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Based on interview and document review it was determined the facility failed to document informed consent was obtained for two (2) of twelve (12) patients included in the survey sample. (Patients #10 and #12)

The findings included:

A review of Patient #10's electronic medical record (EMR) was conducted on 02/23/2017 at 8:45 a.m., with Staff Member #15. The review revealed Patient #10 was admitted to the facility on 10/21/2016 with the diagnosis of Hemoptysis. Patient #10's EMR contained a scanned form titled "Conditions of Admission" that included provisions for "Consent to Treatment," "Consent to Treatment Using Telemedicine," "Consent to Medication Not Yet FDA Approved and/or Medication prepackaged/Repackaged by Outsourcing or Compounding Pharmacy," HIV/Hepatitis B or C Testing," "Consent to Photograph, Videotapes and Audio Recordings," "Financial Agreement," "Consent to Authorize Use of Email and Text for Patient Billing and Financial Obligations," and "Acknowledgement (of reading form)" and "Acknowledgement of Notice of Patient Rights and Responsibilities." Patient #10's "Conditions of Admission" was signed by a physician's assistant only. Patient #10's "Conditions of Admission" did not have a second witness signature if the patient was not able to sign. Patient #10's "Conditions of Admission" form did not indicate whether the patient could sign his/her own form or not. Staff Member #15 verified the findings. Staff Member #15 reported the form should have at least been signed by a second witness if the patient could not sign. Staff Member #15 reported staff should have noted on the patient's signature line whether the patient could sign or not.

Review of Patient #12's EMR was conducted on 02/23/2017 with Staff Members #3 and #15. Patient #12's EMR documented the patient was admitted to the facility on 02/04/2017 for "Respiratory Failure." The review revealed a "Consent to Invasive Diagnostic/Therapeutic Procedures/Treatments" form. The consent form was signed by two (2) nursing staff with the explanation the patient's spouse had provided telephone consent for the patient's procedure "Bronchoscopy." The form's "Doctor Attestation" which read: "I attest to having explained the anticipated benefits, material risks, and alternative methods of treatment of the above -identified procure/treatment (s) with the patient or the patient's representative [Sic]" was blank. The form did not include the required physician's signature, date and time. Staff Member #15 navigated multiple sections of Patient #12's active EMR and paper medical record. Review of the "Bedside Procedure Note" did not provide documentation that the risk and benefits had been explained to Patient #12's spouse. Staff Member #15 verified the informed consent should have been signed dated and timed by the physician performing the procedure. Staff Member #15 verified Patient #12's Medical records did not have documentation the procedure had been explained including the risks and benefits to the patient or the patient's spouse.

Review of the facility's policy titled "Consent (Informed)- Written Confirmation" read in part: " B. Informed consent[:] Informed Consent is the agreement by the patient to the proposed procedure, treatment, or course of treatment after he/she has achieved a reasonable understanding of its risks and benefits, and the risks and benefits of alternative procedures or no treatment ... D. Written Confirmation of the Process [:] The practitioner who has been granted privileges to perform the procedure, should make a timed and dated notation in the patient's medical record documenting the discussion and summarizing the content prior to performing the procedure ... Administrative Considerations: ... D Telephone Consent: When the patient's surrogate decision-maker is not able to come to the hospital to sign the consent form consent may be obtained by the doctor via telephone. Two witnesses should verify the procedure with the party on the telephone and document the conversation on the consent form.

Based on interview and document review it was determined nursing staff failed to obtain a physician's order after placing a patient in restraints for one (1) of four (4) restraint patients included in the survey sample. (Patient #12)

The findings included:

Review of Patient #12's EMR was conducted on 02/23/2017 with Staff Members #3 and #15. Patient #12's EMR documented the patient was admitted to the facility on 02/04/2017 for "Respiratory Failure." Patient #12's EMR documented the patient was placed in soft bilateral upper extremity (UE) restraints from 02/04/2017 through 02/20/2017. Review Patient #12's EMR revealed nursing staff discontinued Patient #12's restraints at 12:30 p.m. on 02/06/2017. Review of Patient #12's EMR documented nursing staff reapplied soft bilateral upper extremity restraints at 1700 (5:00 p.m.) on 02/06/2017. Staff Member #3 navigated Patient #12's EMR and with the surveyor reviewed Patient #12's active paper medical record.

An interview was conducted on 02/23/2017 at 3:47 p.m., with Staff Member #3. Staff Member #3 reported the renewal order covering 02/06/17 "stopped when staff removed the restraints at 12:30" p.m. on 02/06/2017. Staff Member #3 reported a new order; "an initial twenty-four hour restraint order" should have been obtained from the physician when the restraints were started later on 2/6/17.

Review of the facility's policy titled "Seclusion, Restraints, and Restraint Alternatives" read in part: "5. Order for Restraints or Seclusion ... a. 2. If a patient was recently released from restraints or seclusion, and exhibits behaviors that can only be handled through the reapplication of restraints or seclusion, a new order is required ..."

Based on interview and document review it was determined the facility staff failed to document the required two (2) hour assessments for non-violent restraints for two (2) of four (4) restrained patients included in the survey sample (Patients #7 and #12)

The findings included:

An interview was conducted on 02/22/2017 at 8:59 a.m., with Staff Member #3. Staff Member #3 reported the facility's policy for assessment and reassessment of non-violent restrained patients was every two hours.

