QA Investigation Results

Pennsylvania Department of Health
BUTTONWOOD DIALYSIS
Health Inspection Results
BUTTONWOOD DIALYSIS
Health Inspection Results For:


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Initial Comments:


Based on the findings of an onsite unannounced recertification survey conducted from August 24, 2021 through August 27, 2021, Buttonwood Dialysis was found to be in compliance with the requirements of 42 CFR, Part 494.62, Subpart B, Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services - Emergency Preparedness.





Plan of Correction:




Initial Comments:


Based on the findings of an onsite unannounced Medicare recertification survey conducted from August 24, 2021 through August 27, 2021, Buttonwood Dialysis was identified to have the following standard level deficiencies that was/were determined to be in substantial compliance with the following requirements of 42 CFR, Part 494, Subparts A, B, C, and D, Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services.





Plan of Correction:




494.30(a) STANDARD
IC-CDC MMWR 2001

Name - Component - 00
The facility must demonstrate that it follows standard infection control precautions by implementing-
(1)(i) The recommendations (with the exception of screening for hepatitis C), found in "Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients," developed by the Centers for Disease Control and Prevention, Morbidity and Mortality Weekly Report, volume 50, number RR05, April 27, 2001, pages 18 to 28. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. This publication is available for inspection at the CMS Information Resource Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration (NARA). Copies may be obtained at the CMS Information Resource Center. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_regulations/ibr_locations.html.

The recommendation found under section header "HBV-Infected Patients", found on pages 27 and 28 of RR05 ("Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients"), concerning isolation rooms, must be complied with by February 9, 2009.



Observations:


Based upon review of agency Policy, the Center for Disease Control and Prevention, (CDC), observation, and interview with the facility Administrator, it was determined that the agency failed to conduct strict infection control practices to prevent exposure to microbial pathogens from one, (1), of three (3) HBV+ (hepatitis B positive) Patient observed during Hemodialysis care.
Findings Include:
On August 26, 2021, at approximately 2:30 p.m. a review of Facility Policy Titled, " Infection Control and Isolation Measures for Known or Suspected Hepatitis B Surface Antigen Positive Patients, " Subtitled, " Teammate Practices When Caring for The Known or Suspected Hepatitis B Surface Antigen Positive Patient, " section 30, revealed, " PPE will be removed, gloves discarded, and hand hygiene performed immediately when leaving the room or area. " There was no order to " Donning and Doffing PPE. "
Review of documents from the Centers for Disease Control and Prevention (CDC), entitled Using Personal Protective Equipment (PPE), Updated Aug. 19, 2020, Subtitled: " How to Take Off (Doff) PPE Gear, " revealed, " More than one doffing method may be acceptable. Training and practice using your healthcare facility ' s procedure is critical. Below is one example of doffing. 1.Remove gloves. Ensure glove removal does not cause additional contamination of hands. Gloves can be removed using more than one technique (e.g., glove-in-glove or bird beak). 2.Remove gown. Untie all ties (or unsnap all buttons). Some gown ties can be broken rather than untied. Do so in gentle manner, avoiding a forceful movement. Reach up to the shoulders and carefully pull gown down and away from the body. Rolling the gown down is an acceptable approach. Dispose in trash receptacle. 3.Healthcare personnel may now exit patient room. 4.Perform hand hygiene. 5.Remove face shield or goggles. Carefully remove face shield or goggles by grabbing the strap and pulling upwards and away from head. Do not touch the front of face shield or goggles. .

On August 26, 2021 at approximately 9:20 p.m., an observation was conducted for " Isolation Practices, " #2, through the glass barrier. During observation it was revealed that Patient Care Technician, (PCT) #7 was donned in an isolation gown, gloves, and face shield. PCT #7 was caring for a Patient inside of the Isolation room, door closed. As PCT #7 prepared to leave the isolation room, it was observed that with gloves on, PCT #7 loosened the isolation gown, hung it up on a hook for reuse, opened the door to the regular treatment area, as gloves remained on. PCT #7 began taking the gloves off outside the Isolation room, while walking in the regular treatment area toward the trash bin.

On August 27, 2021 at approximately 3:00 p.m., it was confirmed in an exit interview with the facility Administrator, and Corporate Personnel, that the PPE doffing procedure observed, was not standard practice.











Plan of Correction:

V0112

The Facility Administrator (FA) held mandatory in-service for all Clinical Teammates (TMs) on 09/01/2021. Surveyor observations were reviewed. Education Included but was not limited to a review of Policy #1-05-09 Infection Control and Isolation Measures for Known or Suspected Hepatitis B Surface Antigen Positive Patients with the emphasis on but not limited to: PPE will be removed, gloves discarded, and hand hygiene performed immediately when leaving the isolation room or area. Verification of attendance at in-service will be evidenced by TMs signature on in-service sheet.

