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30420

Based on record review and interview the hospital failed to ensure each patient, or when appropriate, the patient's representative, was informed of the patient's rights in advance of furnishing or discontinuing patient care whenever possible. This failed practice was evidenced by outpatients not being provided patient rights.
Findings:

Review of hospital policy # PC.RT.1.21, titled "Patient Rights and Responsibilities", provided by S4QA as current, revealed in part that the patient rights and responsibilities applied to all patients of the hospital. Further review revealed, the employee who had first access to the patient had the responsibility of informing the patient of their rights. The policy indicated every patient must be given a copy of the Patient Handbook that describes rights and responsibilities.

Review of a packet given to inpatients and a packet given to outpatients, provided by S32DirRev as current, revealed no patient rights. Further review revealed a 3 page document titled Consent for Treatment, to be signed by the patient, or patient representative. Under acknowledgements, on page 3 of 3, was " (Please initial on the lines indicated below.)
___ I received/was offered a copy of the Patient Rights and Responsibilities.
___ I have received information about Advanced Directives as required by law."

A review of the outpatient medical records for Patients #25, #26, #27, who had surgical procedures on 01/17/17, revealed that the above: "Under acknowledgements, on page 3 of 3, was " (Please initial on the lines indicated below.)
___ I received/was offered a copy of the Patient Rights and Responsibilities.
___ I have received information about Advanced Directives as required by law."
was not initialed by the above patients on their patient rights forms and was left blank.

In an interview on 01/19/17 at 12:30 p.m. with S44AdmClerk, she indicated that she used to review patient right information with all patients, but she stopped a few months ago when she noticed that no one else in the Admissions department was reviewing patient right's information with outpatients or giving them a copy. She further indicated that she was not getting all patients to initial the patient rights forms.

In an interview 1/18/17 at 9:55 a.m. S32DirRev indicated he supervised the admission process of all hospital inpatients and outpatients. S32DirRev reported only inpatients are provided with patient rights, but not outpatients. S32DirRev verified staff had patients initial the statements that they had received their patient rights and information regarding advances directives and their right to make them, even though the patient had NOT been provided with the information. S32DirRev indicated he was aware outpatients were to be informed of patient rights.

26351




30420


Based on observations, record review and interviews, the hospital failed to ensure each patient received care in a safe setting as evidenced by:
1) Failing to provide 1:1 observation of an ED patient according to hospital policy. This failed practice was evidenced when a 9 year old ED patient was to be on 1 to 1 observation, but the observer was sitting across the hallway, behind a closed door, with the client and most of his environment not in her view, and;
2) Failing to ensure the physical environment was maintained in a manner to assure an acceptable level of safety and quality for patients admitted for acute inpatient psychiatric services. The deficient practice was evidenced by failure to ensure the patients' environment was free of ligature risks.

Findings:

1) Failing to provide 1:1 observation of an ED patient according to hospital policy:

Review of hospital policy #PC.AS.3.14, titled, "Care of the Suicidal Patient", provided by S4QA as current for patients requiring 1:1 supervision, revealed, in part, One to One Visual Contact included the following:* The patient on 1:1 must remain within arm's length and within visual contact of a specifically assigned staff members at all times. This included bathing and toileting.

Review of hospital policy, Nur.ED.1.34, titled, "Psychiatric Patients Within the Emergency Department", revealed in part, Guidelines for 1:1 Observations: 2. The patient remains within the team members visual sight at all times."

Review of the ED record for Patient #1 revealed he was an 8 year old boy admitted to the ED for violent behavior on 1/16/17 at 1:29 p.m. Review of his triage acuity revealed he was assessed as a 2 ESI. His Psychiatric Safety Observation Flowsheet listed his observation level as line of sight.

An observation was conducted on 1/17/17 at 1:30 p.m. of Patient #1 in an ED room with the door closed to Patient #1's ED room. The window in the door was 4 feet from the floor and measured 28 inches by 26 and 1/2 inches. S41CNA was sitting in a chair 10 feet from the closed door. Patient #1 was unable to be visualized by S41CNA due to the position of the window in the door and where the chair she was sitting in was located.

An interview was conducted with S7EDMger on 1/17/17 at 1:45 p.m. He confirmed Patient #1 was not in the line of sight of S41CNA and S41CNA was the individual assigned to monitor the patient at a 1:1 observation level due to safety concerns.


2) Failing to ensure the physical environment was maintained in a manner to assure an acceptable level of safety and quality for patients admitted for acute inpatient psychiatric services:


An observation of the inpatient psychiatric unit was conducted on 01/18/17 at 12:45 p.m. The following safety and ligature risks were identified and confirmed by S3DON and S17RN (Nurse Manager of BHU):
Two patient bathrooms were observed on the unit and both bathrooms were observed to have toilets with cut-out holes in the ceramic toilet bases. The cut-out holes in the ceramic toilet bases provided a possible ligature point. S3DON and S17RN confirmed the opening in the toilet base could be used as a possible ligature point.

Observation of all 6 patient bed room doors and 2 patient use bathroom doors revealed all doors had 3 separate hinges spaced apart which could be used to anchor an item for a ligature risk.

Observation of the door to the activity/dining room revealed the door handle was not an anti-ligature handle and the paddle type door handle was installed with both paddles in the down position, providing a potential ligature point from inside the room. S3DON and S17RN confirmed the door handle was not an anti-ligature handle and stated staff was present in the room when patients were present.