1. A review of Patient #7's electronic Medical record (EMR) was conducted on 02/22/2017 at 9:11 a.m., with Staff Member #3. Patient #7's EMR documented the patient was placed in soft upper extremity (UE) restraints from 01/12/2017 through 02/16/2017. Review Patient #7's EMR revealed nursing staff failed to provide proof of assessments for the following dates and times:

01/16/2017 at 1800 (6:00 p.m.); 01/17/2017 at 1600 (4:00 p.m.) and 1800 (6:00 p.m.); 01/19/2017 an eight hour gap from midnight to 0800 (8:00 a.m.); 01/23/2017 at 1800; 01/29/2017 did not have a 0600 (6:00 a.m.), 1530 (3:30 p.m.), 1730 (5:30 p.m.); 01/30/2017 at 0000 (12:00 a.m.); 01/31/2017 at 0600 (6:00 a.m.); 02/02/2017 at 0400 (4:00 a.m.) and 0600 (6:00 a.m.); and on 02/08/2017 at 0600 (6:00 a.m.). Staff Member #3 verified the findings.

An interview was conducted during the EMR review on 02/22/2017 at 11:07 a.m., with Staff Member #3. Staff Member #3 navigated Patient #7's EMR. Staff Member #3 reported he/she could not find evidence of completed restraint assessments for the dates and times as listed above. Staff Member #3 reported Patient #7's EMR did not provide evidence nursing staff had removed Patient 7's restraints on the listed dates and times. Staff Member #3 stated, "If the restraints were removed new physician's orders should have been obtained."

2. Review of Patient #12's EMR was conducted on 02/23/2017 with Staff Members #3 and #15. Patient #12's EMR documented the patient was admitted to the facility on 02/04/2017 for "Respiratory Failure." Patient #12's EMR documented the patient was placed in soft upper extremity (UE) restraints from 02/04/2017 through 02/20/2017. Review Patient #12's EMR revealed nursing staff failed to provide proof of assessments for the following dates and times: 02/06/ 2017 at 6:00 a.m. and on 02/11/2017 at Midnight and 0200 (2:00 a.m.). Staff Member #3 navigated Patient #12's EMR and at 3:47 p.m. verified nursing staff had failed to document restraint assessments at the above times.

Based on staff interview, clinical record review, and review of facility documents, it was determined the facility staff failed to ensure a care plan was developed regarding the self-administration of medications for one (1) of one (1) patients of the survey sample who had a medication available for self administration, Patient #4.

The findings included:

Patient #4 was admitted on 2/17/17 with diagnoses that included, but were not limited to: Congestive Heart Failure, Chronic Obstructive Pulmonary Disease, Hypertension, Rheumatoid Arthritis and Osteoporosis.

Review of the clinical record for Patient #4 revealed an order for "Xeljanz 5mg (milligrams) po (by mouth) twice a day, Patient's own medication" (Xeljanz is used to treat adults with moderately to severely active rheumatoid arthritis per www.drugs.com).

On 2/22/17 at 10:30 a.m., the surveyor discussed the self administration of medications and "home medications' with Staff Member # 7. Staff Member #7, at that time, stated, "No patient is allowed to self administer medications. Any medications brought from home must be sent to the pharmacy and they are checked and a bar code is applied. The medications are locked up and the nurse administers the medications to the patients. Patients cannot keep medications in their room and they can't self administer. The nurse administers all medications to the patient..." During the review of the clinical record, the surveyor asked Staff #7 to locate documentation regarding the pharmacy review of the medication that Patient #4 had brought from home. Staff #7 stated, "It does not look as though Pharmacy has addressed (Patient #4's) home medications."

Further review of the clinical record for Patient #4 revealed that for the documentation for the administration of the Xeljanz from 2/18 through 2/23/17, the medication was documented as "not administered- taken".

On 2/23/17 at 2:30 p.m., the surveyor interviewed Staff Member # 3 regarding a patient's ability to self administer medications and the facility policy and procedure regarding the same. Staff Member #3 stated, "It depends on what the medication is whether the patient can self administer...some patients may have medications that they self-administer based on what it is- like an insulin pump or something." The surveyor requested a copy of the facility policy and procedure regarding the self administration of medications.

On 2/24/17 at 9:20 a.m., the surveyor inquired as to the reason the Xeljanz was documented as "not administered-taken" by the nurse in the patient's medication administration record, as whether the patient was receiving the medication or not. Staff Member #3 stated, " After speaking with the Nursing Director and the nurse on the unit, that is one med he/she (Patient #4) will not let us take. He/she would not let us take it to the pharmacy and he/she takes it him/herself. That is why it is documented that way because the nurse can't document something they do not administer, but the patient is taking it him/herself."

Further review of the clinical record for Patient #4 revealed no "care plan" information regarding the self administration of medications, nor any nurses notes regarding the same. There was no evidence the physician was aware the patient had refused to allow staff to take the personal medications and was self administering it, and whether the patient had been assessed as being capable of self administration of medications. There was no documentation that the Pharmacy had reviewed the medication and/or spoken with Patient #4 regarding the use of the medication and the self-administration. There was no documentation found in the clinical record that Patient #4 had refused to allow the staff to take possession of the medication.

