QA Investigation Results

Pennsylvania Department of Health
PALMER DIALYSIS CENTER
Health Inspection Results
PALMER DIALYSIS CENTER
Health Inspection Results For:


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Initial Comments:


Based on the findings of an unannounced onsite Medicare recertification survey completed September 15, 2023, Palmer Dialysis Center was determined to be in compliance with the following requirements of 42 CFR, Part 494.62, Subpart B, Conditions for Coverage for End-Stage Renal Disease (ESRD) Facilities-Emergency Preparedness.






Plan of Correction:




Initial Comments:


Based on the findings of an unannounced onsite Medicare recertification survey completed September 15, 2023, Palmer Dialysis Center was identified to have the following standard level deficiencies that 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)(1) STANDARD
IC-WEAR GLOVES/HAND HYGIENE

Name - Component - 00
Wear disposable gloves when caring for the patient or touching the patient's equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station.




Observations:


Based on a review of facility policy/procedure, treatment area observations, and an interview with the facility Administrator, the facility failed to ensure the staff followed infection control protocols, included but not limited to, performing hand hygiene/donning clean gloves, for two (2) of three (3) 'Central Venous Catheter Exit Site Care' and 'Initiation of Dialysis with Central Venous Catheter' observations (Observation #1, Observation #3), two (2) of two (2) 'Access of AV Fistula or Graft for Initiation of Dialysis' observations (Observation #1, Observation #2), two (2) of two (2) 'Discontinuation of Dialysis and Post Dialysis Access Care for AV Fistula or Graft' observations (Observation #1, Observation #2), and two (2) of two (2) 'Cleaning and Disinfection of the Dialysis Station' observations (Observation #1, Observation #2),

Findings include:

A review was conducted of facility policy on September 15, 2023 at approximately 12:00 p.m. Procedure 'Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps Procedure' section (12) states "Place sterile 2x2 gauze over the catheter exit site ...." section (14) states "Remove gloves and discard, perform hand hygiene per procedure and re-glove. Section (15) states "Holding catheter with non-dominant hand,use other hand to place sterile 4x4 under catheter limbs ....." Section (160 states "Using aseptic technique, remove each cap. One at a time,disinfect each CVC hub ...."

Observations conducted in the patient treatment area on September 15 2023 between approximately 8:38 a.m. and 1:00 p.m. revealed the following:

Observation #1: During observation #1 of 3 'Central Venous Catheter Exit Site Care' and 'Initiation of Dialysis with Central Venous Catheter' on 09/13/23 at approximately 9:28 a.m., of patient #11 at station #19; Employee #15 did not remove gloves/perform hand hygiene/don clean gloves after applying the sterile dressing to the CVC exit site and prior to initiating dialysis (placing sterile field under the catheter limbs/disinfecting hubs).

Observation #3: During observation #3 of 3 'Central Venous Catheter Exit Site Care' and 'Initiation of Dialysis with Central Venous Catheter' on 09/13/23 at approximately 10:45 a.m., of patient #12 at station #12; Employee #3 did not remove gloves/perform hand hygiene/don clean gloves after applying the sterile dressing to the CVC exit site and prior to initiating dialysis (placing sterile field under the catheter limbs/disinfecting hubs).

Procedure #1-04-01E 'AV Fistula or Graft Cannulation with Nipro or Medisystems Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose' 'Procedure' (1) states "Have patient wash access site with appropriate antibacterial soap, if able. If patient is unable to wash access site, patient care teammate will clean access extremity with skin cleansing agent." (2) Perform hand hygiene. Put on PPE." ...... (11) "While maintaining aseptic technique, cleanse the site by applying skin antiseptic ...."

Observation #1: During observation #1 of 2 'Access of AV Fistula or Graft for Initiation of Dialysis' on 09/13/23 at approximately 9:38 a.m., of patient #14 at station #15; Employee #14 washed skin over access site and did not remove gloves/perform hand hygiene before applying antiseptic over cannulation site.

