QA Investigation Results

Pennsylvania Department of Health
ALBERT EINSTEIN MEDICAL CENTER ESRD
Health Inspection Results
ALBERT EINSTEIN MEDICAL CENTER ESRD
Health Inspection Results For:


There are  12 surveys for this facility. Please select a date to view the survey results.

Surveys don't appear on this website until at least 41 days have elapsed since the exit date of the survey.



Initial Comments:


Based on the findings of an onsite unannounced Medicare recertification survey conducted on January 13, 2020 through January 16, 2020, Albert Einstein Medical Center ESRD, was found to be in compliance with the requirements of 42 CFR, Part 494.62, Subpart B, Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services-Emergency Preparedness.





Plan of Correction:




Initial Comments:

Based on the findings of an onsite unannounced Medicare recertification survey conducted on January 13, 2020 through January 16, 2020, Albert Einstein Medication Center ESRD, 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)(4)(ii) STANDARD
IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL

Name - Component - 00
[The facility must demonstrate that it follows standard infection control precautions by implementing-
(4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-]
(ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment.



Observations:


Based on observation, review of policy and procedures, and interviews with the Facility Administrator, it was determined, the facility failed to ensure infection control procedures were followed by cleaning and disinfecting the Hansen connectors and waste containers for three (3) of nine (9) hemodialysis machines observed. (Dialysis machines at station #'s 2, 6, 7); the facility failed to clean any part of the hemodialysis machine between patients for four (4) of nine (9) hemodialysis machines observed (Dialysis machines at stations #'s 1, 2, 4, & 6); the facility failed to ensure the bedrails of treatments beds was cleaned for two (2) of nine hemodialysis machine/beds disinfection between patients (Beds located at station #'s 1 & 2).
Based on a review of facility machine disinfection logs, facility maintenance records, facility policy and an interview with the biomedical technician and facility administrator, the facility failed to provide disinfection of the dialysis machine according to facility policy.

Findings include:

A review of policy 2-02-01- "Fresenius Dialysis Delivery system Cleaning and Disinfection Policy" was reviewed on January 15, 2020 at approximate 11:15 AM and states:
"Notes: All dialysis delivery systems, including backup dialysis delivery systems intended for patient use, are required to be disinfected at no more than the 72 hour interval.... "Examples of Cleaning/Disinfection Procedures and Intervals: Bleach or Peracetic Acid Disinfection Weekly, Hot Water Disinfection, and Citric Acid or Vinegar Rinse after each treatment day...6. Facilities will develop a specific Dialysis Delivery System Cleaning and Disinfection Log...Cleani



Plan of Correction:

All RN and Patient Care Tech staff will be re-educated on the importance of following infection control protocols for cleaning and disinfecting the Hansen connectors, waste containers, bedrails, infection control protocols for machine disinfection and properly maintaining the disinfection logs. This education will be completed on or before 2/10/2020.

Beginning 2/11/2020 for a period of four weeks the Hospital Services Administrator will be responsible for conducting 10 observations per week for compliance with appropriate infection control practices. These observations will include cleaning and disinfecting the Hansen connectors, waste containers, bedrails and review of machine maintenance logs. The results will be shared weekly with the Director of Nursing who will be responsible for taking immediate action to correct any identified deficiencies. At the end of the four-week time period the Directors of Nursing will determine the need for continued audits, based on performance. The Director of Nursing has ultimate accountability for this corrective action.




494.40(a) STANDARD
CARBON ADSORP-MONITOR, TEST FREQUENCY

Name - Component - 00
6.2.5 Carbon adsorption: monitoring, testing freq
Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours.

Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet.

Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L].
Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly.


Observations:


Based on a review of facility policy and procedure, direct observation of staff (RN1), and staff interview, facility staff failed to conduct total chlorine testing as per facility policy and procedure for one (1) of one (1) staff observed (RN1)..

