients, visitors, caregivers, and staff, as appropriate, about infections and communicable diseases and methods to reduce transmission in the hospital and in the community.

E. ensure infection control officer maintained and monitored pest control.


The condition and deficient practices were identified under the following Conditions of Participation and were determined to pose Immediate Jeopardy to patient health and safety and placed all patients at risk for the likelihood of harm, serious injury, and possibly subsequent death.

F. ensure the Emergency Room had sterile packets appropriately covered and ensure all patient were offered clean medical supplies and equipment.

G. ensure a surgical instrument set was sterilized according to ANSI (American National Standards Institute)/ AAMI (The Association for Advancement of Medical Instrumentation) sterilization standards.

H. ensure the I-Stat machine cartridges (portable clinical analyzer is a point of care analyzer to be used at the patient's bedside to measure critical care tests such as blood gases, electrolytes, metabolites and coagulation) were stored at temperatures recommended by the manufacturer.

I. ensure the temperature in the Operating room (OR) was within acceptable standards to inhibit microbial growth, reduce the risk of infection, promote patient comfort and assure the physical safety of all patients. The temperature and Humidity was out of range for the months of August and September 2019. There was no documentation on the log to indicate corrective action taken and the temperature on follow up after corrective action was done. The facility failed to follow their own policy.

J. ensure an infection control program that evaluated service areas and maintain a sanitary environment in temporary dietary kitchen, second and third floors of the nursing services units.


Refer to A tag 0749 for additional information.

Based on observation, record review, and interview the facility failed to:

A. ensure a sanitary environment in 34 of 34 area's ( Central Supply/ Warehouse, Surgical floor patient care area, Emergency Room, NICU supply room, L&D Nursery, L&D C- Section Room, L&D sterile instrument storage area, Post-partum patient room 349, ASC OR3, ASC OR4, ASC Equipment storage room, ASC sterile storage room, ASC GI room 3, Cath Lab 1, Cath Lab 3, Cath Lab housekeeping room, Cath Lab sterile storage room, Cove in hallway outside Autoclave 8, Sterile Processing Instrument Storage room, Main OR Room 3,4,9,10, &16, L&D Room 311, Main hallway store room post-partum floor, Bronchoscopy room, Cath Lab Pre-Post storage area, Radiology, Nuclear Medicine Departments, Laboratory,The Breast Center, The Wound Center, Second Floor Patient Care Area, Third Floor Patient Care Area, and Dietary.)


B. ensure patient medical supplies were being stored in a clean, monitored temperature and humidity-controlled storage area in Central Supply warehouse. ensure sterile supplies and sterile instruments that were readily available for patient use was protected from extreme temperature and humidity and sterile supplies and instruments were not contaminated at The Center for Wound Healing and Hyperbaric Medicine.

C. ensure staff removed Personal Protective Equipment (PPE) prior to leaving rooms of patients who were on isolation precaution. Failed to ensure equipment and supplies that were used in rooms of patients on isolation precaution was properly sanitized or discarded before removing it from the room. Failed to ensure housekeeping staff that were cleaning rooms for patients on isolation precautions were properly trained on what PPE they needed to use and what precautions to take.

D. failed to ensure education was provided to patients, visitors, caregivers, and staff, as appropriate, about infections and communicable diseases and methods to reduce transmission in the hospital and in the community.

E. ensure infection control officer maintained and monitored pest control.

These deficient practices were determined to pose Immediate Jeopardy to patient health and safety and placed all patients at risk for the likelihood of harm, serious injury, and possibly subsequent death.

F. ensure the Emergency Room had sterile packets appropriately covered and ensure all patient were offered clean medical supplies and equipment.

G. ensure a surgical instrument set was sterilized according to ANSI (American National Standards Institute)/ AAMI (The Association for Advancement of Medical Instrumentation) sterilization standards.

H. ensure the I-Stat machine cartridges (portable clinical analyzer is a point of care analyzer to be used at the patient's bedside to measure critical care tests such as blood gases, electrolytes, metabolites and coagulation) were stored at temperatures recommended by the manufacturer.

I. ensure the temperature in the Operating room (OR) was within acceptable standards to inhibit microbial growth, reduce the risk of infection, promote patient comfort and assure the physical safety of all patients. The temperature and Humidity was out of range for the months of August and September 2019. There was no documentation on the log to indicate corrective action taken and the temperature on follow up after corrective action was done. The facility failed to follow their own policy.

J. ensure an infection control program that evaluated services areas and maintain a sanitary environment in temporary dietary kitchen, second and third floors of the nursing services units.




Findings include:

Warehouse/ Central Supply
A tour was conducted of the facility's warehouse/central supply area with Staff #48 and #132 on 9/4/19 at 9:00 AM. The warehouse had multiple loading and unloading areas. The warehouse was entered from a door that was unlocked. On one wall of the warehouse there was two garage doors that were currently closed. There were two other large garage doors opened on the other side. The following observations were found:
The concrete floors were heavily soiled with clumps of red dirt, dust, paper trash and insects. The floors had large cracks and holes where pieces of concrete was missing, preventing them from being sanitized properly.
Open plastic tubs of patient medical supplies were sitting on dollies ready to be transported to the hospital uncovered. There was no dirty to clean areas marked out in the warehouse. Trash cans with trash were sitting next to open medical supply containers.

An interview with Staff #132 was conducted on the morning of 9/4/19. Staff #132 reported that there was no dirty, to clean, to patient areas in the warehouse. Staff #132 stated the open bins with unboxed medical supplies were waiting to be taken to the hospital on the truck. Staff #132 confirmed the supplies were not covered before going onto the truck.

Patient medical supplies were found uncovered, sitting next to shipping boxes, wooden pallets, with heavy dust and dirt around the supplies.

Sterile surgical supplies were found unboxed and sitting on heavily dusty shelves next to non- sterile supplies. The supplies were covered in a fine dust.

Packets of unboxed surgical lighting covers sitting with non-sterile products, in an open bin, on a shelf, next to the dirty and soiled floor.

Multiple types of opened and exposed patient supplies were sitting on dusty and dirty shelves.

Bags of sterile water for inhalation were found sitting on a dusty shelf in an uncovered plastic box. The bags were dusty, and a dead bug was in the box.

Unboxed medical supplies found sitting on bare wood shelves covered in dust. The shelves were porous and unable to be properly cleaned.

20 boxes of Lactated Ringers (IV Medication) were found in the warehouse sitting on a dirty pallet on a soiled floor. Some of the shipping boxes were open and the bags were exposed to dust and dirt. The warehouse had no logs of temperature or humidity control.

10 plastic tubs of normal saline syringes were found sitting on the soiled and dirty floor of the warehouse. One of the boxes had a top missing and the syringes were exposed to the dirt, dust, and bugs in the warehouse.

4 blue plastic tubs were found full of Normal Saline 1000 ml bags, used as an IV medication. The tubs had no tops and were sitting on the floor of the warehouse.

Unboxed patient medical supplies were found in blue plastic trays sitting on wooden shelves. The containers were soiled with dust, hair, and insects.

Open yellow plastic containers were found holding patient medical supplies. A container of plain packing strip bottles was found in heavily dusty and soiled trays. The surveyor was able to write her initial in the dust next to dead insects.
Cleaning supplies, paper supplies, patient diapers, and wound care dressings were all shelved together along with patient record information.

Along the walls of the warehouse, bare insulation was observed. Patient medical supplies were unboxed sitting next to the insulation. Insulation was found on top of supplies and in supply boxes. Multiple dead bugs were found lying around the walls and beams where patient medical supplies were stored.

An interview with Staff #132 was conducted on the morning of 9/4/19. Staff #132 reported that the warehouse was airconditioned. The doors to the warehouse could be open for long lengths of time. The warehouse stored medications and surgical supplies that were required to be in temperature and humidity-controlled areas. Staff #132 confirmed there had been no tracking of temperatures or humidity within the central supply area.

