Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey conducted on September 20, 2021 through September 22, 2021, BMA of Bethlehem 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 20, 2021 through September 22, 2021, BMA of Bethlehem 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) 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 treatment area, facility policy and procedures, and an interview with the facility administrator, the facility did not follow its policy with regard to changing gloves and performing hand hygiene for three (3) of twenty (20) observations (OBS #1, OBS #3, and OBS #8).
Findings include:
A review of policy and procedure, "Hand Hygiene" on September 21, 2021 at approximately 2:00 PM revealed the following: "Hand hygiene includes either washing hands with soap and water or using a waterless alcohol-based antiseptic hand rub with 60-90% alcohol content...Hands will be...decontaminated using alcohol-based rub or by washing hands with antimicrobial soap and water when... Before and after direct contact with patients... Before performing any invasive procedure such as vascular access cannulation or administration of parenteral medications... Immediately after removing gloves... After contact with inanimate objects near the patient."
Observations of the treatment area conducted on September 20, 2021 between approximately 10:00 AM and 12:30 PM and on September 21, 2021 between approximately 10:00 AM and 11:30 AM revealed the following:
OBS #1, 9/20/2021 at 10:20 AM: PCT 1 performed hand hygiene, donned clean gloves, and placed sterile dressing over exit site of central venous catheter. Began scrubbing venous limb of central venous catheter with alcohol pad without first removing gloves, performing hand hygiene, and donning clean gloves.
OBS #3, 9/20/2021 at 11:23 AM: PCT 2 performed hand hygiene, donned clean gloves, and placed sterile dressing over exit site of central venous catheter. Began scrubbing venous limb of central venous catheter with alcohol pad without first removing gloves, performing hand hygiene, and donning clean gloves.
OBS #8, 9/21/2021 at 10:08 AM: PCT 3 performed hand hygiene, donned clean gloves in preparation of discontinuation of dialysis with central venous catheter. PCT 3 picked up patient's bag to move away from side of the chair, began disconnecting blood lines, disinfection of venous limb of central venous catheter with alcohol pad without first removing gloves, performing hand hygiene, and donning clean gloves.
An interview with the facility administrator on September 22, 2021 at approximately 2:00 PM confirmed the above findings.
Plan of Correction:
V 113
The Clinic Manager (CM) or designee re-educated all the direct patient care (DPC) staff on the following policy:
- Hand Hygiene
Special emphasis was placed on ensuring that hand hygiene is performed per policy after performing any invasive procedure. This includes when performing catheter care and after touching any inanimate objects.
The in-servicing of staff and patients will be completed by October 8, 2021, with documentation of the training on file at the facility.
The CM or designee will perform daily audits for two (2) weeks. At that time if one compliance is observed, the audits will then be completed two (2) times/week for 2 weeks to ensure that compliance is maintained. At that time, if compliance is sustained, the audits will then follow the monthly Quality Assessment Improvement (QAI) schedule. A Plan of Correction (POC) audit tool will be used for the audits.
Staff found to be non-compliant will be re-educated and referred for counseling.
The CM will review the audit results and report the findings to the QAI Committee at the monthly meeting. Sustained compliance will be monitored by the QAI committee.
Completion Date: November 5, 2021
494.30(b)(2) STANDARD
IC-ASEPTIC TECHNIQUES FOR IV MEDS
Name - Component - 00
[The facility must-]
(2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and
Observations:
Based on observations in the treatment area, a review of facility policy and procedures, and an interview with the facility administrator, the facility did not follow its policy for medication preparation for one (1) of two (2) medication preparation and administration observations (OBS #2).
Findings include:
A review of facility policy, "Medication Preparation and Administration" conducted on September 21, 2021 at approximately 2:00 PM revealed the following: "Infection Control... Perform hand hygiene prior to accessing supplies, handling vials and IV solutions and preparing or administering medications.... Cleanse the diaphragm of a vial with alcohol prior to accessing the vial. If the vial is a multidose vial, cleanse the diaphragm with a new alcohol pad each time the vial is accessed with a needle using friction and 70% alcohol."
Observations of the treatment area conducted on September 20, 2021 between approximately 10:00 AM and 12:30 PM and on September 21, 2021 between approximately 10:00 AM and 11:30 AM revealed the following:
OBS #2, 9/21/2021 at 10:15 AM: PCT 2 removed gloves, picked up vial of Heparin without performing hand hygiene. Inserted sterile needle into diaphragm of vial without cleaning with a new alcohol pad.
An interview with the facility administrator on September 22, 2021 at approximately 2:00 PM confirmed the above findings.
Plan of Correction:
V 143
To ensure compliance the CM or designee will in-service all DPC staff on policy:
- Medication Preparation and Administration
Emphasis on ensuring that hand hygiene is performed prior to accessing supplies, this includes medications. The meeting also reviewed that the diaphragm of all Intravenous (IV) medication ports are wiped with a new alcohol pad each time an IV port is accessed.
In-servicing is scheduled to be completed by October 8, 2021
Documentation of the training will be on file at the facility.
The CM or designee will perform daily audits for 2 weeks. At that time, if improved compliance is observed the audits will then be completed 2 times/week for 2 weeks. If compliance is maintained after the 2 weeks, the audits will be completed monthly following the QAI program. A POC specific auditing tool will be used for the audits.
Staff found to be non-compliant will be re-educated and counseled.
The CM will review the audit results and report the findings to the QAI Committee at the monthly meeting for ongoing guidance and sustained compliance.
