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Based on document review and interview, the facility failed to provide documentation that patients were provided information that allowed the patient to make an informed consent and failed to capture the patient signature on the consent forms in 7 ( #68, #69, #70, #71, # 73, #74 and #75) of 18 (#68-#84) patients whose records were reviewed

This deficient practice had the likelihood to affect all patients of the facility.


Findings included


A review of medical records was conducted on May 5, 2022 at approximately 11:00 AM. The review identified seven patients with consents for admission and treatment that did not have patient or patient representative signatures.

A review of Patient # 68's medical record revealed the patient was admitted on 11/21/2021 at 5:54 pm. A review of a document titled "General Consent for Treatment revealed the patient did not sign the consent form and no patient representative signature was documented as being consulted regarding the admission The section for patient's signature had "Verbal Consent per (proper name) and two sets of initials. There is no way to identify who the initial belonged to. There was no other documentation to explain what steps were taken to contact a patient representative or that a patient representative was ever contacted. There was no documentation that a consent for treatment was ever obtained.




A review of Patient # 69's medical record revealed the patient was admitted on 11/17/2021. A review of a document titled "General Consent for Treatment revealed the patient did not sign the consent form and no patient representative signature was documented as being consulted regarding the admission. The section for patient's signature had "Unresponsive" and two sets of initials. There is no way to identify who the initial belonged to. There was no other documentation to explain what steps were taken to contact a patient representative or that a patient representative was ever contacted. There was no documentation that a consent for treatment was ever obtained.



A review of Patient # 70's medical record revealed the patient was admitted on 11/12/2021. A review of a document titled "General Consent for Treatment" revealed the patient did not sign the consent form and no patient representative signature was documented as being consulted regarding the admission. The section for patient's signature had the patient's name with (sister) written out beside it. There were also only initials under the "Relationship to Patient" section. There is no way to identify who the initial belonged to. There was no documentation why the patient did not sign the consent form and there was no documentation why the "sister" did not sign the consent form. There was no documentation that a consent for treatment was ever obtained.



A review of Patient # 71's medical record revealed the patient was admitted on 12/07/2021. A review of a document titled "General Consent for Treatment" revealed the patient did not sign the consent form and no patient representative signature was documented as being consulted regarding the admission. The section for patient's signature was signed by the patient's mother, however there was no staff signature only initials as a witness.



A review of Patient # 73's medical record revealed the patient was admitted on 12/17/2021. A review of a document titled "General Consent for Treatment" revealed the patient did not sign the consent form and no patient representative signature was documented as being consulted regarding the admission. The section for patient's signature had "Patient Unable to Sign - Gun Shot to the neck" and two sets of initials. There is no way to identify who the initial belonged to. There was no other documentation to explain what steps were taken to contact a patient representative or that a patient representative was ever contacted. There was no documentation that a consent for treatment was ever obtained.


A review of Patient # 74's medical record revealed the patient was admitted on 4/11/2022. A review of a document titled "General Consent for Treatment" revealed the patient did not sign the consent form and no patient representative signature was documented as being consulted regarding the admission. The section for patient's signature had "Verbal Consent" and two sets of initials. There is no way to identify who the initial belonged to. There was no other documentation to explain what steps were taken to contact a patient representative or that a patient representative was ever contacted. There was no documentation that a consent for treatment was ever obtained.


A review of Patient # 75's medical record revealed the patient was admitted on 05/03/2022. A review of a document titled "General Consent for Treatment"revealed the patient did not sign the consent form and no patient representative signature was documented as being consulted regarding the admission. The section for patient's signature had "Verbal Consent" and two sets of initials. There is no way to identify who the initial belonged to. There was no other documentation to explain what steps were taken to contact a patient representative or that a patient representative was ever contacted. There was no documentation that a consent for treatment was ever obtained.

Further review of the document titled "General Consent for Treatment" revealed a section at the bottom of the signature page that is for "Staff Use Only." This section has directions for the staff member to describe an attempt made to obtain acknowledgement and why they were unable to do so.

A review of the facility policy titled "Consent to Treat," with a revision date of 09/21/2021, revealed the following: "Policy: The General Consent to Treat form is required for routine treatment provided during emergency room visits, inpatient hospitalization, and outpatient care. Furthermore, the policy advises patient of critical information before treatment is commenced in a hospital setting.
Procedure:
I. Inpatient/Outpatient Procedures: Consent to Routine Treatment
A. The Admitting staff initiates the Consent to Treatment Process by reviewing the General Consent for Treatment Form with the patient and obtaining the patient's signature during the registration process. Consent to routine treatment applies to all patients admitted as inpatients (scheduled, unscheduled and emergency admissions) or who arrive for hospital-based outpatient procedure(s) or to the emergency department.
B. The General Consent for Treatment form provides authority for routine diagnostic work-up and routine treatment only. Continuing treatment, invasive examinations, as well as invasive procedures, all require Specific Informed Consent (Sec #II below).
C Patient Unable to Sign
I. If a patient is physically unable (due to presenting condition, e.g., sedated, loss of consciousness, etc.) or incapacitated or incompetent (as determined in a court of law), and therefore is unable to sign the General Consent for Treatment fom1 at the time of
presentation, a surrogate decision maker will be asked to sign the form on the patient's behalf Documentation must demonstrate the patient's inability to sign and the necessity for signature by the surrogate decision-maker.
2. If the General Consent for Treatment form is NOT signed at the time of presentation by anyone and/or for any reason, the patient and/or surrogate decision-maker should be approached to sign the form as soon as possible, but when appropriate, after admission. Admitting will be responsible for obtaining the signature of the patient or surrogate decision-maker within the first 24 hours of admission. Admitting will then inform the care manager/designee of the unit where the patient is being treated that they have been unable to obtain a signature. The care manager/designee will contact the patient and/or surrogate decision maker to sign the General Consent for Treatment form. The process for securing consent should follow guidelines as described above. If a patient and /or surrogate decision maker does not sign the form for any reason, there should be documentation of unsuccessful attempts noted in the patient's medical record. For specific concerns, please contact Risk Management or on off hours, the Administrator on Call who will contact Risk Management.
Ill. Consent Authority
A. ADULTS
1. Adult with an Emergent Condition
a. If an adult patient has an emergent condition, and the patient has medical decision-making capacity, the hospital must obtain the patient's consent before providing
treatment, regardless of whether the physician believes that without the treatment, the patient's life, limb, or mental well-being is endangered.
b. If, however, the patient lacks capacity to make or communicate an informed decision and the medical condition represents a clinical emergency where, in the judgment of the physician, delay in treatment will endanger the life, limb or mental well-being of the patient, the procedure(s) required to treat the emergent condition may proceed without infom1ed consent being obtained. If time permits, efforts should be made to secure the consent of a surrogate decision maker or family member. Efforts to reach the surrogate decisionmaker or family member should always be documented in the patient's medical record.
2-Adult with Non-Emergent Condition
a. If an adult patient had decision making capacity, he or she is the only person who can consent to their own medical treatment.
b. If, however, the patient is determined by a physician to lack capacity to make or communicate health care decisions, or a court has deemed the patient incompetent, the patient's surrogate decision-maker (if any) will stand in place of the patient in making treatment decisions for the period of the patient's incapacity.
c. If a surrogate decision-maker cannot be contacted or there is no surrogate decision maker, a member of the Risk Management Department should be contacted during regular business hours. After hours, contact the administrator On-Call through the page operator.
V· Telephone Consent
A. Telephone consent can be obtained in circumstance when the patient lacks capacity and consent is required.
B. Efforts to contact a surrogate decision-maker or, if unavailable, a family member on behalf of an incapacitated adult patient, or a parent/guardian for a minor patient, will be documented in the medical record. If no one who would be legally authorized to consent for the patient can be reached within a reasonable period of time, the Risk Manager or the Administrator On-Call will be contacted.
C. An employee will witness the telephone conversation. If telephone consent is obtained, the LIP and the employee will complete the consent form, and on the line labeled "Signature of Patient," enter the name and relation hip of the person giving consent.
D. The employee witnessing the telephone conversation will sign, date and time as witness on the consent form.

An interview with the staff #2 and #25 was conducted on 05/05/2022 at the time of review. Both staff members confirmed that staff did not follow facility policy when obtaining consent for treatment.

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


A. ensure the staff labeled the jug of dialysate solution with the additive of powdered potassium chloride and /or calcium chloride which were for altering concentration of the dialysate.


B. ensure the security of the dialysis supplies and R/O (Reverse osmosis) water products in the acute dialysis unit.


C. ensure the patient had left the dialysis area prior to cleaning the dialysis area and the dialysis machine. Failure to wear gloves and perform hand hygiene, provided a mode of cross contamination, with the potential spread of infection, which could negatively impact the patients receiving hemodialysis treatments in this facility.


D. ensure staff were wearing gloves when touching the patient and the dialysis machine.


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


Findings included:


A. During a tour of the facility on 05/02/2022 at 9:55 AM, it was observed the jugs of dialysate solution were written
on with a Black marker 3K . When Staff#5 was asked what that indicated. Staff #5 stated, I added potassium and calcium to the jug. In the cabinets of the acute dialysis unit were 11.5 and 5.8 grams of powdered potassium chloride additive packages. Also, there were calcium chloride 5.7 and 11.3 grams of powdered packages. These products were being used to spike the acid and calcium concentrate of the standard jugs. There was no label on the dialysate jug to know how much of the powdered potassium Chloride and calcium chloride had been added to the jug. There were labels provided by the manufacturer that determined the amount of additive that was added to the standard jug and the total amount of concentration after the additive was added. The label had a place for whom added the additive and the date and time.