A review of the concerns were discussed with the facility administrative Staff Members # 1, 2, 3, 25 and 26 on 2/24/17 at 1:00 p.m.

Based on interviews and facility document review, it was determined hospital staff failed to ensure nursing assignments were made in accordance with patient needs and the competency and qualifications of nursing staff by a) failing to evaluate performance annually for 4 of 9 registered nurses' and b) failing to ensure documentation of orientation for 2 of 9 registered nurses' whose personnel files were selected for review.

The findings include:

Personnel files were reviewed on 2/23/2016 and 2/24/2016 with the assistance of Staff Members #22, 23, and 24. Review of personnel files #1, 5, 8 and 13 (all registered nurses) failed to provide evidence of annual performance evaluations. Staff Member #24 stated that completed evaluations are turned into HR (human resources), the evaluations are then sent to a vendor to be scanned into the employee file, he/she was unable to find documentation of evaluations for the calendar year 2015 for the aforementioned personnel. Review of hospital policy "Performance Evaluation" reads in part,..."Employees should receive a formal performance evaluation, at a minimum, on an annual basis."

Personnel files #4 and #5 failed to provide evidence of a completed initial competency assessment for a critical care registered nurse. Core competencies not documented include but are not limited to the following: ability to care for trauma patient, ability to care for cardiac patient, admissions, discharges and transfers, safety and emergency procedures, tracheostomy care and neurological care. Personnel files #4 and #5 were identified as belonging to registered nurses who work in critical care areas of the hospital and have been employed for at least a year. Staff Member #23 stated that he/she would have expected the core competencies to have been completed or marked as not applicable.

The missing evaluations and core competencies were discussed with Staff Members #23 and #24 on 2/24/17. No further information was provided to the survey team.

Based on observation, clinical record review, staff interview and facility document review, it was determined the facility staff failed to ensure patients were supervised during the administration of medications, Patient # 4.

Patient #4 was observed talking his/her medications without supervision from the nurse.

The findings included:

Patient #4 was admitted on 2/17/17 with diagnoses that included, but were not limited to: Congestive Heart Failure, Chronic Obstructive Pulmonary Disease, Hypertension, Rheumatoid Arthritis and Osteoporosis.

On 2/23/17 at 9:40 a.m., the surveyor went to Patient #4's room, escorted by Staff Member # 3 in order to interview the patient. After receiving permission, the surveyor entered the room (Staff Member #3 waited outside the door) and observed Patient #4 to be alone, sitting on the side of the bed, holding a paper souffle cup from which he/she was retrieving pills and placing them in his/her mouth. The surveyor explained the purpose of the visit and requested permission to interview him/her. Patient #4 stated, "Yes, I will talk with you, after I am finished taking my medications." There was no nurse present in the room at the time. The surveyor inquired as to the medications the patient was taking and he/she stated, "I am just getting around to taking my morning medications. I wanted to eat something so I didn't take them until now." The surveyor inquired as to the patient self-administering medications. Patient #4 stated, "The nurse gives me all my medications..."

On 2/22/17 at 10:30 a.m., the surveyor discussed the self administration of medications and "home medications' with Staff Member # 7. Staff Member #7, at that time, stated, "No patient is allowed to self administer medications. Any medications brought from home must be sent to the pharmacy and they are checked and a bar code is applied. The medications are locked up and the nurse administers the medications to the patients. Patients cannot keep medications in their room and they can't self administer. The nurse administers all medications to the patient..."

Further review of the clinical record for Patient #4 revealed no physicians order regarding the patient self-administering medications. There was no "care plan" information regarding the self administration of medications, nor any nurses notes regarding the same.

Review of the facility policy "Adult Medication Administration" revealed, in part: "... A. Prescribing...8. Medications should not be left at the patient's bedside...G. Administration...1d. Explain to the patient what medications they are being given, their intended use, and what reaction, if any, they should expect and/or report. e. Administer the medication...k. No mediations will be left at the bedside for self administration. In the event that a medication is to be self-administered, the nurse caring for the patient will supply the medication at the appropriate time..."

A review of the concerns were discussed with the facility administrative Staff Members # 1, 2, 3, 25 and 26 on 2/24/17 at 1:00 p.m.

Based on interview and document review it was determined nursing staff failed to perform vitals at the required intervals for three (3) of four (4) patients in the survey sample for blood administration. (Patients #7 and #10 and #11)

The findings included:

1. A review of Patient #7's electronic Medical record (EMR) was conducted on 02/22/2017 at 9:11 a.m., with Staff Member #3. Patient #7 was admitted to the facility on 01/11/2017; after being brought in by emergency medical transport. Patient #7 was scheduled for surgical intervention related to bezoar (indigestible material) caused by ingested cigarette butts. Patient #7 had an exploratory laparoscopy performed on 01/11/2017. Review of Patient #7's inpatient EMR documented the patient received blood transfusions on 01/11/2017, 01/13/2017, 01/17/2017 and 01/20/2017. Review of the blood transfusion documentation revealed nursing staff failed to perform the vital signs at the end of the transfusion on 01/13/2017, 01/17/2017 and 01/20/2017. Staff Member #3 navigated Patient #3's EMR to locate vitals documented in other areas of the patient's EMR. Staff Member #3 reported the nursing staff failed to follow the facility's policy and best practices.