Findings Included:

A review of facility policy and procedure conducted on January 15, 2020 at approximately 1:10 p.m. Policy 2-05-02 titled "Daily Water System Total Chlorine Monitoring" states, "Purpose: to establish that total chlorine testing is regularly performed and that patients are dialyzed only with water having chlorine/chloramine levels within the limits specified by DaVita Standards...Total chlorine testing is done on a daily basis prior to the first patient treatment and every four (4) hours until all activities that require use of dialysis quality water are completed..."

During the direct observation of a total chlorine test on January 15, 2020 at approximately 11:00 AM, RN1 removed the test strip from the testing solution and waited less than 60 seconds to compare the test strip to the color chart. Surveyor observed own personal watch while RN1 performed testing and it noted that the testing strip was kept in the testing solution for approximately 20 seconds. When surveyor asked how long he/she should wait before comparing the test strip with the color chart, RN1 stated "60 seconds." Surveyor then asked how they determine 60 seconds has passed and RN1 stated they count in their head. Surveyor did not observe any clocks with a second hand in the Water Treatment room.


An interview with Facility Administrator on January 16, 2020 at approximately 12:00 p.m. confirmed the observed procedure did no

Plan of Correction:

All RN and Patient Care Tech staff will be re-educated on the importance of properly monitoring of free-chlorine, chloramine, or total chlorine. This education will be completed on or before 2/10/2020.


Beginning 2/11/2020 for a period of four weeks the Hospital Services Administrator will be responsible for conducting 10 observations per week for compliance with appropriate monitoring of free-chlorine, chloramine, or total chlorine. The results will be shared weekly with the Director of Nursing who will be responsible for taking immediate action to correct any identified deficiencies. At the end of the four-week time period the Directors of Nursing will determine the need for continued audits, based on performance. The Director of Nursing has ultimate accountability for this corrective action.




494.40(a) STANDARD
DIALYS PROPORT-MONITOR PH/CONDUCTIVITY

Name - Component - 00
5.6 Dialysate proportioning: monitor pH/conductivity
It is necessary for the operator to follow the manufacturer's instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient.




Observations:


Based on observation, interview with the Facility Administrator, and review of policy and procedure, it was determined the facility failed to manually check the conductivity and/or the pH of dialysate for seven (7) of seven (7) hemodialysis machines prior to treatment. (Dialysis station #'s 1 (3 observations), 3 (1 observation), 5 (1 observation), 6 (2 observations).

Findings include:

Observations were made in the in patient treatment area on January 13 and 14, 2020 between the hours of 10:00 AM and 1:30 PM .

Review of policy and procedure: 1-03-02 titled,"Testing and Documenting pH, Conductivity and Temperature of Proportioned Dialysate" on January 15, 2019 at approximately 1:00 PM., states, " Purpose: To provide guidance for testing and documenting pH, conductivity and temperature of proportioned dialysate. Policy: 1. trained teammates will test pH and conductivity of final dialysate utilizing appropriate test strips and/or meters prior to each patient treatment. . . 3. Document results in the treatment record when testing is complete..."

1. At approximately 11:54 AM on January 13, 2020 at station 3, observation of conductivity and/or pH was not verified with an independent meter prior to the initiation of treatment by patient care technician #3 and #4.

2. At approximately 12:23 PM on January 13, 2020 at station # 6, observation of conductivity and/or pH was not verified with an independent meter prior to the initiation of treatment by Registered Nurse #2 and Patient Care technician #1.

3. At approximately 12:28 PM on January 13, 2020 at station #1, observation of conductivity and/or pH was

Plan of Correction:

All RN and Patient Care Tech staff will be re-educated on the importance of properly monitoring pH/conductivity with an independent meter prior to initiation of treatment. This education will be completed on or before 2/10/2020.

Beginning 2/11/2020 for a period of four weeks the Hospital Services Administrator will be responsible for conducting 10 observations per week for compliance with monitoring pH/conductivity using an independent meter prior to initiation of treatment. The results will be shared weekly with the Director of Nursing who will be responsible for taking immediate action to correct any identified deficiencies. At the end of the four-week time period the Directors of Nursing will determine the need for continued audits, based on performance. The Director of Nursing has ultimate accountability for this corrective action.