Based on record review and interview, the hospital failed to ensure the collected Quality Assurance data was measured, tracked, trended and analyzed in a hospital-wide ongoing program approach to show opportunities for improvement and measurable improvement in patient quality of care hospital-wide as evidenced by departmental Quality Assurance rather than an ongoing hospital-wide QA approach.

Findings:
A review of the hospital's QAPI program, as provided by S4QA, revealed no documented evidence that the QA data collected in each department and service was incorporated into an on-going hospital-wide approach that tracked, trended and analyzed the data for opportunities for improvement and corrective actions as a hospital-wide approach.

In an interview on 01/20/17 at 10:00 a.m. with S4QA, he indicated that he was the hospital's QA department manager. S4QA indicated that each department collected data and tracked, trended and analyzed their data for corrective actions in their individual departments. S4QA indicated that the QA reports were mostly departmental rather than hospital-wide. S4QA indicated that he received the QA reports from each department, but he was not tracking, trending and analyzing their departmental data for hospital-wide corrective actions or to show opportunities for improvement and measurable improvement in patient quality of care as an on-going hospital-wide approach.

26351


Based on record review and interview, the hospital failed to ensure a registered nurse supervised and evaluated the nursing care of each patient as evidenced by:
1) Failing to obtain and record vital signs per the emergency room's policy for 2 out of 2 (Patient #1 and #2) patients' records reviewed for assessments in the ED, and;
2) Failing to document every 30 minute observations in the BHU for 6 of 6 (#17, #18, #R1, #R2, #R3, #R4) current patients on the BHU.

Findings:

1) Failing to obtain and record vital signs per the emergency room's policy:

Review of the hospital's policy for Vital Signs in the Emergency Department revealed in part, Vital signs will be obtained and recorded as the patient's condition warrants or no less than: Every 15 minutes for triage level I, every 30 minutes for triage level II, every 2 hours for triage level III if normal, every 1 hour if abnormal.

Review of Patient #1's medical record revealed he was an 8 year old male patient admitted to the ED on 1/16/17 at 1:17 p.m. for violent behavior. Review of his triage assessment revealed he was assessed as a triage acuity of 2 emergent. Further review of his ED record revealed his vital signs were obtained as follows:
1/16/17 at 1:48 p.m.- B/P 128/59 HR 112 Resp 18 Temp 98.3
1/17/17 at 7:00 a.m.-B/P 100/54 HR 94 Resp 18 Temp 98.6
1/17/17 at 11:30 a.m.-B/P 99/50
1/17/17 at 3:30 p.m.-B/P 100/78 HR 95 Resp 18 Temp 98.5

An interview was conducted with S7EDMgr on 1/17/17 at 1:30 p.m. He confirmed Patient #1's vital signs were not obtained frequently enough and the nurses did not follow the hospital policy.


Review of Patient #2's medical record revealed he was a 22 year old admitted to the Emergency Room on 1/13/17 at 11:54 p.m. for suicidal ideation. Patient #2's acuity was triage as ESI (Emergency Severity Index) 2 in the Emergency Department. Further review of his ED record revealed his vital signs were obtained as follows:
1/14/17 at 12:02 am. temp 98.8
1/14/17 at 12:03 a.m. temp 98.9 HR 94 Resp 20 B/P 128/86
1/14/17 at 8:44 p.m. temp 98.3 HR 59 Resp 18 B/P 125/70
1/15/17 at 9:20 p.m. temp 98.8 HR 95 Resp 18 B/P 132/78
1/16/17 at 7:45 a.m. temp 97.6 HR 98 Resp 20 B/P 115/83
1/18/17 at 9:57 a.m. temp 98.2 HR 89 Resp 17 B/P 114/83

An interview was conducted with S7EDMgr on 1/18/17 at 2:00 p.m. He confirmed the patient's vital signs were not taken frequently enough and according to the hospital's policy.


2) Failing to document every 30 minute observations in the BHU:

Review of the hospital policy titled Special Precautions, policy number BAU.2.10, revealed in part the following: Medical record entries should reflect behavioral observations and patient's mental status indicating the necessity for the level of special precautions ordered....Observation frequency of every 30 minutes (routine): guidelines for implementation of this level of precaution include, but are not limited to, the following: Staff should maintain visual and verbal contact sufficient to monitor the patient's condition.

Review of the Patient Rounds and ADL sheets on 01/18/17 at 1:30 p.m. revealed no documented evidence that every 30 minute rounds/observations had been made since 9:30 a.m. for all the current patients on the BHU (#17, #18, #R1, #R2, #R3, and #R4).

In an interview on 01/18/17 at 1:30 p.m., S39MHT confirmed she had not documented any rounds or patient observations since 9:30 a.m.

In an interview on 01/18/17 at 1:45 p.m., S3DON and S17RN confirmed the minimum observation level for all patients on the BHU was every 30 minutes. Both confirmed the MHT had not documented the rounds/observations every 30 minutes since 9:30 a.m.

30420

Based on record review, observation and interview, the hospital failed to ensure all patient medical records were properly stored in secure locations where they were protected from fire, water damage and other threats. This deficient practice was evidenced by the storage of paper patients' medical records being stored in Medical Record rooms on 2 separate floors at the offsite location with no protection from fire or water damage.
Findings:

A review of the hospital policy titled "Confidentiality and Security of Medical Records", as provided by S4QA as a current policy, revealed in part: The purpose of the policy is to define how medical records are to be maintained in a confidential and secure manner. The hospital's Health Information Management Department is responsible for safeguarding the record and its informational content against loss, defacement, and tampering, and use by unauthorized individuals.