2. A review of Patient #10's EMR was conducted on 02/23/2017 at 8:45 a.m., with Staff Member #15. The review revealed Patient #10 was admitted to the facility on 10/21/2016 with the diagnosis of Hemoptysis. Staff Member 15 reported the EMR system used by the facility is a data entry system until the patient is discharged. Staff Member #15 reported when the patient's final medical record is compiled information "may be kicked out or placed in another area."

Review of Patient #10's EMR revealed the physician had ordered two (2) separately timed units of red blood cells (RBC) for 11/01/2016; one (1) unit of platelets on 11/02/2016; seven (7) units of fresh frozen plasma (FFP) on each of the following dates: 11/03/2016. 11/04/2016 and 11/06/2016. Staff Member #15 reported if more than one (1) unit of FFP was ordered the blood bank generally pooled together and infused as one unit. The RBC unit transfused at 2125 (9:25 p.m.) on 11/01/2016 did not have a complete set of ending vital signs. The platelet transfusion on 11/02/2016 did not have the first fifteen minute and ending sets of vital signs. For the seven (7) units of FFP transfused on 11/03/2016 the nursing staff failed to enter a complete ending set of vital signs. On 11/04/2016 nursing staff failed to document a complete set of ending vital signs.

Staff Member #15 navigated Patient #10's EMR to determine if nursing staff had documented portions of the vital signs in other areas of the patient's EMR. Staff Member #15 verified the vital signs were missing as noted above. Staff Member #15 reported Patient #10's EMR did not provide documentation complete vital signs were performed as required. Staff Member #15 reported if nursing staff failed to click the right drop down box; the vital sign would not appear on the document related to the blood transfusion.

3. A review of Patient #11's EMR was conducted on 02/23/2017 at 9:11 a.m., with Staff Member #3. Patient #11's EMR documented the patient was admitted related to "Liver Failure" and gastrointestinal bleeding (GI Bleed). Patient #11's EMR revealed the following physician ordered blood products:

RBC (Red Blood Cells) - 12/17/2016 at 9:20 a.m., 3:41 p.m., and 3:54 p.m.; 12/19/2016 at 6:24 a.m.

Platelets - 12/17/2016 at 12:20 p.m., 12/18/2016 at 1:20 a.m., 12/19/2016 at 6:24 a.m., and 12/20/2016 at 4:40 p.m.

Fresh Frozen Plasma (FFP) - 12/17/2016 at 12:21 p.m.

Staff Member #3 navigated multiple sections of Patient #11's EMR to locate documentation of the required pre-transfusion, fifteen minutes after starting transfusion and ending set of assessment vital signs. The review revealed nursing staff failed to have assessment of the end vital signs for Platelets administered on 12/17/2016 at 1:07 .p.m., 3:00 p.m.; 12/19/2016 at 9:32 a.m. The review revealed nursing staff failed to have assessment of the fifteen minutes after starting transfusion and ending vital signs for: Platelets administered on 12/18/2016 at 0:59 a.m. and 12/20/2016 at 5:15 p.m. The review revealed nursing staff failed to perform an ending assessment of vital signs for RBC administered on 12/17/2016 at 7:28 p.m. and on 12/19/2016 at 7:01 a.m. The findings were verified by Staff Member #3.

Review of the facility's policy titled "Blood & (and) Blood Products, Administration of" read in part: "N. Patient Monitoring 1. RN/LPN (Registered Nurse/Licensed Practical Nurse) remains with the patient for the first fifteen (15) minutes of the transfusion 2. Vital signs: Blood Pressure, Temperature, Pulse, Respirations, Pulse Oximetry [:] a. at the initiation of transfusion b. 15 minutes after the start of the transfusion c. Completion of the transfusion ... Q. Click 'Document' to enter 1st 15 min set of vital signs ... S. 'End' enter the time and date, volume amount defaults but may be edited, enter 'Additional Fluid Volume' T. Click 'Document' to enter Ending set of vital signs ... [Sic]"

Based on observation, staff interview, clinical record review, and review of facility documents, the facility staff failed to ensure that policies and procedures were developed for the self-administration of medications for one (1) of one (1) patient in the survey sample who had medications in the room available for self administration, Patient #4.

During a tour of the facility numerous medications were observed in Patient #4's room. Patient #4 was also self administering a medication which staff had stated the "patient refused to give to staff".

The findings included:

Patient #4 was admitted on 2/17/17 with diagnoses that included, but were not limited to: Congestive Heart Failure, Chronic Obstructive Pulmonary Disease, Hypertension, Rheumatoid Arthritis and Osteoporosis.

