Bringing transparency to federal inspections
Tag No.: A0077
Based on review of minutes from both the multiple-hospital system governing oversight committee, and from the individual hospital governing body committee , the hospital failed to ensure that approval of the budget of the hospital was documented in governing body committee minutes.
The surveyed hospital is the largest in a multi-hospital system and the system has oversight of both UMMC and of a number of additional acquired hospitals, each with unique Centers for Medicare & Medicaid Certification Numbers (CCNs). By intermingling the information about the multi-hospital system and this hospital in committee minutes of the system-level board, and also failing to fully document budget approval at the hospital level, the two governance boards together failed to substantively document the budgetary oversight of the hospital.
If the governing business of an individual hospital is delegated to a board at a multi-hospital system level, the system level board minutes must demonstrate substantive review and discussion of the individual business of each hospital. The multi-hospital system committee minutes revealed that the governing committee at the multi-hospital system level failed to consistently segregate and discuss individual hospital matters. Specifically for example, the system committee minutes stated only that all budgets for all of the system hospitals were approved, while the governing body minutes for the individual hospital under survey failed to disclose or document the budget approval that was specific to that individual hospital. Senior leadership reported to the survey team that they had felt the budget approval information was redundant and did not need to be documented at both the hospital and system level. However, the system level board minutes did not document a discussion about the budget in a manner specific to the UMMC; but rather only documented that all budgets for all hospitals were approved.
Tag No.: A0117
Based on review of the medical record and policy and procedure, it was determined that the hospital failed to provide Medicare recipient s their rights within two days of admission and discharge.
In 5 out 97 medical record reviews, patients #27, 69, and 77, the hospital failed to inform these patients, or their surrogates of their rights related to furnishing and discontinuing their care.
Patient #27 who had both Medicare and Medicaid insurance was admitted to the hospital on 12/11/2013 and discharged 12/23/2013. The medical record did not contain any evidence that the patient received the information contained in the document called An Important Message from Medicare on admission as required. There was also no documentation that staff conducted any follow-up activities regarding the patient ' s Medicare rights prior to discharge.
Patient #46 was admitted to the hospital on 2/7/14 the Important Messaged from Medicare form stated " Patient unable to sign. " No reason was checked why the patient could not sign nor was there documentation in the medical record that the patient ' s family (daughter, son or brother) were given the information regarding the patient ' s rights as a Medicare recipient.
Patient #47 was admitted to the hospital on 2/2/14 the Important Message from Medicare form stated " Patient unable to sign due to physical condition. There was no documentation in the medical record that the patient or her family was given the information regarding the patient ' s rights as a Medicare recipient.
Patient #69 is an 89-year-old admitted for altered mental status. Review of the record reveals an Important Message (IM) dated 2/18/14 which states, " Pt (patient) unable to sign. " No evidence in the record reveals an attempt to inform the patients surrogate or healthcare agent of her rights in her stead.
Patient #77 is a 72-year-old female admitted for GI bleed. Review of the record reveals no IM for this patient who had been 4 days in the hospital at the time of survey.
Tag No.: A0131
Based on a review of Spanish-speaking patient #80 ' s record, it was revealed the one of 97 patients reviewed 1) was restrained to give Intramuscular emergency "prn" medication for agitation without being offered medication by mouth (P.O.), and 2) was secluded twice and placed in quiet room without benefit of an interpreter by which staff could obtain a complete assessment of her status, inform patient #80 of what was occurring, or to inform her of her rights within the plan of care.
Patient #80 is a young Spanish-speaking adult female admitted to the behavioral health unit (BHU) in January 2014. On 1/15/14, a nursing note of 1330 reveals that patient #80 was " able to make her needs known through translation services." The record generally reflects that an interpreter was used for an hour or more each day, though does not appear to have been utilized in the evenings.
On 1/15 at 2235, an RN note reveals that, at about 1600 (patient #80) became agitated and started yelling in Spanish while in her room. The note goes on to explain that patient #80 could not be re-directed and walked into the hallway while yelling, with her bible in hand. The nursing note continues in part, " medication was slightly effective, pt able to calm down in QR (quiet room). "
The medication record for patient #80 reveals orders written on 1/10/14 for Lorazepam intramuscular (IM), every 6 hour interval PRN (as needed) for agitation, and Ziprasidone intramuscular, q6h interval PRN for agitation .... " The medication administration record revealed that patient #80 received the Lorazepam 2 mg IM on 1/15 at 2029 and on 1/16 at 2128, both doses for agitation, and the Zirprasidone on 1/15 at 1620 and on 1/16 at 0256. No documentation reveals that patient #1 was offered by-mouth medication prior to the IMs.
