QA Investigation Results

Pennsylvania Department of Health
ST. LUKE'S WHITEHALL DIALYSIS
Health Inspection Results
ST. LUKE'S WHITEHALL DIALYSIS
Health Inspection Results For:


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Initial Comments:


Based on the findings of an unannounced onsite Medicare recertification survey completed July 8, 2022, St. Luke's Whitehall Dialysis was identified 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 July 8, 2022, St. Luke's Whitehall Dialysis 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, 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 three (3) of three (3) 'Access of AV Fistula or Graft for Initiation of Dialysis' observations (Observations #1-#3) and 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) 'Discontinuation of Dialysis and Post Dialysis Access Care for AV Fistula or Graft observations (Observations #2, #3).


Findings include:

A review was conducted of facility policy on July 8, 2022 at approximately 11:30 a.m. Policy #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 conducted in the patient treatment area on July 6, 2022 at between approximately 9:12 a.m. and 11:25 a.m. revealed the following:

Observation#1: During observation #1 of 'Access of AV Fistula or Graft for Initiation of Dialysis' on 07/06/22 at approximately 9:48 a.m., of patient #7 at station #6, EF#4, 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 'Access of AV Fistula or Graft for Initiation of Dialysis' on 07/06/22 at approximately 9:55 a.m., of patient #8 at station #3, EF#1, washed skin over access site and did not remove gloves/perform hand hygiene before applying antiseptic over cannulation site.

Observation#3: During observation #3 of 'Access of AV Fistula or Graft for Initiation of Dialysis' on 07/06/22 at approximately 11:55 a.m., of patient #14 at station #4, EF#5, washed skin over access site and did not remove gloves/perform hand hygiene before applying antiseptic over cannulation site.


Policy #1-03-121 'Termination of Dialysis Utilizing B Braun Dialog+ Dialysis Delivery Systems with all Single Use Dialyzer Types and Streamline Blood lines' 'Procedure' (7) Close clamps on arterial access and blood line. Aseptically disconnect arterial blood line from arterial access connection. ..." ..... (14) states "Disconnect venous blood line from the venous access. (15) Discard gloves, perform hand hygiene and put on new gloves." 'Rationale' (15) states "Hand hygiene and new gloves are used for performing post dialysis care per procedure."

Observation#2: During observation #2 of 'Discontinuation of Dialysis and Post Dialysis Access Care for AV Fistula or Graft' on 07/06/22 at approximately 9:16 a.m., of patient #9 at station #6, EF#4, reinfused the extracorporeal circuit and disconnected the bloodlines. EF#4 did not remove gloves and perform hand hygiene/don clean gloves prior to removing the needle.

Observation#3: During observation #3 of 'Discontinuation of Dialysis and Post Dialysis Access Care for AV Fistula or Graft' on 07/06/22, of patient #15 at station #12, EF#4, reinfused the extracorporeal circuit and disconnected the bloodlines. EF#4 did not remove gloves and perform hand hygiene/don clean gloves prior to removing the needles.


An interview with the facility administrator on July 8, 2022 at approximately 12:00 p.m. confirmed the above findings.












Plan of Correction:

V 113
The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 07/15/22. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-05-05 "Infection Control for Dialysis Facilities", Policy 1-04-01E "AV Fistula or Graft Cannulation with Nipro or Medisystems Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose" and Policy 1-03-12I "Termination of Dialysis Utilizing B Braun Dialog+ Dialysis Delivery Systems with all Single Use Dialyzer Types and Streamline Blood Lines" with emphasis on but not limited to: 1. Hand hygiene: 1)Hand hygiene is to be performed upon entering the patient treatment area, prior to gloving, after removal of gloves, after contamination with blood or other infectious material, after patient and dialysis delivery system contact, between patients even if the contact is casual, before touching clean areas such as supplies and on exiting the patient treatment area. 2. Cannulation: 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) Perform hand hygiene. Put on PPE. Rational: Hand hygiene protects patient and teammate from cross contamination. 3. Treatment termination: 1) Disconnect venous blood line from the venous access. 2) Discard gloves, perform hand hygiene and put on new gloves. Rationale: Hand hygiene and new gloves are used for performing post dialysis access care per procedure. 3) Perform post dialysis access care per procedure. Verification of attendance at in-service will be evidenced by teammate's signature on in-service sheet. The Facility Administrator or designee will conduct observational infection control audits to verify proper hand hygiene is utilized during cannulation and treatment termination per policy: daily for two (2) weeks and weekly for two (2) weeks. Ongoing compliance will be monitored with the monthly infection control audit. Instances of non-compliance will be addressed immediately. The Facility Administrator or designee will review the audit results with teammates during homeroom meetings and with Medical Director during monthly 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.



