QA Investigation Results

Pennsylvania Department of Health
NORTHERN PHILADELPHIA DIALYSIS
Health Inspection Results
NORTHERN PHILADELPHIA DIALYSIS
Health Inspection Results For:


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Initial Comments:


Based on the findings of an onsite unannounced Medicare recertification survey conducted on December 4, 2023 through December 7, 2023, Northern Philadelphia 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 unannounced, onsite Medicare re-certification survey conducted December 4, 2023 through December 7, 2023, Northern Philadelphia 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)(i) STANDARD
IC-IF TO STATION=DISP/DEDICATE OR DISINFECT

Name - Component - 00
Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient.
-- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient.
-- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient's station should be used only for that patient and should not be returned to a common clean area or used on other patients.



Observations:


Based on observation of the clinical area, facility policy and an interview with the facility administrator, the facility did not follow its policy regarding disinfection of non-disposable equipment for five (5) of five (5) observations. Observation # 1, 2, 3, 4, & 5.

Findings include:

A review of facility policy was conducted on 12/7/23 at approximately 12:00PM and revealed the following:

Policy, " 1-05-01 "Infection Control for Dialysis Facilities" states: "14. Non-disposable items are to be disinfected after each patient use, prior to removal from treatment area/station and if contaminated between uses...Stethoscopes will be disinfected with alcohol prep pad and/or 1:100 (one to one hundred) bleach solution and if they are visibly contaminated with blood or body fluids should be disinfected with a 1:10 (one to ten) bleach solution"


Observations of the clinical area were conducted on 12/4/23 from 10:00 AM to 12:00PM and on 12/5/23 from 10:00AM to 11:00AM.

Observation #1 station #20. 12/4/23 at 10:45 AM. RN#2 used a stethoscope to assess a patient and did not disinfect the stethoscope after use.

Observation #2 station #18. 12/4/23 at 11:20 AM. RN#2 used a stethoscope to assess a patient and did not disinfect the stethoscope after use.

Observation #3 station #6. 12/4/23 at 11:25 AM. RN#1 used a stethoscope to assess a patient and did not disinfect the stethoscope after use.

Observation #4 station #11. 12/4/23 at 11:45AM. RN#3 used a stethoscope to assess a patient and did not disinfect the stethoscope after use.

Observation #5 station #12. 12/4/23 at 11:48 AM. RN#2 used a stethoscope to assess a patient and did not disinfect the stethoscope after use.


An interview with the facility adminstrator on 12/7/23 at 1:30 PM confirmed the above findings.






Plan of Correction:

The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 12/22/23. 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) Non-disposable items are to be disinfected after each patient use, prior to removal from treatment area/station and if contaminated between uses. 2) Stethoscopes taken to the patient's station will be disinfected with alcohol prep pad and/or 1:100 (one to one hundred) bleach solution and if they are visibly contaminated with blood or body fluids should be disinfected with a 1:10 (one to ten) bleach solution. Verification of attendance at in-service will be evidenced by teammate's signature on in-service sheet.
The Facility Administrator or Clinical Coordinator or Manager of Clinical Services will conduct infection control audits to verify non-disposable items are disinfected after each patient use per policy: daily for two (2) weeks, then weekly for two (2) weeks, then monthly during infection control audits. 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 the Medical Director during monthly Quality Assessment and 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.




494.60(b) STANDARD
PE-EQUIPMENT MAINTENANCE-MANUFACTURER'S DFU

Name - Component - 00
The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer's recommendations.



Observations:


Based on review of agency policy/procedure, observation, and interview with facility administrator (FA), agency failed to complete preventative maintenance of one (1) of four (4) oxygen concentrators present at facility (Concentrator #4).


Findings include:

Policy Review conducted on 12/7/23, at approximately 12:00PM and policy "2-01-09 Preventative Maintenance schedules for Equipment" stated, "Purpose: the dialysis delivery systems and any ancillary equipment, are maintained in good working condition and are operating according to the manufacturer's specifications...all miscellaneous equipment will receive PM (preventative maintenance) by trained Biomed teammate or outside vendor per manufacturer's recommendations. Example of Miscellaneous equipment...oxygen concentrators..."

Treatment floor observation occurred on 12/4/23 at approximately 10:30 AM. Concentrator #4 located at station #15 was observed with a preventative maintenance sticker stating the preventative maintenance/calibration was due on 9/2023 and was last done on 9/2022. Facility Administrator was unable to locate any preventative maintenance paperwork for further review.



Interview conducted on 12/7/23, at approximately 1:30PM with Facility Adminstrator who confirmed the above findings.