Observation #2: During observation #2 of 2 'Access of AV Fistula or Graft for Initiation of Dialysis' on 09/13/23 at approximately 10:20 a.m., of patient #13 at station #9; Employee #3 washed skin over access site and did not remove gloves/perform hand hygiene before applying antiseptic over cannulation site.

Procedure: 1-03-12A 'Termination of Dialysis Utilizing Fresenius 2008 Series Dialysis Delivery Systems and Combiset or Nipro Blood Lines' section (14) "Disconnect venous blood line from venous access. Section (15) "Discard gloves, perform hand hygiene and put on new gloves. Section (160 "Perform post dialysis access care per procedure."
'Procedure: 1-04-01B 'Post Dialysis Vascular Access Care: Fistula Graft Using Safety Fistula Needles' section (1) "Perform hand hygiene ...." ....... (7) "Remove needle. ..."

Observation #1: During observation #1 of 2 'Discontinuation of Dialysis and Post Dialysis Access Care for AV Fistula or Graft' on 09/13/23 at approximately 9:15 a.m., of patient #16 at station #7; Employee #9 disconnected the bloodline and did not remove gloves/perform hand hygiene/don clean gloves prior to removing the needle.

Observation #2: During observation #2 of 2 'Discontinuation of Dialysis and Post Dialysis Access Care for AV Fistula or Graft' on 09/13/23 at approximately 9:45 a.m., of patient #15 at station #15; Employee #14 disconnected the bloodline and did not remove gloves/perform hand hygiene/don clean gloves prior to removing the needle.

Policy: 1-05-01 'Infection Control For Dialysis Facilities' 'Disinfection' section (130 "At the end of each treatment, the dialysis station will be cleaned and disinfected." ((ii) "Priming containers are to be emptied prior to disinfection." (Note: Policy does not state to remove gloves/hand hygiene/don clean gloves after emptying the prime waste container and prior to initiating disinfection of the station, as noted on the CMS ESRD Core Survey Version 1.6 'Cleaning and Disinfection of the Dialysis Station' task sequence checklist and in accordance with Centers for Disease Control and Prevention protocol.)

Observation #1: During observation #1 of 2 'Cleaning and Disinfection of the Dialysis Station' on 09/13/23 at approximately 8:40 a.m., of patient #17 at station #4; Employee #9 emptied the prime waste receptacle and did not remove gloves/perform hand hygiene/don clean gloves prior to initiating disinfection of the dialysis station.

Observation #2: During observation #2 of 2 'Cleaning and Disinfection of the Dialysis Station' on 09/13/23 at approximately 9:10 a.m., of patient #18 at station #19; Employee #15 emptied the prime waste receptacle and did not remove gloves/perform hand hygiene/don clean gloves prior to initiating disinfection of the dialysis station.


An interview with the facility Administrator on September 15, 2023 at approximately 12:15 p.m. confirmed the above findings.














Plan of Correction:

