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Based on interview and personnel record review, it was determined that the facility failed to ensure that criminal history record checks pursuant to §32.1-126.02 (Hospital pharmacy employees; criminal records check required. A. A licensed hospital shall obtain, within sixty days of employment of any compensated employee of the hospital whose duties will provide access to controlled substances as defined in § 54.1-3401 within the hospital pharmacy, who is not licensed by the Board of Pharmacy, an original criminal history record information from the Central Criminal Records Exchange. The cost of obtaining the criminal history record information shall be borne by the hospital.) were completed for five (5) of six (6) registered Nurse (RN) personnel files reviewed.

The findings include:

A review of personnel records on April 5, 2018 at 11:00 a.m. revealed that five (5) RNs (Staff Members #12, #13, #14, #15 and #16) failed to have criminal history record checks through the central criminal records exchange (Virginia State Police) as required by the State licensure regulations.

Staff Member #17 was interviewed on 4/5/18 regarding the types of criminal history checks they perform on their staff members and stated, "We use GIS (General Information Services) for our background checks. They do not include a background check with the Virginia State Police."

Based on document review and interview, it was determined the facility staff failed to ensure information related to Patient's Rights included the address and telephone number for the State agency to which the patient or representative could file a complaint.

The findings include:

On 4/4/18 the Patient's Right policy and notice given to patients was reviewed. The last revision date noted was 7/1/17. The policy states, "...Each patient/family admitted to the Hospital will receive a copy of the Patient's Rights policy upon admission."

Section #3 of the policy states, "...You or the individual designated to the Hospital will be made aware of the state Department of Health to which you may address grievances." There was no address or telephone number documented.

Based on document review and interview, it was determined the facility staff failed to ensure the Plan of Care for one (1) of three (3) patients (Patient #1) was updated to include the use of restraints.

The findings include:

The medical record of Patient #1 was reviewed on 4/4/18 with Staff Member #3 and the following information was noted:

Patient #1 was admitted on 2/19/18 and discharged on 2/26/18. Patient #1 was diagnosed with Acute Respiratory Failure, Tracheostomy and Acute injury of the kidney.

Patient #1 was placed in mitten restraints on 2/24/18 and remained in mitten restraints until discharge. The Plan of Care did not address the use of mittens, alternatives that had been used to try and distract Patient #1 from pulling at tubes and lines. Staff Member #3 stated, "We failed to include the use of restraints in the Plan of Care."

Based on clinical record review, staff interview, and facility document review, the facility staff failed to follow physicians orders for the use of physical restraints, and that the orders for the restraints were clarified as necessary for four (4) of five (5) patients reviewed (Patients #1, #3, #4, and #5).


The findings included:

1. Patient # 3, #4, and #5 had orders for the use of non-violent physical restraints. The orders that were written in the EHR (Electronic Health Record) were not specific as to which part of the body was to be restrained (left, right or bilateral) and the restraints that were documented were not in accordance with the orders of the physician.

Patient #3 was admitted to the facility on 12/29/17 with diagnoses that included, but were not limited to: Metabolic encephalopathy, renal disease, hypertension and uncontrolled diabetes type 1. Review of the clinical record revealed multiple physician's orders for the use of non-violent physical restraints. The patient was documented as being confused and "interfering with medical care by pulling at lines and tubes". The following was documented in the clinical record:
2/3/18 - Order written at 2048 (8:48 p.m.) for "soft wrist" - the order did not specify which wrist, or if it was to be bilateral (both) wrists. Corresponding documentation on the "Restraint Flow-sheet" evidenced: type of restraint - mittens, unsecured had been placed on the patient.
2/4/18 Order written at 2051 (8:51 p.m.) for "soft wrist" - the order did not specify which wrist or if the restraint was to be used on both wrists (bilateral). The "Flow sheet" documented: unsecured mittens had been placed on the patient.
2/5/18 the order was written at 2218 (10:18 p.m.) for "mittens untied". The order did not specify whether the mittens were to be placed on one hand, or both and which (left or right). The "flow sheet" documented : SR (siderails) x (times) 4 (four) meaning four siderails to be put in the up position, mittens secured and mittens unsecured had been placed on the patient.
2/16/18 the order was written for "soft wrist" at 2109 (9:09 p.m.). The order did not specify which wrist or if bilateral. The "flow sheet" documented: SR x4 (siderails times four), mittens secures, mittens unsecured and right and left soft wrist restraints had been placed on the patient.
On 2/26/18 there was no renewal or new order for the use of restraints, however the "flow sheet" documented the patient was still in restraints and that the restraints placed on the patient were: Siderails Up x4, mittens secured/tied right, Mittens secured/tied left, mittens unsecured/untied right, mittens unsecured/untied left, soft restraint R (right) wrist, soft restraint L (left) wrist.
The documentation for the restraints continued until 3/12/18, when there was no further orders obtained and no order to discontinue the restraints.
On 4/4/18, Staff Member #6 was made aware of the concerns in regards to the charting of the restraints and the conflict between the orders and what was actually charted as being used. Staff Member #6 stated, "we are not to use multiple types of restraints at one time..." and "I do not see an order to discontinue the restraints..."


