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Tag No.: A0049
Based on staff interview and review of medical records, meeting minutes, and quality documents, it was determined the Governing Body failed to ensure the Medical Staff was accountable for the quality of care provided to 1 of 1 patient (#11) who suffered a wrong site surgery. This increased the likelihood that other patients could experience medical errors without close oversight of individual physicians. Findings include:
Patient #11 was an 83 year old male who was admitted to the hospital on 8/23/16 for elective surgery to remove a kidney and attached tumor. He was discharged on 8/27/16.
Patient #11's "DISCHARGE SUMMARY," dated 8/29/16, stated he was initially "...identified as having a left renal tumor ..." The summary stated Patient #11 had surgery to remove the left kidney. The summary further stated "The evening of that procedure, [the pathologist] identified a normal left kidney as having been removed. A right renal tumor remained, rather than the left kidney, which had been removed."
No documentation was present that the Medical Staff took any immediate action following the discovery of the wrong site surgery.
The Chief of the Medical Staff, interviewed on 5/02/17 beginning at 12:09 PM, stated neither of the surgeons who performed Patient #11's surgery performed any further surgeries until the RCA was conducted. However, there was no documentation the Medical Staff played a role in this outcome.
The hospital conducted an RCA which was completed on 8/29/16. An untitled document that was part of the RCA stated the lead surgeon's office would use the event as part of a process improvement project. It stated the lead surgeon would "...ensure that the patient is seen no later than 5 days prior to the scheduled surgery to review patient's history, and the upcoming surgery. In addition, all radiological images and reports will be thoroughly reviewed..."
There was no documentation the Medical Staff gave the surgeons permission to resume surgeries. There was no documentation the Medical Staff monitored the surgeons' activities or tracked whether the lead surgeon followed his process improvement project.
The first documentation of involvement by the Medical Staff was in Credentialing Committee meeting minutes, dated 9/27/16, 35 days following the incident. The minutes contained a short history of Patient #11's surgery. They stated a root cause analysis was conducted to review the incident. The minutes stated the medical record contained incorrect radiological reports and other documentation that stated the tumor was on the left kidney. The minutes did not discuss the role of the surgeons in reviewing the actual images to identify the tumor and the anatomy. The minutes stated "As a process of improvement, MVH will offer to read the findings to the physician as part of the time-out." No other recommendations were made. The minutes did state the committee unanimously decided no disciplinary action against the surgeon was necessary.
Peer Review Committee minutes documented a meeting on 11/29/16. The minutes stated external peer review of Patient #11's surgery had been conducted. The minutes stated the external peer review was rejected by the committee and a new peer review was ordered. As of 5/02/17, the second peer review had not been completed. No actions or recommendations regarding the surgeons were documented. No documentation was present to indicate whether the actions recommended by the RCA were followed.
Following the wrong site surgery, the Board of Managers (the hospital's Governing Body) met on 10/19/16 and 1/18/17. Minutes from these meetings did not include discussion of the wrong site surgery or of action taken to ensure it would not happen again.
The Chief Compliance Officer was interviewed on 5/02/17 beginning at 12:22 PM. He stated action had been taken by the Medical Staff and Governing Body in response to the wrong site surgery. He stated the action was not documented.
The Governing Body did not ensure the Medical Staff is accountable for the quality of care provided to patients.
Tag No.: A0057
Based on staff interview and review of policies, it was determined the hospital failed to ensure the CEO maintained responsibility for managing services at the hospital's cancer treatment center. This interfered with the hospital's ability to provide safe and effective services to cancer patients. Findings include:
The hospital operated an outpatient cancer treatment center where patients received chemotherapy.
The center used Admixture Technicians to compound, label, and dispense intravenous chemotherapeutic medications. The center did not employ a pharmacist and its medication delivery system was not under any supervision or oversight from a pharmacist.
The Director of Pharmacy was interviewed on 5/04/17 beginning at 10:50 AM. She stated the cancer center had employed a pharmacist. She stated, after communication with the Idaho Board of Pharmacy in 2013, the hospital dropped pharmacy services to the cancer center. She stated, at the direction of the Board of Pharmacy, the hospital no longer provided a pharmacist, other pharmacy services, or pharmacist oversight to the cancer center.
