Park Nicollet Methodist Hospital

“PATIENT RIGHTS: NOTICE OF RIGHTS CFR(s): 482.13(a)(1) A hospital must inform each patient, or when appropriate, the patient’s representative (as allowed under State law), of the patient’s rights, in advance of furnishing or discontinuing patient care whenever possible. This Standard is not met as evidenced by: 43080 Based on interview and document review, the hospital failed to provide An Important Message from Medicare (IM) notice within two days of admission for 3 of 6 Medicare beneficiary inpatient patients (P27, P28, P29). In addition, the facility’s IM deliverance policy failed to reflect the Centers for Medicare and Medicaid Services (CMS) direction for the issuance of the IM notice. Findings include: The CMS Beneficiary Notices Initiative (BNI) website, dated 12/3/24, directed hospitals were “required to deliver the [IM notice] ...CMS-10065 to all Medicare beneficiaries ...” who were hospital inpatients. This notice informed patients of their hospital discharge appeal rights. CMS-10065 notice instructions, located in the Medicare Claims Processing Manual - Chapter 30, dated 8/1/24, section 200.3.3 - Hospital Delivery of the IM, directed hospitals to deliver an initial copy of the IM to “all inpatients, including those in the hospital for a short stay,” “at or near admission, but no later than 2 (two) calendar days following the date of the beneficiary’s admission to the hospital.” In addition, the section identified a follow-up IM was to be delivered “Two days before discharge” and no later than four hours prior to discharge. The section lacked identification for issuance exceptions. On 12/18/24, during the abbreviated medical record review process, which started at 12:15 p.m., the following information was identified: -P27 admitted on 12/4/24 and was an active inpatient on 8W (general medicine unit). Her record lacked an admission provided signed and dated CMS-10065 IM notice, or documentation to support attempt(s) to provide the notice. -P29 admitted on 12/7/24 to the ICU and continued to be an ICU patient. His record lacked an admission provided signed and dated CMS-10065 IM notice, or documentation to support attempt(s) to provide the notice. -P28 admitted on 12/13/24 to the intensive care unit (ICU). P28 expired on 12/17/24. Her record lacked an admission provided signed and dated CMS-10065 IM notice, or documentation to support attempt(s) to provide the notice. On 12/18/24, immediately following the abbreviated medical record review process, the revenue cycle manager (RM)-A reviewed P27, P28, and P29’s hospital financial records as she identified this was where the IM notices were housed. RM-A identified all three patients’ financial record lacked evidence the IM was issued to them and/or their representatives, or that there was documentation to support attempt(s) to provide the notice. While RM-A reviewed these records, she stated P28 and P29 were not issued the IM notice based on the unit they were on while inpatients as if was a “work standard” her staff “do not visit the ICU (intensive care unit);” however, she stated she would have expected an IM notice in P27’s chart. RM-A indicated she lacked knowledge on who provided the notices to ICU patients; however, identified the facility currently worked on discussions related to this process. During a follow-up interview on 12/18/24 at 2:47 p.m., RM-A confirmed her staff delivered the IM notices to patients and/or their representatives. She explained the IM notice was expected to be issued within two days of admission and then again within four hours of discharge, but there were exceptions. She was unsure why the policy identified the exceptions or where the policy exceptions derived from. When RM-A was questioned on discharge IM notices for those impacted by the exceptions, she stated if a patient remained on one of the exception units from admission through discharge, the patient and/or the representative were not provided the IM notice upon discharge; however, if they transferred from an exception unit to another unit, not impacted by the exemptions, then an IM notice was provided. When interviewed on 12/18/24 at 3:04 p.m., appeals specialist (AS)-A stated she was unaware of the rationalization for why the exceptions were present within the IM policy. During the interview, AS-A emailed a “legal” representative; however, at the time of the deficiency writing, a response from legal had yet to be received. On 12/18/24 at 3:42 p.m., the accreditation and regulatory compliance manager (CM)-A and the hospital quality senior director (HQ)-A were interviewed. CM-A identified due to the number of new employees in any IM or policy associated roles, determining rationalization(s) for IM policy exceptions would be extremely difficult to determine. As far as either were concerned, the only exclusion for IM notices was related to a patient being in an observation status (non-inpatient status). A Patient Missing Important Msg [message] From Medicare & Patient Missing Second IMM Signature policy, dated 10/7/21, identified the policy directed the process for IM deliverance which directed the IM to be delivered to patients with an “Inpatient” patient classification. If a patient was unable to understand the notice due to their medical condition, the notice was to be provided to an authorized representative or to a non-authorized representative if there was one in the patient’s room. The policy identified: “IM notice delivery is not required for the following units/patients: 2N (ICU - north unit), 2S (ICU - south unit), 3N (critical care unit), 3S (critical care unit), OR (operating room), EC (emergency center), patients under video monitoring, on a 72-hour hold or if aggression alert was present in Epic (electronic medical record), in active labor, or during end of life, palliative care, admitted to, or with discharge disposition to hospice.”

