HospitalInspections.org

Based on observation and review of the facility Patient Bill of Rights and Responsibilities document, it was determined the state agency number for patients to file a grievance was not provided. This affected all patients served by the hospital.

Findings include:

A tour of the hospital Emergency Department on 2/8/22 at 11:00 AM with Employee Identifier (EI) # 12, Emergency Department Manager, revealed the Patient Rights posted did not include the state agency complaint hotline number.

A review of the written Patient Bill of Rights was requested and reviewed on 2/08/22 at 11:10 AM. The patient rights did not list the state agency complaint hotline number.

In an interview on 2/10/22 at 12:40 PM, EI # 1, the Chief Nursing Officer verified the hospital did not have the state hot line phone number posted to which the patients can voice grievances. In addition, documentation provided to patients did not contain the State Survey Agency hotline number.

Based on facility policy and procedure (p/p), medical record (MR) reviews and staff interviews, it was determined the facility failed to ensure staff followed the facility p/p for patients identified at risk for suicide and provide a safe environment of care in 1 of 2 ED (Emergency Department) record reviews that included ED PI (Patient Identifier) # 1, and in 1 of 1 inpatient records reviewed which affected PI # 7. This had the potential to affect all at risk for behavioral health patients who present to the hospital.

Findings include:

Facility Policy and Procedure
Title:/Description Suicide Risk Assessment
Revised Date: 11/2019

PURPOSE:

To guide staff in identifying patients as risk for suicide, identifying environmental safety risks, and establishing a process to minimize the risk of suicide.

POLICY:

Adolescent and adult patients...treated in the ED...and /or admitted...should be screened for risk of suicide...The screen should take place during the triage process in the Emergency Department...and the admission process for inpatients...The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to screen patients for suicidal risk. Patients who screen positive for high suicide risk should have a full risk assessment completed by the physician or behavioral health provider. Patients should be placed in the observation level that is associated with the level of risk identified by the C-SSRS screening:
1. Low Risk...Routine patient care.
2. Moderate Risk...Notify the physician. Request a behavioral consult.
3. High Risk...Immediate notification of physician. Request a behavioral consult. The patient should remain in 1:1 (1 patient, 1 staff) observation with a safety companion...Safety precautions (Ligature Checklist and Environmental Safety Guidelines Checklist)...completed for the patient's room...mitigate risk...removing objects that pose risks...documentation every 15 minutes on the Safety Companion Behavioral Observation Flow sheet...

1:1 monitoring of the patient should be maintained until there is clear documentation from the physician that the patient is no longer a high suicide risk...

PROCEDURE:

When a patient screens high risk for suicide:
1. Initiate safety precautions (Ligature Checklist and Environmental Safety Guidelines Checklist) to identify environmental and room safety risks...completed every shift by the Registered Nurse (RN)
3. Remove all belonging, sharp objects, cell phones...glass, medications...Document a complete list of personal items...
5. Remove the patients clothing from the room...place in a ligature resistant gown.
7. Assign a safety companion to provide 1:1 observation unit disposition...accompany to the restroom...
9. Initiate chain of command...if the patient becomes aggressive...or presents an elopement risk...

1.ED PI # 1 presented to the emergency room 7/1/21 at 10:30 AM, chief complaint was suicidal thoughts. On 7/1/21 at 5:25 PM the patient was transferred to a psychiatric facility.

Record review revealed ED PI # 1's clinical impression was Depression documented by the ED physician on 7/1/21 at 10:40 AM.

Further review revealed on 7/1/21at 10:42 AM, staff performed C-SSRS screening and documented the patient score was high risk, with suicidal thoughts and intents and a suicide plan. There was no documentation the staff initiated any safety precautions, removed any belonging or items from Trauma B, and no documentation a safety companion for 1:1 observation was assigned. The staff documented patient care at 11:34 AM, 2:15 PM, 2:55 PM, 3:30 PM, 4:20 PM, and 5:25 PM. There was no documentation staff followed the facility policy and procedure and monitored the high risk patient every 15 minutes. On 7/1/21 at 5:25 PM the patient was transferred to a psychiatric facility.

In an interview on 2/10/22 at 8:30 AM, Employee Identifier (EI) #12 , ED Manager verified staff failed to follow the facility p/p Suicide Risk Assessment. EI # 12 confirmed expectations were to provide a safe environment and monitor the suicidal patient every 15 minutes. EI # 12 confirmed staff failed to document supportive interventions including removal of any potential harmful devices and patient monitoring every 15 minutes. There was no documentation ED PI # 1 was placed on 1:1 observation.



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2. PI # 7 presented to the ED 2/7/22 at 5:21 PM with chief complaint of suicidal thoughts and suicide attempt by swallowing an unknown substance. PI # 7 was admitted for observation on 2/8/22 at 1:44 AM and subsequently transferred by ambulance for inpatient psychiatric care on 2/8/22 at 4:34 PM.

Review of the MR revealed the Columbia-Suicide Severity Rating Scale completed 2/7/22 was Red - High Risk. The High Risk interventions included notify the physician, request a behavioral health consult, 1:1 observation with a safety companion...remove objects that pose risks for self-harm when possible.

Review of the Adult General Admission Orders dated 2/8/22 at 12:45 AM included Diagnosis - Suicide Ideation, Schizophrenia, and Multiple Personality Disorder; Vital signs - routine; and Mental Health Consult for Placement. There was no order for 1:1 observation interventions as indicated for High Risk patients and no order for safety precautions.

Review of the Nursing Initial Assessment and Interview dated 2/8/22 at 1:44 AM revealed no documentation a suicide risk assessment was completed upon admission to the medical unit.

Further review of the admission MR revealed no documentation of 1:1 observation as indicated for a high risk patient with suicide ideation.

An interview conducted 2/10/22 at 1:10 PM with EI # 1, Chief Nursing Officer, confirmed the staff failed to follow the facility policy for patients at high risk for suicide.

Based on observation, review of facility procedure, MR (medical record) reviews and staff interviews, it was determined the facility failed to ensure:

1. Staff followed the hospital procedure and documented the care provided for an implanted venous access device in 2 of 2 Outpatient record reviews with implanted venous access devices which included PI (Patient Identifier) # 17, and PI # 14.

2. L&D (Labor and Delivery) Staff conducted and documented the Obstetric (OB) Admission PostPartum Hemorrhage (PPH) Risk Assessment and Record of Delivery PPH Risk Assessment Post-Birth. This affected PI # 19 in 1 of 1 L&D record reviews.

3. Staff followed the procedure for PICC (peripherally inserted central catheter) dresssing change which affected 1 of 1 inpatient record with a PICC line, PI # 18.

4. Staff assessed and documented wounds as directed by faclity procedure and provided and documented wound care as ordered by Physical Therapy. This affected 1 of 1 wound record reviewed including PI # 2.

Findings include:

Filing Number 550-226
Facility Title/Description Implanted Venous Access Device
Revised Date: 6/04

Implanted Venous Access Device...

PROCEDURE:
Nursing Interventions:

I.V. (intravenous) Bolus Injection:
Equipment...need (needed) to accomplish this task is sterile gloves, three betadine wipes...Huber needle, two 5 cc (cubic centimeter) syringes of saline solution, two sterile 5 cc heparin flush (100 units/ml (milliliters) and a sterile extension set.

Continuous IV Infusion:
Equipment...need (needed) to accomplish this task is sterile gloves, three betadine wipes...5 cc syringe of saline solution X (times) 1, 5 cc heparin flush...Huber needle, sterile 4x4's (gauze), I.V. tubing...tape, Tegraderm dressing...

Huber Needle Insertion:
Palpate the implanted venous access device to find the entry septum.
Clean the injection site with the betadine wipes...
Clean area at least 6 inches in diameter from center...and repeat x 2.
Connect Huber needle...prime the set-up using a 5 cc...saline flush.
Don sterile gloves...Insert Huber needle...

Drawing Blood Samples:
Assemble equipment and prime tubing as you would for a Huber needle insertion...

NOTE:
...Use aseptic technique.
Infuse-a-ports are flushed with normal saline followed with heparin flush (10 units/ml) 5 cc in 12 cc syringe...

Filing Number: MS-500
Peripherally Inserted Central Catheters
Revised Date: 06/07

Dressing Change Procedure
1. Carefully remove the old dressing and discard.
2. Inspect the catheter exit site for swelling, redness, or exudate.
4. Clean the site with alcohol swabs or swabsticks and allow to dry.
5. Clean site and PICC with povidone-iodine swabs and allow to dry.
6. Place adhesive wound closure strips across suture wings. Fold a 2x2 (2 inch by 2 inch) gauze in half and place it under the catheter hub.
7. Place transparent dressing over site, the entire catheter and the hub of the PICC under the dressing.
9. Document date, time, sterile technique, and condition of the site.

Filing Number 550-270
Wound Management - Eval / Assess (Evaluation and Assessment)
Revised Date: 10/01

Purpose: To provide guidelines for wound assessment. To accurately and consistently document wound characteristics.

