Based on the findings of an unannounced Medicare[CORE] on-site follow-up survey conducted on February 3, 2017, BMA of Harrisburg was found to not have corrected the deficiencies cited under the requirements of 42 CFR, Part 494, Subparts A, B, C and D, Conditions for Coverage for End-Stage Renal Disease Facilities. The deficiencies were cited as the result of an on-site follow-up Medicare [CORE] survey completed on December 16, 2016.
Plan of Correction:
IC-WEAR GLOVES/HAND HYGIENE
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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.
Based on review of facility policy, patient treatment observations, and an interview with the Clinical Nurse Manager; the facility failed to ensure the staff followed infection control protocols, included but not limited to, hand hygiene/don clean gloves, for one (1) of two (2) Central Venous Catheter Exit Site Care observations (Observation#1) and one (1) of two (2) Initiation of Dialysis with Central Venous Catheter observations (Observations #1). Agency failed to address the Central Venous Exit Site Care deficiency, cited on the follow up onsite survey conducted on 12/16/16, in the stated plan of correction daily audits.
A review of the following policies 'FMS Clinical Services' 'Infection Control Overview' was conducted on February 3, 2017 at approximately 8:30 a.m. revealed the following: 'Page 3', 'Infection Control Policies' "Infection control policies include, but not limited to: *Hand hygiene." 'FMS Clinical Services' 'Hand hygiene' 'Policy: Hand Hygiene "Hands hygiene includes either washing hands with soap and water or using a waterless antiseptic alcohol based antiseptic hand rub with 60-90% alcohol content". "Before performing any invasive procedure ........ or administration of parenteral medications". "After contact with inanimate objects near the patient". " When moving from a contaminated body site to a clean body site of the same patient".
Observations conducted in patient treatment area on February 3, 2017 at approximately between 9:00 a.m. - 10:00 a.m. revealed the following:
Observation #1: On 2/3/17 between approximately 9:00 a.m. and 10:00 a.m. EMP#17 at dialysis station #15, dialysis machine #8, patient #19, did not perform hand hygiene/don clean gloves after completing Central Venous Catheter (CVC) Exit Site Care. Upon completion of CVC Exit Site Care, EMP#17 immediately began the Initiation of Dialysis with CVC, without first performing hand hygiene and donning clean gloves.
The facility Plan of Correction (stated completion date 1/20/17) submitted for the onsite survey conducted on 12/16/16, included 'CVC Treatment Initiation', 'CVC Dressing Change', 'Pre- Treatment Assessments', and RPC/Phoenix Meters Validations' as part of the stated in-service for all direct patient care staff. Documentation was provided with the Training Record showing the in-service being conducted 12/17/16 - 1/18/17. The Plan of Correction also stated "Daily Audits of all staff providing care will be conducted by the CM with assistance by the Education Coordinator for two weeks". Documentation was provided showing daily audits 12/28/16 - 1/27/17. The topics consisted of 'Initiation of Treatment using CVC and Ebeam Dialyzer' and 'Discontinuation of CVC'. The topic 'CVC Exit Site Care', which was cited as a deficiency in the 12/16/16 followup onsite survey, was not included in the daily audits.
An interview with the Clinical Nurse Manager on February 3, 2017 at approximately 10:15 a.m. confirmed the above findings and confirmed the policy is current.
Plan of Correction:
On 2/15/17 through 2/17/17 the CM will conduct daily huddle meetings for all (DPC) staff to reinforce and reeducate on the expectations and responsibilities of facility staff in adhering to the following policy:
FMS-CS-IC-II-155-090A - Hand Hygiene Policy.
FMS-CS-IC I-105-022-C Initiation of Treatment using CVC and optiflux single use beam. This also included the Central Venous exit site care.
Daily audits inclusive of hand hygiene, CVC care and treatment initiation will be conducted by the CM/designee for four weeks beginning on 2/15/17 through 3/15/17 on 10% of all staff providing CVC care/treatment initiation. One more week of audits will be done and completed by 3/22/17. All results will be presented to and reviewed by QAI and GB teams for trending at which ongoing frequency and duration will be determined.
Education records and audit results will be on file in the facility and included in the QAI/GB meeting.
If after initial education is provided staff found to be non-compliant will be provided a progressive form of corrective action.
For ongoing compliance the CM will present audit results at monthly QAI meetings
Completion date: 3/22/17
MD RESP-ENSURE ALL ADHERE TO P&P
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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;
Based on policy review, patient treatment observations, and an interview with the Clinical Nurse Manager; the facility's Medical Director failed to ensure that staff followed infection control protocols, included but not limited to, hand hygiene/don clean gloves, for one (1) of two (2) Central Venous Catheter Exit Site Care observations and one (1) of two (2) Initiation of Dialysis with Central Venous Catheter observations (Observation #1).
42 CFR 494.30 (a)(1)(i) IC-Wear gloves / Hand Hygiene (Tag 113)
An interview with the Clinical Nurse Manager on February 3, 2017 at approximately 10:15 a.m. confirmed the above findings.
Plan of Correction:
On 1/20/17, the Medical Director, Director of Operations, and Clinical Manager discussed via
the Governing Body meeting the Department of Health findings and the Medical Director's
responsibilities and accountability for the quality of medical care provided to all patients, as
defined by the "Conditions of Coverage," the "Fresenius Medical Staff Bylaws,' and the
"Fresenius Medical Director Responsibilities" with emphasis on ensuring staff adhere to all
policy and procedures.
The Medical Director will also be part of the educational process for all staff members within the facility related to:
FMS-CS-IC-II-155-090A Hand Hygiene Policy.
FMS-CS-IC-I 105 002 C Initiation of treatment using CVC and optiflux single use beam dialyzer with the emphasis on the Central Venous exit Site Care.
The Medical Director will ensure that daily audits are completed by the CM and Educational Coordinators and inclusive of 10% of the staff providing care within the facility.
The Medical Director is ultimately responsible for making sure audit results are reported to both the QAI and Governing Body Teams, as well as any disciplinary action that is taken to assure compliance with the Hand Hygiene Policy.
If the Medical director fails to have all staff members adhere to policies within the clinic, the Governing Body team will be responsible to provide education and further intervention associated with the Medical Directors position within the facility. Governing Body will meet 2/28/17 to review updates and thereafter monthly as needed. The audit will continue until 3/22/17 and a Governing Body meeting will be held to discuss all the audit findings.
Completion date 3/22/17