The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

LAUREL REGIONAL MEDICAL CENTER 7300 VAN DUSEN ROAD LAUREL, MD 20707 March 20, 2014
VIOLATION: PATIENT RIGHTS: GRIEVANCES Tag No: A0118
Based on a review of the hospital Patient information pamphlet, " What You Should Know As A Patient and Patient Complaints and Grievances policy, interview of Patient Relations, review of the complaint log and review of 5 complaint and grievances, 1) the hospital does not currently distinguish between complaints and grievances, and therefore, complaints which qualify as grievances are not handled per grievance regulatory directives, and 2) the hospital patient information pamphlet fails to describe the complaint/grievance process, and who to contact.

Interview with Patient Relations approximately 1:30pm reveals that the hospital keeps one complaint/grievance log which does not distinguish between complaints and grievances. Review of the complaint log reveals multiple complaints, some which may have been grievances. However, the log and other documentation did not differentiate between a complaint and grievance.
VIOLATION: PATIENT VISITATION RIGHTS Tag No: A0216
The standard is not met as evidenced by:

Based on review of the patient information pamphlet and the hospital visiting policy, the hospital's policy and patient information pamphlet does not clearly outline the patient's visitation rights including those setting forth any clinical necessary or reasonable restriction or limitation that the hospital may need to place on such rights and the reasons for the clinical restriction or limitation. Review of the hospital patient information pamphlet revealed the patient or support person are not informed of their rights to consent to receive visitors whom he or she designates including, but not limited to, spouse, a domestic partner (including a same-sex domestic partner), another family member, or a friend and his or her right to withdraw or deny such consent at any time. The hospital has limited visitation times per unit/department but identifies the process for special consideration different visitation times and rights. The policy does not outline the role of the support person or process for visitation restrictions for clinical reasons as well as the documentation of the process.
VIOLATION: PATIENT VISITATION RIGHTS Tag No: A0217
Based on review of the hospital's visitation policy, Visitation Guidelines, Policy #901-007 and patient information pamphlet, it was revealed that the policy and the patient information pamphlet does not state that the visitation privileges are allowed regardless of the visitor or patient race, color, national origin, religion, sex, gender identity, sexual orientation or disability. The hospital failed to provide patients and their support persons (as appropriate) with details concerning the rights of visitations.
VIOLATION: PROGRAM DATA, PROGRAM ACTIVITIES Tag No: A0283
The hospital must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that assess processes of care, hospital service and operations.

This regulation is not met as evidenced by:
The hospital staff in the Emergency Department and the inpatient critical care and medical-surgical units are appropriately implementing and monitoring the restraint and seclusion policy/procedure and keeping data regarding the use of seclusion and restraint, however, on the second day of the survey the hospital staff on the inpatient behavioral health unit informed the surveyor that they did not have a log regarding restraints/seclusion for the in-patient psychiatric unit.

Since the hospital had no documented restraint or seclusion usage in 2014, the hospital staff was asked to provide compliance data for 2013. The nurse stated the Administrative manager who was no longer with the hospital kept the data and they could not retrieve the information. The nurse stated that the unit has infrequent use of restraint or seclusion but remembered two occasions of restraint or seclusion use for 2013 but did not know the patient's names or exact dates. When the hospital was asked to pull this information from their quality data or (MIDAS) the Director of Quality stated the review of information from the occurrence reporting system (MIDAS) revealed no patients in restraint or seclusion for 2013. The hospital was unable retrieve information or select medical records since they did not have a log or other documentation and the occurrence reporting system revealed no restraint/seclusion episodes including the two restraint/seclusion episodes staff reported occurred in 2013.

Review of the quality/performance improvement data revealed no documentation of data regarding restraint/seclusion usage in the hospital. There is no indication that the hospital is tracking, analyzing and trending data regarding their restraint/seclusion usage and therefore the hospital failed to monitor or measure quality indicators for restraint and/or seclusion in all locations of the hospital.