Special Consideration:

Staging of wounds should be done in conjuncton with physical therapy...

Wounds are assessed with each dressing change. Measurement in centmeters (cm) of width, length, depth (full thickness or partial thickness) is documented. Wound assessment should include location, measurements, shape, color of wound base, percentage of necrotic tissue present, exudates (amount), skin color surrounding wound (pallor, erythema), tissue indurations, odor (description), presence of granulation tissue and anything else noted...

Documentation:
Document date and time of assessment and any wound care performed...

Filing Number: 550-193
Protocol For Pressure Ulcer Prevention/Treatment
Revised Date: 9/2013

Purpose: To identify patients at risk for pressure ulcers and establish treatment for each patient according to the stage of the pressure ulcer.

Wound Treatment Protocols for Stages I-IV

Policy:
4. Med/Surg, Intensive Care Unit (inpatient areas) assess wound every 8 hours and pm; change dressing if necessary...
Physical Therapy inpatients assess wound daily or as physician ordered.

Stages III and IV
1. Identify stage and obtain physician order for physical therapy consult.

1. During an observation of care on 2/9/22 at 8:30 AM in the Outpatient Oncology Services Department, EI (Employee Identifier) # 15, RN (Registered Nurse) Oncology Services, accessed a right chest implanted venous access device for PI # 17. With sterile gloves, EI # 15 cleaned the port site with a CHG (chlorhexidine gluconate) sponge for 30 seconds, accessed the port with a Huber needle, aspirated blood, obtained the laboratory specimen, flushed the implanted port with a prefilled normal saline (NS) syringe and applied a Tegraderm dressing. At 11:00 AM, EI # 15 initiated a continuous infusion of Pembrolizumab 200 milligram (mg) IV (intravenous) via the implanted venous access device.

Review of PI # 17's medical record documentation dated 2/9/22 at 9:00 AM revealed the following nurse documentation: "Venous Access documentation: The Medi-port single was accessed using a 19 g (gauge) 1/2 in (inch) Huber needle in the right chest. The site was flushed with 10 ml NS. The following was noted at the site: blood return-yes, pain-no, edema-no, redness-no. The lab specimen was collected....De-Access documentation: The needle was removed....The site was dressed with a small bandage. The site was flushed with 10 ml NS and Heparin 500 units.

There was no documentation the implanted venous access device injection site was cleaned with the CHG sponge and a Tegraderm dressing was applied.

On 2/9/22 at 2:45 PM the facility procedure for implanted venous access device care was provided. The facility procedure was to clean the injection site of the implanted venous access device with betadine wipes and not CHG as performed with PI # 17.

2. MR review revealed PI # 14 presented to the Outpatient Department on 2/8/22 for lab tests.

Review of the Daily Outpatient Record documentation revealed the Mediport was accessed with a 1.5 in Huber needle with positive blood return, blood drawn for lab work and the Mediport was flushed with 10 cc NS and 5 cc Heparin flush at 9:12 AM. There was no documentation staff accessed the venous access device using aseptic technique or that the injection site was cleaned prior to access.

In an interview on 2/10/22 at 1:00 PM, EI # 1, Chief Nursing Officer confirmed staff should document how the implanted device injection site was cleaned and the type dressing applied. EI # 1 stated "we do CHG." In addition, EI # 1 verified the implanted venous access device procedure provided to the surveyors was not the care staff provided to an implanted venous access device as with PI # 17's care observations.

3. PI # 19 was admitted to the L&D unit on 2/9/22 at 6:05 AM.

Review of the OB (obstetric) Admission Assessment revealed the reason for admission was Primary C-Section (cesarean section delivery) and tubal ligation. The PPH Risk Assessment was left blank and not completed.

MR review revealed the Nursing Record of Delivery time was 2/9/22 at 8:37 AM. Further review of the Record of Delivery revealed PPH Risk Assessment Post Birth was left blank and not completed.

In an interview on 2/10/22 at 12:46 PM, EI # 1 verified staff failed to conduct/document the PPH Risk Assessment screening on admission and the PPH Risk Assessment Post Birth. EI # 1 confirmed the PPH Risk Assessment should be completed within 60 minutes after birth.



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4. PI # 18 was admitted 2/8/22 with Dyspnea, Cirrhosis of the Liver and Congestive Heart Failure. Review of the MR revealed an order dated 2/9/22 at 12:00 PM to change PICC line dressing today and prn (as needed) according to Protocol.

Review of the nurse progress note 2/9/22 at 8:30 PM revealed "PICC line dressing changed using sterile tech (technique), old dressing removed, BIO (bological) patch removed and stat lock removed, cleaned with chloraseptic swabs X 3, new patch applied and stat lock applied and secured. Tegaderm applied..." There was no documentation of the condition of the site and the hospital protocol did not include cleaning with "chloraseptic" nor the use of a BIO patch and stat lock. The staff failed to follow the hospital protocol.

An interview conducted 2/10/22 at 1:25 PM with EI # 1 confirmed the protocol for PICC line dressing change was not followed.

5. PI # 2 was admitted 2/2/22 at 8:17 PM with diagnoses including Anemia, Transient Hypoxia at home and Decubitus.

Review of the MR revealed a physician's order dated 2/3/22 at 12:54 AM for Physical Therapy (PT) Decubitus wound care.

Review of the Nursing Initial Physical Assessment on 2/3/22 at 9:55 AM revealed "pt has decubitus ulcer on buttock. No drainage noted. Skin excoriated and opening right above coccyx bone" There was no documentation of the wound stage, size, shape, description of the wound bed, condition of the surrounding skin or odor.

Review of the PT Initial Examination Wound dated 2/3/22 (no time documented) revealed Stage IV Decubitus Ulcer to Sacrum, 2.5 cm by 2.25 cm by 2.0 cm and surrounding periwound extremely raw, denuded, and excoriated with 10 cm by 6 cm bloody drainage and severe erythema. Tunnel packed with 1/4 inch iodoform (gauze packing strip), peri-wound covered with Adaptic, 4 by 4's (gauze pads) and ABD (abdominal) pad, secured with paper tape. Dressing to be changed daily for the duration of hospitalization.

Review of the nurse progress note dated 2/4/22 at 11:00 PM revealed 'Dsg (dressing) to coccyx was soiled. Wound cleaned and new dsg applied." There was no documentation of a wound assessment including a description of the wound bed, size, shape, drainage, surrounding skin or odor, and no documentation what the wound was cleaned with and what dressing was applied.

There was no documentation wound care was provided on 2/5/22 (Saturday) by the nursing staff or PT.

Review of the nurse progress note dated 2/6/22 at 6:34 PM revealed 'Dressing changed to coccyx." There was no documentation of a wound assessment including a description of the wound bed, size, shape, drainage, surrounding skin or odor, and no documentation what dressing was applied.

Review of the nurse progress note dated 2/7/22 at 11:50 PM revealed "Wound dressing changed." There was no documentation of a wound assessment including a description of the wound bed, size, shape, drainage, surrounding skin or odor, and no documentation what dressing was applied.

An interview conducted 2/10/22 at 1:00 PM with EI # 1 confirmed the nursing staff failed to assess the decubitus with each dressing change and document wound care provided as directed in facility protocol. EI # 1 further confirmed PT provides wound care Monday-Friday and the nursing staff provides wound care on weekends.

Based on CDC (Center for Disease Control and Prevention) Recommendations for Providers for Injection Safety, observation and staff interviews, the facility failed to ensure staff cleaned the septum (rubber top of a medication vial) on all medication vials with alcohol before piercing with the syringe needle. This affected 1 of 4 parental medication preparation observation and had the potential to negatively affect all patients treated at the facility.

Findings include:

CDC
Injection Safety...Medication Preparation Questions

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

2. How should I draw up medications?
Parenteral medications should be accessed in an aseptic manner...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. Proper hand hygiene should be performed before handling medications and the rubber septum should be disinfected with alcohol prior to piercing it.

Page last reviewed: June 20, 2019

1. During a medication pass observation on 2/10/22 at 10:20 AM in the Emergency Department (ED), EI (Employee Identifier) # 14, ED, Registered Nurse opened a vial of Toradol, pierced the vial's septum with a needle and withdrew medication into the syringe. EI #14 failed to clean the septum before inserting the needle, possibly contaminating the medication. At 10:23 AM, EI # 14 administered Toradol 30 milligrams intramuscularly to the unsampled patient.

Following the observation in an interview, EI # 14 confirmed the above and stated it was not necessary to clean the septum vial because the vial had not been opened.

In an interview on 2/10/22 at 10:30 AM, EI #12, ED Manager confirmed staff must always clean the septum with alcohol before inserting a needle.

Based on observations and interviews the facility failed to assure all medications including medications in the Emergency Crash Carts and biological's available for patient use were not expired and stored properly. This had the potential to negatively affect all patients treated at the facility.