An interview with Staff #5 on 05/02/2022 at 10:00 AM confirmed she wrote 3K with black marker on the jug and did not use the potassium/calcium label as instructed per the facility's policy "Addition of powder Calcium Chloride ad /or potassium chloride to acid concentrate".


An interview with Staff #27 (Acute administrator for the contracted provider) on 05/02/2022 at 3:30 PM confirmed the dialysis staff should use the manufacturer labels for the additives of powdered potassium chloride and /or calcium chloride which were for altering concentration of the dialysate. Staff #27 stated, "That an in-service had just been held with the staff on how to properly label the dialysate concentrate when additives were added. The Facility's policy on "Addition of powder Calcium Chloride ad /or potassium chloride to acid concentrate" was just reviewed a month ago."


A review of the facility's policy titled, "Addition of powder Calcium Chloride ad /or potassium chloride to acid concentrate" revision date October 2021 revealed the following:


"Label the acid concentrate jug with the amount of calcium or potassium chloride added, date, time, initial of licensed nurse teammate mixing additive and indicate the final concentration of altered bath. The concentrate jug with the mixed additive is to be discarded after patient treatment."


B. During a tour of the facility on 05/02/2022 at 4:00 PM, observed the acute dialysis unit had a keypad entry for security to the water room and dialysis products and supplies . A list was provided to the surveyor with numerous names that had access to water room and dialysis products and supplies. Only dialysis staff should have access to water room, dialysate concentrate, and supplies. There should be a means to protect stored acid concentrate from tampering which could cause death.


An interview with Staff # 7 (COO) on 05/02/2022 at 3:00 PM confirmed numerous staff that had access to the acute dialysis unit and he did not know that dialysis products and supplies had to be secure from facility's staff members. Surveyor advised Staff #7 that this deficient practice had the likelihood to allow access to the dialysate jugs and allow additives to be added to the jugs or tampering with the dialysate jugs.


C. During a tour of the acute dialysis on 05/02/2022 at 1:30 PM observed Staff #5 cleaning the dialysis machine with the patient still at bedside. Staff #5 failed to follow the facility's policy on "Termination of dialysis with all dialyzer types utilizing Fresenius 2008 dialysis delivery systems and streamline long blood lines".


A review of the facility's policy titled, "Termination of dialysis with all dialyzer types utilizing Fresenius 2008 dialysis delivery systems and streamline long blood lines" revision date April 2021 revealed the following:


"Once the patient has vacated the dialysis station, empty and rinse priming container if needed. Clean exterior surface of dialysis delivery system and the interior and exterior surface of reusable priming container with hospital approved disinfectant. Follow hospital protocol for removal and cleaning of equipment when exiting an isolation area. According to current recommendations from the CDC, to prevent cross-contamination between patients, it is important that the previous patient completely vacate the station before cleaning and disinfection of the station and set up for the next patient."


D. During an observation tour on 05/02/2022 at 1:30 PM observed Staff #5 with gloves off adjusting the dialysis machines and not washing hands after the procedure was completed. Failure to wear gloves and perform hand hygiene, provided a mode of cross contamination, with the potential spread of infection, which could negatively impact the patients receiving hemodialysis treatments in this facility. Staff #5 failed to follow the facility's policy on "Infection Control in the Hospital Dialysis Setting".


An interview with Staff #5 on 05/02/2022 at 1:30 PM confirmed that she touched the dialysis machine with out wearing gloves.


A review of the facility's policy titled, "Infection Control in the Hospital Dialysis Setting" revision date October 2021 revealed the following:


"10. Gloves should worn when:
* Potential for exposure to blood, dialysate, and other potentially infectious substances
* Inserting or removing the vascular access needles
* Connecting the blood lines to the vascular access needle lines or catheter lines
* Touching the blood lines, dialyzer, or dialysis delivery system during or after a dialysis treatment
* Administering medications, checking vital signs
* Cleaning and disinfecting the dialysis delivery system or other equipment in contact with patient

11. Gloves should be changed when:
* Soiled with blood, dialysate, or other body fluids
* Going from a "dirty" area or task to a "clean" area or task
* Moving from a contaminated body site to a clean body site of the same patient
* 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

12. Gloves should be provided to patients and visitors if these individuals assist with procedures which risk exposure to blood or body fluids such as self-cannulation or holding access sites post treatment.

13. All personal protective equipment (PPE) is to be removed as soon as possible if overtly contaminated and is to be placed in a biohazard waste container."


E. During a tour of the dialysis unit on 05/02/2022 at 1:45 PM observed the following infection control issues:


Acute dialysis room:

1. In the dialysis unit which was 2 large rooms observed the clean sink had large brown water stain on the floor. Housekeeping cleaned the area, but the sink continued to leak water.


Supply and Water Room:

1. In the supply area where patient dialysis supplies were stocked observed dust and trash particles in the blue bins.

2. There were 5 large black trash bags full of dialysis supplies lying on the shelf and in the blue bins. The supplies are bought in large black trash bags from materials management on an open rolling cart that travels the hallways of the hospital. Staff had just placed the large trash bags on the shelf and in the bins without taking the supplies out of the bags and laid them on top of the clean and sterile supplies already in the bins, which contaminated the patient supplies.

3. Observed white ceiling dust particles on top of the R/O water system. A new sprinkler head had been installed couple of days ago and no one had cleaned the particles off the top of the R/O water system.

An interview with Staff #27 on 05/02/2022 at 2:00 PM confirmed the infection control issues found in the acute dialysis unit and storage area.

An interview with Staff #2 (scribe from quality assurance department ) had been with the surveyor during the tour and had observed and confirmed the infection control issues.

The dialysis staff had failed to follow the facility policy "Infection Control in the Hospital Dialysis Setting".


A review of the facility's policy titled, "Infection Control in the Hospital Dialysis Setting" revision date October 2021 revealed the following:

"PURPOSE: To promote a safe, clean environment for all patients and teammates of the dialysis unit and to reduce the risk of spreading infections or bloodborne pathogens in a hospital dialysis setting.

21. Sinks should be easily accessible and readily available in the treatment area and in other appropriate areas. Dedicated hand washing sinks should be for hand washing purposes and remain clean. Avoid placing, cleaning, or draining used items in dedicated hand washing sinks.

25. Clean areas should be clearly designated for the preparation, handling, and storage of unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies ands equipment are handled.

26. Cleaning and/or disinfection of equipment and work surfaces, including sinks will be performed as soon as possible following exposure to blood or other potentially infectious materials. Use an appropriate disinfectant such as 1:100 bleach solution for environmental surfaces or a hospital approved disinfectant.

27. Hand hygiene should be performed after teammate interacts with wall boxes (i.e. plugging in/unplugging acid/bicarb lines from dialysis machines, changing acid type at the wall box, when exchanging a dialysis machine) and should be performed before patient contact. Hand hygiene can be performed using alcohol-based hand rub unless hands are visibly soiled.

28. Protective covering may be used on chairs and beds. The protective covering will be changed between each patient.

29. The outside surfaces of all equipment will be wiped with a bleach solution or hospital approved disinfectant prior to removal from treatment area."

Based on interview and record review, the facility failed to ensure sufficient numbers of nursing staff on 3 of 4 units reviewed for staffing (Intensive care unit, Medical-surgical unit and labor and delivery).

The facility failed to ensure there were sufficient numbers of registered nurses, licensed vocational nurses, certified nurses aides and unit secretaries.

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


Findings include:



Review of the Nursing staffing Matrix (dated 02/25/2022), daily rosters and staff assignment sheets revealed the following:



Labor and Delivery
Review of staffing records from 04/24/2022-05/02/2022 revealed there was a patient census from 0-3 deliveries except for 04/27/2022.

On 04/27/2022 there was 6 deliveries. There were 3 Registered nurses (RNs) and 1 Surgical technician (ST) documented as working both on days and nights.

Review of the staffing matrix revealed there should have been 5 RN's and 1 ST for both shifts for a census of 6. The unit was short 2 nurses.

During an interview on 05/04/2022 after 1:51 p.m., RN #18 confirmed the staffing number. RN #18 said that a program manager probably helped on that day.



Intensive care unit
Review of staffing records from 04/20/2022-05/02/2022 revealed the following shortages:
04/20/2022
The day shift had a census of 17. The matrix called for a total of 9 nurses which included the charge nurse. The facility was short 1 nurse.
The night shift had a census of 16. The matrix called for a total of 9 nurses which included the charge nurse. The facility was short 1 nurse.

04/21/2022
The day shift had a census of 18. The matrix called for a total of 10 nurses which included the charge nurse. The facility was short 2 nurses.
The night shift had a census of 15. The matrix called for a total of 8 nurses which included the charge nurse. The facility was short 1 nurse.

04/22/2022
The day shift had a census of 15. The matrix called for a total of 8 nurses which included the charge nurse. The facility was short 1.5 nurses.
The night shift had a census of 15. The matrix called for a total of 8 nurses which included the charge nurse. The facility was short 1 nurse.