Patient #4 was admitted to the facility on 1/23/18 with diagnoses that included, but were not limited to: acute respiratory failure with hypoxia, end stage renal disease with dialysis and septic shock. Review of the clinical record revealed Patient #4 had orders for the use of non-violent restraints as it was documented the patient was "pulling at multiple lines and tubes and combative/aggressive". The patient was on a mechanical ventilator and had a feeding tube as well as dialysis catheter.
On 2/21/18 the physicians order documented at 2145 (9:45 p.m.) SR (siderails) x (times) 4 (four), soft wrist - comment: right, mittens tied. The documentation on the restraint flow sheet evidenced: siderails x4, mitten tied right, mitten tied left, mitten unsecured right, mitten unsecured left, soft wrist right, soft wrist left, soft restraint right ankle had been placed on the patient.
On 2/26/18 there was no order for the use of the restraints, however the restraint flow sheet documented: Soft wrist restraint, right, soft wrist restraint left, mittens tied right, mittens tied left, siderails x4.
Six orders were randomly reviewed for Patient #4 with concerns noted in each of the orders or documentation. Staff Member #6 was assisting the surveyor to navigate the EHR (Electronic Health Record) on 4/4/18 was aware of the concerns regarding the orders and documentation of the restraints.


Patient #5 was admitted to the facility on 2/2/18 with diagnoses that included, but were not limited to : hemorrhagic cerebral infarction, and seizures. The patient had an order for the use of non-violent restraints due to "pulling at lines and tubes and interfering with medical care and treatment". An order for "soft wrist" restraints was placed on on 2/9/18 at 2129 (9:29 p.m.) however there was no specification as to whether it was for the right or left wrist, or bilateral wrists. The restraint flow sheet documented "right and left wrist". On 2/10/18 at 1336 (1:36 p.m.) the order was written for "Siderails x 4" and "soft wrist". The order was not specific as to which wrist or if the restraint was to be placed bilaterally (both).

On 4/4/18 at 2:45 p.m., Staff Member #2 (CNO) stated, "It is a struggle with EPIC (Electronic Health Record program) to document restraints...we have had a discussion regarding the restraint documentation..."

On 4/5/18 at 8:45 a.m., the surveyor discussed the restraint tracking and monitoring during a review of the Quality program with Staff Member #2. "The supervisors are looking at the restraints and giving reminders to the staff regarding documentation...our audits reveal continuing problems and there are pieces missing. We are working with EPIC and staff to ensure the orders are put in correctly- clearly more education is needed and oversight required...we are still struggling with the process. We plan to have one to one education and do handouts and laminates to help trigger the staff to document correctly as a reference and review. We are not putting four (4) siderails up; I do not know why they are documenting that or multiple use of restraints at one time."

On 4/5/17 at 9:25 a.m., the surveyor spoke with the Medical Director (Staff Member #11) regarding the restraint concerns. Staff Member #11 stated, "I have had to review the policy and procedure for restraints and am aware of the requirements. I was not aware of the problems with the orders or the double restraints that were being ordered. We are working on that."

The facility Policy and Procedure "Restraints and Seclusion" was reviewed and evidenced, in part: "...Restraint is ONLY to meet the patient's individual clinical needs. Restraint must be the least restrictive intervention that protects the patient's safety...A written order, based on an examination of the patient by the MD/DO or LIP is entered into the patient's medical record on a daily basis when restraint use is clinically appropriate...Obtain a physician's order prior to the application of a restraint...Medical Record Documentation and Plan of Care: ...State type of device applied and patient response..."

The concerns regarding the restraint orders and documentation were discussed with the administrative Team Staff Member's #1, #2, and #9 on 4/5/18 at 3:00 p.m.



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2. Patient #1's medical record was reviewed on 4/4/18 with Staff Member #3. Patient #1 was admitted on 2/19/18 and discharged on 2/26/18. Patient #1 was diagnosed with Acute Respiratory Failure, Tracheostomy and Acute injury of the kidney.