included in the meeting minutes. The Facility Administrator is responsible for compliance with The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 09/25/23. Surveyor observations were reviewed. Education included but was not limited to a review of
A. Policy 1-05-01 "Infection Control for Dialysis Facilities", B. Procedure 1-04-02B "Central Venous Catheter with Clearguard HD Antimicrobial End Caps Procedure", C. Procedure 1-04-01E "AV Fistula or Graft Cannulation with Nipro or Medisystems Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose", D. Procedure 1-03-12A "Termination of Dialysis Utilizing Fresenius 2008 Series Dialysis Delivery Systems and Combiset or Nipro Blood Lines" and E. Procedure 1-04-01B "Post Dialysis Vascular Access Care: Fistula Graft using Safety Fistula Needles" with emphasis on but not limited to:
A. Infection control: 1) All teammates, Physicians and Non-Physician (NPP) will perform hand hygiene... prior to gloving and immediately after removal of gloves; after contamination with blood or other infectious material... 2) Disposable gloves will be worn when caring for the patient or touching the patient's equipment at the dialysis station... Gloves should be changed when... when soiled with blood, dialysate or other body fluids; when going from a "dirty" area or task to a "clean" area or task... 3) Priming containers are to be emptied prior to disinfection. 4) Dialysis station must be completely vacated by the previous patient before teammates can begin to bring disinfection supplies to the station, clean or disinfect the station and set up for the next patient. B. CVC care: 1) Step 12: Place sterile 2x2 gauze over the catheter exit. 2) Step 13: Apply label to the dressing... 3) Step 14: Remove gloves and discard, perform hand hygiene per procedure and re-glove. 4) Step 15: Holding catheter with nondominant hand, use other hand to place sterile 4x4 under catheter limbs... 5) Using aseptic technique, remove each cap. One at a time, disinfect each CVC hub... C. AVF/AVG cannulation: 1) Step 1: Have patient wash access site with appropriate antibacterial soap, if able. If patient unable to wash access site, patient care teammate will clean access extremity with skin cleansing agent and pat dry. 2) Step 2: Perform hand hygiene. Put on PPE. 3) Step 11: While maintaining aseptic technique, cleanse the site by applying skin antiseptic... D. Termination of dialysis: 1) Step 14: Disconnect venous blood line from venous access. 2) Step 15: Discard gloves, perform hand hygiene and put on new gloves. 3) Step 16: Perform post dialysis access care per procedure. E. Post dialysis access care: 1) Step 1: Perform hand hygiene. Put on PPE. 2) Step 7: Remove needle... Verification of attendance at in-service will be evidenced by teammates signature on in-service sheet.
The Facility Administrator or designee will conduct infection control audits to verify teammate infection control practices per policy of proper glove wearing/changing with hand hygiene during CVC and fistula/graft care, treatment initiation and discontinuation, dialysis machine and station disinfection: daily for two (2) weeks, then weekly for two (2) weeks. Ongoing compliance will be monitored with monthly infection control audits. Instances of non-compliance will be addressed immediately. The Facility Administrator or designee will review audit results with teammates during homeroom meetings and with the Medical Director during Quality Assessment Performance Improvement meetings known as Facility Health Meetings, with supporting documentation this plan of correction.






494.30(a)(1)(i) STANDARD
IC-SUPPLY CART DISTANT/NO SUPPLIES IN POCKETS

Name - Component - 00
If a common supply cart is used to store clean supplies in the patient treatment area, this cart should remain in a designated area at a sufficient distance from patient stations to avoid contamination with blood. Such carts should not be moved between stations to distribute supplies.

Do not carry medication vials, syringes, alcohol swabs or supplies in pockets.


Observations:


Based on a review of facility policy/procedure, treatment area observations, and an interview with the facility Administrator, the facility failed to ensure the staff followed infection control protocols for one (1) of two (2) 'Cleaning and Disinfection of the Dialysis Station' observations (Observation #1).

Findings include:

Facility policy related to supplies not being placed on or near the dialysis machine until it has been surface disinfected was requested on September 15, 2023 at approximately 12:00 p.m. No specific policy was provided.

Observations conducted in the patient treatment area on September 15 2023 between approximately 8:38 a.m. and 1:00 p.m. revealed the following:

Observation #1: During observation #1 of 2 'Cleaning and Disinfection of the Dialysis Station' on 09/13/23 at approximately 8:40 a.m., of patient #17 at station #4; Employee #9 brought new patient supplies to the dialysis station and began to set up the dialysis machine with the next scheduled patients supplies while Employee #10 was still in the process of disinfecting the dialysis chair, blood pressure cuff, and television.


An interview with the facility Administrator on September 15, 2023 at approximately 12:15 p.m. confirmed the above findings.