04/25/2022
The day shift had a census of 10. The matrix called for a total of 6 nurses which included the charge nurse and the facility was short 1 nurse.

04/26/2022
The day shift had a census of 12. The matrix called for a total of 7 nurses which included the charge nurse. The facility was short 1 nurse.
The night shift had a census of 15. The matrix called for a total of 8 nurses which included the charge nurse. The facility was short 1 nurse.

04/29/2022
The day shift had a census of 13 and there was a total of 8 nurses which included the charge nurse. The matrix called for a total of 7 nurses.
There were 3 patients on 1:1 which took away 3 nurses. This left the unit with 5 nurses for 10 patients.
The matrix called for a total of 6 nurses which included the charge nurse.
The facility was short 1 nurse.

Review of the matrix revealed there should be 1 unit secretary from 7:00 a.m. to 7:00 p.m. (dayshift).

Review of staffing sheets revealed the following shortages of unit secretary:
On 04/21, 04/29, and 05/02/2022 there was only 0.5.
On 04/23, 04/24, 04/30, and 05/01/2022 there was no unit secretary.

During an interview on 05/04/2022 after 2:59 p.m., RN #4 confirmed the staffing number.



Medical/ Surgical unit/Telemetry unit
Review of staffing records from 04/20/2022-05/02/2022 revealed the following shortages:


04/20/2022
The day shift had a census of 51. The matrix called for a total of 11 nurses which included the charge nurse. The facility was short 1 nurse.
The unit needed 5 Certified nurse aides (CNAs), but they had 3 plus 1 on a 1:1 patient.


04/21/2022
The day shift had a census of 51. The matrix called for a total of 11 nurses which included the charge nurse. The facility was short 1 nurse.
The unit needed 5 Certified nurse aides (CNAs), but they had 5 plus 1 on a 1:1 patient.

04/22/2022
The day shift had a census of 48. The matrix called for a total of 11 nurses which included the charge nurse. The facility was short 2 nurses.
On the night shift they had a census of 37 and the unit needed 4 Certified nurse aides (CNAs), but they had 1 CNA plus 1 on a 1:1 patient.

04/23/2022
The day shift had a census of 43. The matrix called for a total of 10 nurses which included the charge nurse. The facility was short 1 nurse.
On the night shift they had a census of 47 and the unit needed 4 Certified nurse aides (CNAs), but they had 0 CNAs plus 1 on a 1:1 patient.

04/24/2022
The day shift had a census of 48. The matrix called for a total of 11 nurses which included the charge nurse. The facility was short 1 nurse.
The night shift had a census of 50. The matrix called for a total of 11 nurses which included the charge nurse. The facility was short 1 nurse.
On the night shift they needed 5 Certified nurse aides (CNAs), but they had 0 CNAs plus 2 on a 1:1 patient.

04/27/2022
The day shift had a census of 48. The matrix called for a total of 11 nurses which included the charge nurse. The facility was short 1 nurse.

04/28/2022
The day shift had a census of 47. The matrix called for a total of 11 nurses which included the charge nurse. The facility was short 2 nurses.
They needed 4 Certified nurse aides (CNAs), but they had 3 CNAs plus 1 on a 1:1 patient.

04/29/2022
The day shift had a census of 48. The matrix called for a total of 11 nurses which included the charge nurse. The facility was short 2 nurses.

05/01/2022
The night shift had a census of 41. The matrix called for a total of 4 Certified nurse aides (CNAs), but they only had 1 CNA and another was with a 1:1 patient.

05/02/2022
The night shift had a census of 39. The matrix called for a total of 4 Certified nurse aides (CNAs), but they only had 1 CNA.

During an interview on 05/04/2022 after 3:41 p.m., RN #15 confirmed the staffing numbers.



During confidential interviews the following was stated about staffing:

"Not enough qualified nurses with experience"

"Because of the shortages the charge nurses and directors have to try to make up the difference. The charge nurses are supposed to be free floating."

"Ratio should be 1 nurse to 2 patients for ICU."

" The night shift is short on CNA's and we are "short on nurses."
"We have a lot of call ins. Sometimes the managers take patients. The free charge nurse may take 2- 3 patients" when the staffing is short."

"Overwhelming at times. We have 6 patients a piece but it's the acuity that makes it overwhelming. The majority of days we are understaffed.
Nurses are pulled to other units sometimes and sometimes the charge nurse has to take patients. It was really an issue when there was 6 patients and having to do total care. They pull aides off the unit to sit with patients. It's gotten somewhat better."










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Confidential Interview revealed ICU (Intensive Care Unit) staff nurses commonly felt they were short-staffed. He described multiple days where ICU assignments were "tripled." (Three patients). He reported occasionally being assigned 4 patients in ICU, with some combination of mixed acuity. He described attrition with "seasoned" Registered Nurses (RN) as a prime reason for staffing issues. He described having more physical beds than they could staff and this limited ICU capacity.

Confidential Interview revealed staffing shortages which impacted ability to care for complex cardiac post-operative patients. He stated there was a "shortage of CV competent nurses" in the ICU. He reported that travel nurses were serving as unit preceptors and were assisting with unit-based competency check-offs due to limitation in experienced staff nurses.

Based on review and interview nursing failed to document patient's home medications and medical history at triage, nurse failed to document patient assessments for changes in condition or changes in care, failed to notify the providers or physicians in elevated vitals or condition changes, failed to assess the patient's pain in triage or during the coarse of the visit, Licensed Vocational Nurse (LVN) was allowed to discharge a patient, allowing the patient to drive home within 1 hour of administering a narcotic and without assessing the patients mental and cognitive ability. Nursing failed to document nursing discharge notes or vital signs on the 2/12/22 visit in 1(89) of 10 (#89-95 and #97-100) charts reviewed.


2/4/22 Visit

Review of Patient #89's chart revealed she came to the facility on 2/4/22 at 1509 (3:09PM). She was triaged at 1539(3:39PM). There was no written evidence when the Nurse Practitioner (NP) saw the patient before 1831 (6:31PM). Review of the Nurses triage note dated 2/4/22 at 1539 stated, "Pt to ED via POV from home for pain in the L heel to medial leg to medial thigh. Pt stated the pain is worse with more movement. Pt has varicose veins in the L leg. Pt states pain is increased x 2 days. Pt see's Dr_____ (Physician #5) and has dx with poor circulation to legs and varicose veins. Pt has warmth and swelling to the Lower leg." Dr.___ (Physician #5) was documented as her Cardiologist and Dr._____(Physician #6) as her primary care physician.

Review of the chart revealed her vital signs at triage were T-98.2, pulse 94 (H), Respiratory rate- 20, Blood pressure was 194/93 (H) O2 sat 99. Review of the chart revealed there was no nursing documentation that the NP or physician was aware of the elevated vital signs. There was no documentation of treatment or education concerning elevated vital signs. There were no vital signs documented again until discharge at 20:55 (8:55PM). The Licensed Vocational Nurse (LVN) documented the same exact vital signs at discharge. There was no documentation that the nurse notified the patient of the abnormal vital signs when patient was discharged.

Patient #89 stated in her complaint that she had waited for hours for someone to perform her x-ray. She stated, "hours had gone by and me pressing the button for a nurse, a radiology staff member finally showed up with the x-ray machine to x-ray my leg. When she was done, she told me she would see if they wanted me to stay in the room or move to the main lobby ... They moved me back to the main lobby and more hours had passed by with no sign of a doctor for the results no word on what was going on with my leg or anything."

There was no nursing or physician documentation found that stated Patient #89 was ever moved out of the ED to a waiting room or the condition of the patient when she was removed out of the ED.

Review of Patient #89's chart revealed an order for the ultrasound was placed on 2/4/22 at 15:51 (3:51PM) for a venous duplex LE LT Stat. There was no order placed for an x-ray. There was no documentation from the nurses from 1509 at triage until discharge at 2100 (9:00PM) on when the patient went to ultrasound or condition of the patient.

Review of the US results dictated at 1930 (7:30PM) and signed by Physician #31 MD at 1935 (7:35PM) revealed the patient had a "Occlusive deep vein thromboses of the left lower extremity ... A critical Direct Communication message has been discussed with____ Staff #30 NP, on behalf of ___ Physician #26 MD and documented in the power Scribe 360/Critical result system on 2/4/22 at 7:33PM"

Review of the patient's chart revealed there was no documentation from Staff #30 NP. There was no documentation that he received the critical value or reported it to Physician #26 potentially causing a delay in care. On 2/4/22 at 20:55 (8:55PM) the Staff #28 NP documented the results of the US and "discussed exam and diagnostics with ____ Physician #26-pt to be prescribed Xarelto and discharge to follow up with Dr.____ (physician #29)."

Review of 89's complaint stated, "Finally, around 9 pm a staff member came to the lobby to give me results of a blood clot in front of everyone waiting in the lobby and administering me an oxycodone pill for pain. I questioned her about what it was, and she stated it was just for pain. I ask how it will affect me I have to drive she shrugged it off and stated it is not too strong I will give you one."