Findings include:

1. On 2/8/22 at 11:02 AM accompanied by EI (Employee Identifier) # 12 ED (Emergency Department) Manager a tour of the ED was conducted.

a. Found in exam 7 was a one 1200 ml (milliliter) Purell CHG (chlorhexidine gluconate) 2% Healthcare Foam hand soap expired 2/2021.

b. Found in Trauma A was one 0.9 % prefilled 10 ml normal saline syringe expired 1/30/21.

c. Found in the ED Medication Room in the patient nourishment refrigerator were 8 plastic baggies that contained PCR (polymerase chain reaction) tests. EI # 3 stated these should be in the lab.

d. Found on the supply cart in the ED Medication Room was one 1000 ml sterile water expired 9/21 and 1 1000 ml sterile water for inhalation expired 3/25/19.

In interviews conducted during the tour EI # 12 confirmed the medications/biological's were expired or not properly stored.


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2. A tour of the surgery department was conducted on 2/8/22 from 10:35 AM to 2:30 PM with EI # 2, Director of Surgical Services. The surveyor requested anesthesia policies and procedures, EI # 2 stated, "We don't have policies for anesthesia, you'll have to get them from anesthesia."

Observation of the anesthesia cart in OR (Operating Room) # 1 revealed:

3- unpackaged single use syringes lying on top of the cart and 4 unpackaged single use syringes in the top drawer of the cart.

1- unpackaged single use stylets lying on the top of the cart.

3- packages of Softrace ECG (Electrocardiogram) pads with the expiration date of 10/18/21.

Observation of the anesthesia cart in OR # 2 revealed:

1- 500 milliliter (ml) bottle of Normal Saline (NS) open 1/2 empty. There was no date labeled when opened.

4- unpackaged single use syringes.

1- unpackaged single use Shiley 6.5.

1- unpackaged single use stylet.

2- Purple top lab tubes with the expiration date of 5/13/21

2- Red top lab tubes with the expiration date of 6/12/21.

IV (Intravenous) Start Kit opened and contained a 6.0 endotrachal tube and Chlorprep swab.

In an interview conducted on 2/8/22 at 1:20 PM, EI # 4, Certified Registered Nurse Anesthetist, CRNA # 2, was asked about the re-use of opened single use supplies and expired supplies. EI # 4 stated, "It's okay to re-use those syringes for air. We keep that trach tube open in that kit as a reminder how to set up a trach in case of an emergency."

The surveyor requested anesthesia policies, procedures or protocols from EI # 4, especially re-use of single use items, labeling containers when opening, and preparation of endotrachal tube and emergency procedures. EI # 4 stated, "They are online. We don't have to have hospitals policies or protocols." The surveyor was never provided with any written policies or protocols from anesthesia.

Observation of the blue and red anesthesia carts revealed the following expired items:

4- Neonate pulse oximeter sensors with the expiration date of 10/9/19.

4- Open, unpackaged syringes and single use Stylets.

6- LMA's (Laryngeal Mask Airway) sizes 3.5, 2.5, and 4.5 with the expiration date of 8/17.

2- LMA's single use packages were open the package had the expiration date of 6/17.

2- Stylets 6 french (fr) with the expiration date of 1/2020.

1- 10 fr Stylet with the expiration date of 9/18.

1- 8 fr Stylet with the expiration date of 10/2006.

1- 4 fr Stylet with the expiration date of 1/19.

1- 5.5 Endotrachal tube with the expiration date of 12/18 (the package was opened and a syringe was attached.)

2- 500 ml bags of NS with expiration dates of 12/12 and 12/16.

The surveyor asked EI # 2, who ensures supplies are not expired and not available for patient use. EI # 2, responded, "Anesthesia is responsible for anesthesia supplies."

Observation of the procedure cart revealed the following:

2- NS 500 ml bottles open and not labeled with open date. EI # 2 was asked when the procedure cart was last used? EI # 2 replied last Thursday and confirmed the bottles should have been discarded.

2- Cauterizing tools were labeled for single use, had been opened and were replaced to procedure cart.

A Xeroform vaseline gauze dressing was open and had been used (previously cut) and the remaining Xeroform gauze was in a plastic bag. The bag was not labeled with a patient name. The dressing was labeled for single use and the remaining dressing was available for re-use.

4- Lidocaine ampules 1% 50 mg 5 ml with the expiration date of 1/1/22.

4- Lidocaine ampules 1% 50 mg 5 ml with expiration date of 2/1/22.

2- Blood Culture bottles with the expiration date of 10/30/21.

6- Culture swaps with the expiration date of 11/19/21.

Observation of the medication room cabinet revealed the following:

1- container of 23 guage needles with the expiration date of 1/19.

6- Zofran 4 mg/2 ml bottles with the expiration date of 12/21.

EI # 2 was asked why is the expired Zofran in the cabinet? EI # 2 stated, "I have no idea why it's in the cabinet." EI # 2 then disposed of the expired supplies and medications.

In an interview conducted on 2/8/22 at 2:35 PM, EI # 2 confirmed the staff failed to ensure expired, single use supplies and medications were not available on the anesthesia carts, procedure cart and medication room.

3. During an observation of care conducted on 2/9/22 at 11:40 AM, EI # 5, obtained blood and performed the blood sugar using the Accu-Chek II Inform glucometer.

Review of the monitor control bottles (1 & 2) revealed instructions discard after 3 months after opening. The control bottles were labeled with the open date of 10/20/21. The staff failed to discard the controls after 3 months as directed.

In an interview conducted on 2/9/22 at 3:30 PM, EI # 2 confirmed the staff failed to discard the controls after 3 months.



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3. A tour of the ICU (Intensive Care Unit) was conducted on 2/8/22 at 2:00 PM.

During the tour of the ICU department the crash cart was checked and the following items were found to be expired:

5 - 1 ml syringes with 20 gauge (ga) 1 inch needles expired on 9/30/21.

1 - 22 ga needle expired 12/1/21

2 - 16 ga 1 1/4 inch needle expired 8/21

Observation of the Airway box was conducted and the following items were found to be expired.

1 - Silicone single use laryngeal mask airway size 1.0 expired 1/22

1 - oral/nasal tracheal tube cuffless 2.5 mm (millimeters) expired 1/31/22

In the medication room the following supplies were found to be expired:

50 - syringe caps expired 4/2/21

84 - IV (intravenous) caps expired 4/2/21

An interview was conducted on 2/8/22 at 2:40 PM with EI # 11, ICU RN (Registered Nurse), who confirmed the items were expired and respiratory was notified of the airway box and replacement of the items which were expired and all other expired supplies will be removed and replaced.

4. A tour of the Respiratory department was conducted on 2/8/22 at 3:35 PM.

During the tour of the Respiratory department the crash cart was observed and the following supplies and medications were found to be expired:

1 - Procanimide 1000 mg (milligrams) / (per) 2 ml expired 1/22

2 - 8.4 % Sodium Bicarbonate 10 meq (milliequivalents) per 10 ml expired 2/1/22.

4 - BD (Becton Dickinson) safety lok 3 ml syringes expired 11/30/21

2 - 22 ga 1 inch needles expired 5/20/20

5 - BD 1 ml syringes with 20 ga, 1 inch needles expired 9/30/21

2 - 16 ga with 1 1/4 inch needles expired 8/21

An interview was conducted on 2/8/22 at 4:00 PM with EI # 25, Director of Cardiopulmonary Department,who confirmed the medication and biological's were expired.

5. A tour of the Medical Surgical area was conducted on 2/9/22 at 9:15 AM and the crash cart was observed for expired mediations and biological's and the following was found:

2 - 16 ga 1 1/4 inch needles were expired on 8/21

4 - 1 ml syringes with 20 ga 1 inch needles expired 9/30/21

1 - syringe with a 21 ga with 1 inch eclipse needle expired 11/30/21

1 - purple top blood tube expired 12/19/21

The supply room on Medical Surgical area was also observed for expired supplies and the following supplies were found to be expired:

15 - pair of Protexis latex gloves size 8 expired 9/21

2 - packs of cotton tipped applicators expired 4/18

1 - BD safety glide TB (tuberculin) syringe 1 ml 26 ga 3/8 needle expired 3/21

An interview was conducted on 2/9/22 at 10:00 AM on the Medical Surgical floor with EI # 26, Manager of Medical Surgical Unit/ICU units, who confirmed the supplies and biological's were expired and would be removed and replaced.

Based on United States Health Public Food Code 2017 regulations,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...

A tour of the Dietary Department was conducted on 2/8/22 at 1:00 PM.

During the tour of the Dietary Department the surveyor found large bins of flour and corn meal which did not contain an ID (Identification) label and the scoops were lying inside the flour and cornmeal.

In another area under the counter by the stove area were 3 small bins. 2 of the 3 bins contained a dry substance which appeared to be flour or grits with no ID label and no expiration date and the third bin contained pasta which also did not contain an expiration label.

In the dry storage area of the Dietary department the surveyor found the following items:

8 - packages of sugar free desert mix in an unmarked bin with no ID label, no lid and no expiration dates.

1 - bin not labled with multiple packs of graham crackers with no expiration date, no ID label and no lid.

1 - bin with multiple packs of club crackers with no expiration date, no ID label and no lid.

