HospitalInspections.org

Based on review of facility policy and procedure, the CDC (Center for Disease Control and Prevention) Medication Preparation Guidelines, ED (emergency department) and inpatient medical records (MR) and staff interviews, it was determined the facility failed to ensure nursing followed acceptable standards of care of patients. This included documentation of assessments, medication/ blood preparation and administration and obtaining and following physician orders.

This deficient practice had the potential to negatively affect all patients admitted to the hospital.

Refer to A 0392, A 0405, A 0410

Based on review of facility policies and procedures, ED (emergency department) and inpatient medical records (MR) and staff interviews, it was determined the facility failed to ensure nursing staff:

1. Obtained complete written and/ or verbal physician orders before providing care for patients in the ED and admitted to hospital.

2. Obtained vital signs/ assessments for unstable patient or patient with respiratory distress.

3. Followed physician orders for withdrawal assessments, vital signs, tests, and wound care for patients admitted to the hospital.

4. Assessed and documented a description of wounds per policy.

5. Performed and documented pain assessments for patients treated in the ED.

This deficient practice affected 6 of 15 inpatient records reviewed and 4 of 10 ED records reviewed including PI # 8, PI #13, PI # 17, PI # 19, PI # 10, PI # 1, PI # 30, PI # 26, PI # 28 and PI # 25. This had the potential to negatively affect all patients admitted to the hospital.

Findings include:

Facility Policy: Verbal and Written Orders (General)
Reference #: 9008
Reviewed date: 12/21

Policy:
Orders for patient treatment and medications, including the administration of medications, to be carried out when given by a qualified physician... who has been approved as a member of the medical staff of this hospital. All orders of medication and treatment shall be written into the medical chart of the patient...

All orders for medications shall include the date and time of the order, the name of the drug, the doseage, the route, frequency of administration and the physician's signature.

All orders for treatment shall include the type of treatment, specific requirements of the treatment (such as wet to dry dressings, etc) and the frequency of the treatment.

Procedure:
Written Orders: These shall be filled when written as stated above and signed by the practitioner.

Verbal/ Telephone Orders... A "read back" process will be conducted by the individual receiving a telephone or a verbal order...

The prescribing practitioner must signed the written record of the verbal/telephone order within 24 hours of giving the order...

New Orders: New orders must be written for the patient upon transfer in to and out of a unit or the hospital at each hospital admission...

Facility Policy: Completion of the Emergency Room Record
Reviewed date: 12/01/2019

1. Every patient presenting to the Emergency Room must have an Emergency Room Record completed..
2. This is permanent legal record and must be filled out correctly and completely...
5. Patient information:
a. Document how patient arrived and what time... also the date must be documented.

7. Check vital signs on arrival to the ER (Emergency Room) and re-check if abnormal. If the patient is acutely ill or not stable, it may be advisable to start a nurse's note so that the vital signs and observations can be monitored closely and recorded; keep the physician informed of any changes in vital signs...

13. Disposition of patient: Always document the condition of the patient, time of discharge, who patient was discharged with...

16. Never leave a blank space...

Facility policy: Wound Care Policy and Procedure
Reviewed date: 12/31/21

Policy: Physicians will provide specific orders for nursing staff to provide wound care.
Procedure:

3. Documentation of wounds must include type of wound, measurements including length, depth, and width, description of the wound bed, surrounding area, undermining, staging, color, odor and estimated amount of drainage ...

5. The RN (Registered Nurse) or LPN (Licensed Piratical Nurse) shall perform/teach wound care as ordered by the physician.

Facility Policy and Procedure Reference # (Number) 2302
Subject: EMTALA (Emergency Medical Treatment and Labor Act)
Department: ED
Reviewed: 12/21

Procedures:

A. Triage...documentation must include:
Complete set of vital signs (including oxygen saturation and pain level if indicated)...

1. PI # 8 was admitted to the Emergency Department (ED) on from 1/8/22 to 1/11/22 and then admitted as inpatient on 1/11/22 at 6:00 PM with diagnoses including Shortness of Breath (SOB), and Covid.

Review of the 1/8/22 ED record revealed the nurse administered at 5:50 PM Humulin R (insulin) 5 units, SQ (Subcutaneous) and Normal Saline (NS) IV (Intravenous) at KVO (keep vein open). There was no physician orders for the insulin and IV fluid.

Review of nursing vital sign documentation revealed on:

1/8/22 at 4:32 PM, BP (blood pressure): 178/103; HR (heart rate) 115; R (Respirations) 24; Oxygen (O2) saturations (Sats) 97%.

1/8/22 at 5:20 PM, HR 110; O2 Sats 88%.

1/9/22 at 5:10 AM, BP 177/88; HR 99; O2 Sats 92%.

1/11/22 at 12:15 AM, BP 101/63; HR 101; O2 Sats 72% (42 hours since last vital signs were documented.)

1/11/22 at 2:00 AM revealed documentation the nurse was called to the patient room by the aide and found PI # 8 had become weak and slid to the floor. HR 122; R 28 and shallow; O2 Sats 55%.

1/11/22 at 6:30 AM, HR 113; O2 Sats 87%. (4 hours and 30 minutes later).

Review of the Adult General Admission Orders revealed vital signs were ordered every 6 hours. There was no time documented the orders were to begin.

1/11/22 at 8:00 AM, HR 106; O2 Sats 75%, there was no documentation the physician was notified for the decreased O2 Sats.

1/12/22 at 1:45 AM, O2 Sats 57% because oxygen tank was empty and there was no further documentation for that shift.

1/12/22 at 8:23 AM, HR 131; O2 Sats 92%.

1/13/22 at 5:39 AM, BP 103/71; HR 97; O2 Sats 70%. (21 hours since last vital signs were obtained.)

In a written response received 1/19/22 at 3:10 PM, Employee Identifier (EI) # 2, Director of Nursing (DON) confirmed nursing failed to ensure complete orders were obtained before administering medications and failed to assess vital signs for unstable patient.

2. PI # 13 was admitted to the facility on 10/28/21 with diagnosis of Medical Stabilization.

Review of the 10/28/21 physician Medical Stabilization Orders written at 3:30 PM included:

6. Vital signs every 4 hours X (times) 36 hours.
7. Complete the Withdrawal Severity Assessment form at a minimal every 4 hours....
11. EKG (Electrocardiogram) if patient: over 50 ... Cocaine User...

Review of the 10/28/21 Rapid Drug Screen resulted at 2:02 PM revealed patient was positive for cocaine. There was no EKG provided dated 10/28/21.

Review of the MR revealed vital signs which included blood pressure, respirations, pulse, temperature, O2 Sats were obtained by the staff on 10/28/21 at 5:35 PM and 7:38 PM.

10/29/21: 1:29 AM (this was 6 hours since vital signs were obtained); 4:00 AM, 9:13 AM (6 hours 13 minutes later); 7:44 PM (7 hours 31 minutes later).

10/30/22: 9:44 AM (14 hours later)

Review of nursing documentation dated 10/30/21 at 7:45 PM revealed patient was found in the floor of the hallway and PI # 13 complained "Can't breathe." Nursing assessment revealed patient was confused, anxious, skin cool, clammy and moist. There was no documentation the nursed assessed the patient's vital signs.

At 8:22 PM revealed the last documented vital signs (11 hours later) PI # 13 was transferred to another acute care hospital.

The surveyor submitted written questions to the facility on 1/12/22 at 3:09 PM, and in written response and interview conducted 1/13/22 at 3:40 PM, EI # 2 confirmed the staff failed provide evidence of EKG dated 10/28/21. EI # 2 confirmed the nurse failed to assess patient's vital signs in a crisis situation or followed physician orders to complete vital signs and withdrawal assessments every 4 hours.

3. PI # 17 was admitted 11/24/21 with chief diagnosis as Bradycardia.

Review of the 11/24/21 at 3:25 PM, ED nursing documentation revealed a bed bath was provided.

Review of the Adult General Admission Orders dated 11/24/21 at 6:00 PM revealed, "Bactroban Ointment to sores post bath."

Review of the 11/24/21 at 8:32 PM Nursing Initial Interview assessment revealed, "Socks stuck to skin. Thick crusted skin peeled off part of left foot ... new skin breaks to buttocks, penis, and legs." The nurse failed to measure and describe the open wounds per policy.

Review of nursing documentation dated 11/24/21 at 8:32 PM to 11/25/21 6:40 PM revealed the staff failed follow physician orders to apply Bactroban to sores.

On 1/13/22/ at 3:55 PM, EI # 16, Detox Clinical Manager returned written responses to surveyor and EI # 2, DON, confirmed the staff failed to follow the facility policy and document a complete assessment of wounds and follow physician orders.

4. PI # 19 was admitted to the facility on 11/11/21 with the primary diagnosis of Abdominal Pain.

Review of the ED record revealed the following medications were administered at: 6:50 AM Toradol 60 mg (milligram) IM (Intramuscular).
9:33 AM Rocephin 1 GM (gram) IVPB (Intravenous Piggyback).
10:00 AM KCL (Potassium Chloride) 40 meq (milliequivalent) PO (by mouth).
11:15 AM NS @ 75 cc.
11:50 AM Flagyl 500 mg IVPB.

There was no physician's order documented for the Toradol, Rocephin, KCL, NS, and Flagyl.

In an interview conducted on 1/13/22 at 3:17 PM, EI # 2 confirmed the ED nurse failed to ensure complete physician orders for medications were documented before administering medications.

5. PI # 10 was admitted to facility on 10/29/21 with diagnoses including Hypernatremia, Weakness, and Altered Mental Status.

Review of 10/29/21 Adult General Admission revealed physician orders written at 7:00 PM to apply TAO (Triple Antibiotic Ointment) 1% to skin daily and PRN (as needed.)

Review of nursing notes dated 10/29/21 to 11/19/21 revealed no documentation of a complete assessment of wounds or application of TAO daily.

Review of the 11/19/21 physician orders revealed wound management for ulcers left arm and hand. Saline lavage, followed by Bactroban and Telfa.

Review of nursing notes dated 11/19/21 to 11/23/21 revealed no documentation nursing assessed the ulcers to left arm and hand or provide wound care as ordered.

In an interview conducted on 1/12/22 at 10:40 AM, EI # 2, DON, confirmed nursing failed to document complete wound assessment or followed physician orders for wound care.



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6. PI # 1 was admitted to the facility on 12/26/21 with an admitting diagnosis of Possible UTI (Urinary Tract Infection), Right Lower Lobe Pneumonia and Unresponsiveness.

Review of the physician orders dated 1/1/22 at 9:05 AM revealed an order for O2 (Oxygen) via NC (Nasal Cannula) at 4 L (liters). Further reveiw of the physician orders revealed no documentation of O2 at 2L per NC.

Review of the MR revealed on 1/3/22 at 12:48 AM the nurse documented the patient was on oxygen at 2 L by NC.

Review of the MR revealed on 1/6/22 at 6:19 AM the nurse documented oxygen at 2 L per NC.

Review of the physician orders revealed no documentation of an order for oxygen at 2L per NC only an order for 4L per NC.

An interview was conducted on 1/13/22 at 2:30 PM with EI # 4, Registered Nurse (RN), who confirmed an order was not written for the 2 liters of oxygen.


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7. PI # 30 presented to the ED 12/1/21 at 5:09 PM, and the cc (chief complaint) was Cat Bite to the right hand.

Review of the nurse triage and assessment documentation failed to contain a pain assessment, no level of pain present or maximum was documented and the pain documentation was left blank and not completed.