494.30(a)(1)(i) STANDARD
IC-HBV-ISOLATION-MACHINES/EQUIP/SUPPLIES

Name - Component - 00
Isolation of HBV+ Patients

To isolate HBsAg positive patients, ... dedicate machines, equipment, instruments, supplies, and medications that will not be used by HBV susceptible patients.


Observations:


Based on a review of facility policy, observations, and an interview with the Administrator, facility failed to label supplies/equipment that are dedicated for use in the isolation area for one (1) of one (1) isolation room observations (Observation #1).

Findings:

A review was conducted of facility policy on July 8, 2022 at approximately 11:30 a.m. Policy #1-05-02 'Hepatitis B Surveillance, Vaccination, Infection Control Measures and Isolation Guidance' 'Purpose' states "To prevent the spread of hepatitis B infections in the dialysis setting." 'Policy' section (19) states (a) "Dedicated ancillary supplies such as .... stethoscope, sharps container, ... centrifuge, and non disposable items will be used." (b) "Such supplies will be labeled "isolation" and will remain in the isolation room/area or station ...."


Observation conducted in the patient treatment area on July 6, 2022 at between approximately 9:12 a.m. and 11:25 a.m. revealed the following:

Observation #1: On 07/06/22 at approximately 1:25 p.m. the isolation room was inspected. One (1) stethoscope, one (1) centrifuge, one (1) sharps container, and one (1) dialysis chair were found to be not labeled "isolation".


An interview with the facility administrator on July 8, 2022 at approximately 12:00 p.m. confirmed the above findings.









Plan of Correction:

V 130
The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 07/15/22. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-05-02 "Hepatitis B Surveillance, Vaccination, Infection Control Measures and Isolation Guidance" with emphasis on but not limited to: 1) Dedicated ancillary supplies such as blood pressure cuffs, clamps, tourniquets, stethoscope, blood glucose meter, bicarb/dialysate jugs, bleach buckets, sharps' container, thermometer, pens, centrifuge, and non-disposable items will be used. 2) Such supplies will be labeled "isolation" and remain in the isolation room/area or station ...Verification of attendance is evidenced by teammate's signature on the in-service sheet. On the day of surveyor's observations, the Facility Administrator directed teammates working in the Isolation room to properly label all dedicated supplies "Isolation", including the stethoscope, centrifuge, sharps container and dialysis chair. The Facility Administrator or designee will perform observational audits daily for two (2) weeks, then weekly for two (2) weeks to verify compliance with proper labeling for "Isolation" supplies. Ongoing compliance will be monitored via the monthly infection control audit. Instances of non-compliance will be addressed immediately. The Facility Administrator or designee will review audit
2
findings with teammates during homeroom meetings and with the Medical Director during the monthly Quality Assessment Performance Improvement meetings known as Facility Health Meeting, with supporting documentation in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.
V 147


494.30(a)(2) STANDARD
IC-STAFF EDUCATION-CATHETERS/CATHETER CARE

Name - Component - 00
Recommendations for Placement of Intravascular Catheters in Adults and Children

I. Health care worker education and training
A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections.
B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters.

II. Surveillance
A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site.

Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients.

VI. Catheter and catheter-site care
B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections].





Observations:


Based on a review of facility policy, observations, and an interview with the facility Administrator, the facility failed to ensure that clinical staff maintain aseptic technique for the care of vascular accesses, including intravascular catheters for one (1) of two (2) observations (Observation #2).

