HospitalInspections.org

Based on interview and record review, the facility's Governing Body failed to ensure the timely review, implementation, and approval of the use of a new dialysis machine prior to use for patients' dialysis treatments and failed to develop policies and procedures for the new dialysis machine, as evidenced by:

The facility failed to ensure the medical staff was accountable to the governing body for the quality of care provided to patients, in that new dialysis machines, Tablo were installed and used for patients' dialysis treatments without documented evidence of the Medical Director and the Governing Body's approval.

Cross refer to Acute Care Hospital tag: A0049

Based on review of facility documents and staff interview, the facility failed to ensure the medical staff was accountable to the governing body for the quality of care provided to patients, in that new dialysis machines, Tablo were installed and used for patients' dialysis treatments without documented evidence of the Medical Director and the Governing Body's approval.

Findings:

A review of the Governing Body meeting minutes October 2018 - October 2019 showed no documented evidence of the approval for trial or use of the Tablo machine for dialysis treatments by the Medical Director of the Hemodialysis Unit (personnel #15) or by the Governing Body prior to use for patients' dialysis treatments.

On 11/13/19 at 6:00 PM, the Vice President (VP) of Quality confirmed in an interview, the facility's QAPI and governing body showed no documented evidence of the approval for trial or use of the Tablo machine for dialysis treatments by the Medical Director of the Hemodialysis Unit (personnel #15) or by the Governing Body prior to use for patients' dialysis treatments.

Based on observation, records review, and interview, the facility failed to ensure patients received care in a safe setting, as evidenced by:

Findings:

A). The facility failed to ensure Hemodialysis Unit staff Registered Nurses (RN) (personnel #38, #39, and #43), a Physician (personnel #16), and a patient (patient #28) wear appropriate Personal Protective Equipment (PPE) during provision of care when it is likely that contact with blood or body substances during hemodialysis treatments, blood transfusion, and isolation precautions to prevent the risk of cross-contamination and/or transmission of infection.


B). The facility failed to ensure safe, appropriate removal, and disposal of used Arteriovenous Fistula (AVF) needles and follow the manufacturer's safe procedure to remove AVF needles by Hemodialysis Unit staff RN (personnel #38, #39, and #42) to prevent the risk of needle stick injuries, cross-contamination, and transmission of infection.


C). The facility failed to ensure Hemodialysis Unit staff RN (personnel #39) clearly separate clean versus dirty supplies, used clean supplies for central venous catheter (CVC) care, and appropriate disposal of syringes filled with blood. This practice placed patients and staff at risk for cross-contamination and transmission of infection.


D). The facility failed to ensure Hemodialysis Unit personnel demonstrate competencies and sustain the skills needed to perform Hemodialysis (HD) and Peritoneal Dialysis (PD) treatments.

1). 5 of 5 personnel (personnel #38, #40, #42, #45, and #46) personnel files showed no documented evidence of competency skills checklist for Hemodialysis (HD) skills and Peritoneal Dialysis (PD) skills,

2). 7 of 7 personnel (personnel #38, #40, #42, #43, #45, #46, and #55) personnel files showed no documented evidence of competency skills for the use of the Fresenius 2008 K2 , and Fresenius 2008 T dialysis machines used for dialysis treatments, and

3). A review of a contracted personnel's (personnel #147) file showed no documented evidence of competency water skills checklist and inservice on water cultures sampling for the new Tablo machines.


E). The facility failed to ensure:

1) medical records were complete and accurate and Patients have documented evidence of an accurate portrayal for the provision of care and of the course of treatment received, citing 1 of 1 patient (patient #139) who did not have documented evidence of blood leak during his dialysis treatment on 08/06/19, and

2) adverse occurrence (blood leak on 08/06/19) was reported to monitor, trend, track, analyze the occurrence and develop action plans to prevent reoccurrence and promote quality of care.


F). The facility failed to ensure Hemodialysis Unit:

1). Personnel demonstrate competencies and skills for the use of a new dialysis machine, 8 of 8 personnel (personnel #38, #39, #40, #42, #43, #45, #46, and #55) files show documented evidence of a competency skills and/or return demonstration checklist for the use of the Tablo machine for dialysis treatments prior to use on dialysis patients,

2) Quality Assessment and Performance Improvement (QAPI) the Hemodialysis Unit Medical Director's approval for trial and use of the new dialysis machine, and

3). Governing Body's approval for trial and use of the new dialysis machine for patients' dialysis treatments.

Cross refer to A0144

Based on interview and record review, the facility failed to inform the patient or patient's family of their rights in advance of furnishing care in that 1 of 5 (Patient #102) patients was not given the Important Message from Medicare (IMM) upon admission and 1 of 5 (Patient #101) patients was not given the Medicare Outpatient Observation Notice (MOON) upon admission.

Findings:

Patient #102 was admitted on 06/01/19, at 0122, to inpatient status for Acute hypercapnic and hypoxic respiratory failure. The IMM dated 06/01/19 at 0400 did not contain a signature. Patient #102 was discharged on 06/10/19 with no further attempts to gain a signature on the form.


Patient #101 was admitted on 05/12/19, at 1401, to Outpatient Observation for Hypertensive Emergency. There was no evidence that the MOON was signed by the patient prior to being changed to Inpatient status on 05/14/19 at 1136.


During an interview with Personnel #105 on 11/12/19 that ended at 1125, Personnel #105 verified the IMM for Patient #102 was not signed and no further attempts had been made to gain a signature on the form. Personnel #105 stated that Patient #101 had been admitted to Observation status on 05//14/19 and had not received the MOON according to policy.


The Policy titled Process for Delivery of the Important Message from Medicare and Medicare Outpatient Observation Notice dated 01/01/17 reflected ..." Important Message from Medicare (IM) must be delivered to all Medicare Fee for Service and Medicare Advantage patients who are admitted as inpatients ...This notice must be delivered within 2 calendar days of admission. The IM must be signed by the patient acknowledging their appeal rights, and a copy of the notice given to the patient ....Medicare Outpatient Observation Notice ...The MOON and oral notification must be given to all patients who are receiving observation services for more than 24 hours and no later than 36 hours after observations begin ...Although this is the CMS (Centers for Medicare and Medicaid Services) guideline, it is Parallon's requirement that the MOON is given at the time the patient is registered as outpatient receiving observations services ..."

During observation on the patient unit 6E East on 11/6/19, Personnel #74 was observed emptying the urinal for Patient #52. After emptying the urinal, the staff member removed the gloves and put on a clean pair of gloves without sanitizing their hands. The staff member proceeded to return to the medication tray to prepare medications for the patient.

In an interview with Personnel #126, she acknowledged the nurse did not sanitize their hands after glove changes between dirty and clean tasks.


During a tour of the nursing unit 6 N West on 11/12/19, the following items were noted in the clean utility room:

* A wooden painted rocker had multiple areas the paint had worn off exposing raw wood. (Raw exposed wood is not impermeable to blood or infectious material).

* A plastic cushion on the seat of the rocker was noted to have 5 rips in the cushion. (Rips/tears will allow blood or infectious materials to enter the foam cushion).

* A crib bed mattress had a cut in the plastic cover of the mattress. (Rips/tears in the mattress will allow blood or infectious materials to enter the mattress).

* A white bin labeled with "dirty toys" contained 5 hard cover books with paper pages, a plastic tray and plastic covered markers. (Paper pages in the book are not surfaces that are cleanable/wipeable by sanitizing wipes).


In an interview with Personnel #128, she stated that the surfaces of equipment that are not intact will allow blood or infectious fluid to enter through the raw wood, rips, tears, and cuts.


In an interview with Personnel #96, she stated that all toys must be of surfaces that are able to be wiped/sanitized with approved cleaning wipes. She acknowledged the pages in the books are paper and they can be damaged with sanitizing wipes.



31016

Based on observation, records review, and interview, the facility failed to ensure patients received care in a safe setting, as evidenced by:

1. failure to use appropriate Personal Protective Equipment (PPE) during provision of care, failure to safely remove and discard used Arteriovenous Fistula (AVF) needles,

2. failure to follow isolation precautions procedures,

3. failure to safely and appropriately discard syringes with blood,

4. failure to show documented evidence of personnel competency skills for hemodialysis (HD) and peritoneal dialysis (PD), competency skills for the use of Fresenius 2008 K2 and Fresenius 2008 T dialysis machines, competency skills for the Tablo dialysis machines, competency skills for the contracted water technician, and

5. failure to show documented evidence of the Medical Director and Governing Body's approval for the trial and use of the new Tablo dialysis machines for dialysis treatments in the dialysis unit.


A). The facility failed to ensure Hemodialysis Unit staff Registered Nurses (RN) (personnel #38, #39, and #43), a Physician (personnel #16), and a patient (patient #28) wear appropriate Personal Protective Equipment (PPE) during provision of care when it is likely that contact with blood or body substances during hemodialysis treatments, blood transfusion, and isolation precautions to prevent the risk of cross-contamination and/or transmission of infection.


B). The facility failed to ensure safe, appropriate removal, and disposal of used Arteriovenous Fistula (AVF) needles and follow the manufacturer's safe procedure to remove AVF needles by Hemodialysis Unit staff RN (personnel #38, #39, and #42) to prevent the risk of needle stick injuries, cross-contamination, and transmission of infection.


C). The facility failed to ensure Hemodialysis Unit staff RN (personnel #39) clearly separate clean versus dirty supplies, used clean supplies for central venous catheter (CVC) care, and appropriate disposal of syringes filled with blood. This practice placed patients and staff at risk for cross-contamination and transmission of infection.


D). The facility failed to ensure Hemodialysis Unit personnel demonstrate competencies and sustain the skills needed to perform Hemodialysis (HD) and Peritoneal Dialysis (PD) treatments.

1). 5 of 5 personnel (personnel #38, #40, #42, #45, and #46) in that personnel files showed no documented evidence of competency skills checklist for Hemodialysis (HD) skills and Peritoneal Dialysis (PD) skills,

2). 7 or 7 personnel (personnel #38, #40, #42, #43, #45, #46, and #55) personnel files showed no documented evidence of competency skills for the use of the Fresenius 2008 K2 , and Fresenius 2008 T dialysis machines used for dialysis treatments, and

3). A review of a contracted personnel's (personnel #147) file showed no documented evidence of competency water skills checklist and inservice on water cultures sampling for the new Tablo machines.


E). The facility failed to ensure:

1) medical records were complete and accurate and Patients have documented evidence of an accurate portrayal for the provision of care and of the course of treatment received, citing 1 of 1 patient (patient #139) who did not have documented evidence of blood leak during his dialysis treatment on 08/06/19, and

2) adverse occurrence (blood leak on 08/06/19) was reported to monitor, trend, track, analyze the occurrence and develop action plans to prevent reoccurrence and promote quality of care.


F). The facility failed to ensure Hemodialysis Unit:

1). Personnel demonstrate competencies and skills for the use of a new dialysis machine, 8 of 8 personnel (personnel #38, #39, #40, #42, #43, #45, #46, and #55) files show documented evidence of a competency skills and/or return demonstration checklist for the use of the Tablo machine for dialysis treatments prior to use on dialysis patients,

2) Quality Assessment and Performance Improvement (QAPI) the Hemodialysis Unit Medical Director's approval for trial and use of the new dialysis machine, and

3). Governing Body's approval for trial and use of the new dialysis machine for patients' dialysis treatments.


Findings:

A review of the Hemodialysis Infection Prevention and Control Policy dated 05/19, showed in part,

"...I. Purpose...to provide an environment that fosters the prevention or infection and cross contamination between...patients and personnel...