8. PI # 26 presented to the ED 10/15/21 at 11:55 AM, and the cc was Asthma.

Review of the nurse triage and assessment documentation failed to contain a pain assessment, no level of pain present or maximum pain was documented and the pain documentation was left blank.

9. PI # 28 presented to the ED 11/2/21 at 4:44 PM, and the cc was Penile Discharge.

Review of the nurse triage and assessment documentation failed to contain a pain assessment, no level of pain present was documented and the pain documentation area was left blank.

10. PI # 25 presented to the ED 10/6/21 at 1:40 PM, and the cc was Chest pain/dizzy.

Review of the nurse triage and assessment documentation revealed a 1 hour 10 minute duration of chest pain/dizziness. However the pain assessment documentation was left blank which included the present pain level on the 0-10 pain scale and maximum pain level.

Written questions were submitted on 1/12/22 which included no nurse pain assessments documentation on the 4 ED records above. In an interview on 1/13/22 from 2:48 PM to 3:09 PM, EI # 2, Director Of Nurses confirmed the nurse failed to perform and document pain assessments on PI's # 30, 26, 28 and PI # 25.

Based on observations, review of facility policy and procedure, medical record (MR), CDC Medication Preparation
FAQs (Frequently Asked Questions) regarding Safe Practices for Medical Injections, Care Through Pain Assessment and Management and interviews, it was determined the facility staff failed to ensure:

1. All supplies available were appropriate for patient use and within the expiration date.

2. Single dose parenteral medications were prepared/administered per CDC recommendations and multidose vials were labeled when open, and discarded after 28 days.

3. Medications not administered were wasted and discarded per facility policy.

4. Medications were not left at the bedside and the medication (med) cart on the Medical Unit was secured/locked when staff were not in attendance.

5. Staff followed the facility policy and procedure for medication preparation/administration including insulin, a high alert drug.

6. Staff followed the facility policy and procedure for patient identification prior to medication administration.

7. Staff completed follow up assessments after administration of pain medications.

This affected PI (Patient Identifier) # 8 and unsampled patients during observations, 2 of 15 inpatient records reviewed including PI # 15 and PI # 5 and had the potential to affect all patients treated at the facility.

Findings include:

Facility Policy # 70245 MS (medical surgical)
Subject: Medication Administration
Reviewed: 1/21

Policy:

...The following policies will govern administration of medication in this institution:

...No medications will be left at the patient's bedside except for...nitroglycerin...respiratory inhalers...antacids, eye drops, throat lozenges and external preps for topical application..Positive identification of the patient will be ascertained by reading the identification wrist band and...additional patient identifiers prior to administration of all medications.

The medication nurse will check for medication allergies prior to administration of all medications.

...Prior to the administration of each...insulin dose, the amount ordered, and amount prepared must be checked by two (licensed) nurses.

...If a medication has been opened and is refused by a patient, it is to be destroyed. This also applies to medications held because of nurse discretion...Wasted drugs will be witnessed and cosigned.

All medication orders should contain one (1) specific dosage, never a dosage range, with the exception of those orders using a sliding scale. All medication orders are to be timed and dated by the authorized person writing the order...

Medication carts will be locked when left unattended.

Each dose of medication administered is to be properly recorded in the patient's medical record...

CDC Medication Preparation

FAQs (Frequently Asked Questions) regarding Safe Practices for Medical Injections

Questions about Single-dose/Single-use Vials

...1. What is a single-dose or single-use vial?
A single-dose or single-use vial is a vial of liquid medication intended for parenteral administration (injection or infusion) that is meant for use in a single patient for a single case, procedure, injection. Single-dose or single-use vials are labeled as such by the manufacturer and typically lack an antimicrobial preservative.
2. Can single-dose or single-use vials be used for more than one patient?
Vials that are labeled as single-dose or single-use should be used for only a single patient as part of a single case, procedure, injection. There have been multiple outbreaks resulting from healthcare personnel using single-dose or single-use vials for multiple patients ...

...Questions about Multi-dose vials

5. When should multi-dose vials be discarded?
Medication vials should always be discarded whenever sterility is compromised or cannot be confirmed. In addition, the United States Pharmacopoeia (USP) General Chapter 797 [16] recommends the following for multi-dose vials of sterile pharmaceuticals:
...If a multi-dose has been opened or accessed (e.g., needle-punctured) the vial should be dated and discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that opened vial.
...If a multi-dose vial has not been opened or accessed (e.g., needle-punctured), it should be discarded according to the manufacturer's expiration date.
The manufacturer's expiration date refers to the date after which an unopened multi-dose vial should not be used. The beyond-use-date refers to the date after which an opened multi-dose vial should not be used. The beyond-use-date should never exceed the manufacturer's original expiration date.

Improving the Quality of Care Through Pain Assessment and Management

Chapter 17 Improving the Quality of Care Through Pain Assessment and Management
Agency for Healthcare Research and Quality (US); 2008 Apr
Hughes RG, editor.
Rockville (MD)

Assessment of Pain:

Assessment of pain is a critical step to providing good pain management.

The most critical aspect of pain assessment is that it is done on a regular basis (e.g., once a shift, every 2 hours) using a standard format. The assessment parameters should be explicitly directed by hospital or unit policies and procedures. To meet the patients' needs, pain should be reassessed after each intervention to evaluate the effect and determine whether modification is needed. The time frame for reassessment also should be directed by hospital or unit policies and procedures.

American Pain Society Current Guidelines:

One of the first quality improvement programs was developed by the American Pain Society. The quality improvement guideline was refined and expanded in 2005 based upon a systematic review of pain quality improvement studies conducted over the past 10 years. The emphasis has shifted from processes to outcomes Recognize and treat pain promptly.

Involve patients and families in pain management plan.

Improve treatment patterns.

Reassess and adjust pain management plan as needed.

Monitor processes and outcomes of pain management.

Principle of Analgesic Management of Pain:

Assessment of effect should be based upon the onset of action of the drug administered; for example, IV opioids are reassessed in 15-30 minutes, whereas oral opioids and nonopioids are reassessed 45-60 minutes after administration.

1. A tour and observations of care in the ED (Emergency Department) were conducted on 1/11/22 from 11:10 AM to 1:20 PM with Employee Identifier (EI) # 4, Registered Nurse (RN) ED Charge Nurse. The following observations were made:

In ED Room 3 was one open pack sterile Curity 4x4 (4 inch long, 4 inch wide) gauze sponges and one Vaseline Petroleum gauze pack expired 9/30/21.

In the ED Drug room was one open vial Thiamine, expiration date 11/22 but no open date label;
One 10 ml (milliliter) single use vial Sterile Water, and 1 single use open vial Potassium Chloride 40 mEq (milliequivalents) /20 ml. EI # 4 was asked if staff reuse medications labeled single use? EI # 4 responded "they are good for 14 days if mixed".

In the narcotic box were Norco 5, 12 tablets in the secure package. There was 1/2 tab (tablet) in a plastic baggie, labeled Norco 5, lot number and expiration date. The 1/2 tablet was gem clipped to the Norco packet. EI # 4 was asked if the 1/2 tablet should not have been wasted and discarded? EI # 4 did not respond.

In the ED Drug room refrigerator was one open vial Humulin 70/30 insulin labeled 6/6/21 and one open vial of Humulin R (Regular), not labeled with the open date.

In the ED Drug cabinet was one open bottle of Dexamethasone Ophthalmologic suspension 5 ml (milliliter) and one Carvedilol 25 mg (milligram) tablet, expiration date 3/22. The Carvedilol individual drug packet was open and available for use.

In the ED Trauma 1 supply cabinet were 2 chest drainage units expired 9/5/21. There were 3 Kendall Feeding Tube and Urethral Catheter, 8 FR/CH labeled "For Veterinary Use Only". The surveyor asked EI # 4 how these Veterinary supplies were obtained and why they were available for ED use? EI # 4 did not respond.

On the emergency cart was one set Quik Comforts of pediatric pacing, defibrillator, ECG (electrogram) leads which were removed from the original packet. The surveyor asked EI # 4 what was the expiration date for the pads? EI # 4 provided no documentation of an expiration date and reported the ED staff could measure and cut pediatric leads from the adult leads.

2. On 1/11/22 at 1:10 PM, EI # 4 entered ED Room 3 with Diphenhydramine 25 mg tablet for administration to an unsampled patient. There were 2 visitors with the unsampled patient. EI # 4 verified the correct patient then exited the ED Room 3 to obtain water for medication administration. EI # 4 left the medication on the table in the room. EI # 4 failed to follow the facility Medication Administration policy.

3. On 1/12/22 from 8:15 AM to 10:45 AM, observations of care were made on the Medical unit with EI # 10, RN.

At 8:25 AM while in the Nurse Station, the surveyor opened medication drawers on the med cart for rooms 208, 218, 220, 211, 217 and 222 and found all 6 medication bins contained medication. The surveyor asked EI # 10 if the patient medication bins were able to be secured? EI # 10 replied "they will have to check this".

At 8:45 AM, EI # 10 attempted to perform hand hygiene at the sink in the "IV (intravenous) room". There was no soap available while EI # 10 washed his/her hands in the employee restroom while the med cart was in the hallway left unattended and not secured.

At 10:15 AM EI # 10 withdrew 10 units (U) Humulin Regular (R) Insulin into an insulin syringe. EI # 10 removed the cap from a prefilled 5 ml 0.9 % NS (Normal Saline) syringe then injected the 10 units of Humulin R from the insulin syringe into the 5 ml NS syringe. The surveyor asked why the insulin was transferred from the insulin syringe to another syringe? EI # 10 responded "the patient had a small port". The Humulin R 10 U was ordered IVP (intravenous push) for a blood sugar of 591 (critical result). In addition, EI # 10 prepared Lantus 24 U via an insulin syringe for subcutaneous administration.

EI # 10 failed to follow the facility medication administration policy for high alert medications and have the insulin doses verified by another nurse.

At 10:20 AM, EI # 10 entered PI # 8's patient room, greeted the patient, and handed PI # 8 a cup with 4 pills, Aspirin 81 mg, Lisinopril 20 mg and Metoprolol 50 mg 2 tablets. While PI # 8 swallowed the 4 pills, then EI # 10 stated, let me look at your name band, are you allergic to any medications? EI # 10 failed to follow the facility medication administration policy and properly identify the patient prior to medication administration.

EI # 10 administered the Lantus sq and Humulin R 10 U IVP, which was transferred from the original insulin syringe into the 5 ml NS syringe. Neither insulin amounts were verified by another nurse per facility policy.

During medication pass observations from 8:45 AM to 10:30 AM, the med cart was left in the Medical unit hallway unattended and medications not secured.

In an interview on 1/12/22 at 12:45 PM, EI # 11, Registered Pharmacist confirmed the alleged Norco 5 1/2 tablet should have been wasted, the med cart should be locked and secured when staff are not in attendance. EI # 11 reported he/she had never heard of injecting insulin from one syringe into another syringe.

In an interview on 1/12/22 at 3:30 PM, the above observations including unsecured medication cart bins, single/multidose medication vial use and failure to ID the patient prior to medication administration were reported to EI # 2, the Director of Nurses. EI # 2 stated the RN must have been nervous and confirmed staff failed to follow facility policy for medication administration.




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4. PI # 15 was admitted on 11/23/21 with an admitting diagnosis of Left Hip Pain.

Review of the MR revealed the nurse medicated PI # 15 with Tordol 30 mg (milligrams) on 1/24/21 at 12:55 AM for the complaint of pain to the left hip. Further review revealed no documentation the nurse provided a pain assessment follow up to ensure the Tordol was effective in relieving the patients pain.