Findings:

A review was conducted of facility policy on July 8, 2022 at approximately 11:30 a.m. Procedure: 1-04-02B 'Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps Procedure' 'Notes' states "Use dialysis precautions and aseptic technique throughout procedure."

Observation conducted in the patient treatment area on July 6, 2022 at between approximately 9:12 a.m. and 11:25 a.m. revealed the following:

Observation #2: On 07/06/22 at approximately 11:25 a.m. while observing 'Central Venous Catheter Exit Site Care' for patient #1, station #1; EF#1, did not ensure the patients shirt was secured away from the exit site. The patients shirt made contact with the access site after the old CVC dressing was removed.


An interview with the facility administrator on July 8, 2022 at approximately 12:00 p.m. confirmed the above findings.












Plan of Correction:

V 147
The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 07/15/22. Surveyor observations were reviewed. Education included but was not limited to a review of Procedure 1-04-02B "Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps Procedure" with emphasis on but not limited to: 1) Verify patient's clothing is secured away from the exit site/work area. Rational: Securing the patient's clothing away from the work area minimizes the risk of cross contamination. Verification of attendance is evidenced by teammate's signature on the in-service sheet. The Facility Administrator or designee will conduct audits to verify CVC care complies with policy: 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 will review audit results with the Medical Director during monthly Quality Assessment Performance Improvement Meeting known as Facility Health Meeting, with supporting documentation in the meeting minutes. The Facility Administrator is responsible for ongoing 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 a review of facility policy, a review of medical records, a review of patient treatment flow sheets, and an interview with the facility Administrator; the facility failed to ensure the staff followed facility procedure for early termination of treatment for three (3) out of five (5) in-center hemodialysis clinical records reviewed (CR#1, CR#2, CR#4).

Findings include:

A review was conducted of facility policy on July 8, 2022 at approximately 11:30 a.m. Policy # 1-01-09 'Prescribed Treatment Time Not Met' 'Policy' '(A) Completion of the Early Termination Against Medical Advice Form' section (1) states "The RN will verify that a patient signs the 'Early Termination Against Medical Advice' form any time the patient requests to terminate their treatment earlier then the prescribed run time". Section (3) states "The RN will obtain the patients signature on the 'Early Termination Against Medical Advice' form' ......" (B) 'Prescribed Treatment Time Not Met' (3) states "If a patients treatment time is shortened/early terminated, the RN will document the event in the patients medical record. Documentation will include, as appropriate, .... A copy of the 'Early Termination Against Medical Advice' form signed by the patient."

A review of medical records was conducted on July 8, 2022 between approximately 9:00 a.m. - 11:30 a.m. Patients admission date is listed below.

CR#1 Date of admission 04/25/22: Physician orders for Hemodialysis dated 5/11/22 state treatment time "210" (3.5 hours). Patient treatment flow sheets were reviewed from 6/24/22-7/6/22.
On 6/24/22 patient treatment flow sheet stated Duration : "205". On 7/1/22 patient treatment flow sheet stated Duration : "194". No documentation of the early termination form being signed, and/or the physician being notified, and/or documentation by the registered nurse documenting patient refusal to sign.

CR#2 Date of admission 05/20/19: Physician orders for Hemodialysis dated 2/1/22 state treatment time "210" (3.5 hours). Patient treatment flow sheets were reviewed from 6/24/22-7/6/22.
On 6/24/22 patient treatment flow sheet stated Duration : "200". On 7/1/22 patient treatment flow sheet stated Duration : "182". No documentation of the early termination form being signed, and/or the physician being notified, and/or documentation by the registered nurse documenting patient refusal to sign.

CR#4 Date of admission 05/20/19: Physician orders for Hemodialysis dated 2/1/22 state treatment time "180" (3 hours). Patient treatment flow sheets were reviewed from 6/24/22-7/6/22.
On 6/27/22 patient treatment flow sheet stated Duration : "150". No documentation of the early termination form being signed, and/or the physician being notified, and/or documentation by the registered nurse documenting patient refusal to sign.


An interview with the facility administrator on July 8, 2022 at approximately 12:00 p.m. confirmed the above findings.











