Fmc - Bma of Burlington Inc.

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 32003 Based on policy review, observations, medical record reviews, and interviews, the facility staff failed to provide personal protective equipment for chairside extended stay visitors for 3 of 3 patients (#13, #14, and #15) for 2 of 2 in-center treatment area observations. Findings included: Review on January 11, 2024 of the facility’s policy, “Visitor Policy” published February 6, 2023 revealed, “Purpose...Responsibility...Background...Visitors in the Patient Care Area ...Request for Extended Visits ...Children in the Facility ...Visitors Assisting with Care [space] ...PPE will be provided along with instructions for proper use if there is a likelihood that the visitor may be exposed to blood borne pathogens during the time that he/she is in the treatment area. ...” 1. Observation on January 9, 2024 from 2:45 PM to 3:30 PM (45-minutes) revealed, Patient #13 was located in Bay E/F as dialysis treatment was underway and a visitor was at the chairside. Observation revealed the visitor was not wearing PPE. Open medical record review on January 11, 2024 revealed in October 2021, Patient #13 was admitted to the in-center facility and on July 4, 2023, the patient had a special attention order for a visitor to be at the chairside for every treatment. Interview on January 11, 2024 at about 12 noon with the Clinical Manager revealed visitors that have extended stays in the in-center treatment area should wear PPE. 2. Observation on January 11, 2024 from 10:15 AM to 11:20 AM (65-minutes) revealed Patient #14 and #15 were located in Bay B1/B2 as dialysis treatment was underway. Each patient had one visitor at the chairside. At some point, the visitor for Patient #15 went to the chairside of Patient #14 and began to have an extended conversation with that patient’s visitor. Observation revealed, as staff began treatment discontinuation for Patient #14, it was difficult for staff because of the two visitors that were at the chair side and the visitors were not wearing PPE. Observation revealed the two chairside visitors were not wearing PPE during dialysis treatment and at initiation of treatment discontinuation. Open medical record review on January 11, 2024 revealed in November 2018, Patient #14 was admitted to the in-center facility and on August 1, 2023, the patient had a special attention order for a visitor to be at the chairside for every treatment. Open medical record review on January 11, 2024 revealed in February 2018, Patient #15 was admitted to the in-center facility and on August 1, 2023, the patient had a special attention order for a visitor to be at the chairside for every treatment. Interview on January 11, 2024 at 11:20 AM with the visitor for Patient #15 revealed, the visitor should be at the chairside of Patient #15 and not at Patient #14 due to the interference with patient care. Interview failed to reveal facility staff offered the visitor PPE. Interview on January 11, 2024 at about 12 noon with the Clinical Manager revealed visitors that have extended stays in the in-center treatment area should wear PPE.”

“MIXING SYSTEMS-PERM RECORD/VERIF TEST CFR(s): 494.40(a) 5.4.4.1 Mixing systems: perm record/verification testing In addition to container labeling, there should be permanent records of batches produced. These records should include the concentrate formula produced, the volume of the batch, the lot numbers of powdered concentrate packages, the manufacturer of the powdered concentrate, the date and time of mixing, any test results, the person performing the mixing, the person verifying mixing and test results, and the expiration date (if applicable). 6.4.1 Mixing systems Acid and bicarbonate concentrates may be tested by using conductivity or by using a hydrometer. Concentrates should not be used or transferred to holding tanks or distribution systems until all tests are completed. The test results and verification that they meet all applicable criteria should be recorded and signed by the individuals performing the tests. This Standard is not met as evidenced by: 32003 Based on policy review, granuflo mixing log review, quality meeting minutes review, and staff interviews, the facility staff failed to ensure a second staff member verified granuflo batch preparation results prior to transferring to the holding tank for patient use for 2 of 2 months (November and December 2023). Findings included: Review on January 11, 2024 of the facility’s policy, “Acid Concentrate Mixing and Handling: Dry Acid Dissolution Unit” published September 5, 2023 revealed, “Purpose ...Introduction ...Responsibility ...Acronyms and Definitions ...Manufacturer Instructions for Use (IFU) ...General ...Self-Designed Systems ...Quality Assurance Testing ...Batch Records [space] Each batch record must be reviewed and verified as complete by two qualified staff members at the end of batch preparation. ...” Review on January 10, 2024 of the November and December 2023 granuflo logs revealed: 1. on October 27, 2023 at 4:40 AM a technician prepared a batch of 2201 granuflo mix. At 5:58 AM, the mixture was transferred to the holding tank without a second staff member verifying the test results. 2. on November 1, 2023 at 11:54 AM, a technician prepared a batch of 2251 granuflo mix. At 1:30 PM, the mixture was transferred to the holding tank without a second staff member verifying the test results. 3. on November 2, 2023 at 10:10 AM and 1:18 PM, a technician prepared a batch of 2201 granuflo mix. At 1:00 PM and 3:50 PM, the mixtures was transferred to the holding tank without a second staff verifying the test results. 4. on November 8, 2023 at 1:31 PM, a technician prepared a batch of 2201 granuflo mix. At 2:00 PM, the mixture was transferred to the holding tank without a second staff member verifying the test results. 5. on November 10, 2023 at 11:00 AM, a technician prepared a batch of 2202 granuflo mix. At 2:00 PM, the mixture was transferred to the holding tank without a second staff member verifying the test results. 6. on November 20, 2023 at 10:00 AM, a technician prepared a batch of 2201 granuflo mix. At 2:30 PM, the mixture was transferred to the holding tank without a second staff member verifying the test results. 7. on November 22, 2023 at 10:00 AM, a technician prepared a batch of 2201 granuflo mix. At 2:00 PM, the mixture was transferred to the holding tank without a second staff member verifying the test results. 8. on November 29, 2023 at 7:57 AM, a technician prepared a batch of 2251 granuflo mix. At 10:00 AM, the mixture was transferred to the holding tank without a second staff member verifying the test results. 9. on December 1, 2023 at 10:00 AM, a technician prepared a batch of 2201 granuflo mix. At 1:00 PM, the mixture was transferred to the holding tank without a second staff member verifying the test results. 10. on December 7, 2023 at 9:03 AM, a technician prepared a batch of 2251 granuflo mix. At 10:43 AM, the mixture was transferred to the holding tank without a second staff member verifying the test results. 11. on December 16, 2023 at 8:44 AM, a technician prepared a batch of 2201 granuflo mix. At 12:00 noon, the mixture was transferred to the holding tank without a second staff member verifying the test results. 12. on December 18, 2023 at 12:00 noon, a technician prepared a batch of 2251 granuflo mix. At 4:00 PM, the mixture was transferred to the holding tank without a second staff member verifying the test results. Review on January 10, 2024 of quality meeting minutes from June 2023 through November 2023 (6-months) failed to address why no second staff member verified the granuflo mixture test results. Interview on January 10, 2024 at about 2:30 PM with the Biomed technician failed to reveal the second staff member(s) that verified the granuflo mixture test results. Interview on January 11, 2024 at 9:45 AM with the Clinical Manager revealed the electronic granuflo logs were changed in October 2023. The manager did not receive notification of the change. Interview revealed this was local and a system-wide problem that was not identified in the November and December 2023 meeting minutes.”