Review of the MR revealed the nurse medicated PI # 15 with Tordol 30 mg on 1/24/21 at 12:30 PM for the complaint of pain to the left hip. Further review revealed no documentation the nurse provided a pain assessment follow up to ensure the Tordol was effective in relieving the patients pain.

Review of the MR revealed the nurse medicated PI # 15 with Tordol 30 mg on 1/25/21 at 12:20 AM for the complaint of pain. Further review revealed no documentation the nurse provided a pain assessment follow up to ensure the Tordol was effective in relieving the patients pain.

Questions were provided to the facility on 1/13/22 for response. Upon exit from the facility the facility failed to provide supporting documentation to the surveyor's questions concerning the medical record.

5. PI # 5 was admitted to the facility on 1/5/22 with admitting diagnoses of Alcohol Abuse, Bipolar Disorder and Major Depression.

Review of the MR revealed on 1/5/22 at 9:30 PM EI # 5 was given Motrin 600 mg for the complaint of Left foot pain. Further review revealed no documentation a follow up pain assessment was completed by the nurse to ensure EI # 5's pain had been relieved.

Review of the MR revealed on 1/10/22 at 9:50 PM EI # 5 was given Motrin for the complaint of pain to Left foot. Further review revealed no documentation the nurse provided a follow up pain assessment to ensure the Motrin was effective in relieving the patient's pain.

Questions were provided to the facility on 1/13/22 at 11:30 AM for response. Upon exit from the facility on 1/13/22 at 4:445 PM the facility failed to provide supporting documentation to the surveyor's questions concerning the medical record.



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6. During a tour of the Medical unit conducted on 1/11/22 at 11:30 AM to 12:15 PM the surveyor observed the following medication vials were open and not labeled with date first used:

Thiamine HCL 20 mg/ml 10 ml vial;
Toradol 30 mg/ml 5 ml vial;

Dexamethasone 20 mg/5 ml, 5 ml vial was open and not labeled with date first used and had the expiration date of 12/21.

The above open medication vials and not labeled with date open and expired medication were confirmed by EI # 17, LPN on 1/11/22 at 12:15 PM.

Based on review of medical records (MR), policy and procedure and interviews it was determined the facility failed to ensure staff followed the policy and transfused a unit blood in four (4) hours or less. This affected Patient Identifier (PI) # 9, 1 of 3 records reviewed with blood transfusions and had the potential to negatively affect all patients receiving blood transfusions at this facility.

Facility Policy: Administering a Blood Transfusion
Effective date: 8/01/2021

Policy:
A blood transfusion is the introduction of blood into the body circulation via venipuncture.

Procedure:
12. Unless transfusion is ordered to be given with deliberate slowness, finish in four hours... Infusion time is not to exceed 4 hours...

1. PI # 9 was admitted to the facility on 10/20/21 with the diagnoses of Bronchitis and Chronic Obstructive Pulmonary Disease.

Review of the Blood Transfusion nursing documentation dated 10/22/21 revealed a unit of blood was started at 9:00 AM and was completed at 2:05 PM, which was 5 hours and 5 minutes. The nursing staff failed to ensure the unit of blood was transfused with in 4 hours.

In an interview conducted on 1/12/22 at 10:40 AM, Employee Identifier # 2 confirmed the nurse failed to transfuse the unit of blood within 4 hours per policy.

Based on review of medical records (MR), facility policy and procedure, Facility Medical Staff Rules and Regulations, Monoclonal Antibody Use and interviews with the staff it was determined the facility failed to ensure medical records were complete, accurate, authenticated contained all documentation required.

This deficient practice had the potential to negatively affect all patient served at this hospital.

Findings include:

Refer to: A 0449, A 0450, A 0454, A 0454, A 0464 and A 0467.

Based on review of medical records (MR), facility policy and procedure, Facility Medical Staff Rules and Regulations and interviews with the staff it was determined the facility failed to ensure Physician progress notes were written on a daily basis.

This affected 2 of 2 in-patient medical records reviewed and did affect Patient Identifier (PI) # 1, PI # 8 and had the potential to negatively affect all patients served by the facility.

Findings include:

Facility Medical Staff Rules and Regulations
Facility Policy: Acknowledgement Statement, Provider Enrollment, Credentialing Process
Date: 1/26/21

8. Each member of the Medical Staff shall name another member of the Medical Staff as an alternate to be called to attend his patients in an emergency when the attending physician is not available or until the attending physician can be present...
... Patient rounds (including 23 hour admissions) should be conducted by the in-house physician daily. Failure of a member of the Staff to meet those requirements may result in disciplinary action...

Facility Policy: Medical Records Department-Medical Record Content
Review Date: 12/1/2019

Policy:
It is the policy of Hill Hospital that the medical record shall contain sufficient information to identify the patient, support the diagnosis, to justify the treatment and document the results accurately.

Procedure:

E. Clinical observations are made daily in the progress notes by the physician...These progress notes give a pertinent chronological report of the patient's course in the hospital and reflect any change in the condition and the results of treatment...

1. PI # 1 was admitted to the facility on 12/26/21 with an admitting diagnosis of Possible UTI (Urinary Tract Infection), Right Lower Lobe Pneumonia and Unresponsiveness.

Review of the physician progress notes revealed a progress note per the physician on 1/1/22, 1/2/22 and 1/6/22. There were no physician progress notes within the medical record at the time it was reviewed on 1/12/22 at 11:00 AM for 12/26/21, 12/27/21, 12/30/21, 12/31/21, 1/3/22, 1/4/22, 1/5/22, 1/7/22, 1/8/22, 1/9/22, 1/10/22 and 1/11/22.

An interview was conducted on 1/12/22 at 11:15 AM with EI (Employee Identifier) # 4, Registered Nurse, was asked about the progress notes EI # 4 replied the progress notes were in the paper chart and no other notes were provided to the surveyor for this time frame.



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2. PI # 8 presented to the ED (Emergency Department) on 1/8/22 at 4:32 PM with chief complaint SOB, COVID (Coronavirus Disease 2019).

Review of the ED record revealed documentation by the physician documented PI # 8 had tested + (positive) for COVID 9 days ago.

Record review revealed there was no physician progress notes dated for 1/9/22, 1/10/22, or 1/11/22.

PI # 8 was admitted an in-patient on 1/11/22 with Shortness of Breath and COVID symptoms and expired on 1/13/22.

In a written response received 1/19/22 at 3:10 PM, EI # 2, Director of Nursing, failed to provide evidence of physician progress notes dated for 1/9/22, 1/10/22 and 1/11/22.

Based on review of medical records (MR), facility policies and procedures and staff interviews, it was determined the facility failed to ensure medical records were complete and included documentation for:

1. Patients requiring Cardiopulmonary Resuscitation (CPR).

2. The ED physicians failed to document the time of the initial patient screenings occurred.

3. Signed consents.

4. Extended stay ED patient.

5. Pain assessments.

This has the potential to negatively affect all patients treated at this hospital and did affect 21 of 39 records reviewed. This affected PI # 8, PI # 11, PI # 19, PI # 20, PI # 10, PI # 14, PI # 21, PI # 24, PI # 26, PI # 28, PI # 29, PI # 30, PI # 31, PI # 1, PI # 3, PI # 4, PI # 5, PI # 6, PI # 7, PI # 15 and PI # 16.

Findings include:

Facility Policy: Cardiopulmonary Resuscitation (CPR)
Reference # 1049
Reviewed date: 12/21

Policy: In the event a patient is found to be without discernible pulse and/or respirations, the Cardiopulmonary Resuscitation (CPR) shall be instituted...

CPR Procedure: ...
The Nurse and other assigned staff record the Code process and collect the rhythm strips and secure with the medical record.

Facility Policy: Consents
Reviewed date: 12/01/2019

Procedure:

1. All consents will be written consents...

2. All consents should include the following information:
A. Identity of the patient
B. Current date...
G. Signature of the patient or legal guardian
H. Signature of the witness

9. If the patient has been admitted for a specific course of treatment... the anticipated treatment changes, a new consent form will be signed.

Facility Policy: Medical Record Content
Reviewed date: 12/01/2019

Policy:
... that the medical record shall contain sufficient information to identify the patient, support the diagnosis, to justify the treatment and document the results accurately.

Procedure:
B. The history and physical examination is recorded in the medical record at the time of the patient's admission...
D. There is evidence of informed consent in the patient's medical record.
E. Clinical observations are made daily in the progress notes by the physician ... give a chronological report of the patient's course in the hospital and reflect any change in the condition and the results of treatment.
N. Copy of discharge instructions are given to the patient and filed in the medical record.

Facility Policy: Completion of the Emergency Room Record
Reviewed date: 12/01/2019

1. Every patient presenting to the Emergency Room must have an Emergency Room Record completed..
2. This is permanent legal record and must be filled out correctly and completely...
5. Patient information:
a. Document how patient arrived and what time... also the date must be documented.

7. Check vital signs on arrival to the ER (Emergency Room) and re-check if abnormal. If the patient is acutely ill or not stable, it may be advisable to start a nurse's note so that the vital signs and observations can be monitored closely and recorded; keep the physician informed of any changes in vital signs...

13. Disposition of patient: Always document the condition of the patient, time of discharge, who patient was discharged with...

16. Never leave a blank space...

1. PI # 8 was admitted to the Emergency Department (ED) on from 1/8/22 to 1/11/22 and then admitted as inpatient on 1/11/22 at 6:00 PM (per nurse) with diagnoses including COVID 19, Bronchitis, and Diabetes.

During a tour of the medical unit conducted on 1/11/22 at 11:20 AM the surveyor observed 8 occupied patient rooms and only 7 patients listed on the census provided. EI (Employee Identifier) # 17, Licensed Practical Nurse (LPN) stated one of the patients on the floor was an ED patient and the ED nurse takes care of that patient.

The surveyor requested on 1/11/22 at 11:40 AM from EI # 17 and EI # 10, ED Registered Nurse (RN), a copy of PI # 8's ED record and any documentation from the medical unit at the time of the tour. There was none provided.

PI # 8 was admitted as an inpatient on 1/11/22 (6:00 PM per nurse). On 1/12/22 and 1/13/22 the surveyor requested a copy of PI # 8's record from EI # 2, Director of Nurses (DON) and EI # 3, Quality Assurance and Risk Management RN and it was not provided.

Review of the sheet of plain paper labeled "1/13/22 Code Note 10:28 AM" revealed no documentation of the physician was present to run the Code and no signature of who wrote the "1/13/22 Code Note".

Review of the Release of the Body form revealed documentation as the time of death as 1/13/22 at 10:15 AM.

Review of the code strips provided revealed date and time of 1/13/22 at 11:46 AM and 1/14/22 at 5:52 AM.

There was no documentation of who was present during the code, who administered the medications, a rhythm strip with the times the code was in progress or who pronounced the death of the patient.

During the exit interview conducted on 1/13/22 at 4:30 PM, the surveyor was provided a portion of PI # 8 medical record that included several hand written papers.

In a written response received 1/19/22 at 3:10 PM, Employee Identifier (EI) # 2, Director of Nursing (DON) failed to confirmed the staff failed to follow facility policy for CPR and complete and provide medical records timely.

2. PI # 11 was admitted to the facility on 9/27/21 with diagnoses including Alcohol and Oxycodone Abuse.

Review of ED physician's assessment revealed severe symptoms included aggravation, craving, sweating, and abdominal pain, There was no time documented the physician's assessment was completed.