II. Policy...provides patient care...that minimizes infection risks...and personnel...

III. Procedure...
A. Personnel...6. Standard precautions will be observed...at all times...Appropriate barriers will be used...a. Gloves will be worn when it is likely that hands will be in contact with patient's...body substances...b. Gowns/plastic...will be worn when it is likely that clothing may be soiled...d. Needles...or otherwise manipulated by hand. Needle and syringe units and other...will be discarded in puncture-resistant point-of-use containers...

C. Records...1. Patient Hemodialysis records will have clearly noted...b. Any mishaps such as blood leaks, blood spills...and machine malfunction...c. The number of machine used for...d. The name of staff member who placed the patient on and removed them from the Hemodialysis machine...

D. Patient Care...1. Hemodialysis machines...

E. Environment...4. There shall be clearly defined geographical boundaries between clean and soiled utility...areas...

F. Transmission-based Isolation Precautions...Patients with infections...or contact Isolation Precautions...The hospital policy and procedures on Transmission-based Isolation Precaution shall apply...

G. Blood and...Blood/body fluids is not to remain on floors..."


A review of the Instructions for Use for WingEater (Arteriovenous Fistula Needles) Dial Medical Supply, showed in part, "...Step 1...slide WingEater up until it just touches the wings...Step 2...place your hand flat on the site...Step 3...Gently pull the tubing until the needle is completely retracted in to the WingEater...making sure the wings are below the safety line..."


During a tour of the facility's Hemodialysis unit on 11/04/19, the surveyor observed the following:

A). At 10:20 AM, the Hemodialysis unit Registered Nurses (RN) (personnel #38 and #39) touched the dialysis machine and cleared dialysis machine alarm during dialysis treatment without gloves on and were beside the dialysis patients during provision of care without gowns on.

At 10:22 AM, the dialysis nursing supervisor (personnel #40) confirmed in an interview, personnel #38 and #39 touched the dialysis machine and cleared dialysis machine alarm during dialysis treatment without gloves on and were beside the dialysis patients during provision of care without gowns on. When asked at what point and/or where in the Hemodialysis unit should staff and visitors wear or remove their Personal Protective Equipment (PPE), she stated that they know where to use their PPE.


B). At 10:30 AM, an RN (personnel #38) discontinued patient #22's dialysis treatment. Personnel #38 removed and pulled the Arteriovenous Fistula (AVF) needles from patient #22's AVF vascular access using her right hand while her left hand pressed the AVF site to stop the bleeding. Personnel #38 held the used AVF needle and pointed the AVF needle on the white pad where patient #22's arm rested, where personnel #38 continued to hold pressure on the AVF site with her left hand and proceeded to apply the built in safety of the needle. After the needle safety was activated, personnel #38 placed the used AVF needle beside patient #22's arm. Personnel #38 removed the second AVF needle from patient #22's AVF site the same way above.

At 10:34 AM, the RN manager (personnel #37) confirmed in an interview personnel #38 pulled the AVF needle out of patient #22's AVF site, pointed the AVF needle to the bed and then activated the built in safety of the needle, and placed the AVF needles beside patient #22's arm, twice. When the dialysis nursing supervisor (personnel #40) was asked what type of AVF needles do they use, she stated, they use the WingEater AVF needles.

At 10:45 AM, an RN (personnel #39) removed and pulled the Arteriovenous Fistula (AVF) needles from patient #23's AVF vascular access using her right hand while her left hand pressed the AVF site to stop the bleeding. Personnel #39 held the used AVF needle and pointed the AVF needle on the white pad where patient #23's arm rested, where personnel #39 continued to hold pressure on the AVF site with her left hand and proceeded to apply the built in safety of the needle. After the needle safety was activated, personnel #39 placed the used AVF needle beside patient #23's arm. Personnel #39 removed the second AVF needle from patient #23's AVF site the same way above.

At 10:47 AM, the RN Scribe (personnel #36) confirmed in an interview personnel #39 pulled the AVF needle out of patient #23's AVF site, pointed the AVF needle to the bed and then activated the built in safety of the needle, and placed the AVF needles beside patient #23's arm, twice.


A review of the Hemodialysis Unit's Hemodialysis Catheter Care for Blood Draws, Medications and Infusions Policy dated 12/18, showed in part, "...III. Procedure...B. Supplies...sterile 4x4s...Masks...2. Don masks...9. Clean...for adults use a 10 milliliters (ml) syringe and withdraw...blood and discard..."

During a tour of the facility's Hemodialysis unit on 11/05/19, the surveyor observed the following:

A). At 10:15 AM, an RN (personnel #43) was at dialysis bed #1 with patient #25 receiving blood transfusion during his dialysis treatment, personnel #43 touched the dialysis blood lines and dialysis machine without a gown or face shield on.

At 10:16 AM, the dialysis nursing supervisor (personnel #40) confirmed in an interview, personnel #43 was at dialysis bed #1 with patient #25 receiving blood transfusion during his dialysis treatment, personnel #43 touched the dialysis blood lines and dialysis machine without a gown or face shield on.

At 10:25 AM, a physician (personnel #16) went inside the isolation room without a gown and talked to patient #28 during her Hemodialysis treatment. Patient #28 had a gauze on her forehead with blood and was in the isolation room for Methicillin Resistant Staphylococcus Aureaus (MRSA) precautions.

At 10:30 AM, the dialysis nursing supervisor (personnel #40) confirmed in an interview, the physician (personnel #16) went inside the isolation room for patient #28 during dialysis treatment and was on MRSA precautions, without a gown and stated, "I did not touch the patient."


B). At 11:00 AM, the surveyor and the RN scribe (personnel #44) observed an RN (personnel #42) pulled and removed AVF needle with her right hand from patient #27's AVF site, held the AVF needle on her hand without the safety at the same time held pressure on the AVF site with both hands, and proceeded to activate the needle's safety. There were 2 prep pads with blood on the floor beside the patient's bed, behind personnel #42.

At 11:03 AM, the RN scribe (personnel #44) confirmed in and interview, an RN (personnel #42) pulled and removed AVF needle with her right hand from patient #27's AVF site, held the AVF needle on her hand without the safety at the same time held pressure on the AVF site with both hands, and proceeded to activate the needle's safety. There were 2 prep pads with blood on the floor beside the patient's bed, behind personnel #42.


C). During a tour of the hemodialysis unit on 11/05/19 at 10:45 AM, the surveyor observed patient #28 was in the isolation room for MRSA during her dialysis treatment, as follows:

An RN (personnel #39) accessed patient #28's right Intrajugular (IJ) central venous catheter (CVC), aspirated 10 milliliters (ml) syringes of blood 1 from each CVC port, placed the 10 ml syringes X 2 filled with blood on top of patient #28's lap, mixed with clean supplies such as alcohol prep pads and 10 ml Normal Saline (NS) syringes.

Personnel #39 proceeded to use the alcohol prep pads and NS syringes that were mixed with the used 10 ml syringes with blood, on patient #28's CVC.

Personnel #39 picked up the leftover unused alcohol prep pads from patient #28's lap and placed them with the clean supplies on top of the beside table.

During the CVC care procedure, patient #28's face mask was placed below her nose and did not cover her nostrils.


At 10:55 AM, the RN manager (personnel #37) confirmed in an interview, patient #28's face mask was placed below her nose and did not cover her nostrils, personnel #39 placed the 10 ml syringes X 2 filled with blood on top of patient #28's lap, mixed with clean supplies such as alcohol prep pads and 10 ml Normal Saline (NS) syringes, proceeded to use the alcohol prep pads and NS syringes that were mixed with the used 10 ml syringes with blood, on patient #28's CVC, and picked up the leftover unused alcohol prep pads from patient #28's lap and placed them with the clean supplies on top of the beside table.

At 11:05 AM, the surveyor observed an RN (personnel #43) cleansed patient #26's right upper arm AVF and cannulated the AVF without assessing for bruit or thrill, and without using a tourniquet to stabilize patient's arteriovenous fistula (AVF).

At 11:07 AM, personnel #40 confirmed in an interview, personnel #43 cannulated patient #26's vascular site without assessing for bruit or thrill, and without using a tourniquet to stabilize patient's arteriovenous fistula (AVF).


D). On 11/13/19, the Hemodialysis Unit staff personnel files were reviewed as follows:

1). There were no documented evidence of competency skills checklist for Hemodialysis (HD) skills and Peritoneal Dialysis (PD) skills for personnel #38, #40, #42, #45, and #46.

When the HD manager (personnel #37) was asked for the documented evidence of competency skills checklist for HD and PD for the rest of the HD she stated the new RN (personnel #39) was the only one who had documented evidence of competency skills for HD and PD.


2). There were no documented evidence of competency skills for the use of the Fresenius 2008 K2, Fresenius and 2008 T dialysis machines for personnel #38, #40, #42, #43, #45, #46, and #55.


3). A review of a contracted personnel's (personnel #147) file showed no documented evidence of competency water skills checklist and inservice on water cultures sampling for the new Tablo machines. Personnel #147 had been drawing water cultures samples for the hemodialysis unit water systems and machines since May 2019.

On 11/13/19 at 1:30 PM, the HD manager (personnel #37) confirmed in an interview personnel #38, #40, #42, #45, and #46's personnel files did not show documented evidence of competency skills checklist for HD and PD , no documented evidence of competency skills for the use of the Fresenius 2008 K2 and Fresenius 2008 T dialysis machines for personnel #38, #40, #42, #43, #45, #46, and #55, and personnel #147's personnel file showed no documented evidence of competency water skills checklist and inservice on water cultures sampling for the new Tablo machines.


E). A review of the Equipment Failure tag dated 08/06/19, showed in part, "...floor: Dialysis...reported by: personnel #38...equipment involved...model...Tablo #4...description of problem...device error (blood leak)...patient care affected...yes...patient involved...yes...comments...unable to return blood..."

On 11/12/19 at 1:50 PM, the RN (personnel #42) was asked for an adverse occurrence report regarding blood leak incident for patient #139's dialysis treatment on 08/06/19, she stated there was no adverse occurrence reported.

A review of patient #139's Hemodialysis treatment flow sheet dated 08/06/19 showed no documented evidence of patient #139's treatment start or treatment end time, assessment of patient #139's reaction to the blood leak, how much blood was lost due to the blood leak, and/or what was the course of action personnel #38 did for the blood leak.

On 11/13/19 at 10:30 AM, when personnel #46 was asked for the treatment sheet for 08/06/19 where patient #139's treatment was affected by the blood leak, she stated personnel #38 changed the dialysis machine and did not have a treatment sheet recorded for the treatment of patient #139 with the incident of the blood leak. When asked where was the documented evidence of patient #139's vital signs, assessments, reaction to the blood leak, and what actions personnel #38 took for the blood leak, she stated there's none because personnel #38 restarted patient #139 on a different machine on 08/06/19 and did not have a treatment sheet for the event.

When personnel #46 was asked for the adverse occurrence report for the blood leak on 08/06/19, she stated they did not report an adverse occurrence.

On 11/13/19 at 10:40 AM, the RN Manager for Hemodialysis (personnel #37) confirmed in an interview there was no documented evidence of patient #139's vital signs, assessments, reaction to the blood leak, and what actions personnel #38 took for the blood leak, she stated personnel #38 restarted patient #139 on a different machine on 08/06/19 and did not have a treatment sheet for the event.


F). The Hemodialysis Unit started using a new dialysis machine (Tablo) to provide dialysis treatments to their patients from December 2018. There are 4 Tablo machines in use by the dialysis staff.