During an observation of the off-site facility medical records department on 01/18/17 at 11:50 a.m. with S3DON, paper patient medical records were observed to be stored on a rolling metal shelving system. There were 12 shelves with paper records from 2014 to present with no means to protect the medical records from fire and water damage. S3DON indicated the hospital began using an electronic medical record system on 06/19/16. S40ROI also present for the observation stated she was unable to provide a number of the medical records stored in this room. S3DON and S40ROI both confirmed the records were not protected from fire or water damage. S40ROI stated she remembered using tarps to cover the medical records in a weather event, but she did not know where the tarps were stored. S40ROI was unable to provide the number of patient records stored in the room. S40ROI stated there were paper patient records stored in 2 other rooms in the facility.

Observation of the 2 other medical record storage rooms revealed they were located on the second floor of the facility. The first room contained open stationary shelving with multiple patient records stored on the shelves with no means to protect the medical records from fire and water damage. S3DON stated there were several hundred records stored on these shelves. Observation of the next room revealed approximately 3000 medical records were stored on open metal shelves with no means to protect the medical records from fire and water damage. S3DON and S40ROI confirmed the records in both rooms were not protected from fire or water damage.


In an interview 1/19/17 at 12:15 p.m. S38RHIA indicated she was responsible for providing supervision of the Medical Records department. She confirmed patient records, in paper format, for the last 2 years until last August when electronic medical records were implemented, were stored at the hospital's offsite location. She indicated the offsite location, in addition to an inpatient unit, had a main file room on the 1st floor and 2 other locked rooms on the 2nd floor. S38RHIA verified some of the files were on rolling shelves, and some were on open shelves. She indicated the files were not protected from potential fire or water damage. S38RHIA reported she had no idea how many records were stored at the offsite location.

30420

Based on record review and interview, the hospital failed to ensure medical records included a properly executed informed consent for procedures and treatments. This deficient practice was evidenced by informed consents that were not completed as per hospital policy, when information required was omitted in the informed consent and required information areas were left blank for 4 of 4 (#6, #7, #8, #22) patients reviewed for properly executed informed consents out of a total sample of 30.
Findings:

Review of the hospital policy #PC.RT.1.11, titled " Informed Consent", provided by S4QA as current, revealed in part that Informed consent included an explanation of the risks and benefits of treatment and alternatives and likelihood of success associated with that treatment. Further review revealed, regarding Hospital Consent all blanks on the consent form should be filled in. All blanks on the consent form describing the surgical or special procedure should be completed in works understandable to the patient.


Patient #6
Review of the medical record of Patient #6 revealed she was admitted to the hospital 1/15/17 with a IUP at 38 weeks gestation, for delivery. Further review revealed consents signed by Patient #6, with blanks as follows:
-Consent for Blood Transfusion : blank for (#3) the patient's condition or ailment for which the medical treatment, surgical procedure or other therapy described in item number 2 (Blood transfusion description and purpose) is indicated and recommended.
-Consent for Delivery(vaginal): blanks for (#3) Patient's diagnosis, description of the nature of the condition or ailment for which the medical treatment, or surgical procedure or other therapy described in Item 2 is indicate;, (4.b) Additional risks (if any) to the patient because of a complicating medical condition are:___; and, (#5), Reasonable therapeutic alternatives and risks associated therewith, risk of no treatment include:___.
-Consent for Cervical Ripening for Induction of Labor had a blank for the therapeutic alternatives and risks associated. The consent did not describe which method of cervical ripening, or what medication would be used.
-Consent for Delivery by Cesarean Section, had blanks for the purpose, the patient's condition for which the surgical procedure was indicated or recommended, and additional risks(if any) to the patient because of a complicating medical condition, and for reasonable therapeutic alternatives and risks associated therewith, risk(s) of no treatment.

Patient #7
Review of the medical record for Patient #7 revealed he was born (and admitted) 1/16/17 at 2:19 p.m. Further review of Patient #7's medical record revealed a consent for a Circumcision, signed by his mother 1/18/17, with no time documented of the mother's signature. The purpose and patient's diagnosis, description of the nature of the condition or ailment for which the medical treatment/surgical procedure was indicated and recommended, the additional risk(s), if any, to the patient because of a complicating medical condition, and reasonable therapeutic alternatives and risks associated therewith, risk of no treatment were all blank, as well as the physician (or physician group) authorized to perform the procedure. A blank line was noted under, "If the consent is signed by someone other than the patient, state the reason and relationship."


Patient #8
Review of the medical record for Patient #7 revealed she was admitted to the hospital 1/16/17 for the delivery of an IUP at 39 and 3/7 weeks. Patient #7 delivered a female neonate 1/17/17 at 2:50 p.m. Further review revealed the following consents had blanks in the consents, with the patient's signature with a date and time of 1/16/17 at 3:06 p.m.:
-Consent for Blood Transfusion : blank for (#3) the patient's condition or ailment for which the medical treatment, surgical procedure or other therapy described in item number 2 (Blood transfusion description and purpose) is indicated and recommended.
-Consent for Delivery(vaginal): blanks for (#5), Reasonable therapeutic alternatives and risks associated therewith, risk of no treatment include:___.
-Consent for Cervical Ripening for Induction of Labor had a blank for the therapeutic alternatives and risks associated. The consent did not describe which method of cervical ripening, or what medication would be used.
-Consent for Delivery by Cesarean Section, had blanks for the purpose, the patient's condition for which the surgical procedure was indicated or recommended, and additional risks(if any) to the patient because of a complicating medical condition, and for reasonable therapeutic alternatives and risks associated therewith, risk(s) of no treatment.