Review of Patient Progress Note and nursing notes dated 9/27/21 2:55 PM to 9/27/21 at 11:46 PM revealed the following at:

2:55 PM, heart rate (HR) of 126.
8:00 PM, HR 120.
11:46 PM, HR 126.

9/28/21 at 2:10 AM patient sitting up in bed and complains unable to breathe HR 122, respirations 40 and O2 Sats 77%. There was no documentation the physician was notified.

2:15 AM patient was placed on O2 at 6 liters/FM (face mask) O2 Sats improved to 94%.

2:25 AM patient stopped breathing and CPR was started. Physician was notified of change in patient status.

2:45 AM patient was was intubated by physician. See monitor strip for rhythm.

2:55 AM code stopped by physician.

The surveyor requested documentation of code and rhythm strips and none were provided.

In an interview conducted on 1/13/22 at 2:35 PM, EI # 2 confirmed the staff failed to document assessment of pain, notify physician timely, and provide documents required for initiation of CPR per policy.

3. PI # 19 was admitted to the facility on 11/11/21 with the primary diagnosis of Abdominal Pain.

Review of the ED record revealed no date or time documented by the physician for the initial medical screening.

Review of the 11/12/21 Discharge Summary revealed no date the discharge summary was completed.

In an interview conducted on 1/13/22 at 3:17 PM, EI # 2 confirmed the physician failed to document date and time the initial medical screening was conducted and document the date the discharge summary was completed.

4. PI # 20 admitted to the facility on 10/25/21 with the primary diagnosis of Seizures.

Review of the ED record revealed no time was documented the initial medical screening was conducted by the physician.

In an interview conducted on 1/13/22 at 3:40 PM, EI # 2 confirmed the physician failed to document the time the initial medical screening was performed.

5. PI # 10 was admitted to facility on 10/29/21 with diagnoses including Hypernatremia, Weakness, and Altered Mental Status.

Review of the 10/29/21 ED record revealed no time was documented the initial medical screening was conducted by the physician.

In an interview conducted on 1/13/22 at 3:40 PM, EI # 2 confirmed the physician failed to document the time of the initial medical screening was performed.

6. PI # 14 was admitted to the facility on 7/28/21 with the Covid Pneumonia.

Review of the 7/28/21 ED record revealed no time was documented the initial medical screening was conducted by the physician.

In an interview conducted on 1/13/22 at 3:17 PM, EI # 2 confirmed the physician failed to document the time of the initial medical screening was performed.



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7. Review of 7 of 12 MR's for patients who presented to ED for treatment revealed no documentation of a signed consent for treatment. This included PI's (Patient Identifiers) # 21, PI # 24, PI # 26, PI # 28, PI # 29, PI # 30, PI # 31.

In addition, MR review revealed no documentation of the time the ED physician evaluated PI # 21, PI # 23, PI # 25, PI # 27, PI # 28, PI # 29, PI # 31.

Written questions were submitted on 1/12/22 which included a request for documentation that consent for treatment were obtained and times of the ED physician evaluation. In an interview on 1/13/22 from 2:48 PM to 3:09 PM, EI # 2, Director of Nurses reported consents were obtained electronically but that the consents were unable to be found in the system (electronic record system). EI # 2 confirmed there were no time( s) documented in which the ED physician evaluated the patients.




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8. Review of 6 of 9 in patient medical records revealed no documentation an informed consent was signed prior to treatment upon admission to the facility. This included PI # 1, PI # 3, PI # 4, PI # 5, PI # 6 and PI # 7.

Further review revealed 2 of 2 discharged charts to include PI # 15 and PI # 16 revealed no documentation an informed consent for treatment was signed upon admission to the facility.

Review of 1 of 9 in patient medical records PI # 5, revealed questions concerning the MR and the surveyor's questions were submitted to the facility on 1/12/22 for PI # 5. The facility failed to answer the questions. The surveyor's questions were submitted again while on site to EI # 2 on 1/13/22 and not answered prior to leaving the facility. The surveyor's questions were then emailed to the administrator but not answered or returned to the surveyor.

Review of 9 medical records revealed 1 of 2 discharge charts, PI # 15 were reviewed and the surveyor's questions were given to the facility on 1/13/22 while on site. The facility failed to answer the surveyor's questions. The surveyor's questions were again submitted to the facility while on site on 1/13/22 and given to EI # 2 and not answered prior to leaving the facility. The surveyor questions were then emailed to the administrator but not answered or returned to the surveyor.

An interview was conducted on 1/13/22 at 3:00 PM with EI # 2 who confirmed the consents are signed in the computer system and the staff is unable to pull the consents up to include the signatures. EI # 2 stated the consents are all blank.

Based on review of medical records (MR), facility policies and procedure and interview with administrative staff, it was determined the facility failed to ensure all physician orders, written and verbal order (VO), were authenticated and complete per policy.
This included 11 of 30 records reviewed which were Patient Identifier (PI) # 8, PI # 9, PI # 17, PI # 14, PI # 35, PI # 23, PI # 21, PI # 25, PI # 28, PI # 30, and PI # 5 and had the potential to negatively affect all patients served by this facility.

Facility Policy: Verbal and Written Orders (General)
Reference #: 9008
Reviewed date: 12/21

Policy:
- Orders for patient treatment and medications, including the administration of medications, to be carried out when given by a qualified physician... who has been approved as a member of the medical staff of this hospital. All orders of medication and treatment shall be written into the medical chart of the patient...

- All orders for medications shall include the date and time of the order, the name of the drug, the dosage, the route, frequency of administration and the physician's signature.

- All orders for treatment shall include the type of treatment, specific requirements of the treatment (such as wet to dry dressings, etc. (et cetera) and the frequency of the treatment.

Procedure:
- Written Orders: These shall be filled when written as stated above and signed by the practitioner.

- Verbal/ Telephone Orders... A "read back" process will be conducted by the individual receiving a telephone or a verbal order...

The prescribing practitioner must sign the written record of the verbal/telephone order within 24 hours of giving the order...

- New Orders: New orders must be written for the patient upon transfer in to and out of a unit or the hospital at each hospital admission...

1. PI # 8 was admitted to the Emergency Department (ED) on 1/8/22 to 1/11/22 and then admitted as inpatient on 1/11/22 at 6:00 PM with diagnoses including Shortness of Breath (SOB) and COVID-19 (Coronavirus Disease).

Review of the 1/8/22 ED record nursing documentation at 5:50 PM of Normal Saline (NS) IV (Intravenous) at KVO (keep vein open), Fingerstick Blood Sugar (FSBS) and Humulin R (Regular) (insulin) 5 units was administered at 5:50 PM and lab results for Chem 14 (Chemistry Profile), CBC (Complete Blood Count) and D-Dimer. There was no documentation physician orders for IV, FSBS, insulin or labs obtained.

Review of the documentation for Monoclonal Antibodies for Adult Patients >12 years old revealed the patient signature for consent and the date 1/11/22. Regeneron 10 ml (milliter), 4 -2.5 ml sub Q (subcutaneous) shots.
There was no documentation of a physician order for the monoclonal antibody therapy.

In a written response received 1/19/22 at 3:10 PM, Employee Identifier (EI) # 2, Director of Nursing (DON) failed to provide evidence the physician had written complete orders for ED medications administered and the monoclonal antibody therapy.

2. PI # 9 was admitted to the facility on 10/20/21 with the diagnoses of Bronchitis and Chronic Obstructive Pulmonary Disease.

Review of the 10/20/21 VO written by the LPN (Licensed Practical Nurse) revealed at 8:45 PM Change Blood Sugars to AC (before meals)and HS (hours of sleep). 9:10 PM Start pt (patient) on reg (regular) sliding scale for blood sugar results. The physician failed to sign the verbal orders.

Review of the 10/22/21 VO written at 9:50 AM included give Ativan 0.5 mg IVP (intravenous push) and Benadryl 25 mg IVP. The physician failed to sign the verbal orders.

In an interview conducted on 1/12/22 at 10:40 AM, EI # 2 confirmed the physician failed to sign the VO's.

3. PI # 17 was admitted to facility on 11/24/21 with the chief diagnosis as Bradycardia.

Review of the ED record revealed VO's that included CBC, Amylase, Lipase, and IV fluids dated 11/24/21 at 2:25 PM. There was no physician signature for the VO.

Further review of the 11/24/21 ED record revealed VO written at 2:40 PM for EKG (Electrocardiogram) and 4:30 PM UA (Urinanalysis). There was no physician signature for the VO.

On 1/13/22 at 3:55 PM, EI # 16, Detox Clinical Manager returned written responses to surveyor and EI # 2, DON, confirmed the physician failed to sign verbal orders.

4. PI # 14 was admitted to the facility on 7/28/21 with the COVID Pneumonia.

Review of the 7/28/21 VO at 11:30 AM for Sliding Scale insulin revealed no physician signature.

In an interview conducted on 1/13/22 at 3:17 PM, EI # 2 confirmed the physician failed to sign the 7/28/21 VO.



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5. PI # 35 presented to the ED on 11/8/21 at 11:52 AM with cc (chief compliant), body aches, loss of taste/smell and fatigue.

Review of the ED Physician Order Sheet documentation included Regern (Regeneron) COVID 600/600, 4 (four) 2 1/2 (2.5) cc (cubic centimeter) SUB Q (subcutaneous-under the skin), as outpatient. There was no date and/or time documented on the physician's order for the Regeneron injection.

Further record review revealed PI # 35 was discharged to follow up in outpatient for Regen-COVID inj (injection) at 1:30 PM.

In addition, there record included a document titled, Monoclonal Antibodies for Adult Patients Equal to, Greater than 12 years old Orders: Regeneron-subcutaneous injection, withdraw 2.5 ml (milliliters) into 4 separate syringes...inject SQ in 4 different spots. Avoid navel. The lot number and expiration date were documented however, there was no date/time of the order and no physician signature documented on the Monoclonal Antibody Order.

In an interview on 1/13/2022 at 2:49 PM, EI # 2, confirmed staff failed to follow the policy and document date/time of the Regeneron order.

6. PI # 23 presented to the ED on 10/4/21 at 2:17 PM with cc, request detox (detoxification), ETOH (alcohol) cocaine abuse.

Review of the ED Record Physician Order Sheet documentation included DETOX labs. There was no date/time documented on the lab order.

7. PI # 21 presented to the ED on 1/10/22 at 6:55 PM with cc, chills, fever, body aches.

Review of the ED Record Physician Order Sheet revealed orders for "Tylenol 650 mg (milligram) po,(by mouth) noted 10:10 PM" and a seperate order for Tylenol 500 mg po. There was no date, no time, and no physician signature for the two Tylenol orders.

8. PI # 25 presented to the ED on 10/6/21 at 5:57 PM, cc was chest pain, heroin, and cocaine use.

Review of the ED Record Physician Order Sheet documentation included DETOX labs. There was no date/time documented on the lab order.

9. PI # 28 presented to the ED 11/12/21 at 4:44 PM, and cc was penile discharge.

Review of the ED Record Physician Order Sheet revealed a po (phone order) for UA (urinalysis) at 5:20 PM. The po had not been signed by the physician.

Further review of the ED Record Physician Order Sheet revealed medication orders for Rocephin 1 gram intramuscularly (IM) and Doxycycline 100 mg by mouth. There was no date/time documented on the 2 medication orders.

10. PI # 30 presented to the ED 12/1/21 at 5:09 PM and the cc was cat bite to the left hand.

Review of the nurse documentation revealed at 5:50 PM Tetanus 0.5 mg IM to left deltoid was administered.

Review of the ED physician documentation revealed no physician order for Tetanus.