A review of the Hemodialysis Unit personnel files (personnel #38, #39, #40, #42, #43, #45, #46, and #55) showed no documented evidence of a competency skills and/or return demonstration checklist for the use of the Tablo machine for dialysis treatments.

On 11/13/19 at 4:45 PM, the HD manager (personnel #37) confirmed in an interview personnel files (personnel #38, #39, #40, #42, #43, #45, #46, and #55) showed no documented evidence of a competency skills and/or return demonstration checklist for the use of the Tablo machine for dialysis treatments.


A review of the facility's Quality Assessment and Performance Improvement (QAPI) showed no documented evidence the Hemodialysis Unit Medical Director (personnel #15) approved the use of the new machine for dialysis treatments.


A review of the Governing Body meeting minutes October 2018 - October 2019 showed no documented evidence of the approval for trial or use of the Tablo machine for dialysis treatments by the Medical Director of the Hemodialysis Unit (personnel #15) or by the Governing Body prior to use for patients' dialysis treatments.


On 11/13/19 at 6:00 PM, the Vice President (VP) of Quality confirmed in an interview that the facility's QAPI and governing body showed no documented evidence of the approval for trial or use of the Tablo machine for dialysis treatments by the Medical Director of the Hemodialysis Unit (personnel #15) or by the Governing Body prior to use for patients' dialysis treatments.


An IJ (immediate jeopardy) was determined to be present on 11/13/19 at 4:45 PM, related to failure to show documented evidence of personnel competency skills checklists for the provision of care for Hemodialysis(HD) and Peritoneal Dialysis (PD) treatments, for the skills and use of the Fresenius 2008 K2, Fresenius 2008 T dialysis machines and Baxter PD machines, and documented evidence of competency skills and/or return demonstration checklist for the use of the new dialysis machine for patients' dialysis treatments.

The facility took the following actions on 11/13/19 at 10:15 PM to abate the IJ:

11/13/19:

Dialysis patients requiring emergent dialysis will be transferred out until 0700, 11/14/19.

Tablo machines to be removed from service. Policy/procedure and competency to be developed. The use of the new Tablo machine will be approved by the governing body along with the new policy and procedure. This will go through for immediate approval to the Pediatric Dialysis Medical Director, Infectious Disease Medical Director, CMO, CNO, Medical staff president, Chairman of the Board.


11/14/19 - Scheduled dialysis patients included 7 inpatient dialysis unit, 4 Intensive Care Unit (ICU), 1 Heart/Spine (H/S), 3 Peritoneal Dialysis (PD). Total 15 patients currently scheduled.


Fresenius HD
11/14/19 - Personnel #129, Medical City Plano will arrive at Medical City Dallas and will observe and sign off dialysis nursing staff using the Fresenius 2008 T.

Personnel #129 competencies, re-validated by the Plano Dialysis Medical Director (personnel #141) and co-signed by Pediatric Dialysis Medical Director (personnel #142) Medical City on 11/14/19.

11/14/19 - RNs will be signed off by personnel #129.
Pediatric Medical Director (Personnel #142) will sign off on competent preceptors to continue observing nursing staff for competency. Personnel #15 will sign off on competency upon his return.


Fresenius K2
Renal Physicians of North Tarrant (RPNT) Acute Services, Inc. contract in place to administer dialysis treatment. RN (personnel #130) competent in HD and PD. The RPNT RN (personnel #130) will observe and sign off dialysis nursing staff for both HD/PD.


Peritoneal Dialysis (PD)
Personnel #39, deemed competent per initial competency to provide PD 11/13/19.

RPNT Acute Services, Inc. contract in place to administer dialysis treatment.

RN (personnel #130) will observe and sign off dialysis nursing staff for both HD/PD.

Designated Preceptors

RN (personnel #46)
RN (personnel #40)
RN (personnel #45)

Heart and Spine requiring dialysis will be transferred to the main campus.

Training to be provided on Fresenius machines with detailed competency.

Competencies to be completed by all staff:
~ Initial Competency Assessment.
~ Detailed Fresenius competency.
~Peritoneal Dialysis competency.






33326

Based on observation and interview, the facility failed to administer drugs in accordance with Federal and State law and accepted standards of practice in that 1 of 1 (Patient #33) patients was administered the wrong dose of medication.

Findings.

Patient #33 was admitted on 11/02/19 with a diagnosis of Respiratory Syncytial Virus (RSV) Bronchiolitis. On 11/06/19, there was an order for Omnicef Suspension Feed Tube 35 mg (0.7 ml per dose) BID (twice daily) 9A, 9P. At 0930, RN 52# scanned Patient #33's arm band and the bottle of Omnicef Suspension 250 mg per 5 ml. RN#52 drew up 5 ml of Omnicef and handed it to RN #48. RN #48 began administering the medication to Patient #33 via the feeding tube while RN#52 was explaining the medication administration process to the State Surveyor and RN #26. RN #48 stopped administering the medication with 1 ml left in the syringe and asked RN #52 to show the order for the medication. RN #48 read the order then told the State Surveyor that a medication error had been made. The order was for Omnicef 0.7 ml to be administered.

The policy titled Medication Administration and Monitoring dated 10/00 and last revised 03/19 reflected ..." II Medication administration procedures will be followed to ensure patient ...follows the Seven Rights of Medication Administration, including ...3. Right dose ...III A. General Medication Administration Safety Principles ...6. Verify the patient's medication(s) against the EMAR (Electronic Medication Administration Record) by visualizing the medication to the order and the calculation, as applicable ...16. Other key safety practices include ...b. A nurse may not give medications prepared by another nurse ..."

Based on medical record review, policy review, and staff interview, the facility failed to ensure their staff followed their own policy for ensuring patient's had accurate and complete informed consents signed prior to procedures performed on the patients.

Findings:

Facility policy titled "Consent and Disclosure for Medical and Surgical Procedures" states in part:

"Policy:
It is the policy of XXXXXXX that all patients and/or other surrogate decision maker have the right to be informed about and participate in decisions regarding their care. Prior to the performance of a medical, diagnostic, or surgical procedure(s), the medical staff must provide informed consent.

A. Physician Responsibility:
The physician is responsible for providing the patient and/or surrogate the following information prior to completion of the informed consent form.

6. The physician will sign, date, and time the standardized informed consent form in accordance with this policy and the Medical Staff Rules and Regulations.

B. Nursing Responsibility :
The nurse caring for the patient has the responsibility for confirming with the patient/surrogate decision maker that he/she has been provided consent by the proceduralist/surgeon. As part of this process, the nurse may transcribe information onto the standardized informed consent form for the patient/surrogate's signature from the physician's order.

1. Print the name of the proceduralist/surgeon performing the procedure on the informed consent form.

9. The staff witnessing the patient's/surrogate's signature; signs first name, last name and title in the witness blank, and document the date and time.

10. The completed consent is placed in the front of the patient's chart and becomes a permanent part of the Medical Record.

C. Approved Informed Consent Forms:
10. The patient must indicate and initial if they "Do" or "Do Not" consent for vendors to be present in the room.

Appendix A
Procedures Requiring Documented Informed Consent
1. Any surgical, medical, or invasive diagnostic procedure including blood and blood products."


Review of medical record for patient #22 revealed, the physician ( physician #15) signing the consent form did not match the name of the attending physician (physician #144) listed on the consent form.

In an interview with staff #31, during review of the patient medical record, she acknowledged the physician signing the consent form was not the physician listed as the attending physician for the patient.


Review of medical record for patient #26 revealed no signed consent form for the performance of hemodialysis.

In an interview with staff #31, during review of the patient medical record, she acknowledged there was no consent form found in the patient medical record nor in the dialysis unit.


Review of medical record for patient #123 revealed, the physician's entire name was not noted on the consent form. It further revealed the staff witnessing the patient signature only signed their first name with no last name on the consent form. The consent did not have the section completed regarding if the patient would or would not receive blood transfusions.


In an interview with personnel #123 she stated that personnel #124 did not follow their policy and should have signed both first and last name and their credentials on the consent form. She further stated the consent form was not completed as to the consent for blood transfusions as per hospital policy.


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Based on review of documentation and staff interviews, the facility failed to ensure that properly executed consent forms were completed before patient receive treatments.

Findings:

Review of policy Procedure for Registration Forms and Signatures. Department Patient Access, effective 05/01/2015 stated, "Reasonable attempts will be made for follow-up signatures not obtained during the registration process. Each facility will establish an appropriate process for follow-up and obtainment of patient signatures. Any exceptions to this policy must be documented in Meditech collection notes."


Review of medical record for patient #4 revealed, patient was admitted to the hospital on 11/04/2019 at 12:50 am and began receiving in-patient treatment. The conditions of admission and consent for outpatient care was not signed by the patient #4.

In an interview with staff #84 RN on 11/5/19, at 9:46 am, the surveyor asked staff #84 what is the procedure when patients do not sign their consent forms. Staff #84 said, she did not know.


Review of medical record for patient #102 admitted 6/1/19 and discharged 6/10/19, conditions of admission and consent for outpatient care was not signed by the patient.

In an interview with staff #105 Director of Patient Access on 11/12/19, 11:10 am, staff #105 agreed with the findings


31016

Based on medical record review, policy review, and staff interview, the facility failed to ensure their staff followed their own policy for ensuring patients had a completed informed consents signed prior to procedures performed on the patients, citing 1 of 1 patient (patient #136) in that patient #136 had several Peritoneal Dialysis (PD) treatments and there was no documented evidence that a consent was signed by the parent or guardian.

Findings:

Patient #136 was admitted on 07/27/19 as a transfer patient to the Neonatal Intensive Care Unit (NICU). A review of patient #136's medical records showed, he had a Peritoneal Dialysis Catheter Placement on August 15, 2019, and was started on Peritoneal Dialysis (PD). The medical record showed no documented evidence that a consent was obtained and signed by the patient parent or guardian for patient #136's PD treatments.

On 11/13/19, at 2:50 PM, the Hemodialysis Registered Nurse (RN) (personnel #45) confirmed in an interview patient #136's medical record showed no documented evidence a consent was obtained and signed by the parent or guardian for his PD treatments.

Based on medical record review and staff interview, the hemodialysis flowsheets did not include the specific dialysate bath to be used on the patient as per physician orders; 5 of 5 patient treatment flowsheets reviewed did not include the dialysate bath being used.

Findings:

Review of dialysis treatment flowsheet 11/13/19 for patients #22, #26, #28, #132, and #133 revealed the treatment flowsheets did not have documentation of the composition of the dialysate bath for the patient.

In an interview with Personnel #45, he acknowledged there was no documentation on the treatment flowsheet to indicate the specific dialysate bath was used as per physician order.


31016


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

1) ensure hemodialysis flowsheets include the specific dialysate bath to be used by the patient as per physician orders, 2 of 2 patients' (patients #24 and #25) treatment flowsheets reviewed did not include the dialysate bath being used for the dialysis treatment, and

2). have documented evidence of an accurate portrayal for the provision of care and of the course of treatment received by patients, citing 1 of 1 patient (patient #139) who did not have documented evidence of blood leak during his dialysis treatment on 08/06/19.

Findings:

1). Review of dialysis treatment flowsheet 11/13/19 for patients #24 and #25 revealed the treatment flowsheets did not have documentation of the composition of the dialysate bath for the patient.

In an interview with Personnel #45, he acknowledged there was no documentation on the treatment flowsheet to indicate the specific dialysate bath was used as per physician order.


A review of the Hemodialysis Infection Prevention and Control Policy dated 05/19, showed in part,

"...I. Purpose...to provide an environment that fosters the prevention or infection and cross contamination between...patients and personnel...

