QA Investigation Results

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


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Initial Comments:

Based on the findings of an onsite unannounced Medicare recertification survey completed January 9, 2020, Bradford Dialysis was found to have the following standard level deficiencies that were determined to be in substantial compliance with the following 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:




494.62(a)(1)-(2) STANDARD
Plan Based on All Hazards Risk Assessment

Name - Component - 00
403.748(a)(1)-(2), 416.54(a)(1)-(2), 418.113(a)(1)-(2), 441.184(a)(1)-(2), 460.84(a)(1)-(2), 482.15(a)(1)-(2), 483.73(a)(1)-(2), 483.475(a)(1)-(2), 484.102(a)(1)-(2), 485.68(a)(1)-(2), 485.625(a)(1)-(2), 485.727(a)(1)-(2), 485.920(a)(1)-(2), 486.360(a)(1)-(2), 491.12(a)(1)-(2), 494.62(a)(1)-(2)

[(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:]

(1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.*

(2) Include strategies for addressing emergency events identified by the risk assessment.

* [For Hospices at 418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:
(1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.
(2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice's ability to provide care.

*[For LTC facilities at 483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following:
(1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents.
(2) Include strategies for addressing emergency events identified by the risk assessment.

*[For ICF/IIDs at 483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:

(1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients.
(2) Include strategies for addressing emergency events identified by the risk assessment.

Observations:


Based on review of facility's hazard risk assessment, policy and procedure, facility's emergency preparedness plan, observation, and staff (EMP) interviews, the facility failed to ensure its plan was based on its all-hazards community-based risk assessment, and included strategies for addressing emergency events identified by the risk assessment.

Findings included:

Review of facility policy and procedure on January 9, 2019, at 9 a.m. showed, "Policy: 4-07-01 ... TITLE: FACILITY EMERGENCY MANAGEMENT PLAN ... POLICY The governing body shall establish and maintain a facility specific emergency management program designed to manage the consequences of emergencies and disasters that may disrupt the facility's ability to provide care."

Train tracks are located directly behind facility, and were noted during observations of facility and facility grounds from January 6 to January 9, 2020.

During interview with EMP5 on January 6, 2020, at 1 p.m. he/she noted a train travels by facility several times per day, and it carriers material from local refinery which is also nearby.

During interview with EMP12 on January 9, 2020, at 9:22 a.m. he/she estimated the train tracks to be about 100 feet away from rear of facility.

Observation of facility grounds on January 9, 2020, at 9:30 a.m. revealed train tracks located approximately 100 feet from rear of facility.

Review of facility's "Emergency Management Plan" binder was conducted on January 9, 2020, at 9 a.m. The binder did not contain a plan for rail disaster.

Review of "Facility Hazard Vulnerability Analysis Tool" on January 9, 2020, at 11:10 a.m. showed it was completed September 2019. The assessment showed facility was required to develop a plan for train derailment and refinery disasters. Review of another HVA completed December 2019 also showed "train derailment" and indicated "hazard plan is required" for this topic.

Interview with EMP1 (facility administrator) on January 9, 2020, at 11:20 a.m. confirmed above findings, and no plan for rail and refinery disasters.













Plan of Correction:

Bradford
CMS Core Survey 01-09-2020
Completion date 02/08/2020
E0006
The Governing Body meet to review the finding of the survey completed 1/09/20. The Facility Emergency Management Plan was updated to include a plan for rail disaster and refinery disaster as identified by the Facility Hazard Vulnerability Analysis Tool. The Facility Administrator (FA) led a tabletop discussion to review the Facility Emergency Management Plan along with Facility Action Plan for rail derailment and refinery disaster. In addition, all Teammates (TMs) will be educated on the Facility Emergency Plan changes that include train derailment and refinery disaster by 1-21-2020. Verification of attendance is evidenced by TM signature on in-service sheet. The FA is responsible for reviewing the Facility Emergency Management Plan with all new TMs upon hire and annually for existing TMs. The FA is responsible for compliance with this plan of correction.