Review of the chart revealed Patient #89 had no pain assessment documented from triage. There was no pain assessment documented until Patient #89 was given 5mg of Roxicodone for pain by Staff #42 LVN (Licensed Vocational Nurse) on 2/4/22 at 1951 (7:51PM). The LVN documented the pain level was at an 8 out of a 1-10 scale. There was no previous nursing documentation of (any) assessment of the patient since 15:39 (3:39PM). There was no nursing documentation on the tolerance of the medication, the patients understanding of the medication, the effectiveness of the medication, or the fact that the patient had no one with her to drive her home. There was no documentation that the patient was placed in the waiting room or brought back into a triage waiting area to speak to the Nurse practitioner.

Review of Patient #89's complaint stated, " ... another nurse practitioner came to call me to a room to the side and prescribed me a blood thinner. I asked her if it would have an interaction with my current medications and she stated she did not know I had to ask my own doctor on Monday ..." Review of the chart revealed there was no documentation of home medications or previous diagnosis.

Review of the chart revealed Patient #89 was discharged home on 2/4/22 at 20:55 (8:55PM) by the LVN. The patient was discharged one hour after the patient had been given Roxicodone (oxycodone hydrochloride tablets USP) an opioid analgesic. According to fda.com Roxicodone begins working to relieve pain in about 15 to 30 minutes, although it reaches its peak effect in 1 hour. It will continue to work for 3 to 6 hours. The patient was discharged alone without a driver. Roxicodone can alter a person's mental and cognitive abilities. There was no nursing documentation of the patient's cognitive abilities or mental status before allowing her to drive herself home.

Review of the chart revealed Patient #89's vital signs were taken at triage. Her vital signs were Temp.98.2, pulse 94 (H), respirations 20, blood pressure 194/93 (H) and O2 Sat 99.There was no nursing documentation that the NP or physician was made aware of the elevated vital signs. There was no documentation from the NP that the vital signs were addressed. Review of the nursing discharge notes revealed Staff #42 LVN discharged the Patient #89. The nurse's notes revealed the vital signs were the same as the triage vital signs pulse 94 (H) and a blood pressure of 194/93 (H). There was no documentation that the RN, NP, or physician was notified of the vital signs at discharge. There was no documentation that the patient was safe to leave the facility on her own.

2/12/22 Visit

Review of Patient #89's complaint stated on 2/12/22 stated she came back to the ED due to adverse reactions from the Xarelto that was prescribed to her in the ED on 2/4/22. She reported that she was having itching, swelling, muscle spasms and throat beginning to swell. "I was seen by another NP and still no doctor. I waited in the main lobby for 2 hours before being called to a room off to the side." Patient #89 reported the nurse practitioner looked in her mouth and asked where she was diagnosed. She told him the time and date she was diagnosed at the facility. Patient #89 stated, "He never pulled up any test results or my chart information to verify or compare anything. He proceeded to Google blood thinners on his cell phone and ask me, "what do you think I should try on you?" I told him I know nothing about blood thinners and began to show him the name and list of current medications I was taking which he never pulled up in the system to even check.

Review of Patient #89's chart dated 2/12/22 revealed she came back to ED at 7:31AM for swelling and itching. The triage note stated, "45-YEAR-OLD FEMALE PRESENTS TO EMERGENCY ROOM WITH POSSIBLE ALLERGIC REACTION TO XARELTO. PATIENT WAS SEEN HERE 1 WEEK AGO AND DIAGNOSED WITH LEFT LOWER EXTREMITY DEEP VEIN THROMBOSIS. SHE WAS PRESCRIBED XARELTO 50 MG B.I.D. FOR ACTIVE TREATMENT OF DEEP VEIN THROMBOSIS. PATIENT REPORTS DEVELOPING ITCHING AND SENSATION OF GENERALIZED SWELLING TO HER FACE, NECK, EXTREMIDES OVER THE PAST 4-5 DAYS. SIGNIFICANT MEDICAL HISTORY INCLUDES HIV POSITIVE STATUS. PATIENT TAKES SEVERAL ANTIVIRAL MEDICATIONS FOR ACTIVE TREATMENT OF HIV. (Staff #37 NP)"

Review of the patient's chart revealed there was no documentation of her home medications for this visit or for the 2/4/22 visit. The NP saw the patient and discharged the patient on 2/12/22 at 9:24AM on Eliquis.

- MDM
Medical Decision Making Narrative:
02/12/22 09: 10
DIFFERENTIAL DIAGNOSES INCLUDE: DEEP VEIN THROMBOSIS (PER RECENT DIAGNOSIS), ACUTE ALLERGIC REACTION, ANAPHYLAXIS, ANXIETY DISORDER, ADVERSE MEDICATION INTERACTION.
I REVIEWED AND AGREE WITH NURSES NOTES. VITAL SIGNS REVIEWED. LABS REVIEWED. I PERSONALLY VISUALIZED RADIOLOGICAL IMAGES.
PATIENT IS NOT HAVING ANY DIFFICULTY BREATHING OR SWALLOWING. PHYSICAL EXAM IS UNREMARKABLE. DUE TO PATIENT'S PERSISTENT COMPLAINTS OF PRURITUS AND GENERALIZED SWELLING SINCE STARTING XARELTO, WE WILL CHANGE MEDICATION TO ELIQUIS 10 MG B.I.D.
FOR 1 WEEK FOLLOWED BY 5 MG B.I.D. THEREAFTER. PATIENT IS ADVISED TO FOLLOW-UP WITH HER CARDIOLOGIST LOCALLY (DR. ABDULLAH). SHE IS ADVISED TO FOLLOW-UP WITH HER PRIMARY CARE PROVIDER AND HIV SPECIALIST IN HOUSTON AS WELL. PATIENT IS FURTHER ADVISED TO DISCUSS TRANSITIONING FROM XARELTO TO ELIQUIS WITH HER LOCAL PHARMACIST (Staff #37 NP).


- Discharge
Clinical Impression:
Allergic reaction caused by a drug
Disposition: Home or Self-C.are
Instructions: ED Drug Reaction, Other, Allergy Overview
Care Plan Goals:
DISCONTINUE XARELTO. START ELIQUIS AS PRESCRIBED. YOU SHOULD FOLLOW-UP LOCALLY WITH DR. ____ (Physician #29) AND ADVISED HIM OF RECENT DISCOVERY OF LEFT LOWER EXTREMITY DVT. DR ______(Physician #29) CAN FOLLOW YOU FOR THIS DIAGNOSIS AND MAKE ANY RELATED MEDICATION CHANGES AS NEEDED. YOU SHOULD ALSO DISCUSS CURRENT MEDICATIONS WITH YOUR PRIMARY CARE PROVIDER IN HOUSTON. DISCUSSED DISCONTINUATION OF XARELTO AND STARTING ELIQUIS WITH LOCAL PHARMACIST.
Prescriptions:
New Eliquis 5 mg tablet."

This patient had a visit on 2/4/12 and diagnosed with a DVT. She was given blood thinners that she had never had before and came back on 2/12/22 with an allergic reaction to the medication. She was seen again in the ED by only a NP. This patient has multiple comorbidities, was discharged with elevated vital signs, given a narcotic and discharged to drive home alone. Patient #89 was only seen by a NP on her first visit but failed on the therapy prescribed and returned to the ED where she was only seen by a NP. The documentation revealed on the 2/12/22 visit that the NP never consulted with a physician concerning this patient. The patient was taken off a blood thinner and put on another medication without physician oversight. The NP documented that the patient needed to let the pharmacist instruct her on how to "transition" medications.

Review of the chart revealed there was no nursing discharge notes or vital signs included in this chart. No further nursing assessment was documented on this chart after the patient was triaged at 7:31AM.

Based on interview and record review, the facility failed to ensure there was a nursing plan of care which included physician orders for dressing changes when needed in 1 of 2 patients that were reviewed for wound care (Patient #51)

This deficient practice had the potential for affect all patientS.

Findings include:

Review of the clinical record of Patient #51 revealed he was a 68-year-old male who presented to the Emergency department on 04/26/2022 for weakness. Patient #51 was admitted as an in-patient with a diagnosis of cellulitis.
Review of a nursing assessment dated 04/27/2022 at 1:41 a.m., revealed that Patient #51 had redness to the right side of his chest, puss and draining coming from the armpit region. There was swelling to the right arm and right chest.

Review of physical therapy notes dated 04/28/2022 at 1:50 p.m., revealed Patient #51 underwent an incision and drainage with a washout of the right pectoral region on 04/27/2022. The wound bed was described as being clean today and was 6 centimeters in depth at the deepest point at the 12 o'clock position. The wound was cleansed with a Vashe hypochlorous solution (wound cleanser) and packed. The treatment plan said "daily wound care during los"

Review of nursing notes revealed that on 04/30/2022 at 6:27 a.m., Patient #51's gown was changed because he was moderately soaked with serous output. The dressing was changed and the old dressing fell on the floor when the patient was taken to the toilet. Ribbon gauze was still packed in the post op wound so it was reinforced. It was covered with sterile gauze and secured with Aquacel dressing (foam sterile dressing) by nursing.

Review of therapy notes revealed they performed a dressing change on Patient #51 on 04/30/2022 at 10:30 a.m.

Review of consents dated 05/01/2022 revealed Patient #51 had another incision and drainage of the right chest wall.

Review of physician orders dated 05/01/2022 at 2:05 p.m., revealed Patient #51 was to have a physical therapy consult.

Review of physical therapy notes revealed they provided wound treatments on 05/01 and 05/02/2022. On 05/03/2022 there was documentation that they were going to initate vacuum therapy and perform dressing changes on Monday, Wednesdays and Fridays.

