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301 SAINT PAUL PLACE

BALTIMORE, MD 21202

PATIENT RIGHTS: INFORMED CONSENT

Tag No.: A0131

Based on review of hospital policies and 32 open and 10 closed medical records, it was determined the hospital failed to uphold one patient's right to being informed and involved in their care and treatment by not providing timely interpreter services for patient #4. In addition, the hospital policy for "Informed Consent" (reissued 3/2016) failed to accurately describe the process for determining a patient's capacity or incapacity to make informed decisions about his or her care.

Per hospital policy titled "Communication Challenged Patients" (Dated 08/14), "(The facility) will provide health care services that are respectful and responsive to the cultural and linguistic needs of our patients. This means staff will make every effort to provide communication in the preferred language of the patient and ensure that the patient understands all clinical and administrative information." The policy also stated, "Bilingual (hospital) employees deemed competent to interpret by (the hospital) may be used for interpretation/translation services in either of the following situations:" "The physical presence of an interpreter is necessary" and the "Language Line is not available for interpreter services."

Patient #4 was a 70+ year old Spanish speaking patient who presented to the hospital as an emergency transfer from another hospital for a surgical procedure. Patient #4 was then transferred to the intermediate care unit (IMC) that night. Per the IMC nurse at 0000, it was documented "pt Spanish speaking only. RN currently speaking Spanish to patient-will need interpreter if RN cannot speak Spanish and family not present." The nurse speaking with the patient was not, at that time, on the hospital's list of certified staff interpreters. In addition, if a patient wants their family member to interpret, a baseline assessment needed to be determined with a qualified interpreter.

From the chart review it was revealed there were multiple instances of interaction with patient #4 and physicians (MD), physician assistants (PA), respiratory therapists (RT), occupational therapist (OT), and nurses (RN) that did not indicate a translator was used. These instances included the initial history and physical exam (H &P) completed by a PA, MD and PA daily progress notes, and nursing assessments.

In addition, a note by OT on the patient #4's second day of admission at 14:24 stated, "educated on precautions via language line using family members phone." "Patient and family member educated on abdominal precautions via using an app on family members phone that [family member] was comfortable with."

A note by PT on patient #4's 4th day of admission at 1437 stated "Patient speaks no English. Physical Therapy accessed Google Translate via Nurse's request. Patient agrees to work with therapy."

Per discussions with hospital staff during onsite survey, a language line and telephone are available throughout the hospital to patients who require interpretive services. In the above two instances, the use of the hospital language line was not used. Furthermore, Google translate and a language app on the patient's families were not listed as being approved by the hospital.

The hospital failed to obtain adequate and timely interpretive services for multiple interactions involving patient #4's care and treatment and therefore failed to uphold the patient's right to make informed decisions regarding his or her care.

The hospital policy for informed consent stated in part under "Procedure," 3. "Competent means able to understand or evaluate treatment issues and to communicate a decision about treatment." The policy went on to state who may Consent, "2. Substitute consent for Incompetent Adults ..." However, the term "Competent" and "Incompetent" refer to a legal judgement, rather than a clinical evaluation of competence or the certification of a patient's incapacity to make decisions.

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0174

Based on a review of the hospital policy "Management of Restraint Use for Non-Violent and Violent Patients" (effective 12/18) and the medical records of two patient restrained for violent behavior in the past six months, it was revealed that the hospital failed to release patient #42 (P42) and patient #43 (P43) at the earliest possible time.

Per the "Management of Restraint Use for Non-Violent and Violent Patients" policy Effective 12/18, "xiii Restraints and seclusion are discontinued at the earliest possible time, regardless of the scheduled expiration of the order."

Patient #42 presented in July 2018 to the emergency department. Review of P42's record revealed that patient #42 was placed in 4-point restraint at 0200 and received an intramuscular (IM) sedative. Nursing flow documentation revealed that P42 was initially "agitated" at 0200 when placed into restraints, and was then sleeping from 0215 through 0330. P42 was then documented as "quiet from 0345 through 0445. No RN assessment of any kind for termination of restraint was noted between 0200 and 0500 though P42 was no longer violent and met criteria for release.

Per a neurological form of 0500, P42 was "briefly arousable" to "Speech" and "Withdrew to pain." That meant that at 0500, P42 was sleeping, but was awakened by nursing and given a pain stimulus. Next to documentation for 0500 of sleeping, P42 was documented on restraint documentation to be "agitated," and was given another IM sedative based on that brief period of agitation in response to a painful stimulus. An additional order for restraint was written at that time even though P42 was sleeping. P42 was documented as asleep from 0500 until 0715, then "loud/noisy" at 0730 and was then was taken out of restraint at 0800.

Nursing failed to recognize that P42 had met criteria for termination of restraint by 0215, and instead kept P42 in restraint without justification to do so for another approximate 6 hours.