494.62(d)(1) STANDARD
ESRD EP Training Program

Name - Component - 00
494.62(d)(1): Condition for Coverage:
(d)(1) Training program. The dialysis facility must do all of the following:
(i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles.
(ii) Provide emergency preparedness training at least every 2 years.
Staff training must:
(iii) Demonstrate staff knowledge of emergency procedures, including informing patients of-
(A) What to do;
(B) Where to go, including instructions for occasions when the geographic area of the dialysis facility must be evacuated;
(C) Whom to contact if an emergency occurs while the patient is not in the dialysis facility. This contact information must include an alternate emergency phone number for the facility for instances when the dialysis facility is unable to receive phone calls due to an emergency situation (unless the facility has the ability to forward calls to a working phone number under such emergency conditions); and
(D) How to disconnect themselves from the dialysis machine if an emergency occurs.
(iv) Demonstrate that, at a minimum, its patient care staff maintains current CPR certification; and
(v) Properly train its nursing staff in the use of emergency equipment and emergency drugs.
(vi) Maintain documentation of the training.
(vii) If the emergency preparedness policies and procedures are significantly updated, the dialysis facility must conduct training on the updated policies and procedures.

Observations:


Based on review of facility's hazard risk assessment, policy and procedure, emergency preparedness plan, personnel files (PF), observation, and staff (EMP) interviews, the facililty failed to provide initial and annual emergency preparedness training for train, rail, and refinery disasters.

Findings included:

Review of facility policy and procedure on January 9, 2019, at 9 a.m. showed, "Policy: 4-07-01 ... TITLE: FACILITY EMERGENCY MANAGEMENT PLAN ... POLICY The governing body shall establish and maintain a facility specific emergency management program designed to manage the consequences of emergencies and disasters that may disrupt the facility's ability to provide care. ... TRAINING AND EDUCATION 1. The FA [facility administrator], ... is responsible to provide training of [EMERGENCY MANAGEMENT PLAN]: a. Teammates: i. ANNUALLY 1. Policy Facility Emergency Management Plan 2. Appropriate hazard policies, per HVA [hazard vulnerability assessment] ... iii. Upon Hire iv. Any changes and/or updates."

Train tracks are located directly behind facility, and were noted during observations of facility and facility grounds from January 6 to January 9, 2020.

During interview with EMP5 on January 6, 2020, at 1 p.m. he/she noted a train travels by facility several times per day, and it carriers material from local refinery which is also nearby.

During interview with EMP12 on January 9, 2020, at 9:22 a.m. he/she estimated the train tracks to be about 100 feet away from rear of facility.

Observation of facility grounds on January 9, 2020, at 9:30 a.m. revealed train tracks located approximately 100 feet from rear of facility.

Review of "Facility Hazard Vulnerability Analysis Tool" on January 9, 2020, at 11:10 a.m. showed it was completed September 2019. The assessment showed facility was required to develop a plan for train derailment and refinery disasters. The assessment also showed facility was required to provide training on these topics. Review of another HVA completed December 2019 also showed "train derailment" and indicated "education required" for this topic.

Review of personnel files on January 8, 2020, at 11 a.m. did not show staff received initial or annual emergency preparedness training for train, rail, and refinery disasters.

Interview with EMP1 (facility administrator) on January 9, 2020, at 11:20 a.m. confirmed above findings.







Plan of Correction:

E0038
The Governing Body meet to review the finding of the survey completed 1/09/20. The Facility Emergency Management Plan was updated to include a plan for rail disaster and refinery disaster as identified by the Facility Hazard Vulnerability Analysis Tool. The FA led a tabletop discussion to review the Facility Emergency Management Plan along with Facility Action Plan for rail derailment and refinery disaster. In addition, all Teammates (TMs) will be educated on the Facility Emergency Plan changes that include train derailment and refinery disaster by 1-21-2020. Verification of attendance is evidenced by TM signature on in-service sheet. The FA is responsible for reviewing the Facility Emergency Management Plan with all new TMs upon hire and annually for existing TMs. The FA or designee will audit TM files quarterly to verify training has been completed. Instances of non-compliance will be addressed immediately. The results of the audits will be reviewed in Facility Health Meetings (FHM-QAPI) with supporting documentation included in the meeting minutes.



Initial Comments:

Based on the findings of an onsite unannounced Medicare recertification survey completed January 9, 2020, Bradford Dialysis was found 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 review of facility policy and procedure, observation (OBS), and staff (EMP) interview, the facility failed to ensure staff and patients changed gloves and performed hand hygiene. Two (2) of two (2) patients observed holding access sites to stop bleeding failed to perform hand hygiene immediately after glove removal (OBS#5.2, & OBS#5.3); and one (1) of two (2) staff members observed during discontinuation of dialysis failed to perform a glove change and hand hygiene when going from a dirty to a clean task (OBS#5.1).