During a tour of the facility on 2/21/17 at 2:00 p.m., the surveyor observed the following medications sitting out on the windowsill of Patient#4's room: Fluticasone nasal spray (open container)(Fluticasone nasal spray is used to relieve sneezing, runny, stuffy, or itchy nose and itchy, watery eyes caused by hay fever or other allergies [caused by an allergy to pollen, mold, dust, or pets]), Ventolin inhaler, in open packaging, (VENTOLIN HFA is used to treat or prevent bronchospasm), Spiriva inhaler , in an opened packaging, (Spiriva HANDIHALER is used for maintenance treatment of bronchospasm), Alkaseltzer heartburn relief gummies (over the counter medication in an opened container), and Nasal decongestant spray (over the counter medication in an opened packaging).

Also the surveyor observed a bottle of Xylocaine 1% 200mg/20 mg (two-hundred milligrams per twenty milliliters) bottle (small amount of medication remaining in the bottle) sitting on the patient's sink and a syringe containing sodium chloride (3 milliliter syringe) attached to a t-connector extension tube lying also in the window sill. (Medication information obtained from 2014 Drug Nursing Handbook Springhouse Corporation).

Review of the clinical record for Patient #4 revealed a physicians order for the Fluticasone and Spiriva, however there was no order for the medication to be left in the patient's room or self-administered. There was no order for the Ventolin Handihaler, however the patient did have an order for Ventolin which was administered via a jet nebulizer by respiratory therapy. There was no physician's order for the Alkaseltzer gummies, or the nasal decongestant spray. Further review of the clinical record for Patient #4 revealed an order for "Xeljanz 5mg (five milligrams) po (by mouth) twice a day, Patient's own medication" (Xeljanz is used to treat adults with moderately to severely active rheumatoid arthritis per www.drugs.com).

On 2/22/17 at 10:30 a.m., the surveyor discussed the self administration of medications and "home medications' with Staff Member #7. Staff Member #7, at that time, stated, "No patient is allowed to self administer medications. Any medications brought from home must be sent to the pharmacy and they are checked and a bar code is applied. The medications are locked up and the nurse administers the medications to the patients. Patients cannot keep medications in their room and they can't self administer. The nurse administers all medications to the patient..."

Further review of the clinical record for Patient #4 revealed that for the documentation for the administration of the Xeljanz from 2/18 through 2/23/17, the medication was documented as "not administered- taken".

On 2/23/17 at 2:30 p.m., the surveyor interviewed Staff Member # 3 regarding a patient's ability to self administer medications and the facility policy and procedure regarding the same. Staff Member #3 stated, "It depends on what the medication is whether the patient can self administer...some patients may have medications that they self-administer based on what it is- like an insulin pump or something." The surveyor requested a copy of the facility policy and procedure regarding the self administration of medications. At that time the surveyor discussed with Staff Member #3 the observations regarding the medications in the room of Patient #4.

On 2/24/17 at 8:40 a.m., the surveyor again discussed self administration of medications with Staff Member #3 and requested the facility policy and procedure. Staff Member #3 stated, "The medications are at the physicians' discretion..." The surveyor requested a list of medications that patients were permitted to self administer based on the "physician's discretion". Staff Member #3 stated, "There is no specific list, It is at the physicians discretion, and no policy reflects this. The other medicines in the room, the Xylocaine and syringe were left over from a procedure the patient had..." At 9:20 a.m., the surveyor inquired as to the reason the Xeljanz was documented as "not administered-taken" by the nurse in the patient's medication administration record, as whether the patient was receiving the medication or not. Staff Member #3 stated, " After speaking with the Nursing Director and the nurse on the unit, that is one med he/she will not let us take. He/she would not let us take it to the pharmacy and he/she takes it him/herself. That is why it is documented that way because the nurse can't document something they do not administer, but the patient is taking it him/herself."

Further review of the clinical record for Patient #4 revealed no physician orders regarding the patient self-administering medications. There was no "care plan" information regarding the self administration of medications, nor any nurses notes regarding the same. There was no evidence the physician was aware the patient had the medications and was self administering it, and whether the patient had been assessed as being capable of self administration of medications.

The facility policy and procedure "Patient's Personal Medications" was reviewed and evidenced, in part: "...Policy Statement: Medications brought to the hospital by a patient should not be given except by written order of the physician. Medications brought into the hospital by the patient are not administered unless they have been identified by a pharmacist and are in an appropriately labeled (label applied by the pharmacy or manufacturer original label) container...Procedure: When a patient brings personal medications to the hospital at the time of admission, one of the following occurs: A. The medication is identified by the nurse for medication reconciliation, and then sent home with a family member or are giver within 24 hours after admission. B. If home medication must be kept in the facility, the following procedure will be followed: ...D. A prescriber may order the patient may use(sic) his/her home medication(s) under the following conditions: 1. The Pharmacy and Therapeutics Committee classifies the medication as non-formulary and no suitable formulary option is acceptable to the prescribing licensed independent practitioner. 2. The pharmacy cannot obtain the formulary medication...E. If the above criteria are met in section "D" for a patient to use home medications, the pharmacist will enter and dispense the medication as follows: 1. Verify the integrity of the product using qualified drug information reference...2. Enter the medication on the MAR to generate a bar coded label as most appropriate...3. Label the medication without occluding the original dispensing or identifying label...4. Dispense appropriately labeled medication in its original container to the nursing unit...F. The Pharmacist will NOT identify and label the medications in the following situations: 1....or the integrity of the medication cannot be determined- the drug will be withheld from the patient and the prescribing physician contacted for an alternative medication therapy...2. Note that opened multiple dose containers such as liquids, inhalers, creams, ointments, ect. CANNOT be verified as the labeled ingredient..."