Patient #43 (P43) was an adult who presented to the emergency department in August 2018. P43 was placed into 4-point restraint from 0457 to 0729. Review of the restraint/seclusion flow sheet revealed only one initiating RN entry for behavioral documentation during an approximate 2.5 hours of restraint.

Review of the Hospital "Management of Patient Restraints" training directed in part under "Restraints/Seclusion Documentation Flow Sheet" that "Violent" restraint documentation was "every 15 minutes to ....Document Behavior..." This direction was in contrast to physician orders for restraint which could prescribe intervals of flow documentation. For patient #43, the physician prescribed 20-30 minute monitoring which failed to meet documentation standards for 4-point restraint, and demonstrated inconsistent restraint processes.

However, for P43, no ongoing behaviors were documented during the approximate 2.5 hour restraint period by which to determine the earliest possible time for release. One progress note entry of 0650 revealed that P43 was in 3-point restraint, though no behaviors were documented to indicate why P43 was released from one but not all 4 restraints at that time.

In summary, P42 was not released at the earliest possible time, and it was not possible to tell if P43 was released at the earliest possible time. Neither patient's record contained objective descriptors of the actual behaviors that predicated the application and continued use of restraints.

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0179

Based on review of restraint events for patient #42 and patient #43, it was determined that no face to face assessment

Per the "Management of Restraint Use for Non-Violent and Violent Patients" policy Effective 12/18, "(c) (ii) The Provider Performs a face-to-face assessment of the patient within (1) hour ..." Review of P42's restraint record revealed a running physician note dictated at 0621 which stated P42 was seen at 0130. P42 was restrained at 0150, but no face to face assessment of the four required elements was found.

Review of P43's restraint record revealed a physician note dictated at 0811 which started at 0711. P43 was restrained at 0457 though no face to face was found in the medical record.

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0194

Based on a review of restraint processes, policies, and training, it was determined that the hospital failed to provide 1) restraint competencies and training intervals in the job description for security personnel; 2) training to identify when a patient is in distress; 3) CPR for security staff; and 4) a Use of Force policy which required clinical oversight of patient restraint episodes, and which described parameters on the use of security batons and handcuffs. In addition, it was determined that the training content for clinical staff contained inaccuracies which could result in inappropriate restraint use.

Per the "Management of Restraint Use for Non-Violent and Violent Patients" policy Effective 12/18, "vi Staff is trained on the use of restraint and seclusion during orientation and on a periodic basis thereafter."

Review of security staff job descriptions revealed no evidence of restraint specific competency requirements. Interview with security staff on 1/22/18 at approximately 1030 revealed that security received restraint training on orientation, but not again on any interval basis. Review of hospital training identified no information related to training security staff how to determination when a patient was in distress. Additionally, the hospital had no requirement that security be trained in Cardiopulmonary Resuscitation.

Additional interview with security revealed that security staff are certified in the use of batons and handcuffs. Review of the hospital "Use of Force Policy" (revised April 10, 2018) revealed no parameters related to the use of these police implements, and no requirement for clinical guidance when dealing with persons who may display aggressive behaviors due to underlying conditions.

Review of the hospital "Management of Patient Restraints" training tool revealed a compare/contrast of the reasons for using violent vs. non-violent restraints. The phrase "Potential or imminent harm to self and others" was listed under Violent Restraints. The term "Potential" referred to a subjective judgement about possible future events, and did not describe a situation in which the patient was presenting actual or imminent harm.

Additionally, the violent compare/contrast stated that the causes of the patient's violent and harmful behavior that would require violent restraints "Are often not attributable to underlying medical conditions." This information contradicted the requirement of determining if an underlying medical condition, for instance, hypoglycemia, contributed to the violent behavior.
While there were no findings of patient harm found during the survey that were attributable to erroneous training content, the potential for misunderstanding both the causes of violent behavior and the circumstances requiring use of restraints for violent behavior had the potential for patient harm.

DATA COLLECTION & ANALYSIS

Tag No.: A0273

Based on a review of QAPI data during the validation survey on January 22, 2019, it was determined that, while the hospital collects some data related to restraint use, the data collected was not of sufficient depth or quality to enable the hospital to determine compliance with regulatory requirements or to determine if patient rights were supported and staff performance metrics were met.

Nurse managers reported restraint documentation audits through the electronic incident reporting system. These data points included whether an order was present and whether alternatives to the restraint were documented, but contained no analysis of the appropriateness of the restraint or whether the patient was released at the earliest possible time. The QA restraint audit also lacked a component for tracking whether the face to face was completed within an hour of the application of restraints for violent or dangerous behavior, and did not track the total time in restraints.

QUALITY IMPROVEMENT ACTIVITIES

Tag No.: A0283

Based on interviews, document review, and observations in the perioperative area, it was determined that the hospital was collecting data related to hand hygiene (HH), but has not implemented any additional corrective actions to improve HH compliance in procedural areas.