Following the withdrawal of pharmacy services, a policy defining how medication services would be provided as well as how supervision and oversight of the medication delivery system to the cancer center would occur was not present.
The Chief Compliance Officer was also interviewed on 5/04/17 beginning at 10:50 AM. He stated policies defining the medication delivery system and oversight of medications at the cancer center were not developed after hospital's pharmacy stopped providing services. He stated new policies to fill this void were not developed and implemented.
The CEO failed to ensure the cancer center's medication delivery system was defined.
Tag No.: A0117
Based on staff interview and review of patient rights information, it was determined the hospital failed to ensure patients were informed of their rights. This affected all patients who received care at the hospital. The lack of information impeded patients' ability to exercise their rights. Findings include:
On admission to the hospital, patients were given a copy of a pamphlet titled "Patient Rights." The pamphlet contained the hospital's privacy rights and rights related to medical records. The pamphlet did not inform patients of their general rights, such as the right to be informed of their medical condition, the right to participate in their plans of care, and the right to refuse treatment.
The Chief Compliance Officer reviewed the pamphlet on 5/05/17 at 11:00 AM. He stated the pamphlets were given to all patients on admission. He stated the wrong information had been published in the pamphlets. He stated patients comprehensive rights should have been included in the pamphlets.
The hospital did not inform patients of their rights.
Tag No.: A0118
Based on staff interview and review of patient rights information, it was determined the hospital failed to ensure patients were informed of whom to contact to file a grievance. This affected all patients who received care at the hospital. The lack of information had the potential to prevent patients from filing grievances regarding their care. Findings include:
On admission to the hospital, patients were given a copy of a pamphlet titled "Patient Rights." The pamphlet contained the hospital's privacy practices and rights related to medical records. The pamphlet stated patients could file a complaint if they thought their privacy rights were violated. The pamphlet listed a contact person. The pamphlet did not discuss the hospital's grievance process or direct patients who to call if they had a complaint about hospital care.
The Chief Compliance Officer reviewed the pamphlet on 5/05/17 at 11:00 AM. He stated the wrong information had been published in the pamphlets. He stated information regarding the grievance process and who to notify if patients wished to file a grievance was missing from the pamphlet.
The hospital did not inform patients whom to contact to file a grievance.
Tag No.: A0143
Based on record review, policy review, and staff interview, it was determined the hospital failed to ensure patient privacy was protected according to facility policy for 2 of 4 OB patients (#4 and #30) whose records were reviewed. This had the potential to result in the violation of patients' personal privacy and interfere with the personal privacy of all OB patients at the facility. Findings include:
A hospital policy "MVH Texting Policy," approved 3/15/13, stated "SMS [short message service or text messaging] may not be used to transmit protected health information unless appropriate administrative, physical and technical safeguards are in place. [sic] a nurse may notify a provider of patient condition as long as PHI is not connected with patient name.
1. Sample Text: Call the MVH nursing floor need to talk. [sic] or your requested results are in please contact MVH ____ nursing department or your patient in room number is doing well.
2. DO NOT text any PHI to providers request them to call you instead."
Additionally, the policy stated "At no time may medical orders be transmitted using SMS unless they are used for a read back confirmation process. Nurse requested text for verbal confirmation of order." This policy was not followed.
1. Patient #4 was a 30 year old female admitted to Labor and Delivery on 12/22/16, for a repeat Cesarean section after a failed VBAC.
Patient #4's record included nursing notes while she was in Labor and Delivery. An RN note, dated 12/22/16 at 1:36 PM, under the section "Communication Comments," stated "Provider texted in for update, RN texted Epidural is in, SVE [sterile vaginal exam] @ 1213 was 7.5 cm, still high, second dose abx [antibiotic] due 1530, can hang at 1500. UCs [uterine contraction] q 3-5 min [minute]."
A subsequent RN note, dated 12/22/16 at 2:27 PM, stated "RN texted provider, 'SROM [spontaneous rupture of membranes]...meconium [infant's first stool].' Provider texted back, 'OK thanks."