Written questions were submitted on 1/12/22 and in an interview on 1/13/22 from 2:48 PM till 3:09 PM, EI # 2, Director of Nurses confirmed staff failed to ensure orders for care were documented and included a physician signature, time/date for PI # 35, PI # 23, PI # 21, PI # 25, PI # 28, PI # 30.




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11. PI # 5 was admitted to the facility on 1/5/22 with admitting diagnoses of Alcohol Abuse, Bipolar Disorder and Major Depression.

Review of the medical record revealed no documentation of any physician orders within the medical record which was copied per the facility.

Questions were provided to the facility on 1/13/22 at 11:30 AM for response. Upon exit from the facility on 1/13/22 at 4:45 PM the facility failed to provide supporting documentation to the surveyor's questions concerning the medical record and the request for a copy of all physician orders.

Based on review of medical records (MR), facility policy and procedure, and interviews with the staff it was determined the facility failed to ensure written consults ordered by the physician for patients were followed and documented in the medical record. This affected 1 of 1 patient with a hospice consult and did affect Patient Identifier (PI) # 1 and had the potential to negatively affect all patients served by this facility.

Findings include:

Facility Policy: Medical Records Department-Medical Record Content
Review Date: 12/1/2019

Policy:
It is the policy of Hill Hospital that the medical record shall contain sufficient information to identify the patient, support the diagnosis, to justify the treatment and document the results accurately.

Procedure:

F. Consultation reports contain a written or dictated opinion by the consultant that reflects an actual examination of the patient, when applicable and the patient's medical record...

1. PI # 1 was admitted to the facility on 12/26/21 with an admitting diagnosis of Possible UTI (Urinary Tract Infection), Right Lower Lobe Pneumonia and Unresponsiveness.

Review of the MR reveled an order written on 1/2/22 to consult Hospice regarding end of life care.

Further review of the MR revealed in the nursing notes and the physician progress notes no documentation the consult had been completed.

Review of the physician orders dated 1/2/22 to 1/12/22 revealed no documentaton of a physician order to cancel the consult with Hospice.

An interview was conducted on 1/13/22 at 2:30 PM with Employee Identifier (EI) # 4, Registered Nurse, who stated there was no documentation in the MR stating the consult with Hospice had been performed.

Based on review of the facility Outpatient Department documentation of patients who received Monoclonal Antibody, the facility policy and procedure titled, Monoclonal Antibody Use, facility medical records (MR) and interview it was determined the facility failed to ensure staff followed its own policy and procedure for Monoclonal Antibody Use.

This affected PI # 34, PI # 35, 2 of 3 Outpatient infusion MR's reviewed and PI # 8, 1 of 1 ED extended stay patients. This had the potential to affect all patients who received monoclonal antibody treatments at the facility.

Findings include:

Subject: Monoclonal Antibody Use (Regeneron, Regen-COV)
Revised: 1/11/22
Department: Emergency Department (ED)

Policy:

Hill Hospital will allow use of FDA (Food and Drug Administration) authorized monoclonal antibodies therapies of adults and pediatrics greater than, equal to 12 (years). when the following apply:

...positive COVID ( novel corona virus infectious disease) test result
The patient is a high risk of severe COVID-19 hospitalization if not treated
...In lieu of a designated outpatient space, the ER (emergency room) or any room where the patient can be isolated will be utilized

Procedures:
Contraindications: Ascertain that checklist (was) completed and patient meets criteria. See page 6 of the FDA's EUA (Emergency Use Authorization) guidelines
The Order: Check for a physician's order. Order should specify the route to be given.
Consent: Ascertain that procedure has been explained to patient and consent obtained and a copy of the patient's fact sheet given

...Dose preparation for the Subcutaneous (SQ) Injections: Providers will follow the EUA guidelines issued by the US Food and Drug Administration...
Patient Monitoring/Documentation: Clinically monitor and document patients response during therapy, including vital (vital signs) every 15 minutes. Continue to monitor and document for at least 1 hour after therapy is completed.
...Documentation in the MR included, but not limited to: Date and time, Medications/solution, rate and/or method, site assessment, complications and interventions, and patient response to procedure and/or medications

A log of patients receiving Regeneron therapy will be maintained...

Review of the facility Outpatient Infusion log documentation revealed 11 patients received monoclonal antibody treatment from 8/16/2021 to 1/11/2022 which included PI # 34 and PI # 35.

1. PI # 34 presented to the ED on 9/1/21 at 12:23 PM with chief complaint (cc) sore throat, "flu" and body aches with COVID exposure.

Record review revealed the ED physician documented the patient was COVID-19 positive. At 2:20 PM, the ED record physician order sheet included "Regen-COV 4 2 1/2 CC (cubic centimeter) injection and lot number. There was no Regeneron dosage and no injection route ordered. There was no documentation the facility Monoclonal Antibody Use policy and procedure was followed, and the contraindication checklist was completed, and the patient met the criteria for Regeneron. There was no consent for Regeneron obtained and no documentation the procedure was explained. There was no anatomical location(s) of the injections, no site assessment, and no patient response to the procedure and/or medication documented.

In addition, vital signs were documented at 1:47 PM and at 4:15 PM. There were no documentation vital signs were monitored every 15 for 1 hour following Regeneron administration.

In an interview on 1/13/2022 at 2: 45 PM, EI (Employee Identifier) # 2, Director of Nursing (DON) confirmed staff failed to follow the facility Monoclonal Antibody Use policy and procedure as there was no documentation the contraindication checklist was completed, and the patient met the criteria for Regeneron. There was no consent for Regeneron treatment, no documentation the procedure was explained, and received a copy of the fact sheet per facility policy. There was no documentation for the Regeneron dosage, the route of injection (sq or intramuscularly) administration, the injection site(s), site assessment and patient response to the procedures and/or medication.

2. PI # 35 presented to the ED 11/8/21 at 11:52 AM. Review of the ED physician order sheet documentation included Regern COVID 600/600, 4 (four) 2 1/2 (2.5) cc (cubic centimeter) SUB Q (subcutaneous-under the skin), lot number as outpatient. At 1:30 PM, the record revealed an ED discharge was performed and PI # 35 was "discharged to follow up in outpatient for Regen-COVID inj (injection)".

Further record review revealed positive COVID-19 Rapid Antigen results were reported on 11/8/21 at 1:51 PM and an Outpatient Department Monoclonal Antibodies for Adult Patients greater than or equal to 12 years old patient, screening and patient consent was documented.

In addition, there was a document titled, Monoclonal Antibodies for Adult Patients Equal to, Greater than 12 years old Orders: Regeneron-subcutaneous (sq) injection, withdraw 2.5 ml (milliliters) into 4 separate syringes...inject SQ in 4 different spots. Avoid navel. The lot number and expiration date were documented, however there were no date/time of the order and no physician signature documented.

There was no date/time documented for the Regeneron order for sq injections and no dosage, of the total and/or the individual 4 separate syringes. There were no site selection/injection site locations documented. There was no site assessment and no patient response to the Regeneron injections documented. At 3:05 PM, the nurse documented, discharged home with COVID discharge instructions. There was no documentation for the patient response to the procedure and/or medication.

In an interview on 1/13/2022 at 2:49 PM, EI # 2, confirmed staff failed document the date/time, the Regeneron dosage, the name of the staff who administered the injections, the injection site(s), site assessments and patient response to the procedures and/or medication.



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3. PI # 8 presented to the ED on 1/8/22 at 4:32 PM with chief complaint SOB, COVID + (positive) for 9 days.

Review of the Monoclonal Antibodies for Adult Patient dated 1/11/21 at 8:50 AM Regeneron10 ml 4 2.5 ml sub IQ shots with lot number. The only vital signs were documented at 9:50 AM.

There was no documentation of the sites the medication was administered or site assessments after the injections.

There was no documentation vital signs were monitored every 15 minutes for 1 hour following Regeneron administration.

In a written response received 1/19/22 at 3:10 PM, EI # 2, DON, confirmed the physician /nurse failed to document the Monoclonal Antibody therapy treatment per policy.

Based on a review of the facility Medical Staff Bylaws, the pharmacy policy and procedure manual, and interview it was determined the facility failed to have developed, approved, and reviewed policies and procedures for provision of pharmacy services. This had the potential to affect all patients treated at the facility.

Findings include:

Review of Medical Staff Bylaws 12.4-6 Pharmacy and Therapeutics:
The duties involved in developing and maintaining surveillance over drug utilization polices and practices are to:
(a) Assist in the formulation of the professional polices regarding the evaluation, appraisale, use, safety procedures and all other matters relating to drug in the Hospital; (b) Make recommendations concerning drugs to be stocked on the nursing unit...(c) Develop and review periodically a formulary ...

On 1/12/22 at 12:07 PM during a tour of the hospital pharmacy and interviews with Employee Identifier (EI) # 11, the Registered Pharmacist and EI # 14 Pharmacy Technician, the surveyor requested to review the pharmacy policies and procedures. EI # 11 presented the surveyor with a white manual which contained a document titled, Pharmacy Policy (&) and Procedure Manuel (manual): Emergency numbers, Conversion tables, Laboratory values, Common abbreviation, Poison treatments and Formulary.

Review of the Pharmacy policy and procedure manual revealed the 6 documents listed above and included the Hill Hospital of Sumter County Pharmacy Services Formulary 2020. The 2020 formulary revealed the signature of the supervising pharmacist, EI # 11 and dated 1/2/2020. The Chief of Staff (COS) signature/date was left blank. There was no documentation of review/approval by the COS/Medical Director. There were no written and approved Pharmacy policies and procedures.

In the interview on 1/12/22 at 12:20 PM, EI # 11 confirmed the pharmacy policy and procedure manual did not include written and approved policies and procedures governing provision of pharmacy services, developed by the Director of Pharmacy and/or approved by the pharmacy Medical Director.

Based on United States Health Public Food Code 2017 regulations, facility policy and procedure, observations and interview, it was determined the hospital failed to ensure food was stored in a safe and sanitary manner. This had the potential to negatively affect all patients served by the facility.

Findings include:

United States Health Public Food Code 2017

3-302.12 Food Storage Containers, Identified with
Common Name of Food.
Except for containers holding FOOD that can be readily and unmistakably recognized such as dry pasta, working containers holding FOOD or FOOD ingredients that are removed from their original packages for use in the FOOD ESTABLISHMENT, such as cooking oils, flour, herbs, potato flakes, salt, spices, and sugar shall be identified with the common name of the FOOD...

3-501.17 Ready-to-Eat, Time/Temperature Control for Safety Food, Date Marking.
...commercially processed food open and hold cold
(B) Except as specified in (E) - (G) of this section, refrigerated, READY-TO-EAT, TIME/TEMPERATURE CONTROL FOR SAFETY FOOD prepared and PACKAGED by a FOOD PROCESSING PLANT shall be clearly marked, at the time the original container is opened in a FOOD ESTABLISHMENT and if the FOOD is held for more than 24 hours, to indicate the date or day by which the FOOD shall be consumed on the PREMISES, sold, or discarded, based on the temperature and time combinations specified in
(A) of this section and: Pf (Prepared food) (1) The day the original container is opened in the FOOD ESTABLISHMENT shall be counted as Day 1; and (2) The day or date marked by the FOOD ESTABLISHMENT may not exceed a manufacturer's use-by date based on FOOD safety. Pf
(C) A refrigerated, READY-TO-EAT TIME/TEMPERATURE CONTROL FOR SAFETY FOOD ingredient or a portion of a refrigerated, READY-TO-EAT TIME/TEMPERATURE CONTROL FOR SAFETY FOOD that is subsequently combined with additional ingredients or portions of FOOD shall retain the date marking of the earliest- prepared or first prepared ingredient.
(D) A date marking system that meets the criteria stated in (A) and (B) of this section may include:...
(2) Marking the date or day of preparation, with a procedure to discard the FOOD on or before the last date or day by which the FOOD must be consumed on the premises, sold, or discarded as specified under (A) of this section;
(3) Marking the date or day the original container is opened in a FOOD ESTABLISHMENT, with a procedure to discard the FOOD on or before the last date or day by which the FOOD must be consumed on the premises, sold, or discarded as specified under (B) of this section...