II. Policy...provides patient care...that minimizes infection risks...and personnel...

III. Procedure...A. Personnel...6. Standard precautions will be observed...at all times...C. Records...1. Patient Hemodialysis records will have clearly noted...b. Any mishaps such as blood leaks, blood spills...and machine malfunction...c. The number of machine used for...d. The name of staff member who placed the patient on and removed them from the Hemodialysis machine..."


A review of the facility's Handling Blood Leaks Policy dated 12/09, showed in part,

"...I. Purpose...to provide safe dialysis treatment in the event of a minor or major blood leak...

III. Procedure...In case of...B. Check the dialysate effluent visually for...coloration...check...with a blood leak test strip...E. In case of a major...the dialyzer...blood lines must be replaced. Blood transfusion depends on the size of the leak and is a medical decision to be made by the attending physician..."


2. A review of the Equipment Failure tag dated 08/06/19, showed in part, "...floor: Dialysis...reported by: personnel #38...equipment involved...model...Tablo #4...description of problem...device error (blood leak)...patient care affected...yes...patient involved...yes...comments...unable to return blood..."

On 11/12/19 at 1:50 PM, the RN (personnel #42) was asked for an adverse occurrence report regarding blood leak incident for patient #139's dialysis treatment on 08/06/19, she stated there was no adverse occurrence reported.


A review of patient #139's Hemodialysis treatment flow sheet dated 08/06/19 showed no documented evidence of patient #139's treatment start or treatment end time, assessment of patient #139's reaction to the blood leak, how much blood was lost due to the blood leak, and/or what was the course of action personnel #38 did for the blood leak.


On 11/13/19 at 10:30 AM, when personnel #46 was asked for the treatment sheet for 08/06/19 where patient #139's treatment was affected by the blood leak, she stated personnel #38 changed the dialysis machine and did not have a treatment sheet recorded for the treatment of patient #139 with the incident of the blood leak. When asked where was the documented evidence of patient #139's vital signs, assessments, reaction to the blood leak, and what actions personnel #38 took for the blood leak, she stated, there's none because personnel #38 restarted patient #139 on a different machine on 08/06/19 and did not have a treatment sheet for the event.

When personnel #46 was asked for the adverse occurrence report for the blood leak on 08/06/19, she stated they did not report an adverse occurrence.


On 11/13/19 at 10:40 AM, the RN Manager for Hemodialysis (personnel #37) confirmed in an interview there was no documented evidence of patient #139's vital signs, assessments, reaction to the blood leak, and what actions personnel #38 took for the blood leak, she stated personnel #38 restarted patient #139 on a different machine on 08/06/19 and did not have a treatment sheet for the event.

Based on interview and record review, the facility failed to ensure that medical records were completed within 30 days of discharge in that 2 of 5 (Patients #36 and 38) patients Discharge Summaries were completed more than 30 days following discharge from the facility.

Findings:

Patient #36 was admitted on 05/21/19 with a diagnosis of Left Above-the-knee Amputation. Patient #36 was discharged on 05/23/19. The Discharge Summary reflected a dictation date of 07/11/19, 49 days after discharge.

Patient #38 was admitted on 07/11/19 with a diagnosis of Multiple Myeloma and Amyloid. Patient #38 was discharged on 08/07/19. The Discharge Summary reflected a dictation date of 09/11/19, 35 days after discharge.

During a chart review on 11/06/19 ending at 1445 Personnel #31 confirmed the Discharge Summaries were dictated over 30 days past discharge.

The Medical Staff Bylaws approved on 10/23/17 reflected ..." Page 9 ... 21 ...Delinquent Record: A record shall be considered delinquent if the record remains incomplete 30 days after patient discharge ..."

Based on observation, review of documentation, and interviews with staff, the facility failed to monitor temperatures where medication and medical supplies were stored causing potential for medications and medical supplies to be unusable.

Findings:

During a tour of the pharmacy located at Spine Heart Hospital on 11/6/19, at 1:04 PM, the surveyor asked staff #91, pharmacy director, how are the temperatures monitored in the pharmacy supply storage room? Staff #91 showed the surveyor a thermometer on a metal shelf. The surveyor asked staff #91, was there any documentation to verify the temperatures were being monitored? Staff #91 said, no. Staff #112 said, the temperatures are monitored by environmental services who notify the managers when the temperatures are not within normal ranges.

Observations conducted in the facility revealed the following:

10th floor- Surgical Oncology Unit

11/04/2019 at 1:25 PM: Observation of the medication room where the unit's Pyxis machine and medication storage were located revealed that the temperature inside the room felt very warm. The unit's Nurse Manager staff #116 was asked if the medication room and Pyxis machine were temperature monitored and he stated, he was not sure. Continued observation of the room revealed no fresh lock temperature monitor.


5th floor- Bariatrics Unit

11/05/2019 at 10:45 am: Observation of the medication room where the unit's Pyxis machine and medication storage were located revealed that the temperature inside the room felt very hot. The unit's Nurse Manager staff #120 was asked if the medication room and Pyxis machine were temperature monitored and he stated, "No, they are not." Continued observation of the room revealed no fresh lock temperature monitor. When asked by the surveyor where the main temperature control was located for the room (thermostat), the staff #120 stated, it was located at the 5th floor nurse's station.

11/05/2019 at 10:58 am: Observation of the air conditioning control thermostat, which controlled the temperature of the 5th floor medication room, revealed the temperature was set to between 78-80°F (Fahrenheit). In an interview conducted at the time of observation, staff #120 verified the above finding and further stated that the medication room could be above 80°F due to the small size of the room, heat being released from the Pyxis machine and refrigerator. However, staff #120 had no way to know what the temperature of the room is because there was no fresh lock system installed.


8th floor- Gynecology Unit

11/05/2019 at 2:00 PM: Observation of the clean supply room revealed the room was very small and the temperature inside the room felt very warm. Continued observation revealed that staff were storing Intravenous fluids (IV) in the clean supply room. Instructions printed on the outside bags of the IV fluids stated that the fluids must be kept/ stored at 77°F.

Record review of the facility document entitled: 8 N Clean Supply Temperature (Sensor 94886), dated 06/01/2019 to 11/12/2019 revealed that temperature spikes above 80°F between 11/04/2019 and 11/10/2019.


6th Floor- Pedi ICU

11/06/2019 at 2:32 PM: Observation of the medication room where the unit's Pyxis machine and medication storage were located revealed a clear straw like material sticking straight out of the wall located over the medication room door. Further observation revealed that the straw like structure extended through the wall into the patient care hallway on the other side of the medication room.


In an interview conducted on 11/06/2019, at the time of discovery, the Unit's Registered Nurse staff #104, supervisor, stated that the straw like structure was the "fresh lock" system for the medication room and that it was responsible for monitoring temperatures. When the surveyor asked if the system was functional, the #104 RN supervisor stated, "Yes we get email alerts all the time."


In an interview conducted on 11/07/2019 at 8:50 am, with staff #6, Vice President of Operations, stated that the straw like structure over the medication room door in the Pedi ICU was not a functioning fresh lock system. He further stated that it was instead the remains of a system that was either never installed or had been removed at some point in the past.


During continued interview on 11/12/2019 at 11:40 am, with staff #6, Vice President of Operations, further revealed that the facility is not monitoring temperatures in any of the patient care unit's medication rooms and stated that the facility's Pyxis machines are not temperature and/or humidity controlled. He further revealed that the facility only monitors temperature and humidity in areas where sterile supplies are kept.


Review of email on 11/5/19 10:47 am, from pharmacy director staff #81. "Please see attached document (page 6). This is not specific in MCD policy; we follow USP Guidelines. Room Temp for medications, USP Temp and Storage Requirements stated, "Control room temperature: The temperature maintained thermostatically that encompasses the usual and customary working environment of 20-25 degree (68-77-degree F)."


In an interview with staff #6 11/12/2019 at 11:40 am, the Vice President of Operations revealed that the facility is not monitoring temperatures in any of the patient care unit's medication rooms and stated that the facility's Pyxis machines are not temperature and/or humidity controlled. He further revealed that the facility only monitors temperature and humidity in areas where sterile supplies are kept.

Based on observation, review of documentation, and staff interviews, the pharmacy failed to monitor staff for safe handling of hazardous medications.

Findings:

During the tour of the pharmacy storage area on the afternoon of 11/5/19, an interview was conducted with staff #83, pharmacy tech. Staff #83 said, he unpacks the medications and pharmacy supplies including the chemotherapy medications. The surveyor asked staff #83, how do you protect yourself when handling chemotherapy medications? Staff #83 said, he wears a mask and gloves.

The surveyor asked to see the PPE staff #83 uses. Staff #83 located a yellow mask in another room in the pharmacy. Staff #83 was able to locate a chemical spill kit on a shelf in the storage area after much searching.

Review of Chemotherapy/Biotherapy Policy #MM.3.40, Revised 10/16, page 4 of 28 stated, "E. Safe Handling/Disposal will comply with OSHA work practice guidelines for dealing with cytotoxic medications. a. All staff handling chemotherapy/biotherapy agents must don Personal Protective Equipment (PPE)."

In an interview with staff #83 during the tour the findings were confirmed.

Based on observation and interviews, the hospital failed to ensure outdated, mislabeled, or otherwise unusable drugs and biologicals were not available for patient use in that:

Glucose test strips and glucose control solution had either expired or wrongly dated.

A bottle containing urine dipstick testing strips (Multistix 8 sg) for bedside urinalysis had expired.

These failures placed the patients at an increased risk of receiving inaccurate readings and facility not able to validate the accuracy of the glucometer.

Findings:

Tour of the facility N Tower 4th floor (NICU) on 11/05/19, at 09:45 a.m., revealed a Stat Strip Glucose Test Strips canister with a discard date of 02/02/19. This was confirmed by the RN # 27.

Interview with RN # 27 on 11/05/19, at 09:46 a.m., revealed, it was nurse's responsibility to make sure the strips were not expired and reflected the correct dates. She stated, "it's a mistake, it should read 02/02/20."

During the tour of N Tower 6th floor (Pediatrics) on 11/05/19, at 10:25 a.m., revealed a Stat Strip Glucose control solution Level 1 had a discard date of 10/21/19. This was confirmed by the RN # 26. When asked who was responsible for making sure the reagents were not expired, RN # 26 stated "the nurses are supposed to check on them daily."

Tour of the facility N Tower 9th floor (Antepartum) on 11/05/19, at 01:45 p.m., revealed a Stat Strip Glucose Test Strips canister with a discard date of 04/21/19. There was also a bottle containing urine dipstick testing strips (Multistix 8 sg) for bedside urinalysis with an expiry date of 2019/10/31. This was confirmed by the RN # 28. She reported the test strips were wrongly dated. She said "it should read 04/21/20.

Based on observation, review of documentation, and interviews with facility staff, the facility failed to maintain adequate laboratory services as expired laboratory specimen tubes were found in 4 of 6 phlebotomy carts checked in the main hospital lab storeroom.

Findings:

During a tour of the main hospital laboratory store room on the afternoon of 11/6/19, in the company of the phlebotomy supervisor, personnel #54, the following expired laboratory supplies were found available for use in patient care.

1. Found in phlebotomy PM cart #4: Microtainer yellow top lab tube, 3 expired 10/31/19.

2. Found in the phlebotomy supply room in a plastic bin: Microtainer yellow top lab tube, 3 expired 10/31/19.

3. Found in phlebotomy cart #4: Microtainer gray top lab tube, 4 expired 10/31/19.

4. Found in phlebotomy cart #8: Microtainer gray top lab tube, 1 expired 10/31/19; BD Bactec 40 ml culture vial, expired 10/31/19.