1 - bin with multiple packs of saltine crackers with no expiration date, no ID label and no lid.

1 - bin with with bags of what appeared to be vanilla wafers with no expiration date, no ID label.

1 - bin with individual salt packets, individual pepper packets and individual sugar packets with no expiration date label and the lid sitting on shelf.

1 - box with 41 individual packs of Nestle Rich Chocolate Cocoa Mix opened with no open date label and a best if used by date of January 2019.

1 - bin with individual boxes of Fruit Loops with no expiration date label.

1 - bin with individual boxes of Corn Flakes with no expiration date label.

1 -1 bin with individual boxes of Rice Krispies with no expiration date label.

2 - boxes 7.05 oz (ounces) 50 packs Granulated Chicken flavor bouillon with no expiration date.

9 - 6 lb (pounds) 6.5 oz cans of diced tomatoes (sysco brand) with no expiration date.

6 - 6 lb 9 oz cans of tomatoe sauce (sysco brand) with no expiration date.

3 - 6 lb 8 oz cans spaghetti sauce (Angela Mia brand) with no expiration date.

2 - 6.88 lbs cans black eyed peas (sysco brand) with no expiration date.

5 - 6.63 lbs cans diced beets (sysco brand) with no expiration date.

2 - 6.75 lbs cans cheddar cheese sauce (sysco brand) with no expiration date.

1 - 6.75 lb can of medium lima beans (sysco brand) with no expiration date.

6 - 6.63 cans of whole kernel corn with no expiration date.

11 - cans of cut sweet potatoes with no expiration date.

In the walk in cooler located in the dry storage area the following items were found:

3 - 32 oz packages of cherry wood smoked ham slices with no expiration date.

3 - packages of unidentifiable food on top shelf wrapped with clear wrap with no ID label, expiration date or open date.

1 - container of rutabagas covered with clear wrap with a use by date of 2/6/22.

In the walk in freezer the following items were found:

1 - container of chicken pot pie covered with clear wrap with a use by date of 2/7/22.

1 - container of beef tips with a use by date of 2/7/22.

1 - container which contained zip lock bags of unidentifiable food with no ID label and no expiration date label.

2 - large plastic bags of breaded food with no ID label and no expiration date.

2 - small clear plastic bags wrapped with clear wrap with unidentifiable food with no ID label, no open date and no expiration date.

1 - zip lock bag with an unidentifiable piece of meat with no ID label, no open date label and no expiration date.

In the main area of the dietary department was a reach in refrigerator and the following items were found:

2 - Styrofoam cups of tropical fruit with use by dates of 2/2/22.

7 - Styrofoam cups of apple sauce with use by date of 2/7/22.

11- Styrofoam cups of peaches with use by date of 2/7/22.

In the main area of the dietary department was the cooks refrigerator and the items were found:

1 - package of bacon open and no ID label and no open date and was not sealed.

1 - gallon of cattlemen's barbecue (BBQ) sauce open and no open date.

1 - zip lock bag with 10 sausage links on open date and no expiration date.

1 - large pan with scrambled eggs, biscuits and toast covered with clear wrap no expiration date or use by date label.

1 - container covered with foil and clear wrap with BBQ pork and use by date was 1/30/22.

In the main area of the dietary department next to the cooks refrigerator was a stand up freezer and the following items were found:

2 - large bags of breaded okra with no expiration date label or ID label.

2 1/2 - bags of open breaded okra with no open date or expiration date labels.

On a shelf in the dietary department the following items were found:

1 - 10 oz bottle of parsley flakes open and no open date and no expiration date.

1 - 14 oz bottle of ground cayenne pepper open with no open date and no expiration date.

1 - 24 oz bottle of taco seasoning mix open with no open date and no expiration date.

1 - 6 oz bottle of rosemary leaves opened with no open date and no expiration date.

1 - 5 oz bottle of bay leaves open with no open date and no expiration date.

1 - 11 oz bottle of ground thyme open with no open date and no expiration date.

1 - 16 oz bottle of ground nutmeg open with no open date and no expiration date.

1 - 18 oz bottle of Hungarian style paprika open with no open date and no expiration date.

1 - 16 oz bottle of whole celery seed open with no open date and no expiration date.

1 - 13 oz bottle of mediterranean style ground oregano open with no open date and no expiration date.

1 - 19.5 oz whole black pepper open with no open date and no expiration date.

1 - 6 oz bottle sage open with no open date and no expiration date.

1 - 18 oz bottle of paprika open and no open date and no expiration date.

1 - 30 oz bottle celery salt open and no open date and no expiration date.

1 - 32 oz bottle of red dye open and no open date label.

1 - 14.4 oz box of cinnamon graham crackers open and no open date label.

1 - 7.5 lb bottle of old bay seasoning open and no open date label.

1 - 5 oz bottle of ranch seasoning open and no open date label.

1 - 4.34 oz of salad supreme seasoning open with no open date label.

1 - 5 lb bag (less than half a bag left) yellow corn meal open with no open date label and expired 12/10/21.

2 - 32 oz bottles of distilled vinegar open with no open date label or expiration date label.

1 - 16 oz bottle of red wine vinegar open with no open date label.

1 - 16 oz bottle balsamic vinegar open with no open date label or expiration date label.

1 - 13.5 oz box of kebler graham cracker crumbs no open date label and expired 12/2/21.

1 - 32 oz bottle karo light corn syrup open and no open date label.

1 - bag of Martha White flour open and not sealed and placed in an open walmart bag with no open date or expiration date labels.

An interview was conducted on 2/8/22 at 1:00 PM with Employee Identifier (EI) # 8, Dietary Supervisor, and EI # 9, Registered Dietition (by phone) who confirmed there are no labels to identify certain foods, expiration dates/use by dates and some of the foods are expired and should have been removed by the use by date. EI # 8 confirmed when food products are opened each item should have an open date marked on the container. The flour bins were discussed and EI # 8 stated "when the dietary department was taken over by a contracted service that service had us store the scoops in each container on top of the flour or what ever was in the container but we are no longer under the contracted service we are back under the hospital so the scoops should have been removed."

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 conducted in the inpatient medical / surgical area it was determined the facility failed to maintain the hospital environment in a manner to assure the safety and well-being of patients.

1. During observations of care on 2/9/22 at 9:00 AM on the medical/surgical unit the surveyor observed several (3-4) acoustic type ceiling tiles with broken corners and/or large water stains in the hallway of occupied patient rooms.

2. During observation of terminal room cleaning on 2/9/22 at 1:30 PM in room 23, designated as a Covid positive room, the surveyor observed 2 high-back, vinyl covered visitor chairs. Each chair had long splits in the seat, one was approximately 6 - 8 inches and the other was approximately 3-4 inches in length. The non-intact surface prevents proper cleaning and disinfection.

Employee Identifier # 1, Chief Nursing Officer, was notified of the damaged ceiling tiles and visitor chairs in room 23 in an interview conducted 2/10/22 at 1:20 PM.

Based on observations, policies and procedures, CDC (Centers for Disease Control) and Prevention Guidelines for Hand Hygiene in Health-Care Setting, CDC Clean Hands Count for Patients and interviews with the staff it was determined the facility failed to ensure:

1. Staff performed hand hygiene and wore gloves per hospital policy and per CDC recommendations .

2. Supplies used to access implanted venous access devices (VAD) which is an aseptic technique procedure were not opened until use.

This affected PI (Patient Identifier) # 12 and PI # 17, in 1 of 1 observations of care with an implanted VAD.

Findings include:

Facility Policy: Hand Hygiene Program
Revised Date: December 1/ 2005

Purpose:

To reduce, as low as possible, the number of viable microorganisms on the hands in order to prevent transmission of healthcare associated pathogens from one patient to another and to reduce the incidence of healthcare associated infections.

Procedure:

Handwashing:

When hands are visibly dirty or contaminated with proteinaceous material or are visibly soiled with blood or body fluids...

Wet hands first with water and apply an amount of product recommended by the manufacture to hands. Rub hands together vigorously for 15 seconds, covering all surfaces of the hands and fingers. Rinse hands with water and dry thoroughly with a disposable towel. Use towel to turn off faucet...

Alcohol Hand Rubs:

If hands are not visibly soiled, use an alcohol-based hand rub for decontaminating hands in all other clinical situations.

Before direct contact with a patient's intact skin.

Before donning gloves...

Moving from a contaminated-body site to a clean-body site during patient care.

Apply alcohol product to palm of one hand and rub hands together, covering all surfaces of hands and fingers,until hands are dry. Follow the recommendations of the manufacture regarding the volume of product to use. Never resume patient care until hands are dry...

Facility Policy for Nutritional Services: Hand Hygiene - CDC Guidelines
reference Number: 4002
Revised Date: 1/2014

Purpose:

To provide guidelines for effective hand hygiene, in order to prevent the transmission of bacteria, germs and infections.

Policy:

All staff shall use the hand-hygiene techniques, as set forth in the following procedures...

Before handling food, utensils and single-serve articles.