“PATIENT RIGHTS: CARE IN SAFE SETTING CFR(s): 482.13(c)(2) The patient has the right to receive care in a safe setting. This Standard is not met as evidenced by: 48109 Based on observation, interview, and record review the facility failed to ensure medications were securely stored in 2 of 10 hospital units when a medication cabinet and/or drawer had a broken lock system. Findings include: During a tour of 7 West on 12/16/24 at 1:30 p.m., the nurse’s station was a room off the hallway with no door. The room contained workstations along the left and right walls closest to the hallway. The back half of the room had a Pyxis (a computerized medication management system) machine on the left wall and upper and lower cabinets and drawers along the right wall. Registered nurse (RN)-O pulled on the handles of a cabinet, the left side stayed locked, but the right side opened. There were patient medications in blue and yellow bins stored inside. The clinical nursing director (CD)-B stayed with the medications until it could be properly locked. These medications included: -amantadine hydrochloride (an anti-viral medication used to treat Parkinson’s), two tablets -carbidopa-levodopa (a combination medication used to treat Parkinson’s), two tablets -latanoprost eye drops (a prescription eye medication used to treat high pressures in the eyes), two bottles -Lovenox (an injectable medication used to treat and prevent blood clots) one syringe -Vancomycin (an antibiotic used to treat infections) in normal saline ready for intravenous administration -aspirin rectal suppositories, two suppositories -analog insulin, three vials -cilostazol (an oral medication used to dilate the vessels), one dose -albuterol inhaler -Veltassa (an oral medication used to treat higher levels of potassium in the blood) -sodium bicarbonate packets, two packets. -saline nasal spray, one bottle On 12/16/24 at 1:50 p.m., the medication cabinet on 7 West had been repaired by maintenance. RN-O demonstrated how the left-hand cabinet door had the actual locking mechanism on it, and the right-hand cabinet door had a spring-loaded latch mounted on the inside which could be released once the left-hand door was opened. RN-O explained the latch was the broken part, but he was not sure how long it had been that way, he stated that latch could break at any time. RN-O stated the risk of not having medications locked was that the medications could be accessible and not secure. During a tour of 8 West on 12/16/24 at 2:25 p.m., the nurse’s station was a room off the hallway with no door. The room contained workstations along the left and right walls closest to the hallway. The back half of the room had a Pyxis (a computerized medication management system) machine on the left wall and upper and lower cabinets and drawers along the right wall. RN-A pulled the handle for a locked medication drawer and the drawer opened. RN-A tested the lock and found it not to be working. RN-A stated this drawer should be locked and was not sure how long it had not been working. RN-A called another RN to come and stand with the medications while RN-A called maintenance. Taylor says the risk of having these medications unlocked would be that other patients could get into them. The drawer contained the following medications: - nystatin powder, one bottle -Gastrografin (a contrast agent used for x-rays or other tests) oral liquid, one bottle -ziprasidone (antipsychotic medication injection), one vial During an interview on 12/17/24 at 10:27 a.m., maintenance worker (MW)-A confirmed he repaired the medication cabinets. MW-A explained a screw was pulled off the locking mechanism, so he needed to replace it. MW-A added things like locks were repaired on a break-fix situation and not on a preventive maintenance one, there were too many locks to do it that way. During an interview on 12/18/24 at 9:04 a.m., the pharmacy director confirmed not all medications are stored in the Pyxis. Medications which would not be in the Pyxis were non-formulary medications, medications that needed to be compounded, or medications the patient brought from home. The pharmacy director added these cabinets were to be locked and they did check them frequently but there was not an audit report for tracking. The pharmacy director stated the risk of unsecured medication would be for another patient, the public, or a family having access to them. During an interview on 12/18/24 at 9:36 a.m., RN-B confirmed she gave medications and accessed the locked medication cabinets. RN-B stated if the lock were not working, she would put in a maintenance ticket online, but added she could also call them if needed. During an interview on 12/18/24 at 9:39 a.m., RN-C confirmed she gave medications and accessed the locked cabinets but has not had a time where they were not locked. RN-C stated if she found it not working, she would tell her manager and then file a maintenance request. RN-C added if the medication cabinets were not locked someone who was not supposed to access them could access them or tamper with them. During an interview on 12/18/24 at 9:43 a.m., RN-D confirmed she accesses the locked medication cabinets and did have incidents where it was not locked. RN-D would let maintenance know via phone call or computer. RN-D would also let her charge nurse know and make sure