Failure to provide a clean, monitored, temperature, humidity-controlled storage, transportation for patient medical supplies and medications, places the patient at serious risk for the likelihood of harm, serious injury, and possibly subsequently death.


A tour was conducted of the surgical Floor and Emergency department on 9/3/19 with Staff # 72. The following conditions were found:

Surgical Floor Patient Room 149
A shower chair was found rusted underneath and on the bottom of the legs.
A wooden arm chair was worn on the legs and handles. Bare wood was exposed.
The window blinds had significant dust and the top of the cabinet was dusty.
Multiple holes were found in the fitted bottom sheet.

Nourishment Room Surgical Floor #1
The refrigerator was soiled with spilled dry liquids and dried food particles.
The ice machine had a tag of "cleaned on 12-17." There was no further documentation of when the ice machine was last cleaned. The ice machine was soiled in the water spout. Filter on side of ice machine was heavily soiled with dust and dirt.

Nourishment Room Surgical Floor #2

The freezer area of the refrigerator was soiled with dust and hair.
The ice chest used to fill patient water pitchers was found to be soiled with brown stains.
The plastic rolling cart holding the ice chest was soiled with dust and dried spilled liquids.
Behind the refrigerator the floor was heavily soiled with dust and trash.

Surgical Floor Medication Room
Medication refrigerator sitting on the floor. The refrigerator was a small unit. The unit was soiled with dust and hair on the inside.
The window seal and blinds were soiled with dust.
The ceiling vent above the medication preparation area was soiled with dust and debris.

Emergency Room
In the public bathroom a cabinet was found holding specimen cups, urine hats, and patient medical supplies.
An interview was conducted on 9/3/19 with Staff #65. Staff #65 was asked why the patient medical supplies were being stored in a public bathroom unsecured. Staff #65 stated that the room in the ED is very limited and they were keeping the supplies in there. Staff #65 confirmed that he could not ensure the supplies had not been tampered with or contaminated.

Emergency Room Trauma Room #2
Two sterile packs (cast spreader and a straight cutter) were found in a cabinet with no plastic covering the pack.
Inside a cabinet, clean laundry was mixed with toilet paper and emesis buckets.

Emergency Room Clean Equipment Room
A broken commode chair was found with missing rubber on the bottom of the legs.

Emergency Biohazard Room
Patient food trays were found sitting on a shelf above the biohazard trash. The trays were being sent back into the kitchen after sitting in the biohazard room.

Second Floor Patient Room 231
Observation of room 231 revealed there was PPE box hanging on the door. A sign was noted to be hanging sideways. The laminated sign was dark with blue and black background and very small print. The sign when looked at closely stated the patient was in isolation. There was no clear signage on the patients door to stop a visitor from going into the rooms before talking with the nurse. A small child and man was in the contact isolation room. The patients nurse was asked if the visitors had received any education before entering. The nurse reported that she was not aware anyone was in the room and she had not spoken to anyone. The nurse went into the room to discuss with the visitors on the use of PPE.

An interview was conducted with Staff #67 on 9/4/19. Staff #67 was asked if she had ever gone to the warehouse to see where the patient medical supplies were being stored as "central supply." Staff #67 stated that environmental rounds were being done monthly but was not aware that the patient medical supplies were at the warehouse. Staff #67 stated that she had never been over to that area and was not aware what was in the warehouse. Infection Control was not being monitored or observed at the central supply area or during the transportation of these supplies.

Review of Staff #67's infection control plan revealed it was not signed by anyone but her. Staff # 67 confirmed that she had not seen anything signed from Medical Executive or Governing Body that the infection plan was ever viewed or accepted. Staff #67 stated, " I do one each year but I do not think it goes any where." Staff #67 stated the only Performance Improvement she is involved in right now was hand hygiene.

Staff #67 reported that the facility uses the CDC guidelines in reportable's and infection control. Staff #67 reported that when she comes in everyday she can run a list of all the patients in isolation and what patients are taking antibiotics. Staff #67 stated that she looks at the patient charts to see if they are in isolation appropriately or if they need to call the physician to remove the patient from isolation. Staff #67 reported that she had not done any recent education of isolation with the staff and had not observed the nursing staff or housekeeping donning on and off of the PPE equipment.


41831

Isolation patients

Observation made on 09/03/19 at 3:30 p.m.
Patient in room 245 was on contact isolation. Staff # 24 was observed entering patient's room donning the appropriate personal protective equipment (ppe), gown and gloves. Staff # 24 was observed taking the patient's vital signs and using dedicated equipment. Staff # 24 was observed writing down something on a paper towel she pulled from the patient's room. Staff # 24, then doffed her ppe, placed the paper towel she wrote on in her pocket, and exited the room and used alcohol-based hand scrub upon exiting the room. Staff # 24 then entered the clean utility room. Staff # 24 was asked where the paper towel was she had placed in her pocket from the patient's room was, she reached into her pocket and pulled the paper towel out. Staff # 24 when asked stated she was not aware that she couldn't bring anything out of the room.


Observation made on 09/04/19 at 12:34 p.m.
Housekeeping staff # 35 was observed entering room 273 without the appropriate PPE. The patient in room 273 was on droplet isolation precautions, staff # 35 only had gloves on when entering or exiting the room. Staff # 35 mopped the floor, removed the used mopping pad and placed it in a bucket on her cart, placed the mop handle on her cart and removed her gloves. Staff # 35 was asked what the procedure was for entering an isolation patient's room, and staff # 35 stated she was told by a previous supervisor, that as long as she didn't touch the patient, she was not required to wear ppe.


Observation made on 09/04/19 at 1:15 p.m.
Respiratory Therapy staff # 38 and # 39 were observed entering room 273. The staff donned the appropriate ppe and left their work station on wheels outside of the patient's room. Staff # 39 was observed exiting the patient's room wearing their ppe and the mask was below their nose. Staff # 39 was observed getting something off the work station on wheels in the hallway in front of the room. A few minutes later staff # 38 was also observed exiting room 273 with ppe on and getting something off the workstation on wheels with gloved hands. Staff # 38 and Staff # 39 were interviewed regarding the procedure for entering an isolation patient's room, both stated, it depended on the isolation. Staff # 39 was asked for room 273, what was the procedure, staff # 39 stated you would wear, gloves, mask and gown since they were on droplet isolation. Staff # 38 was asked the procedure for exiting an isolation patient's room, she stated, you take it all off before exiting the room. Staff # 38 was asked what the procedure was if you needed something off a cart in the hallway, she stated, you are supposed to take all of the ppe off before exiting the room, "I just needed something and didn't think about it."


39801



IUSS (IMMEDIATE USE STERILIZATION)

Review of the facility document, "IUSS" for 8-23-2019 revealed the following:

The item listed was 3m Carpal Tunnel Set. The instrument was sterilized on an immediate use cycle of 4 minutes sterilization and 1-minute exhaust time. The reason listed for IUSS was listed as: "D. case load exceeds # of sets available."

During an interview on 9-5-2019 after 11:30 a.m., Staff #60 confirmed the instrument set was sterilized on a IUSS. Staff #60 was asked to clarify the reason for that sterilization. Staff #60 stated, "We only had two arthroscopic carpal tunnel sets and we had an add on case. There was not enough time to sterilize the set on a terminal sterilization cycle." Staff #60 said the number of arthroscopic carpal tunnel cases had increased and they did not have enough instruments. Staff #59 < stated, "We have ordered more sets, but they have not been approved."

Staff #59 & #60 confirmed the IUSS cycle completed on the surgical instrument set was not done for an emergency surgery, but for convenience.

