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7503 SURRATTS ROAD

CLINTON, MD 20735

PATIENT RIGHTS: INFORMED CONSENT

Tag No.: A0131

Based on interview, and review of 10 patient records, including 6 behavioral health unit patients, it was determined that the behavioral health unit staff gave 3 of 6 patients antipsychotic, antianxiety, and antihistamine medications intramuscularly without offering oral medication, and contravening the patients right to refuse treatment in the absence of a behavioral emergency.

In an interview with a staff RN on 4/28/15 at approximately 10:30 am, this was confirmed as a current practice as of the date of survey. Please see also A-169

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0168

Based on a review of 10 patient records including 6 behavioral health unit patients, it was determined that; staff failed to obtain restraint/seclusion orders consistent with regulation for 3 of 6 behavioral health patients.

Patient #5 (P5) was an adult female who admitted in April 2014. On 4/12/2015 at 0316 and 2044, a physician wrote order #44 and #49 for seclusion stating "Put patient in seclusion stat." Further, the order states "Contin (continue) routine until discontinued." This seclusion order does not include a time limitation of no more than 4 hours.

On 4/20/15 at 1920, P5 was placed in 4-point restraints. According to documentation on the nursing 15-minutes flows, P5 was placed in 4-point for "Danger to self, Danger to others, physically threatening/assaultive Hitting, Other." Following being placed into restraints, P5 then fell asleep. The record revealed a physician order written at 2018 for the restraint. Nursing 15-minute flows revealed that P5 was taken out of restraint and initiated into seclusion by 1950, though no new order was written to do so. P5 continued in seclusion for 2 ½ hours until 2220 without an order to seclude her.

Patient #6 (P6) was a female admitted to the behavioral health unit. shortly after admission, P6 requested discharge but met criteria for involuntary admission and remained on the behavioral health unit for 2 weeks.
On 4/11 at 2330, documentation revealed that P6 was placed into seclusion. No order is found in the record related to this action, and no end time is noted, though nursing flow documentation continues on until 2359. The medical record contained an incomplete order #44, written by the psychiatrist on 4/12 at 0314 which stated only "Put patient in seclusion stat," and continue routine until discontinued. This order lacks a time limitation.
On 4/12/2015 at 2015 a physician wrote an order for 4-point restraints, though the order read "Acute Medical Surgical Once STAT Maximum Order Duration is 24 hours." Even though P6 exhibited violent behaviors, an incorrect order for non-violent restraints was written.

On 4/15 at 1503, a physician wrote order #82 for seclusion stating, "Seclusion stat for violent behavior." The order stated "Contin (continue) routine until discontinued." This seclusion order is incomplete for lacking a time limitation of no more than 4 hours.


Patient #9 (P9) was an adult male who admitted voluntarily to the behavioral health unit in April 2014.
Per quality monitoring documentation, on 4/14/15 at 1551, P9 was placed in what the hospital called a "Therapeutic hold" for the purpose of giving multiple medications at a time when he was agitated and also being secluded. There is no policy that defines a "Therapeutic hold" though for the purpose of forcibly administering IM medication, this constitutes a restraint and must have an accompanying order. There is no order for restraint in the record.

Based on all documentation, the hospital failed to write consistent, appropriate orders for 3 of 6 behavioral health unit patients reviewed.

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0169

Based on an onsite investigation consisting of interview, review of policies, other documentation and 10 patient records, it was determined that on the behavioral health unit; orders for as needed (PRN) intramuscular (IM) injections for "severe psychotic agitation" were written and utilized for 3 of 6 behavioral health unit patients, which constituted the use of PRN chemical restraints.