Further, the hospital policy under #12 Performance Improvement revealed:
1. That every episode of restraint use is entered into the hospital's occurrence reporting system MIDAS, which is reported on a monthly basis to Leadership and the Patient Safety Committee. Based on evaluation of data, changes will be made to the policy and education of the changes will be completed.
2. The hospital identifies, collects, compiles and analyzes each episode of restraint and seclusion usage to identify levels of performance, patterns, trends, and variations in the use of seclusion and restraints. From this data, opportunities to reduce risks associated with restraint and seclusion use through preventative strategies, alternatives and process improvement, if identified, will be prioritized.
3. In behavioral health, data on restraint and seclusion episodes are collected from and classified for all settings and locations by: a) shift, b) staff who initiated the process, c) the length of episode, d) date and time each episode initiated, e) day of the week each episode was initiated, f) type of restraint used, g) whether injuries were sustained by the individual or staff, h) age of the individual, i) gender of the individual, j) debriefing data, k) multiple incidences of restraint or seclusion by an individual within 12 hours, l) number of episodes per individual served, m) instances of restraint or seclusion that last longer than 12 consecutive hours and n) use of psychoactive medications as an alternative to, or to enable discontinuation of restraint or seclusion.
4. A restraint/seclusion log book will be maintained on each patient care unit for the purpose of identifying: patients who are in restraint/seclusion, date/time/week restraint were initiated, date/time/week were discontinued, restraint type, reason for restraint, whether the patient was displaying acute care or behavioral health (violent or self-destructive) behaviors and whether the care of the patient in restraint/seclusion complied with policy.

Based on staff interview and policy/procedure, it is determined that 1) the hospital electronically tracks restraint/seclusion episodes via occurrence reporting system, but is inconsistent for tracking quality processes for restraint/seclusion and, 2) quality tracking documentation in the form of a log is not being documented and shared, and 3) the surveyor cannot validate that quality tracking occurred on the inpatient behavioral health unit during 2013 since the unit does not keep a log per policy and procedure and must rely on staff to input information into the occurrence reporting system which may be inconsistent. The surveyor was not able to compare the log to the occurrence reporting system (MIDAS) to validate the staff recollection regarding two patients placement in restraint/seclusion in 2013. The hospital failed to monitor or measure quality indicators for restraint and/or seclusion in all locations of the hospital.
VIOLATION: PATIENT RIGHTS Tag No: A0115
Based on staff interviews, review of policies and procedures, medical records, and observation of hospital physical environment, it was determined that the hospital failed to provide care in a safe setting as related to the physical environment and to maintain the privacy of the patients.

As indicated in A0142, based on observation of staff interaction with patients, families, and significant others in the Emergency Department and Intensive Care Unit, it was determined that the hospital failed to maintain the privacy of the patients including their name and health information as required by the Standards for Privacy of Individuals Identifiable Health Information (the Privacy Rule). In addition as indicated in A0144 observation of patient care areas, it was determined that not all areas were maintained in a safe and secure manner to prevent potential environmental hazards as related to patient safety.
VIOLATION: PATIENT RIGHTS: REVIEW OF GRIEVANCES Tag No: A0119
The hospital's governing body must approve and be responsible for the effective operation of grievance process, and must review and resolve grievances, unless it delegates the responsibility in writing to a grievance committee.

This regulation is not met as evidenced by:

Based on review of DHS Policy #200-35 Patient Complaints and Grievances, the governing body has not delegated in writing the responsibility to review and resolve grievances to a grievance committee. The hospital refers all grievances to Patient Relations who refers the grievance to the involved hospital unit or department for review and investigation. The hospital failed to meet regulatory requirements since the complaint/grievance policy does not delegate the responsibility in writing to a grievance committee. There was also no documentation that the governing body had delegated that responsibility to the grievance committee.
VIOLATION: PATIENT RIGHTS: GRIEVANCE REVIEW TIME FRAMES Tag No: A0122
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

The grievance process must specify time frames for review of the grievance and the provision of a response.

The standard is not met as evidenced by:

Based on review of the hospital policy and interview with the Director of Quality, it was determined that the hospital does not meet the expected length of time for resolution of grievances nor provision of a written response.