Review of "ANSI/AAMI ST79:201 7 - Comprehensive guide to steam" revealed the following:

"2 Definitions and abbreviations
2.50 immediate-use steam sterilization (IUSS) Sterilization method that involves the shortest possible time between a sterilized item's removal from the sterilizer and its aseptic transfer to the sterile field. Immediacy implies that a sterilized item is used during the procedure for which it was sterilized and in a manner that minimizes its exposure to air and other environmental contaminants. A sterilized item intended for immediate use is not stored for future use nor held from one case to another. Immediacy, rather than being defined according to a specific time frame, is established through the critical analysis and expert collaboration of the health care team,

10 Sterilization
10.2 Sterilization parameters
10.2.3 immediate-use steam sterilization

Items processed by IUSS should be
a) decontaminated as specified in Section 7;
b) placed in a rigid sterilization container system that is intended for the cycle parameters to be used;
c) used immediately and not stored for later use or held from one procedure to another; and
ci) identified as IUSS.

Rationale: Rigid sterilization container systems protect the sterilized item from environmental contaminants during transfer from the sterilizer chamber to the point of use.

Immediate-use steam sterilization (IUSS) should not be used for purposes of convenience or as a substitute for sufficient instrumentation. Instrument inventories should be sufficient to meet anticipated surgical volume and to ensure that there is enough time to complete all critical elements of reprocessing.

Immediate-use steam sterilization should be kept to a minimum and should be used only in urgent clinical situations."


I STAT CARTRIDGES

During a tour on September 4, 2019 after 2:00 p.m. the following observations were made:

Two I-Stat cartridge boxes were stored on a cabinet in the manufacturer box at room temperature. The thermostat on the wall was set at 55. Staff #47 was asked if the department stored the I-stat cartridges on the cabinet routinely. Staff #47 stated they did. Staff #47 confirmed the department set the thermostat on 55 daily.

Review of the manufacturer package for Abbott Point of Care I-Stat ACT cartridges revealed the following:

"Room temperature storage 64 degrees Fahrenheit to 86 degrees Fahrenheit. Cartridges can be stored for 14 days at room temperature."

Staff #47 confirmed the department was not storing the cartridges at the manufacturer guidelines for storage a room temperature.


SANITARY ENVIRONMENT

During a tour on September 3, 2019 after 11:00 a.m. the following observations were made:


NICU SUPPLY ROOM

There was a mixture of sterile (sponges, feeding tubes, suction tubes) with non-sterile supplies (batteries, Disinfectant cleaning wipes, warming pads for infants). There were cleaning supplies stored above sterile supplies. There were warming pads used to warm infants post-delivery were hanging off the shelf and touching floor. The base of the metal cart storing sterile supplies was coated in rust, dust, dirt, and debris. The bins storing patient supplies were coated in dust, dirt, and debris.

At the back of the room where sterile supplies were stored there were bins containing donated supplies; i.e., books, and clothes. There was no way to determine if the donated items had been cleaned. They were stored in the same room as sterile supplies.

In the NICU storage room there were several plastic bins of infant linen stored on a wire rack. Observed that the plastic bins had linen hanging out of the bins touching the floor and touching the bottom shelf of the wire rack. When the surveyor pulled the wire rack away from the wall, there were several infant gowns lying on the dusty floor. The infant linen was not properly placed in the plastic bins with the lids closed. Several infant gowns were hanging out of the bins and lids not closed. There were non-clean items stored above the infant bins and the lid was open. This allowed the non-clean item to be drag across the top shelf allowing dust particles to be dropped into the clean infant bin. During the tour observed some infant clothing that was in open bins with no lids. These plastic bins on the bottom shelf had no type of coverage. This allowed debris that had been swept and splatters from mopping to contaminate clean linen.

There were numerous neonatal information paper packets, books that had been donated to the nursery, and office supplies mixed with the sterile and clean nursery supplies. Also, equipment for the nursery was being stored on the same shelf. During the tour, one nursery staff reported that one piece of equipment was clean. Surveyor observed the cord to that piece of equipment to be hanging down to the floor and coiled on the dirty floor.

The room was in disarray. There was equipment stored in the room with non-sterile and sterile supplies and patient linen.


L&D NURSERY

There was a wooden rocking chair that had scrapes and chips of wood missing. There was no way to properly sanitize the wooden rocking chair.

There was a mixture of sterile supplies (sponges, syringes, feeding tubes, saline syringes) stored with non-sterile supplies (Chux pad, suction canister, urine measurement container). There were corrugated cardboard boxes in an area with sterile supplies.

In the biohazard room there was a biohazard container that had an employee purse and jacket stored on top of the container.

The linen on the linen cart in the nursery was hanging out of the cart on the floor.

L&D Room 311

In Room 311 there was several areas of plaster missing off the walls in the labor room.

C-SECTION ROOM AREA

In the soiled sub sterile room observed blood on the wall above the bio-hazard trash can.

In the instrument room there were bins that contained peel packs (Sterilization packs) stacked up and packed tightly in the bins. The packages were stored in a manner that would allow crush, bend, and puncture of the package compromising the sterility of the item. One of the peel packs was dated 10/27/2017. Also, observed that the sterile instrument sets were tagged with missing instruments. Staff #13 was asked do you have a process/procedure for missing instruments from your instrument sets.
An interview with Staff #13 on 09/03/2019 at 2:15 PM stated, "We do not have a process for the missing instruments, but we did have a process few years ago, but we are not following that process anymore."

Review of ANSI/AAMI S179:2017 - Comprehensive guide to steam sterilization and sterility assurance in health care facilities revealed the following:

"11 Storage and transportation

11.1 Sterile storage
11.1.l Storage facilities

Sterile items should be stored under environmentally controlled conditions in a manner that reduces the potential for contamination.
Sterile storage areas should be kept clean and dry.
Sterile items should be
1) stored far enough away from the floor, the ceiling, and outside walls to allow for adequate air circulation, ease of cleaning, and compliance with local fire codes;
2) stored at least 8 to 10 inches above the floor, at least 18 inches below the ceiling or the level of the sprinkler heads, and at least 2 inches from outside walls;
3) stored in such a way that wrapped packages are not stored beneath rigid sterilization containers on the same shelf; and
4) positioned so that packaging is not crushed, bent, compressed, or punctured and so that their sterility is not otherwise compromised."

VITAL CARE is the company that manufactures the peel packs of which the hospital was using for sterilization and storage of sterile instruments.

Review of a Shelf life study for Vital Care Industries Shelf life study revealed the following:

"SUMMARY
One hundred packages containing surgical instruments were subjected to ethylene oxide and
steam sterilization and stored in standard room conditions. Packages were opened at intervals up
to and including 365 days of storage. All instruments were found to be sterile when tested after
opening".

An interview with Vital Care customer representative confirmed that Vital Care industries only validates sterility on sterilization packs after sterilization process is completed one to one year.

In a morning interview on 09/05/2019, Staff #60 reported that sterile peel packs were all re-sterilized every year.
During the tour of the C-section room #1, it was observed that the valley lab Bovie (used to cauterize and cut surgical tissue) had chips of missing paint and rust on the Bovie machine and caster wheels. The "Dornach" (a suction machine) had chips of missing paint. There was no way to properly disinfect the equipment. The handle was missing off the cabinet located in the C-section room #1. There was exposed raw particle board. There was no way to properly disinfect raw wood.

During the tour of the Labor & Delivery storage area for sterile and clean supplies on 09/03/2019 at 2:53 PM, it was observed that sterile supplies were being stored close to the floor. The storage was not arranged so that sterile supplies were on top and non-sterile supplies were on the bottom. Some of the plastic bins were over filled with supplies and falling to the floor. This allowed debris that had been swept and splatters from mopping to contaminate clean and sterile supplies.

On the main hallway to the post-partum area toured a storage room on 09/03/2019 at 3:05 PM. The linen on the linen cart was hanging out and exposed to the dirty floor. In the same room observed a wire rack storing lactation kits. The cart was dirty with dust particles, dirt particles, paper trash, and debris.


POST-PARTUM Room 349

In Room 349 there was a vinyl chair that had tears and cracks in the vinyl. There was no way to properly disinfect the chair. The wheel locks had a buildup of dust, dirt, and debris.

