Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey conducted on November 2, 2020 through November 4, 2020, with an onsite visit also conducted at Fox Subacutes, Philadelphia, PA, Point Breeze Dialysis was identified to have the following standard level deficiency that was determined to be in substantial 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:
494.62(d)(3) STANDARD
ESRD Patient Orientation Training
Name - Component - 00
The dialysis facility must provide appropriate orientation and training to patients, including the areas specified in paragraph (d)(1) of this section.
Observations:
Based on a review of medical records (MR), facility policy, and an interview with the administrator, the facility did not provide appropriate training to patients regarding emergency preparedness policies and procedures of the facility for three (3) of four (4) MR's. MR # 1, 2, and 3)
Findings include:
A review of facility policy was conducted on November 4, 2020 at 10:30 AM. Policy 4-07-07 "Emergency Preparedness Drills" states: " 3. Fire Safety Drills: b. Reuqired on a QUARTERLY basis. c. One drill to be conducted on each shift of patients..."
A review of MRs was conducted on November 3, 2020 from 8:45 AM- 10:45 AM and 1:00 PM-2:30 PM.
MR #1 admission date 6/6/18 did not have a fire drill documented for the first and third quarters of 2020.
MR#2 admission date 1/22/18 did not have a fire drill documented for the first and third quarters of 2020.
MR #3 admission date 3/3/20 did not have a fire drill documented for the second and third quarters of 2020.
An interview with the administrator, regional operations managers, regional operations director, and clinical services coordinator on November 4, 2020 at 1:00 PM confirmed the above findings.
Plan of Correction:The Facility Administrator (FA) will hold a mandatory in-service for all clinical TMs on 11/13/20. The In-service will include but not be limited to reviewing Policy #4-07-01: Facility Emergency and Disaster Plan, and Policy & Procedure #4-07-07: Disaster and Emergency Preparedness Training Drills. Verification of attendance is evidenced by signature sheet. Teammates were instructed using surveyor observations of examples with emphasis on, but not limited to: 1) The FA, or designee, is responsible to provide training of the Emergency Management Plan (EMP): Patients: i. ANNUALLY 1. Facility Emergency Management Plan ii. QUARTERLY 1. Fire Safety Preparedness 2. Emergency diet, per dietitian iii. Upon admission to the facility iv. Any changes and/or updates v. Document training in patient medical record 1. Utilize Reggie form "Emergency Evacuation Acknowledgement Form". The Facility Administrator (FA) or designee will audit 100% of patients' medical records to verify that each patient has documentation that the patient was informed of emergency preparedness procedures. Any patient missing this documentation will have the education provided and documented by 12/11/20. Ongoing compliance will be monitored by 10% of medical records monthly per the medical record audit. The FA will report findings to the Medical Director in the monthly QAPI meeting, known as the Facility Health Meeting (FHM). The FA is responsible for ongoing compliance with this Plan of Correction (POC).
Completion Date: 12/11/2020
Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey conducted on November 2, 2020 through November 4, 2020, with an onsite visit also conducted at Fox Subacutes, Philadelphia, PA, Point Breeze 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 STANDARD
IC-SANITARY ENVIRONMENT
Name - Component - 00
The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas.
Observations:
Based on observation of the clinical area, facility policy and an interview with the administrator the facility did not maintain a sanitary environment that minimizes transmission of infectious agents.
Findings include:
A review of facility policy was conducted on November 4, 2020 at 10:30 AM. Policy 1-05-01 "Infection Control for Dialysis Facilities" states: "Clean areas should be separated from contaminated areas...All red disposal bags...will be removed from treatment area and placed in the labeled designated area and locked, to await transport to the licensed disposal site..."
Observation of the clinical area was conducted on 11/2/2020 from 8:45 AM-9:45 AM and 11:15 AM-1:30 PM
All biohazard trash containers throughout the clinical area were observed to be open. The lids were observed to be at a 45 degree angle to the container top. Facility staff were observed placing biohazard trash within the container without shutting the lid.
An interview with the administrator, regional operations managers, regional operations director, and clinical services coordinator on November 4, 2020 at 1:00 PM confirmed the above findings.