A review of the hospital's Patient Complaints and Grievances policy, under Procedure "g" and "h" revealed the complainant will receive acknowledgement of the complaint/grievance within 7 days and complaint/grievances will be reviewed, resolved and communicated to the complainant, as soon as possible, but not to exceed thirty (30) days. "The hospital must attempt to resolve all grievances as soon as possible. The regulation requires the resolution of grievances with an expected resolution and written response on average within 7 days. If a grievance cannot be resolved within the 7 day time frame, the hospital will inform the patient or the patient's representative that the hospital will follow-up with written response within a stated number of days in accordance with the hospital's grievance policy.





05/01/14 Visit
Based on review of a telephone complaint received by the hospital on [DATE] and assigned complaint # 7993, it was determined that the complainant alleged she was unhappy with the care her husband received prior to him expiring. Further review of the complaint indicates that a family meeting was requested by the complainant to discuss her concerns.

A meeting was scheduled for 03/17/14 however; the meeting was cancelled due to the physician being unable to attend. Patient Relations subsequently called the complainant with additional dates for a meeting. However, there was no indication that given the 30 day time frame set forth in the policy/procedure " Patient Complaints and Grievances Management " that the hospital followed the complaint and grievance process as outlined in the policy.

According to the policy and procedure, when a complaint is not resolved in the 30 day time frame set forth in the policy, then the complainant is to receive weekly written updates until resolution. Written notice to the complainant includes the steps taken to investigate the grievance, the results and date of completion. However, review of the complaint indicates that a meeting with the complainant was not held until 04/17/14 at which time the complainant and another family member was invited to join a new family advisor group to which they agreed. However, no formal written resolution was documented or provided to the surveyor during the complaint reviews.
VIOLATION: PATIENT RIGHTS: PRIVACY AND SAFETY Tag No: A0142
The hospital must ensure the privacy and safety requirements are met.

The standard is not met as evidenced by:

Based on observation of staff interaction with patients, families, and significant others in the Emergency Department and Intensive Care Unit, it was determined that the hospital failed to maintain the privacy of the patients including their name and health information as required by the Standards for Privacy of Individuals Identifiable Health Information (the Privacy Rule).

On March 10, 2014 the Office of Health Care Quality surveyors conducted a Federal survey at Laurel Regional Medical Center. During tour and survey of the Emergency Department (ED) and Intensive Care Unit (ICU) the surveyors observed physicians and nursing staff discussing patient's information in such a fashion that it did not afford the patient their right to privacy. The ED has primarily single occupancy rooms with glass sliding doors. While touring the ED it was noted that in the Fast Track area there was one room with two beds separated by a curtain and one large four bed room in the Main ED also separated by curtains. When staff was questioned how they maintain privacy due to the environmental challenge, they were informed that they speak in low tones. While the surveyors were sitting at the far right of the nursing station reviewing medical records, the surveyor overheard a nurse interviewing a patient in the Main ED curtained four bedroom area located in front of the nurses station. Although the curtain was drawn the surveyor could hear the nurse clearly ask the patient about her health history in particular her COPD. The VP/Patient Services/CNO intervened pulling the two nurses out into the hall to inform them of the concern. The patient was temporarily moved to a private room to complete the assessment and then returned to the curtained room. In addition to the patient being assessed there was one other patient in the curtained four bedroom area.

The ICU has private rooms with glass sliding-doors. In the ICU the surveyor's witnessed a physician making rounds and at the nursing station speaking to the nurse regarding the patient's laboratory results and orders. Another physician was observed to stand in the doorway of the patient's room talking to her family. The ICU besides having single occupancy rooms that afford privacy to patient/family/significant others has a conference room that can be used by the treatment team to discuss issues with the family.