The FA or designee will conduct infection control audits daily for two (2) weeks then weekly for two (2 ) weeks then monthly during internal infection control audits. Instances of non-compliance will be addressed immediately. The FA will review results of the audits with TMs during homeroom meetings and with Medical Director during monthly Facility Health Meetings (FHM-QAPI) with supporting documentation included in the meeting minutes.

The FA is responsible for compliance with this plan of correction.




494.60 STANDARD
PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT

Name - Component - 00
The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment.


Observations:


Based on a clinical floor observation, and interview with the facility administrator, the facility failed to provide a safe and functional environment by failing to identify and discard outdated supplies for twenty-five (25) RPC Blue Caps.

Findings include:

Review of agency Policy: 1-05-01 titled "Incenter Hemodialysis Policies & Procedures" on September 1, 2021 at approximately 1:45PM states, " (20) The expiration date will be checked on all disposable supplies before the package is opened and the contents are used. (21) The contents of packages will not be used beyond the expiration date on the package.

Clinical floor observation on August 24, 2021 from approximately 10:00AM - 11:00AM, revealed:

One (1) RPC Blue Cap (Lot Number: 1600025) - Expiration Date: 6/1/2019
Two (2) RPC Blue Caps (Lot Number: 1600043) - Expiration Date: 11/1/2019
One (1) RPC Blue Cap (Lot Number: 1700055) - Expiration Date: 11/24/2020
Four (4) RPC Blue Caps (Lot Number: 1800004) - Expiration Date: 2/8/2021
Seventeen (17) RPC Blue Caps (Lot Number: 1800039) - Expiration Date: 6/21/2021

During discussion with facility administrator on 8/24/2021 at approximately 11:05AM, facility administrator stated that the facility no longer uses the blue caps.
Interview with the facility administrator on August 24, 2021 at approximately 11:15AM confirmed the above findings.














Plan of Correction:

V401

The FA held mandatory in-service(s) for all Clinical TMs starting on 09/01/2021. Surveyor observations were reviewed. Education included but was not limited to a review of Policy # 1-05-01 Infection Control for Dialysis Facilities with the emphasis on but not limited to: 1) The expiration date will be checked on all disposable supplies before the package is opened and the contents are used. 2) The contents of packages will not be used beyond the expiration date on the package. All supplies are checked monthly for expiration dates. Verification of attendance at in-service will be evidenced by TMs signature on in-service sheet. The facility did an audit of all supplies to verify expiration dates are current. All expired items were discarded.

The FA or designee will conduct supply audits daily for two (2) weeks then weekly for two (2) weeks then monthly during internal infection control audits to verify compliance. Instances of non-compliance will be addressed immediately.

The FA will review the results of the audits with TMs during homeroom meetings and with the Medical Director during monthly FHM-QAPI with supporting documentation included in the meeting minutes. The FA is responsible for compliance with this plan of correction.



494.90(a)(1) STANDARD
POC-MANAGE VOLUME STATUS

Name - Component - 00
The plan of care must address, but not be limited to, the following:
(1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient's volume status;


Observations:


Based on review of dialysis treatment documentation, medical records (MR), and administrative interview, the facility failed to ensure patient received the necessary services outlined in their plan of care (POC) for one (1) of eleven (11) medical records (MR) reviewed, (MR #5).

Findings include:

Review of agency Policy: 1-03-08 titled "Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment" on September 1, 2021 at approximately 12:50PM states, "Pre-Treatment Data Collection/Assessment - (4) Any abnormal findings or findings outside of any patient specific physician ordered parameters discovered during pre-treatment data collection will be documented and immediately reported to the licensed nurse .....Intradialytic Data Collection/Assessment - (11) Abnormal findings or findings outside of any patient specific physician ordered parameter will be reported to the licensed nurse immediately .....The licensed nurse will use his/her clinical judgement based on individual patient needs to determine if any clinical interventions are necessary. (12) The licensed nurse notifies the physician (or NPP if applicable) as needed of changes in patient status ...Post-Treatment Data Collection/Assessment - (16) If an abnormal finding(s) or concern is identified post treatment, this needs to be reported to the licensed nurse. The license nurse will assess the patient prior to discharge. (17) Licensed nurse will use his/her clinical judgement based on patient needs to determine if any clinical interventions or notification of physician (or NPP as applicable) is necessary prior to discharge of the patient from facility. "

" Abnormal Findings - Unless other abnormal parameters are established by the facility Governing Body and documented in the Governing Body Meeting Minutes, the following are considered abnormal findings and should be reported to the licensed nurse and documented in the patient ' s medical record .....In addition, the teammate who is observing or collecting information should report to the licensed nurse whenever there is concern for the patient ' s condition or potential safety of initiating dialysis ....Members of the patient care team should report ANY changes in patient conditions or concerns of patient well-being immediately to the licensed nurse at any time. " " Blood Pressure: Pre-Dialysis - Systolic greater than 180 mm/Hg or less than 90 mm/Hg, Diastolic greater than or equal to 100 mm/Hg; Blood Pressure: Intradialytic - Difference of 20 mm/Hg increase or decrease from patient ' s last intradialytic treatment blood pressure reading; Blood Pressure: Post-Treatment - If patient can stand: Systolic BP greater than 140 mm/Hg or less than 90 mm/HG, Standing diastolic BP greater than 90 mm/HG or less than 50 mm/HG. "