Plan of Correction:

V 543
The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 07/15/22. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-01-09 "Prescribed Treatment Time Not Met" with emphasis on but not limited to: 1) If a patient's treatment is shortened/early terminated, the RN will document the event in the patient's medical record. Documentation will include, as appropriate... A copy of the 'Early Termination of Treatment against Medical Advice' form signed by the patient, if shortened voluntarily by patient... Verification of attendance is evidenced by teammate's signature on in-service sheet. The Facility Administrator or designee will conduct flowsheet audits to verify patient treatments that are not are meeting prescribed treatment times are correctly documented and that 'Early Termination of Treatment Against Medical Advice' form is completed by RN: on twenty five percent (25%) of the flow sheets daily for two (2) weeks, then weekly for two (2) weeks. Ongoing compliance will be monitored with the monthly ten percent (10%) medical records 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 monthly 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.



494.90(a)(6) STANDARD
POC-P/S COUNSELING/REFERRALS/HRQOL TOOL

Name - Component - 00
The interdisciplinary team must provide the necessary monitoring and social work interventions. These include counseling services and referrals for other social services, to assist the patient in achieving and sustaining an appropriate psychosocial status as measured by a standardized mental and physical assessment tool chosen by the social worker, at regular intervals, or more frequently on an as-needed basis.


Observations:


Based on review of facility policy, review of clinical records, and an interview with facility Administrator, the failed to ensure that the standardized mental and physical assessment tool (KDQOL-36) was administered and repeated at least annually for one (1) of five (5) patient clinical records (CRs) reviewed (CR#2) and the facility failed to ensure that the standardized mental and physical assessment tool (KDQOL-36) was administered by the time of the first reassessment (i.e., within 4 months of initiating treatment) for two (2) of five (5) patient clinical records reviewed (CR#4, CR#5).

Findings:

A review was conducted of facility policy on July 8, 2022 at approximately 11:30 a.m. Policy 3-01-10 'Quality of Life Assessment Survey' 'Policy' section (1) states " The Quality of Life (QOL) assessment survey is to be administered by the Social Worker to patients within the first four (4) months of initiating treatment, on an as needed basis, and repeated at least annually thereafter". Section (2) states "If a patient refuses to complete the KDQOL-36 at any time, the Social Worker needs to document the refusal in the KDQOL psychosocial condition in the electronic medical record."

A review of medical records was conducted on July 8, 2022 between approximately 9:00 a.m. - 11:30 a.m. Patients admission date is listed below.

CR#2 Date of admission 05/20/19: No documentation of the 2020 nor 2021 annual KDQOL-36 being administered. No exemption to completing the KDQOL-36 was documented in the medical record.

CR#4 Date of admission 07/29/20: No documentation of the initial KDQOL-36 being administered. No exemption to completing the KDQOL-36 was documented in the medical record.

CR#5 Date of admission 08/12/21: No documentation of the initial KDQOL-36 being administered. No exemption to completing the KDQOL-36 was documented in the medical record.


An interview with the facility administrator on July 8, 2022 at approximately 12:00 p.m. confirmed the above findings.









Plan of Correction:

V 552
The Facility Administrator or designee held mandatory in-services for all clinical teammates and the Interdisciplinary Team (IDT) starting on 07/15/22. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 3-01-10 "Quality of Life Assessment Survey" with emphasis on but not limited to: 1) The Quality of Life (QOL) assessment survey is to be administered by the Social Worker to patients within four (4) months of initiating treatment, on an as needed basis, and
repeated at least annually thereafter. 2) If a patient refuses to complete the KDQOL-36 at any time, the Social Worker needs to document the refusal in the KDQOL Psychosocial condition in the electronic medical record. Verification of re-education will be evidenced by teammate's signature on the in-service sheet. The Facility Administrator or designee, with assistance from the Master Social Worker, will complete an audit of one hundred percent (100%) of the patient medical records for current KDQOL surveys by 07/22/22. Patients without a current survey will have one completed by 08/15/22. Ongoing compliance will be monitored with the monthly ten percent (10%) medical records audit. The Facility Administrator or designee will review audit findings with the Interdisciplinary Team and 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.