QA Investigation Results

Pennsylvania Department of Health
COTTMAN KIDNEY CENTER
Health Inspection Results
COTTMAN KIDNEY CENTER
Health Inspection Results For:


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Initial Comments:

Based on the findings of an onsite unannounced Medicare recertification survey conducted on September 25, 2018 through September 28, 2018, Cottman Kidney Center 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 September 25, 2018 through September 28, 2018, Cottman Kidney Center 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(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/procedure and an interview with facility staff, the facility did not ensure proper disinfection of the central venous catheter (CVC) connections for two (2) of two (2) observations. Observation # 5 and 6.

Findings include:

A review of facility policy was conducted on 9/28/18 at 9:00 AM.
Procedure 1-04-02A "Central Venous Catheter (CVC) Procedure" states; "Upon Completion of Dialysis...44. Scrub CVC limbs at blood line connection with LARGE alcohol prep pad, one (1) per limb for 60 seconds..."

Observation of the clinical area was conducted on 9/25/18 from 10:00 AM- 12:30 PM and 9/26/18 from 9:45 AM- 12:30 PM.

Observation #5 station #4 on 9/25/18 at 10:51 AM: Upon completion of dialysis, the PCT did not scrub the CVC limbs at blood line connection with an alcohol prep pad, one per limb for 60 seconds. The limbs were not scrubbed until after reinfusion of the extracorporeal blood (after the opening of the clamped CVC lumens) and were scrubbed for approximately 10 seconds.

Observation #6 station#12 on 9/26/18 at 10:32 AM: Upon completion of dialysis, the PCT did not scrub the CVC limbs at blood line connection with an alcohol prep pad, one per limb for 60 seconds. The limbs were not scrubbed until after reinfusion of the extracorporeal blood (after the opening of the clamped CVC lumens) and were scrubbed for approximately 10 seconds.

An interview with the facility administrator, clinical coordinator, regional director, and clinical services specialist on 9/28/18 at approximately 1:15 PM confirmed the above findings.









Plan of Correction:

V0146
The Facility Administrator (FA) or designee will hold mandatory in-service for all clinical teammates (TMs) on October 15 and 16, 2018. In-service will include but not limited to review of Policy & Procedure 1-04-02A: Central Venous Catheter (CVC) Care procedure emphasizing scrubbing the CVC limbs at bloodline connection with LARGE alcohol prep pad, one (1) per limb for sixty (60) seconds. 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, weekly for two (2) weeks, and then monthly during internal infection control audits (Clean Sweep). Instances of non-compliance will be addressed immediately. The FA will review results of all audits with TMs during homeroom meetings and with medical Director during monthly Facility health Meeting (FHM-QAPI) with supporting documentation included in the meeting minutes. The FA is responsible for compliance with this plan of correction.



494.60 STANDARD
PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT

Name - Component - 00
The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment.


Observations:


Based on observation of the clinical area, facility policy and an interview with facility staff, the facility did not provide patients and staff a safe and functional environment by not encouraging patients to wash their hands after treatment before leaving the treatment area, allowing vascular accesses to be covered and invisible to staff, by storing nutritional supplements in a contaminated area (laboratory), and by not cleaning a water spill in a timely fashion.

Observation of the clinical area was conducted on 9/25/18 from 10:00 AM- 12:30 PM and 9/26/18 from 9:45 AM- 12:30 PM.

A review of facility policy was conducted on 9/28/18 at 9:00 AM.

Policy 1-05-01 "Infection Control for Dialysis Facilities" on states: "Teammate/Patient Safety 37. "Patients are encouraged to wash their hands and access extremity upon entering the treatment area prior to the initiation of dialysis and wash their hands after treatment before leaving the treatment area. Individually wrapped antimicrobial hand wipes should only be used when a patient is unable to get to a sink to wash their access site...
49. Clean areas should be clearly designated for the preparation, handling, storage of medications, and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Teammates will not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled...
58. All containers used to soak clamps, or other non-disposable equipment will be cleaned and disinfected at the conclusion of the
day..."