Plan of Correction:

The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 09/25/23. Surveyor observations were reviewed. Education included but was not limited to a review of
Policy 1-05-01 "Infection Control for Dialysis Facilities" with emphasis on but not limited to: 1) at the end of each treatment, the dialysis station will be cleaned and disinfected. Surfaces to disinfect include but are not necessarily limited to: all surfaces in contact with the patient or their belongings (e.g., dialysis chair, tray tables, blood pressure cuffs) and frequently contacted by healthcare personnel (e.g., control panel; top, front and sides of dialysis machine; touchscreens; countertops). 2) Dialysis station must be completely vacated by the previous patient before teammates can begin to bring disinfection supplies to the station, clean or disinfect the station and set up for the next patient. Verification of attendance at in-service will be evidenced by teammate's signature on in-service sheet.
The Facility Administrator or designee will conduct infection control audits to verify dialysis station is vacant while station disinfection and set up for the next patient takes place: daily for two (2) weeks, then weekly for two (2) weeks. Ongoing compliance will be monitored with monthly infection control audits. Instances of non-compliance will be addressed immediately. The Facility Administrator or designee will review audit results with teammates during homeroom meetings and with the Medical Director during Quality Assessment Performance Improvement meetings known as Facility Health Meetings, with supporting documentation included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.



494.150(c)(2)(i) STANDARD
MD RESP-ENSURE ALL ADHERE TO P&P

Name - Component - 00
The medical director must-
(2) Ensure that-
(i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers;



Observations:


Based on a review of facility policy/procedure, patient medical record review, and an interview with the facility Administrator, it was determined the facility failed to ensure a registered nurse completed an initial nursing evaluation prior to initiating treatment for two (2) of ten (10) medical records (MR) initial treatments reviewed (MR#3, MR#9) and failed to ensure a licensed nurse was made aware of patient hypotension/change in patients condition during treatment for one (1) of eight (8) in-center patient medical records (MR) reviewed (MR#7).


Findings include:

A review was conducted of facility policy on September 15, 2023 at approximately 12:00 p.m. Policy: 1-03-07 'CWOW-Initial Patient Nursing Assessment For New Patients' section (1) "A registered nurse (RN) as required by federal regulation will perform an initial pre-treatment evaluation of all patients prior to their first treatment at the facility."
(2) "The minimal nursing evaluation prior to initiating treatment for a patient new to the facility should include: (a) Neurologic, (b) Respiratory, (c) Cardiovascular, (d) Gastrointestinal, (e) Fluid status, (f) General assessment, (g) Personal, (h) Subjective complaints, (i) Access: Assessment."

A review of patient medical records conducted on September 15, 2023 between approximately 9:00 a.m. - 11:45 a.m. revealed the following:

MR#3 Date of Admission 07/04/23: Patient's first in center hemodialysis treatment flowsheet dated 07/04/23 was reviewed. Treatment initiated at 10:17 a.m. The 'Initial Patient Nursing Assessment' documentation was completed by a registered nurse with a time stamp of 10:25 a.m., after initiation of treatment.

MR#9 Date of Admission 08/02/21: Patient's first peritoneal dialysis treatment nursing note dated 08/09/21 with a time stamp of 4:46 p.m. was reviewed. The 'New PD Patient Pre-Treatment Initial Nurse Assessment' documentation was completed on 08/09/21. No registered nurse signature/time stamp included on the form. The section was left blank.


Policy: 1-03-08 'CWOW-Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment' '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 (refer to 'Abnormal Findings' section of this policy). 'Abnormal Findings' " ...In addition, the teammate who is observing or collecting information should report to the licensed nurse whenever there is a concern for the patients condition or the potential safety of initiating dialysis, even in the absence of specific abnormal findings."