After touching any part of body or uniform.

After handling dirty equipment. dishes or utensils.

After blowing or wiping the nose.

If hands are not visibly soiled, hands may be disinfected with either an alcohol-based hand rub or soap and water...

Wash hands before putting on gloves and after removing the gloves.

Procedure:

Using antimicrobial soap and water or non-antimicrobial soap and water:

Turn on water and adjust temperature for your comfort.

Wet hands and apply manufacturer's recommended amount of soap to hands.
Lather well.

Wash hands thoroughly, using rigorous scrubbing action for at least 15 seconds...

Rinse hands and wrists under running water.

Dry hands with clean paper towel.

Turn off faucets with used paper towel and discard.

Using an alcohol-based hand rub:

Apply the manufacturer's recommended amount of alcohol-based hand rub to palm of one hand.

Rub hands together, covering all areas of the hands and fingers, until hands are dry.

CDC and Prevention Guidelines for Hand Hygiene in Health-Care Setting
Last Updated June 25, 2018

When to Perform Hand Hygiene:

Before and after having direct contact with a patient's intact skin (taking a pulse or blood pressure, performing physical examinations, lifting the patient in bed)

After contact with blood, body fluids or excretions, mucous membranes, non-intact skin, or wound dressings.

After contact with inanimate objects (including medical equipment) in the immediate vicinity of the patient.

After glove removal.

CDC "Clean Hands Count for Patients"

How should your healthcare providers clean their hands?

Using soap and water:
1. Wet their hands with water.
2. Apply an amount of soap recommended by the manufacturer to their hands.
3. Rub their hands together for at least 15 seconds, covering all surfaces of the hands and fingers.
4. Rinse their hands with water and dry with a disposable towel.
5. Use the towel to turn off the faucet.

Filing Number 550-226
Facility Title/Description Implanted Venous Access Device
Revised Date: 6/04

Implanted VAD...implanted in the chest wall, with flexible tubing inserted in the external jugular or the subclavian vein into the superior vena cava.

PROCEDURE:
Nursing Interventions:

I.V. (intravenous) Bolus Injection:
Equipment...need (needed) to accomplish this task is sterile gloves, three betadine wipes...Huber needle, two 5 cc (cubic centimeter) syringes of saline solution, two sterile 5 cc heparin flush (100 units/ml (milliliters) and a sterile extension set.

Continuous I.V. Infusion:
Equipment...need (needed) to accomplish this task is sterile gloves, three betadine wipes...5 cc syringe of saline solution X (times) 1, 5 cc heparin flush...Huber needle, sterile 4x4's (gauze), I.V. tubing...tape, Tegraderm dressing...

Huber Needle Insertion:
Palpate the implanted venous access device to find the entry septum.
Clean the injection site with the betadine wipes...
Clean area at least 6 inches in diameter from center...and repeat x 2.
Connect Huber needle...prime the set-up using a 5 cc...saline flush.
Don sterile gloves...Insert Huber needle...

Drawing Blood Samples:
Assemble equipment and prime tubing as you would for a Huber needle insertion...

NOTE:
...Use aseptic technique...

1. An observation was conducted on 2/8/22 at 11:40 AM in the dietary area to observe the plating of patient food trays.

During the plating of the patient food trays Employee Identifier (EI) # 22, Dietary Aide # 2, left the plating line, went to the 3 compartment sink and turned the water off in the sink. EI # 22 failed to remove gloves and wash or sanitize hands and don clean gloves prior to returning to the plating line. While on the plating line EI # 22 sneezed on gloved hand and failed to remove gloves and sanitize hands and don clean gloves. EI # 22 continued plating the food with the same gloves.

EI # 24, Dietary Cook, left the plating line with gloves on and opened the the heating/warming oven and removed a container with hamburger steaks and placed the container on the plating line. EI # 24 failed to remove gloves after touching the handle and door of the warming oven and sanitize/wash hands and don clean gloves prior to returning to the plating line. EI # 24 returned to the plating line with the same gloves on and began plating the food.

Once the main plating of the patient trays were complete EI # 22 began returning food items to the refrigerators with the same gloves used to plate the food. Once food items were returned EI # 22 returned to the plating line with the same gloves on after touching the refrigerators and rolled a cart with patient plates up to the plating line and began placing food items on each plate. EI # 22 failed to remove gloves and wash/sanitize hands and don clean gloves prior to returning to the plating line.

During the plating EI # 24 was plating rice in a container for patients, spilled rice on the plating table and with the scoop used to plate the rice EI # 24 placed the rice which was on the plating table back into the container with the rice.

An interview was conducted on 2/8/22 at 1:15 PM with EI # 8, Dietary Supervisor, who stated the staff know they are to remove their gloves and wash their hands when leaving the plating area and are to don clean gloves each time. EI # 8 also stated when food is spilled on the table it should not be placed back in the containers on the plating line and if the staff sneeze onto their gloves the gloves should be removed immediately and the staff member should wash their hands and don clean gloves.




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2. During observations of care on 2/9/22 at 8:30 AM in the Outpatient Oncology Services Department, the surveyor observed 1 unsampled patient present at a treatment station. There were open packages of supplies at 3 treatment stations which included sterile glove packs, open packs of chlorhexidine gluconate sponges and Huber needles laying on the treatment chair tables with no patients present. At 9:00 AM, PI # 17 entered the treatment station where 1 of the 3 open packages were observed and EI # 15, Registered Nurse, Oncology Services perfomered VAD care using the open supplies.

In an interview on 2/9/22 at 8:55 AM, the surveyor asked why the packages of supplies were opened and no patients were present for care? EI # 15 reported the supplies (sterile supplies) were opened to save time, but they probably should not be opened.

During an interview on 2/10/22 at 1:30 PM, EI # 1, Chief Nursing Officer confirmed the patient supplies for venous access device care should not have been open until time of use.





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3. PI # 12 was admitted to the facility's outpatient surgery on 2/9/22 for Colonscopy, 2 degree Screening, History of Polyps.

During observations of care conducted on 2/9/22 from 9:25 AM to 11:35 AM, the surveyor observed the following:

At 9:25 AM, EI # 3, Certified Registered Nurse Anesthetist, (CRNA) Manager, entered Pre-Op (Operation) room 1 and failed to perform hand hygiene upon entering the room. EI # 3 completed an assessment which included touching the patient's bearded face and throat with ungloved hands. EI # 3 documented assessment on the Pre-anesthesia Evaluation form and then returned to the nursing station and continued to document on the form.

EI # 3 failed to perform hand hygiene upon entering the patient room, before or after conducting the physical assessment, or when exiting the patient room and returning to the nursing station.

At 10:27 AM, EI # 3 entered Pre-Op room 1, failed to perform hand hygiene and began to administer the Midazolam to the patient's intravenous (IV) line.

At 10:29 AM, EI # 3 went to the Pyxxis (Automated Drug Dispensing), removed medications and placed on the anesthesia cart. EI # 3 then applied gloves and proceeded to draw medications into a syringe. EI # 3 failed to perform hand hygiene before entering Pyxxis or applying gloves.

In an interview conducted on 2/9/22 at 3:30 PM, EI # 2, Director of Surgical Services, confirmed EI # 3 failed to follow hand hygiene policy.

Based on observations, review of facility policies and procedures, Accu-Chek Inform II Blood Glucose Monitoring System Operator's Manual and interviews it was determined the surgery department failed to ensure the:

1. Manufacturer's directions were available for the cleaning of endoscopes after use.

2. Post-Anesthesia Care Unit (PACU) rooms were cleaned and sanitized between patients.

3. Accu-Chek Blood Glucose Monitoring machine was cleaned per manufacturers guidance after patient use.

4. All containers containing chemicals were safe for use and labeled with name of the chemical.

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

Findings include:

Facility Policy and Procedure: Care and Disinfection of Endoscopes
Effective Date: September 2000

Purpose:

To prevent cross-contamination of patients when using the endoscope for multiple procedures.

Equipment:

Hospital Approved disinfectant enzyme solution
10 milliliter (ml) syringe
Disposable gloves

Procedure: Clean scope according to manufactures's directions, then rinse and process in Steris for sterilization.

In the Cleaning Room (Instructions on the wall)
1. Make sure soaking cap is attached.
2. Perform dry leak test.
3. Remove all accessories.
4. Perform wet leak test then immerse scope completely (Water).
5. Move scope and accessories to detergent water.
6. Wipe scope completely with sponge.
7. Use pink brush on all parts of scope 3 X (times).
8. Wash all accessories:
(Brush interior/exterior 30 seconds 4 X)
(Manipulate valves under water 4 X)
(Open black flip top and wash X 2)
9. Inject 3 cc (cubic centimeters) detergent in Red button, Purple button, and tractor tire.
10. Inject 10 cc of detergent into the irrigation tube...
15. Attach metal slider and black flip top.
16. Inject 110 cc of detergent into nipple suction & air, water.
17. Attach syringe adapter to waster ejected port and inject 35 ml of detergent.
18. Remove all accessories and soak for 3 minutes....