Plan of Correction:The FA or designee will hold a mandatory in-service for all clinical teammates on 11/13/20. In-service included but was not limited to review of Policy & Procedure # 1-05-01: Infection Control for Dialysis Facilities. Verification of attendance is evidenced by signature sheet. Teammates were instructed using surveyor observations of examples with emphasis on, but not limited to: 1) Clean areas should be separated from contaminated areas..., and 2) All red disposal bags and sharp containers that are 3/4ths full will be removed from the treatment area and placed in the labeled designated area and locked, to await transport to the licensed disposal site. The Clinical Nurse Manager (CNM) or designee will conduct infection control audits daily for 2 weeks, weekly for 2 weeks, every other week for 2 times and then monthly. FA will review results of all audits with teammates during home room meetings and with Medical Director during monthly FHM-QAPI, minutes will reflect. Facility Administrator is responsible for compliance with this plan of correction.
Completion date: 12/11/20
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 observation of the clinical area, facility policy and an interview with the facility administrator, the facility did not follow policy with regard to changing gloves and performing had hygiene for four (4) of twelve (12) observations. Observations #1-4.
Findings include:
A review of facility policy was conducted on 11/4/2020 at 11:30 AM.
Policy 1-01-01 "Infection Control for Dialysis Facilities" states:"Hand hygiene is to be performed upon entereing 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..."
Observation of the clinical area was conducted on 11/2/2020 from 8:45 AM-9:45 AM and 11:15 AM-1:30 PM
Observation #1 PCT #3 at Station #8 did not perform hand hygiene after removing dirty gloves while cleaning the dialysis machine.
Observation #2 PCT #3 at Station #9 did not perform hand hygiene after removing dirty gloves after taking the patient's temperature.
Observation #3 PCT #3 at Station #9 did not perform hand hygiene after removing dirty gloves prior to going to the nurse's station for supplies.
Observation #4 PCT #3 went from touching the dialysis machine at Station #10 to touching the dialysis machine at Station #11 without changing gloves or performing hand hygiene.
An interview with the administrator, regional operations managers, regional operations director, and clinical services coordinator on November 4, 2020 at 1:00 PM confirmed the above findings.
Plan of Correction:The FA or designee will hold a mandatory in-service for all clinical teammates on 11/13/20. In-service included but was not limited to review of Policy & Procedure # 1-05-01: Infection Control for Dialysis Facilities. Verification of attendance is evidenced by a signature sheet. Teammates were instructed using surveyor observations as examples with emphasis on, but not limited to the following: 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 contact is casual, before touching clean areas such as supplies and on exiting the patient treatment area. The CNM or designee will conduct infection control audits daily for two weeks, and then weekly for one month and document via the quantitative Infection Control Audit form. Ongoing compliance will be monitored with the facility's monthly infection control audit. The FA will report findings to the Medical Director in the monthly QAPI meeting, known as the Facility Health Meeting (FHM). The FA is responsible for ongoing compliance with this POC.
Completion date: 12/11/20
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 an interview with the Facility Administrator, it was determined, the facility failed to ensure infection control procedures were followed by cleaning and disinfecting the Hansen connectors for two (2) of sixteen (16) hemodialysis machines observed. (Dialysis machines at station #8 and 9).
Findings include:
Observation of the clinical area was conducted on 11/2/2020 from 8:45 AM-9:45 AM and 11:15 AM-1:30 PM
1. A review of policy number 1-05-01 titled, "Infection Control for Dialysis Facilities " was conducted on November 4, 2020 at approximately 11:00 AM states, " Purpose: To minmize the spread of infections or bloodborne pathogens in the dialysis facility environment. . .58. The wall box, drain and water supply lines are considered part of the dialysis delivery system and should be cleaned with 1:100 bleach as part of routine station disinfection between each patient treatment...66. Teammates will thoroughly wipe down all non-disposable items and equipment . . . with an appropriate disinfectant after every treatment. . ."
1. On November 2, 2020 at approximately 11:55 AM, it was observed that PCT #3, did not disinfect the Hansen connectors of the dialysis machine at Station #8, prior to the start of the next dialysis treatment.
2. On November 2, 2020 at approximately 12:35 AM, it was observed that RN #2, did not disinfect the Hansen connectors of the dialysis machine at Station #9, prior to the start of the next dialysis treatment.
An interview with the administrator, regional operations managers, regional operations director, and clinical services coordinator on November 4, 2020 at 1:00 PM confirmed the above findings.