Another RN note, dated 12/22/16 at 4:32 PM, stated "Text message sent to [physician's name], 'Complete at 1506 ...did trial push ...no descent. Now in lateral position. Will keep changing position to se [sic] if baby will come down. FYI. Reactive FHR [fetal heart rate]."
During an interview on 5/05/17 at 8:40 AM, a staff RN reviewed the record and confirmed the physician was contacted via text messaging. She stated she frequently used text messaging to update the physician or relay information regarding her patients in Labor and Delivery. The RN stated she would not text message a physician with critical results or if she required an immediate response. She stated she was not aware of the facility policy until 5/05/17.
The hospital failed to protect Patient #4's PHI and follow their policy for text messaging.
2. Patient #30 was a 30 year old female admitted to Labor and Delivery on 2/07/17, for contractions at 35 weeks gestation. She had a repeat Cesarean section performed on 2/08/17.
Patient #30's record included nursing notes while she was in Labor and Delivery. An RN note, dated 2/07/17 at 4:24 PM, stated "Texted [physician name] that there was no change in cervix." At 4:30 PM on the same day, the RN documented the physician texted her back and it included an order for Terbutaline. Terbutaline is a medication sometimes used for preterm labor.
During an interview on 5/05/17 at 8:40 AM, a staff RN reviewed the record and confirmed the physician was contacted and an order was received via text messaging. She stated she was not aware of the facility policy until 5/05/17.
The hospital failed to protect Patient #30's PHI and follow their policy for text messaging.
Tag No.: A0450
Based on medical record review, hospital policy review, and staff interview, it was determined the facility failed to ensure patients' medical record entries were authenticated, dated and timed for 4 of 10 surgical patients (#19, #21, #22, and #24) whose records were reviewed. This resulted in a failure to establish a timeline of events on which to base future actions, assessments and interventions, potentially impacting patient safety and quality of care. Findings include:
A facility policy titled Medical Records Standards, revised 2/2017, stated "All entries in the record are to be dated, timed and authenticated."
1. Patient #19 was a 50 year old female who was admitted on 3/02/17 for a tonsillectomy.
Her record included a surgical consent form that was untimed, and an operative report that was undated and untimed.
2. Patient #21 was a 63 year old female who was admitted on 11/04/16 for a left total hip arthroplasty.
Her record contained an undated, untimed OT initial evaluation, an undated, untimed PT initial evaluation, an updated H&P that was untimed, and an operative report that was undated and untimed.
3. Patient #22 was a 72 year old male who was admitted on 11/07/16 for treatment of a non-healing right foot wound.
His record contained an undated, untimed PT initial evaluation, an undated, untimed physician consultation ordering two diagnostic tests, an undated, unsigned VTE assessment showing Patient #22 to be a high risk, and an unsigned, undated, untimed H&P.
Further, Patient #22 was discharged on 11/11/17 to hospice services. His POST (a form that expresses a terminal patient's instructions for care), present in his medical record, was signed by a physician, but was undated, untimed, and did not have a signature by the patient or the patient's surrogate. The POST gave directions for Patient #22 to be DNR.
4. Patient #24 was an 18 year old female who was admitted on 3/08/17 for a cholecystectomy.
Her record contained an undated, untimed surgical consent, and an undated, untimed operative report.
During an interview on 5/05/17 at 12:05 PM, a Medical Records staff reviewed the above four patient medical records and confirmed the missing dates, times and authentications.
Medical records were not timed, dated or authenticated for four patients.
Tag No.: A0454
Based on record review, policy review, and staff interview it was determined the hospital failed to ensure medication and treatment orders were signed, dated, and timed by providers in a timely and prompt manner for 9 of 36 patients (#15, #19, #21, #22, #23, #24, #26, #29, and #30), whose records were reviewed. This had the potential to result in medication and treatment provided to patients without the order of a provider. Findings include:
A hospital policy "Medical Record Standards," approved 2/17, stated "All entries in the record are to be dated, timed, and authenticated." This policy was not followed. Examples include:
a. Patient #15 was a 28 year old female admitted to Labor and Delivery on 1/24/17, for premature rupture of membranes with active labor at 35 weeks gestation.