Patient #80 was placed in seclusion, described as LDS (locked door seclusion) by the RN. Seclusion was discontinued at 2150. A nursing note of 2235 states in part, "Pt was compliant with nighttime medication after taking a shower. Pt then went in the QR and lay in bed. While patient #80 was described as waving a Bible as she yelled, staff could not have understood the content of her verbalizations enough to say that they were truly a result of her mental illness, or of some other concern which could have been remedied prior to utilizing restraint, seclusion and quiet room. Additionally, had patient #80's mental illness been the only precipitant of her behaviors, staff could offer no real comfort or redirection to patient #80 without the help of an interpreter. Further, staff could neither inform patient #80 of criteria for release seclusion, nor inform her that quiet room is a voluntary process that may be refused.
Based on all documentation, staff failed to offer patient #80 medication by mouth prior to giving IMs. Additionally, there is no documentation of staff having obtained the services of an interpreter during the restraint to inform patient #80 of what was occurring, criteria for release related to two subsequent seclusions, nor her rights related to the voluntary process of the quiet room following those seclusions. Therefore, the hospital failed to include patient #80 in her plan of care, and inform her of her rights to refuse parts of that care.
Tag No.: A0168
Based on a review of 4 out of 97 patient records, 1) patient #5, #12 and #82 were placed in non-violent restraints without timely acquisition of orders and 2) patient 61' s nonviolent order for restraint was not a complete order.
Based on review of the medical record, patient #5 was placed into bilateral wrist restraints at 1700 on 2/23/14 without an order obtained timely. This 1700 episode of restraints ended after 2.5 hours at 1930 on 2/23/14. Later the same evening, at 2230 on 2/23/14, a second episode of restraint use was initiated which lasted more than 30 hours (through 0600 on 2/25/14). The first order for restraint use was not entered into the record until nearly 16 hours after the first episode (entered at 0855 the following morning 2/24, and this order documentation referenced 17:00 time/episode. In addition to the lateness of this order, no order was ever entered into the medical record for the episode of restraint use that began at 2230. The order for the 1700 episode was then renewed at 19:52 on 2/24 nearly 24 hours after this episode had actually ended. Thus, patient #5 was in bilateral wrist restraints without any valid order from 2230 on 2/23/14 until the renewal order was entered at 19:52 the following day; and documentation supported that the practitioner was made unaware that the 1700 episode of restraints had ended and that staff had initiated a new episode of restraints at 2230 without an order. Based on review of numerous records and numerous restrain episodes, the concern that staff were not communicating with providers clearly and consistently about restraint use, including both initiation and discontinuation, was confirmed to be a pattern within the hospital.
1. Documentation revealed that patient #12 was in bilateral mitts at 0800 on 2/18 but an order for mitts was not entered until two hours later at 1000. Flow-sheet documentation was left blank throughout the day, until 0000 when the patient was placed into bilateral wrist restraints.
Documentation revealed that patient #12 was placed into bilateral wrist restraints at 0000 on 2/19 but an order was not entered until 0141.
Review of the medical record revealed a 2/19 restraint flow-sheet document that was incomplete. No safety interventions were documented at the 0600 hour on 2/20 (same sheet) and behaviors justifying the continued use of restraint were not documented from 2000 on 2/19 through 0600 on 2/20.
Review of the medical record revealed a 2/20 restraint flow-sheet document that was incomplete. Only one (untimed) narrative note was entered, i.e. reassessment was not documented. Although an order was placed for the use of bilateral wrist restraint at 742 on 2/19, that order expired at 741 on 2/20, yet restraint use continued. Additionally even the type of restraint use employed was not documented during this window with no order. Behaviors justifying the continued use of restraint were insufficient indicating only that the patient was agitated, and no documentation of the use of or consideration of less restrictive measures was found documented. A physician progress note entered at 1509 stated that patient was " without complaints " and no information about restraints was entered, yet restraints were in use at this time. (Restraint use continued unabated for more than 3 full days from 0000 on 2/19 through 0600 on 2/22.)