Policy 1-03-20 "Patient Fall Prevention Policy and Program" states: "Keep spills wiped up...Place "Wet Floor" signs on any area on the floor that is wet."

Policy 1-04-01E "AV Fistula or Graft Cannulation with Nipro or Medisystems Safety Fistula Needles (SFN) and Administration of Heparin"states: ...32. Access sites are to remain visible at all times during treatment..."

During the observational tour on 9/25/18 at 10:10 AM nine bottles of Liquacel protein drink were observed to be located on a shelf a over the sink in the laboratory area for processing blood specimen. 3 boxes of Nova Source Renal-vanilla, 3 bottles of Liquacel, 3 bottles of Liquacel were located in the cabinet over the centrifuge in the laboratory area.

During observations on 9/25/18 and 9/26/18 at approximately 11:00 AM both days, it was noted that the bleach/water levels in containers used to soak used access clamps did not cover the clamps that were soaking within.

It was observed on 9/26/18 at 10:46 AM that the patients at stations # 17 and #1 did not wash their hands after treatment prior to leaving the clinical area. The patient who dialyzed in the isolation room was also observed washing hands using the sink in the scale area outside the isolation room.

It was also observed on 9/26/18 at 10:00 AM that the patients located at stations #7, 9, and 12 had their dialysis accesses covered by a blanket.

An interview with the facility administrator, clinical coordinator, regional director, and clinical services specialist on 9/28/18 at approximately 1:15 PM confirmed the above findings.






Plan of Correction:

V0401
The nine (9) bottles of Liquacel protein, over the sink in the laboratory area, the three (3) boxes of Nova Source Renal-vanilla, and three (3) bottles of Liquacel located in the cabinet over the centrifuge in the laboratory area were removed from the laboratory area and will be stored in the medication room. The Facility administrator (FA) conducted a mandatory In-service October 16, 2018 with Inventory Tech who receives and stores supplies and all teammates . In-service include but not limited to Policy 1-05-01 Infection Control #49 Clean areas should be clearly designated for the preparation ,handling, storage of medication , and unused supplies and equipment. Teammates will not handle and store medications or clean supplies in the same or an adjacent area to where used equipment or blood samples are handles. The FA or designee will conduct inventory audit using SCAT tool daily for two (2) weeks, weekly for two (2) weeks, and then monthly ensuring Nutritional supplements are not stored in contaminated area. Instances of non-compliance will be addresses immediately. The FA will review results of all audits with TMs during home room meetings and with Medical Director during monthly Facility Health Meeting (FHM-QAPI) with supporting documentation included in the meeting minutes. FA is responsible for compliance with this plan of correction.

The FA or designee conducted mandatory in-service for all clinical TMs on October 15 and 16, 2018. In-service will include but was not limited to: a review of Policy 1-05-01 Infection Control for Dialysis Facilities and Policy 1-04-01E AV Fistula or Graft Cannulation with Nipro or Medisystems Safety needles (SFN) and Administration of Heparin with emphasis on but not limited to: 1) Hemostats (blood line clamps) should be in the open position and fully submerged in an appropriate disinfectant solution; 2) Patients are encouraged to wash their hands and access extremity upon entering the treatment area prior to the initiation of dialysis and wash their hands after treatment before leaving the treatment area. Individually wrapped antimicrobial hand wipes should only be used when a patient is unable to get to a sink to wash their access site; 3) patients dialyzing in the isolation room will perform hand hygiene prior to leaving the isolation room/area. TMs will offer alcohol based hand rubs or individually wrapped antimicrobial hand wipes to isolation patients prior to leaving the isolation station or area; 4) access sites are to remain visible at all times during treatment. Verification of attendance at in-service will be evidenced TMs signature on in-service sheet. In addition, the TMs will re-educate the patients on the importance of access visibility and provide educational sheet on uncovering access by October 13, 2018. Acknowledgement of education will be placed in patient medical record. PCT's and RN's reviewed DaVita's Patient Vascular Access Education with all patients from October 3 to 8, 2018. Education included handout for Renal Network 4 You have a Voice / Patient and Visitors Clean Hands Count. Effective September 29, 2018 team is encouraging all patients to wash their access prior to the start of dialysis. Those patient who refuse will be given PAWS to clean access area prior to betadine and alcohol pads. At the end of patients treatment TMs will put alcohol based hand gel in patient's hands as they exit their chair / treatment area. Also included in the education was a review of Policy 1-04-01E AV Fistula or Graft Cannulation with Nipro or Medisystems Safety needles (SFN) and Administration of Heparin emphasizing access sites are to remain visible at all times during treatment. The Clinical Manager will re-educate the patients emphasizing the importance of access visibility and provide educational sheet on uncovering access by October 13, 2018. Acknowledgement of education will be placed in patient medical record. The FA or designee will conduct observational audits every shift for one (1) week then daily for one (1) week then weekly for four (4) weeks. Instances of non-compliance will be addressed immediately. The FA will review results of audits with the TMs during homeroom meetings and with the Medical Director during monthly FHM-QAPI with supporting documentation in the meeting minutes. The FA is responsible for compliance with this plan of correction.