Staff #14 confirmed the above findings for NICU, L&D, and post-partum areas.


During a tour on September 4, 2019 after 9:00 a.m. the following observations were made:

AMBULATORY SURIGICAL CENTER

OR 4

There were Operating room beds and stretchers stored made with linen. There was no way to determine if the linen was clean or dirty. There were seams in the linoleum flooring that had disintegrated exposing cracks that would harbor bacteria. There were metal surgical tables that had rust on the wheel casters. The base of the bins that stored sterile supplies were coated in dust, dirt, and debris


OR 3

The base of the bins that stored sterile supplies were coated in dust, dirt, and debris.

STORAGE EQUIPMENT ROOM

The valley lab Bovie (used to cauterize and cut surgical tissue) had chips of missing paint. There was no way to properly disinfect the equipment. The wheel casters on the Bovie were coated in rust, dust, dirt, and debris. The foot pedal was coated in a buildup of dirt and debris. There was a separation in the seam of the linoleum that caused an opening in the corner seam exposing the floor to contaminates. There were scrapes and missing chips of paint missing from paint on the walls.

STERILE STORAGE OUTSIDE OR 1

There was a metal table that had sterile supplies (sterile gloves, drapes, suction catheters) on it. The sterile supplies were stacked to the point of touching the bottom of the wall bins and the supplies were stored in a fashion that touched the wall. There were ophthalmic sterile packs stored on a shelf approximately 2 inches off the floor. There was rust on the wheel casters of metal surgical tables.

Review of ANSI/AAMI S179:2017 - Comprehensive guide to steam sterilization and sterility assurance in health care facilities revealed the following:

"11 Storage and transportation

11.1 Sterile storage
11.1.l Storage facilities

Sterile items should be stored under environmentally controlled conditions in a manner that reduces the potential for contamination.
Sterile storage areas should be kept clean and dry.
Sterile items should be
1) stored far enough away from the floor, the ceiling, and outside walls to allow for adequate air circulation, ease of cleaning, and compliance with local fire codes;
2) stored at least 8 to 10 inches above the floor, at least 18 inches below the ceiling or the level of the sprinkler heads, and at least 2 inches from outside walls;
3) stored in such a way that wrapped packages are not stored beneath rigid sterilization containers on the same shelf; and
4) positioned so that packaging is not crushed, bent, compressed, or punctured and so that their sterility is not otherwise compromised."

GI ROOM #3

The following were expired items found in GI room #3:

Extractor Pro expired 7/10/2019

One Action Stent introduction expired 8/11/2019

Pancreatic Stent expired 8/19/2019

Staff #42 confirmed the above findings at the ASC.


During a tour on September 4, 2019 after 2:00 p.m. the following observations were made:

CATH LAB 3

There were scrapes and chips of paint missing on the base of the Cath Lab table. The seams of the linoleum floor were disintegrated. There was rust on the wheel casters of the metal surgical tables. There was chips and scrapes of paint missing on the Valley lab Bovie in the room. There was no way to properly disinfect the equipment. There was corrugated cardboard boxes stored with sterile supplies (Cath lab guide wires and contrast). The air conditioning vents in the room were coated with dust, dirt, and debris. The biohazard containers in the room were open. The patient linen was hanging off the shelf and touching the floor. There was a bag of Normal Saline .9% stored opened and outside of the manufacturer package. There was no way to determine when the package was opened. There were sterile supplies (Normal Saline irrigation, prep packs, and sterile medicine cups stored with non-sterile supplies (urinals, denture cups, and bed pans). The electrodes were stored in an open package. There was no way to determine when the package was opened. The electrodes were stored in a manner that could expose the pads to drying, creating a fire risks to the patients.

There were sterile camera coves in the sterile wrapper, however, the security tape and indicator that shows the package to be sterile was peeling off. The sterile item was stored in the cabinet with non-sterile items. The cabinet had bedpans lying on top of sterile 3-way flush system and sterile IV tubing connectors. The supplies were disorganized and piled on top of each other sterile with non-sterile items. There were cords lying in the mist of the sterile supplies.

The Cath lab cabinets were in disarray.


During a patient tracer on Cath Lab #3 on 9-4-2019 after 3:00 P.M., the following was observed:

PATIENT #87

Physician #46 was observed to prep the right groin area of Patient #87 with a CHG (ChloraPrep) prep. Physician #46 was observed to prep the right radial site with the same prep used to prep the right groin. Physician #46 did not allow the site to dry per manufacturer's instruction. Physician #46 picked up a drape after the prep was completed and began to fan the prep site with the drape.

Staff #47 confirmed the above findings.

CATH LAB 1

The anesthesia machine had an anesthesia circuit set up on the machine, outside of the manufacturer package. There was no way to determine if the circuit was clean or dirty.

The base of the Cath Lab had missing scrapes and chips of paint. There was no way to properly clean the equipment. The Med Rad injector (used to inject contrast into the patient during catheterization procedures) was stored on the floor. The was a buildup of a shiny substance on the floor next to the Cath Lab table that appeared to be contrast. There was a sterile yankauer suction tip laying on the floor next to the med rad injector. There was a buildup of rust, dirt, and debris on a Valley Lab Bovie. The contrast was stored in corrugated cardboard boxes. The linen hamper had a base that was coated in dust, dirt, and debris. There were sterile Biosense Webster Interf

Based on review of documents and interview, the facility failed to ensure that Discharge Planning staff were documenting the conversations with patients or patient representatives concerning the results of the Discharge Planning Assessment.

Findings included:

An interview was conducted with Staff #112 on the morning of 9-4-2019. The Discharge Planning High Risk Screen and Discharge Planning Assessment tool were reviewed to ensure all required elements were covered on the tool. Staff #112 was asked to show where Discharge Planning staff documented in the patient chart about the conversation with the patient or the patient's representative concerning the results of the Discharge Planning Assessment. Staff #112 confirmed that the conversation between Discharge Planning staff and the patient or the patient's representative discussing the results of the Discharge Planning Assessment was not ever documented. Staff #112 advised that the only documentation available in the chart would be the results of the Discharge Planning Assessment and documentation of patient choice of services if new services were needed.

Based on interview and record review, the facility failed to ensure there were clear policies and procedures which addressed their responsibilities when it came to organ donation. The facility failed to:

A. ensure their policies was clear on the documentation of medical suitability for potential donors.

B. ensure their policy was clear on the timeframe to notify the Organ procurement organization after death.

C. ensure their policy was implemented when obtaining potential tissue donations and documenting consent.


This deficient practice had the likelihood to cause harm to all potential order donors.

Findings include:

Patient #7


Review of Patient #7's "DEATH" form dated 03/12/2019 revealed the organ procurement organization (OPO) was notified Patient #7's death. There was documentation on the form which read as follows:

"At the time of routine death notification, patient/decedent was determined to be a potential candidate for donations of:" The options listed was organs or tissue. The staff member selected tissue.


The next section read as follows:

"STA (Southwest Transplant Alliance) determined the patient/decedent to be medically suitable for donation. The family was offered the opportunity to donate by:"

There was a place for a signature, date, time, opportunity accepted or declined ... There was a question if there was a donation consent form signed.

The entire area was left blank.


Review of the facility's policy named "Nursing-Organ Donation Policy" dated 06/2019 revealed the following:

"Note: Organ donation requires pronouncement of brain death as well as oxygenation and perfusion of all vital organs up to the time of actual recovery. If tissue donation is occurring without organ donation, oxygenation and perfusion of organ are not required. All individual who are pronounced dead, either by cessation of cardiopulmonary function or by brain death criteria, are referred to STA's donor referral line."


"..Physician and /or hospital staff introduces OPO personnel and if desired participates in discussion of donation with family. OPO requests donation from family and provides expert specific information so that the family can make informed consent."



During an interview on 09/03/2019 after 1:59 p.m., Staff #115 confirmed the missing documentation. Staff #115 said she could not tell if Patient #7 had donated tissue or not. Staff #115 said she did not know if they got consent at the hospital if it was just for tissue donation.