The hospital was requested to provide quality date related to hand hygiene practices within procedure areas. The hospital provided an Assess Improve Implement Measure (AIIM) project outline, data tracking, and instructions for staff training. The AIIM project start date was August 2016. This document included the hospital's hand hygiene goal of 92% not being met and nine specific actions that were implemented. However, the AIIM documentation listed no mechanism of how compliance would be measured, evaluated, or tracked. The Infection Control Practitioner (ICP), in an interview during the survey on 1/23/19, stated that the hospital used a mixture of known and unknown observers for tracking HH compliance and these staff made an average of 1200 HH observations a month. Interventions for individual non-compliance included on-the-spot verbal correction or reporting the staff person to the manager.

The metrics of hand hygiene compliance in procedural areas, from November 2016 through December 2018, were reviewed. The documentation indicated waxing and waning improvement shown for 5 of 6 most recent months; however, these values remain below the goal. No documentation was provided to show that new interventions were implemented related to the evaluation results of the tracked data.

Please see A-0749.

PHYSICAL ENVIRONMENT

Tag No.: A0700

Based on deficiencies identified during the Life Safety Code survey, it was determined that the hospital is out of compliance with the Condition of Physicial Environment. See LSC survey ID 1CRY21.

FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE

Tag No.: A0724

Based on observation and interview with the kitchen staff, it was determined that the facility kitchen had two areas not well maintained.
1. Can opener holder on food prep table with a dried dark substance.
2. Several damaged food serving trays.

INFECTION CONTROL PROGRAM

Tag No.: A0749

Based on interviews, review of QAPI data, and observations conducted while reviewing the Perioperative Care Unit (PCU), Post Anesthesia Care Unit (PACU), and within the Operating room (OR) core, multiple staff members in varying professional roles failed to adhere to the hand hygiene practices established by the hospital and infection control standards.

The PCU, and PACU were toured on 1/23 and 1/24/19. Various clinicians including physicians, anesthesia, and nursing staff were observed entering and exiting patient rooms without hand washing or using alcohol-based hand sanitizers (ABHS). It was noted that the alcohol-based sanitizer in the PCU were in the patient rooms, some clinicians were seen exiting rooms still rubbing hands in ABHS, while others were observed leaving rooms without evidence of using ABHS.

A surgical patient was tracked from PCU assessment, throughout entire surgical procedure, and to the PACU. During the OR portion of this tracker, an OR staffer not involved in the case entered the sterile OR, inquired about and looked for equipment before exiting, with no observed hand hygiene. In addition, during this same case, a delay in hand hygiene by the incoming circulating nurse was observed.

The hospital was requested to provide quality date related to hand hygiene practices within procedure areas. The hospital provided an Assess Improve Implement Measure (AIIM) project outline, data tracking, and instructions for staff training. The AIIM project start date was August 2016. This document included the hospital's hand hygiene goal of 92% not being met and nine specific actions that were implemented. However, the AIIM documentation listed no mechanism of how compliance would be measured, evaluated, or tracked. The Infection Control Practitioner (ICP), in an interview during the survey on 1/23/19, stated that the hospital used a mixture of known and unknown observers for tracking HH compliance and these staff made an average of 1200 HH observations a month.

The metrics of hand hygiene compliance in procedural areas, from November 2016 through December 2018, were reviewed. The documentation indicated waxing and waning improvement shown for 5 of 6 most recent months; however, these values remained below the goal. No documentation was provided to show that new interventions were implemented related to the evaluation results of the tracked data.

Please see Tag A-283

DIRECTOR OF RESPIRATORY SERVICES

Tag No.: A1153

Based on an onsite survey on 1/22/19, interviews with staff and review of hospital policies it was determined the hospital did not have a formal reporting structure or a medical director of respiratory care services to supervise respiratory therapy services.

In an interview during the survey on 1/22/19, the Manager of Respiratory Services, a licensed respiratory therapist, indicated that the position reported to the Hospital's Chief Nursing Officer (CNO) and Medical Director of Pulmonology. Further inquiry revealed no formal reporting structure between the manager and the medical director.

This was evidenced by the respiratory manager being evaluated on their annual performance review by the CNO and not the medical director. In addition, the "Leadership Plan" document that was approved by the Medical Executive Committee (MEC) in February of 2018, stated the "Manager of Respiratory Care" reported to the "Vice President of Patient Care Services" who was determined to also be the CNO while on survey. The respiratory manager had clinical duties, but was not evaluated for clinical competencies by the Medical Director of Pulmonology. The last performance evaluation was signed by the CNO with no formal input from the medical director.

Monthly meetings with the medical director were mentioned to occur, however, no minutes were taken of those meetings. When requested, agenda lists were supplied to the surveyor, but no meeting notes or outcomes were found.

It was also noted that several policies that pertain to the respiratory department were approved by the respiratory manager and not the Medical Director of Pulmonology. Of the seven policies reviewed that indicated the responsible unit to be respiratory therapy, only two polices had the Medical Director's approval.