A review of the concerns were discussed with the facility administrative Staff Members # 1, 2, 3, 25 and 26 on 2/24/17 at 1:00 p.m.

Based on observation, staff interview, clinical record review, and review of facility documents, the facility staff failed to ensure that policies and procedures were followed for the self-administration of medications for one (1) of one (1) patient of the survey sample who had a medication (non-formulary) brought from home and was self administering the medication. Patient #4.

Patient #4 was self administering a medication which staff had stated the "patient refused to give to staff".

The findings included:

Patient #4 was admitted on 2/17/17 with diagnoses that included, but were not limited to: Congestive Heart Failure, Chronic Obstructive Pulmonary Disease, Hypertension, Rheumatoid Arthritis and Osteoporosis.

Review of the clinical record for Patient #4 revealed an order for "Xeljanz 5mg (five milligrams) po (by mouth) twice a day, Patient's own medication" (Xeljanz is used to treat adults with moderately to severely active rheumatoid arthritis per www.drugs.com).

On 2/22/17 at 10:30 a.m., the surveyor discussed the self administration of medications and "home medications' with Staff Member # 7. Staff Member #7, at that time, stated, "No patient is allowed to self administer medications. Any medications brought from home must be sent to the pharmacy and they are checked and a bar code is applied. The medications are locked up and the nurse administers the medications to the patients. Patients cannot keep medications in their room and they can't self administer. The nurse administers all medications to the patient..." During the review of the clinical record, the surveyor asked Staff #7 to locate documentation regarding the pharmacy review of the medication that Patient #4 had brought from home. Staff #7 stated, "It does not look as though Pharmacy has addressed (Patient #4's) home medications."

Further review of the clinical record for Patient #4 revealed that for the documentation for the administration of the Xeljanz from 2/18 through 2/23/17, the medication was documented as "not administered- taken".

On 2/23/17 at 2:30 p.m., the surveyor interviewed Staff Member #3 regarding a patient's ability to self administer medications and the facility policy and procedure regarding the same. Staff Member #3 stated, "It depends on what the medication is whether the patient can self administer...some patients may have medications that they self-administer based on what it is- like an insulin pump or something." The surveyor requested a copy of the facility policy and procedure regarding the self administration of medications. At that time the surveyor discussed with Staff Member #3 the observations regarding the medications in the room of Patient #4.

On 2/24/17 at 8:40 a.m., the surveyor again discussed self administration of medications with Staff Member #3 and requested the facility policy and procedure. Staff Member #3 stated, "The medications are at the physicians discretion..." The surveyor requested a list of medications that patients were permitted to self administer based on the "physicians discretion". Staff Member #3 stated, "There is no specific list, It is at the physicians discretion, and no policy reflects this." At 9:20 a.m., the surveyor inquired as to the reason the Xeljanz was documented as "not administered-taken" by the nurse in the patient's medication administration record, as whether the patient was receiving the medication or not. Staff Member #3 stated, " After speaking with the Nursing Director and the nurse on the unit, that is one med he/she (Patient #4) will not let us take. He/she would not let us take it to the pharmacy and he/she takes it him/herself. That is why it is documented that way because the nurse can't document something they do not administer, but the patient is taking it him/herself....that medication is a non-formulary medication..."

Further review of the clinical record for Patient #4 revealed no "care plan" information regarding the self administration of medications, nor any nurses notes regarding the same. There was no evidence the physician was aware the patient had refused to allow staff to take the personal medications and was self administering it, and whether the patient had been assessed as being capable of self administration of medications. There was no documentation that the Pharmacy had reviewed the medication and/or spoken with Patient #4 regarding the use of the medication and the self-administration. There was no documentation found in the clinical record that Patient #4 had refused to allow the staff to take possession of the medication.

Review of the facility policy "Adult Medication Administration" revealed the following, in part: "... A. Prescribing :...9. Medications brought to the hospital by a patient should not be given except by written order of the physician. Drugs brought into the hospital by the patient are not administered unless they have been identified by Pharmacy and are in an adequately labeled (label applied by a pharmacy or manufacture's original label) container. All medications taken by the patient including patients own meds, are recorded on wither the MAR (medication Administration Record) or eMAR (electronic medication administration record)...F. Procedure:...1 d. Patients own medications should be reviewed by pharmacy prior to administration only after the order is written by the physician...G. Administration:...k. No medications will be left at the bedside for self administration. In the event that a medication is to be self-administered, the nurse caring for the patient will supply the medication at the appropriate time..."