Review of the chart revealed no signed physician orders for wound treatments for nursing to follow when needed.

During an interview on 05/05/2022 after 11:35 a.m., RN#15 confirmed the information in the chart and said that physical therapy performed all of the treatments. RN #15 said nursing can do after hour dressing changes. When questioned about where the physician's order was, she said they did not have one.

During an interview on 05/05/2022 after 12:21 p.m., Physical therapy (PT)#50 said that therapy received their treatment orders from the physician. PT #50 said that nursing should use the same treatments they were applying to the wound. When questioned about where the physician order was for nursing, PT #50 said that he was not a doctor and could not write orders for nursing.

Review of a facility's policy named "Patient Assessment, Reassessment and Documentation of Care Chapter:Provision of Care ..." revised on and 03/24/2020 revealed the following:





" ...A plan of care is developed to address care treatment and services based on the patient assessment. Once the admission assessment is complete, the RN incorporates findings obtained from interdisciplinary team members to develop and implement the plan of care on all patients. The plan of care is an ongoing process and the problems and outcomes are assessed and updated needed.."

Based on interview and record review, the facility failed to ensure blood was administered as ordered by the physician in 1 of 3 sampled patients reviewed for blood administration (Patient #51).

Patient #51 received a blood infusion which was ordere to be administered Stat (meaning immediately) over 9 hours after it was ordered.

This deficient had the likelihood to cause harm to all patients who received blood.

Findings include:


Review of the clinical record of Patient #51 revealed he was a 68-year-old male who presented to the Emergency department on 04/26/2022 for weakness. Patient #51 was admitted as an in-patient with a diagnosis of cellulitis.
Review of consents dated 05/01/2022 revealed Patient #51 had an incision and drainage of the right chest wall.


Lab results dated 05/01/2022 at 6:45 a.m., revealed Patient #51 had a red blood cell level of 3.3 (reference ranges of 4.60-6.20), hemoglobin of 9.8 (reference ranges of 14-18) and a hematocrit of 29.5 (reference ranges of 38-52).

Lab results dated 05/02/2022 at 3:30 p.m., revealed Patient #51 labs had dropped to a red blood cell level of 2.2, hemoglobin of 6.5 and a hematocrit of 19.8. There was documentation on the lab report of nursing being informed of the critical lab at 3:57 p.m.

Review of physician orders dated 05/02/2022 at 4:23 p.m., revealed orders to transfuse red blood cells stat 1 of 2 units. There was documentation on another order at 4:24 p.m. that read "Number of RBC Units to transfuse now :1" and the duration was to transfuse over 2-4 hours. There was also an order at 4:24 p.m., to Type and Screen.

Blood administration records showed the first unit of blood was given over 9 hours later at 1:38 a.m. on 05/03/2022 and stopped at 4:28 a.m.

The second unit of blood was started at 8:20 a.m. on 05/03/2022.

During an interview on 05/03/2022 after 2:00 p.m., RN#15 confirmed the documentation in the chart.

During an interview on 05/05/2022 after 10:20 a.m., RN #15 said the order called for the blood to be given stat and that's how it should have been given.



Review of the facility's policy named "Administration of Blood and Blood Components Chapter: Provision of Care and revised on 04/16/2019 revealed the following:
" ...The LIP (licensed independent practitioner) order for the blood component includes the number of units to be prepared and special requirements. NOTE: an order to prepare a blood component does not imply an order to transfuse. The LIP order for transfusion is verified. Transfusion orders include the numbers of units to be administered and duration of each transfusion (not to exceed 4 hours) ..."

Based on record review and interview, the facility failed to follow its own medical staff policy to ensure a current history and physical was on the chart within 24 hours after admission in 1(#61) out of 17 charts reviewed for history and physicals.

Findings include:

Review of the policy and procedure "Chapter: Medical Staff, Policy Number MS 08: History and Physical Examinations" revised 09/01/2020 stated, "the LIP who is responsible for the care of the patient during the patient's inpatient stay is responsible for ensuring that an H&P is performed, documented, and authenticated for each hospital inpatient ...within 24 hours after the patient's admission."

Review of patient #61's chart on 05/03/2022 3:35 p.m. with Staff RN (Registered nurse) #7 revealed the patient was admitted through the emergency department on 4/25/2022 to the ICU (Intensive care unit) for altered mental status and hypotension. Physician orders were placed 4/25/2022 2:08 p.m. for admission to ICU. Patient #61 was held in the ED (Emergency department) until admission to ICU 04/25/2022 9:27 p.m. due to lack of bed availability in ICU. There was no evidence of a history and physical in the medical record and the patient remained a current inpatient at the time of surveyor chart review.

An interview with Staff RN ID# 7 revealed the facility did have a policy and procedure on history and physical requirements stating they need to be placed in the medical record within 24 hours of admission. She confirmed the facility failed to follow the medical staff policy referring to history and physicals for Patient ID #61.

An interview with Staff ID#55, HIM Director on 5/4/2022 11:25 a.m. revealed that one of the current quality/performance improvement medical record initiatives included ensuring all medical records have history and physicals on the chart within 24 hours of admission.

Based on observation, interview and record review, the facility failed to ensure pharmaceutical services met the needs of patients. The facility failed to:

Ensure the pharmacy was administered according to acceptable professional principles in 5 of 5 pharmacy rooms that were checked (Main pharmacy (campus A), Medical surgical unit (campus A), Main Pharmacy (campus B), Emergency department (campus B) and surgical unit campus B). The facility failed to ensure:

Medications were stored and prepared in a manner to prevent cross contamination. The facility failed to ensure medications, supplies and biohazards were separated.

Medications were stored in a temperature regulated area.

Medications were rotated in a manner to prevent usage of expired medications.

Equipment used in the pharmacy was functional and sanitary.

There was a system to ensure prescription pads were accurately accounted for and maintained in a manner to prevent improper usage and/or drug diversion in 4 of 5 medication rooms that were checked (Main campus (A), Medical surgical unit (campus A), Emergency department (campus B) and the surgical unit at Campus B

Refer to A tag 0491 for additional information.



B. The facility failed to ensure there were adequate numbers of staff in 2 of 2 Main Pharmacies (campus A and B).

The facility failed to ensure there were adequate numbers of pharmacist and pharmacy technicians from 04/17/2022 to 05/02/2022.

The facility failed to ensure new employees received adequate supervision and complete orientation training in 2 of 2 pharmacy technicians (Staff #'s 10 and 11).

Refer to A tag 0493 for additional information.



C. The facility failed to ensure staff compounded medications in a manner to prevent cross contamination in 1 of 2 compounding rooms (Main campus A). Staff contaminated their hand during the process and failed to sanitize before proceeding.

Refer to A tag 0501 for additional information.

Based on observation, interview and record review, the facility failed to ensure the pharmacy was administered according to acceptable professional principles in 5 of 5 pharmacy rooms that were checked (Main pharmacy (campus A), Medical surgical unit (campus A), Main Pharmacy (campus B), Emergency department (campus B) and surgical unit campus B). The facility failed to ensure:


A. Medications were stored and prepared in a manner to prevent cross contamination. The facility failed to ensure medications, supplies and biohazards were separated.

B. Medications were stored in a temperature regulated area.

C. Medications were rotated in a manner to prevent usage of expired medications.

D. Equipment used in the pharmacy was functional and sanitary.

E. There was a system to ensure prescription pads were accurately accounted for and maintained in a manner to prevent improper usage and/or drug diversion in 4 of 5 medication rooms that were checked (Main campus (A), Medical surgical unit (campus A), Emergency department (campus B) and the surgical unit at Campus B


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


Findings include:


During an observation on 05/02/2022 after 9:49 a.m., the following was found:

Main Storage Room (Campus A)

A storage room was found with cardboard boxes of supplies and medications. Some of the boxes were open and supplies had been removed. A bag of sterile Clinimix intravenous solution (IV) was found on top of one of the cardboard boxes. Sterile needles had been removed from a box and placed in an open plastic bin. The open plastic bin was underneath shelves of cardboard boxes. There was an open box of 20 cc syringes which were on a shelf underneath cardboard box. There was also an open box of total parental intravenous filters on a shelf.
In another corner of the storage room was boxes of paper stored in the room.

Staff #10 was observed to bring a soiled crash cart to the storage room and Staff #9 (pharmacy technician) rolled the cart into the door of the room. Two trays of medication which was covered with a plastic wrap was removed from the cart and placed on a stainless-steel cart in the room.

Registered nurse (RN) #35 brought a clean crash cart back to the storage room. Staff #9 (pharmacy technician) placed the trays of medication that were removed from the soiled cart into the clean cart without replacing or sanitizing the plastic wrap.


Attached Storage Room (Campus A)

The smaller storage room had boxes of vials of Sodium bicarbonate, Verconium bromide (anesthesia agent), Propofol (anesthesia agent), 0.9 percent sodium chloride and Norepinephrine bitartrate injections (vasopressor agent), and Cardizem (anti-hypertensive agent) stored on shelves and carts in the room.
Review of labels on the side of the medication boxes read to store at 68 to 77 degrees Fahrenheit.

Staff #9 (pharmacy technician) stated she did not know what the temperature of the room was and that the room was not temperature regulated.