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 a review of the preventive maintenance schedule log, facility policy and an interview with the biomedical technician and administrator, the facility failed to ensure that annual preventive maintenance document was completed according to facility policy for one (1) out of five (5) hemodialysis machines reviewed (Machine 6TOS-169358).

Review of facility policy was conducted on January 15, 2020 at approximately 12:00 PM revealed, Policy "Preventive Maintenance Schedules for Equipment" states, "Purpose: to provide guidance for the dialysis delivery systems and all ancillary equipment, are maintained in good working condition and are operating according to the manufacturer's specifications...Preventive Maintenance schedules must be made in accordance with the manufacturer's recommendation.."

Review of Facililty policy 7-13-06 was conducted on January 15, 2020 at approximately 12:00 PM revealed policy titled, "Documentation of Repairs, Maintenance and Calibration on Equipment" states, "Purpose: to provide guidance for documentation of maintenance, calibration and repair on DaVita Maintained equipment...All repairs, maintenance and calibrations performed by a trained Biomed teammate on any related dialysis equipment will be documented...Each time a preventive maintenance is performed on a piece of equipment, a checklist of the necessary procedures will be filled out and initialed by the technician..."

A review of preventive maintenance logs was conducted on January 15, 2020 at 12:00 PM.

Machine 6TOS-169358 had a semi annual maintenance conducted on 5/22/19. The annual preventive maintenance was conducted on 12/16/19 which is not according to the maintenance schedule.

Per interview with the biomedical technic

Plan of Correction:

Biomedical staff will be re-educated on the importance of conducting semi-annual and annual preventive maintenance in accordance with the maintenance schedule. This education will be completed on or before 1/30/2020.

Beginning 2/1/2020 the Hospital Services Administrator will be responsible for reviewing the preventive maintenance records monthly for a period of 3 months to ensure maintenance is conducted in accordance with the maintenance schedule. These results will be shared monthly with the Director of Nursing who will be responsible for taking immediate action to correct any identified deficiencies. At the end of the three-month period the Director of Nursing will determine the frequency for review moving forward. The Director of Nursing has ultimate accountability for this corrective action.



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 clinical observations, review of facility policy and procedure, and interview with the Facility Administrator, the medical director did not ensure that staff followed policy and procedure regarding utilizing vascular access clamps during two clinical observations.

Findings include:

Review of policy titled, "Utilizing Vascular Access Clamps Procedure" on January 15, 2020 at approximately 11:30 AM states, "Only one clamp should be used at a time...Clamp may remain in place for 5-10 minutes before checking to see if bleeding has stopped. Clamp should not be left on longer than 20 minutes..."

Observation #1 occurred on January 13, 2020, at 12:43 PM at Station #2, Tech #3 applied two clamps on patient's dialysis access site. Tech #1 removed both clamps at 1:08 P.M, a total of 25 minutes. During the time the two clamps were applied no patient care techinician or nurse assessed the site to determine if bleeding had stopped.

Observation #2 occurred on January 14, 2020, at Station#5, Tech #1 who applied one clamp to patient's dialysis access site at 10:58 A.M. Tech #1 removed clamp at 11:14 A.M. Clamp was applied for a total of 16 minutes without being removed or being assessed to determine if bleeding had stopped by a patient care techinican or nurse.

Interview with the Facility Administrator on January 16, 2020 at approximately 12:00 P.M. confirmed the above findings.




















Plan of Correction:

All RN and Patient Care Tech staff will be re-educated on the importance of following the policy "Utilizing Vascular Access Clamps Procedure". This education will be completed on or before 2/10/2020.

Beginning 2/11/2020 for a period of four weeks the Hospital Services Administrator will be responsible for conducting 10 observations per week for compliance with the policy "Utilizing Vascular Access Clamps Procedure". These observations will specifically review to ensure only one clamp is used and that the clamp remains on for the appropriate amount of time as stated in the policy. The results will be shared weekly with the Director of Nursing who will be responsible for taking immediate action to correct any identified deficiencies. At the end of the four-week time period the Directors of Nursing will determine the need for continued audits, based on performance. The Director of Nursing has ultimate accountability for this corrective action.