The facility policy and procedure "Patient's Personal Medications" was reviewed and evidenced, in part: "...Policy Statement: Medications brought to the hospital by a patient should not be given except by written order of the physician. Medications brought into the hospital by the patient are not administered unless they have been identified by a pharmacist and are in an appropriately labeled (label applied by the pharmacy or manufacturer original label) container...Procedure: When a patient brings personal medications to the hospital at the time of admission, one of the following occurs: A. The medication is identified by the nurse for medication reconciliation, and then sent home with a family member or are giver within 24 hours after admission. B. If home medication must be kept in the facility, the following procedure will be followed: ...D. A prescriber may order the patient may use(sic) his/her home medication(s) under the following conditions: 1. The Pharmacy and Therapeutics Committee classifies the medication as non-formulary and no suitable formulary option is acceptable to the prescribing licensed independent practitioner. 2. The pharmacy cannot obtain the formulary medication...E. If the above criteria are met in section "D" for a patient to use home medications, the pharmacist will enter and dispense the medication as follows: 1. Verify the integrity of the product using qualified drug information reference...2. Enter the medication on the MAR to generate a bar coded label as most appropriate...3. Label the medication without occluding the original dispensing or identifying label...4. Dispense appropriately labeled medication in its original container to the nursing unit...F. The Pharmacist will NOT identify and label the medications in the following situations: 1....or the integrity of the medication cannot be determined- the drug will be withheld from the patient and the prescribing physician contacted for an alternative medication therapy...2. Note that opened multiple dose containers such as liquids, inhalers, creams, ointments, ect. CANNOT be verified as the labeled ingredient..."

A review of the concerns were discussed with the facility administrative Staff Members # 1, 2, 3, 25 and 26 on 2/24/17 at 1:00 p.m.

3

Based on interview and document review it was determined facility staff failed to ensure an accurate and complete medical record was maintained for two (2) of twelve (12) patient's medical records reviewed as part of the survey sample. (Patients #7 and #9)

The findings included:

A review of Patient #7's electronic Medical record (EMR) was conducted on 02/22/2017 at 9:11 a.m., with Staff Member #3. Patient #7's EMR documented he/she was admitted to the facility on 01/11/2017; after being brought in by emergency medical transport. The review revealed Patient #7 was scheduled for surgical intervention related to bezoar caused by ingested cigarette butts. Patient #7 had an exploratory laparoscopy perform on 01/11/2017. Review of Patient #7's inpatient EMR for this admission revealed a scanned form titled "Outpatient: Endoscopy Physicians order form. The form was signed by a physician. The form read in part "The following medications are administered under the direct supervision of physician." Under this subheading there were two handwritten notations "5 mg (milligram) Midazolam IV (intravenous) and 50 mcg (microgram) Fentanyl IV." The form did not have a date and time documented at either entered medication or anywhere on the form. Two additional medications were handwritten on the form under the section "Additional Orders: Levaquin and Flagyl [dose and route not legible for both medications]" these mediations were not dated or timed. Staff Member #3 navigated reviewed Patient #7's EMR for clarification and reported the form appeared to be a part of the patient's 01/11/2017 admission. Staff Member #3 verified the findings. Staff Member #3 reported the physician should have timed and dated the medications

According to the online medical dictionary.com; "A bezoar is a ball of swallowed foreign material most often composed of hair or fiber. It collects in the stomach and fails to pass through the intestines."

A review of Patient #9's EMR was conducted on 02/23/2017 at approximately 8:29 a.m., with Staff Member #15. Patient #9"s EMR documented he/she was admitted to the facility on 02/17/2017 for "Mood Disorder." Patient #9's EMR contained a "Patient Rights and Responsibilities" for behavioral health service was signed by the patient, his/her parent, and facility staff. On Patient's #9's "Patient Rights and Responsibilities" form the line designated for "Time" for all three signatures were blank. Staff Member #15 verified the "Patient Rights and Responsibilities" form signatures should have been timed. Staff Member #15 reported he/she was not sure the facility had a specific policy related signing, dating, and timing general forms. Staff Member #15 reported if the form "has a line for time then it should have been filled in."

No policy was provided prior to exit on 02/24/2017.

Based on observations, staff interviews, personnel record review and review of the facilities policies and procedures, it was determined facility staff failed to ensure appropriate use of PPE (personal protective equipment including gowns, gloves, masks and eye protection devices), that isolation techniques were followed, and that staff followed the facility's policy and procedure for discharge cleaning of an isolation room. Also the facility staff failed to ensure annual tuberculosis screening questionnaires were completed for 4 of 14 staff members whose personnel records were reviewed. (Personnel Records #1, 4, 5 and 12.)

Findings include:

1. A tour of the hospital was conducted by the surveyors on 2/21/17 between 1:15 PM and 2:30 PM; the following observations were made:
At 1:30 PM, the surveyor noted a sign for "Enhanced contact precautions" posted outside Room #20 on the CVICU (Cardio-vascular intensive care unit) stepdown unit. The sign included instructions that hand hygiene, gown, and gloves were mandatory before entering the room. Staff Member #3, who was accompanying the surveyors on the tour was asked what "Enhanced Contact precautions" meant, and he/she stated "it's used for C-diff, when soap and water must be used for handwashing".

A surveyor observed a staff member in Room #20, identified as a Nurse Practitioner (NP) by Staff Member #3. The NP was wearing an isolation gown; however, it was not tied, and was gaping open leaving the clothes beneath the gown exposed. The NP removed his/her gown, washed hands with soap and water, then walked across the room from the sink, past the bottom of the patient's bed, to throw away paper towels into the trash. The NP then exited the room rubbing clothing against the curtains on the way out the door.