494.110 STANDARD
QAPI-COVERS SCOPE SERV/EFFECTIVE/IDT INVOL

Name - Component - 00
The dialysis facility must develop, implement, maintain, and evaluate an effective, data-driven, quality assessment and performance improvement program with participation by the professional members of the interdisciplinary team. The program must reflect the complexity of the dialysis facility's organization and services (including those services provided under arrangement), and must focus on indicators related to improved health outcomes and the prevention and reduction of medical errors. The dialysis facility must maintain and demonstrate evidence of its quality improvement and performance improvement program for review by CMS.



Observations:


Based on a review of the facility quality assessment program improvement (QAPI) program and an interview with facility staff, the facility did not consistently include the home training nurse for peritoneal dialysis in its meetings.

Findings include:

A review of the facility QAPI program meeting minutes from January, 2018 through August, 2018 was conducted on 9/27/18 at 11:00 AM.

Although peritoneal health outcomes data was included in the meeting minutes,
the home therapy nurse for the peritoneal dialysis program was not present at the following meetings: 4/4/18, 5/15/18, 7/25/18 and 8/30/18.
An interview with the clinical services specialist on 9/27/18 at 12:00 indicated that the home therapy nurse was on a leave of absence. The program is covered by the area home therapy nurse. A new home therapy nurse is currently hired and is in training.


An interview with the facility administrator, clinical coordinator, regional director, and clinical services specialist on 9/28/18 at approximately 1:15 PM confirmed the above findings.







Plan of Correction:

V0626
The FA or designee held an in-service for Facility Health Team on October 1, 2018 reviewing Policy 1-14-06: Continuous Quality Improvement program emphasizing all members of the IDT including but not limited to Medical Director, FA, Renal Dietitian, Social Worker, and BMT must attend monthly FHM-QAPI emphasizing the attendance of home therapy nurse for peritoneal dialysis. All members will be notified that if they are unable to attend FHM-QAPI in person that they may attend telephonically, or they may report off to a committee member and designate another person from his/her discipline to attend in their absence. The dialysis facility must develop, implement, maintain and evaluate an effective, data-driven quality assessment and performance improvement program with participation by the professional members of the interdisciplinary team. The program must reflect the complexity of the dialysis facility's organization and services (including those services provided under arrangement), and must focus on indicators related to improved health outcomes and the reduction of medical errors. The dialysis facility must maintain and demonstrate evidence of its quality improvement program for review by CMS. Verification of attendance at in-service will be evidenced by TMs signature on in-service sheet. The Clinical Service Specialist (CSS) and/or Regional Operation Director (ROD) or Group Facility Administrator (GFA) will attend FHM-QAPI or review meeting minutes for the next three (3) months to verify compliance evidenced by FHR sign-in sheet. The FA on behalf of the Governing Body is responsible for compliance with this plan of correction.