5. Found in phlebotomy cart #16: Microtainer yellow top lab tube, 5 expired 10/31/19.


In an interview with personnel #54 during the tour on 11/6/19 at approximately 2 PM, personnel #54 agreed that the above listed lab supplies were expired.


The facility policy entitled "Inventory Management" #Lab 2.1012 dated 8/19 reflected in part "I. Purpose: To maintain adequate supplies in the laboratory for phlebotomy collections ...II. Policy/Procedure ...D. When items are received, the expiration dates are checked against items in stock. The shortest expiration dates are moved to the front to be used first. E. All supplies that are out of date must be disposed of properly."

Based on observation, review of documentation and interview, it was determined that the hospital failed to ensure that the physical plant was maintained in a safe and sanitary manner.

Findings:

Maintenance issues were found during the onsite survey to include:

On the morning of 11/04/2019, an inspection of the hospital loading dock area revealed that the area immediately surrounding the hydraulic lift for the trash compactor had visible trash observed on the ground. This included blue disposable gloves, empty disposable water bottle and remnants of food products. Beside the large dumpster located near the trash compactor, there were what appeared to be two black bags of trash laying on the ground.

Expired employee first aid supplies were found in a wall mounted first aid kit located in the Central Accumulation area. These included: a 59 ml bottle of first aid antiseptic spray with expiration date of 12/2012, a 59 ml bottle of burn relief spray with expiration date of 09/2013 a box of Aypanal non-aspirin pain reliever with expiration date of 11/13, and a box of Cherry Flavored Menthol Cough Supplement Cough Drops with expiration date of 03/14.

In an interview with staff member# 7 on the afternoon of 11/04/2019 the above findings were confirmed.


Two stained ceiling tiles were observed above the wall mounted medical gases box located adjacent to the Day Surgery/Litho Hallway. In an interview with staff member# 8 on the afternoon of 11/04/2019 the above finding were confirmed.


On 11/04/2019, at approximately 2:45 PM, on the tenth floor of the Care Tower A - South Medical Tower, it was observed that the floor coverings in rooms 1010 and 1013 had multiple damaged areas consisting of grooves, scrapes, and scratches which penetrated the floor covering. These damaged areas make cleaning the floor difficult.


Review of hospital policy #5.51, entitled: "Environmental Services-Infection Prevention and Control, Maintenance of a Clean Sanitary Hospital Environment" stated in the purpose section, "Maintenance of a clean sanitary patient care environment through the removal of microorganisms that could be transmitted to patients and personnel." The policy section stated: "It is the policy of Medical City Dallas that all patient care areas will be thoroughly cleaned and disinfected on a daily basis."


In an interview with staff members RN# 12 and RN# 13 on the afternoon of 11/04/2019, the above finding was confirmed.


On the fifth floor North Tower PICU, there was a hole observed in the wall between room 558 and 559, the hole was approximately 4" x 2". In an interview with staff members #3 and #8 on the afternoon of 11/05/2019, the finding was confirmed.


On the sixth floor North Tower treatment room, the under-sink area was soiled and dirty in appearance. In an interview with staff members# 3 and RN# 26 on the afternoon of 11/05/2019, the finding was confirmed.


The floor of the supply receiving area was dirty in appearance with visible pieces of debris/trash observed underneath wire storage racks. In an interview with staff member# 13 on the afternoon of 11/05/2019, the finding was confirmed.


On the second floor of public corridor Building A/Building D there was an alcove sitting bench (under a print of a gentleman fly fishing) covered in a reddish cloth material, the covering was stained and soiled in appearance. Also observed on the second floor of building A near the Children's Tower Elevator was another similar style bench with similar covering which was also soiled and stained in appearance. In an interview with staff member# 8 on the afternoon of 11/05/2019, the finding was confirmed.


On the second floor of Building D South Soiled Utility Room, there were 3 red bio hazard bags observed laying on the floor, 4 black bags of regular garbage laying on the floor, as well as 4 disposable blue examination gloves and 4 full sharps containers which were also on the floor. In an interview with staff member# 8 on the afternoon of 11/05/2019, the finding was confirmed and staff member# 8 stated that these items should have been placed in a bio hazard cart.


During tour on 11/12/2019 the following was observed:

One stained ceiling tile in the E, 4th floor (4E) tower critical care waiting room. Ripped vinyl covering on the seating area of chair in the same waiting room. Confirmed in interview on the morning of 11/12/2019, with staff members # 3 and #8.


Linen cart in the 4th floor clean equipment room, (4E West), had a cloth cover that was soiled in appearance. Confirmed in interview on 11/12/2019, with staff member RN#64.


Clean supply room for Telemetry unit (5E East), one ceiling mounted fluorescent light fixture not working. Confirmed in interview on 11/12/2019, with staff member RN# 116.


Tour on 11/13/2019 at the Heart/Spine hospital location:

Findings:

Supply chain warehouse, South Tower Heart Side, one stained ceiling tile. Confirmed in interview with staff member # 3. Housekeeping closet on 2 South Heart, one stained ceiling tile. Confirmed in interview on 11/13/2019 with staff member # 3.

Medication room, 2 South Heart, corner of horizontal counter laminate had broken edge, approximately 1" x ¾". Confirmed in interview on 11/13/2019 with staff member # 3.

In the supply room, 3 South. One of three NX Stage dialysis machine had piece of clear tape on left front side of machine, whitish tape residue on front of machine. In same room two of the three NX Stage machines had visible small (approximately 2) stains on each machine, stains were approximately the size of a number two pencil lead. Confirmed in interview on 11/13/2019 with staff member RN# 100.

Clean equipment storage room, 4th floor by the Nurse Station there was a plastic brown colored three shelf roll able cart which was stained and dirty in appearance. On the top shelf were three each white paper bags containing patient sleeping masks which were to be given to patients. Confirmed in interview on 11/13/2019 with staff member RN# 100.


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Maintenance issues were found during the onsite survey to include:

On the morning of 11/04/2019, an inspection of the hospital what was described by Staff # 8 the heart of the hospital. This was a hallway that lead to the loading dock that lead to the office area Staff #8 and #9. The hallway area revealed that the walls had crash rails on them that were damaged, cracked in half along the hallway walls and corners of walls leading to other areas of the hospital. The floor has tiles with cracks and chips in areas of the tile. The walls were dinged and in need of replacement paper and/or paint in areas.


When Staff #8 was asked about the crash rails, tiles, and walls. He informed the survey team that this has been brought to the attention of administration several times. The hospital has rejected the plan of reconstruction of this area due to not having developed a non-disruptive detour of other areas of the hospital.



36834


Based on observations, interviews, and record reviews, the facility failed to ensure hospital environment was maintained in such a manner that the safety and well-being of patients was assured, in that:

1. One ER bathroom used by patients at Heart and Spine hospital had no emergency pull cord alarms installed.

2. The hospital (Heart and Spine) docking area was grossly dirty, soiled gloves were observed strewn on the floor and on top of compacter container, and Lidocaine 1% vial containing medication remnants of the medication was discarded on the docking floor.

3. An EKG machine and a portable X-ray Machine at Heart and Spine hospital had no preventive maintenance sticker(PM) indicating they had been inspected for safety and performance.


Findings:


During a tour of the Heart and Spine hospital ER on 11/13/19, at 09:35 a.m., one ER bathroom used by patients had no emergency pull cord alarms installed. This was confirmed by Personnel # 9.


A tour of the hospital (Heart and Spine) docking area on 11/13/19, at 09:55 a.m., revealed soiled gloves, paper waste, and a medication vial strewn on the floor and on top of the compacter container. This was confirmed by Personnel # 9.


During a tour of the hospital (Heart and Spine) 2nd floor on 11/13/19, at 10:15 a.m., in the company of Personnel # 125 revealed an EKG machine and a portable X-ray machine had no preventive maintenance sticker (PM) to indicate they had been inspected for safety and performance. This was confirmed by Personnel # 125 who stated, "I didn't know they were not inspected. They're supposed to have an inspection sticker."


Interview with Personnel # 134 on 11/13/19, at 10:45 a.m., revealed the two-medical equipment's needed to be tested for safety. He stated, "I need to do safety test on them." He said, staff members were required to notify his department for equipment's noted without an inspection sticker.


Review of hospital policy #5.51, entitled: "Environmental Services-Infection Prevention and Control; Maintenance of a Clean Sanitary Hospital Environment" stated in the purpose section: "Maintenance of a clean sanitary patient care environment through the removal of microorganisms that could be transmitted to patients and personnel."

Based on observation, policy review, and staff interview, the facility failed to ensure their staff followed their own policy in the safe handling of medical waste.

Findings:

Facility policy titled "D-101 EPA and TCEQ Hazardous Waste Compliance Plan" states is part,

"The purpose of this document is to provide for the proper identification, waste determination, labeling, handling, shipment and disposal of wastes generated at XXXXX per EPA, TCEQ, and XXXXX requirements.

General Requirements for Hazardous Waste:

Hazardous waste may not be mixed with non-hazardous waste. If mixed together the entire contents are hazardous waste.

Hazardous waste must not be placed in un-washed containers that previously held an incompatible waste or material.

Regulated Medical Waste Shipments-Biohazardous Waste Management (2.06)

Biohazardous waste is generally defined as liquid or semi-liquid blood or other potentially infectious materials, contaminated items that would release blood or other potentially infectious materials in a liquid or semi-liquid state if compressed, items that are caked with dried blood or other potentially infectious materials and are capable of releasing these materials during handling......

Plastic bags used inside of containers must typically be a red color and have sufficient strength to prevent tearing."


Tours of the soiled utility rooms on the nursing units revealed the following:

On 11/4/19, in the soiled utility room in the NVICU, a container had a red biohazard bag that has 4 holes in the bag. The red hard sided container in the room had trash consisting of cardboard boxes, gloves, paper, styrofoam cups, and multiple filled red biohazardous bags.

In an interview with staff #33, she stated she makes the holes in the red biohazard bags to release air from under the bag.

In an interview with staff #34 and staff #35, both stated the red hard sided containers should not contain waste other than red biohazard bags. Both stated when there is other materials in the bottom of the container, the staff has to sweep it up and place in a red biohazard bag. Both stated they were unsure how long the materials had been in the bottom of the red hard sided container.


On 11/6/19, in the soiled utility room on 4E West, the red hard sided container in the room had trash consisting of a cardboard box, gloves, paper towels, and multiple filled red biohazardous bags.

In an interview with staff #34 and staff #35, both stated the red hard sided containers should not contain waste other than red biohazard bags. Both stated when there is other materials in the bottom of the container the staff has to sweep it up and place in a red biohazard bag. Both stated, they were unsure how long the materials had been in the bottom of the red hard sided container.


On 11/12/19, in the soiled utility room on 8 North, staff #140 was leaving the room pushing a red biohazard container with no gloves on. When asked if he needed to wear gloves, he stated he picked up the red bags in the container and removed his gloves and sanitized his hands. He stated, the container he was pushing was clean as they were cleaned downstairs before coming to the floor. Upon entering the soiled utility room, it was noted there were gloves, patient menus, cardboard boxes, plastics, fluids on the bottom that had paper and plastic stuck to the bottom of the container.

In an interview with staff #35, he stated the red biohazard container should not have materials in the bottom of the container and when it does contain these items the bin should be taken downstairs and cleaned out and washed thoroughly. He further stated, all materials in the biohazard bin was to be bagged in a red biohazard container.