Findings included:

Review of facility procedure on January 9, 2020, at 10 a.m. showed, "Procedure: 1-04-01B ... TITLE: POST DIALYSIS VASCULAR ACCESS CARE: ... Procedure ... 9. The patient will be encouraged to hold their own access sites if their condition permits. When the patient holds their cannulation sites, the patient will be offered gloves and performs hand hygiene when completed."

Review of infection control policy on January 9, 2020, at 11 a.m. showed, "Policy: 1-05-01 ... TITLE: INFECTION CONTROL FOR DIALYSIS FACILITIES ... 1. Hand hygiene is performed ... after gloves are removed ... 13. Gloves should be changed when: ... When going from a 'dirty' area or task to a 'clean' area or task."

Observation (OBS#5.1) of discontinuation of dialysis with arteriovenous fistula (AVF) was conducted on January 6, 2020, at 2:15 p.m. at station 5. EMP4 donned gloves and retrieved red sharps biohazard container (dirty) and brought it to the station. Then with the same gloved hands, EMP4 removed needles from patients AVF (clean task). Interview with EMP4 after the observation confirmed findings.

Observation (OBS#5.2) of discontinuation of dialysis with AVF was conducted on January 6, 2020, at 2 p.m. at station 3. EMP6 removed needles from patients AVF and covered them with bandages and tape. The patient held pressure to bandages with gloved right hand. Once bleeding had stopped, the patient removed glove from right hand but did not perform hand hygiene. The patient left the station and walked to the scale and touched scale's grab bar with both hands. Interview with EMP6 after the observation confirmed findings.

Observation (OBS#5.3) of discontinuation of dialysis with AVF was conducted on January 6, 2020, at 2:24 p.m. at station 9. EMP5 removed needles from patients AVF and covered them with bandages and tape. The patient held pressure to bandages with gloved right hand. Once bleeding had stopped, the patient removed glove from right hand but did not perform hand hygiene. The patient left the station and walked to the scale and touched scale's grab bar with both hands. Interview with EMP5 after the observation confirmed findings, and he/she noted, "Because she didn't."

















Plan of Correction:

V113
Per findings day 1 by surveyor of infection control patient hand hygiene/ gloving, FA and patient care team instructed all patients to perform hand washing pre/post treatment, access pre-treatment washing, and hand hygiene post glove removal. The FA held mandatory in-service(s) for all Clinical TMs starting on 1-13-2020. Surveyor observations were reviewed. Education included but was not limited to a review of Policy # 1-05-01 Infection Control for Dialysis Facilities and 1-04-01B Post Dialysis Vascular Access Care with the emphasis on but not limited to: 1) TMs will remove gloves and perform hand hygiene between clean and dirty tasks. 2) TMs will encourage patients to perform hand hygiene after glove removal when holding their sites and prior to touching anything else in the treatment area. 3) TMs instructed to offer hand sanitizer to patient prior to leaving the station. 4) Patients who do not follow facility infection control Policy and Procedures will be re-educated and will not be allowed to hold access if they continue to refuse. 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 to verify compliance. Instances of non-compliance will be addressed immediately. The FA will review results the audits with TMs during homeroom meetings and with 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 facility policy and procedure, clinical records (CR), and staff (EMP) interview, the interdisciplinary team (IDT) failed to provide the necessary care and services to manage the patient's volume status as identified in the comprehensive assessment for one (1) of two (2) incenter hemodialysis patients (CR2).

Findings included:

Review of facility policy on January 9, 2019, at 8:36 a.m. showed, "Policy: 1-14-01 ... TITLE INTERDISCIPLINARY TEAM (IDT) PATIENT ASSESSMENT AND PLAN OF CARE ... POLICY: ... PLAN OF CARE: 8. The facility's interdisciplinary team will develop and implement a written, individualized comprehensive plan of care that specifies the services necessary to address the patient's needs, ... 9. The plan of care will address, ... Dose of dialysis which addresses care and services to manage the patient's volume status; ... 13. In addition, if the expected outcome is not achieved, the interdisciplinary team (or individual IDT member) will adjust the patient's plan of care to achieve specified goal. When a patient is unable to achieve the desired outcomes, the team will: Adjust the plan of care to reflect the patient's current condition ... Document in the patient's medical record the reasons why the patient was unable to achieve the goals ... Implement plan of care changes to address the issues identified."