Two refrigerators that were not being used were stored on a counter next to vials of medication.

Three used containers of the RX destroyer (drug disposal units) were stored on a cart in the room which was also being used for storage of medications. One of the RX destroyer containers had a dried brown substance down the side of it. On another shelf in the room were used and unused containers of RX destroyer containers stored together.

A biohazard container was stored in the same room and had used personal protective equipment (PPE) in it.
There was no separation of clean and soiled items.


Main Pharmacy (Campus A)

In one station in the pharmacy were trays of medication that had been removed from the crash carts on the units. The trays were stacked ½ way up the wall. Some of the trays had the expiration date of 04/30/2022 on them.

Two medication caddies were stored on the floor in the same area. When opened one of the caddy's had a box of Sodium bicarbonate syringes in it.
Staff #9 said they were unable to process the trays because of not having enough staff in the area. Staff #9 identified the caddies as being cardiovascular caddies which needed to be refilled.

Another crash cart was found stored in a corner and was pushed up against a shelf of intravenous fluids. The label on the cart revealed it was a cart that needed to be replaced because the antibiotic Cipro expired in it January 2022 (4 months ago).

Plastic bins of intravenous fluids were stored on the shelves. The fluids were stored in a manner where the ones that were due to expire at an earlier date were at the bottom of the bin.

The tube system used to send medications to the medical units were found with dried brown spills and debris in it.

The wall hand sanitizer had a drip pan which was soiled with dust and debris.

A medication transportation cart was stocked with bags of intravenous fluids and there was no protective guard at the bottom for protection from cross contamination.

While checking the Medication Carousel for expired medications it started turning and the indicator lights did not come on.

Staff #9 (pharmacy technician) stated the indicator lights notified the staff of where the next medication bin was that needed filling. Staff #9 (pharmacy technician) stated sometimes the lights work and sometimes they don't. The equipment has been malfunctioning since 1995. Someone came out and did maintenance on it about 6-8 months ago.



Review of the facility's policy named "Medication Security and Storage Chapter: Medication Management" dated 06/16/2020 revealed the following:

" ...1. Medications Stored in the Pharmacy
A. All designated and authorized pharmacy personnel shall observe proper storage and security requirements for medications and supplies ....
D. All medications are stored according to the package insert or per additional manufacturer information, if available.
E. Proper environmental control must be maintained (i.e., proper lighting, temperature and humidity, conditions of sanitation, ventilation and segregation) in the pharmacy ...

H. Inventory Management ...
6. Medication inventory shall be rotated such that items with longer manufacturer's expiration or beyond use dating are placed at the rear of on the bottom. Inventory with shorter dating will be used first ...

...Expired, beyond use, discolored, damaged or inappropriate labeled medications are removed from active stock and quarantined until removed from the facility ..."



46010

Medical Surgical Unit (Campus A):
Observation during tour of 4th floor Medical Surgical Nursing unit on 5/3/2022 1:16 p.m. with Staff RN #15 included medication room with locked entry door. When accessed by Staff RN #15, there were 10 medications in clear labeled pharmacy bags, with patient labels for multiple patients affixed to the front of the bags. There were blue bins with patient labels which she stated were where medications should be placed. She stated the spikes on left side of medication room wall were labeled for hanging IV medications and fluids for patients.

In addition, IV medication phytonadione (vitamin K1) 10 mg in 50 cc normal saline was found lying on the counter in the medication room and labeled for a patient on the unit. However, there was no light protection for the IV phytonadione.

Interview with Staff RN #15 5/3/2022 1:20 p.m. validated the medications lying on the counter were both brought by pharmacy technician and delivered to that location or placed by nursing staff on counter when retrieved from tube station system. She confirmed that each patient had a labeled medication bin that the medications should be placed in and a labeled wall hanging location for IV medications/fluids however the practice has been to lay them on the counter.

Interview 5/3/2022 1:20 p.m. with Staff RN #15 confirmed that phytonadione (vitamin K1) was light sensitive and should have had a brown bag covering for protection for light. She validated she was aware that light may render the medication ineffective and therefore fail to adequately treat a patient who has potential for or active bleeding.

Review of the facility's policy named "Medication Security and Storage, Medication Management" dated 6/16/2020 stated "Locations should ensure medications are stored in an orderly manner in bins, drawers, and carts ...". This policy stated "All medications are stored according to package insert or per additional manufacturer information."

Record review 5/4/2022 2:55 p.m. of phytonadione package insert from Pfizer includes the following instructions, "Protect from light at all times."


Main Pharmacy (Campus B)
Observation 5/4/2022 09:09 a.m. during tour of first floor pharmacy at campus B with Staff #14. There were 18 bags of 1000 ml Lactated Ringers IV fluids in the pharmacy supply bin. All lactated ringers fluids in the bin had an expiration date of April 2022.

Interview 5/4/2022 09:35 a.m. with Staff #14 validated that all 18 bags of 1000 ml lactated ringers IV fluids were expired as of April 30, 2022. She then removed these from the stock when brought to her attention by surveyors and placed them in an adjacent pharmacy office to process.

Review of the facility's policy named "Medication Security and Storage, Medication Management" dated 6/16/2020 stated stated "expired, beyond use, discolored, damaged or inappropriately labeled medications are removed from active stock and quarantined until removed from the facility.


Prescription pads
Observation of Campus A Main Pharmacy on 5/2/2022 11:30 a.m., revealed a narcotic pyxis. The controlled narcotic prescription pads were noted to be in a clear, unsealed plastic bag. There were multiple thicker pads noted and a few thinner pads which appeared to have prescriptions removed. There was "1012" written on a yellow sticky note with prior sets of numbers crossed out. The pharmacy pyxis displayed "1012" expected prescriptions.

Staff #9 (pharmacy technician) confirmed the observation and provided "Open discrepancy Report" forms with run dates to 02/01/2021. Staff #9 (pharmacy technician) said there "had been a discrepancy issue for a while" and they had not "figured out yet what the discrepancy is" with the prescription pads.

Observation of Campus B Main Pharmacy 5/4/2022 9:05 a.m., with Staff #14 (Pharmacy Director). Pharmacy pyxis prescription pads noted to have numbers on the back in black marker. There were 12 "full" pads present and 1 partial pad. The individual prescriptions on each pad were not inventoried. There was no available log demonstrating which Pad numbers have been utilized for filling pyxis stations.

Staff #14 (Director of Pharmacy) confirmed the observation and said there were 100 prescriptions per pad. It was not the practice of the counting pharmacists or technician to count each individual prescription on the "full" pads.

Observation of the Emergency department (ED) medication room on 5/4/2022 at 9:33 a.m., revealed the room door has a keypad lock to access. Staff #14 (Director of Pharmacy) accessed the pyxis upon request. The pyxis monitor screen revealed there should be "114" prescriptions present. When the drawer popped open, the prescription pads were unsecured in an open pyxis drawer with other medications present. The pads were counted and verified with the surveyors. There was 1 "full pad" with 100 prescriptions and a partial pad with 17. This meant the actual count was 3 more than archived. The inventory log showed last verification count was performed by Staff #13 (pharmacy tech) on 4/28/2022. Pyxis activity log showed there was 14 present and she refilled 100 at that time (total 114).

The two prescription pads in the pyxis had the numbers 13 and 15 written on the back of them.

Interview 5/4/2022 at 9:55 a.m., with Staff #14 (Pharmacy director) stated "I will have to go back and try and figure out where the count went off since this is an overage." She confirmed that she was responsible for ensuring proper counts exist and inventory was performed "Monthly." Staff #14(Pharmacy director) was asked about prescription pad #14 and she stated not knowing where it was.

Interview 5/4/2022 at 10:00 a.m., with RN #8 revealed he had been employed at Campus B for "2.5 years." RN #18 stated regarding prescription pads, "if we take the pads out, we count them." He said he was not aware of any "routine inventory" being performed on the pyxis by nursing. RN #18 confirmed that "we do not count the pads in the drawer when the drawer pops open for other medications."

Observation of the Campus B "PSU" (Post-Surgical Care Unit) medication room on 5/4/2022 at 11:00 a.m., revealed prescription pads in the Pyxis. Staff RN #20 performed a pyxis inventory. The pyxis screen revealed the count should be "121." A count with surveyors' present was performed of each pad. A larger pad with number "14" on the back had 100 prescriptions. A thinner pad with number "22" on the back had 20 prescriptions. The total count was 120 which was 1 short from what the pyxis count was expected to be.

Interview 5/4/2022 11:05 a.m., with Staff RN #20 confirmed the prescription pads had a shortage of 1 prescription. She stated that narcotic inventory, including prescription pads was performed weekly by the night shift nurses. She pointed out the calendar on the wall, adjacent to the pyxis, which had documentation that the pyxis had already been counted in the early am on 5/4/2022. There was no documentation of a discrepancy had been recognized at that time for the prescription pads. She stated being pharmacy would be notified to assist with identifying source of incorrect count.

Record review of the "Steward Health Care System Job Description - Pharmacy Director" revealed that a "key responsibility of the pharmacy director" was to be "responsible for all drug storage areas in accordance with legal and best demonstrated practice." In addition, the pharmacy director job description stated, "The Director of Pharmacy shall establish and lead the hospital P&T committee, assuring but not limited to the following items: ..... controlled substance audit reporting, automation reporting."