Review of the medical record revealed a 2/21 restraint flow-sheet document that again was incomplete. Only one narrative note was entered (at 0800), i.e. reassessment was not documented, behaviors justifying the continued use of restraint were insufficient indicating that the patient was asleep, calm, and/or cooperative from 0800 through 1800, then only agitated at 2000 and 2200, and then asleep again from 0000 through 0600 on 2/22. Despite these documented behaviors, the use or consideration of less restrictive measures was not found documented. A physician progress note entered at 1703 stated only that patient #12 was oriented only to person and confused.
Then review of the medical record revealed that staff working with patient #12 on the morning of 2/22 was in fact able to remove him from restraint throughout the day, but he was returned to restraints again by 2300.
A 2/23 restraint flow-sheet document revealed that patient #12 was in wrist and vest restraints at 07:25 and later at 18:51 was noted to be in mitts and vest restraints. However, no order for the use of a vest restraint on this date was found in the medical record. The first order for use of vest restraint was not found in the record until more than 24 hours later on 2/24 at 09:13.
Patient #12 was maintained in restraints for more than three days from 0000 on 2/19/14 through 0600 on 2/21 and then again for more than three more consecutive days from 2300 on 2/22 through 0900 on 2/26/14. Restraint orders were not consistently obtained by staff in a timely manner, sufficient documentation supporting the use of restraint was not found in the medical record, and consideration of less restrictive measures was not consistently evident in the medical record. Even with documentation of the patient calm, cooperative, asleep for many hours restraint use continued. The ongoing use of restraint, for which the record did not demonstrate justification, placed resident #12 at increased for serious harm associated with these many days of ongoing restraint use.
2. Patient #61 is a 33-year-old who required surgical services at the hospital. Patient #61 was intubated during surgery, and placed in restraints post-op to prevent accidental extubation. A review of the Post Operative Anesthesia Orders reveals a check box next to the word " restraint. " No other order is found describing an order for nonviolent restraint, how many points were ordered, or a rationale for the order. Therefore, the hospital failed to write an appropriate order for the use of nonviolent restraint.
3. Patient #82 is a young adult male who presented via emergency medical services to the emergency department (ED) in January 2014 due to an altered mental status and agitation. Patient #82 was very combative on presentation to the ED and required 4-point restraint to bring him under control for treatment at 0345. An order at 0340 for violent restraints appears in the record for 4-point restraints. A new order should patient #82 require a continuation, would have appeared in the record at 0740. However, no new order appears in the record until 1031, effectively leaving patient #82 in restraint for 3 hours without a physician order to do so. Patient #82 was released from restraint at 1345.
The hospital failed to write continuation orders for violent restraint every 4 hours as required by regulation during the duration of patient #82 ' s restraint episode.
Hospital Policy COP-029, last updated in October 2013, required that staff obtain orders for non-violent restraint use " immediately " and other documentation revealed that the hospital had defined immediately as within 15 minutes.
Hospital policy COP-029 also provided that restraints can be applied without attempting less restrictive measures in emergency situations. The policy defined emergency situations as those in which " a patient ' s behavior poses a threat to the physical or medical safety of self or others and in which case the use of restraint alternatives is not appropriate. " While emergency use of restraints might be necessary on occasion in these identified cases, patients remained in restraints for many hours and sometimes even many days, without evidenced oversight, timely orders, or attempts to move the patients to less restrictive measures. As such, these cases lasting for many hours and sometimes many days cannot be deemed " emergencies " where the consideration of less restrictive measures would " not be appropriate " as described in the hospital policy.
This pattern of staff placing critical-care patients into various types of restraints without sufficient oversight, without timely written orders as required in Federal regulations, and without consideration of less restrictive measures greatly increased the risk for serious patient harm and possible death associated with the use of restraints in a vulnerable patient population.
Tag No.: A0179
Based on hospital policy and review of patient #80's record, it is revealed that for one of 97 patients reviewed no face-to-face was written over the course of two evening/night seclusions.
Patient #80 is a young Spanish-speaking adult female admitted to the behavioral health unit (BHU) in January 2014. On 1/15, a nursing note of 1330 reveals that patient #80 was able to make her needs known through translation services. At note of 2235 reveals that, at about 1600 (patient #80) became agitated and started yelling in Spanish in her room. The note goes on the explain that patient #80 could not be re-directed and walked into the hallway yelling with her bible in hand. The nursing note continues in part, " medication was slightly effective, pt able to calm down in QR (quiet room). LDS (locked door seclusion) was discontinued at 2150. Pt was compliant with nighttime medication after taking a shower. Pt then went in the QR and lay in bed.