Based on observation, interview, and record review, the facility failed to provide care in a sanitary environment in order to prevent the spread of infectious diseases, as evidenced by:

a.) The facility's isolation policy does not include the required staff and visitor handwashing instructions for patients with C-difficile infections. The policy allows the option of using hand sanitizer, not the soap and water that is required to prevent the transfer of the C-Difficile organism and the facility did not have the Enteric Isolation Precaution signage, as the facility policy requires.

b.) The facility's Congenital Heart Intensive Care Unit (CICU) was using cloth baby mobiles that could not be cleaned to prevent the spread of infectious diseases.

c.) The facility staff were observed taking items out an isolation room to use in other rooms, a nurse was observed in an isolation room resting their hand on their face with contaminated gloves and a staff dropped a glove on the floor, then picked it up and placed it on top of the isolation cart, contaminating the top of the cart.

d.) The electronic door openers on the facility's Intensive Care Units (ICU) had a dark brown substance stuck into the indented EXIT wording that patients, visitors and staff had to touch to leave and enter the units, creating an unsanitary environment and possible spread of infections.


Findings:

a.) Record review of the facility policies:

CLOSTRIDIUM DIFFICILE (C-DIFF) IDENTIFICATION AND TRANSMISSION PREVENTION (approval date 9/18) reflected in part, "3. Isolation a. Place patients with suspected or confirmed C. Difficile diarrhea in Enteric Isolation. Place an Enteric Isolation sign on the door ... c. Soap and water is the preferred method of hand hygiene, but alcohol-based hand sanitizer will continue to be available.


INFECTION PREVENTION AND ISOLATION PRECAUTIONS (approval date 09/19) reflected in part, " ...The following is a breakdown of the transmission-based isolation guidelines recommended by the Centers for Disease control and Prevention.

...Signage designating the category of transmission based isolation precautions will be placed on the door of the patient rooms and appropriate personnel protective equipment (PPE) will be available at or in the patient room ...

III. STANDARD PRECAUTIONS ...To view the entire CDC standard Precaution Guideline to go: https://www.cdc.gov/infectioncontrol/guidelines/isolation/index.html reflected

IV.A.4. Wash hands with non-antimicrobial soap and water or with antimicrobial soap and water if contact with spores (e.g., C. Difficile or Bacillus anthracis) is likely to have occurred. The physical action of washing and rinsing hands under such circumstances is recommended because alcohols, chlorhexidine, iodophors, and other antiseptic agents have poor activity against spores...A Contact Enteric Precautions sign is posted for patients with diarrheal illness (Clostridium Difficile, rotavirus, norovirus)...visitors to Contact Enteric precautions rooms should be educated and encouraged to use soap and water for hand hygiene by the nursing staff caring for the patient..."


An observation on the morning of 11/5/19 revealed the following sign on room E452's door.
STOP
ALTO
INFECTION ALERT
REPORT TO NURSING BEFORE ENTERING
HYGIENE REQUIRED GOWN REQUIRED GLOVES REQUIRED

A display under the wording depicted a hand under a liquid dispenser, a gown, and gloves. The display's background was brown.
Contact Precautions Always Observe Standard Precautions


Review of Patient# 47 medical record reflected a history of loose stools and a positive Clostridium Difficile result on 10/29/19.


During an interview on the afternoon of 11/6/19, Staff # 78, RN Infection Preventionist, when asked how staff and visitors needed to clean their hands before leaving a patient room who is known to have C-Difficile, Staff # 78 stated, "for C-diff I would say soap and water ..." When informed the policy states, 'Soap and water is the preferred method of hand hygiene' Staff # 78 stated, "It's not an option ... They can use the sanitizer until they can get to a sink to wash with soap ..."

During an interview on the afternoon of 11/5/19, when asked if the facility had an Enteric Contact Sign, Staff # 79, Infection Control Director, stated, "that's the only sign we use for Enteric Precautions ... I agree, it looks like you can use the sanitizer." Staff # 79 confirmed the signage does not match the facility's current policy.


b.) An observation on the morning of 11/12/19, on the Congenital Heart Intensive Care Unit (CICU), revealed cloth Take-Along Mobile mobiles above the infant's beds.

During an interview on 11/12/19, on the CICU, when asked how the infant mobiles are cleaned, Staff # 122, CICU Manager stated the mobiles are wiped with antiseptic wipes before being reused on other patients.

During an interview on 11/12/19, in the administrative offices, Staff # 135, Child life Specialist, when asked how the cloth mobiles are cleaned stated, "...They are single patient use, we send them home with the family, if they don't want them we dispose of them...Child Life handles all of the toys on the unit." When asked, if the mobile has been in a room on isolation precautions for a contagious disease would they send the mobile home with the family, Staff # 135 stated, "We hadn't thought of that, that's something we have to look into."


Review of the facility policy TOY CLEANING (dated 2/17) reflected, "B. Only washable toys are selected for use with children in isolation ... D. Toys made of fabric or fur are considered single patient use..."


Review of the facility policy PEDIATRIC INTENSIVE CARE & CONGENITAL HEART SURGERY UNIT- INFECTION PREVENTION AND CONTROL (dated 10/15) reflected, "...9. Toys are to be made of non-porous materials..."


c.) Observations on the morning of 11/5/19, on the SICU, revealed Staff # 74, housekeeper, taking an empty red isolation bag out of a room with a Contact Isolation sign. Staff # 74 proceeded to hang the red bag onto the empty trash can located outside of the room. When asked why they had removed the bag from the room and hung it on the side of the trash barrel. Staff # 74 stated, "I thought I was going to be needing two bags, but I only needed one." Staff # 74 confirmed the empty bag was going to be used for another room.


At 11:15 am Staff # 37, LD/RD was observed outside an isolation room donning gloves. Staff # 37 dropped a disposable glove on the floor, picked it up and placed the glove on top of the isolation cart. Staff # 37 proceeded to put on clean gloves, then picked up the contaminated glove that had been on the floor and put it on top the isolation room.

Staff # 63, SICU manager, confirmed the findings and cleaned the top of the isolation cart.


d.) An observation on the mornings of 11/7/19, on 3N West CICU, the Pediatric Intensive Care Unit, and on the afternoon of 11/8/19 on the 8 North Gynecology Oncology Unit revealed approximately 4- inch red round plastic buttons at the exit and entrance to the different units. The lettering is approximately 2 inches high and are white. An observation on these units revealed brown to dark brown substances obstructing the white lettering in the exit buttons. Staff # 122, NICU Manager confirmed the findings.

Based on observation, record review, and interview, the facility's infection control policies, training, and oversight failed to ensure safe infection control practices throughout the hospital. The facility failed to:

1.) Ensure nursing staff followed nationally accepted standards of infection control measures by appropriately applying and/or removing Personal Protective Equipment (PPE) when working in isolation rooms.

2.) Ensure that durable medical equipment which was designated as clean and ready for patient use was sanitized appropriately prior to storage.

3.) Ensure Environmental Services/Housekeeping maintained isolation precautions to prevent cross contamination while conducting housekeeping services.

4.) Ensure patient rooms were terminally cleaned and hospital floor coverings were without grooves, scrapes, gouges and scratches following use by patients with the likelihood of infectious disease.


This deficient practice placed all patients receiving treatment in the facility at an increased risk of life threatening infections, leading up to and including the possibility of death.


Findings:

1.) -Bone Marrow Transplant Unit

Record review of the medical record for patient #14 revealed that he was a 60-year-old male admitted on 09/28/2019 with a diagnosis of Diffuse Large B-Cell Lymphoma Stage IV. Further review revealed that he was placed on Contact Isolation due to a positive Methicillin Resistant Staphylococcus Aureus (MRSA) Culture.


During a tour of the facility conducted on 11/04/2019 at 10:45 am, RN#81 was observed entering patient#14's Contact Isolation room without donning any Personal Protective Equipment (PPE). RN#81 was then observed to exit patient#14's isolation room a few minutes later, walking across the patient care unit.


In an interview conducted on 11/04/2019, at the time of observation, RN#81 stated that Patient #14 was on contact isolation for MRSA of a wound. When asked by the surveyor why she did not wear PPE into the contact isolation room, RN#81 stated that the patient had just came back from procedures and wanted to talk to her, so she just walked in for a second to see what he needed.


Medical Unit

Record review of the medical record for patient #105 revealed that he was an 82-year-old male admitted on 11/04/2019 with diagnoses of: Congestive Heart Failure, Chronic Kidney Disease, Chronic Obstructive Pulmonary Disease, and history of lobectomy. Further review revealed that he was placed on Droplet and Contact Isolation due to a positive Herpes Simplex Type 1 Culture of the Nares.

Observations conducted on 11/05/2019, at 9:45 am, revealed that patient #105 was on droplet and contact isolation precautions. PPE was observed sitting on the hand rail outside the patient's room. The PPE observed consisted of a box of gloves and a package of gowns. There were no masks present outside the isolation room for staff use.

In an interview conducted on 11/05/2019, at 9:55 am, RN#80 stated that she was Patient#105's primary nurse. When asked by the surveyor if she knew where to find the facility policies/procedures regarding isolation precautions, RN#80 stated that she did not know where they were located or where to find them in the computer.


Record review of the facility policy# 2.0.0 entitled: "Infection Prevention and Isolation Precautions", Revised 08/19 revealed in part the following information:

-Transmission Based Precautions:

B.) Droplet Precautions-

Droplet transmission involves contact of conjunctivae or mucous membranes of the nose or mouth either large particle (greater than 5 microns) droplets which contain the infectious organisms. Coughing, Sneezing, talking or participating in procedures such as bronchoscopy or suctioning are the primary sources of droplet transmission. Transmission occurs when there is close contact (up to 3 feet or less) between the source and the recipient.

3.) Mask- A surgical mask is to be donned before entering the patient room. Be sure to remove and properly dispose of the mask whenever you leave the room and perform hand hygiene.

C.) Contact Precautions-

Transmission of infectious microorganisms occurs by either direct or indirect contact. Direct contact is person to person, skin to skin contact that occurs when giving patient care. Indirect contact involves touching an item or object contaminated by the patient.

3.) Gown- Don a gown Before entering the patient's room and remove the gown before leaving the room, dispose of it appropriately, and perform hand hygiene.

4.) Gloves and Hand Hygiene- Don gloves before entering the patient room and perform hand hygiene after removing gloves.


2.)-Surgical Oncology Unit

- Welch Alleyn and Dinamap machines, which were visibly soiled with human hair and an unidentified sticky substance were being stored in the hallway outside of patient rooms. Nursing staff were observed to be actively obtaining these machines and taking them into patient rooms for use.


- Soiled Utility Room: A used Pleur- Evac chamber, which was full of a patient's potentially infectious bodily fluid, was observed sitting on top of a cart in close proximity to the utility room door. The Pleur-Evac chamber was not enclosed in a biohazard bag and/or container.


In an interview conducted on 11/04/2019, at the time of observation, RN Nurse Manager #12 and RN Director# 13 confirmed the above findings.


Review of hospital policy #5.51, entitled: "Environmental Services-Infection Prevention and Control; Maintenance of a Clean Sanitary Hospital Environment" stated in the purpose section, "Maintenance of a clean sanitary patient care environment through the removal of microorganisms that could be transmitted to patients and personnel." The policy section stated: "It is the policy of Medical City Dallas that all patient care areas will be thoroughly cleaned and disinfected on a daily basis."


3.)-General Pediatrics Unit

Record review of Patient #109's medical record revealed, she was a 7-month-old female admitted on 11/05/2019 with a diagnosis of Respiratory Syncytial Virus (RSV) and placed on contact and droplet isolation precautions.


