Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey conducted on July 28, 2020 through July 30, 2020 Dialysis Center at Oxford Court 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 July 28, 2020 through July 30, 2020, Dialysis Center at Oxford Court 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(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 a observation, facility policy and procedure and an interview with the administrator, the facility failed to ensure that the registered nurse demonstrate compliance with current asceptic techniques when dispensing and administering medication from vials for two (2) of two (2) observations.
Findings include:
A review of procedure1-06-01A "Preparation and Administration of Parenteral Medications (Non-EPO, non -Parsabiv) With All Dialyzer Types was conducted on July 29, 2020 at 12:45 PM and states: "2. Prior to each medication preparation, disinfect medication preparation surface area with 1:100 bleach solution and disposable wipes...7. If the medication is in a vial, remove the vial cap, and clean vial stopper with an alcohol prep pad. A new alcohol prep pad is used prior to each time a vial is entered."
Observations of the treatment area were conducted on July 28, 2020 from 8:45 AM -12:30 PM and July 29, 2020 from 8:50 AM -11:30 AM.
Prior to Observations 1 and 2, the registered nurse did not wipe the medication preparation surface with 1:100 bleach solution.
Observation #1 The registered nurse did not clean the multidose vial stopper with an alcohol prep pad prior to entering vial to withdraw Epogen (anemia medication) for a second administration (the unopened vial was wiped with the alcohol prep pad for the first medication withdrawal).
Observation #2 The registered nurse did not clean the multidose vial stopper with an alcohol prep pad prior to entering vial to withdraw Hectorol (vitamin D analogue medication) for a second administration (the unopened vial was wiped with the alcohol prep pad for the first medication withdrawal).
An interview with the administrator on July 30, 2019 at 11:40 AM confirmed the above findings. The administrator stated that the medication preparation surface is wiped with 1:100 bleach prior to the start of each patient shift.
Plan of Correction:V143
The Facility Administrator (FA) held mandatory in-service (s) for all Clinical Teammates (TMs) starting on 7/30/2020. Survey observations were reviewed. Education included but was not limited to a review of Policy 1-06-01 Medication Policy and 1-06-01A Preparation and Administration of Parenteral Medications (Non-EPO, Non-Parsabiv) with All Dialyzer Types with the emphasis on but not limited to: 1) disinfection of the medication preparation surface area with 1:100 bleach solution and disposable wipes must be performed prior to each medication preparation. 2) TMs will remove the vial cap, and clean vial stopper with an alcohol prep pad. A new alcohol prep pad is used prior to each time a vial is entered. Verification of attendance is evidenced by TM signature on in-service sheet. The FA of designee will conduct observational audits for medication preparation and administration daily for two (2) weeks then weekly for two (2) weeks then monthly during internal infection control audits. Instances of non-compliance will be addressed immediately. The FA will review the results of the audits with TMs during homeroom meetings and with the Medical Director during monthly Facility Health Meetings (FHM-QAPI) with supporting documentation included in the meeting minutes. The FA is responsible for compliance with this 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, facility policy and procedure and an interview with the administrator, the facility did not follow its policy for the initiation of dialysis with a central venous catheter for two (2) of two (2) observations. Observation #1 and #2.
Findings include:
A review of procedure 1-04-02A "Central Venous Catheter Procedure" was conducted on July 29, 2020 at 12:45 PM and states: "8. Remove old dressing and discard. 9. Observe site...10. Observe CVC (central venous catheter) exit site...11. Clamp both arterial and venous catheter limbs. 12. Remove gloves and discard. Perform hand hygiene and reglove...18. Place sterile 2x2 gauze over the catheter exit site...20. Remove gloves and discard, perform hand hygiene per procedure and re-glove..29. Rationale-Excessive pressure should be avoided since such force could cause rupture of the catheter or expulsion of a clot into the circulation..."
Observations of the treatment area were conducted on July 28, 2020 from 8:45 AM -12:30 PM and July 29, 2020 from 8:50 AM -11:30 AM.
Observation #1 PCT 2 during initiation of dialysis procedure for the patient at machine #1 conducted the following: after connecting sterile saline syringes to instill to each port, withdrew and reinfused blood three times using force. A step that is not included in the procedure cited above.
Observation #2 PCT 4 during initiation of dialysis procedure, removed gloves after connecting sterile syringes to the patient at machine #5, did not perform hand hygiene prior to donning clean gloves. The PCT removed gloves after discarding the old dressing for the patient at machine #5, did not perform hand hygiene prior to donning clean gloves.
An interview with the administrator on July 30, 2020 at 11:40 AM confirmed the above findings.
Plan of Correction:V146
The FA held mandatory in-service (s) for all Clinical TMs starting on 7/30/2020. Survey observations were reviewed. Education included but was not limited to a review of Policy 1-04-02A Central Venous Catheter (CVC) Procedure with emphasis on but not limited to: 1) after removing and discarding old dressing, remove gloves and discard. Perform hand hygiene per procedure and re-glove. 2) Aspirate an amount greater than the catheter limb lumen, generally about 5 ml from each limb. 3) Aseptically discard syringe containing indwelling solution from arterial limb and attach a saline filled syringe. Repeat step for venous limb. 3) Unclamp and flush each limb with saline and re-clamp. Excessive pressure should be avoided since such force could cause rupture of the catheter or expulsion of a clot into the circulation. Verification of attendance is evidenced by TM signature on in-service sheet. The FA or designee will conduct observational audits for CVC care during initiation of treatment daily for two (2) weeks then weekly for two (2) weeks then monthly for two (2) months. Instances of non-compliance will be addressed immediately. The FA will review the results of the audits with TMs during homeroom meetings and with the Medical Director during monthly FHM-QAPI with supporting documentation included in the meeting minutes. The FA is responsible for compliance with
V146
The FA held mandatory in-service (s) for all Clinical TMs starting on 7/30/2020. Survey observations were reviewed. Education included but was not limited to a review of Policy 1-04-02A Central Venous Catheter (CVC) Procedure with emphasis on but not limited to: 1) after removing and discarding old dressing, remove gloves and discard. Perform hand hygiene per procedure and re-glove. 2) Aspirate an amount greater than the catheter limb lumen, generally about 5 ml from each limb. 3) Aseptically discard syringe containing indwelling solution from arterial limb and attach a saline filled syringe. Repeat step for venous limb. 3) Unclamp and flush each limb with saline and re-clamp. Excessive pressure should be avoided since such force could cause rupture of the catheter or expulsion of a clot into the circulation. Verification of attendance is evidenced by TM signature on in-service sheet. The FA or designee will conduct observational audits for CVC care during initiation of treatment daily for two (2) weeks then weekly for two (2) weeks then monthly for two (2) months. Instances of non-compliance will be addressed immediately. The FA will review the results of the audits with TMs during homeroom meetings and with the Medical Director during monthly FHM-QAPI with supporting documentation included in the meeting minutes. The FA is responsible for compliance with this plan of correction.
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