Patient #15's record included verbal orders written by the RN on 1/24/17. A verbal order written at 10:45 AM, signed by the RN, was not signed, dated, or timed by the physician. A subsequent verbal order, at 12:28 PM on 1/24/17, was signed by the physician but was not dated or timed.
During an interview on 5/05/17 at 10:30 AM, the Manager for Point of Care reviewed the record and confirmed Patient #15's record included orders which were not dated or timed by the physician.
b. Patient #26 was a 33 year old female admitted to Labor and Delivery on 12/13/16, for a repeat Cesarean section.
Patient #26's record included verbal orders written by an RN on the following dates: 12/13/16, 12/14/16, 12/15/16, and 12/16/16. Five of the verbal orders documented on the "Physician Orders" form during those dates were not timed or dated next to the physician's signature. One of the verbal orders documented was not signed, dated, or timed by the physician to authenticate the order.
During an interview on 5/05/17 at 12:05 PM, a Medical Records staff reviewed Patient #26's record and confirmed there were physician orders which were not signed, dated, or timed. She confirmed phsycians and providers are required to sign, date, and time their orders according to the facility policy.
c. Patient #30 was a 30 year old female admitted to Labor and Delivery on 2/07/17, for contractions at 35 weeks gestation. She had a repeat Cesarean section performed on 2/08/17.
Patient #30's record included verbal orders written by an RN on the following dates: 2/07/17, 2/08/17, and 2/09/17. Eleven of the verbal orders, documented on the "Physician Orders" form, were signed by the physician. However, there was no date or time next to the physician's signature for those verbal orders.
During an interview on 5/05/17 at 10:30 AM, the Manager for Point of Care reviewed the record and confirmed Patient #30's record included orders which were not dated or timed by the physician.
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d. Patient #19 was a 50 year old female who was admitted on 3/02/17 for a tonsillectomy.
Her record contained a list of home medications with check boxes indicating whether the medications were to be continued during Patient #19's hospital stay. The physician did not include the date or time of his signature when completing the order.
e. Patient #21 was a 63 year old female who was admitted on 11/04/16 for a left total hip arthroplasty.
Her record showed admission orders that were not dated or timed. Four verbal orders for PRBCs and saline boluses were not authenticated, dated or timed on 11/05/17 and 11/06/17.
f. Patient #22 was a 72 year old male who was admitted on 11/07/16 for treatment of a non-healing right foot wound.
His record contained the following:
- One unsigned, undated, untimed physician order for wound care and diagnostic testing on 11/09/17.
- Three undated, untimed physician orders on 11/09/17, 11/10/17, and 11/12/17 for diagnostic testing and blood testing.
- Six verbal orders that were authenticated but not dated or timed on 11/09/17, 11/10/17, 11/11/17, and 11/12/17.
- Three undated, untimed communications titled MVH Pharmacy Clinical Interventions.
- A Medication Reconciliation Report, discontinuing sixteen medications, that was undated and untimed.
g. Patient #23 was a 25 year old female admitted on 1/10/17 for an appendectomy.
Her record contained two verbal orders, on 1/10/17 and 1/14/17, that were not dated and timed by the physician at the time of signature.
h. Patient #24 was an 18 year old female who was admitted on 3/08/17 for a cholecystectomy.
Her medical record contained admission orders written on 3/08/17 that were untimed, and one verbal order on the same date that was not dated or timed when the physician signed.
During an interview on 5/05/17 at 12:05 PM, a Medical Records staff reviewed Patient medical records for Patients #19, and #21 - #24. She confirmed there were physician orders which were not signed, dated, or timed. She confirmed physicians and providers are required to sign, date, and time their orders according to the facility policy.
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i. Patient #29 was a 51 year old male admitted to the hospital on 10/18/16 for kidney surgery. He was discharged on 10/21/16.