Plan of Correction:The FA or designee will hold mandatory in-service for all clinical teammates on 11/13/20. In-service will include but will not be limited to: review of Policy & Procedure # 1-05-01: Infection Control for Dialysis Facilities. Verification of attendance at in-service will be evidenced by teammates signature on in-service sheet. Teammates were instructed using surveyor observations as examples with emphasis on, but not limited to the following: 1) The wall box, drain and water supply lines are considered part of the dialysis delivery system and should be cleaned with 1:100 bleach as part of routine station disinfection between each patient treatment..., and 2) Teammates will thoroughly wipe down all non-disposable items and equipment... with an appropriate disinfectant after every treatment... The FA or designee will conduct infection control audits daily x 2 weeks, weekly x 2 weeks, and then monthly. FA will review results of all audits with Teammates during home room meetings and with Medical Director during monthly FHM-QAPI, minutes will reflect. Facility Administrator is responsible for compliance with this plan of correction.
Completion date: 12/11/2020
494.30(c)(2) STANDARD
IC-CATHETERS:GENERAL
Name - Component - 00
(2) The "Guidelines for the Prevention of Intravascular Catheter-Related Infections" entitled "Recommendations for Placement of Intravascular Catheters in Adults and Children" parts I - IV; and "Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients," Morbidity and Mortality Weekly Report, volume 51 number RR-10, pages 16 through 18, August 9, 2002. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. This publication is available for inspection as the CMS Information Resource Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration (NARA). Copies may be obtained at the CMS Information Resource Center. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_regulations/ibr_locations.html
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 catheter care for one (1) of four (4) observations (OBS). OBS #2
Findings include:
A review of facility policy was conducted on November 4, 2020 at 10:30 AM. Policy 1-04-02B "Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps Procedure" states: "Upon Completion of Dialysis 28. Discard existing barrier and place a new clean, moisture proof barrier under catheter to prevent contamination. 29. Remove gloves and discard, perform hand hygiene per procedure and re-glove. 30. Clamp arterial catheter limb and blood line. Aseptically disconnect arterial blood line from arterial CVC limb. Attach 10 ml syringe...33. Remove syringes and disinfect the CVC hubs with a new alcohol prep pad for each CVC hub. Scrub the sides, threads and end of hub thoroughly with friction for 15 seconds..."
Observation of the clinical area was conducted on 11/2/2020 from 8:45 AM-9:45 AM and 11:15 AM-1:30 PM
OBS#2: PCT#2 at station 2 did not place a new clean moisture proof barrier under the catheter to prevent contamination prior to discontinuing dialysis. PCT#2 did not remove gloves and perform hand hygiene/reglove but proceded to place the 10 ml saline syringe on the arterial catheter hub, repeating process for venous catheter hub. Note that prior to placing the saline syringes onto the catheter hubs, the hubs were not centered on the barrier but were touching the patient's shirt. Old gloves were then removed with hand hygiene/regloving after accessing the catheter. PCT#2 then applied clearguard microbial end caps to the catheter hubs without disinfecting/scrubing the hubs. After applying the caps, PCT#2 scrubbed the outside of the caps with an alcohol prep pad.
An interview with the administrator, regional operations managers, regional operations director, and clinical services coordinator on November 4, 2020 at 1:00 PM confirmed the above findings.
Plan of Correction:The FA or designee will hold mandatory in-service for all clinical Teammates on 11/13/2020. In-service will include but will not be limited to review of Policy & Procedure 1-04-02B "Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps Procedure". Verification of attendance at in-service will be evidenced by teammates signature on in-service sheet. Teammates were instructed using surveyor observations as examples with emphasis on, but not limited to the following: 1) Upon completion of dialysis...Discard existing barrier and place a new clean, moisture proof barrier under catheter to prevent contamination, 2) Remove gloves and discard, perform hand hygiene per procedure and re-glove, 3) Clamp arterial catheter limb and blood line. Aseptically disconnect arterial blood line from arterial CVC limb. Attach 10 ml syringe...., and 4) Remove syringes and disinfect the CVC hubs with a new alcohol prep pad for each CVC hub. Scrub the sides, threads, and end of hub thoroughly with friction for 15 seconds.... The FA or designee will conduct CVC procedure audits daily x 2 weeks, weekly x 2 weeks, and then monthly. Facility Administrator will review results of all audits with teammates during home room meetings and with Medical Director during monthly FHM-QAPI, minutes will reflect. Facility Administrator is responsible for compliance with this plan of correction.
Completion date: 12/11/2020
494.100 STANDARD
H-IDT RESP FOR SERVICES=IN-CENTER PTS
Name - Component - 00
A dialysis facility that is certified to provide services to home patients must ensure through its interdisciplinary team, that home dialysis services are at least equivalent to those provided to in-facility patients and meet all applicable conditions of this part.