In an interview 1/18/17 at 1:00 p.m. S18RN reviewed the patient records for Patients #6, #7, and #8, and verified the consents had blank lines/spaces as described above.

Patient #22
Review of the medical record for Patient #22 revealed she was admitted to the hospital on 1/14/17 for Cardiac arrest and Drug Abuse. Further review of her medical record revealed a consent for an EGD (Esophagogastroduodenoscopy) with possible biopsy and Esophageal Dilation dated 1/17/17. Consent for EGD, had blanks for the purpose, the patient's condition for which the surgical procedure was indicated or recommended, and additional risks (if any) to the patient because of a complicating medical condition, and for reasonable therapeutic alternatives and risks associated therewith.

An interview was conducted with S4QA on 1/19/17 at 11:30 a.m. He confirmed the consent for the EGD for Patient#22 was incomplete.

Based on record review and interview, the hospital failed to ensure drugs and biologicals were controlled and distributed in accordance with applicable standards of practice, consistent with state law. This deficient practice was evidenced by failing to ensure all medication orders entered by the ED physicians (except in emergency situations) were reviewed by a pharmacist, before the first dose was dispensed, for therapeutic appropriateness, duplication of a medication regimen, appropriateness of the drug and route, appropriateness of the dose and frequency, possible medication interactions, patient allergies and sensitivities, variations in criteria for use, and other contraindications.
Findings:

Review of the Louisiana Administrative Code, Professional and Occupational Standards, Title 46: LIII, Pharmacist, Chapter 15, Hospital Pharmacy, §1511. Revealed in part: Prescription Drug Orders:
A. The pharmacist shall review the practitioner's medical order prior to dispensing the initial dose of medication, except in cases of emergency.

In an interview on 01/18/17 at 10:30 a.m., S7EDMgr stated a first dose review by the pharmacist was not being done for any medications ordered anytime in the ED. S7EDMgr confirmed not all medications ordered in the ED were in emergency situations.

In an interview on 01/18/17 at 11:10 a.m. S8RPh and S3DON stated the pharmacist is doing first dose reviews on medications ordered by the nurse practitioner and physician's assistant that are working in the ED. S8RPh was unable to confirm if a first dose review was conducted for medications ordered by the ED physicians. S3DON stated they were researching this to determine if ED physician medication orders were included in the first dose review process.

In an interview on 01/18/17 at 5:10 p.m., S2CNO stated the current process allows the ED physician to enter orders and those orders were not included in the first dose review by the pharmacist. S2CNO confirmed non-emergent medications ordered by the ED physicians were not included in the first dose review done by the pharmacist.

Based on occurrence report reviews, record review and interview, the hospital failed to ensure medication administration errors were documented in the patients' medical records for 3 of 3 (#19, #20, #21) patients reviewed with known medication errors.

Findings:

Review of the hospital policy titled Medication Variance, PI.15.7, revealed the house supervisor, physician and the pharmacy department would be notified of any medication administration error. There was no documented evidence of a provision in the policy for documentation of the medication error other than in an occurrence report.

Patient #19
Review of the adverse event report revealed Patient #19 received 250 mg. of Zoloft (Anti-depressant) on 07/01/16, 07/02/16, and 07/03/16. The report revealed Zoloft 150 mg. was ordered. The report indicated the physician was notified.

Review of the medical record for Patient #19 revealed no documentation of the medication error on 7/01/16, 07/02/16, and 07/03/16, nor was there documentation of notification of the error to the attending physician. Review of the medication administration record revealed the patient did receive 250 mg. of Zoloft on 07/01/16, 07/02/16, and 07/03/16. Further review of the patient's medical record revealed the patient was admitted to the hospital's behavioral health unit on 06/29/16 with a chief complaint of, "Zoloft not working well." Review of the discharge summary revealed no documented evidence that the patient received 250 mg. of Zoloft on the 3 days prior to the discharge of the patient on 07/04/16. The discharge summary revealed the patient improved due to increasing the Zoloft to 150 mg. a day.

In an interview on 01/18/17 at 4:10 p.m., S3DON reviewed the adverse event report log and the patient's electronic medical record and confirmed the patient received the 250 mg of Zoloft on 07/01/17, 07/02/17, and 07/03/17 in error. S3DON confirmed the medication error was not documented in the patient's medical record, and the physician notification of the medication error was not documented in the patient's record.


Patient #20
Review of the adverse event report revealed Patient #20 was to receive Vancomycin 1.5 mg. IVPB every 8 hours. The report revealed Patient #20 did not receive the Vancomycin on 07/01/16 as ordered.

Review of the medical record for Patient #20 revealed no documentation of the medication error on 07/01/16. Review of the medication administration record for 07/01/16 revealed the Vancomycin was not given as ordered. There was no documented evidence of the medication error or physician notification of the medication error in the patient's medical record.

In an interview on 01/18/17 at 4:45 p.m., S3DON reviewed the medical record for Patient #20 and confirmed the medication error on 07/01/16 where the Vancomycin dose was omitted was not documented in the medical record, and she confirmed there was no documentation that the physician was notified.


Patient #21
Review of the adverse event report revealed Patient #21 revealed Synthroid 125 mcg. daily before breakfast was ordered. The report revealed the patient received the following: 07/19/16 at 7:00 a.m. Synthroid 125 mcg. was given by the night nurse.
07/19/16 at 8:09 a.m. Synthroid 125 mcg. was given by the day nurse. The report indicated the patient received an extra dose of 125 mcg. and that the physician was notified.