someone was there until maintenance could fix the lock. During an interview on 12/18/24 at 9:49 a.m., RN-E stated he was familiar with the locked medication cabinets but had not had a time where they would not lock or was not locked. RN-E added he would contact his manager about getting it fixed or put in a work order to have it fixed. He would make sure someone was in that room with the medications until it could be fixed. During an interview on 12/18/24 at 9:55 a.m., RN-F confirmed she was familiar with the locked medication cabinets and has had times where the lock was not working. RN-F stated she would put the medications into a cabinet that did lock and then put in a maintenance ticket. During an interview on 12/18/24 at 10:48 a.m., with the clinical nursing director (CD)-A and the clinical operations director (OD)-A, the CD-A stated it was her expectation that medications not stored in the Pyxis would be under a locked cabinet or drawer or in someone’s possession and not set down unattended. When asked about the security of the nursing station where the medications are stored, CD-A acknowledged it was a room off the hallway with no door, but it would be rare the nurse’s stations would not have someone in there. CD-A supposed it would be possible for a patient to go in there. The OD-A stated the process for repairs would be to submit a request, and to submit right away as this was a high priority. If maintenance were not quick enough, they would escalate it to nurse leadership. CD-A stated the expectation was they would keep security of the medications from the time they discovered the lock not working to the time it was repaired and have someone stay with the medications. CD-A stated the locks were not on a specific audit schedule, but they did have environment of care rounds where they looked at the safety of the unit. Neither CD-A nor the OD-A were aware of situations where patients got into the medications in the cabinets. CD-A did not know if there was a process to keep track of what was in those medication cabinets. CD-A stated the risks for having medications not secured would be the patient’s protected health information on the labels could be visible. An undated policy, Medication Storage, identified the purpose to ensure all medications were safely stored in accordance with laws, regulations, and organizational policies under proper conditions of sanitation, temperature, light, moisture, ventilation, segregation, and security. All medications and biologicals shall be securely stored to maintain safety and integrity, promote the availability of medications when needed, minimize the risk of diversion, and reduce the potential for dispensing and administration errors. Medications stored outside the pharmacy would be secured in automated dispensing machines (ADM) that controls and monitors all access to medication; secured in a locked storage cabinet, drawer, or room. Patient specific medication storage locations will be separated by nursing unit and room number.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(4)(ii) [The use of restraint or seclusion must be--] (ii) implemented in accordance with safe and appropriate restraint and seclusion techniques as determined by hospital policy in accordance with State law. This Standard is not met as evidenced by: 43080 Based on observation, interview and document review, the facility failed to perform restraint release and an associated skin assessment every two hours per facility policy for 1 of 2 patients (P28) reviewed for non-violent bilateral soft-wrist restraints and who was observed to have altered skin integrity when the restraint was removed for skin visualization. Findings include: On 12/17/24 at 12:28 p.m., P28’s bilateral soft-wrist restraints were removed by staff per request for skin visualization. P28’s entire right wrist/forearm areas were free of observed concerns; however, her left posterior wrist area displayed a superficial, 1.5 cm (centimeter) by 1 cm, irregular shaped wound that was dry and without drainage. The wound bed was pink in color and the periwound edges were without redness or other concerns. The material on the inside of the soft-wrist restraint showed several areas of a fainter darker discoloration that lined up with placement against the wound. As staff immediately started to assess the wound with measurements and a photo, P28’s assigned registered nurse (RN)-G stated he observed a 1-inch Mepilex (wound dressing) on one of P28’s hands the previous day but he was unable to recall which hand. He was unaware of the reason for the Mepilex, and this was the first time being aware of the observed wound. RN-G stated he had yet to check P28’s skin that shift. On 12/17/24 at 12:40 p.m., RN-G was interviewed with RN nurse manager (RN)-H as a witness. RN-G explained, if a patient utilized a soft-restraint, such as P28’s wrist restraints, he was expected to assess the restraint(s) every 2 (two) hours. Overall, he completed this check when the patients were turned and/or cares were provided in which he placed two of his fingers between the restraint and the patient’s skin to ensure appropriate fit, and then he released the restraint teethers that secured the restraint to the bed. RN-G denied he removed the restraint from around the patient’s limbs at these 2-hour checks as he