Review of medical records was conducted on August 26, 2021 at approximately 11:40AM revealed:

MR #5. Start of Care: 7/12/2017. Dialysis Treatment Orders: Order Date: 10/12/2017; EDW: 59 Kg; Frequency: Tuesday-Thursday-Saturday; Dialyzer: Gambro Revaclear 300; Dialysate: 2.0 K, 2.5 Ca, 34, NA 138; BFR: 475; DFR: 800; Treatment Duration: 3 hours and 25 minutes. Medication Order: Clonidine 0.10 mg oral PRN . Notify physician if blood pressure (BP) is greater than 180/90 and monitor every thirty (30) minutes

Treatment Record for 8/12/2021:
Pre-Treatment B/P sitting 174/107, standing 174/97 documented by PCT
10:40AM B/P 174/93 "Treatment initiated, 200mL Normal Saline Prime Given; Access visible" documented by PCT.
11:02AM B/P 168/96 " Patient watching television; Access visible " documented by RN.
11:31AM B/P 167/98 " Patient watching television; Access visible " documented by PCT.
12:01PM B/P 180/89 " Eyes closed resting comfortably; Access visible " documented by PCT.
12:31PM B/P 159/94 " Eyes closed resting comfortably; Access visible " documented by PCT.
13:01PM B/P 180/96 " Alert; Access visible " documented by PCT.
13:31PM B/P 177/99 " Eyes closed resting comfortably; Access visible " documented by PCT.
13:58PM B/P 180/104 " Treatment terminated; Access visible " documented by PCT.
Post-Treatment sitting B/P 193/101, standing B/P 177/104

No notification to RN of abnormal findings documented.
No documentation that any blood pressure medication was administered, or any other interventions were implemented.


Treatment Record for 8/14/2021:
Pre-Treatment B/P sitting 190/98, standing 181/98 documented by PCT
10:53AM B/P 168/94 "Treatment initiated, 200mL Normal Saline Prime Given; Access visible" documented by PCT.
10:55AM B/P 173/90 "Cannulated without difficulty; Access visible" documented by PCT.
11:01AM B/P 198/103 " No complaints " documented by PCT.
11:31AM B/P 172/98 " No complaints; Access visible " documented by PCT.
12:01PM B/P 182/96 " Patient watching television; Access visible " documented by PCT.
12:31PM B/P 174/94 " Patient watching television; Access visible " documented by PCT.
13:01PM B/P 183/97 " No complaints; Access visible " documented by PCT.
13:31PM B/P 181/96 " Patient watching television; Access visible " documented by RN.
14:01PM B/P 186/98 " Patient watching television; Access visible " documented by PCT.
14:10PM B/P 193/100 " Treatment terminated, with normal 250 mL normal saline rinse back; Access visible " documented by PCT.
Post-Treatment sitting B/P 185/97, standing B/P 166/99

No notification to RN of abnormal findings documented.
No documentation that any blood pressure medication was administered, or any other interventions were implemented.

An interview with the facility administrator on August 27, 2021 at approximately 3:00PM confirmed the above findings.

















Plan of Correction:

V543

The FA held mandatory in-service(s) for all Clinical TMs starting on 9/01/21. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-03-08 " Pre-Intra-Post Treatment Data Collection Monitoring and Nursing Assessment emphasizing under Subtitle "Abnormal Findings", member of the patient care team should report ANY changes in patient conditions or concerns of patient well-being immediately to the licensed nurse at any time". Abnormal findings are laminated and available at each snappy carts for reference. TMs must report and document any significant changes during treatment and post treatment, compare pre-dialysis findings to post for indicators that may preclude the discharge of the patient and report to licensed nurse. Licensed nurse must take appropriate action, contact physician if warranted, and follow physician orders including utilizing patient PRN orders. All findings, interventions and patient response will be documented in patient's medical record. Charge nurse is responsible for daily monitoring. The licensed nurse will use his/her clinical judgement based on individual patient needs to determine if any clinical interventions are necessary prior to discharge of the patient from the facility. Verification of attendance at in-service will be evidenced by TMs signature on in-service sheet.

The FA or designee will conduct audits on twenty five percent (25%) of the flow sheets daily for one (1) week then weekly for four (4) weeks then on ten percent (10%) monthly medical records audits. Instances of non-compliance will be addressed immediately. FA will address specific trends and issues with specific teammates.

The FA will review the results of the audits with TMs during homeroom meetings and with the Medical Director during monthly FHM-QAPI with supporting documentation included in the meeting minutes. The FA is responsible for compliance with this plan of correction.