Review of the medical record for Patient #21 revealed no documentation of the medication error on 07/19/16. Review of the medication administration record for 07/19/16 revealed the Synthroid 125 mcg. was administered twice. There was no documented evidence of the medication error or physician notification of the medication error in the patient's medical record.

In an interview on 01/18/17 at 4:45 p.m., S3DON reviewed the medical record for Patient #21 and confirmed the medication error on 07/19/16 where the Synthroid 125 mcg dose was administered twice was not documented in the medical record, and she confirmed there was no documentation that the physician was notified.

30172

Based on record reviews, observations, and interviews the hospital failed to ensure a functional and sanitary environment was maintained according to acceptable professional standards of practice relating to infection control as evidenced by: a) failing to ensure hand hygiene was performed after removing soiled gloves; b) failing to ensure hospital staff who did not receive the flu vaccine wore a mask as per hospital policy; c) failing to ensure the dialysis machine was properly disinfected after use; d) failing to ensure that equipment available for patient use was not rusty or in disrepair so as to ensure effective cleaning/disinfecting; and e) failing to ensure sharps containers were replaced when full.

Findings:

a) failing to ensure hand hygiene was performed after removing soiled gloves;

A review of hospital policy #IP.7.1, titled "Handwashing/Surgical Scrub", provided by S4QA as current, revealed in part, all employees were to comply with the documented guidelines. Further review revealed handwashing should be be done by all personnel before and after removing gloves, and before and after patient contact.

An observation 1/17/17 at 1:25 p.m. revealed S28Phle perform a venipuncture on an ED patient, with gloves on. Upon completion of the procedure, S28Phle was observed to store the drawn blood in her carrying case, remove her gloves, and walk to the nurses' station where she put her hands on the counter top of the nurses' station, then leave to exit the ED. S28Phle was observed to not perform hand hygiene after removing her gloves. At the door to exit the ED into the hospital hallway, S28Phle verified she had not performed hand hygiene after removing her gloves, and indicated that she should have done so.

An observation 1/17/17 at 1:30 p.m. in the ED revealed S19RN walking through the nurse's station carrying a specimen cup containing a thin yellow fluid while wearing gloves. S19RN was observed to remove her gloves and discard them, and shifting the specimen cup to her other hand. S19RN was stopped at the doorway as she was exiting the ED. S19RN verified she had not performed hand hygiene after removing her gloves, and was carrying the specimen (identified by her as urine) without it being contained in a bag to prevent contamination. S19RN confirmed she should have performed hand hygiene after removing her gloves, and should have had the specimen cup in a bag to prevent cross contamination.


b) failing to ensure hospital staff who did not receive the flu vaccine wore a mask as per hospital policy;

A review of the hospital policy titled "Influenza Vaccination", as provided by S4QA as a current policy, revealed in part: In an effort to prevent healthcare transmission of influenza, the hospital will provide the flu vaccine annually to all hospital employees. The vaccine must be obtained by a designated date set by the facility each year. Individuals may qualify for exceptions to the mandatory influenza vaccination policy. All persons that are granted an exception for any reason or who fail to be vaccinated by the designated date, will be required to wear a surgical mask at all times while being within six (6) feet of a patient during the influenza season.

An observation 1/18/17 at 1:00 p.m. , revealed S41CNA in L & D, with a mask that hooked over her ears and covered her mouth. The mask was noted to be worn with the top below her nose. In an interview at that time, S18RN, present for the observation, verified the observation and indicated the CNA wore the mask because she did not receive the flu vaccination. S18RN reported that hospital staff that did not receive the flu vaccination had to wear a mask while at the hospital. S18RN confirmed S41CNA's mask should have covered her nose, and should not be worn with her nose exposed.


c) failing to ensure the dialysis machine was properly disinfected after use;

An observation was conducted on 1/17/17 at 1:00 p.m. of the dialysis room. The dialysis room was unoccupied and the dialysis machine was not in use. Blood was observed on the dialysis machine. The observation was confirmed by S3DON and S7EDMgr.


d) failing to ensure that equipment available for patient use was not rusty or in disrepair so as to ensure effective cleaning/disinfecting;

An observation was conducted on 1/17/17 at 1:15 p.m. of 5 out of 5 (Room 343, 344, 346, 347, and 349) rooms on the third floor observed for cleanliness that had rusted toilet side handles. The observation was confirmed by S7EDMgr and he agreed the toilet side handles could not be disinfected due to the rust on the handles.

An observation was conducted on 1/18/17 at 1:30 p.m. of the outpatient lab area. In the outpatient lab area there were 3 phlebotomy chairs. One of the phlebotomy chairs had an arm rest with cracked vinyl making it incapable to being disinfected properly. S27LabMgr confirmed the observation and agreed the chair could not be disinfected properly.

An observation on 01/18/17 at 12:30 p.m. with S6ORMgr of OR #1 and OR #2 revealed that the electrosurgical bovie machine casings, carts and casters in both rooms were visibly rusty and had some pitting.

In an interview on 01/18/17 at 12:45 p.m. with S6ORMgr she was asked how she ensured that the electrosurgical bovie machines, after use in a patient ' s procedure, were able to be effectively disinfected. S6ORMgr indicated that she was unsure.

e) failing to ensure sharps containers were replaced when full.

An observation on 01/18/17 of OR #1 revealed a sharps container on the anesthesia machine that was filled past the full line.

In an interview on 01/18/17 at 12:20 p.m. with S12CRNA he indicated that the sharps container should have been emptied when it got to the "full" line.


In an interview on 01/19/17 at 3:30 p.m., S5IC was made aware of the above infection control breaches. S5IC indicated that acceptable infection control practices were not being followed by staff.