Important Information Regarding Cleaning and Disinfection Materials for the Accu-Chek Inform II Blood Glucose Meter (Copy of these instructions were under the Accu-Chek machine)

The Accu-Chek Inform II Blood Glucose Monitoring System Operator's Manual currently lists two (2) products for cleaning and disinfection...
Clorox Germicidal Wipes Preciseness disinfecting cloths.
Super Sani-Cloth Germicidal Disposable Wipes.

Facility Policy: Preparation of Instruments for Sterilization
No effective date/ 180 at bottom of page.
Applies to: Surgery

Policy: All instruments, equipment, and supplies to be used for patient care and ...

Responsibilities:
Housekeeping will clean the rooms after each case according to established hospital policy...

1. During an observation of care conducted on 2/9/22 at 11:40 AM, Employee Identifier (EI) # 5, Registered Nurse (RN) Surgery, obtained blood and performed the glucose monitoring using the Accu-Chek II Inform glucometer.

After obtaining blood sugar results, EI # 5 cleaned the Accu-Chek II Inform gluometer with a large alcohol pad.

Review of the monitor control bottles (1 & 2) revealed instructions discard after 3 months after opening. The control bottles were labeled with the open date of 10/20/21. The staff failed to discard the controls after 3 months as directed.

In an interview conducted on 2/9/22 at 3:30 PM, EI # 2, Director of Surgical Services, confirmed the staff failed to clean the Accu-Chek II Inform gluometer per manufacture's guidance and discard the controls after 3 months.

2. An observation of cleaning of PACU room after patient discharge was conducted on 2/9/22 at 12:03 PM, with EI # 18, Housekeeping.

EI # 18 removed the linen to soiled utility room. EI # 18 thoroughly cleaned the patient bed, mattress, replaced linen. EI # 18 failed to clean the overbed table and chair in the PACU room.

The surveyor followed EI # 18 to the housekeeping closet and asked what did you clean the bed with? EI # 18, replied, "Virex, that's the only chemical we use for cleaning."

The surveyor observed in the housekeeping closet a spray bottle labeled with QUAT STAT 5, a spray bottle not labeled but contained a clear chemical and a water bottle with discolored liquid (bleach).

The surveyor asked EI # 18, "Is Virex the same as QUAT STAT 5 or what is the QUAT STAT 5 used for?" EI # 18 stated, "I'm not sure what's in the bottles, I didn't put them in here."

The surveyor asked EI # 18, "Did you clean the overbed table and chair in the PACU?" EI # 18 replied, "I guess I forgot." EI # 18 was paged overhead and left the surgery department.

EI # 3 confirmed housekeeping failed to clean PACU room after patient discharge and bottles of chemicals should be labeled with the contents on 2/9/22 at 2:00 PM and discarded the contents of the bottles.

In an interview conducted on 2/10/22 at 9:30 AM, EI # 19, Housekeeping Supervisor, confirmed bottles should be labeled with contents and only appropriate bottles should be used (not water bottles).

3. An observation of cleaning and disinfection of endoscopes was conducted on 2/9/22 at 2:40 PM with EI # 7, Scrub Technician (ST). The surveyor had requested the manufacturer's guidance for the cleaning and disinfection of the endoscopes prior to the observation and none were provided.

EI # 7 removed the 2 scopes used during the procedure to the cleaning room and placed the first scope used into the soapy water, conducted a leak test, removed accessories and cleaned with a brush.

EI # 7 continued to clean the dirty endoscope and then placed the endoscope in the clean water. The surveyor asked EI # 7, "When did you follow step # 16 and inject 110 cc of detergent into nipple suction & air, water?" EI # 7 replied. "We don't follow those instructions anymore, since we got the Steris" Referring to the guidance on the wall. EI # 7 continued to clean the endoscope and then placed the endoscope into the once clean water. Then removed to the Steris machine.

EI # 7 then placed the second endoscope used in the procedure in the used soapy water and began to clean the scope.

In an interview conducted on 2/9/22 at 3:30 PM, EI # 3 confirmed EI # 7 failed to follow instructions for cleaning and disinfection of endoscopes and manufacturer's guidance for cleaning and disinfection were not provided to the surveyor before the observation.

Based on facility policies and procedures, observations and interviews it was determined the facility failed to ensure:

1. All surgical instruments were inspected for oxidation, damage, tape/tape residue, water spotting, and pitting which resulted in unsafe instruments available for patient use.

2. Patient supplies specified as "single use" and "do not sterilize" in the ED (Emergency Department) were not re-processed in central sterile.

This deficient practice had the potential to affect all patients requiring surgical instruments processed in the central sterile department.

Findings include:

Facility Policy: Central Service Department Policies
Applies to: Surgery
Date Last Revised: 09/2019

Statement of Purpose:

Sterile Central Service shall receive, prepare, process, store maintain and dispense sterile reusable items to all clinical departments.

Personnel:

The Surgical staff is responsible for sterile central. They receive and process items from all other departments requiring steam sterilization.

Work Flow Patterns:

All reusable supplies and equipment used in patient care are considered potentially infections [infectious] and handled accordingly.

All used and contaminated equipment is transported ...

All contaminated supplies and equipment to be resterilized should be returned to the decontamination room.

Facility Policy: Disposable (Single Use Devices) Versus Non-Disposable Items Applies to: Sterile Central
Date Last Revised: 10/2019

It is the policy of this hospital that all disposable or single use devices (SUD's) are not reused or reprocessed.

Any item designated in writing with the description "disposable" or "single use only" is intended for a single use only and then discarded as trash when used. The item is usually designated as disposable on the outer wrapper...and sometimes on the item itself. These items are not reprocessed for use again.

Most stainless-steel surgical instruments are intended for reuse and may be processed for sterility again and again. Sterility is obtained with steam sterilization.

1. An inspection of a small procedure tray was conducted on 2/9/22 at 8:10 AM with Employee Identifier (EI) # 6, Lead Operating Room (OR) Registered Nurse (RN) and EI # 5, Surgery RN. The procedure tray, which had been processed on 2/4/22, was pulled from the instrument room located in the OR department. The following unsafe instruments were identified:

a. Two pair of hemostats with pits and oxidation.

b. One Allis clamp with oxidation and pits.

c. One towel clip with (rust) on the shaft.

d. One needle driver with oxidation and pits.

e. One tissue forceps with pits and rust.

f. One scissors with rust on the hinge and pits.

g. Basin with tape residue on one side.

The surveyor observed sterilized instruments ready for packaging in the processing room. EI # 6 stated, "All of these (instruments) are labeled with Pakistan, have pits or rust."

EI # 6 and EI # 5 confirmed on 2/9/22 at 8:40 AM the instruments were not safe for patient use and should have been discarded.

In an interview conducted on 2/9/22 at 3:30 PM, EI # 2, Director of Surgical Services, confirmed the instruments were not safe and should be discarded.



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2. During an ED tour on 2/8/22 at 11:15 AM with EI # 12, ED Manager, found in the ED triage room were 11 packets of instruments re-processed from central sterile. The surveyor asked EI # 12 if there were re-usable supplies/instruments? EI # 12 stated yes, and this had been the practice for years with such items as staple removers, I & D (incision and drainage kits) and suture kits.

On 2/10/22 at 10:45 AM in a follow up ED visit and interview, the surveyor and EI # 12 identified patient supplies in the ED medication/supply room. Medline I& D packages were labeled "do not re-sterilize" and Medline Laceration Trays were labeled "single use". During the ED follow up visit and interview, EI # 12 confirmed the ED staff were not following the manufacturer's instructions for use as documented on the packaging.

3. During the tour of the L&D (labor and delivery) unit on 2/8/22 at 2:27 PM with EI # 13, L&D RN the following was observed:

Found in OB (obstetric) Room 5 was an OB Tray with 2 pair of hemostats, 1 with rust at the hinges and 1 with spotting on the handle.

Found in the L&D medication room were 3 newborn circumcision trays, one tray was opened and the following was observed:
From Pakistan:
a. 1 pair of tweezers with oxidation,
b. 1 hemostat with rust and stain spots
c. 1 hemostat with rust on the hinge

From China:
d. 1 pair scissors with rust on blade and hinge

From USA (United States of America):
e.1 stainless tray on the back of the tray were 2 green and brown spots of residue, possible tape residue

In an interview on 2/8/22 at 2:35 PM, EI # 13 confirmed the oxidized, rust and stain and residue spots on the instruments used in L&D. EI # 13 reported L&D staff soak the instruments in enzyme soak for 15 minutes and take them to Central Sterile for re-processing.

Based on review of Monroe County Hospital Medical Staff Rules and Regulations, medical record (MR) reviews and staff interviews, it was determined the facility failed to provide a history and physical (H&P) for 3 of 6 surgery records reviewed including Patient Identifier (PI) # 11, PI # 10, PI # 8 and had the potential to affect all patients served by the hospital.

Findings include:

Monroe County Hospital Medical Staff Rules and Regulations

B. Medical Records

1. The attending practitioner shall be responsible for the preparation of a complete and legible medical record for each patient. ...This record shall include...history and physical examination...