explained he was trained to remove the restraint from the skin every 8 (eight) hours during the expected full skin assessment process, unless there were concerns prompting additional checks. This process was important to decrease the risk of skin breakdown. If he was unable to perform the expected assessment upon starting his shift, he attempted to perform the assessment around 12:00 p.m. to 2:00 p.m. When questioned further, for clarification on his process for restraint related skin injury assessment processes, he stated it depended on the patient and remarked he had “not done that today [for P28],” despite starting his shift around 8:00 a.m. (approximately 4.5 hours earlier). RN-G identified P28 “like[d] to fidget” due to her mental status and he was “sure there [was] always some rubbing [restraint on the skin].” In addition, he stated P28 “jerk[ed] a lot of the time,” and the wound “could be” from the restraint but he was “not certain.” RN-G stated he was unsure of P28’s 12/16/24 skin status when he worked with her as he had not assessed P28’s skin during his 7:00 a.m. to 7:00 p.m. (12-hour) shift: other than to check for the 2-finger fit every 2 hours. He explained the lack of this 12/16/24 assessment process was due to that shift being “busier than it was today” related to P28’s increased cares and nursing needs, and this day’s lack of assessment centered around P28’s family taking up much of his time with questions and discussions around transitioning P28 to comfort [palliative] care and the follow-up needed for this transition. RN-G indicated there were no reports from the night shift related to any wounds on P28’s left wrist. When interviewed on 12/17/24 at 1:02 p.m., RN-H stated she expected soft-limb restraints to be assessed every 2 hours for CMS (circulation, movement, sensation) and then every 8 hours for a skin assessment in which the restraint would be removed at those intervals. She explained that typically staff assessed skin integrity around 8:00 a.m., 4:00 p.m., 8:00 p.m., and then 12:00 a.m.; however, at a minimum she expected a skin check at least 3 (three) times a day in which the fourth check was “like a bonus.” RN-H stated she expected P28’s skin was assessed by RN-G on 12/16/24 and then again that morning: “You should be able to take that device off and look under it within the shift. [The restraints] are foam and they think they are protected.” RN-H identified she felt P28’s wound most likely occurred when a wound dressing was removed and not from the restraint; however, she would obtain a WOC (wound care) consult if there was information P28 pulled on the restraints or if there were shearing. RN-H identified RN-I placed an IV (intravenous) into P28’s left wrist area that prior night and she expected documentation in P28’s chart if he had observed any skin impairments. On 12/17/24 at 1:10 p.m., P28’s medical chart was reviewed with RN-J and the following information was identified: -12/13/24, P28 admitted in response to a seizure. -12/14/24, bilateral soft-wrist restraints were ordered and applied at 2:00 a.m. The restraints continued. -12/14/24, 12/15/24, and 12/16/24, a flow sheet section for drain devices and wounds identified skin assessments at 8:00 a.m., 4:00 p.m., and 8:00 p.m. each day. On 12/17/24, documentation was recorded at 4:00 a.m. and 8:00 a.m. The flow sheets lacked identification of the left wrist wound. -12/14/24, a non-violent restraint care plan directed staff to protect skin and joint integrity per clinical practice guidelines with the following interventions: frequently check restraint application site and document findings, release and replace at regular intervals per facility protocol, and assist with frequent joint range of motion activity. -A Non-Violent Restraint flow sheet identified a section labeled Monitoring that directed the following “on initiation and every 2 hours:” circulation check, safety check, skin care/reposition check, physical needs assessed, range of motion performed, and behavior status. This flow sheet section identified entries within all the categories without any notable missed entries. When RN-J was questioned on expectations for the skin care/reposition check, she stated staff were expected to check the skin every 8 hours; however, she was unsure what that direction truly indicated, and she needed to get this clarified. The flow sheet lacked direction for restraint removal or that the restraint was released from the limb and the skin was assessed. -12/17/24 at 1:05 p.m., an LDA (lines, drains, airway) monitoring was entered for P28’s for an abrasion to her left posterior hand. P28’s medical chart lacked any details of the wound prior to this LDA setup. When interviewed on 12/17/24 at 3:29 p.m., nursing assistant (NA)-A stated that when he provided one-to-one supervision on a patient who had soft-restraints, he removed the restraint and visualized the skin underneath every 45 minutes as he needed “to make sure it is good” as continually wearing a restraint was a skin integrity issue. During an interview on 12/17/24 at 3:38 p.m., RN-K stated restraint documentation was expected every 2 hours. At those times, she checked the restraint for proper fit and CMS confirmation. After this, every 8 hours, she was expected to remove the restraint, assess skin integrity, and re-evaluate if