The hospital Restraint and Seclusion policy states in part, "The use of PRN orders for drugs or medications is prohibited when a drug or medication is being used as a restraint. Using a drug to restrain a patient is expressly prohibited."
Under the "Patient Rights" section of the hospital's "Adult Behavioral Health Patient Handbook" , it states "As a patient, you have the right to: ... 10. Be free from restraints or seclusion except if there is immediate danger of harm to you or someone else, and if non-physical interventions have failed."
During an interview with a behavioral health unit manager on 4/28/15 at approximately 10:30 am, it was determined that patients who are ordered PRN IM medications, receive ordered PRN IM antipsychotic and sedation medications in the absence of emergencies. Based on this information, nursing may give PRN IM medication in the absence of an emergency, at nursing discretion, without patient consent; and without the oversight or notification of psychiatry.

In addition, interview and record review confirmed that IM antipsychotics and sedation are also given based on PRN orders to patients during behavioral emergencies without consulting with the physician.

Examples include:

Patient #5 (P5) was an adult female who admitted in April 2014. On admission to the behavioral health unit, daily PO (by-mouth)/oral medications were written; including:

Antipsychotic medication of:
- Olanzapine (Zyprexa) 10 mg PO twice a day
- Loxapine Succinate 10 mg PO twice a day

Mood stabilization medication of:
Lithium Carbonate 600 mg PO twice a day

Antianxiety medication of:
- Clonazepam (Klonopin) 1 mg PO three times a day along with,
- Lorazepam (Ativan) 2 mg PO every 6 hours PRN (as needed) for agitation

Medications to prevent side effects of antipsychotics:
- Diphenhydramine HCL (Benadryl) 50 mg PO every 6 hours PRN for severe psychotic agitation along with,
- Benztropine (Cogentin) 1 mg PO every 4 hours PRN

Additionally, orders for PRN (as needed) IM (intramuscular) medications were written; including:

Alternating antipsychotics of:
- Chlorpromazine 50 mg IM (an antipsychotic) every 6 hour PRN with an indication of "severe agitation"
- Olanzapine 10 mg every 4 hours IM PRN with an indication of "Severe agitation;"

Antianxiety medication of:
-Lorazepam 2 mg IM (an antianxiety agent) every 6 hours PRN with an indication of "Agitation"

Sedating antihistamine:
- Diphenhydramine 50 mg IM to every 6 hours PRN with an indication of "severe psychotic agitation;"

These PRN IM medications were often given at the same time, for example: Chlorpromazine with Lorazepam and Diphenhydramine.

Review of P5's record revealed that although P5 had orders for daily PO medications, and PO PRN medications, she received (11) IM injections of Diphenhydramine PRN, (6) IM injections of Olanzapine PRN, (9) IM injections of Ativan PRN, and (5) IM ' s of Chlorpromazine PRN, over the course of 10 days. These IM's were given based on staff assessments of severe agitation, and represented standing orders for PRN chemical restraint.
Patient #6 (P6) was a female admitted to the behavioral health unit. shortly after admission, P6 requested discharge but met criteria for involuntary admission and remained on the behavioral health unit for 2 weeks. On admission to the behavioral health unit, daily PO (by-mouth) medications were written including:

Antipsychotic medications of:
- Haldol 10 mg twice a day PO
- Olanzapine (Zyprexa) 10 mg PO at hour of sleep
-Risperdal 2 mg at bed time
Antipsychotic medications for P6 changed over time though there was always at least one, and sometimes two PO antipsychotics.

Antianxiety medication:
- Lorazepam (Ativan) 1 mg PO every 6 hours PRN
-Clonazepam (Klonopin) 0.5 mg three times a day
Antianxiety medications for P6 changed over time though there was always one PO antianxiety medication except on 4/14, and 4/15.