Completion date: November 5, 2021
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 and procedures, medical records (MR), dialysis treatment documentation, and an interview with the facility administrator, the facility did not follow it's policy for reporting and documentation of abnormal findings pre, post, and during dialysis for two (2) of five (5) medical records reviewed (MR #1 and MR #3).
Findings include:
A review of policy titled "Patient Assessment and Monitoring" on September 22, 2021 at approximately 2:00 PM states for "During Treatment", "The Registered Nurse will assess/reassess any findings addressed pre or during treatment as needed." Policy states for "Post Treatment", "If any changes or abnormal findings in the patient's condition, vital signs, or vascular access are observed or reported by the patient, the PCT/LPN MUST report the changes in the patient condition to a registered nurse who will further assess the patient prior to discharge after the treatment." Policy states for "Monitoring During Treatment", "Report to the Nurse: systolic blood pressures greater than 180 mm/Hg; diastolic blood pressure greater than 100 mm/Hg; blood pressure less than or equal to 100 mm/Hg systolic." Policy states for Assessment Data Collection: "Obtain the patient's post weight. Ensure the post weight is consistent with the goal set of the machine."
A review of medical records and dialysis treatment records was conducted on September 21, 2021 between approximately 11:30 AM and 3:00 PM and September 22, 2021 between approximately 10:00 AM and 12:00 PM revealed the following:
MR #1, Start of Care: 7/22/2021, Dialysis treatment orders from 9/9/2021: Estimated Dry Weight (EDW): 67.5 kg; Frequency: Tuesday-Thursday-Saturday; Dialyzer: Optiflux 160NRe; Dialysate: 2.0 K, 2.5 Ca, 38 HCO3, 137 Na; Blood Flow Rate (BFR): 450; Dialysate Flow Rate (DFR): Autoflow 1.5; Treatment Duration: 4 hours.
Treatment record for 9/14/2021:
11:10 AM Pre-weight 71.70 kg; Available Weight (AW) 4.2 kg; Total Weight to Remove (TWR) 2.0 kg. Note from RN stating, "denies sob/n/v/b/d uf goal as tol."
13:25 PM Post-weight 70.20 kg; Weight Change -1.50 kg; Hours on 02:08
No post-assessment from RN addressing shortened treatment time, documentation acknowledging the target weight was not attained with an assessment of the reason for not attaining it.
MR #3, Start of Care 8/12/2020, Dialysis treatment orders from 2/12/2021: EDW 70 kg; Frequency: Monday-Wednesday-Friday; Dialyzer: Optiflux 180NRe; Dialysate: 2.0 K, 2.5 Ca, 36 HCO3, 137 Na; BFR: 450; DFR: Autoflow 1.5; Treatment Duration: 4 hours.
Treatment record for 9/6/2021:
07:57 AM B/P 180/85 documented by PCT without comments.
08:28 AM B/P 184/91, "Denies complaints; access visible" documented by PCT.
08:58 AM B/P 190/88, "Denies complaints" documented by PCT.
09:16 AM Hours on 03:02.
No follow-up note addressing blood pressures from RN after PCT documentation, or post-assessment from RN addressing systolic blood pressures greater than 180 mm/Hg and shortened treatment time.
Treatment record for 9/13/2021:
08:26 AM B/P 184/77 documented by PCT without comments.
08:55 AM B/P 182/86, "Denies complaints; yellow amp" documented by PCT.
09:30 AM B/P 196/86, "Denies complaints; UF off; treatment discontinued without problem; bfr to 150; cleared well, yellow amp" documented by PCT.
09:29 AM Hours on 03:01.
No follow-up note addressing blood pressures from RN after PCT documentation, or post-assessment from RN addressing systolic blood pressures greater than 180 mm/Hg and shortened treatment time.
Treatment record for 9/20/2021:
06:45 AM Pre-weight 75.30 kg, AW 5.3 kg, TWR 1.8 kg.
06:58 AM B/P 191/90, "Green AMP light; denies complaints" documented by PCT.
09:54 AM B/P 188/97, "Denies complaints; UF off; treatment discontinued without problem; bfr to 150, cleared well, pt stable" documented by PCT.
09:52 AM Post-weight 73.90 kg, Weight Change -1.40 kg, Hours on 03:02.
No follow-up note addressing blood pressures from RN after PCT documentation, or post-assessment from RN addressing systolic blood pressures greater than 180 mm/Hg, shortened treatment time, and documentation acknowledging the target weight was not attained with an assessment of the reason for not attaining it.
An interview with the facility administrator on September 22, 2021 at approximately 2:00 PM confirmed the above findings.
Plan of Correction:
V 543
To ensure compliance the clinic manager (CM) or designee will in-service all the direct patient care (DPC) staff on policy:
- Patient Assessment and Monitoring
Emphasis will be placed on ensuring that a follow up note for any treatment interventions out of range vital signs (VS) are documented by the Registered Nurse (RN) either in the clinical notes or in the discharge note. The meeting will also address that any shortened treatments, or dry weights not attained also need to be documented with the assessment and reasons.
Inservicing will be completed by October 8, 2021. All training documentation is on file at the facility.
The CM or designee will perform daily audits for 2 weeks. At that time, if improved compliance is observed the audits will then be completed 2 times/week for 2 weeks. If compliance is maintained after the 2 weeks, the audits will be completed monthly following the QAI program. A POC specific auditing tool will be used for the audits.
Staff found to be non-compliant will be re-educated and counseled.
The CM will review the audit results and report the findings to the QAI Committee at the monthly meeting for ongoing guidance and sustained compliance.
Completion date: November 5, 2021
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