Plan of Correction:

Immediate action included verifying with the outside vendor that the oxygen concentrator was not included in the last maintenance visit, and scheduling return maintenance visit by 01/15/24. The concentrator was immediately removed from used on the treatment floor.
The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 12/22/23. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 8-04-01 "Physical Environment" and Policy 2-01-09 "Preventive Maintenance (PM) Schedules for Equipment" with emphasis on but not limited to: A. Physical environment: 1) The dialysis facility will implement and maintain a program to verify that all equipment, including emergency equipment, dialysis delivery systems and the water treatment systems are maintained and operated in accordance with the manufacturer's recommendations.
B. Preventive maintenance: 1) Purpose: the dialysis delivery systems and all ancillary equipment, are maintained in good working condition and are operating according to the manufacturer's specifications. 2) Preventive maintenance (PM) schedules must be made in accordance with the manufacturer's recommendation for all equipment used to perform a patient treatment. A copy of the equipment PM schedule will be filed in the appropriate Equipment Maintenance Manual. 3) All miscellaneous equipment will receive PM performed by trained Biomed teammate or outside vendor per manufacturer's recommendations. Examples of miscellaneous equipment may include, but are not limited to... oxygen concentrators...
Verification of attendance at in-service will be evidenced by teammate's signature on in-service sheet.
The Facility Administrator will review the preventive maintenance schedule with the Biomed teammate and verify the updated schedule is filed in the Equipment Maintenance Manual per policy. The Facility Administrator or designee will conduct daily physical plant observational audits to verify all oxygen concentrators have received preventive maintenance: daily for two (2) weeks, and weekly for two (2) week. Ongoing compliance with the Equipment Maintenance scheduled will be monitored with the Monthly OSHA and Safety Checklist. Deficiencies not corrected immediately will be documented on the Monthly OSHA and Safety Plan of Correction [last page of the checklist] outlining the: deficiency, cause of the deficiency and corrective action: expected date of correction and actual date of correction.
The Facility Administrator or Biomed or designee will review the audit results, the maintenance schedule and maintenance results with the Medical Director during monthly Quality Assessment and 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)(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 policies/procedure, medical records (MR), hemodialysis (HD) treatment records, and interviews with the facility administrator (FA), the facility failed to follow its policy for monitoring vital signs, reporting and/or documenting abnormal findings during HD, for one (1) of seven (7) MR reviewed: MR#4.

Findings include:

A review of the facility's policy Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment (Policy: 1-03-08) on 12/7/23 at approximately 12:00PM stated,"Patient data will be obtained and documented by the patient care technician (PCT) or a licensed nurse. Data collection includes ... measurement of BP (blood pressure), Heart or pulse rate;" "The nursing assessment will be performed and documented by a licensed nurse. The assessment includes the following components: review of patient reports, data collection, response to treatment...Pre-Treatment Data Collection/Assessment: any abnormal findings during pre-treatment data collection will be documented and immediately reported to the licensed nurse. If an abnormal finding is reported to the licensed nurse pre-treatment, the nurse will assess the patient prior to the initiation of dialysis ...the licensed nurse will use his/her clinical judgement based on individual patient needs to determine if any clinical interventions are necessary. The physician (or non-physician practitioner if applicable) will be notified of any concerns that may preclude the initiation of dialysis. If there are no abnormal findings or concerns identified during the pretreatment data collection, the treatment may be initiated....Intradialytic Data Collection/Assessment: the licensed nurse will round on those patients without reported abnormal findings and complete the nursing assessment within one (1) hour of dialysis treatment initiation .... Vital signs and treatment monitoring - for non-nocturnal treatments is completed at least every thirty (30) minutes ....Abnormal findings 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. The licensed nurse notifies the physician (or non physician practitioner if applicable) as needed of changes in patient status...Abnormal Findings - any weight loss from last post weight .... Blood Pressure Pre-Dialysis: Systolic greater than 180 mm Hg or less than 90 mm Hg; Diastolic greater than or equal to 100 mmHg; Blood Pressure - Intradialytic: Difference of 20 mmHg increase or decrease from patient ' s last Intradialytic treatment BP reading; Blood Pressure Post Treatment: Standing systolic BP greater than 140 mmHg or less than 90 mmHg; Standing diastolic BP greater than 90 mmHg or less than 50 mmHg; Sitting BP for patient ' s that cannot stand: Sitting systolic BP greater than 140 mmHg or less than 90 mmHg; Sitting diastolic BP greater than 90 mmHg or less than 50 mmHg; Heart or Pulse Rate Pre/Intra/Post: Less than 60 beats per minutes or greater than 100 beats per minutes and/or an irregular heart beat."


A review of medical records took place on 12/5/23 from approximately 12:00PM-3:00PM and 12/6/23 from approximately 10:00-2:00PM and revealed the following:

MR #4. Start of Care at facility: 2/25/22.

HD Treatment on 11/17/23 was initiated at 11:32 AM by the PCT. At 12:57 PM, the PCT documented a BP of 100/54. BP was checked again by the PCT at 1:30PM and found to be 194/92. There was no documentation about RN notification about the sudden difference in blood pressure readings. BP was not checked again until 1:57 PM and was 141/114. There was no documentation about RN notification. In addition, Post-Treatment there was no RN assessment completed.



An interview conducted with Facility Administrator on 12/7/23 at approximatley 1:30PM confirmed the above findings.



