Medications to prevent side effects of antipsychotics:
-Benztropine (Cogentin) 1 mg PO twice a day
-Diphenhydramine (Benadryl) 25 mg PO every 6 hours as needed

Additionally, orders for PRN (as needed) IM (intramuscular) medications were written to include:

Alternating antipsychotics of:
- Haloperidol Lactate (Haldol) 5 mg IM every 6 hours PRN with an indication of " severe psychotic agitation; "
- Chlorpromazine 50 mg IM every 6 hour PRN with an indication of "severe agitation"
- Olanzapine 7.5 mg every 6 hours IM PRN with an indication of "Severe agitation"

Antianxiety medication of:
-Lorazepam 2 mg IM every 6 hours PRN with an indication of "Severe psychotic agitation";

Antihistamine medication:
- Diphenhydramine 50 mg IM every 6 hours PRN with an indication of "severe psychotic agitation"

These PRN IM injections were often given at the same time, for example: Haloperidol with Lorazepam and Diphenhydramine.

Review of P6's record revealed that although P6 had orders for daily PO scheduled medications, and PO PRN medications, she received (18) IM injections of Diphenhydramine PRN, (14) IM injections of Haloperidol PRN, (10) IM injections of Olanzapine PRN, (5) IM injections of Lorazepam PRN, and (2) IM injections of Chlorpromazine PRN over the course of two weeks. These IM's were given due to staff determinations of severe agitation, and represented standing orders for PRN chemical restraint.
Patient #9 (P9) was an adult male who admitted voluntarily to the behavioral health unit in April 2014.
On admission to the behavioral health unit, daily PO (by-mouth)/ORAL medications were written including:

Antipsychotic medications of:
- Risperdal 2 mg PO twice a day
- Haldol 5 mg PO every 6 hours PRN, agitation

Antianxiety medications of:
- Lorazepam (Ativan) 2 mg every 6 hours as needed, agitation

Additionally, orders for PRN (as needed) IM (intramuscular) medications were written to include:

Antipsychotic medications of:
- Haloperidol Lactate (Haldol) 5 mg IM every 4 hours PRN, agitation

Antianxiety medications of:
- Lorazepam (Ativan) 2 mg IM every 6 hours as needed PRN, agitation

Medications to prevent side effects of antipsychotics:
- Benztropine 2 mg IM every 6 hours PRN, extrapyramidal side effects

Review of P9's record revealed that although P9 had orders for daily PO scheduled medications, and PO PRN medications, he received (4) IM injections of Haloperidol PRN, (4) IM injections of Lorazepam PRN, and (1) IM injection of Benztropine PRN over the course of three days. These IM's were given due to staff determinations of severe agitation, and represented standing orders for PRN chemical restraint.
Based on all information, the hospital routinely writes for PRN IM orders which represent standing orders for chemical restraints.

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0174

Based on a review of restraint/seclusion policy and 10 patient records, it is revealed that for patient #5 (P5) and #6 (P6), the hospital; 1) Failed to document the criteria for release that is actually given to patients; 2) failed to document behaviors requiring initiating and ongoing restraint and seclusion; 3) and failed to demonstrate that P5 and P6 were released at the earliest possible time.

The hospital Restraint and Seclusion policy (revised 10/13) states in part,

"Indications: 1. The decision to restrain or seclude is driven by ongoing, comprehensive, individual patient assessment. The comprehensive, individual patient assessments also used to determine the use of least restrictive measures and discontinuation of restraint and/or seclusion at the earliest possible time, when behavior or condition that was the basis for the restraint is resolved."

According to restraint/seclusion documentation, patients are informed of criterion for release from restraint/seclusion. Documentation revealed an area of the nursing restraint/seclusion flow sheet which stated "Explained to patient, Explained to family." However, the actual criterion information given to the patient is not found in the record. The hospital staff failed to document specific release criteria in the records of 2 patients.

Patient #5 (P5) was an adult female who admitted in April 2014.

On 4/19/2015 from 0745 to 1145, P5 was secluded due to aggression and "Hitting." During the seclusion, the nursing 15-minute flow revealed that nursing documentation did not consistently coincide with the consecutive timeline. For instance, documentation for 0915 carried an electronic time stamped for 1032. This may indicate that 15-minute assessments were not done in a timely manner. Additionally, nursing failed to document P5's ongoing behaviors. Instead, for every 15-minute interval, nursing justified seclusion by documenting non-specific behavior such as "Patient at risk, Others at risk. " Based on late documentation and the lack of descriptive behavioral documentation, the hospital failed to demonstrate that P5 was released at the earliest possible time.