The hospital " Use of Seclusion and/or Restraints for Uncontrolled, Violent and/or Aggressive Behavior " (revised 2/14) reveals in part, " Management of Orders, d. Within one hour of initiation of restraint or seclusion, the LIP must (1) Complete a face-to-face evaluation of the patient (i) Assessment must be completed even if patient is no longer restrained or secluded. " No face to face appears in the record by an LIP (licensed independent practitioner) within one hour for either of two seclusions on 1/15 and 1/16. Therefore, the hospital failed to conduct a face-to-face for patient #80 who was twice secluded.
Tag No.: A0283
Based on review of record , it was determined that the hospital had identified some inconsistencies in its blood transfusion process but failed to identify opportunities for improvement and make changes that will lead to improvement.
Based on review of the medical records, quality initiatives and quality data the hospital is tracking and trending information regarding blood and blood product transfusion. The hospital identified problems with obtaining two signatures on the blood transfusion slips, dates and times the blood was started or ended and documentation of volumes. The hospital identified the problem as a safety issue. As the surveyors reviewed charts in various units the review of blood transfusion slips revealed the continued failure to document both signatures during the verification process, start and end dates and times. The reviews revealed that the patients receive blood in the operating room prior to transfer to the units and additional blood was given once admitted to the units. The lab slip review revealed blood slip compliance by the unit staff and CRNAs. On further investigation it was determined that the non-compliance was largely occurring in the operating room by the anesthesia providers. The Director of Anesthesia informed the surveyors that he was not aware of the issue until a few weeks before the surveyors arrived at the hospital.
The transfusion of blood and blood products is a high risk, high volume, problem prone process that must be continually evaluated to identify areas of improvement and to prevent transfusion errors.
Based on the medical record reviews the hospital has failed to ensure blood and blood products provided in the operating rooms are administered safely in accordance with regulatory and accreditation standards. In addition, although they identified the issue and implemented initiatives to remediate the problem, the re-evaluation determined that other services besides nursing were involved but the focus continued to be on the nursing services and no initiatives for the other services such as surgical services and anesthesia.
Tag No.: A0395
Based on a review of 1 out of 97 patient records, it is revealed that nursing failed to identify patient #75 ' s inability to effectively reposition him-self, resulting in a deep tissue injury of the gluteal cleft.
Patient #75 is a 65-year-old admitted for abdominal pain, and required a surgical procedure. On entry to care, patient #75 was documented as low risk on the Braden scale and was found to have no wounds. Patient #75 had pre-existing conditions including diabetes.
Patient #75 developed a deep tissue injury which was noted on 2/20. Review of patient #75 ' s activity and turning revealed the " Daily Patient Profile (DPP), and " Activity and Treatment Record (ATR) " which describe in part, activities of daily living, and nursing care as related to the patient ability to care for self. Under " Activity, " the nurse may note if the patient requires an assist, or if they can turn themselves.
Starting on 2/17, patient #75 began having an alteration of his mental status. On this day, his nursing note revealed him to be oriented to person only, yet the ATR indicated that patient #75 continued to be able to turn himself.
On 2/18 nursing did assist patient #75, but on 2/19 when patient #75 was noted as non-responsive to the physician, nursing documented that he could turn himself. Also on this day, patient #75 was noted to use his PCA (Patient Controlled Analgesia) two and three times the amount he had been using. Patient #75 was placed on a soft care mattress.
On 2/20 a wound consult assessment was conducted. The wound care nurse found a decubitus of the gluteal cleft which she staged as a deep tissue injury (DTI) measuring 8.5 cm in length and 9.3 cm in width, and covered by a blister. She documented, " Referred to pt for assessment of gluteal cleft/coccyx pressure ulcer. Patient had developed a DTI (deep tissue injury) within affected area. Wound continues to evolve. " The wound nurse wrote recommendations which included the active nursing process of every- 2-hour turning. "
Patient #75 appeared to regain his orientation. On 2/21, nursing noted patient #75 as needing an assist to turn, but all other days through 2/25 (the day of the survey), patient #75 is noted as being able to turn himself. Of note in nursing documentation of 2/24 where the nurse consulted the wound care nurse due to patient complaints of buttock pain while sitting in a chair. The wound nurse suggested that he not sit for long periods, and that she would come to further assess patient #75.