2. A complete admission history and physical examination shall be recorded within twenty-four hours of admission....In the event that a history and physical was dictated previously...and no major changes...have occurred, the time frame for submission of an acceptable report will be within 30 days prior to admission...

3. A documented history and physical examination is required before an operative or any potentially hazardous diagnostic procedure is performed...

1. PI # 11 was admitted to the hospital on 12/1/21 with diagnosis including Acute Cholesystitis.

Review of the Pre-Op (Operation) Orders dated 12/2/21 revealed the procedure to be performed: Laparoscopic Cholecystectomy under general anesthesia.

Review of the Discharge Summary signed by the physician on 2/6/22 revealed PI # 11
underwent a Laparoscopic Cholecystectomy on 12/2/21 and was discharged from the hospital on 12/3/21 and there was no documentation of a history and physical.

An interview conducted on 2/9/22 at 3:10 PM with Employee Identifier (EI) # 1, Chief Nursing Officer (CNO) confirmed there was no documentation of a history and physical.



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2. PI # 10 was admitted to surgery on 1/13/22 for Laparoscopic Bilateral Inguinal Hernia Repair.

Review of the Pre-Op Orders dated 12/23/21 revealed Laparoscopic Bilateral Inguinal Hernia Repair with the surgery date of 1/13/22.

Review of the 1/13/22 surgery outpatient record revealed no documentation the physician assessed the patient before surgery and no H&P.

In an interview conducted on 2/10/22 at 12:45 with EI # 2, Director of Surgery Services, confirmed there was no H&P.

3. PI # 8 to admitted to facility on 11/2/22 with the diagnosis of Foreign Body Lodged in Throat.

PI # 8 was scheduled for an Esophagogastroduodenoscopy (EGD) on 11/3/22 and there was no H&P found.

In an interview conducted on 2/10/22 at 12:30 PM, EI # 2 confirmed there was no H&P in the surgical record.

Based on observations, review of the Monroe County Hospital (MCH) Medical Staff Rules and Regulations, facility policies and procedures, surgical records (SR), Clinical Pharmacology, Centers for Disease Control (CDC) and Prevention
Frequently Asked Questions (FAQ) and interviews, it was determined the hospital failed to ensure:

1. Certified Registered Nurse Anesthetist (CRNA)'s safely mixed, administered and labeled medications.

2. The staff practiced infection prevention and control measures for hand hygiene, ensured single use items were disposed of after patient use.

3. Policies, procedures, protocols were developed for Anesthesia and reviewed annually as stated in the MCH Medical Staff Rules and Regulations.

This affected 2 of 2 surgical observations conducted Patient Identifier (PI) # 12 and PI # 21. This deficient practice had the potential to negatively affect all patients receiving anesthesia at this hospital.

Findings include:

Monroe County Hospital Medical Staff Rules and Regulations
Revised on 7/22/2008

B. MEDICAL RECORDS

1. The attending practitioner shall be responsible for the preparation complete and legible medical record for each patient. Its contents shall be pertinent and current.... course of treatment and progress...

AC. GENERAL CONDUCT OF CARE

7. Protocols or appropriate pertinent orders, applying to all patients or to groups of patients, may be formulated from time to time by the staff in conference with the Chief Executive Officer and the Medical Staff. The Executive Committee or entire Medical Staff shall approve all protocols at least annually...

Clinical Pharmacology
Administration Information for Propofol & IV (Intravenous) Compatibility Report
Printed 2/9/22 4:00 PM- Facility Pharmacist

"Do not mix Propofol with other medications before administration. If Lidocaine is to be administered the minimize pain on injection of Propofol immediately before administration and in quantities not exceeding 20 mg Lidocaine/200 mg Propofol."

CDC FAQ regarding Safe Practices for Medical Injections
March 2, 2011

Medication Preparation Questions:
Parental 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. Proper hand hygiene should be performed before handling medications...

Facility Policy: Disposable (Single Use Devices) Versus Non-Disposable Items
Date Last Revised: 10/2019

It is the policy of this hospital that all disposable or single use devices (SUD's) are not reused or reprocessed.

Any item designated in writing with the description "disposable" or "single use only" is intended for a single use only and then discarded as trash when used. The item is usually designated as disposable on the outer wrapper...and sometimes on the item itself. These items are not reprocessed for use again.

1. During a tour of the surgery department conducted on 2/8/22 from 10:35 AM to 2:30 PM with Employee Identifier (EI) # 2, Director of Surgical Services. The surveyor requested anesthesia policies and procedures, EI # 2 stated, "We don't have policies for anesthesia, you'll have to get them from anesthesia."

The surveyor observed on the anesthesia cart an opened IV (Intravenous) Start Kit opened and contained a 6.0 endotrachal tube and a Chlorprep swab.

In an interview conducted on 2/8/22 at 1:20 PM, EI # 4, CRNA, was asked about the re-use of opened single use supplies and the opened endotrachal tube in the IV start kit package. EI # 4 stated, "We keep that kit as a reminder how to set up a trach in case of an emergency."

The surveyor requested anesthesia policies, procedures or protocols from EI # 4, for re-use of single use items, preparation of endotrachal tube and emergency procedures. EI # 4 stated, "They are online. We don't have to have hospitals policies or protocols, we follow AANA (American Association of Nurse Anesthesiology) guidelines." The surveyor asked for something in writing as to what practices the CRNA's follow. The surveyor was never provided with any written policies, procedures or protocols from the anesthesia staff.

2. PI # 12 was admitted to the facility's outpatient surgery on 2/9/22 for Colonscopy, 2 degree Screening, History of Polyps.

During observations of care conducted on 2/9/22 from 9:25 AM to 11:35 AM, the surveyor observed the following:

At 9:25 AM, EI # 3, CRNA Manager, entered Pre-Op (Operation) room 1 and failed to perform hand hygiene upon entering the room. EI # 3 completed an assessment which included touching the patient's bearded face and throat with ungloved hands. EI # 3 documented assessment on the Pre-anesthesia Evaluation form and then returned to the nursing station and continued to document on the form.

EI # 3 failed to perform hand hygiene upon entering the patient room, before or after conducting the physical assessment, or when exiting the patient room and returning to the nursing station.

During an interview conducted on 2/9/22 at 10:00 AM with EI # 3 the surveyor observed a syringe in EI # 3's shirt pocket and asked what was in the syringe and who was it for? EI # 3 removed the syringe from pocket and said the medication was for PI # 12 and was labeled Midazolam (Versed). There was no patient name or the time the medication was placed in the syringe.

At 10:27 AM, EI # 3 entered Pre-Op room 1 and began to administer the Versed to PI # 12's intravenous (IV) line. EI # 6, (Surgery Registered Nurse [RN] # 1) quickly asked PI # 12 to verify patient identifiers times (X) 2. EI # 3 failed to identify patient before administering medication.

At 10:29 AM, EI # 3 then went to the Pyxxis (Automated Drug Dispensing) machine and removed 2 vials of Propofol 200 milligram (mg)/20 milliliter (ml) vials and 1 small clear vial. EI # 3 added the clear medication and then added the Propofol to the syringe.

The surveyor asked what's the name of the medication placed in the syringe before the Propofol. EI # 3 replied, "It's Lidocaine 2%. I add 3 ml which would be 60 mg in the syringe to keep the Propofol from burning at the site."

At 10:46 AM, EI # 3 placed the second bottle of Propofol in a syringe and began to administer.

At 11:06 AM in the PACU (Post Acute Care Unit), EI # 3 held up a syringe containing between 15 ml of Propofol and quickly squirted the Propofol into the sink next to the ice machine and said, "Some of this was IV fluid and Lidocaine." EI # 3 did not add Lidocaine to the second syringe of Propofol.

A review of the Anesthesia Record dated 2/9/22 was completed with EI # 20, Pharmacist, at 4:00 PM to identify the medications documented. EI # 20 identified one medication as Propofol 300 mg and the other was unknown and there was no total for second medication listed.

EI # 20 was asked is Propofol and Lidocaine Compatible? EI # 20 replied, "I would not recommend mixing anything with Propofol because it's a fat emulsion." Then EI # 20 reviewed Clinical Pharmacology regarding administration information for Propofol & IV (Intravenous) Compatibility Report: "Do not mix Propofol with other medications before administration. If Lidocaine is to be administered the minimize pain on injection of Propofol immediately before administration and in quantities not exceeding 20 mg Lidocaine/200 mg Propofol."

The surveyor informed EI # 20, Propofol was added to a syringe containing 3 ml of Lidocaine and administered to PI # 11 during procedure. EI # 20 stated, "3 ml would equal 60 mg of Lidocaine/Propofol 200 mg. That exceeds the recommended amount." The surveyor asked EI # 20, should the wasted amounts of controlled medications be documented on the Anesthesia record? EI # 20 replied, "For best practices I think it should be."