Patient #8



Review of the Patient #8's "DEATH" form dated 08/04/2019 revealed the time of death was 2:35 p.m. and the organ procurement organization was notified of the death at 4:25 p.m. (almost 2 hours later).

Written on the side of the form was the following " Staff and Family called while pt on vent in ICU and family declined organ donation at that time."

There was no signature to indicate who wrote the entry on the form.


There was an area on the form that read as follows:

"STA (Southwest Transplant Alliance) determined the patient/decedent to be medically suitable for donation. The family was offered the opportunity to donate by:"

There was a place for a signature, date, time, opportunity accepted or declined ... There was a question if there was a donation consent form signed.

The entire area was left blank.



Review of the facility's policy updated 06/2019 and named "Nursing-Organ Donation Policy" failed to have clear directives on who would notify the Organ procurement organization (OPO) about potential donors. The policy failed to give clear directives on notification of each individual death in a timely manner.

During an interview on 05/03/2019 after 1:59 p.m., Staff #115 confirmed the policy needed to be clarified. Staff #115 said the nurses had the time frame to call the organ procurement organization after a patient's death on their badges and it was in their agreement, but not in the policy.

Based on observation, interview, and record review, the facility failed to:

A. ensure a sanitary environment for the provision of surgical services and patient care in 4 (Catheterization Lab (CL) #1, CL #3, CL supply storage, CL holding area) of 4 areas observed.

B. ensure the temperature was monitored for sterile supplies stored in the CL holding area according to the manufacturing guidelines.

C. the employees in the CL followed the facility policy on required personal protective equipment to be worn during surgical/invasive procedures. Also, the employees failed to follow recommended national guidelines.

D. ensure signed job descriptions outlined department specific duties being performed by CL employees.

E. ensure the CL had written policies approved by the Governing Body that outlined the following:
1. Cardiac ARRT job responsibilities, competencies required, and all procedures approved by facility that Cardiac ARRT may perform.
2. new hire and annual competencies required for staff in the CL.

Cross refer to Tag A0951




This deficient practice had the likelihood to cause harm to all patients undergoing procedures in the Cardiac Cath Lab.


Findings include:


A. CLEAN AND SANITARY ENVIROMENT

An observation tour was conducted on 1/7/2020 in the Cath Lab (CL) department after 10:00 AM with Staff #34 and #20.


CATH LAB #1

Ultrasound gel found on the back of the ultrasound machine had a handwritten opened date of 10/25 and expiration date of 11/25. This was 43 days past expiration and readily available for patient use. Inside the cabinets was sterile supplies used during procedures and readily available for patient use. The shelves were covered with dirt, dust, and debris. The blue cart that held the Valley Lab bovie (a generator used during procedures to cauterize vessels and stop bleeding) was missing paint and rusted. The wheel casters were rusted on all four wheels. The bio-hazard bin lid was noted to be opened.


CATH LAB #3

The fluoroscopy unit (x-ray machine that will take continuous x-rays during a procedure) was found to have blood on the bottom of the unit. Staff #20 was asked if the room was cleaned and ready for a new procedure. Staff #20 said, "Yes, it is. We clean in-between cases and housekeeping does a terminal cleaning at night." On the wall behind the cabinet was a large hole approximately 11X14 in size exposing electrical wires. The large hole could allow rodents and insects to enter the sterile area without staff knowing and increasing the risk of contamination of surgical procedures. Staff #20 was asked how long the hole had been there or if she was aware of the hole. Staff #20 stated, "No I was not, and it looks like they were replacing some wires or something. I will have to put in a work order for them to fix that." The blue cart that held the Valley Lab bovie (a generator used during procedures to cauterize vessels and stop bleeding) was missing paint and rusted. The wheel casters were rusted on all four wheels. On the front of the generator was a white dried substance that appeared to be a dried liquid.




SUPPLY STORAGE ROOM

Multiple plastic blue bins used to store sterile supplies were noted to be covered with dirt and dust. On a metal shelf close to the back of the room it was noted sterile and non-sterile items were stored on the metal shelf. The sterile Mitra Clip supplies (a device used to treat mitral valve regurgitation for patients who should not have open-heart surgery) was stored next to unsterile metal equipment used for these procedures. There was no way to determine if the metal equipment had been cleaned or not. Two bottom row metal shelves on the back wall were noted to not have a protective barrier to protect the supplies from dirty mop water during cleaning of the room.






CATH LAB HOLDING

The area is a holding room with curtains dividing spaces that are awaiting their procedures. During the tour this surveyor observed a supply cart being stored in this area. A cart covered by a red drape was noted to store sterile supplies readily available for patient use. The drape was noted to be unzipped on one side exposing the sterile items to environmental contaminants. The protective barrier on the bottom shelf was heavily covered with dust. A metal cart holding sterile supplies (Rotapro, a catheter with a spinning tip used to clear away plaque on your artery walls) and equipment used for procedures was being stored in the room uncovered and exposed to environmental contaminants. The sterile supplies were being stored next to a tank with compressed air on the same cart. The tank was missing paint and dirty. The bottom barrier on the cart was soiled with a brown dirt and dust next to the compressed air tank. The wheel casters were covered with dirt and dust.


PHYSICIAN EDUCATION

After repeated requests, the facility failed to provide documentation on the education to the physicians for the proper method on completing surgical preps as previously cited on survey exit date of 9/9/19.





B. MONITORING OF TEMPERATURE ON STERILE SUPPLIES

CATH LAB HOLDING

During the tour this surveyor observed a supply cart being stored in this area. A cart covered by a red drape was noted to store sterile supplies readily available for patient use. A rolling metal cart was observed holding sterile supplies (Rotapro, a catheter with a spinning tip used to clear away plaque on your artery walls). Staff #20 was asked how she ensured the sterile items stayed within the temperature ranges per the manufacturers guidelines. Staff #20 stated, "I don't monitor the temperature in this room. We cannot fit them in the supply room because we just do not have the space. The Rotapro has to be available for emergencies and we can't leave it in the hallway, so we have to put it in this room." An additional tour on 11/9/2020 revealed and additional cart covered with a blue cover was noted in the holding area. This blue cart was storing sterile supplies. Staff #20 was asked if the cart always stayed in the holding area. Staff #20 replied, "Yes it does because we don't have storage space in the supply room. During the day if we are doing procedures we leave it in the hallway next to the room doing the procedure."

Staff #20, #34, and #35 confirmed the findings.



A review of ANSI/AAMI S179:2017 - Comprehensive guide to steam sterilization and sterility assurance in health care Facilities (Engineering department) revealed the following:

" ...11 Storage and transportation

11.1 Sterile storage
11.1.l Storage Facilities (Engineering department)

Sterile items should be stored under environmentally controlled conditions in a manner that reduces the potential for contamination.
Sterile storage areas should be kept clean and dry ..."


Review of the AORN Perioperative Standards and Recommended Practices,

" ...Temperature should be maintained between 68 degrees Fahrenheit (F) to 75 degrees Fahrenheit (20 degrees to 23 C) within the operating room suite. Procedure rooms should be maintained between 70 degrees F to 75 degrees F. Temperature should be maintained at a maximum of 75 degrees F in sterile storage areas ..."

A review of the facility's policy titled, "Policy Title: EC.02.06. Of - Maintaining a Safe, Functional Environment Policy" revealed the following:

" ...EC.02.06. O1 .13
Longview Regional Medical Center consistently strives to reduce the potential for hospital-acquired illnesses by monitoring and maintaining ventilation, temperature, and humidity levels in appropriate areas.
This is accomplished through a proactive approach of preventative maintenance, engineering controls, and periodic inspections and testing of related equipment and resources.
1. Preventative maintenance, engineering controls, and periodic inspections/testing shall be inclusive of, but not limited to the systems and equipment serving the following:
a. Areas treating infectious diseases requiring isolation ventilation systems.
b. Areas requiring reverse isolation ventilation systems.
c. Areas where sterile supplies are processed or stored.
U. Areas that utilize or store hazardous materials, hazardous gases or chemicals (e.g. ethylene oxide, formaldehyde, Glutaraldehyde, Metracide, Xylene, etc.)
e. Construction and maintenance sites that may produce dust that could migrate into ventilation systems serving the medical center or patient care areas.