Observations conducted on 11/06/2019 at 2:30 PM revealed the following information:

Environmental Service (EVS) Staff #5 was observed cleaning patient#109's isolation room. She was observed, while wearing her contaminated gloves, going to her cleaning cart and opening the drawer. She placed washcloths inside a biohazard bag and closed the housekeeping cart drawer while wearing the same contaminated gloves. She then took the mop off the housekeeping cart and began mopping the patient's room. When she finished mopping the floor, she went back to her cart and placed the mop pole back on the housekeeping cart. She did not de-contaminate the pole or the housekeeping cart.

In an interview conducted on 11/06/2019, at the time of observation, the Director of Infection Prevention confirmed the above findings.


Record review of Patient #106's medical record revealed, he was a 10-year-old male admitted on 11/07/19 with diagnosis of: Fever, Shortness of Breath, and diarrhea. Further review revealed that he was placed on contact isolation and droplet isolation precautions due to positive Flu B test results.

Observations conducted on 11/07/2019 at 11:00 am revealed EVS Staff# 80 exiting Patient# 106's isolation room still wearing her PPE.

In an interview conducted on with Staff# 80 on 11/07/19, at the time of observation, EVS Staff# 80 stated that she forgot to remove her PPE prior to exiting the room.

In an interview conducted on 11/07/19 at 11:12 a.m., RN Supervisor#115 confirmed the above findings and stated that PPE should be removed and left in the patient's isolation room in the biohazard container.


During continued observations conducted 11/07/19, at 11:15 a.m., EVS Staff#74 was observed exiting room 625 D still wearing a mask. The Patient was noted to be on contact isolation and droplet precautions.

In an interview conducted on 11/07/19, at the time of observation, EVS Staff#74 confirmed she exited the room wearing the mask and stated she should have removed it. RN Supervisor#115 confirmed the above findings.


Record review of the facility policy# 2.0.0 entitled: "Infection Prevention and Isolation Precautions", Revised 08/19 revealed in part the following information:

B.) Droplet Precautions-

Droplet transmission involves contact of conjunctivae or mucous membranes of the nose or mouth either large particle (greater than 5 microns) droplets which contain the infectious organisms. Coughing, Sneezing, talking or participating in procedures such as bronchoscopy or suctioning are the primary sources of droplet transmission. Transmission occurs when there is close contact (up to 3 feet or less) between the source and the recipient.

3.) Mask- A surgical mask is to be donned before entering the patient room. Be sure to remove and properly dispose of the mask whenever you leave the room and perform hand hygiene.


The hospital's 2018 Review "Infection Prevention Annual Evaluation" reflected, "Objective ...Hospital compliance with hand hygiene is >/= 90%...Goal Not Met ..."


The 6/25/19 "Infection Prevention RO Workgroup" meeting minutes reflected, "Hand Hygiene: 398 observations in May ...compliance rate 82.6%...Isolation compliance: remove PPE upon leaving the isolation room or (operating room) OR 91%...wearing appropriate PPE for the isolation type 95%...appropriate isolation sign on the door 99%...appropriate isolation supplies readily available 99%...EVS (environmental services): AP (a process of rapidly measuring actively growing microorganisms through detection of adenosine triphosphate) testing started ...measuring bioburden ...inspected 65 rooms ...areas of opportunities include nurse call button, doorknob, and tray table. EVS is tracking high and low performers with increased education and rounding on low performers ..."


The hospital's September 2019 "Environmental Services - Infection Prevention and Control; Maintenance of a Clean Sanitary Hospital Environment" required, "Maintenance of a clean sanitary patient care environment through the removal of microorganisms that could be transmitted to patients and personnel ...all patient care areas will be thoroughly cleaned and disinfected on a daily basis ...when cleaning a patient room that has a transmission-based isolation sign on the door, Environmental Services personnel will follow isolation sign guidelines for appropriate PPE (Personnel Protective Equipment). Only essential equipment and supplies necessary for cleaning are taken into the room. Isolations rooms should be the last rooms cleaned on the unit assigned ...All cleaning equipment will be cleaned on a regularly scheduled basis ..."


The hospital's 9/27/19 revised "Isolation Patient Room Discharge and Terminal Cleaning" required, "Gloves must be changed after each room ...Whenever gloves are removed, staff must always clean their hands ...EVS staff must collect all needed cleaning supplies and take them into the room with them ...One rag must be utilized for the bathroom only and another rag utilized for the patient room ...mop the patient rest room ...mop the patient room ...EVS staff must disinfect the tools that were used in the patient room. This can be done by using an approved disinfectant and wiping down the tools ..."


4.)-Surgical Oncology Unit

Observations conducted on 11/04/2019 between 1:00 PM- 2:45 PM revealed the following information:

- Patient rooms 1001, 1002, and 1003 were marked as clean and ready for patient admission/use. Observation revealed dust and unidentified debris located in the creases of the "clean" bed mattresses. The computer keyboards located in the bedside charting stations had dust, dirt, hair, and a dried, thick, brown substance stuck between the keys.

- Bariatric Unit
Observations Conducted on 11/05/2019 at 10:30 am revealed the following information:

- Patient Room 505, the floor covering had multiple damaged areas consisting of deep gouges, grooves, scrapes, and scratches which penetrated the floor covering, making cleaning the floor difficult, increasing the possibility of harboring bacteria.

In an interview conducted on 11/05/2019 at the time of observation, RN Nurse Manager #16 confirmed the above findings.


22125


On 11/04/2019, at approximately 2:45 PM, on the tenth floor of the Care Tower A - South Medical Tower it was observed that the floor coverings in rooms 1010 and 1013 had multiple damaged areas consisting of grooves, scrapes and scratches which penetrated the floor covering. These damaged areas make cleaning the floor difficult.


Review of hospital policy #5.51, entitled: "Environmental Services-Infection Prevention and Control; Maintenance of a Clean Sanitary Hospital Environment" stated in the purpose section: "Maintenance of a clean sanitary patient care environment through the removal of microorganisms that could be transmitted to patients and personnel." The policy section stated: "It is the policy of Medical City Dallas that all patient care areas will be thoroughly cleaned and disinfected on a daily basis."

In an interview with staff members RN# 12 and RN# 13 on the afternoon of 11/05/2019 the above finding was confirmed.


25373


Based on observation, interview, and record review, the hospital's infection control officer/officers failed to identify proper infection control practices in several areas of the hospital on 11/06/19 through 11/12/19.

(1) 2 of 2 preoperative nurses (RN #34 and RN #35) in the day surgery area did not appropriately perform hand hygiene;

(2) 1 of 1 environmental service individual (Personnel #141) did not dispose of a glove found close to where he was sweeping;

(3) 5 of 8 healthcare providers in operating room (OR) #8 (Physician #40, Physician #41, and Physician #142, Personnel #129, and Personnel #143) of the main surgery unit were observed wearing mask inappropriately, and/or improper hair restraints, and/or not appropriately performing hand hygiene as required;

(4) 1 of 1 vendor (Vendor #122) was observed wearing a mask hanging around the neck outside the restricted area of the cardiac catheterization unit; and

(5) 23 of 23 sterilized "Cocher" instruments in peel packs were sterilized in a closed position.


Findings:

(1) On 11/06/19, at 10:24 AM, tracer patient #1 (Patient #20) was followed. Patient #20 was scheduled for a left forearm graft. In the preoperative area the following was observed: RN #34 was conducting the assessment and RN #35 was assessing the patient's right arm for an intravenous (IV) start and to obtain blood samples. RN #35 was observed wearing a hair scrunchy/tie around her right wrist.

At 10:29 AM, RN #34 donned on a pair of gloves and explained she was waiting for RN #35's IV start so she could obtain blood for Patient #20's blood sugar as ordered by the physician. RN #34 stated this way the patient would only be stuck once.

At 10:31 AM, RN #35 started Patient #20's IV. The blood flow was minimal. RN #34 decided she would obtain the patient's blood sugar later and took off her gloves. Without proper hand hygiene, RN #34 proceeded to assess Patient #20's central venous catheter (CVC) in the right chest.

At 10:34 AM, RN #35 took off her gloves and donned on a pair of clean gloves without proper hand hygiene. RN #35 then took off the gloves and without appropriate hand hygiene, proceeded to enter patient data in the computer.

During an interview on 11/07/19 at 2:55 PM, RN # 14 and RN # 113 were informed of the above findings and confirmed the findings.


(2) On 11/06/19, at 8:40 AM, a blue glove was found in the parking area close to the entrance of the hospital. The surveyor previously observed 2 gloves on 11/05/19 at 4:05 PM in the parking area. Personnel #141 was observed sweeping outside the hospital area close to the hospital entrance. Personnel #141 was informed about the blue glove and was requested if he could properly dispose of the glove. Personnel #141 asked the surveyor how many gloves were found. The surveyor replied one and pointed out the area where the blue glove was located. Personnel #141 told the surveyor that someone would get the blue glove.

On 11/06/19, at 8:50 AM, Personnel #131 was informed of the above findings and confirmed the findings. At 9:00 AM, Personnel #131 informed the surveyor that Personnel #141 was talked to. After 10 minutes, Personnel #6 informed the surveyor that Personnel #141 was a contract worker.


(3) On 11/07/19, at 1:12 PM, a female wearing light blue scrubs was observed wearing a mask and passed by the main surgical unit's nurse station/central control (located outside the restricted area). Personnel #42 who was with the surveyor was informed of the observation. The name of the individual was not obtained.

At 1:16 PM, with Personnel #42, tracer patient #2 (Patient #65) was followed to OR #8. Patient #65 was a 25-day old baby and was scheduled for an umbilical hernia repair.

At 1:19 PM, Physician #41 was observed wearing a mask that was not tied securely that allowed venting.

At 1:20 PM, Physician #40, Physician #142, and Personnel #143, were observed wearing hair restraints that did not cover the hair of their sideburns and nape of the neck.

At 1:23 PM, Personnel #129 was observed taking off the gloves and without proper hand hygiene, provided direct patient care.

At 1:55 PM Physician #41 was observed taking off the gloves and without appropriate hand hygiene, Personnel #41 repositioned Patient #65's sterile disposable surgical drape.

Personnel #42 who was with the surveyor at all times in OR #8 was informed of all the findings as it was observed from 1:12 PM to 1:55 PM on 11/07/19. Personnel #42 confirmed the findings and was asked to provide the infection control policy.


(4) On the morning of 11/12/19, a tour was conducted in the Spine and Heart Hospital with RN #107. At 9:40 AM, a vendor (Vendor #122) was observed wearing a mask hanging around the neck outside the restricted area of the cardiac catheterization unit. RN #107 was immediately informed of the observation. RN #107 talked to Vendor#122.


(5) On 11/12/19, at 11:15 AM, a tour was conducted in the Spine and Heart Hospital's clean supply room where sterilized instruments were stored. There were a total of 23 sterilized "Cocher" instruments in peel packs that were found sterilized in a closed position. RN #107 was informed of the findings and confirmed the findings. A policy and procedure for sterilizing hinged instruments was requested.


The hospital policy and procedure #6.1.0 "Hand Hygiene" approved on 09/2019 required "...hand hygiene will be performed (even if gloves are worn) before and after patient contact, after contact with patient surroundings (supplies, furniture-even without touching the patient), before and after any procedure..."


The hospital policy and procedure was adopted from "2017 Association for the advancement of Medical Instrumentation-ANSI/AAMI ST79:2017" required "8.2 Instruments...b. Instruments should be positioned to allow the sterilant to come into contact with all surfaces...d. Ratcheted instruments should be unlatched. Racks, pins, stringers, or other specifically designed devices can be used to hold the instruments in the unlatched position."