30420

Based on record reviews, observations, and interviews the hospital failed to ensure the hospital ' s Surgical Services followed acceptable professional standards of practice governing surgical services and infection control as evidenced by:

1) failing to ensure that staff adhered to acceptable standards of professional practice in surgical attire in the restricted area as evidenced by multiple observations of surgical attire breaches,

2) failing to ensure that the hospital processed/sterilized surgical supplies according to acceptable surgical practice in the processing and sterilization of surgical items in paper-plastic peel pouches as evidenced by the hospital sterilizing heavy surgical instruments in paper-plastic peel pouches.

3) failing to ensure that equipment available for patient use was not rusty so as to ensure effective cleaning/disinfecting,

4) failing to ensure that single use items were not reprocessed in surgical instrument trays,

5) failing to ensure that surgical hand scrubs, prior to surgical procedures, followed MFU,

6) failing to ensure that the surgery decontamination room was monitored for negative air pressure, and

7) failing to store the reprocessed endoscopy scopes in a drying cabinet that included a drying system that circulated HEPA-filtered air through the cabinet.

Findings:

1) failing to ensure that staff adhered to acceptable standards of professional practice in surgical attire in the restricted area as evidenced by multiple observations of surgical attire breaches,

A review of the hospital policy titled " Surgical Attire " as provided by S6ORMgr as the most current, revealed in part: The purpose of the policy is to provide guidelines for attire worn within the restricted area to prevent cross contamination from uncontrolled environments. A short-sleeved T-shirt may be worn under the scrubs. All personal clothing should be completed confined under scrubs. All head and facial hair should be covered and includes sideburns and necklines. Personal cloth caps shall be covered with a disposable bouffant head covering. Masks will cover both mouth and nose and be secured in a manner that prevents venting.

The AORN Guidelines for Perioperative Practice, 2016 edition - Guideline for Surgical Attire:
Recommendation I revealed in part: All individuals entering the restricted surgical area (OR suite) should wear a surgical mask when scrubbed personnel, sterile supplies and/or sterile equipment are present. A surgical mask protects the patient from transfer of microorganisms. The mask should cover the mouth and nose and be secured in a manner to prevent venting. Surgical masks should not be worn hanging down from the neck. Surgical masks are intended to contain and filter droplets from the nasopharynx. The filter portion of the surgical mask harbors bacteria collected from the nasopharyngeal airway and should not be worn hanging from the neck. Surgical masks should be tied securely and discarded after each procedure or when soiled. Masks with ear loops may not have been designed and intended for use as a surgical mask and may not provide a secure facial fit that prevents venting at the side of the masks. A mask that is securely tied at the back of the head and behind the neck decreases the risk of staff transmitting nasopharyngeal and respiratory microorganisms to patients. Recommendation I further revealed in part: When in the semi-restricted or restricted surgical areas, all non-scrubbed personnel should wear a freshly laundered or single use long sleeved scrub top or jacket snapped closed with the cuffs down to the wrists. Long sleeved attire helps contain skin squames shed from bare arms. All personal clothing, not laundered by a health care-accredited laundry facility, should be completely covered by the surgical attire. Undergarments such as T-shirts with a V-neck, and shirts with sleeves which can be contained underneath the scrub top, may be worn; personal clothing that extends above the scrub top neckline or below the sleeve of the surgical attire should not be worn or should be laundered in a health-care-accredited laundry facility after each daily use.

Recommendation III revealed in part: All personnel should cover head and facial hair, including the sideburns, the ears and the nape of the neck, when in semi-restricted and restricted areas. Human hair can be a site of pathogenic bacteria such as MRSA. Hair acts as a filter when it is uncovered and collects bacteria. A clean surgical head covering or hood that confines all hair and covers the ears, scalp skin, sideburns and nape of neck, to include beards, should be worn in the semi-restrictive and restrictive areas. The head covering or hood should be designed to minimize microbial dispersal. Skull caps (surgeon caps) fail to contain the side hair above and in front of the ears and hair at the nape of the neck and the ears. Reusable head coverings (cloth head coverings) should be laundered in a health care-accredited laundry facility or completely covered by a disposable bouffant hat if home laundered.

Recommendation IX revealed in part: Restricted areas in a surgical suite includes the OR and procedure rooms, the clean core and the scrub sink areas. People in the restricted areas are required to wear full surgical attire (scrub attire, head coverings, masks, and shoe covers if applicable). The Semi-Restricted areas include the peripheral support areas of the surgical suite, the storage areas, the work areas, and corridors leading to the restricted areas of the surgical suite.

Observations on 01/17/17 from 12:15 p.m. to 1:00 p.m. and on 01/18/17 from 12:00 p.m. to 1:00 p.m. revealed the following surgical attire breaches in the restricted surgical suite area:
Observations of surgical staff in the restricted surgical suite area who wore disposable bouffant hats were not observed wearing the hat in a way that covered their ears.
Observations were made of surgical staff not wearing surgical masks in the surgery restricted area when scrub personnel were present at the scrub sinks.
S11CRNA wearing a skull cap that did not completely cover all the hair on the head and neck and with facial hair (beard) that was not completely covered by his surgical mask
S12CRNA with the surgical mask worn hanging from the neck and wearing a T-shirt that was not completely covered by the surgical attire,
S14RN, S42RN wearing a T-shirt that was not completely covered by the surgical attire,
S15RN with a home laundered cloth cap not completely covered by a disposable bouffant hat,
S21LPN with facial hair (beard) that was not completely covered by the surgical mask and wearing a T-shirt that was not completely covered by the surgical attire,
S43RN in the restricted area with a long-sleeved scrub jacket that was not buttoned down the front,
S37Pod wearing a skull cap that did not completely cover all the hair on the head and neck.