Based on the medical record review; nursing failed to account for patient #75 ' s altered mental status and his increasing use of the PCA as related to his ability to turn himself. Additionally, once patient #75 had a wound assessment, and 2-hour turning was recommended, nursing documented only one day of turning assist to patient #75. All other turning documentation after 2/21 reveals that patient #75 could turn himself. While patient #75 may have been able to self turn on those days, documentation does not show that he actually did turn himself or any form of nursing encouragement for patient #75 to turn, nor did documentation show that his attempts to turn were effective. Therefore, the hospital failed to supervise and evaluate the nursing care for patient #75 related to his ability to turn himself, resulting in an evolving deep tissue injury.
Tag No.: A0450
Based on review of the medical record, policies and procedures, and staff interviews, the hospital failed to ensure the medical records were complete and accurate as required by the Federal regulation and as evidenced by:
In 3 of 97 medical record reviews for patient #3, 6 and patient #60 parts of the medical record are inaccurate and incomplete. The transfusion records for these patients were incomplete including no date and time of initiation of blood transfusion or documentation of safety check with one or more signatures missing including the person performing the transfusion.
In 1 out of 97 medical record reviews for patient #34 revealed a History and Physical (H & P) Prep-Adult Preoperative document completed on 12/18/2013; however, the attending physician failed to sign, date and time the H & P.
In 1 out of 97 medical record reviews for patient #29 revealed a consult report that was not dated or signed by the consultant. The report did not identify the type of consultation. The patient had been discharged on 12/23/2013.
In 2 of 97 medical record reviews, patient #46 and patient #47 were unable to sign consent for medical care and treatment. Although the patients had a length of stay lasting more than two weeks, the consent documentation was not updated to demonstrate attempts were made to get consent from the patient, guardian, or family during the hospital stay.
Patient #46 was admitted to the hospital on 2/7/14 both the uniform consent which includes consent to treat and his Important Messaged from Medicare forms stated " Patient unable to sign. " The uniform consent form did not have a reason checked why the patient could not sign nor was the reason checked on the IM form. No documentation could be found demonstrating staff attempts to get consent from the patient, guardian or family for a patient who had been inpatient for 18 days.
Patient #47 was admitted to the hospital on 2/2/14 both the uniform consent and the Important Message from Medicare forms stated " Patient unable to sign due to physical condition. No documentation could be found demonstrating staff attempts to get consent from the patient, guardian or family for a patient who had been inpatient for 23 days.
In 1 of 97 medical record reviews, patient #44 had a Initial Consult/H&P performed and documented in the medical record on 2/7/14. On page 3 of the 4 page form under the " Extremities " category the information written in the block is scratched through. There ' s no indication of the date and time and by whom this was done. The hospital has a policy for the correction of written documentation errors. The resident failed to follow the hospital policy and procedure for the correction of information written in error on patient #44 ' s medical record.
Tag No.: A0469
Based on a review medical records, it was determined that 1out of 98 records contained discharge summaries that were not signed within the 30-day timeframe for closed records.
Patient #35 was admitted to the hospital 12/19/13. The patient was transferred to MICU/CCRU) 12/24/13 and discharged on 12/25/13. The patient had an addendum discharge summary completed but not signed by the physician. The initial discharge summary was signed electronically on 2/3/14 which outside of the 30 day regulatory guidelines.
Tag No.: A0700
Based on observations during a tour of the hospital and interviews with hospital staff, it was determined that the Condition of the Physical Environment was not in compliance due to numerous deficiencies cited during Life Safety Code survey that included :
K018 - All doors were not equipped with astragel , rabbet or bevel as required to eliminate the gap between door leaves;
K027- There was a large gap between on set of doors on the basement level rendering the doors not smoke resistive;
K029 - A set of doors was held open by non approved devices;
K034 - A ladder was stored in a stairway next to an egress door;
K052 - The heat detector located in the Trauma building was heavily soiled with lint.