Based on observation, interview and record review, the facility failed to ensure there were adequate numbers of staff in 2 of 2 Main Pharmacies (campus A and B). The facility failed to ensure:


A. There were adequate numbers of pharmacist and pharmacy technicians from 04/17/2022 to 05/02/2022.

B. New employees received adequate supervison and complete orientation training in 2 of 2 pharmacy technicians (Staff #'s 10 and 11).


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

Findings include:


During an observation on 05/02/2022 after 9:49 a.m., there were 3 techs and one Pharmacist working in the Main Pharmacy (campus A). Two of the techs working were identified by Staff #9 (pharmacy tech) as being new hires and she stated that one of the pharmacists did not come in today. Staff #9 (pharmacist technician) was observed refilling crash carts, answering phones, compounding medications, assisting to fill orders, assisting the orientees and trying to assist the surveyors.

In one station in the pharmacy were trays of medication that had been removed from the crash carts on the units. The trays were stacked ½ way up the wall. Some of the trays had the expiration date of 04/30/2022 on them.
Staff #9 (pharmacy technician) said they were unable to process the trays because of not having enough staff in the area. Staff #9 identified the caddies as being cardiovascular caddies which needed to be refilled.

During interviews on 05/02/2022 after 1:30 p.m.,

Staff #12 (prn Pharmacist) went over staffing numbers for 05/02/2022. Staff #12 (prn Pharmacist) read from a schedule that there was 2 Pharmacist and 4 pharmacy technicians working on 05/02/2022. Staff #12 confirmed that the schedule was incorrect and that there was only 1 pharmacist and 3 pharmacy technicians on days. Staff #12 (prn Pharmacist) provided the actual time sheets for staff for the timeframe of 04/17-30/2022.

Staff #14 (Pharmacy Director) said they had lost staff to another hospital because of higher wages. She said that she tried to schedule 5-6 pharmacy technician per day and that 4 was the bare minimum. Two pharmacists were scheduled for days and 1 pharmacist for nights. Staff #14 said she lost her buyer on 04/20/2022.


Review of pharmacy time sheets from 04/17-30/2022 revealed there was 2 -4 trained pharmacy techs who worked on day shift to cover both campuses. Two more-time sheets were provided, but they were for orientees which could not be counted.

Review of timesheets provided revealed 1 pharmacist working on dayshift for the timeframe of 04/21-26/2022.
The facility was not meeting the minimal number of staff they needed.



During confidential interviews the following was stated:

"Were a little short staffed. The emergency trays are stacked in the corner because we can not get them processed. We do not have a Buyer. The buyer usually fills the emergency trays and takes care of all the inventory."

"Right now, we have 3 pharmacy techs (one intravenous tech, prescription tech and Pyxis tech). We need or would normally work with 5-6 techs on days and 2 on nights. Right now, we are working 12 hour shifts and weekends, sometimes with 1 day off. The normal shift hours are supposed to be 8 hours."

"Because of the staff we are behind on Quality stuff and paperwork. The reports that run off at midnight where we check for shortages. The reports are for auditing-controlled substances are behind 6-8 months."



46010

On 5/2/2022 at 09:50 A pharmacy tour was initiated. The pharmacy staff were observed and interviewed. This revealed the following:

The pharmacy was commonly "short-staffed" due to attrition. There is only 1 pharmacist in the pharmacy, they were not able to participate in clinical patient rounds as the pharmacist must stay in the pharmacy to dispense medications. There is a contracted off-site mobile pharmacist available, however, they could not specify exactly when this pharmacist was available or what exact functions this pharmacist performed besides "verifying new orders." The pharmacy was without a pharmacy buyer currently and short pharmacy techs. It was reported that pharmacists were "filling in as pharmacy techs at times" due to the shortage which precluded them from consistently participating in on-unit patient rounds. "We don't have enough staff. They are not paid enough so they leave for other hospitals. We should have 2 pharmacists here on day shift: one available for rounding and clinical duties and one here in pharmacy for filling prescriptions." They had a clinical pharmacist "2-3 years ago" who "quit and was not replaced."

One staff reported being without a "buyer" and pharmacist and pharmacy tech shortages. When asked who was performing the duties of the vacant positions, it was stated they were "all helping out." The staff member reported being scheduled to work six 12+ hour shifts the week of May 1, 2022, to help cover and reported they had been "working extra" since pre-covid times ("years").

Staff Training
On 05/02/2022 at 09:50 a.m. A pharmacy tour was initiated. The pharmacy staff were observed and interviewed. This revealed the following:

There was 1 pharmacist (Staff ID 8) and 3 pharmacy technicians (Staff IDs 9-11) in the pharmacy for the six hours surveyors were in the pharmacy (0930-1530) on May 2, 2022. 2 of 3 pharmacy technicians (Staff IDs 10-11) were employed less than 1 month and had not completed orientation.

Interview 5/2/2022 at 3:00 p.m., with Staff ID 11 revealed that she received training and orientation on "RXT role" her first week "week of April 3, 2022." She stated that she was "expecting carousel training" week of April 10, 2022 however "I ended up working by myself because we were so short." She expressed she had prior experience at another hospital so she was using her skills gained in that role to function presently. She believed she was working as if orientation was completed.

Interview 5/2/2022 at 3:05 p.m., with Staff ID 10 revealed that she started general hospital orientation April 18,2022. She was scheduled to train on the RXT role the remainder four days of that week. She stated she received sporadic training the following week of April 24 however described short staffing limiting this training. She stated she would be working overtime the week of May 1, 2022 because "they were short-staffed and the director had asked her to work extra."


Interview 5/3/2022 10:02 a.m., with Staff ID 14 pharmacy director was performed via video call. This revealed that new pharmacy technicians are "supposed to participate in general hospital orientation and then role specific training in pharmacy." She stated "we go over the orientation checklist and they have to evaluate themselves." She stated the technician orienting the trainee should be signing off "as they go" and then stated she reviews fully at the "end of orientation." She stated "I have gone with Staff ID 10 & 11 for RXT and pyxis training but I have not signed them off yet." She stated, "I usually do at the time of training but I had a lot going on."

Record review titled "Initial Skills Checklist (Pharmacy Tech-TMCSET & TMCSET Beaumont Campus" showed the following components of the orientation skills checklist included pyxis, unit dose packaging, quality assurance, filling labels, tube system, ordering and receiving medications, CII safe, compounding, code carts, EMR tech functions, IV room procedures, policies, drug trays, communication, USP 800 and carousel competency.

Record review with Staff ID# 10 on 5/2/22 at 3:00 p.m. of her orientation packet titled "Initial Skills Checklist (Pharmacy Tech - TMCSET & TMCSET Beaumont Campus" revealed a completely blank packet with no name on packet and none of the 110 "essential skills" either self-evaluated or validated by staff members. She validated this was her orientation packet and stated she retrieved it from her locker. She stated "I was supposed to have staff check-off as we go, but we have been too busy."

Record review with Staff ID #11 on 5/2/22 at 3:05 p.m. of her orientation packet titled "Initial Skills Checklist (Pharmacy Tech-TMCSET & TMCSET Beaumont Campus" revealed she had self-evaluated 61 of 110 "essential skills". 6 of the 61 self-evaluations were ranked as "1 - some experience, need review and supervision." 0 of 110 essential skills on her checklist had been signed off or validated.

Based on observation and record review, the facility failed to ensure staff compounded medications in a manner to prevent cross contamination in 1 of 2 compounding rooms (Main campus A).

This deficient practice had the likelihood to cause harm to all patients who needed their medications compounded.

Findings include:


On 05/02/2022 after 12:45 p.m., Staff #9 (pharmacy technician) was observed compounding medication. Staff #9 drew up Sodium bicarbonate from a vial into a syringe and inserted it into a bag of ½ normal saline intravenous fluids. Staff #9 reached down and pushed back the top on the biohazard container. With the same gloves and no sanitizing, Staff #9 drew up another syringe of Sodium bicarbonate from a vial and inserted it into the bag of ½ normal saline intravenous fluids.

Review of the United States Pharmacopoeia (USP) Resource Guide <797>dated 2013 revealed "Most CSP (compounded sterile preparations) contamination results from touch. Proper hand hygiene and garbing procedures minimize the risk to your patients."



"Personal hygiene and garbing are essential to maintain microbial control of the environment. Most microorganisms detected in cleanrooms are transferred from individuals..."

Based on observation and interview the facility failed to ensure the dietary department maintained frozen foods in a sanitary environment in 2 of 2 freezer units observed and failed to store 12 or more clean food ladles in a sanitary fashion on campus A, during a 5/2/2022 tour.

This deficient practice had the likelihood to effect all patients of the facility.

Findings included.

On the morning of 5/2/2022 the dietary department on Campus A was toured. Food intended for patient preparation was found open to air, in the freezer. Food that is not properly sealed prior to storage will risk cross contamination and nutrition value and flavor will be compromised. Observations are recorded below.

Reach in freezer:

1. A plastic bag of "tater tots" was picked up in the refrigerator and the content spilled out into the freezer and onto the floor.
2. Mixed vegetables were found in a non sealed plastic bag in the freezer.
3. Chicken Pieces were found in a plastic bag open to the air.
4. A bag of carrots was found open in the freezer.