In an interview on 01/19/17 at 1:00 p.m. with S6ORMgr she indicated that the hospital ' s surgical scrub sinks were located in the restricted area, right outside of the operating rooms, and that staff did not have to don a surgical mask until they actually entered an operating room. She further indicated that the hospital had a policy on the wearing of surgical attire. S6ORMgr indicated that the Surgical Services department followed the AORN Guidelines.

2) failing to ensure that the hospital processed/sterilized surgical supplies according to acceptable surgical practice in the processing and sterilization of surgical items in paper-plastic peel pouches as evidenced by the hospital sterilizing heavy surgical instruments in paper-plastic peel pouches.

A review of the hospital policy titled " Sterilization Guidelines, Instrument Processing and Storage " as provided by S6ORMgr as the most current, revealed in part: The purpose of the policy is to provide guidelines for achieving decontamination, disinfection, sterilization and storage of instruments, supplies, and equipment used in the surgical environment. The wrapper used in instrumentation sterile reprocessing must be durable enough to allow for normal handling and storage and distribution.
A review of the AORN Guidelines for Perioperative Practice, 2016 edition- Guideline for Packaging Systems: Recommendation III revealed in part: Sterilized items should be considered sterile until an event occurs to compromise the sterility of the sterile item. The sterility of sterile items is event related and not time related. Recommendation VII revealed in part: Paper-plastic pouch packages should be used only for small, lightweight, low-profile items. Paper-plastic pouch packaging may be used to facilitate containment of multiple small items to be sterilized.
An observation of the Central Sterile Supply Room revealed that several sterile paper-plastic peel pouches contained heavy surgical instruments where visible stress was noted to the sealed edges causing the sealed edges to begin to separate and compromise the integrity of the sterile package.
In an interview on 01/18/17 at 1:00 p.m. with S22LPN she indicated that she was mostly responsible for the Surgical Services decontamination and sterile processing areas. S22LPN indicated that many heavy surgical instruments were sterilized in paper-plastic peel pouches and in reviewing some of the heavy sterile packages with S22LPN, she indicated that some of the instruments were probably too heavy to be peel-packed and were causing noticeable stress along the sealed edges and compromising the integrity of the sterile package.

3) failing to ensure that equipment available for patient use was not rusty so as to ensure effective cleaning/disinfecting,

An observation on 01/18/17 at 12:30 p.m. with S6ORMgr of OR #1 and OR #2 revealed that the electrosurgical bovie machine casings, carts and casters in both rooms were visibly rusty and had some pitting.

In an interview on 01/18/17 at 12:45 p.m. with S6ORMgr she was asked how she ensured that the electrosurgical bovie machines, after use in a patient ' s procedure, were able to be effectively disinfected. S6ORMgr indicated that she was unsure.

4) failing to ensure that single use items were not reprocessed in surgical instrument trays,

A review of AORN Guidelines for Perioperative Practice, 2016 edition- Guideline for Product Selection, Recommendation II revealed in part: The FDA requires health care organizations who reprocess single use items/devices to have policies in place that listed those single use items that were acceptable for reprocessing and that the reprocessing adhere to the same regulations and guidelines required for the original manufacturer. Single use items should not be reprocessed unless the FDA guidelines for the reprocessing of single use items can be met.

In an interview on 01/18/17 at 2:00 p.m. with S22LPN (in the presence of S6ORMgr) she indicated that the hospital did not reuse or reprocess single use items. S22LPN indicated that she un-wrapped sterile towel packs and used them as tray liners to protect the instruments in the instrument tray during sterilization. A review of the manufacturer ' s label on the sterile towel packs with S22LPN revealed that the manufacturer indicated that the sterile towels after opening were not to be re-sterilized or reprocessed. S22LPN indicated that she did not think of the towels as being reprocessed/re-sterilized since they were not really used yet.

5) failing to ensure that surgical hand scrubs, prior to surgical procedures, followed MFU,

A review of the Surgical Services Policy and Procedure manual revealed no policy in place for the use of the surgical hand scrub used by the OR staff/physicians for hand scrubs prior to surgical and other invasive procedures.
A review of the MFU on the surgical hand scrub used by the OR when performing a surgical hand scrub prior to aseptic gowning and gloving, prior to a patient ' s surgical procedure, revealed in part: Dispense one pump into palm of hand. Dip fingers into the hand prep and work under the nails. Spread the remaining hand prep over the hand and up to just above the elbows covering all surfaces. Using a second pump, repeat for the other hand. Dispense a third pump into either hand and reapply to all aspects of both hands up to the wrist. Allow to dry before donning surgical attire.

An observation on 01/18/17 at 12:30 p.m. of S37Pod during his surgical hand scrub, prior to a patient ' s surgical procedure, revealed he dispensed only two pumps of the surgical hand scrub into his hands and rubbed the surgical scrub over his hands and lower arms simultaneously for less than 15 seconds and then immediately proceeded to the OR where he donned sterile surgical attire prior to a patient ' s surgical procedure.

6) failing to ensure that the surgery decontamination room was monitored for negative air pressure

A review of AORN Guidelines for Perioperative Practice, 2016 edition - Guideline for Sterilization: Recommendation III revealed in part: Items to be sterilized should be cleaned, decontaminated, inspected, sterilized, and stored in a controlled environment. Room temperature, humidity and ventilation must be controlled and monitored. The decontamination area should have a negative airflow with the required number of air exchanges.