Patient #1 was placed in mitten restraints on 2/24/18 and remained in mitten restraints until discharge on 2/26/18. The physician's order for the restraint was obtained on 2/24/18 at 22:21 (10:21 P.M.). Documentation in the medical record by Staff Member #7 indicates Patient #1 was placed in mitten restraints at 8:00 P.M. on 2/24/18 due to Patient #1 disconnecting themselves from the ventilator.

The order for the restraints on 2/24/18 was not signed by the physician until 3/19/18 at 11:36 A.M.
There were no nursing notes related to the restraints.

A physician's order indicated Patient #1 was released from the restraint on 2/25/18 at 23:01 (11:01 P.M.) and placed back in the restraint on the same date and time but there was never an order to discontinue the restraint. The physician signed the second order for the restraint on 2/26/18 at 14:17 (2:17 P.M.). The nursing notes for restraints were initiated on 2/25/18 at 8:00 A.M. and as continue at the following dates and times:
2/25/18:
12:00 Noon, 14:00 (2:00 P.M.), 16:00 (4:00 P.M.), 18:59 (6:59 P.M.), 19:00 (7:00 P.M.), 19:01 (7:01 P.M.), 19:04 (7:04 P.M.), 19:06 (7:06 P.M. and 22:00 (10:00 P.M.)
2/26/18:
0000 (Midnight), 02:00 A.M., 04:00 A.M., 08:06 A.M., 08:07 A.M., 08:09 A.M., 08:28 A.M., 11:24 A.M. and 14:02 (2:02 P.M.).

The physician order for the restraints was two (2) hours and twenty-one (21) minutes after the restraints were initiated.

The facility Policy titled Restraints an Seclusion with a revision date of 07/2017 does not define "immediately as clinically possible" when discussing the time frame for obtaining a physician's order for the use of a restraint. The policy also does not address the timeframe the physician must sign the order.

Staff Member #3 stated, "It looks like an order was written then canceled but the patient stayed in restraints. There should have been an order to initiate the restraints and each day they were continued. We are still trying to work on this."

Based on staff interview, medical record review, and review of facility policies and procedures, staff failed to ensure that the facility's policy and procedure for administration of blood and blood components was followed.

Findings include:

Patient #8 was admitted to the facility on 1/16/18. Over the course of Patient #8's hospital stay between 1/16/18 and 2/14/18, he/she received multiple units of fresh frozen plasma (FFP) and packed red blood cells (PRBC).
Patient had orders on 1/17/18 at 11:35 a.m. to transfuse two (2) units of FFP and 2 units of PRBC.
A Physician progress note dated 3/18/18 at 3:21 p.m. documented "...Patient did receive 2 U (2 units) of FFP and
2 U of blood with follow-up H&H (hemoglobin and hematocrit) 1 (one) hour after the 2nd unit of blood which was still 6.8 and in need of 2 more units of blood...".
On 4/4/18 at 12:15 p.m., the surveyor interviewed Staff Member (SM) #12, registered nurse (RN), and chart navigator regarding transfusion of blood and blood products, and he/she stated "There is a tight timeline on transfusions. They send both units refrigerated, I believe there's a thermometer in the box, but I can't be sure. As soon as one (1) unit is finished, the second one goes up; if it's more than four hours after received from the blood bank, blood has to be trashed".

An interview was conducted with SM #2, the Chief Nursing Officer (CNO), on 4/4/18 at 2:40 p.m. related to how blood/blood products are received in the facility from the blood bank after a physician order to transfuse is written. SM #2 provided the surveyor with a copy of a document entitled "Request for blood issue to off-site facilities". SM #2 told the surveyor that the form was completed by the facility staff and sent to the bloodbank at (facility name) in order to obtain the blood product. SM #2 then stated "The blood is brought to our facility in a cooler that stays at the nurse's station until it is administered. We do not monitor the temperature. Our policy and procedure (P&P) is that we administer within 30 minutes. I don't think there is a thermometer or indicator in the cooler that contains the blood, but I will check with the bloodbank and see how it is monitored". SM returned after calling the blood bank, and stated: "The blood bank said if blood stays in the cooler, it is good for 24 hours, it is defiantly good for eight (8) hours".

The facility's P&P entitled "Number: B04-N, Subject: Blood/Blood Components Administration (Packed Cells, Plasma, Platelets, Cryoprecipitate) included the following information in part: "...3. Hospital will utilize the contracted Blood Bank for their blood product needs. Blood and/or blood products will be picked up and signed for by a Contracted Courier and/or Hospital staff...11...Ideally blood is to be started within 30 minutes of receipt from Blood Bank. Under NO circumstances is blood to be stored in refrigerator on the nursing units. Only one unit of blood is released per patient at one time. If unable to give within 30 minutes, return blood to Blood Bank with transfusion form".