Walk in freezer:

1. Chicken frozen in a bag was left open to the air.
2. Taco shell were in a plastic bag open to the air.
3. Pre-made meat patties were in a plastic bag open to the air.
4. Hot links were in a plastic bag open to the air.
5. Fish fillets were in a plastic bag open to the air.

Service implements used to measure and serve food must be sanitized in a wash, and either dried with a non lint cloth, or stored to air dry in a way that allows moisture to drain and evaporate from the bowl, such has hanging to dry.

Pre area:
A stainless steel counter top was observed with a tall clear tub full of food ladles standing up with the handles down and the bowl of the ladles up. The dietary manager, staff #1 confirmed she was aware of the storage of ladles should be hung to dry and a solution was being worked on.

Based on document review and interview the facility failed to ensure the operating surgeon documented specific tasks performed by 2 (First Assistant #24 and #25) of 2 First Assistants in 5 (Patient #56, #65, #66, #87, and #88) of 5 medical records reviewed.

Findings at Campus A Include:


PATIENT #56

Patient #56 was a 77-year-old male scheduled for a Left Above the Knee Femoral Popliteal Bypass on 5/03/2022 by Physician #9. Patient #56 was taken to the operating room at 7:00 AM on 5/03/2022. Further review of the medical record revealed Physician #9 and #25, Registered Nurse (RN) #9, #24, #32, and Staff #34 were all present during the surgical procedure.

A review of the Post-Operative documentation by Physician #9 revealed RN #24 was the First Assistant for the surgical procedure. No documentation was made by Physician #9 for the specific tasks performed by RN #24 during the surgical procedure.


PATIENT #65

Patient #65 was a 72-year-old female scheduled for a Coronary Artery Bypass with Endovascular Vein Harvest on 5/03/2022 by Physician #9. Patient #65 was taken to the operating room at 10:00 AM on 5/03/2022. Further review of the medical record revealed Physician #9 and #25, Registered Nurse (RN) #9 and #32, and Staff #34 and #56 were all present during the surgical procedure.

A review of the Post-Operative documentation by Physician #9 revealed Staff #56 was the First Assistant for the surgical procedure. No documentation was made by Physician #9 for the specific tasks performed by Staff #56 during the surgical procedure.


PATIENT #66

Patient #66 was a 64-year-old female taken to the OR for an emergent Exploration of the Right Femoral Artery on 4/27/2022 by Physician #9. Patient #66 was taken to the operating room at 5:14 PM on 4/27/2022. Further review of the medical record revealed Physician #9 and #24, Registered Nurse (RN) #34, Certified Registered Nurse Anesthetist (CRNA) #33, and Staff #34 and #57 were all present during the surgical procedure.

A review of the Post-Operative documentation by Physician #9 revealed Staff #56 was the First Assistant for the surgical procedure. No documentation was made by Physician #9 for the specific tasks performed by Staff #56 during the surgical procedure.



PATIENT #87

Patient #87 was a 55-year-old male scheduled for a CABG On Pump with Endovascular Vein Harvest on 4/14/2022 by Physician #9. Patient #87 was taken to the operating room at 7:45 AM on 4/14/2022. Further review of the medical record revealed Physician #9 and #25, RN #9 and #32, and Staff #34 and #56 were all present during the surgical procedure.

A review of the Post-Operative documentation by Physician #9 revealed Staff #56 was the First Assistant for the surgical procedure. No documentation was made by Physician #9 for the specific tasks performed by Staff #56 during the surgical procedure.


PATIENT #88

Patient #88 was a 64-year-old male scheduled for a CABG On Pump with Endovascular Vein Harvest on 4/29/2022 by Physician #9. Patient #88 was taken to the operating room at 8:38 AM on 4/29/2022. Further review of the medical record revealed Physician #9 and #25, RN #9 and #32, and Staff #34 and #56 were all present during the surgical procedure.

A review of the Post-Operative documentation by Physician #9 revealed Staff #56 was the First Assistant for the surgical procedure. No documentation was made by Physician #9 for the specific tasks performed by Staff #56 during the surgical procedure.



An interview was conducted with RN #9 on 5/04/2022 after 10:00 AM. RN #9 was asked if RN #24 performed specific tasks during the surgical procedure for Patient #56. RN #9 confirmed RN #24 does perform specific tasks on all cases. RN #9 was asked what kind of tasks RN #24 performed. RN #9 stated, "Well, everything. RN #24 can harvest veins, open and close the surgical site, assist in placing implants, control bleeding vessels, and whatever Physician #9 needs her to do." RN #9 was asked if Physician #9 stays in the operating suite until the surgery is complete. RN #9 stated, "He will leave the Operating Room (OR) once the critical part of the surgery is over and let RN #24 close the surgical site."

An interview with Staff #34 was conducted on 5/5/2022 after 10:00 AM. Staff #34 was asked what specific tasks were performed by RN #24 during the surgical procedure. Staff #34 replied, "RN #24 can harvest the vein with the certification that she has. RN #24 ligates tissue and closes the surgical site when the procedure is complete. RN #24 sutures and ligates tissues" Staff #34 was asked if the Physician #9 was in the OR while RN #24 was closing the surgical site. Staff #34 stated, "No, he usually leaves the room and goes and writes physician orders for postoperative care and RN #24 closes all three layers of the wound; the subcutaneous tissue, the fascia, and the skin. Staff #56 works with Physician #9 on a regular basis also. I don't think Staff #56 has the certification to harvest the vein like Staff #24 does but I am not sure." Staff #34 was then asked if the First Assistants privileges were posted in the Surgery Department so that staff were aware of the specific privileges allowed by the Medical Staff. Staff #34 stated, "Not that I am aware of."


An interview was conducted with RN #13 on 5/4/2022 after 10:00 AM. RN #13 was asked if RN #24 and Staff #56 were employees of the facility. Staff #13 stated, "No, they are not employees of the facility. They are in a group that the facility has a contract with. We use them for our First Assistants. Some of them used to work privately for the surgeons but decided to create their own group and just contract with the facility. They bill the facility directly for cases they are involved in." RN #13 was then asked if the surgeon leaves the OR and the First Assistant closes the wound without the surgeon present. RN #13 replied, "Yes they do on most cases, but I cannot say they do that on all of them." Staff #13 also confirmed that the First Assistants perform specific tasks they are credentialed for during the surgical procedures that require supervision by the Surgeon, but supervision is not always done."



A review of the credential file for Staff #56 was completed on 5/5/2022 with Staff #21. Reappointment was approved on 2/08/2022 for a two-year period ending on 12/31/2023.

Further review of the credential file revealed:

" ...PROCEDURE

All privileges are performed under the direct supervision of the surgeon.

Intra-operatively:
Assists with patient positioning, skin prep and draping
Provides wound exposure, closure, and dressing application
Handles tissue appropriately to reduce the potential for injury
Uses and manipulates surgical instruments
Assists in controlling blood loss
Sutures tissue-subcutaneous and skin
Apply electrodes, tourniquets
Surgical counts with circulator
Suctioning
Assist with placement and securement of drains
Utilizes appropriate techniques to assist with Hemostasis
Injection of local anesthetic into the skin and subcutaneous tissue

Non-Core Privileges: UNDER DIRECT SUPERVISION WHILE SURGEON REMAINS PRESENT AND SCRUBBED IN.

Use of staplers, clip appliers, etc.
Closure of very deep tissue layer (peritoneum, muscle, fascia)
Endovascular Vein Harvesting ..."



A review of the credential file for RN #24 was completed on 5/5/2022 with Staff #21. Reappointment was approved on 11/09/2021 for a two-year period ending on 08/31/2023.

Further review of the credential file revealed:

" ...DUTIES IN PRESENCE OF PHYSICIAN ONLY

Assist in surgery
Use of Hemostatic devices (Ligasure, Harmonic Scalpel, Enseal) while surgeon is present and scrubbed in
Use of staplers, clip appliers, etc. while surgeon is present and scrubbed in
Closure of every deep tissue layer (peritoneum, muscle, fascia) while surgeon is present and scrubbed in
Endovascular Vein Harvesting while surgeon is present and scrubbed in ..."


Staff #56, RN #13, and RN #9 confirmed the above findings.

Based on interview and record review the facility failed to establish and implement a policy, that permitted Respiratory Therapist to provide lab services on hospital campus B on the weekend. Respiratory Therapy job duties included laboratory services from January 2022 through May 3, 2022 (5 months).

This deficient practice had the likelihood to effect all patients of hospital campus B.

On 5/3/2022, during the morning tour of the laboratory services area on the Beaumont campus, an interview with the lab technician, # 30 explained that campus B had a Monday-Friday lab technician who provided laboratory services. On the weekend, should laboratory services be required, the Respiratory Therapist (RT) would also function as laboratory technician.

On 5/3/2022 the job descriptions for RT's # 19 and #29 were reviewed. The was no policy to support the RT while providing lab services and the RT job description failed to include specific lab services they would be responsible for when the RT worked the weekend.

On 5/3/2022, in the afternoon, an interview with staff member #41, the Manager over the Respiratory Therapist, confirmed, there was a verbal process but no policy had been written or approved by the Governing Body/Medical Staff permitting Respiratory Therapist to provide laboratory services on weekends. She also confirmed that although competencies had been completed for the Respiratory Therapist, the additional job duties had not been included in the Respiratory Therapist Job Description.