An observation of the surgery decontamination room revealed no negative air pressure monitoring system mounted on the walls, as observed in other areas of the hospital where negative air pressure was required and was being monitored by a negative air pressure monitoring system mounted on the walls.

In an interview on 01/19/17 at 10:30 a.m. with S9PlantOp he was asked about the monitoring of the negative air pressure in the surgery decontamination room. He indicated that the surgery decontamination room should have a negative air pressure. S9PlantOp indicated that he was not monitoring it and had no documented evidence to present. He indicated that other areas of the hospital that required negative air pressure had a monitor on the walls to ensure that the rooms were under negative pressure. S9PlantOp further indicated that the surgery decontamination room had no monitor system in place to ensure that the room was always under negative air pressure.

7) failing to store the reprocessed endoscopy scopes in a drying cabinet that included a drying system that circulated HEPA-filtered air through the cabinet.


A review of AORN Guidelines for Perioperative Practice, 2016 edition - Sterilization and Disinfection: Flexible Endoscopes- Recommendation IX revealed in part: Flexible endoscopes and endoscope accessories should be stored in a manner that minimizes contamination and protects the device or item from damage. Flexible endoscopes should be stored in a drying cabinet to facilitate drying, decrease the potential for contamination, and provide protection from environmental contaminants. Drying cabinets are to include a drying system that circulates HEPA-filtered air through the cabinet while filtered air under pressure is forced through the endoscope channels where the endoscopes are continuously dried, suppressing bacterial growth.

An observation 01/18/17 at 3:45 p.m. of the endoscope storage cabinet, containing over 8 (eight) reprocessed endoscopes, revealed no HEPA- filtered air being circulated in the storage cabinet.

In an interview on 01/18/17 at 3:45 p.m. with S6ORMgr she indicated that the endoscope storage cabinet had no HEPA- filtered air being circulated in the storage cabinet. She further indicated that she heard a couple of years ago that HEPA-filtered air was going to be required in endoscopy cabinets and she did not think that the hospital ' s endoscopy storage cabinet had one in place.

In an interview on 01/19/17 at 10:20 a.m. with S9PlantOp he indicated that the endoscope storage cabinet had no HEPA- filtered air being circulated in the storage cabinet.

In an interview on 01/19/17 at 1:00 p.m. with S6ORMgr, the above observations and interviews were reviewed. S6ORMgr indicated that the hospital ' s Surgical Services Department followed the AORN Guidelines and based their surgical service ' s policies and protocols on the AORN Guidelines.

Based on record review and interview, the hospital failed to ensure that an updated examination (History and Physical) of the patient was completed and documented before the surgery or procedure was performed, even if the surgery or procedure occurred less than 24 hours after admission or registration as evidenced by no documentation of an updated examination (History and Physical) for 2 (#25, #26) of 3 (#25, #26,#27) patient medical records reviewed for an updated examination (History and Physical) out of a total sample of 30 medical records.

Findings:
A review of Patient #25's medical record revealed the patient had a surgical procedure on 01/17/ 17. A further review of the patient's medical record revealed no documented evidence of an updated examination (History and Physical) by the physician prior to the start of the patient's procedure.

A review of Patient #26's medical record revealed the patient had a surgical procedure on 01/17/ 17. A further review of the patient's medical record revealed the documented updated examination (History and Physical) by the physician was performed after the start of the patient's procedure.

In an interview on 01/19/17 at 11:00 a.m. with S34RN, she indicated that she worked in the pre-operative area. She indicated that the pre-op nurses do not check for an updated examination (History and Physical) by the physician prior to the start of the patient's procedure and that it was the responsibility of the OR/RN.

In an interview on 01/19/17 at 11:10 a.m. with S43RN, she indicated that she worked in the OR. She indicated that she only checks that a History and Physical was performed by a physician within 30 days and that the OR/RN did not normally check for an updated examination (History and Physical) by the physician prior to the start of the patient's procedure, only History and Physical by a physician within 30 days.

Based on record review and interview the Governing Body failed to ensure that the direction of the Anesthesia Department was under the supervision of a Medical Doctor based upon established criteria and qualifications for the Director of Anesthesia Services established by the Medical Staff and approved by the Governing Body as evidenced by no documentation of requirements and/or qualifications in the Medical Staff ByLaws, Medical Staff Rules and Regulations or the Governing Body ByLaws for the criteria and qualifications for the Director of Anesthesia Services.

Findings:
In an interview on 01/18/17 at 10:30 a.m. with S35MD he indicated that he was a gastroenterologist and that he was the Chief Medical Officer and the Director of the Anesthesia Department.

A review of the Medical Staff ByLaws, Medical Staff Rules and Regulations, and the Governing Body ByLaws, as provided by S1CEO, revealed no documented evidence for the requirements and/or qualifications of the Director of Anesthesia Services.

In an interview on 01/19/17 at 2:30 p.m. with S1CEO, after he reviewed the Medical Staff ByLaws, Medical Staff Rules and Regulations, and the Governing Body ByLaws for the established criteria and/or qualifications for the Director of Anesthesia Services, he indicated that there was no documented criteria and/or qualifications for the Director of Anesthesia Services established in the Medical Staff ByLaws, Medical Staff Rules and Regulations, or the Governing Body ByLaws for the Director of Anesthesia Services. He further indicated that the Director of Anesthesia Services was part of the Chief Medical Officer's position, as noted on the hospital's organizational chart.