Patient #29's record included verbal orders written by the RN on 10/20/16 at 3:15 PM. The orders included a diet change, a change in an IV flow rate, an order to discontinue a patient controlled anesthesia pump, and an order for oral pain medication. The orders were not signed by a physician.
During an interview on 5/05/17 at 10:45 AM, the Chief Compliance Officer reviewed the record and confirmed Patient #29's record included orders which were not signed by the physician.
The hospital failed to ensure orders were dated, timed, and authenticated.
Tag No.: A0843
Based on staff interview, it was determined the hospital failed to ensure an assessment of its discharge planning process, including a review of discharge plans, was conducted on an on-going basis. This prevented the hospital from determining whether patients' discharge plans were responsive to their needs. Findings include:
The hospital had 2 case managers. Both were interviewed on 5/05/17 beginning at 8:50 AM. Both stated the hospital did not have a process to review the discharge planning process. Both stated the hospital had not reviewed discharge plans within the past year to determine if discharge plans were responsive to patients' needs.
The hospital failed to reassess its discharge planning process.
Tag No.: A0951
Based on observation, policy review, and staff interview, it was determined the hospital failed to ensure infection prevention measures related to patient care were followed. This directly impacted 2 of 2 surgical patients (#12 and #14) whose procedures and care were observed and whose records were reviewed. This had the potential to result in the possible infection of patients receiving procedures and/or surgical services at the hospital. Findings include:
1. A hospital policy "Hand Hygiene - CDC Guidelines," approved 9/15, stated "Soap and water must be used when hands are visibly soiled. If hands are not visibly soiled, hands may be disinfected with either an alcohol-based hand rub (ABHR) or soap and water. In these situations the CDC encourages the use of ABHRs." The policy also stated when hand hygiene should be performed, which included:
- Before each patient encounter
- Before applying gloves and inserting indwelling catheters, peripheral vascular catheters, other invasive devices
- After coming in contact with patient's skin
- After contact with medical equipment/supplies in patient areas
- After removing gloves or facemasks
This policy was not followed.
a. An observation was conducted of Patient #14 during the pre-operative period on 5/02/17, beginning at 5:30 AM. The RN was observed admitting Patient #14 for her surgery and performing an assessment, vital signs, and 2 IV starts. There were several missed opportunities for hand hygiene observed.
- The RN left the patient area and upon return did not perform hand hygiene.
- The RN removed his gloves after performing a task and did not perform hand hygiene
- After starting an IV in Patient #14's left forearm, the RN removed his gloves and moved to her right side and put on another set of gloves and then proceeded to insert a second IV. There was no hand hygiene after removing the first set of gloves and prior to donning the second set and inserting the IV.
During an interview on 5/03/17 at 3:15 PM, the Director of Surgery was informed of the observations and confirmed there were missed opportunities for hand hygiene by the RN.
The hospital failed to ensure patient care included infection prevention practices by staff were followed and their policy for hand hygiene was followed.
b. An observation was conducted of Patient #12 during his surgery on 5/03/17, beginning at 8:00 AM. The CRNA was observed during Patient #12's surgery. During the surgery there were several missed opportunities for hand hygiene by the CRNA.
The CRNA assisted in moving Patient #12 from the gurney to the surgical table. He also assisted with placing monitor electrodes on Patient #12's chest. The CRNA did not perform hand hygiene before or after these tasks.
Patient #12 received several IV medications from the CRNA during his surgery. The CRNA was observed accessing and administering medication in Patient #12's IV a minimum of 6 times. The CRNA did not perform hand hygiene prior to drawing medications from vials or prior to administering them.
Patient #12 was in the OR from 8:32 AM to 9:05 AM, a total of 33 minutes. The CRNA was observed using the alcohol based hand rub, available on his anesthesia cart, once during the surgery.
During an interview on 5/03/17 at 3:15 PM, the Director of Surgery confirmed there were missed opportunities for hand hygiene by the CRNA. When she was asked whether anesthesia providers, who were contracted by the hospital, participated in hospital education or training the Director of Surgery stated she was not aware whether they did or not.
The hospital failed to ensure patient care included infection prevention practices by staff were followed and their policy for hand hygiene was followed.