Facility Policy: Food Storage Labeling
Policy Number: FP.8
Revised Date: 10/19

Policy:

The facility will ensure the safety and quality of food by following good storage and labeling procedures.

Procedure:

1. All food items must be labeled with the date they are received.
2. All food items that are not in their original containers must be labeled with the common name of the food and the date they are received.

TCS (Time/Temperature Control for Safety) food held longer than 24 hours must be labeled and date marked to indicate the use by date.
1. TCS foods can be stored for only 7 days if held at 41 degrees F (Fahrenheit) or lower.
2. Suggested labeling includes:
a. Common name
b. Date of Preparation or Use By Date...

7. Product Placement:
Food is stored in containers intended for food that are durable, leak proof and can be tightly sealed or covered and labeled.

A tour of the Dietary Department was conducted on 1/11/21 at 11:00 AM. During the tour of the Dietary Department the surveyor found on a metal shelf the following items:

1- Large bag of elbow macaroni opened and only half full. No open label or expiration date on the bag.
1- Large Uncle Bens corn bread mix 3.5 lbs (pounds) open and not sealed and no open label with date.
1- Large bag of egg noodles approximately 1/3 of the bag left open and no open label with date.
1- Large bag of noodles open and no open label with date.
1- opened box of spaghetti pasta contained a bag of pasta inside the box and the bag was opened and not sealed closed and no open label with date.

During the tour the surveyor saw 2 trays under the counter filled with seasonings and spices and the following was found:

Fajita Marinade and Seasoning 30 ounces (oz) opened and no open date.
Onion powder 20 oz opened and no open date.
3- Kosher Salt 48 oz each opened and no open date.
2- Ground black pepper 16 oz each open and no open date.
2- Ground nutmeg 16 oz each open and no open date.
Ground cinnamon 18 oz open and no open date.
Brown gravy mix 15 oz bag not sealed and no open date.
Kitchen bouquet browning and seasoning sauce 128 fluid oz opened and no open date.
Lemon Pepper seasoning 28 oz opened and no open date.
Ground Cinnamon 16 oz open and no open date.
All purpose seasoned salt 7 lbs (Pounds) open and no open date.
Rubbed Sage 6 oz opened and no open date.
Ground Cumin 14 oz opened and no open date.
Basil leaves 5 oz open and no open date.
Garlic 5.5 lbs open and no open date.
Italian seasoning 6.25 oz opened and no open date.
Garlic Salt 2 lbs 9.25 oz open and no open date.

Inspection of the stand- up freezer side by side during the tour revealed the following:
1- gallon zip lock bag with a piece of meat which was freezer burn with no label to identify the content.
1- box of Parker House dinner rolls in original box with a bag inside the box was open and not sealed and no open date on box.
1- box of Bakers Source biscuits in original box with a bag inside the box which was open and not sealed and no open date on box.
1-12 lb box of sausage patties in original box and the box was not sealed and no open date on box.
2- 32 oz 1/2 bags of breaded okra opened and no open date on either bag.
1- large clear bag of what appears to be fish filets was not labeled with an identification label.
1- box 12 lbs of sausage patties in original box and opened and no open date and box not sealed.

During the tour of the Dietary Department the surveyor inspected the large chest freezer and the following was found:

1- bag of opened sliced carrots and no open date.

An interview was conducted on 1/11/22 at 12:40 PM with Employee Identifier # 5, Dietary Supervisor, who confirmed all foods when open should be marked with an open date and all foods are to be sealed and properly marked with an identification label prior to storing or freezing.

Based on observations during facility tour with hospital staff by the Fire Safety Compliance Officer and staff interviews, it was determined that the facility was not constructed, arranged and maintained to ensure patient safety. This had the potential to negatively affect all patients served by the facility.

Findings include:

Refer to Life Safety Code violations

Based on observations, review of the facilities Infection Control (IF) Plan, Medical Staff By-laws, manufacture's directions for use instructions, Centers for Disease Control (CDC) hand hygiene guidelines for healthcare settings, FAQs (frequently asked questions) regarding Safe Practices for Medical Injections, World Health Organization (WHO) recommendations for preparing injections, facility policies and procedures and staff interviews it was determined, the hospital failed to ensure an effective IC program and antibiotic stewardship program were established and identified facility wide IC noncompliance and implemented appropriate actions to address IC non-adherence.

Refer to A 0749, A 0750, A 0760, A 0761, and A 0762 for findings.

Based on observations, Micro-Kill Q3 Concentrated Disinfectant/Cleaner and Deodorizer and Signet Cleaner/Disinfectant manufacture's directions for use, review of Centers for Disease Control (CDC) hand hygiene guidelines for healthcare settings, FAQs (frequently asked questions) regarding Safe Practices for Medical Injections, World Health Organization (WHO) recommendations for preparing injections, hospital policies and procedures, and interviews, it was determined the hospital failed to ensure:

1. A sanitary ED environment was maintained, and staff cleaned ED patient rooms according to Micro-Kill Q3 disinfectant product recommendations for 1 of 1 ED terminal room cleaning observation.

2. Staff were knowledgeable regarding the correct use of the Signet Heavy Duty Non-Acid Cleaner/Disinfectant.

3. Work surfaces used during medication preparation were cleaned prior to the preparation of injections and reconstituted intravenous (IV) medications.

4. Staff performed hand hygiene after contact with potentially contaminated inanimate objects prior to medication preparation/administration.

5. Staff followed CDC recommendations for Safe Practices for Medical Injections and minimized opportunities for parental medication contamination.

6. Dietary staff sanitized hands per facility policy after removal of gloves and contact with potentially contaminated surfaces.

7. Dietary staff removed apron prior to exiting the dietary department.

8. All open food is labled with an open date and all open food is sealed tight after opening.

9. All food taken out of the original package/box should have an identification label on each package.

10. Labatory personnel checked all solutions on a routine basis for expiration dates and discarded as necessary.

This affected PI (Patient Identifier) # 8, in 1 of 3 observations of medication passes and EI (Employee Identifier) # 5 Dietary Suprevisor, # 6 Dietary Cook and PI # 7, Dietary Aide during the dietary observations and PI # 10 during medication administration and and had the potential to negatively affect all patients served by this facility.

Findings Include:

Micro-Kill Q3 Quaternary Disinfectant
Manufacturer Description...3- minutes contact time for many bacteria and viruses...For hard, nonporous surfaces...

Signet Product Information Sheet
Heavy Duty Non-Acid Washroom Cleaner/Disinfectant

Usage

...When used as directed, this product is highly effective against a variety of pathogenic microorganisms including...antibiotic resistant bacteria, viruses, fungi, mold, and mildew....

For use as a One-Step Cleaner/Disinfectant
Pre-clean heavily soiled surfaces. Apply use solution to hard, nonporous environmental surfaces. All surfaces must remain wet for 10 minutes. Wipe surfaces and let air dry...

WHO
Best Practices for Injections and Related Procedures Toolkit
Geneva: World Health Organization; 2010...
...2.2.3. Preparing injections
Injections should be prepared in a designated clean area where contamination by blood and body fluids is unlikely...
Practical guidance on preparing injections
Three steps must be followed when preparing injections.
1. Keep the injection preparation area free of clutter so all surfaces can be easily cleaned.
2. Before starting the injection session, and whenever there is contamination with blood or body fluids, clean the preparation surfaces with 70% alcohol (isopropyl alcohol or ethanol) and allow to dry.
3. Assemble all equipment needed for the injection:

Facility Policy: Hand Hygiene
(No number no date)

Policy Statement
...all employees shall follow specific hand hygiene practices...minimize the spread of infectious microorganisms.

...Policy Standards

A. Hand hygiene shall be performed in each of the following situations

1. Upon entering and leaving a patient room...
2. Before and after each patient contact.
a. Between patient contacts...

Procedure Actions

B. Alcohol-based hand rub (ABHR)
1. Apply the product to palm of hand.
2. Spread across hands, rub hands together.
3. Rub in briskly until dry...

CDC and Prevention
Guidance for Hand Hygiene in Healthcare Setting
Page last reviewed: 1/30/2020

...Healthcare personnel should use an alcohol-based hand rub or wash with soap and water for the following clinical indications:

Immediately before touching a patient
Before performing an aseptic task (e.g., placing an indwelling device) or handling invasive medical devices
Before moving from work on a soiled body site to a clean body site on the same patient
After touching a patient or the patient's immediate environment
After contact with blood, body fluids, or contaminated surfaces
Immediately after glove removal

Healthcare facilities should:

Require healthcare personnel to perform hand hygiene in accordance with Centers for Disease Control and Prevention...recommendations
Ensure that healthcare personnel perform hand hygiene with soap and water when hands are visibly soiled
Ensure that supplies necessary for adherence to hand hygiene are readily accessible in all areas where patient care is being delivered
Unless hands are visibly soiled, an alcohol-based hand rub is preferred over soap and water in most clinical situations due to evidence of better compliance compared to soap and water. Hand rubs are generally less irritating to hands and, in the absence of a sink, are an effective method of cleaning hands

CDC FAQs (frequently asked questions) regarding Safe Practices for Medical Injections

...Medication Preparation Questions
...How should I draw up medications? Parenteral medications should be accessed in an aseptic manner ...This includes using a new sterile syringe and sterile needle to draw up medications while preventing contact between the injection materials and the non-sterile environment ...

Medication Administration Questions

4. Is it acceptable to re-use a syringe and/or needle to enter a medication vial for the same patient if the medication vial and syringe will be discarded at the end of the procedure and not used for subsequent patients?
The safest practice is to always enter a medication vial with a sterile needle and sterile syringe, even obtaining additional doses of medication for the same patient...

Facility Policy: Hand and Single Use Glove Sanitation Practices
Policy Number: SI.13
Revised Date: 10/17

Policy:

Facility employees shall follow sanitary practices when handling food to prevent the spread of foodborne illness. Food employees shall keep their hands and exposed portions of the arms clean. Contact with food with bare hands is not allowed.

Procedure:

2. Hand Care:

a. Food service employees wash their hands after the following activities:
vii. Handling chemicals and sanitizing equipment
x. Touching clothing or aprons.
xi. Touching anything that may contaminate hands such as unsanitized equipment, work surfaces, or washcloths.
xii. Before putting on gloves and after removing gloves...

Facility Policy: Employee Work Practices
Policy Number: SI.7
Revised Date: 10/17

Policy:

Food service employees shall follow sanitary practices to prevent the spread of food borne illnesses.

Procedure:

2. Proper Work Attire:

vi. Aprons are removed when leaving the food production area...

1. EI (Employee Identifier) # 13, Environmental Service Manager was observed on 1/11/22 at 11:26 AM cleaning ED treatment room 3 following a patient discharge. EI # 13 used a plastic spray bottle labeled "Micro-Kill Q3" and applied the solution to the bed, and mattress and immediately wiped the solution from the two surfaces. EI # 13 then sprayed the stool top and cabinet top and immediately wiped the Micro-Kill Q3 solution from the surfaces. Next, EI # 13 sprayed the Micro-Kill Q3 solution onto the floor, then mopped the solution from the floor and swept the trash to the door during mopping.