MR#7, Date of admission 09/02/20: Treatment flowsheet dated 09/06/23 reviewed. Treatment initiated at 6:33 a.m. Blood pressure (BP) was "107/26", treatment started...... (entered by Employee #9, patient care technician).
At 6:34 a.m. BP recheck was "91/32", (entered by Employee #9, patient care technician).
At 7:03 a.m. BP "113/28" (entered by Employee #14, patient care technician).
At 7:33 a.m. BP "103/25" (entered by Employee #9, patient care technician).
At 8:02 a.m. BP "118/27" (entered by Employee #14, patient care technician).
At 8:33 a.m. BP "113/33" (entered by Employee #9, patient care technician).
At 9:03 a.m. BP "108/37" (entered by Employee #9, patient care technician).
At 9:33 a.m. BP "104/49" (entered by Employee #9, patient care technician).
At 10:03 a.m. BP "128/37" (entered by Employee #9, patient care technician).
At 10:04 a.m. BP "131/30" , treatment terminated.... (entered by Employee #9, patient care technician).

No documentation provided of the personal care technician notifying the registered nurse of the patients lowered blood pressure readings during treatment.


An interview with the facility Administrator on September 15, 2023 at approximately 12:15 p.m. confirmed the above findings.









Plan of Correction:

A Governing Body meeting was held on 9/20/23 with the Medical Director, Facility Administrator, Director of Nursing and Regional Operations Director to review the results of the survey ending on 09/15/23. The Governing Body reviewed Policy COMP-DD-017 "Medical Director Qualifications and Responsibilities" with the Medical Director, who acknowledges that he/she is responsible to ensure that all policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and non-physician providers. Plans of correction have been developed and initiated to correct identified deficiencies and to sustain compliance.
The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 9/25/23. Surveyor observations were reviewed. Education included but was not limited to a review of policies with areas of emphasis on but not limited to:
1. Policy 1-03-07 "CWOW-Initial Patient Nursing Assessment for New Patients": 1) A registered nurse (RN) as required by federal regulation will perform an initial pretreatment evaluation of all new patients prior to the initiation of their first treatment at the facility. 2) The minimal nursing evaluation prior to initiating treatment for a patient new to the facility should include: a. Neurologic; b. Respiratory; c. Cardiovascular; d. Gastrointestinal; e. Fluid status; f. General assessment; g. Personal; h. Subjective Complaints; and i. Access: assessment. 3) Whenever possible, the registered nurse will review the patient's current home medications and determine any potential treatment implications, e.g., potential for hypotension. 4) This pre-treatment evaluation will be documented on the 1-03-07A New Patient Pre-Treatment Initial Nurse Assessment 0910 rev 0421, which includes Registered Nurse signature, date and time of completion.
The Facility Administrator or designee will audit one hundred percent (100%) of new admissions for the presence of the initial pre-treatment nurse assessment, monthly for three (3) months. Ongoing compliance will be monitored with the monthly ten percent (10%) medical records audit. Instances of non-compliance will the addressed immediately.

2. Policy 1-03-08 "CWOW- Pre- Intra- Post Treatment Data Collection, Monitoring and Nursing Assessment": 1) Pre-treatment: 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... 2) Intra-dialytic: Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately ... The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary. 3) Post treatment: If an abnormal finding(s) or concern is identified post treatment, this needs to be reported to the licensed nurse. The licensed nurse will assess the patient prior to discharge. 4) All findings, interventions and patient response will be documented in the patient's medical record.
The Facility Administrator or designee will audit treatment records to verify abnormal findings are documented, reported to the RN and addressed appropriately: on twenty five percent (25%) of treatment records daily for two (2) weeks, then weekly for two (2) weeks.

Ongoing compliance for each audit series will be monitored with the monthly ten percent (10%) medical records audit. Instances of non-compliance will be addressed immediately.

Verification of attendance at all in-services will be evidenced by teammates' signatures on the in-services sheets. The Medical Director will review progress of teammate education, results of audits, and adherence to this plan of correction, as provided by the Facility Administrator during monthly Quality Assessment Performance Improvement meetings known as Facility Health Meetings, with supporting documentation included in the meeting minutes. Action plans will be evaluated for effectiveness, new plans developed as applicable to achieve compliance with teammate adherence to policy and procedure. The Facility Administrator on behalf of the Governing Body is responsible for compliance with this plan of correction.