From 1300 to 1700 of the same day, P5 was placed in seclusion again for "hitting and throwing items." The RN failed to describe and document specific behaviors ongoing behaviors, but justified continued seclusion at each 15-minute interval with "Patient at risk, staff at risk." Documentation of every 15-minute assessments was completed, in some cases, up to 3 hours after the actual 15-minute interval occurred. For instance, the 15-minute interval of 1500 was not completed until 1753. Based on the fact that continued restraint/seclusion requires documentation of ongoing need, supported by specific behavioral documentation, meant that P5 was in seclusion for 8 hours with inadequate justification.


From 1701 to 2101, P5 was again placed in seclusion, though no documentation of behaviors warranting seclusion were found. Additionally, no behaviors justifying seclusion were documented during the 4 hours of seclusion. At 2101, the RN documented "Seclusion ended. Pt calmer, verbally contracted for safety. Pt back to normal routine." While compliance is desirable, a safety contract is not required for release from restraint/seclusion. Based on the lack of documentation regard on-going need for seclusion, supported by timely documentation of specific behavioral justification, as well as the apparent use of a safety contract as release criterion, it is unknown why P5 was kept in seclusion for 8 hours.


Patient #6 (P6) was a female admitted to the behavioral health unit. shortly after admission, P6 requested discharge but met criteria for involuntary admission and remained on the behavioral health unit for 2 weeks.
On 4/12/2015 at 2010, P6 was placed in seclusion due to "spitting and kicking." Nursing documentation failed to identify and document ongoing behaviors necessitating continued seclusion. At 2100, the RN documented "Spoke to patient, still has poor insight, not yet ready." Based on this documentation, P6 who was able to speak with the RN, not only had to cease imminently dangerous behaviors, but also was expected by the RN to gain "insight" during the seclusion. Having "insight" cannot be utilized as a criterion for release from seclusion. The only criterion for release is a cessation of the imminently dangerous behavior which resulted in the seclusion/restraint. At 2145, the RN documented "Pt still not following orders or directions." While patient compliance is desirable, it is also not a requirement for a patient to follow staff orders in order to be released from restraint or seclusion.

In summary, based on the hospital staff's failure to document the criteria for each patient's release from restraint/seclusion, and minimal nursing documentation for specific behaviors related to initiation and ongoing restraint/seclusion, the hospital failed to demonstrate that 2 of 6 patients were released at the earliest possible time.

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0175

Based on a review of policy, and 10 patient records including 6 behavioral health records, 1) documentation for care given to patients during restraint/seclusion, fails to describe specific care rendered for 3 of 6 patients reviewed and 2) documentation of care given to patient #9, a diabetic, fails to address a condition which could be exacerbated during restraint and seclusion.

Review of hospital Restraint and Seclusion policy #31 (revised 10/13) revealed in part, " Patient Monitoring: Other Monitoring Activities (i.e., comfort measures, repositioning, fluids, hygiene, circulation checks, and elimination needs) will be completed and documented every one (1) hours or sooner according to patient need."

Review of restraint/seclusion records for 3 of 6 behavioral health records, revealed nursing documentation which stated only "Meals addressed, foods addressed, toileting addressed." This documentation did not indicate if the restrained or secluded patient actually took in nutrition and fluids, or if they were able to eliminate. For example:

Patient #9 (P9) was an adult male who admitted voluntarily to the behavioral health unit in April 2014.
On 4/26/2015 from 0930 to 1329, P9 was secluded due to aggression towards a peer. Documentation revealed only "Fluids Addressed, Foods Addressed, Toileting Addressed." There was no documentation of an intake and output found despite its greater importance due to possible wide variations in blood sugars for a diabetic patient.

Documentation indicated the hospital failed to describe the actual care given to to patients who were secluded.