6. Monitoring and recording of temperature and humidity conditions shall be the responsibility of the department in which the room lay.
a. Temperature and humidity conditions shall be monitored and recorded daily in at least the following locations:
o Operating Rooms
o Cystoscopic Rooms
o C-Section Rooms
o Recovery Rooms
o Catheterization Rooms
o Trauma Rooms
o Endoscopy Procedure Rooms
o Central Sterile Clean Work Room
o Sterile Storage
o Decentralized locations where small quantities of sterile items are stored ..."



C. APPROPRIATE PPE DURING SURGICAL PROCEDURES

On 1/9/2020 a tour of the CL Department was conducted with Staff #35 at 11:00 AM. Upon entering CL #1 it was noted Staff #31 was scrubbed in and assisting in the sterile procedure on Patient #32. Staff #31 was observed removing a wire from the inserted sheath in the femoral area. Staff #31 was not wearing a head covering, mask, or goggles. The Anesthesia provider was also not wearing a mask. Staff in the control room was asked who were the staff members in the room not wearing PPE's? Staff #36 came to this surveyor while putting on his hat and shrugging his shoulders with his hands at shoulder level stating, "What's the problem? It's not like it's a sterile case, we aren't putting in a generator or pacemaker."


Staff #35 confirmed the above findings.


An interview was conducted on 1/9/2020 with Staff #20. Staff #20 was asked what the policy on PPE's were and what national standards and guidelines the department follows. Staff #20 replied, "My staff know they must wear PPE's during every case. That includes hat, mask, protective eyewear, gown, and gloves. We follow the same guidelines as the Operating Room which is AORN (Association of periOperative Registered Nurses.)" Staff #20 was then asked why Staff #31, or the anesthesia provider did not have on the proper PPE's. Staff #20 said, "I do not know and there is no excuse or justification as to why they did not wear them. They know they should be in full PPE's to do cases." Staff #20 was asked why no other staff or Staff #36 ensured that Staff #31 and the anesthesia provider followed the policy and abided by the AORN guidelines to prevent cross contamination to the patient and exposing the patient to possible hospital acquired infections. Staff #20 said, "There is no excuse why they are not wearing them. I'm very disappointed in my staff."

An interview was conducted with Staff #33 on 1/9/2020 at 12:35 PM. Staff #33 what was his position in the department. Staff #33 replied, "I am the Clinical Coordinator." Staff #33 was asked what PPE's were required during surgical cases. Staff #33 stated, "PPE's, a hat, mask, protective eyewear, gown and gloves was required on all surgical cases." Staff #33 was then asked if he had ever been told that PPE's were not needed for certain surgical cases. Staff #33 said, "No we are encouraged to wear all PPE's for any procedure."

On 1/9/2020 an interview was conducted with Staff #32 at 12:45 PM. Staff #32 was asked what PPE's were required during procedures and if there was a procedure that did not require PPE's. Staff #32 stated, "PPE's are required on all cases except a Transesophageal Echocardiography or a Cardioversion. We have to wear a hat, mask, glasses, gown, gloves, and a beard cover." Staff #32 was then asked if Staff #36 always wore PPE's during his surgical cases. Staff #32 stated, "He always wears a hat, mask, and glasses for sure." During this interview, Staff #31 entered the room to obtain sterile supplies with the mask hanging down at his chin.

An interview was conducted with Staff #31 on 1/9/2020 after 12:50 PM. Staff #31 was asked what the PPE Policy says that you must wear during surgical cases. Staff #31 said, "We have to wear hat, mask, gloves, gowns, and they encourage us to wear protective eyewear." Staff #31 was then asked why he did not follow the facility policy and guidelines for PPE's during the surgical procedure on Patient #32. Staff #31 replied, "Staff #36 broke scrub because he needed to go to the restroom and said he would be back and asked me to switch out the sheaths and hook up the cables. I just put on a gown and gloves and did not think about a mask or a hat. I don't know what I was thinking but I just got in there and started doing what he asked me to do." Staff #31 was then asked what national standard guidelines the department used. Staff #31 stated, we go by the AORN guidelines and I always wear my PPE's and I don't have an excuse for this." Staff #31 was asked if he was the staff that opened the supplies for the case and if he wore his PPE's while opening the case. Staff #31 replied, "Yes I did open the case and I did wear my PPE's. I usually assist in the cases with Staff #36 and after he gained access on Patient #32 I had a short window of 5-10 minutes to drop and go grab something to eat quick. When I returned Staff #36 asked me to come in and switch out the sheaths and hook up the cables." Staff #31 was then asked if he was qualified to get access on the patients for these procedures. Staff #31 replied, "I am also a Registered Vascular Interventionalist and I am trained to do that, and we have to have competencies checked off by the doctors. We have to have to have 10 venous, 10 arterial, and 10 radial check offs by the doctors before we can do them independently."


A review of the facility policy titled "Operating Room Infection Control" revealed the following:


" ...PURPOSE
1. To provide the Operating room personnel with Infection Control protocols that are designed to prevent acquisition of infection by a clean surgical patient.
2. To provide the Operating Room with guidelines so as to prevent spread from one site to another by infected patients.


POLICY
Personal Protective Equipment:
1. Protective barrier is provided for and will be worn by, each Operating Room staff member, specifically the Operating Room Surgical Team, to minimize or eliminate exposure to blood ...


Principles of Aseptic Technique:
1. Definition: Basic principles and practices for establishing and maintaining a sterile filed and safe environment for the patient in the Operating Room.
2. Implementation of and adherence to aseptic practices during all Peri-operative phases minimizes the potential of wound contamination.
3. The following standards and recommended practices per Association of Operating Room Nurses (AORN) are established protocol in the Operating Room.
a. Scrubbed persons will wear masks, gowns, and gloves.
b. Sterile drapes will be used to establish a sterile field.
c. Items used within a sterile field will be sterile.
d. All items introduced onto a sterile field will be opened, dispensed, and transferred by
methods that maintain sterility and integrity.
e. A sterile field will be constantly monitored and maintained ..."



A review of the AORN Perioperative Standards and Recommended Practices revealed the following:

"Recommendation 1.1.
Before preparing a sterile field, implement practices to prevent contamination of the sterile field.
The perioperative setting is a controlled environment that is designed to minimize the risk of infection during operative and other invasive procedures. In addition to environmental controls, the work practices of perioperative personnel are essential for preventing contamination of the sterile field. Wearing clean surgical attire that has been laundered by a health care-accredited laundry facility, wearing a clean surgical mask, and performing hand hygiene are all work practices that may prevent contamination of the sterile field.

Recommendation 1.2.
Wear clean surgical attire and a surgical head covering when entering an OR or invasive procedure room for any reason (i.e., stocking supplies, delivering equipment, transporting specimens).
Surgical attire helps contain bacterial shedding and promotes environmental cleanliness. Clean surgical attire supports patient safety and helps preserve the integrity of the sterile field. Covering all hair with a clean surgical head covering minimizes the risk of hair and scalp skin contaminating the sterile field. Specific guidance regarding surgical attire is provided in the AORN Guideline for Surgical Attire.

Recommendation 1.3.
When open sterile supplies are present, wear a clean surgical mask that covers the mouth and nose and is secured in a manner that prevents venting at the sides of the mask.
The Centers for Disease Control and Prevention (CDC) 2017 Guideline for the Prevention of Surgical Site Infection recommends that a surgical mask that fully covers the mouth and nose be worn when a surgical procedure is beginning or in progress or when sterile surgical instruments are open. The CDC and various professional organizations recommend mask use in specific procedures, including:
placement of central venous catheters (CVCs), placement of peripherally inserted central catheters (PICCs), and guidewire exchange;
high-risk spinal canal procedures (i.e., myelogram, lumbar puncture, spinal anesthesia); and
interventional radiology procedures."