K056 - Suspended ceiling tiles were removed that resulted in improper placement of the upright sprinkler heads;
K064 - Failure to maintain some fire extinguishers;
K069 - Failure to provide appropriate signage on the hood extinguishing system;
K070 - The use of non compliant portable heaters;
K075- The use of oversized mobile trash and soiled linen collection receptacles;
K130 - The storage of flammable and combustible gas in a health care facility; and
K135 - Due to non- compliant electrical applications
Tag No.: A0701
Based on a tour of the facility it was determined that the hospital had not adequately addressed an potential employee safety issue.
On February 24, 2014 and as part of the survey activities of one of the Life Safety surveyors, it was revealed that oxygen monitoring equipment was disconnected from its electrical power supply. The location where this was found, rooms S9C10 and S9C12 of the South Building, was determined to be a Cell Therapy/Graft Engineering Laboratory that employed cryogenic freezers that utilized refrigerated Nitrogen gas. As refrigerated Nitrogen gas evolves from the cryogenic storage equipment, there is the potential for displacement of Oxygen below levels required to support human life. The oxygen monitoring equipment was installed to assure adequate levels of oxygen for safe entry by staff.
Interview of the staff from the laboratory staff and physical plant staff revealed that due to erroneous alarming of the oxygen monitoring system due to Nitrogen off-gassing, oxygen levels within were safe for staff entry. Unfortunately, failure to employ other approaches to assure a safe environment for staff left this laboratory with the potential for injury to the staff that worked there.
The condition of the physical plant and the overall hospital environment must be developed and maintained in such a manner that the safety and well-being of patients and staff are assured.
Tag No.: A0724
Based on the February 25, 2014 observation of the Special Chemistry Laboratory, North Building - Second Floor, University of Maryland Medical Center, it was revealed that laboratory regents dating back to the year 2000 were being stored underneath of a laboratory sink with hood. Inspection of the bottles of regents revealed expiration dates from 2000 to 2002, where these products should have been identified through in-house inspection for proper disposal.
During the inspection of the Special Chemistry Laboratory, North Building - Second Floor, University of Maryland Medical Center, it was revealed that laboratory regents dating back to the year 2000 were being stored underneath of a laboratory sink with hood. These products, all acids which including Nitric Acid and Acetic Acid, had reached their expiration dates more than a decade ago yet were never discovered and identified for proper disposal by laboratory management or staff.
Facilities, supplies, and equipment must be maintained to ensure an acceptable level of safety and quality. This would be inclusive of scheduled and regular inspections to assure safe conditions and to identify issues that required interventions and improvements. The failure of staff to identify expired reagents would be one such example. Not only does the storage of expired laboratory reagents create the potential for staff injury, it may result in the alteration of laboratory assays.
Tag No.: A0726
Observation and tour on 02/27/14 in the am of the NICU Unit located in the S6H building and interview of the Nurse Manager, revealed that not all breast milk refrigerators are plugged into red outlets for a continuous power source for milk preservation. This was evident for four out of five designated breast milk refrigerators observed. Observation of individual NICU cluster rooms revealed that the following rooms had breast milk refrigerators connected/plugged into regular power outlet sources: P6H04, P6H11, P6H14, and PGH15 which meant the refrigeration units would not have electricity if there were a loss of power.
Interview of the Nurse Manger revealed that the NICU staff would take the breast milk out of the refrigeration units with loss of power and place them in the red outlet connected refrigerator unit located in room P6H05. The surveyor requested the Nurse Manager to provide a written plan of management in the vent this event should happen. Further interview of the Nurse Manager, revealed that the NICU Unit is moving early 03/14 in anticipation that a new NICU will be under construction. The Nurse Manager indicated that the new unit plans design includes the addition of more red outlets for refrigeration units.
Failure to have breast milk refrigerators connected to red outlet creates the potential to have milk spoilage if not managed in a timely manner.
Tag No.: A0940
Based on the interviews with staff, policies and procedures and other pertinent documentation, it was determined that the hospital failed to execute safety practices related to administration of blood and blood products in the operating room.
As indicated in A0951, during survey begun on February 24, 2014 at University of Maryland Medical Center the medical record review revealed patients in the operating room are receiving blood transfusions without completed documentation of the two-person verification process and failure to document date and start and end times.