At 2:50 p.m. on 4/4/18, SM #2 provided the surveyor with a copy of the contracted blood bank's procedure entitled "308 Blood Transport Coolers", which stated the following in part: "I. (Blood bank Facility name) does not have a monitored storage device for blood products outside of the Transfusion Services department. To facilitate the availability of red cell products for surgical procedures and patients in imminent demise situations, red cell products are transported and temporarily stored in the surgical suite, trauma room, or off-site to (facility names). When transporting and storing these red cell products, the transporting and storage containers must be able to maintain the red cell units at the appropriate temperature for the time and conditions until they are returned to a monitored storage device. The transport/storage container must also be able to withstand leakage, pressure and other conditions incidental to routine handling. These coolers will maintain up to 6 units of packed red cells at 1-10C (during transport) for 24 hours or 1-6C for 6 hours (during storage) when packed according to instructions...".The procedure further explained the type of equipment provided, the proper way to sign the cooler in and out, and the policy for packing blood in the cooler.

SM #2 added "On our unit, the P&P clearly states we will not store blood on the unit, and after 30 minutes it should be sent back to the blood bank. Yes, the blood bank is following their policy, but it is totally contradictory to our policy. I think there should be a way to merge these 2 P&P's".

The concerns related to adherence to the facility's P&P related to blood products was discussed with SM #2 between approximately 2:30 p.m. and 3:15 p.m. on 4/4/18. The concerns were also discussed with SM's #1, #2, and #9 on 4/5/18 during the exit conference.

Based on clinical record review, staff interview and facility document review, the facility staff failed to ensure orders for the use of restraints were authenticated as soon as possible for two (2) of 4 (four) patients of the survey sample who had orders for restraints (Patient #3 and #1).

The findings included:

1. Patient #3 had orders for the use of restraints that were not authenticated timely.

On 2/4/18 at 2048 (8:48 p.m.) an order was entered into the EHR (Electronic Health Record), but was not signed until 2/12/18 at 12:47 p.m.
An order was entered into the EHR on 3/10/18 at 1609 (4:09 p.m.), but was not signed until 3/16/18 at 1900 (7:00 p.m.) by the ordering physician.
An order dated 3/11/18 at 2126 (9:26 p.m.) was entered, however was not signed until 3/16/18 at 1900 (7:00 p.m.).

Staff Member #2 (CNO) stated on 4/4/18 at 2:45 p.m., "There seems to be a glitch in the physicians orders, and the physicians that are not signing it seems to be the weekend coverage...they only work weekends so they don't see the orders until they return. We need to enable the system to flag the medical director so that (he/she) can look at the orders and co-sign..."

On 4/5/18 at 9:25 a.m., the surveyor discussed with Staff Member # 11 (Medical Director) the concern regarding the orders not being authenticated timely. He/She stated, "In the electronic system I do not have access to the other physicians orders, however if they make it possible that I can review them, I will sign off the orders. The other physicians do consult with me regarding any orders they place and make me aware of any concerns or orders they have had to give on the patients when they are there."



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2. Patient #1's medical record was reviewed on 4/4/18 with Staff Member #3. Patient #1 was admitted on 2/19/18 and discharged on 2/26/18. Patient #1 was diagnosed with Acute Respiratory Failure, Tracheostomy and Acute injury of the kidney.

Patient #1 was placed in mitten restraints on 2/24/18 and remained in mitten restraints until discharge on 2/26/18. The physician's order for the restraint was obtained on 2/24/18 at 22:21 (10:21 P.M.). Documentation in the medical record by Staff Member #7 indicates Patient #1 was placed in mitten restraints at 8:00 P.M. on 2/24/18 due to Patient #1 disconnecting themselves from the ventilator.

The order for the restraints on 2/24/18 was not signed by the physician until 3/19/18 at 11:36 A.M.
There were no nursing notes related to the restraints.

Staff Member #3 stated, "It appears the patient was placed in restraints at 8:00 P.M. on the 2/24/18.

Staff Member #7 was interviewed on 4/4/18 at 1:05 P.M. and stated, "I don't typically chart on a patient being placed in mitts. I might make a comment about them being in mitts. I think I was probably charting in the patient's chart (medical record) at the same time a nurse was charting and the two notes merged. You have to choose continue or discard to keep documenting. I have had this happen before but that was after I realized it was a problem. I now write my notes about 5 minutes after the nurses finish their notes. I don't remember talking to anyone about this problems with the notes from two staff merging."

Staff Members #8 and #9 were asked about the merging of notes and both stated it was impossible because the different staff types (like nurses and respiratory techs) have different accesses to the medical record.