At 1:35 PM, a surveyor observed Staff Member #27, an RN (registered nurse) touch the curtains covering the glass doors of the room with contaminated gloved hands several times while providing care to the patient. Staff Member #27 pushed back the curtains with gloved hands while trying to get the attention of another staff member. Staff Member #28 retrieved supplies requested by Staff Member #27, went to Room #20, touched the curtain with ungloved hands, reached inside the room past the curtain with ungloved hands, and without sanitizing hands before or after, placed supplies on a table inside the door.

At 1:40 PM, a surveyor observed housekeeping staff touch the privacy curtain in front of the glass door of
Room #20 with ungloved hand, without sanitizing or washing his/her hands, turned to the housekeeping cart, and pushed the cart down the hall to another room.

Staff Member #27 removed his/her PPE gown, but left his/her gloves on. Wearing dirty gloves, Staff Member #27 pushed the EKG machine through the curtains, stopping just outside the door, and wiped off only the top of the EKG (electro-cardiogram) machine used for the patient in Room #20. While still wearing the same gloves,
Staff Member #27 pushed the machine to a storage area where it was available for use on another patient. Staff Member #27 went back into the room, removed gloves, washed hands; there were no paper towels in the room with which to dry his/her hands, then exited the room, again brushing his/her scrubs against the curtain covering the door to room #20.

The surveyor requested the facility's policy related to isolation precautions, and was given the policy and procedure titled "Guideline for Isolation Precautions in Hospitals". The policy did not include "Enhanced Contact Precautions"; however, it included the following information regarding contact precautions: "Contact precautions are designed to reduce the risk of transmission of epistemologically important microorganisms by direct or indirect contact. Direct-contact transmission involves skin-to-skin contact and physical transfer of microorganisms to a susceptible host from an infected or colonized person, such as occurs when personnel turn patients, bathe patients, or perform other patient-care activities that require physical contact....""...Indirect-contact transmission involves contact of a susceptible host with a contaminated intermediate object, usually inanimate, in the patient's environment....". Under "gloves and hand hygiene" the policy states "...3. Remove gloves before leaving the patient's environment and wash hands immediately with an antimicrobial agent or a waterless antiseptic agent; 4. After glove removal and hand hygiene, ensure that hands do not touch potentially contaminated environmental surfaces or items in the patient's room to avoid transfer of microorganisms to other patients or environments". Under the heading "C. Gown: ...3. After gown removal, ensure that clothing does not contact potentially contaminated environmental surfaces to avoid transfer of microorganisms to other patients or environment". Under "E. Patient Care equipment: 2. If use of common equipment or items is unavoidable, then adequately clean and disinfect them before use for another patient".

2. While standing in the hallway of a unit interviewing Staff Member #6, the Director for that unit, the surveyor observed housekeeping staff cleaning the room of a patient who had been discharged, and who had been on contact isolation. A housekeeper entered the room wearing gown and gloves, and put trash into one large bag. Another housekeeping staff member went into the room without PPE, taking trash in ungloved hands, placed it into a cart with other trash, and pushed the cart down the hallway. The staff member was not observed washing or sanitizing his/her hands. The trash bag was clear plastic bag, not a hazardous waste bag, and did not indicate that it came from an isolation room.

The housekeeping staff who was cleaning the room removed a dust mop from the cleaning cart outside the door, carried it into the room, swept the dust/trash on the floor out into the hallway, sweeping it into a pan, and placed into the trash. The dust mop was then placed back onto the cleaning cart.

The facility's policy and procedure titled "Cleaning Facility" states in part : "D. Isolation discharge cleaning
1. Employees shall wear appropriate protective clothing according to sinage posted on the patient's door. These rooms will be serviced last using newly mixed cleaning solution, new mop head, and cleaning cloth. Sanitize all equipment prior to usage and then follow the Seven-Step Cleaning Procedure. Remove cubicle curtains and shower curtain. Place in a blue linen bag at the patient room door for removal to soiled linen area. Remove linen by following Infection Control Guidelines. Wash all walls using hospital approved disinfectant. Follow the Regulated Medical Waste Disposal methods. Sanitize all equipment using a hospital-approve disinfectant...".

The concerns were discussed with staff on 2/24/16 between 11:00 AM and 11:30 AM.


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3. Personnel records of 14 staff members were reviewed on 2/23/17 and 2/24/17 with the assistance of Staff Member #22, 23 and 24. Review of Personnel Records #1, 4, 5 and 12 failed to provide evidence of an annual "Tuberculosis Screening Questionnaire".

Upon discovering the missing screenings, a staff member assisting the survey team contacted the Occupational Health Department, the surveyor was told that if it (the screening) was not in the employee file, then it was not current. The surveyor was told that previous practice had been to obtain the screenings when "fit testing" was done for respirators but had been changed to the employees hire date in order to increase compliance.

The surveyor was later provided with "Tuberculosis Screening Questionnaires" for Personnel Records #1, 4, 5 and 12 on 2/24/17. The documents were dated 2/24/17.