In an interview conducted on 2/9/22 at 11:45 AM, EI # 3, confirmed the dose of Lidocaine exceeded the recommended dose and the total amount was not documented. EI # 3 also confirmed the amount of Propofol was not documented on the Anesthesia record and stated, "It's in the Pyxxis."

3. PI # 21 was admitted to outpatient surgery on 2/9/22 with the diagnosis of Rectal Bleeding Colonscopy.

During an observation of care conducted on 2/9/22 at 2:25 PM, EI # 3 failed to perform hand hygiene, removed 2 vials of Propofol 200 mg/20 ml and 1 vial of Lidocaine 2% from the Pyxxis.

EI # 3 applied gloves drew up Lidocaine and then added Propofol to a syringe. The surveyor asked how much Lidocaine did you use? EI # 3 replied, "I always use 3 ml."

EI # 3 slowly administered Lidocaine 60 mg and Propofol 200 mg to PI # 21.

At 2:33 PM the surveyor observed the blood pressure of 152/126.

Review of the 2/9/22 Anesthesia Record revealed no documentation of the amount of Propofol administered or the elevated blood pressure.

Further review of the 2/9/22 Anesthesia Record revealed the total amounts for Propofol or Lidocaine administered were not documented.

In an interview conducted on 2/9/22 at 4:15 PM, EI # 20, Pharmacist, confirmed EI # 3 exceeded the recommended amount of Lidocaine to PI # 21 and document medication totals.

In an interview conducted on 2/10/22 at 11:45 AM, EI # 3 confirmed there was no amount of Propofol documented. And also confirmed the elevated blood pressure and medication totals for Propofol or Lidocaine were not documented.

Based on review of the Monroe County Hospital (MCH) Medical Staff Rules and Regulations and interviews, it was determined the hospital failed to ensure anesthesia records were legible and complete. This affected 4 of 6 surgical records reviewed including PI # 12, PI # 21, PI # 10, PI # 8. This deficient practice had the potential to negatively affect all patients receiving anesthesia at this hospital.

Findings include:

Monroe County Hospital Medical Staff Rules and Regulations
Revised on 7/22/2008

B. MEDICAL RECORDS

1. The attending practitioner shall be responsible for the preparation complete and legible medical record for each patient. Its contents shall be pertinent and current.... course of treatment and progress...

1. PI # 12 was admitted to the facility's outpatient surgery on 2/9/22 for Colonscopy, 2-degree Screening, History of Polyps.

Review of the 2/9/22 Pre-Anesthesia Medications administered revealed Versed 2 milligram (mg) IV (Intravenous) and the time of administration was not documented.

The Anesthesia Record dated 2/9/22 was illegible. The surveyor took the record to Employee Identifier (EI) # 20, Pharmacist, at 4:00 PM to identify the medications documented. EI # 20 identified one medication as Propofol and the other was unknown.

Further review of the Anesthesia Record dated 2/9/22 revealed the total amount of the second medication was not documented.

In an interview conducted on 2/10/22 at 11:25 AM, EI # 2, Director of Surgery Services, was unable to identify the name of the second medication.

In an interview conducted on 2/10/22 at 11:30 AM, EI # 3, Certified Registered Nurse Anesthetist (CRNA) Manager, EI # 4, (CRNA # 2) and EI # 23, Surgeon, confirmed the Anesthesia record was not legible and incomplete.

2. PI # 21 was admitted to outpatient surgery on 2/9/22 with the diagnosis of Rectal Bleeding Colonscopy.

Review of the 2/9/22 Anesthesia Record revealed no amount was documented of the amount of Propofol administered.

Further review of the 2/9/22 Anesthesia Record revealed the total amounts for Proprofol or Lidocaine administered were not documented.

In an interview conducted on 2/9/22 at 4:15 PM, EI # 20 confirmed EI # 3 failed to safely administer Propofol and Lidocaine to PI # 21.

In an interview conducted on 2/10/22 at 11:45 AM, EI # 3 confirmed the amount of Propofol and total amounts of Propofol or Lidocaine were not documented.

3. PI # 10 was admitted to surgery on 1/13/22 for Laparoscopic Bilateral Inguinal Hernia Repair.

Review of the 1/13/21 Pre-Anesthesia Medications administered included Versed 2. There was no dose, route or time the Versed was administered.

The 1/13/22 Anesthesia Record was illegible on 2/9/22. The surveyor reviewed Anesthesia Record with EI # 20 at 4:00 PM, to identify the name of the medications documented or the total amounts administered EI # 20 stated, "There is no totals documented. I can't read all of the medications. I'd have to pull a Pyxxis report and try to compare the documentation with report."

In an interview conducted 2/10/22 at 11:45 AM, EI # 3 and EI # 4 confirmed the total amount of medications were not totaled and were not able to identify all medications listed on the anesthia record.

4. PI # 8 was admitted to the facility on 11/2/21 with the diagnosis of Foreign Body Lodged in Throat.

PI # 8 was scheduled for Esophagogastroduodenoscopy (EGD) 11/3/21.

Review of the 11/3/21 Pre-Anesthesia Medications included Versed 2 mg IV and the administered time was not documented.

In an interview conducted on 2/10/22 at 11:45 AM, EI # 3 confirmed the CRNA failed to document the time the Versed was administered.

Based on medical record (MR) review, American Heart Association Blood Pressure range recommendations and interviews, it was determined the facility failed to ensure ED (Emergency Department) staff:
1. Monitored the patients vital signs/pulse oximetry (oxygen saturation level) per Chest Pain protocol/physician orders in 1 of 1 record reviewed for chest pain.

2. Re-assessed/re-evaluated an elevated BP (blood pressure) and abnormal pain scale assessment during the ED stay for 1 of 10 ED record reviews for patients who received emergency treatment in the ED.

This affected ED Patient Identifier (PI) # 2, ED PI # 13, in 2 of 10 patients treated for an emergent condition and had the potential to affect all patients treated in the ED.

Findings include:

American Heart Association (AHA)
The Facts About High Blood Pressure
High blood pressure (also referred to as HBP, or hypertension) is when your blood pressure, the force of blood flowing through your blood vessels, is consistently too high.

The five blood pressure ranges as recognized by the American Heart Association are:

Normal
Blood pressure numbers of less than 120/80 mm Hg (millimeters mercury) are considered within the normal range. If your results fall into this category, stick with heart-healthy habits like following a balanced diet and getting regular exercise.

Elevated
Elevated blood pressure is when readings consistently range from 120-129 systolic (systolic blood pressure [the first number] - indicates how much pressure your blood is exerting against your artery walls when the heart beats) and less than 80 mm Hg diastolic (diastolic blood pressure [the second number] - indicates how much pressure your blood is exerting against your artery walls while the heart is resting between beats). People with elevated blood pressure are likely to develop high blood pressure unless steps are taken to control the condition...

High blood pressure threatens your health and quality of life
In most cases, the damage done by HBP...takes place over time. Left undetected (or uncontrolled), high blood pressure can lead to:

Heart attack - High blood pressure damages arteries that can become blocked and prevent blood flow to the heart muscle.
Stroke - High blood pressure can cause blood vessels in the brain to clog more easily or even burst.
Heart failure - The increased workload from high blood pressure can cause the heart to enlarge and fail to supply blood to the body.
Kidney disease or failure - High blood pressure can damage the arteries around the kidneys and interfere with their ability to filter blood effectively...

1. ED PI # 2 presented to the ED on 7/5/21 with chief complaint was chest pain.

MR revealed a Chest Pain Screening Tool (Chest Pain Evaluation only for patients greater than equal to 18 years old) which included physician orders for vital signs/pulse oxymetery are to be obtained at least every 15-30 minutes.

Further record review revealed vital signs and pulse oximetry were documented at 3:25 PM and 3:55 PM and at 3:55 PM Nitroglycerin 1 inch Paste was applied. The next vital signs/pulse oximetery was documented at 7:00 PM which was 2 hours 55 minutes later. The last vital signs/oximetery results were documented at 7:15 PM. At 10:25 PM, which was 3 hours 10 minutes later the patient was transferred by emergency transport to a facility with cardiology speciality care.

In an interview on 2/10/22 at 8:39 AM, EI (Employee Identifier) # 12, ED Manager confirmed ED staff failed to follow physician orders/Chest Pain protocol and monitor/document vital signs/pulse oximetry on a patient with chest pain.

2. ED PI # 13 presented to the ED on 8/8/2020 at 11:40 AM per emergency transport, chief complaint was motorcycle accident, injury to hands, left elbow, and left ankle.

Review of the nurse triage documentation dated 8/8/2020 at 11:31 AM revealed BP (blood pressure) 152/112 and pain 6/10 (1-10 pain scale-10 worst pain).

Further MR review revealed at 2:26 PM, 2 hours 26 minutes later the patient was discharged home in stable condition. There was no documentation the patient's blood pressure and pain were re-assessed.

In an interview on 2/10/22 at 8:39 AM, EI # 12 confirmed staff failed to re-evaluate the patient after abnormal findings, such as HBP and abnormal pain assessment were identified. EI # 12 stated we follow the AHA recommendations.