In an interview following the observation on 1/11/22 at 12:00 PM, the surveyor asked to see the Micro-Kill Q3 bottle and view the instructions for use. The bottle included no instructions for use. The surveyor asked EI # 13 what was the surface contact time for the Micro-Kill Q3? EI # 13 reported he/she was not sure. The surveyor requested manufacturer information for Micro-Kill Q3's use.

2. During a tour of the radiology department services and interview with EI # 12, Radiology Technician on 1/11/22 at 3:01 PM, the surveyor asked EI # 12 what was the process for cleaning equipment and surfaces following a radiology procedure? EI # 12 pointed to a bin of Wipes Plus Disinfecting Wipes and a spray bottle with Signet handwritten on the bottle. EI # 12 stated she/he sprays everything down with Signet, the bed and equipment, then wipes the solution from the surface. EI # 12 was asked what the surface contact time of the Signet solution was? EI # 12 reported she/he sprays then wipes immediately with no wait time after spraying. The surveyor requested the manufacturer information regarding surface contact time for the Signet Disinfectant Cleaner in use.

On 1/13/22 at 8:15 AM during an interview, EI # 13 provided manufacturer documentation for Micro-Kill Q3 which revealed the product had a 3 minute contact time for many bacteria and virus. EI # 13 confirmed there was not a 3 minute contact time on surfaces disinfected at ED treatment room 3 on 1/11/22. In addition, EI # 13 provided the Signet Product Information Sheet which revealed all surfaces must remain wet (with solution) for 10 minutes. EI # 13 confirmed staff failed to follow manufacturer's instructions for use for facility disinfectants.

3. On 1/12/22 from 8:45 AM to 10:45 AM observations of care on the medical unit were performed with EI # 10, Registered Nurse (RN) which included medication passes to 3 patients.

EI # 10 failed to clean/disinfect the medication (med) cart counter workspace before medication preparation began.

At 9:40 AM after administering the second patient's medications (med), EI # 10 exited the patient room to the chart room then documented on the personal computer. EI # 10 failed to perform hand hygiene after patient care.

After EI # 10 completed charting, EI # 10 exited the chart room to the 23 hour pharmacy. EI # 10 failed to perform hand hygiene upon exiting the chart room or upon entry to the pharmacy. After medications were obtained, EI # 10 exited the 23 hour pharmacy and locked the door with keys. No hand hygiene was performed.

Next, EI # 10 pushed the med cart down the medical hallway and parked the med cart at the entrance to IV Room. EI # 10 then prepared Humulin R (Regular) 10 U (units), and Lantus 24 U for the third patient. No hand hygiene was performed before insulin preparation. The med cart workspace was not cleaned prior to injection preparation.

In addition, EI # 10 injected the Humulin R 10 Units from an insulin syringe into another syringe, a prefilled 5 ml 0.9 % NS (normal saline). The surveyor asked EI # 10 what was the reason she/he injected the Humulin R insulin, ordered IVP (intravenous push) into the prefilled NS syringe? EI # 10 reported "the patient has a short port."

EI # 10 transferred the IV insulin from one syringe to another, thus potentially contaminating the medication/syringe during the process.

At 10:01 AM, EI # 10 entered the IV Room. EI # 10 failed to perform hand hygiene and failed to clean the counter workspace. Next, EI # 10 reconstituted 1 gram IV (intravenous) Rocephin with 10 cc (cubic centimeter) NS from a single use vial. EI # 10 failed to disinfect the septum of the NS with alcohol before puncturing the vial with the syringe needle.

On 1/12/22 at 10:30 AM following the medication pass observations to PI # 8, the surveyor reviewed the hand hygiene breaches and failure to clean the vial septum with alcohol. EI # 10 asked the surveyor, doesn't hand sanitizer count? The surveyor responded yes if it is performed, you last sanitized hands upon entering the second patient room for med pass. EI # 10 failed to follow the facility policy and CDC guidelines for hand hygiene, and injection safety practice.



32470

4. An observation was conducted on 1/11/21 at 11:00 AM in the dietary department to observe plating of food, and inspection of the department and staff for proper handling and storage of food items.

During the observation in the dietary department at 11:30 AM EI # 6, Cook, was observed donning clean gloves without sanitizing or washing hands and then began plating the food for the patients.

At 11:37 AM EI # 7, Dietary Aide, was observed placing the patient food trays on the cart, removed gloves, did not sanitize or wash hands per facility policy and then left the dietary area with his/her apron on to deliver the trays to the patient area. EI # 7 did not remove the apron prior to leaving the dietary area.

During the observation of the dietary department once the trays for the patients were complete at 11:50 AM, EI # 7 tested the dishwasher with the strips. Once complete the staff began cooking for the employees, EI # 7 failed to wash or sanitize hands after using the chemical strip for the dishwasher and donned clean gloves and began to cook french fries. Once complete the basket for the fries remained in the cooking oil and EI # 7 removed one glove to remove basket and turn the cooker off, donned one clean glove and did not sanitize or wash hands per facility policy.

While in the dietary department at 12:30 PM EI # 5, Dietary Supervisor, left the dietary area wearing his/her apron and went into the supply room. When EI # 5 failed to remove the apron prior to leaving the dietary area per facility policy.

At 12:40 PM EI # 7 removed gloves, failed to wash or sanitize hands and began to clean the counters with a wet cloth.

An interview was conducted on 1/11/22 at 12:45 with EI # 5 who stated the staff are to wash or sanitize their hands prior to and after removing gloves and the apron worn by the dietary staff are not to be worn outside the dietary department. The aprons should be removed prior to exiting the dietary department.

5. An observation was conducted on 1/12/22 at 10:55 AM with EI # 10, Registered Nurse, to observe the administration of medications.

During the observation of medications to 5 patients on the detoxification unit, EI # 10 exited 2 of the 5 rooms, sanitized hands and failed to rub together until hands were dry and waved hands in the air.

An interview was conducted on 1/12/22 at 11:20 AM with EI # 10 who confirmed he/she did not rub his/her hands together,when using hand sanitizer, until they were dry.

6. An observation was conducted in the laboratory on 1/11/22 at 2:10 PM with EI # 9, Laboratory Director.

During the observation the refrigerators in the laboratory were checked for expired solutions.

During the observation the small refrigerator in the laboratory was checked, and in the refrigerator were 2 boxes of BSA (Bovine Serum Albumin, a diluting agent) 7 %. Each box which contained a total of 17/ 5 ml (milliter) bottles had expired on 12/16/21 and was available for use.

An interview was conducted on 1/11/22 at 2:35 PM with EI # 9 who confirmed the 17 bottles of diluting agents in the refrigerator were expired.



34107

Based on observations of care from 1/11/22 to 1/13/22, review of the hospital's Infection Control (IC) Program hand hygiene compliance surveillance data (secret shoppers) the hospital failed to identify opportunities for improvement in staff hand hygiene adherence/performance and initiate improvement actions when goal(s) were not met.

This had the potential to negatively affect all patients admitted to the hospital, staff, and visitors.

Findings include:

Title: Infection Control Program
No date listed

Purpose:
To objectively, systematically and continuously perform surveillance in the hospital to prevent and eliminate infection and to "persue" (pursue) opportunities to improve patient care.

The Infection Control Committee is charged with the responsibility of ensuring proper surveillance and policies and procedures.

ELEMENTS OF THE INFECTION CONTROL PROGRAM:
1. Definitions of nosocomial infections, for surveillance purposes, and to provide for early uniform identification and reporting of infections and to determine pertinent infection rates.

2. A practical system for reporting, evaluating and maintaining records of infections among "patietns" (patients) and personnel. This must include assignment of responsibility or the ongoing collection and analytic review of such data, as well for required follow-up action.

3. Ongoing review and evaluation of all aseptic isolation and sanitation techniques employed in the hospital. Such techniques shall be defined in written polices and procedures...

5. Preventive, surveillance and control procedures relating to the "inamimate" (inanimate) hospital "enviorment" (environment), including sterilization and disinfections practices, central services, ... Such procedures shall be evaluated and revised as necessary...

1. A review of the the facility IC program was conducted on 1/13/22 at 12:28 PM with Employee Identifier (EI) # 3, Quality Assurance/ Risk Manager.

The surveyor requested all infection control monitoring tools used to identify, monitor, report, review, evaluate, and preventative procedures in place to ensure the quality of care of patients.

The surveyor was provided with documents for "Secret Shoppers" for infection control and hand hygiene.

Review of the Secret Shopper observations for hand washing revealed no dates the observations occurred, who completed the observations, the unit or staff being observed. There was also no deficient practices in infection control practices identified, no other tools were submitted during the interview.

The surveyor reviewed infection control concerns observed by the surveyors: Hand hygiene (all areas of hospital), medication preparation, medication administration, cleaning, storage of food, and expired medications and supplies available for use.

EI # 3 stated, "We have been so busy with Covid testing, immunizations, and staffing issues some things have fallen through the cracks."

There was no documentation the hospital had developed or implemented a system to evaluate measures governing the identification, investigation, reporting, prevention and control of infections and communicable diseases within the hospital, including both healthcare-associated infections and community-acquired infections as stated in Infection Control Plan.

In an interview conducted on 1/13/22 at 12:28, EI # 3 confirmed the facility failed to provide evidence of hospital wide surveillance of infection control practices and followed it's own infection control plan.

Based on review of the Medical Staff Bylaws, facility Infection Control (IC) Program and interviews with administrative staff, it was determined the facility failed to ensure the Governing Body established an antibiotic stewardship program. This had the potential to negatively affect all patients admitted to this hospital.

Findings include:

Medical Staff Bylaws
Approval date: 1/21/21

12.4-7 Antibiotics Review

The duties involved in performing the review of clinical use of antibiotics are to:

(a) Conduct studies to review the prophylactic use of antibiotics for inpatients, outpatients, and emergency care patients.

(b) Establish criteria for the prophylactic therapeutic use of antibiotics in problem areas and review variations from criteria, take necessary action and assure resolution of problems; and

(c) Documentation of the performance of this function shall be reflected in the appropriate committee minutes quarterly.

1. A review of the facility IC program was conducted on 1/13/22 at 12:28 PM with Employee Identifier (EI) # 3, Quality Assurance/ Risk Manager. The surveyor asked who leads the antibiotic stewardship program? EI # 3, stated, "I've never heard of that."

In the exit conference conducted on 1/13/22 at 4:30 PM, EI # 1, Administrator, and EI # 2, Director of Nursing, both stated they had never heard of the hospital being part of an antibiotic stewardship program.

Based on review of the facility Infection Control (IC) Program, Medical Staff Bylaws and staff interviews the facility failed to demonstrate coordination among all components of the hospital responsible for antibiotic use and resistance including the facility IC Program.

This had the potential to negatively affect all patients admitted to the hospital, staff, and visitors.

Findings include:

Medical Staff Bylaws
Approval date: 1/21/21

12.4-7 Antibiotics Review

The duties involved in performing the review of clinical use of antibiotics are to:

(a) Conduct studies to review the prophylactic use of antibiotics for inpatients, outpatients, and emergency care patients.

(b) Establish criteria for the prophylactic therapeutic use of antibiotics in problem areas and review variations from criteria, take necessary action and assure resolution of problems; and

(c) Documentation of the performance of this function shall be reflected in the appropriate committee minutes quarterly.