Plan of Correction:

The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 12/22/23. 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" with emphasis on but not limited to:
[Pre-treatment] 1) Patient data will be obtained and documented by the patient care technician (PCT) or a licensed nurse, including but not limited to: measurement of Blood Pressure (BP)... Sitting and standing BP measurement required pre and post treatment (if patient unable to stand, document reason in the patient electronic record or flow sheet)... 2) 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). If an abnormal finding is reported to the licensed nurse pre-treatment, the nurse will assess the patient prior to the initiation of dialysis. 3) If there are no abnormal findings or concerns identified during the pretreatment data collection, the treatment may be initiated. 4) The licensed nurse will round on those patients without reported abnormal findings and complete the nursing assessment within one (1) hour of dialysis treatment initiation.
[Intradialytic] 5) Intra dialytic treatment monitoring and data collection which may be performed by the PCT or licensed nurse includes vital signs and treatment monitoring at least every 30 minutes. 6) Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately... 7) the licensed nurse notifies the physician (or NPP if applicable) as needed of changes in patient status. 8) All findings, interventions and patient response will be documented in the patient's medical record.
[Post treatment] 9) 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. 10) ABNORMAL FINDINGS: Fluid Status: Pre-treatment- Any weight loss from last post weight; Post-treatment- If patient is above or below 1 kg from the target weight. Blood pressure: a. Pre dialysis: Systolic greater than 180 mm/Hg or less than 90 mm/Hg; Diastolic greater than or equal to 100 mm/Hg; b. Intradialytic: Difference of 20 mm/Hg increase or decrease from patient's last intradialytic treatment BP reading; c. Post Treatment: Standing / sitting systolic BP greater than 140 mm/Hg or less than 90 mm/Hg, Standing / sitting diastolic BP greater than 90 mm/Hg or less than 50 mm/Hg... If patient is not able to stand, document reason and sitting BP. Heart or Pulse Rate Pre/ Intra/ Post: Less than 60 beats per minute or greater than 100 beats per minute and/ or an irregular heartbeat. 11) All findings, interventions and patient response will be documented in the patient's medical record. Verification of attendance at in-service will be evidenced by teammate's signature on in-service sheet.
The Facility Administrator or designee will conduct treatment records audits to verify timely nursing assessments, proper documentation of data collection, with appropriate notification of abnormal findings to nurse and response by nurse: on twenty five percent (25%) of the treatment records 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 the audit results with teammates during homeroom meetings, and with the Medical Director during monthly Quality Assessment and Performance Improvement meetings known as Facility Health Meeting, with supporting documentation included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.




494.90(b)(2) STANDARD
POC-INITIAL IMPLEMENTED-30 DAYS/13 TX

Name - Component - 00
Implementation of the initial plan of care must begin within the latter of 30 calendar days after admission to the dialysis facility or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session.



Observations:


Based on a review of medical records (MR), policies and procedures and an interview with the Facility Administrator, the facility failed to ensure an initial "Comprehensive Interdisciplinary Assessment/Plan of Care" was completed within thirty (30) days or thirteen (13) outpatient hemodialysis treatments of the initial hemodialysis treatment for one (1) of seven (7) hemodialysis patients. (MR # 6)

Findings include:

A review of the Facility Policy 1-14-01 titled " Interdisciplinary Team (IDT) Patient Assessment and Plan of Care," was conducted on 12/7/23 at approximately 12:00 PM. and stated "An initial Plan of Care, based on the findings from the comprehensive assessment will be completed on all patients new to dialysis within 30 calendar days (or 13 outpatient dialysis sessions for hemodialysis) beginning with the first outpatient dialysis treatment or per state guidelines."

A review of medical records took place on 12/5/23 from approximately 12:00PM-3:00PM and 12/6/23 from approximately 10:00-2:00PM and revealed the following:

MR #6. The first hemodialysis treatment at this facility for the patient was 2/17/23. The medical record showed an initial comprehensive interdisciplinary assessment/ Plan of Care was completed on 10/16/23 (approximately 8 months after the first outpatient dialysis treatment was completed).


An interview was conducted with the Facility Administrator on 12/7/23 at approximately 1:30 P.M. who confirmed the above identified findings.





Plan of Correction:

The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 12/26/23. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-14-01 "Interdisciplinary Team (IDT) Patient Assessment and Plan of Care" with emphasis on but not limited to: 1) the interdisciplinary team is responsible for providing each patient with an individualized and comprehensive assessment documenting his/her needs. The comprehensive assessment will be used to develop the patient's treatment plan and expectations for care. 2) An initial Plan of Care, based on the findings from the comprehensive assessment, will be completed on all patients new to dialysis within 30 calendar days (or 13 outpatient dialysis sessions for hemodialysis) beginning with the first outpatient dialysis treatment or per state guidelines. Verification of attendance is evidenced by teammate's signature on in-service sheet.
The Facility Administrator or designee or care plan manager will audit one hundred percent (100%) of new patient care plans monthly for three (3) months to verify initial assessments and plans of care are completed within thirty (30) days (or thirteen (13) outpatient dialysis sessions for hemodialysis) per policy, with ongoing compliance being monitored with monthly ten percent (10%) medical records audit.
Instances of non-compliance will be addressed immediately.
The Facility Administrator or designee will review the audit results with the IDT during Core Team meetings and with the Medical Director during monthly Quality Assessment and 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.