Observations:
Based on a review of medical records (MR), facility policy, quality assessment performance improvement meeting minutes and an interview with the administrator, dietitian, home training nurse, the facility did not ensure that home dialysis services are at least equivalent to those provided to in center patients for one (1) of four (4) MRs. MR#4.
Findings include:
A review of facility policy was conducted on November 4, 2020 at 10:30 AM. Policy 12-01-27 "Support Services" states: " A home dialysis training facility will furnish (either directly, under agreement or by arrangement with another ESRD facility) home dialysis support services...9. Support services will be provided on a monthly basis. 10. Clinic visits are the preferred method of routine support. 11. Clinic visits may include the following: Data collection and assessment of...Renal Dietitian assessment, Social Worker asssessment."
A review of MRs was conducted on November 3, 2020 from 8:45 AM- 10:45 AM and 1:00 PM-2:30 PM.
MR#4 admission date 6/17/2020. Patient transferred from another facility of the same dialysis company.
Per interview with the administrator on 11/4/2020 at 11:00 AM the nephrologist wanted to resume the home hemodialysis program. Interview also revealed that a home hemodialysis nurse from another company facility was hired to allocate hours to this facility in order to coordinate care for MR#4 on approximately 10/26/2020.
An interview with the home training nurse EMP#6 on 11/4/2020 at 11:45 AM states that she was hired to split time between her current facility and this one "last Monday." She also stated that she gave MR#4 her contact information and was to meet MR#4 at this facility on 11/6/2020 for clinic visit and administration of venofer (intravenous iron for anemia management).
An interview with the facility dietitian on 11/4/2020 at 9:40 AM revealed that the facility dietitian was unaware of the resumption of the home hemodialysis program at this facility and denied following MR#4. An interview with the facility social worker on 11/4/2020 at 11:00 AM denied following MR#4.
A review of the facility Quality Assessment Performance Improvement program for July and August, 2020 on 11/4/2020 at 9:30 AM revealed no input from the facility dietitian or social worker or program nurse under the home hemodialysis program. All notations/discussions in the meeting minutes were conducted by the facility administrator (in communication with the nursing, social work and dietary staff of the patient's original facility).
Further review of MR#4 progress notes from July -October, 2020 revealed that MR#4 was being followed by various members the interdisciplinary team of the original home training facility from which patient transferred.
MR#4 was not being followed by the current facility interdisciplinary team. MR#4 was accepted for treatment without a home hemodialysis training nurse and interdisciplinary team in place.
An interview with the administrator, regional operations managers, regional operations director, and clinical services coordinator on November 4, 2020 at 1:00 PM confirmed the above findings.
Plan of Correction:Nephrologist along with other Interdisciplinary team members (RD, SW, PD RN) will meet with patient on 11/18/20 for clinic visit to furnish home dialysis support services. PD RN was assigned to home patient #4 on 11/17/20 and support services will be provided on a monthly basis as evidenced by progress notes which include data collection and assessment of... Renal Dietitian assessment, Social worker assessment.
The Facility Administrator or designee held mandatory in-service starting on 11/17/20 on but not limited to 1) Policy 12-01-27 # Support Services" states:" A home dialysis training facility will furnish (either directly, under agreement or by arrangement with another ESRD facility) home dialysis support services... 9. Support services will be provided on a monthly basis. 10. Clinic visits are the preferred method of routine support. 11. Clinic visits may include the following: Data collection and assessment of...Renal Dietitian assessment, Social Worker assessment. 2) Policy 12-16-06 Continuous Improvement Program. Emphasis was placed on notations, discussions in the meeting minutes input from the facility dietitian or social worker or program nurse under the home hemodialysis program with regards to communication that the patients were being followed by IDT team when a patient transfers from original training home facility. Verification of attendance at In-service will be evidenced by TMs signature on in-service sheet.
The FA or designee will audit 100% of HHD assessments/plans of care monthly x2 to verify IDT involvement. Ongoing compliance will be monitored by 10% of medical records audited per the medical record audit. The FA will report findings to the Medical Director in the monthly FHM.
The Manger of Clinical Services (MCS) and or Regional Operations Director (ROD) will attend FHM-QAPI for three (3 months) to provide coaching on effective QAPI meeting management and to review all documentation prior to submission.
The FA is responsible for ongoing compliance with this POC.
Completion date: 12/11/2020
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