1. In an interview on 1/12/22 at 11:00 AM, Employee Identifier (EI) # 11, Registered Pharmacist was asked if he/she participated in the facility antibiotic stewardship program? EI # 11 responded, No. The surveyor then asked EI # 11 if he/she was aware if the facility had an antibiotic stewardship program? EI # 11 responded he/she did not know if the hospital had an antibiotic stewardship program.

2. A review of the the facility IC program was conducted on 1/13/22 at 12:28 PM with Employee Identifier (EI) # 3, Quality Assurance/ Risk Manager. The surveyor asked who leads the antibiotic stewardship program? EI # 3, stated, "I've never heard of that."

In the exit conference conducted on 1/13/22 at 4:30 PM, EI # 1, Administrator, and EI # 2, Director of Nursing, both stated they had never heard of the hospital being part of an antibiotic stewardship program.

Based on review of the facility Infection Control Program and interview, it was determined the facility failed to ensure there was a system developed to evaluate measures governing the identification, investigation, reporting, prevention and control of infections and communicable diseases within the hospital. This had the potential to negatively effect all patient served by this facility.

Findings include:

A review of the facility Infection Control Program was conducted with Employee Identifier (EI) # 3, Quality Assurance/Risk Management/Infection Control Officer on 1/13/22 at 12:28 PM.

The surveyor requested all infection control monitoring tools used to identify, investigate and report all infections in the hospital and antibiotics used to treat. The surveyor was provided with documents for "Secret Shoppers" for infection control. EI # 3 stated, "We have been so busy with Covid testing, immunizations, and staffing issues."

Review of the Secret Shoppers observations for hand washing there were no dates the observations occurred, who completed the observations, the unit or staff being observed. There was also no deficient practices in infection control practices identified. There were no other tools submitted.

There was no documentation the hospital had developed or implemented a system to evaluate measures governing the identification, investigation, reporting, prevention and control of infections and communicable diseases within the hospital, including both healthcare-associated infections and community-acquired infections.

In an interview conducted on 1/13/22 at 12:28, EI # 3 confirmed the facility failed to provide evidence of hospital wide use of antibiotics and control of infections.

Based on review of medical records (MR), facility policy and interviews with the staff it was determined the facility failed to ensure the discharge evaluation was documented and in the patient's MR. This affected 2 of 2 Discharged MR's reviewed and did affect Patient Identifier (PI) # 15 and PI # 16 and had the potential to negatively affect all patients served by the facility.

Findings include:

Facility Policy: Discharge Planning
Review Date: 12/21

Purpose:

To promptly identify patient discharge needs. To coordinate timely discharge planning during the hospital stay so that patient needs are met, and continuity of care is not interrupted by discharge from the acute care setting.

Policy:

Discharge Planning begins on admission and continues throughout the hospital stay as needs are identified and care is planned to meet those identified needs.

Following identification of anticipated discharge needs, utilizing the discharge screening criteria form...

Discharge planning notes shall reflect any referrals made regarding discharge needs and/or patient education performed in accordance with discharge goals.

1. PI # 15 was admitted to the facility on 11/23/21 with an admitting diagnosis of Pain in Left Hip and was discharged on 11/25/21.

Review of the MR revealed no documentation of Discharge Planning, no discharge evaluation upon admission to the facility, no on going discharge documentation by the staff and no documentation the discharge plans were discussed with each patient.

2. PI # 16 was admitted to the facility on 10/19/21 with an admitting diagnosis of Ileus, Fecal Retention, Obstipation and Epigastric Pain and was discharged on 10/25/21.

Review of the MR revealed no documentation of Discharge Planning, no discharge evaluation upon admission to the facility, no on going discharge documentation by the staff and no documentation the discharge plans were discussed with each patient.

An interview was conducted on 1/12/22 at 1:00 PM with Employee Identifier (EI) # 2, Director of Nursing. When asked who the Discharge Planner was, EI # 2 responded by stating there is not a discharge planner and there is not an actual Discharge Department. EI # 2 was asked where the Discharge Evaluation can be found in the MR. EI # 2 stated there is not an actual form and the documentation might be found in the nursing progress notes or the physician progress notes. EI # 2 was asked how often is the patient re-evaluated to identify any changes and to modify the Discharge Plan. EI # 2 stated the patients are not re-evaluated and if anything is documented it would be in the progress notes but not always. EI # 2 was asked if the Discharge Evaluation was discussed with the patient and caregiver. EI # 2 stated the discharge is not discussed with the patient or caregiver unless the patient needs something and then it is discussed at the time of discharge.

Based on review of medical records (MR), facility policy and interviews with the staff it was determined the facility failed to ensure a list of service providers were provided to the patient and caregiver prior to discharge from the facility.
This affected of 1 of 2 MR's reviewed and did affect Patient Identifier (PI) PI # 16, and had the potential to negatively affect all patients served by the facility.

Findings include:

Facility Policy: Discharge Planning
Reviewed Date: 12/21

Policy:

Following identification of anticipated discharge needs, utilizing the discharge screening criteria form, the nurse and/or physician shall consult the appropriate service for assistance in meeting the patients needs.

1. PI # 16 was admitted to the facility on 10/19/21 with an admitting diagnosis of Ileus, Fecal Retention, Obstipation and Epigastric Pain and was discharged on 10/25/21 to be transfered to Sumter Health and Rehabilitation.

Review of the MR revealed no choice form or a list of service providers form within the MR. Employee Identifier # 2, Director of Nursing (DON), was asked if a service provider form is provided to the patient and/or caregiver if being transfered or discharged from the facility. EI # 2 stated " its possibly listed on the nurses notes or the discharge orders but not always." The service provider list was explained to the DON and was asked to see one of their forms. None was provided.

An interview was conducted on 1/12/22 at 1:00 PM with EI # 2 who confirmed there may not be an actual form provided to the patient but it is explained to the patient the current DME (Durable Medical Equipment) Home Health agencies and Hospice, and Rehabilitation Centers.

Based on ED (Emergency Department) policy and procedure, medical record (MR) reviews and staff interviews, it was determined the facility failed to ensure ED staff provided examination and treatment documentation to the receiving facility at the time of transfer. This affected 2 of 2 ED transfer record reviews which included PI's (Patient Identifier) # 24, PI # 31 and had the potential to negatively affect all ED transfers.

Findings include:

Facility Policy and Procedure Reference # (Number) 2302
Subject: EMTALA (Emergency Medical Treatment and Labor Act)
Department: ED
Reviewed: 12/21

J. Types of Transfers:
...
Stable
Unstable

a) Appropriate Transfer

...Transferring hospital provided medical treatment...minimizes the risk to the individual...
The receiving facility has...agreed to accept the transfer...
Transferring hospital completes all documentation, including sending copies of medical record...

K. Medical Record Content for Transfer:
...Records related to the Emergency Medical Condition...

1. PI # 24 presented to the ED on 10/7/21 at 1:00 AM, chief complaint (cc) was Chest Pain.

MR review revealed ED physician documentation that PI # 24 collapsed in the ER (emergency room), a witnessed arrest, unresponsive, agonal respirations, asystole, and ventricular fibrillation rhythms were documented. ED treatment included oxygen, cardiopulmonary resuscitation, epinephrine 1 mg (milligram), Nitroglycerin, Aspirin, Nitro paste, Morphine with labs ordered including CPK(Creatine phosphokinase) /CKMB (creatine kinase myocardial band), Troponin.

Further review revealed PI # 24 was transferred to a facility for higher level of care via emergency transport on 10/7/21. Discharge vitals were documented at 4:00 AM, though the departure time was left blank.

Review of the Transfer of Emergency Patient Form, the ED Nurse and the ED physician documentation failed to reveal examination and treatment records were provided to the receiving facility at the time of transfer.

In an interview on 1/13//22 at 2:48 PM, EI (Employee Identifier) # 2, Director of Nursing confirmed there was no documentation ED staff provided the receiving facility with ED MR documentation at time of transfer.

2. PI # 31 presented to the ED on 12/10/21 at 3:56 PM, cc was possible sexual abuse.

MR review revealed PI # 31 was transferred to a specialty facility via private vehicle on 12/10/21 at 7:17 PM, accompanied by Social Services.

Review of the Transfer of Emergency Patient Form, the ED Nurse and the ED physician documentation failed to reveal ED examination and treatment records were provided to the receiving facility at the time of transfer.

In an interview on 1/13/22 at 3:01 PM, EI #2 confirmed there was no documentation ED staff provided the receiving facility with patient ED records at time of transfer.

Based on review of the Emergency Preparedness (EP) Program and interviews with the staff it was determined the EP Program had no policy concerning the tracking of patients or the staff during an emergency. This had the potential to negatively affect all staff and patients within the facility.

Findings include:

Review of the EP Program on 1/13/22 at 11:35 AM revealed no documentation of a policy for the tracking of the location of on-duty staff and sheltered patients in the facility during an emergency or if the patients and staff have been transferred to another location. The surveyor met with EI (Employee Identifier) # 9, Laboratory and Emergency Preparedness Director, who stated he/she will have to research this and get back to the surveyor. At 12:40 PM the surveyor went to the Laboratory to speak with EI # 9 who stated he/she has not found the policy as of this time.

An interview was conducted on 1/13/22 at 3:40 PM with EI # 9 and EI # 3, Quality Assurance/ Risk Management Director who confirmed there was no documentation of a policy for tracking the location of on-duty staff and the patients nor was there a policy for tracking the staff and patients if transferred to another location.

Based on review of the Emergency Preparedness (EP) Program and interviews with the staff it was determined the EP Program had no policy or procedure for the use of volunteers in an emergency situation to include the integration of healthcare professionals during a surge of patients in an emergency. This had the potential to negatively affect all staff and patients within the facility.

Findings include:

Review of the EP Program on 1/13/22 at 11:35 AM revealed no documentation of a policy or procedure for the use of volunteers in an emergency situation. The surveyor met with EI (Employee Identifier) # 9, Laboratory and Emergency Preparedness Director, who stated he/she will have to look and see if there is a policy for volunteers.

An interview was conducted on 1/13/22 at 3:40 PM with EI # 9 and EI # 3, Quality Assurance/ Risk Management Director, who confirmed there was no documentation of a policy for the use of volunteers during an emergency.

Based on review of the facility Emergency Preparedness Program (EP) and interviews with the staff it was determined the facility failed to initiate and document the initiation of the EP program for the pandemic of Covid (SARS-CoV-2)- 19 and failed to complete a community/facility based or table top exercise and document the analysis of any exercises conducted. This had the potential to negatively affect all patients and staff within the facility.

Findings include:

On 1/13/22 at 11:35 AM the Emergency Preparedness Program was reviewed. During the review of the EP program the surveyor failed to find any documentation the facility initiated the EP Program for the Covid 19 Pandemic nor was there any documentation the facility had completed a community wide/ facility based exercise or a table top exercise. Further review revealed no documentation of an analysis of the exercises if conducted.

On 1/13/22 at 3:41 PM Employee Identifier (EI) # 9, Laboratory and Emergency Preparedness Director, and was asked if the EP program was initiated for the Covid 19 pandemic or did EI # 9 have documentation a table top, community wide or facility based exercise was conducted for the past 2 years. EI # 9 stated he/she would have to go look in other binders. No documentation was provided.

An interview was conducted 1/13/22 at 3:40 PM with EI # 9 and EI # 3, Quality Assurance/Risk Management Director, who met with the surveyor and stated there was no documentation found to confirm the EP Program was initiated for the pandemic of Covid 19 nor was there documentation a table top exercise was conducted or a community wide or facility base exercise complete.