Review of facility policy on January 9, 2019, at 10 a.m. showed, "Policy: 1-03-08 ... TITLE: PRE-INTRA-POST TREATMENT DATA COLLECTION, MONITORING AND NURSING ASSESSMENT ... PURPOSE: ... This information will be used in planning and documenting the patient's dialysis treatment, ... and for reviewing the patient's response to the treatment and status prior to discharge. POLICY: ... ABNORMAL FINDINGS: ... the following are considered abnormal findings and should be reported to the licensed nurse and documented in the patient's medical record. ... Blood pressure [blood pressure]: Pre dialysis: Systolic [heart at work] greater than 180 mm/Hg [millimeter of mercury: unit of measure for pressure] or less than 90 mm/Hg ... Diastolic [heart at rest] greater than or equal to 100 mm/Hg ... Blood Pressure Post Treatment: ... Standing 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 CR2 on January 7, 2020, at 10 a.m. showed patient was admitted to incenter hemodialysis on 7/3/2014. Review of CR2's comprehensive assessment and plan of care showed it was completed on 1/24/2019. The plan identified patient was not meeting goal for "BP and Fluid Management," and included goals, "To meet or trend toward of Pre-dialysis Blood Pressure of less than 140/90. Comments ... Blood Pressure remains high. PCP and nephrologist will continue to monitor. BP lowers as treatment progresses." The patient reviewed and signed his plan at chairside on 1/29/2019.

Review of CR2's treatment sheets from 12/18/2019 to 1/3/2020 showed the IDT failed to provide necessary care and services to ensure the patient achieved his BP and fluid management goal during eight (8) of eight (8) treatments:

12/18/2019: Pre-treatment BP (PREBP) 198/67 sitting and 200/67 standing; post treatment BP (POSTBP) 186/70 sitting and 180/78 sitting
12/20: PREBP 181/70 sitting and 189/64 standing; POSTBP 168/70 sitting and 177/65 standing
12/22: PREBP 176/62 sitting and 200/79 standing; POSTBP 146/89 sitting and 193/103 standing
12/24: PREBP 195/74 sitting and 161/91 standing; POSTBP 186/71 sitting and 188/73 standing
12/27: PREBP 145/67 sitting and 158/69 standing; POSTBP 160/64 sitting and 182/65 standing
12/29: PREBP 180/57 sitting and 197/73 standing; POSTBP 166/60 sitting and 185/60 standing
12/31: PREBP 201/68 sitting and 201/82 standing; POSTBP 179/7 (incomplete reading) sitting and 175/78 standing
1/3/2020: PREBP 169/69 sitting and 195/105 standing; POSTBP 161/65 sitting and 183/66 standing

Interview with EMP1 (facility administrator), and EMP12 (registered nurse) on January 9, 2020, at 10:45 a.m. confirmed findings.















Plan of Correction:


V543
The Interdisciplinary Team will meet to adjust the plan of care for patient #2 by 1/31/2020 to include a specific plans to achieve blood pressure and fluid management goals: 1) Challenge patient volume status. 2) Continue follow-up with cardiologist. 3) Patient education. If the expected outcome is not achieved, IDT will: 1) adjust the plan of care to reflect patient's current condition. 2) Document in the record the reason(s) the patient was unable to achieve the goals. The FA held mandatory in-service(s) for all Clinical TMs starting on 1-17-2020. 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 but not limited to: 1) Abnormal findings including blood pressures must be reported to license nurse. The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary. The licensed nurse notifies the physician as needed of changes in patient status. All findings, interventions and patient response will be documented in the patient's medical record. 2) 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. 3) Pre dialysis blood pressure of systolic greater than 180 mm/Hg or less than 90 mm/Hg and/or diastolic greater than or equal to 100 mm/Hg; intradialytic blood pressure of a difference of 20 mm/Hg increase or decrease from patient's last intradialytic treatment BP reading; Post dialysis systolic BP greater than 140 mm/Hg or less than 90 mm/Hg and/or diastolic BP greater than 90 mm/Hg or less than 50 mm/Hg must be reported to the licensed nurse. Additionally the Interdisciplinary Team reviewed policy 1-14-01 Interdisciplinary Team (IDT) Patient Assessment and Plan of Care with the focus on: 1) the facility's IDT will develop and implement a written individualized comprehensive plan of care that specifies the services necessary to address the patient's needs. The plan of care must address dose of dialysis, which addresses care and services to manage the patient's volume status. 2) If the expected outcome is not achieved, the IDT must adjust the patient's plan of care to reflect the current status. 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 two (2) weeks then weekly for two (2) weeks then on ten percent (10%) monthly medical records audits. Instances of non-compliance will be addressed immediately. The FA will review results the audits with TMs during homeroom meetings and with Medical Director during monthly FHM-QAPI with supporting documentation included in the meeting minutes. The Core Team will review BP Monitoring Tool to assess all patient's volume status weekly and implement plans if not meeting criteria. The FA is responsible for compliance with this plan of correction.