Association of periOperative Registered Nurses (AORN) Perioperative Standards and Recommended Practices for Inpatient...2014 edition page 53 and 56 reflected "Surgical Attire...All personnel should cover head and facial hair, including sideburns and the nape of the neck, when in the semi-restricted and restricted area...VI.a. The mask should cover the mouth and nose and be secured in a manner to prevent venting. VI.b.1 Mask should not be worn hanging down from the neck. The filter portion of a surgical mask harbors bacteria collected from the nasopharyngeal airway...VI.c. Surgical masks should be discarded after each procedure."


27128


Based on observation, interview, and record review, the designated infection control officer did not ensure infection control policies were adhered to, in that appropriate hand hygiene was not followed during medication administration by 3 of 4 Registered Nurses (RN) (RN #7, #11, and #110).

Findings:

During observations on 11/04/19, at approximately 2:15 PM, RN #7 entered Patient #6's room to administer an oral medication and an IV (intravenous) solutions. RN #7 sanitized her hands then touched the computer's mouse and keyboard. RN #7 then put on clean gloves without sanitizing her hands. With gloved hands, the RN touched the keyboard, scanned the patient's armband, and touched the patient's chair. RN #7 spiked a bag of 0.9% Sodium Chloride with the existing tubing and adjusted the drip rate. Without removing her gloves and sanitizing her hands, RN #7 then emptied a tablet into a medication cup and handed it to the patient. RN #7 touched the patient on the arm. She then entered information into the computer using the keyboard. She closed the desk and then removed her gloves.


During observations on 11/04/19, at approximately 3:00 PM, RN #11 entered Patient #18's room after sanitizing his hands. He put on clean gloves. RN #11 then touched the keyboard, scanned the patient's armband, touched the keyboard again, opened a cabinet and removed a medicine cup, placed a tablet in the medication cup and handed it to Patient #18. RN #11 then touched the keyboard and closed a cabinet. He then removed his gloves.

During an interview with RN #31 on 11/04/19 at 3:15 PM she confirmed the above observations of RN #11.


During observations on 11/12/19, at approximately 10:00 AM, RN #110 entered Patient #114's room after sanitizing her hands and putting on clean gloves. She touched the computer's keyboard, scanned the patient's armband and medication, and placed 3 pills in a medication cup. She touched the patient's arm and handed the medication cup to the patient. RN #110 touched the arm of the patient's chair. RN #110 scanned and then opened the patient's insulin and drew up the medication into an insulin syringe. She injected the insulin into the back of Patient #114's left upper arm. RN #110 gathered trash and threw it away. She then touched the keyboard, and entered information into the computer. She then removed her gloves.


Hospital policy #MM.3.220 "MEDICATION ADMINISTRATION AND MONITORING." The policy indicated on page one, "...Perform hand hygiene before administering medications..."

Hospital policy #2.0.0 "INFECTION PREVENTION AND ISOLATION PRECAUTIONS." The policy reflected on page 2, "...Hand hygiene will be performed (even if gloves are worn) before and after patient contact, after contact with patient's surroundings (supplies/equipment/furniture-even if patient was not touched), before and after any procedure or aseptic task, and after exposure risk to a body fluid..."




31016

Based on observation, record review, and interview, the facility failed to ensure that infection control practices and techniques were followed and maintained to prevent risk to patients' health and safety.

A). The facility failed to ensure Hemodialysis Unit staff Registered Nurses (RN) (personnel #38, #39, and #43), a Physician (personnel #16), and a patient (patient #28) wear appropriate Personal Protective Equipment (PPE) during provision of care when it is likely that contact with blood or body substances during hemodialysis treatments, blood transfusion, and isolation precautions to prevent the risk of cross-contamination and/or transmission of infection.


B). The facility failed to ensure safe, appropriate removal, and disposal of used Arteriovenous Fistula (AVF) needles and follow the manufacturer's safe procedure to remove AVF needles by Hemodialysis Unit staff RN (personnel #38, #39, and #42) to prevent the risk of needle stick injuries, cross-contamination, and transmission of infection.


C). The facility failed to ensure Hemodialysis Unit staff RN (personnel #39) clearly separate clean versus dirty supplies, used clean supplies for central venous catheter (CVC) care, and appropriate disposal of syringes filled with blood. This practice placed patients and staff at risk for cross-contamination and transmission of infection.

Findings:

A review of the Hemodialysis Infection Prevention and Control Policy dated 05/19, showed in part,

"...I. Purpose...to provide an environment that fosters the prevention or infection and cross contamination between...patients and personnel...

II. Policy...provides patient care...that minimizes infection risks...and personnel...

III. Procedure...A. Personnel...6. Standard precautions will be observed...at all times...Appropriate barriers will be used...a. Gloves will be worn when it is likely that hands will be in contact with patient's...body substances...b. Gowns/plastic...will be worn when it is likely that clothing may be soiled...d. Needles...or otherwise manipulated by hand. Needle and syringe units and other...will be discarded in puncture-resistant point-of-use containers...

C. Records...1. Patient Hemodialysis records will have clearly noted...b. Any mishaps such as blood leaks, blood spills...and machine malfunction...c. The number of machine used for...d. The name of staff member who placed the patient on and removed them from the Hemodialysis machine...

D. Patient Care...1. Hemodialysis machines...

E. Environment...4. There shall be clearly defined geographical boundaries between clean and soiled utility...areas...

F. Transmission-based Isolation Precautions...Patients with infections...or contact Isolation Precautions...The hospital policy and procedures on Transmission-based Isolation Precaution shall apply...

G. Blood and...Blood/body fluids is not to remain on floors..."


A review of the Instructions for Use for WingEater (Arteriovenous Fistula Needles) Dial Medical Supply, showed in part,

"...Step 1...slide WingEater up until it just touches the wings...

Step 2...place your hand flat on the site...

Step 3...Gently pull the tubing until the needle is completely retracted in to the WingEater...making sure the wings are below the safety line..."


During a tour of the facility's Hemodialysis unit on 11/04/19, the surveyor observed the following:

A). At 10:20 AM, the Hemodialysis unit Registered Nurses (RN) (personnel #38 and #39) touched the dialysis machine and cleared dialysis machine alarm during dialysis treatment without gloves on and were beside the dialysis patients during provision of care without gowns on.

At 10:22 AM, the dialysis nursing supervisor (personnel #40) confirmed in an interview, personnel #38 and #39 touched the dialysis machine and cleared dialysis machine alarm during dialysis treatment without gloves on and were beside the dialysis patients during provision of care without gowns on. When asked at what point and/or where in the Hemodialysis unit should staff and visitors wear or remove their Personal Protective Equipment (PPE), she stated that they know where to use their PPE.


B). At 10:30 AM, an RN (personnel #38) discontinued patient #22's dialysis treatment. Personnel #38 removed and pulled the Arteriovenous Fistula (AVF) needles from patient #22's AVF vascular access using her right hand while her left hand pressed the AVF site to stop the bleeding. Personnel #38 held the used AVF needle and pointed the AVF needle on the white pad where patient #22's arm rested, where personnel #38 continued to hold pressure on the AVF site with her left hand and proceeded to apply the built in safety of the needle. After the needle safety was activated, personnel #38 placed the used AVF needle beside patient #22's arm. Personnel #38 removed the second AVF needle from patient #22's AVF site the same way above.


At 10:34 AM, the RN manager (personnel #37) confirmed in an interview personnel #38 pulled the AVF needle out of patient #22's AVF site, pointed the AVF needle to the bed and then activated the built in safety of the needle, and placed the AVF needles beside patient #22's arm, twice. When the dialysis nursing supervisor (personnel #40) was asked what type of AVF needles do they use, she stated, they use the WingEater AVF needles.


At 10:45 AM, an RN (personnel #39) removed and pulled the Arteriovenous Fistula (AVF) needles from patient #23's AVF vascular access using her right hand while her left hand pressed the AVF site to stop the bleeding. Personnel #39 held the used AVF needle and pointed the AVF needle on the white pad where patient #23's arm rested, where personnel #39 continued to hold pressure on the AVF site with her left hand and proceeded to apply the built in safety of the needle. After the needle safety was activated, personnel #39 placed the used AVF needle beside patient #23's arm. Personnel #39 removed the second AVF needle from patient #23's AVF site the same way above.


At 10:47 AM, the RN Scribe (personnel #36) confirmed in an interview personnel #39 pulled the AVF needle out of patient #23's AVF site, pointed the AVF needle to the bed and then activated the built in safety of the needle, and placed the AVF needles beside patient #23's arm, twice.


A review of the Hemodialysis Unit's Hemodialysis Catheter Care for Blood Draws, Medications and Infusions Policy dated 12/18, showed in part, "...III. Procedure...B. Supplies...sterile 4x4s...Masks...2. Don masks...9. Clean...for adults use a 10 milliliters (ml) syringe and withdraw...blood and discard..."


During a tour of the facility's Hemodialysis unit on 11/05/19, the surveyor observed the following:

A). At 10:15 AM, an RN (personnel #43) was at dialysis bed #1 with patient #25 receiving blood transfusion during his dialysis treatment, personnel #43 touched the dialysis blood lines and dialysis machine without a gown or face shield on.

At 10:16 AM, the dialysis nursing supervisor (personnel #40) confirmed in an interview, personnel #43 was at dialysis bed #1 with patient #25 receiving blood transfusion during his dialysis treatment, personnel #43 touched the dialysis blood lines and dialysis machine without a gown or face shield on.

At 10:25 AM, a physician (personnel #16) went inside the isolation room without a gown and talked to patient #28 during her Hemodialysis treatment. Patient #28 had a gauze on her forehead with blood and was in the isolation room for Methicillin Resistant Staphylococcus Aureus (MRSA) precautions.

At 10:30 AM, the dialysis nursing supervisor (personnel #40) confirmed in an interview, the physician (personnel #16) went inside the isolation room for patient #28 during dialysis treatment and was on MRSA precautions, without a gown and stated, "I did not touch the patient."


B). At 11:00 AM, the surveyor and the RN scribe (personnel #44) observed an RN (personnel #42) pulled and removed AVF needle with her right hand from patient #27's AVF site, held the AVF needle on her hand without the safety at the same time held pressure on the AVF site with both hands, and proceeded to activate the needle's safety. There were 2 prep pads with blood on the floor beside the patient's bed, behind personnel #42.


At 11:03 AM, the RN scribe (personnel #44) confirmed in and interview, an RN (personnel #42) pulled and removed AVF needle with her right hand from patient #27's AVF site, held the AVF needle on her hand without the safety at the same time held pressure on the AVF site with both hands, and proceeded to activate the needle's safety. There were 2 prep pads with blood on the floor beside the patient's bed, behind personnel #42.


C). During a tour of the hemodialysis unit on 11/05/19 at 10:45 AM, the surveyor observed patient #28 was in the isolation room for MRSA during her dialysis treatment, as follows:

An RN (personnel #39) accessed patient #28's right Intrajugular (IJ) central venous catheter (CVC), aspirated 10 milliliters (ml) syringes of blood 1 from each CVC port, placed the 10 ml syringes, X 2, filled with blood on top of patient #28's lap, mixed with clean supplies such as alcohol prep pads and 10 ml Normal Saline (NS) syringes.

Personnel #39 proceeded to use the alcohol prep pads and NS syringes that were mixed with the used 10 ml syringes with blood, on patient #28's CVC.

Personnel #39 picked up the leftover unused alcohol prep pads from patient #28's lap and placed them with the clean supplies on top of the beside table.

During the CVC care procedure, patient #28's face mask was placed below her nose and did not cover her nostrils.


On 11/05/19 at 10:55 AM, the RN manager (personnel #37) confirmed in an