D. SIGNED JOB DESCRIPTIONS

A review of Staff #20's employee file revealed a signed job description for Cardiac Cath Lab Supervisor. The job description was signed on 6/12/2018. Further review revealed a letter written by Human Resources confirming Staff #20's new position as the Director of Cardiac Cath Lab effective 3/17/2019 and signed by Staff #20 on 3/26/2019. No signed job description for Cardiac Cath Lab Director was found in Staff #20's employee file.

An interview was conducted with Staff #20 on 1/9/2019 after 10:00 AM. Staff #20 was asked if she was responsible for training new staff on sterile technique and scrubbing sterile cases. Staff #20 stated, "No I don't feel competent to do that, so Staff #33 does all that training."

Staff #7, and #10 confirmed the above findings


A review of Staff #33's employee file revealed a signed job description for Radiologic Technologist II-Cath Lab/ EP Clinical Coordinator. The job description was signed on 412/2019.

An interview was conducted with Staff #33 on 1/9/2020 after 12:30 PM. Staff #33 was asked what his role was in the department. Staff #33 replied, "I am the Clinical Coordinator. I'm responsible for training all new employees on all cases that are done in this department." Staff #33 was asked if the Registered Nurses partake in the scrub role and who was responsible for training them in scrubbing and ensuring the Registered Nurses knew sterile technique. Staff #33 stated, "I train them, and I got my scrub training from the staff in Interventional Radiology Department." Further review of the signed job description does not delineate specific training to be performed by Staff #33.

A review of the document titled, "Donning Personal Protection Equipment (PPE)" located within Staff #33's employee file revealed Staff #33 had signed his own competencies as satisfactory on 5/28/2018.


A review of Staff #31's employee file revealed a signed job description for Radiologic Tech II-Cath Lab dated 4/15/19.

An interview with Staff #31 was conducted on 1/9/2020 after 12:00 PM. Staff #31 asked what duties he could perform while scrubbed into surgical procedures. Staff #31 stated, "I am also a Vascular Interventionalist, so I am trained to get access for procedures, but we have to get checked off by the doctor before we can do them. We must perform 10 of each type of access. 10 venous, 10 arterial, and 10 radial with one of the doctors and once that is complete then we can do them." Further review of Staff #31's job description does not include these skills to be performed.

After reviewing the job descriptions of Staff #20, #33, and #31 it was determined the job descriptions do not outline the actual duties that staff are performing.

Staff #7, #10, and #20 confirmed the above findings.

Based on observation and interview the facility failed to ensure the CL had written policies approved by the Governing Body that outlined the following:

1. Cardiac American Rigistry of Radiologic Technologists (ARRT) job responsibilities, competencies required, and all procedures approved by facility that Cardiac ARRT may perform.

2. new hire and annual competencies required for staff in the CL.




ARRT RESPONSIBILITIS AND COMPETENCIES

An interview was conducted with Staff #7, #10, and #20 on 1/9/2020 after 12:00 PM.
Staff #20 was asked if there was a policy that clearly stated what staff qualifications were deemed necessary to perform certain skills in a CL procedure. Staff #20 replied, "No, there is no policy outlining the qualifications needed." Staff #20 provided a policy titled, "Cath Lab-Procedures Performed by Personnel Other Than Physician Policy' revealed:



" ...POLICY:
Due to specialized services of the Cardiac Catheterization Lab and potential need for immediate/emergency action by the staff and other hospital personnel, the following procedures may be performed by adequately trained personnel.

PROCEDURE:

Cath Lab RN's or Technologist may draw arterial blood samples from an existing arterial line
in an emergency or upon the order of a physician.

CPR may be performed by department/hospital personnel in the event of a cardiopulmonary
arrest. Supervision is provided by the Cath Lab RN's.

Defibrillation may be performed without supervision by the Cath Lab staff for sustained
ventricular tachycardia or ventricular fibrillation.

Assisted ventilation (o2, bag/mask, oral airway) may be performed without supervision
by RN's, LVN's, and Cardia Cath Techs.

Radial or Brachial arterial blood gases may be drawn without supervision by Registered
Cardiopulmonary Technicians upon order of a physician.

Venous blood samples from peripheral veins or an existing femoral vein line may be drawn
without supervision by Cath Lab Staff upon order of a physician.

RN's may initiate ACLS measures as indicated to preserve or attain stable patient condition.

Closure devices may be deployed by Cath Lab personnel, following competency checklist,
if physician approves.

Radial access may be obtained by a Respiratory Therapist that has been supervised and has
competencies signed by a Cardiologist or Cardiologists ..."



Staff #20 was asked if the policy only applied to emergencies in the CL. Staff #20 stated, "It looks like it is directed more for emergencies." Staff #20 was then asked if there any other policies were available for review that would allow the CL staff to perform skills that were not described on their signed job descriptions. No further documentation was provided for review.

Staff #10 and #20 were asked if there was a policy governing the physician oversight and the amount and type of observations needed to complete competencies and perform skills independently. Staff #10 and #20 confirmed there was no policy that governed physician oversight in the CL.



NEW HIRE AND ANNUAL COMPETENCIES

An interview was conducted with Staff #7, #10, and #20 on 1/9/2020 after 12:00 PM.
Staff #20 was asked if there was a policy that clearly defined the annual competencies of the CL employees assisting in surgical procedures. Staff #20 stated, "We do annual training, but it is not specific to CL skills."

Staff #7, #19, and #20 confirmed the above findings.

Based on record review and interview, the surgeon and anesthesia providers failed to sign, date, and time the Disclosure and Consent form for 5 (# 30, #41, #42, #87, and #88) of 12 surgical records reviewed. Also, the facility failed to follow their own policy on Informed Consent.

This deficient practice had the likelihood to cause harm to on surgery patients.

Findings include:


Patient #41

Patient #41 was an 80-year-old male admitted to "Same Day Surgery" on 9-5-2019 for Ultra-sound and Computerized Axil Tomography Guided Percutaneous Needle Aspiration Biopsy of Bone Marrow.

Review of the facility document titled, "Disclosure and Consent, Medical and Surgical Procedures" revealed the physician signed the consent at 13:20 PM (1:30 PM).; 40 minutes after the procedure was started. Procedure was started at 12:40 PM. Versed 1 mg was given at 13:10 (1:10 PM). Procedure completed at 13:48 (1:48 PM).

An interview with Staff #57 at 2:00 PM confirmed the physician had signed the consent after the procedure had started.


Patient #87

Patient #87 was a 75-year-old female admitted as an inpatient on 9-3-2019 for epigastric pain. The patient was consented for a Left Heart Catheterization.

Review of the facility's document titled, "Disclosure and Consent, Anesthesia and/or Perioperative Pain management (Analgesia)" revealed the patient was going to receive all the ones listed below:
General Anesthesia
Regional Block Anesthesia/Analgesia
Spinal Anesthesia/Analgesia
Epidural Anesthesia/Analgesia
Deep Sedation
Moderate Sedation
Prenatal/Early Childhood Anesthesia

An interview with Staff #47 on 09/04/2019 at 3:00 PM confirmed the Cath lab nurse was having the patient initial by every type of anesthesia that could possibly be given. Patient was to be receiving moderate sedation by the Cath lab registered nurse.


39801


During a record review on September 4, 2019 after 11:00 a.m., the following observations were made:


Patient #30

Patient #30 was a 6-year-old male admitted to the ASC on 9-4-2019 for tonsillectomy & adenoidectomy, removal of left cerumen impaction, and exam under anesthesia bilateral ears.