494.90(a)(5) STANDARD
POC-VA MONITOR/PREVENT FAILURE/STENOSIS

Name - Component - 00
The patient's vascular access must be monitored to prevent access failure, including monitoring of arteriovenous grafts and fistulae for symptoms of stenosis.




Observations:


Based on review of the National Kidney Foundation (NKF), facility policy and procedure, observation (OBS), and staff (EMP) interview, the facility failed to ensure two (2) of two (2) patients washed their arteriovenous fistula (AVF) with soap and water prior to insertion of needles (OBS#4.1, & OBS#4.2).

Findings included:

Review of NKF on January 9, 2020, at 11 a.m. showed, "HEMODIALYSIS ACCESS What You Need to Know ... Tips for Everyday Care of AV Fistula or Graft ... Prevent Infection ... Wash your access site before every dialysis treatment. Your dialysis center has hand washing sinks and ... soap." Retrieved from https://www.kidney.org/sites/default/files/11-50-0216_va.pdf

Review of facility policy and procedure on January 9, 2020, at 10 a.m. showed:

"Policy: 1-04-01 TITLE: ARTERIOVENOUS FISTULA (AVF) ... VASCULAR ACCESS CARE ... 4. Patients are encouraged to wash access extremity with soap and water upon arrival for dialysis, if able."

"Procedure: 1-04-01E ... TITLE: AV FISTULA OR GRAFT CANNULATION WITH NIPRO ... SAFETY FISTULA NEEDLES ... Materials required: Liquid soap or other skin cleansing agent ... Procedure 1. Have patient wash access site with appropriate soap, if able."

Observation (OBS#4.1) of initiation of dialysis with AVF was conducted on January 6, 2020, at 1:30 p.m. at station 10. The patient walked into treatment area and weighed himself. The patient then proceeded to the station where EMP5 disinfected the patient's AVF, and inserted needles. Interview with patient at 2:22 p.m. confirmed it is routine for him to weigh himself and then sit at station where staff disinfect his AVF. The patient confirmed he has never washed his access prior to treatment.

Observation (OBS#4.2) of initiation of dialysis with AVF was conducted on January 6, 2020, at 2:34 p.m. at station 7. The patient entered treatment area in wheelchair, stood briefly on scale, and was then wheeled to the station by staff. EMP3 disinfected the patient's AVF and inserted needles. Interview with patient confirmed he is able to wash his access with soap and water. Interview with EMP3 after observation confirmed the patient did not was his access with soap and water, "He [patient] could of wheeled his wheelchair over there .. sinks are handicap accessible."










Plan of Correction:

V551
The FA will in-service the clinical staff on Policy 1-04-01 AVFistula or AVGraft Vascular Access Care emphasizing: 1) Patients are encouraged to wash access extremity with soap and water upon arrival for dialysis, if able. 2) If patient unable to wash access site, patient care TMs will clean access extremity with skin cleansing agent and pat dry. Verification of attendance is evidences by TM signature on in-service sheet. In addition, the patients will receive education on Hemodialysis Access: Patient tips every day care of fistula or graft. Patients will be instructed to wash access before every dialysis treatment. A signed copy of the patient education will be kept in the medical record. 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 to verify compliance. Instances of non-compliance will be addressed immediately. The FA will review audit results with the TMs during homeroom meetings and with the Medical Director during the monthly QAPI-FHM with supporting documentation included in the meeting minutes. The FA is responsible for compliance with this plan of correction.