Initial Comments:
Based on the findings of an on-site, unannounced complaint investigation survey conducted on June 8, 2022, Carlisle Regional Dialysis Center, was identified to have the following standard level deficiencies that were determined to be in compliance with the following requirements of 42 CFR, Subparts A, B, C, and D: Conditions for Coverage for End-Stage Renal Disease Facilities.
Plan of Correction:
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 review of facility policies/procedures, patient treatment area observations and interview with the group facility Administrator (EMP# 1), charge nurse (EMP# 2) and patient care technician (EMP# 3), it was determined the facility failed to ensure facility staff followed medication preparation and labeling protocols, including but not limited to, ensuring staff label multi-use vials for one (1) of three (3) observations (Observation #1); and failed to ensure drawn medication labels included time, date and initials for one (1) of three (3) observations (observation # 2) and failed to ensure facility staff only prepared medication for the current shift for one (1) of three (3) observations. (Observation # 3)
Findings include:
Review of the ' Medication Policy: 1-06-01 ' section, " POLICY " on June 8, 2022 at approximately 10:00 a.m. states, " ...3. Medications administrated during the hemodialysis treatment are given via the medication infusion line whenever possible. Refer to policy: Preparation and Administration of Intravenous Epogen for specific guidance on Epogen administration ....16. Medication preparation should be performed only for the current shift of patients, i.e., do not prepare medications for more than one shift of patients ...20 ....If the medication is not immediately administered or is to be administered by another teammate, the medication must be labeled with the patient name, name of medication, date, time prepared and dose and initials of the teammate preparing the medication ... "
Review of the ' Preparation and Administration of Intravenous Epogen with All Dialyzer Types: 1-06-04A ' section, " Procedure " June 8, 2022 at approximately 10:15 a.m. states, " ...14..If opening a multi-dose vial for the first time, label with the initials of the person opening the vial and the expiration date ... "
Observations conducted in the patient treatment area on June 8, 2022 between approximately 9:00 a.m. and 11:00 a.m. revealed the following:
Observation #1: At the medication counter surveyor observed, one (1) Epogen 20, 000 units/2 mL (milliliters) vial and one (1) Hectorol 4 mcg (micrograms)/2 mL vial that had been accessed with no label on it to note the time, date and initials of the individual that had access the bottle and when. On June 8, 2022, at approximately 9:05 a.m. surveyor asked EMP# 2 how long these vials have been sitting out here and why they were unlabeled with the appropriate label. EMP# 2 replied, " I am the only nurse here, so I know when they were opened. We are short staffed. " EMP# 2 proceeds to write the labels to put on the vials. The surveyor explained that the surveyor did not know that and that the medication had to be discarded due to not being previously labelled and having no way of knowing for sure. EMP# 2 stated, " So the medication has to be discarded? " The surveyor replied, " Yes. " EMP# 2 stated, " These are expensive medications, there goes taxpayer dollars. "
Observation #2: Surveyor observed the following on the medication counter:
- For Patient # 1.: one (1) filled syringe of Heparin Port Bolus/Infusion <1125> units - Label missing date, time, and initials of teammate who prepared the medication; and one (1) filled syringe of Heparin Pork Bolus 2600 units- Label missing date, time, and initials of teammate who prepared the medication.
- For Patient # 2.: one (1) filled syringe Heparin Pork Bolus/Infusion <2000> units- Label missing date, time, and initials of teammate who prepared the medication; and one (1) Heparin Pork Bolus 400 units- Label missing date, time, and initials of teammate who prepared the medication.
- For Patient # 3.: one (1) filled syringe of Heparin Bolus/Infusion <2100> units- Label missing date, time, and initials of teammate who prepared the medication; and one (1) filled syringe of Heparin Pork Bolus 2600 units- Label missing date, time, and initials of teammate who prepared the medication.
- For Patient # 4: one (1) filled syringe of Heparin Port Bolus/Infusion <1000> units- Label missing date, time, and initials of teammate who prepared the medication; and one (1) filled syringe of Heparin Pork 2800 units- Label missing date, time, and initials of teammate who prepared the medication.
- For Patient # 5: one (1) filled syringe of Heparin Pork Heparin/Infusion <900> units- Label missing date, time, and initials of teammate who prepared the medication; and one (1) filled syringe of Heparin Pork Bolus 600 units- Label missing date, time, and initials of teammate who prepared the medication.
- For Patient # 6: one (1) filled syringe of Heparin Bolus/Infusion <1350> units- Label missing date, time, and initials of teammate who prepared the medication; and one (1) filled syringe of Heparin Pork Bolus 1600 units- Label missing date, time, and initials of teammate who prepared the medication.
All sets of syringes were in a separate little plastic bags per patient names.
On June 8, 2022, at approximately 9:13 a.m. surveyor asked EMP # 3 why these were prepped without all the proper label information on them. EMP# 3 replied, " I was doing that and then shift change happened and we are short staffed. I was going to come back and write the date, time and initials. " Surveyor asked EMP# 3 if she was aware what the medication policy stated regarding medication preparation and EMP # 3 replied, " I actually don ' t. "
Observation #3: After surveyor reviewed the facility policies/procedures, surveyor asked EMP# 2 if the patients that had the filled syringes were from first shift or second shift. EMP# 2 replied, All the syringes were for second shift patients. Surveyor asked when second shift is starting. EMP # 2 replied, " Now. "
An interview with EMP# 1 on June 8, 2022 at approximately 11:00 a.m. confirmed the above findings.
Plan of Correction:05285 Carlisle PA CMS Comp 060822
POC Completion Date: 06/24/22
V715
A Governing Body meeting was held on 6/24/2022, with the Medical Director, Facility Administrator, Director of Nursing and Regional Operations Director to review the results of the survey ending on 06/08/22. The Governing Body reviewed Policy COMP-DD-017 "Medical Director Qualifications and Responsibilities" with the Medical Director, who acknowledges that he/she is responsible to ensure the facility teammates are trained and follow policy and procedure, with emphasis on but not limited to medication preparation, labeling and medication administration. Deficiencies identified need to be corrected timely with the support of the facility team. Plans of correction have been developed and initiated to correct identified deficiencies and to sustain compliance.
The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 06/08/22. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-06-01 "Medication Policy" with emphasis on but not limited to: 1) Medications containing a preservative must be discarded 28 days after opening or accessed... Each vial is labeled with the initials of the person opening the vial and the expiration date. 2) ...If the medication is not immediately administered or is to be administered by another teammate, the medication must be labeled with the patient name, name of medication, date, time prepared, dose and initials of teammate preparing the medication. 3) Medication preparation should be performed only for the current shift of patients, i.e., do not prepare medications for more than one shift of patients. Verification of attendance is evidenced by teammate's signature on the in-service sheet. The Facility Administrator or designee will conduct medication preparation and administration audits to verify compliance with policy starting on 06/17/22: daily on treatment days for two (2) weeks, starting then weekly for two (2) weeks. Ongoing compliance will be addressed with monthly infection control audit. Instances of non-compliance will be addressed immediately. The Medical Director will review progress of teammate education, results of all audits, and adherence to this plan of correction during monthly Quality Assessment Performance Improvement meetings known as the Facility Health Meeting. The Facility Administrator will report progress, as well as any barriers to maintaining compliance, with supporting documentation included in the meeting minutes. Action plans will be evaluated for effectiveness, new plans developed as applicable to achieve compliance with teammate adherence to policy and procedure. The Facility Administrator is responsible for compliance with this plan of correction.
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