Tag No.: A0951
Based on staff interviews, policies and procedures, and other pertinent documentation, the hospital failed to safely administer blood in the operating room. Review of other pertinent documentation revealed that the hospital was aware of concerns with blood administration in the surgical services area, and based on observation and interviews in the surgical services area, only anesthesiologists transfuse blood products in the operating rooms. Six weeks before the survey date of record, Policy COP-024 was revised to address concerns that had been identified with transfusion of blood including interventions to improve the documented timing of the start of a blood transfusions and the utilization of new bracelets.
Review of documentation by the survey team throughout the hospital revealed that the documentation of unsafe blood administration practices was limited to the surgical services arena. Also, specific to the surgical services area, primarily anesthesiologists hang blood products during surgical procedures. During the survey exit conference, the Director for Anesthesiology Services acknowledged that he had only become aware of the safety concerns with blood administration two weeks prior to the survey, even though it had been a hospital-wide area of concern that quality staff were actively working on much longer. In addition to a failure to ensure all staff including those in surgical services were aware of the blood administration safety concerns and of the policies that had been changed to address the concerns; even two weeks after the acknowledged awareness of the unsafe practice in anesthesia services, the ongoing pattern of unsafe blood administration practices by anesthesiologists in the surgical services arena was still not corrected at the time of the survey.
Patient #3 received blood during a surgical procedure performed in the operating room on 2/19/14. Medical record review revealed that documentation of critical safety checks prior to administration of blood was not completed. Paper forms for the administration of four units were reviewed in the clinical record.
The first blood administration documentation form for patient #3 revealed only initials from someone indicating that the blood was checked, but there was no name or discipline noted with those initials. The rest of the administration documentation was entirely blank including the transfusionist signature, the date and time the unit was hung, the date and time administration ended, and the volume that was transfused. In addition, the documentation of on-set of initials reveals that the verification process was not performed per policy which requires two clinicians, RNs, MDs, or LIP to perform independent double check. On the blood slip there is space for the two clinicians to sign after completion of the verification process. There is only one signature in the transfusionist space and the checked by space is blank.
The second blood administration documentation form for patient #3 was identical to the first, revealing only initials from someone indicating that the blood was checked with no name or discipline noted for the person with those initials. The rest of this administration documentation was left entirely blank including the transfusionist signature, the date and time the unit was hung, the date and time administration ended, and the volume that was transfused.
The third blood documentation form for patient #3 was identical to the first revealing only initials from someone indicating that the blood was checked, again with no name or discipline noted. The rest of this administration documentation was also entirely blank including the transfusionist signature, the date and time the unit was hung, the date and time administration ended, and the volume that was transfused.
Of the four forms, only the fourth documented a signature and discipline for the second check, the transfusionist signature, and the date and time that the transfusion started and ended.
Patient #6 received blood during a surgical procedure performed in the operating room on 1/22/14. Medical record review revealed that documentation of critical safety checks prior to administration of blood was not complete. Paper forms for the administration of four units of blood were reviewed in the clinical record.
The first two forms for patient #6 revealed only initials for the individual who attested to checking the blood product to ensure the correct patient and blood type, and both of these documentation forms failed to show the time the transfused units started or ended. Also, the transfusionist signature was not timed, not dated, and not legible.
The third blood administration form revealed only initials for the individual who attested the accuracy of the blood product, no times or dates for when the transfused units started or ended, and a transfusionist signature that was not timed, not dated, and not legible.
The fourth blood administration form revealed only initials for the individual who attested to the accuracy of the blood product, no times for when the transfused units started or ended, and a transfusionist signature that was not timed, not dated, and not legible.
Patient #60 received blood during a surgical procedure in operating room on 02/25/15. The medical record review revealed that documentation of critical safety checks prior to administration of blood was not complete. The paper forms for the administration of two units of blood were reviewed in the clinical record. One of the two forms revealed no transfusionist signature and the other form revealed one person initials in the transfusionist space but no signature in the checked by space which calls into question whether the safety checks were performed before administration of blood.
Tag No.: A0955
Based on policies and procedures, and medical record review the hospital failed to properly executed informed consent for surgery for patient #33.
In 1 of 98 medical records reviewed (patient #33), the hospital failed to ensure a properly executed informed consent for surgery. Patient #33 had surgery on 12/23/13. In the medical record review for patient #33 a Consent for surgery and other procedures form was signed by patient on 12/23/2013 related to a cystoscopy procedure but the form was not dated, timed or signed by the healthcare provider.