Review of the facility document titled, "Disclosure and Consent, Medical and Surgical Procedures" revealed an illegible signature under the patient or legal representative signature line timed at 0700 a.m. The relationship listed was father. The witness signature was signed at 0700 a.m., there was no indication who the witness was. The physician signed the consent at 07:30 a.m.; 30 minutes after the consent was signed by the father.

During an interview with Staff #43 on September 4, 2019 after 11:00 revealed the following:

Staff #43 was asked what the facility process was for ensuring the risks and benefits had been explained to the patient and or the representative prior to having the consent signed. Staff #43 stated, "The physician writes the order for the nurses to get the consent before the consent is signed."

Review of the facility document titled, "Pre-Op orders" for Patient #30 revealed the following:

There was an order that stated, "Sign consent for T&A, Removal of Left Cerumen Impaction, exam under anesthesia bilateral ears." The signature was illegible. The date and time were 9-4-2019 at 07:30 a.m.; 30 minutes after the patient's father signed the consent.

Staff #42 &43 confirmed the above findings on the consent.

There was no way to ensure that the physician provided all necessary information, including risks and benefits of the proposed procedure prior to surgery.


Review of the facility policy titled, "Admissions - CHS - Informed Consent Policy with an effective date of 9-1-2014 revealed the following:

"Patients of Longview Regional Medical Center shall receive from their physician information necessary to give informed consent prior to the initiation of an invasive procedure and/or treatment ...

The hospitals role in the consent process is to verify that the patients/representative's informed consent has been obtained by the responsible practitioner prior to the performance of the procedure. This is accomplished through documentation of the physician's signature on the consent form which fulfills the medico-legal requirement of all persons involved in the process ..."



40989


Patient #88

A review of Patient #88's medical record revealed:

Patient #88 was a 35-year-old male admitted on 8/28/2019 for a scheduled outpatient CT Guided Renal Biopsy to be performed in the Interventional Radiology Department.


Review of the document titled, "LONGVIEW REGIONAL MEDICAL CENTER DISCLOSURE AND CONSENT-MEDICAL AND SURGICAL PROCEDURES", revealed Patient #88 signed and dated the consent for the CT Guided Renal Biopsy on 8/28/2019. Further review of the consent revealed the physician scheduled to perform the procedure was not documented. There was no documentation on the informed consent to confirm which kidney would be biopsied.


Patient #42

A review of Patient #42's medical record revealed:

Patient #42 was a 72-year-old male admitted on 9/03/2019 for a scheduled outpatient Right Internal Ureteral Stent Exchange to be performed in the Interventional Radiology Department.

Review of the document titled, "LONGVIEW REGIONAL MEDICAL CENTER DISCLOSURE AND CONSENT-MEDICAL AND SURGICAL PROCEDURES", revealed Patient #42 signed and dated the consent for Right Internal Ureteral Stent Exchange on 9/03/2019. Further review of the consent revealed the physician scheduled to perform the procedure was not documented.


An interview was conducted with Staff #74 on 9/06/2019 at 1:00 PM. Staff #74 was asked who is responsible for obtaining the signature on the informed consent? Staff #74 replied, "The nurse gets the patients signature once the doctor has talked to the patient." Staff #74 was then asked who ensures the validity of the consent before it is signed by the patient. Staff #74 replied, "The PCP (Primary Care Physician) is listed at the top of the consent because he is the one that orders the procedure. We list all our providers on the consent because at the time it is ordered we do not know who will be doing the procedure. Then when the consent gets signed by the patient the nurse is supposed to choose the provider who will be performing the procedure and it doesn't look like that is happening."


A review of the facility's policy titled, "Longview Regional Medical Center Admissions: CHS-Informed Consent Policy" revealed:

" ...Patients of Longview Regional Medical Center shall receive from their physician information necessary to give informed consent prior to the initiation of an invasive procedure and/or treatment. Except in emergencies, such information for informed consent should include but not necessarily be limited to: [the following language may vary if your state has specific language governing consents]
1. explanation of the patient's condition;
2. the specific procedure and/or treatment;
3. the potential benefits of treatment;
4. the medically significant risks involved;
5. problems related to recuperation;
6. the probable duration of incapacitation;
7. the likelihood of success of the treatment; and,
8. any treatment alternatives.

This information includes the identity of the physician/practitioner with primary responsibility for the patient's care, and the identity and professional status of individuals responsible for authorizing and performing procedures or treatments ..."
Staff #48, #74, and #115 confirmed the above findings.

Based on record review and interview, the anesthesia provider failed to enter the time on the Pre-Anesthesia Evaluation Assessment form on 1 (#28) of 12 surgical records reviewed. There was no documented evidence to know if the patient had been evaluated for anesthesia risks prior to the surgical procedure. Also, the facility failed to follow their own medical staff rules and regulations.


This deficient practice had the likelihood to cause harm to on surgery patients.

A review of Patient #28's record revealed the Pre-Anesthesia Evaluation Assessment form did not have the time entered by the anesthesia provider.

There was no documented evidence to know if the patient had been evaluated for pre-anesthesia complications related to respiratory function, cardiovascular function, temperature, pain control, nausea and vomiting, and hydration before the surgical procedure was performed.


An interview with Staff #42 on 09/04/2019 at 10:30 AM confirmed the above findings.

Based on record review, and interview, the facility failed to ensure that the post anesthesia assessments were completed prior to the patient sufficiently recovering from anesthesia in 1 of 4 patients reviewed.

This deficient practice had the likelihood to cause harm in all patients receiving anesthesia at the facility.

Findings include:

PATIENT #40
Patient #40 underwent a Right Humeral Rodding on 9-5-2019. The patient was admitted to the PACU (Post anesthesia care unit) at 10:07 a.m. Patient #40 met the discharge criteria for PACU at 11:50 a.m. Patient #40 was discharged from PACU at 12:00 p.m.

Review of the post-anesthesia assessment revealed the assessment was completed at 10:58 a.m., almost 1 ½ hours prior to the patient meeting the discharge criteria for PACU. Patient #40 had a documented FLACC pain scale of 5 at 1105. Patient was given pain medications at 10:50 a.m. and 10:55 a.m. Patient #40 had a FLACC pain scale of 0 at 11:20 a.m. and did not meet discharge criteria until 11:50 a.m.

Interview with Staff #61 revealed the following:

Staff #61 was asked what the facility process was for discharging patients from the PACU (Post Anesthesia Care Unit). Staff #61 stated when the patients are ready to be discharged, then the nurse will call anesthesia for a discharge. Staff #61 was asked if anesthesia ever signs the Post Anesthesia Evaluation prior to the nurse calling them to say the patient is ready for discharge. Staff #61 stated, "Yes, they sometimes come by early. I don't know why, but they do."

Staff #59 confirmed the findings on the post anesthesia evaluation.

Based on observation, document review, and interview, the facility failed to ensure a qualified individual was appointed as Director of the Outpatient Infusion Clinic.


This deficient practice had the likelihood to cause harm to all patients admitted for outpatient services.


Findings include:


An observation tour of the Outpatient Infusion Clinic was conducted on 9/03/2019 with Staff #48. Staff #48 was asked what services were provided in this clinic. Staff #48 stated, "This is only outpatient and they do blood transfusions, chemotherapy infusions, injections, and IV antibiotics." Staff #48 was then asked, who was the director of the department? Staff #48 replied, "Staff #34 is the director of the Outpatient Infusion Clinic."

A review of the Organizational Chart revealed the Outpatient Clinic was not listed as a department. Further review revealed Staff #34 was listed as the "Director Medical Unit." A review of Staff #34's personnel file on 9/06/2019 with Staff #116 revealed a signed job description titled, "Medical Unit Director." No additional job description was found within the personnel file of him being the director over the Outpatient Infusion Clinic.

An interview was conducted with Staff #34 on 9/03/2019 at 10:55 AM. Staff #34 was asked if he was the Director over the Outpatient Infusion Clinic? Staff #34 stated, "Yes."


Staff #116 confirmed the above findings.