the restraint needed to continue. This skin assessment was documented in an area outside of the restraint documentation. RN-K explained when she documented in the section for skin care/reposition check, this meant she performed a check to ensure the restraint fit properly, “not necessarily” that she physically observed the skin underneath. After some attempted clarifying questions, RN-K stated her usual process was to visualize the skin “usually” every 2 hours; however, she was unsure whether this was protocol or not. After the restraint policy was reviewed, RN-K identified the policy lacked some clarity on the exact expectations for when the restraint was to be unsecured from the wrist, but she confirmed the policy directed skin integrity was to be monitored every 2 hours, or more frequently if the patient’s condition warranted. RN-K explained this was required to catch skin breakdown before it happened “especially in the ICU when everyone’s skin is frail, a lot of medications [were] being used, and they [were] not moving around.” She indicated she would assess the skin “more frequently” if a patient were jerking or moving their arms around more. When interviewed on 12/18/24 at 9:36 a.m., RN-B stated when restraint fit was checked, the restraint could be moved down to look at the skin for a skin assessment. During an interview on 12/18/24 at 9:36 a.m., RN-C stated, when she checked restraints every 2 hours, she ensured a proper fit and then she either removed the restraint or moved the restraint aside to check the skin. When interviewed on 12/18/24 at 9:43 a.m., RN-D stated she was expected to “open up” the restraint every 4 hours and check skin and circulation. During an interview on 12/18/24 at 10:04 a.m., RN-L stated she was expected to assess restraint use every 2 hours in which she checked the pulse, the skin, and sensation while she ensured there was enough room; however, she was expected to “physically remove” the restraint every 8 hours when a full body skin assessment was required. When interviewed on 12/18/24 at 10:13 a.m., RN-N, a nursing manager, stated a non-violent (soft limb) restraint required every 2-hour assessments. At these intervals, the restraint teether may be removed from the bed and the skin checked without removing the restraint from the patient’s body. On 12/18/24 at 10:18 a.m., RN-H approached the surveyor and updated that P28’s wound was investigated. She explained a nurse, on 12/15/24, had removed a dressing/bandage off P28’s left wrist area, where P28 had a procedure and dressing/bandage application, and this dressing removal was where the wound originated from. After treating the area, due to the workload of the nurse, the nurse inadvertently missed the documentation related to the incident. In addition, another nurse, who removed the dressing applied on 12/15/24 to insert and IV also failed to document his wound interaction and/or the wound’s status. On 12/18/24 at 10:39 a.m., clinical nursing director (ND)-A and clinical operations director (COD) were interviewed. ND-A stated staff were expected to follow the restraint policy related to skin checks which she identified was to occur every 2 hours as “those in restraints [were] at risk of pressure and shearing injury.” This check required staff to “look under” the restraint. ND-A explained RN-G “had the entire shift to do [the skin] assessment” on 12/17/24; however, she expected RN-G would have performed “at least” one skin assessment on P28 during his 12/16/24 shift “per our policy.” When updated on more specific details related to P28’s missed restraint skin assessments over a 12-hour period, ND-A stated that was “concerning” as “that would not be the standard,” especially when P28 was found with a wound underneath the restraint. During an interview on 12/18/24 at 10:42 a.m., RN-M stated the restraint policy directed her to remove restraints every 2 hours and provide range of motion; however, at these times, the restraint teethers were released from the bed, not the patient’s limb(s). On 12/18/24 at 1:46 p.m., an email was received from the hospital quality senior director (HQ)-A in response to a request for any P28 WOC note(s) in relation to the 12/17/24 identified wound. The email indicated P28’s medical record was free of a WOC note as the staff assessed this wound to be a skin tear, which based on their practice did not require a WOC consult. A Restraints policy, dated 2/13/24, identified the facility was committed to preserving patient safety, rights, well-being, and dignity. To assist with this, a section labeled “Restraints for non-violent, not self-destructive behavior” contained a subsection labeled Monitoring and evaluation which directed the following: Status of each device in use ( ...continued ...released) must be documented upon initiation and every 2 hours while patient was in restraints; Monitoring for safety, ...circulation, and skin integrity/reposition needs must be conducted upon initiation and every 2 hours while the patient was in restraints or more frequently if patient condition warrants; Positioning, release of restraints and range of motion (ROM) must be conducted upon initiation and every two hours. The policy does not outline specific restraint “release” steps and/or directions or where documentation for skin checks and releases are located.”