The hospital practice of speaking to patients, family and significant others in open areas without affording the patient privacy or limiting the disclosure of the patient's information including their presence in the hospital, name, age address or health information without prior consent does not meet the regulatory requirements nor is it in accordance with State law.
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
Based on surveyor observation of the Automated Medication Dispensing System (AMDS) Units (Omnicell) and interview of the licensed nursing staff of each unit/service (Emergency Department and Intensive Care) on 03/10/14, it was discovered that critical and controlled medications were not being counted daily by staff to ensure adequate stock. Staff also had difficulty gaining access into the unit on first time attempts.
The findings were:
Observation and interview of two emergency room nurses in the morning after the initial tour, revealed that the nurses had difficulty accessing the AMDS Unit after more than one attempt upon the surveyors' request. A recently hired emergency room Nurse Manager attempted to access the AMDS after the previous attempts by the two nursing staff failed. The emergency room Nurse Manager's access attempt also failed.
Interview of the nursing staff as to how often the critical and controlled medications were counted was explained that the medications are counted once a week, usually by two nurses with one nurse functioning in the "Charge Nurse" capacity. One nurse while in the presence of the surveyors demonstrated counting the AMDS medications(critical and controlled) which involved opening drawers, reaching down inside individual lidded compartments, pulling the stock medications out, counting, and key padding a remaining number of each medication.
The Nurse Manager of the ICU reported on interview that she thought the medications in the AMDS Units was counted once a week and was unclear as to what staff perform this function. The Nurse Manager also shared that there was no document indicating a weekly check of these critical and controlled medications.
Interviews of the licensed nursing staff in the ED and ICU on 03/10/14 revealed that nursing staff are not consistently entering into the AMDS a used and remaining number of a particular critical and controlled medications with each withdrawel. The staff reported that there have been occassions that the pharmacy had to be called for replacement both in an emergency and non-emergency situtaion. Additional interview of the staff revealed that if the critcal medications are unavailable when needed then the emergency crash carts would be utilized as a source. No staff member on interview could recall that a patient expired or had a poor outocme as a result of medications being low or unavailable. However, staff felt that the sooner medications are consistently available would potentailly benefit or assist a patient in a better outcome.
Failure to conduct a daily check of critical and controlled medications potentially places patients and staff at risk for incurring a shortage of medications that could impact patient care causing a delay in treatment.
Also, observation of Patient Care Areas revealed that not all areas were maintained in a secure manner to prevent potential environmental hazards. This was evident in the B.Side of the emergency department on 03/10/14.
The findings were:
On 03/10/14 during the tour of the emergency department B. Side, the housekeeping closet was found unlocked and accessible to anyone. The closet contained multiple bottles of foam hand wash and a wall mounted dispensing disinfectant/cleaner unit. Three mop handles were observed propped up in the closet.
Unsecured chemicals and cleaning equipment potentially could be accessed by confused or disoriented patients creating a potential for injury to self and others.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0168
The use of restraint or seclusion must be accordance with the order of a physician or other license independent practitioner who is responsible for the care of the patient as specified under 481.12(c) and authorized to order restraint or seclusion by the hospital in accordance State law.

The standard is not met as evidenced by:

Based on review of the hospital policy Use of Restraint and Seclusion Policy #901-037, the hospital failed to address the timely acquisition of the order for restraint or seclusion prior to application of restraint/seclusion or in emergency application situations. The policy (non-violent/non-self-destructive behavior) review under Physician Order/Physician Evaluation revealed restraint is initiated by the physician or LIP (Licensed Independent Practitioner) order. Only in emergent situations for safety of the patient is endangered may an RN initiate restraint. The attending physician or another designee will be notified within one hour. In all cases, a written and/or cosigned order based upon the examination of the patient will be entered in the medical record within 12 hours of the initiation of the restraint. For the violent/self-destructive behavior the policy review revealed the restraint or seclusion is initiated only by physician order. Only in emergent situations when the immediate safety of the patient or others is endangered may an RN initiate restraint or seclusion without and order. The attending physician or another designee will be notified immediately and will respond within one hour. In all cases, a verbal/telephone order will be entered into the medical record within (1) hour of initiation of the restraint. If the order is not obtained within one hour, the patient should be released from seclusion or restraint.

This regulation requires the physician order to be obtained prior to the application of seclusion or restraint. In recognition that a restraint or seclusion intervention may occur so quickly that an order cannot be obtained prior to the application of restraint or seclusion, the regulation states that in these emergency application situations, the order must be obtained either during the emergency application of restraint or seclusion, or immediately (within a few minutes) after the restraint or seclusion has been applied.

The surveyor's review of medical records for patients in restraints for non-violent/non-self destructive behaviors revealed orders written within 2-5 minutes of placing patients in restraint, however, hospital policy has not met the regulatory requirements since it does not address the process for an immediate acquisition of restraint or seclusion in the restraint/seclusion policy and procedure.