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Based observation, interview, and record review, the facility's Governing Body failed to:

1. Assure Outpatient Surgery Services and Outpatient Pain Services were included in the Hospitals contracted services and was included in the Hospital's Licensed Scope of Services. Maintain an ongoing Transfer agreement with an accepting hospital if a Patient needs to transfer for higher level of care. The Governing Body failed to provide Contracted services in a safe and effective manner. (See A0084)

2. Assure ongoing studies monitoring and tracking of SPD practices, assuring SPD followed manufacturers weight guidelines when sterilizing packaged/wrapped surgical instruments; ICRA for ongoing Construction; studies in Radiological Services studies; monitoring Contracted Services including Hospital Transfer agreement, Outpatient Surgery and Outpatient Pain services. (See A0283)

3. Implement an infection control program that followed acceptable standards of practice: in handling and storage of sterile medical supplies in OR Supply storage; Sterile Processing of Surgical instruments followed manufacturers guidelines; assure running water was available in the central OR scrub sink, and restrict traffic behind the red line in the OR; assure Infection control risk assessment (ICRA) for ongoing construction was monitored reevaluated and updated. Assure Medical Staff had documented Hep B vaccination or waiver on file. (See A0951, A0756 respectively)

4. Assure Outpatient Surgery Services and Outpatient Pain services were approved Services by the Governing Body and Licensed under the Scope of Services Provided by the Facility. (See A1081)

5. Ensure all hospital services were licensed and within the scope of Service. (See A0084)

6. Assure the appointment of a qualified Director of Radiology who provided oversite of Radiologic Services. (See A0546)

7. Maintain sanitary environment for surgical services; follow accepted standards of handling and storage of sterile medical supplies; assure running water was available in the central operating room (OR) scrub sink; restrict traffic behind the red line in the OR; transport soiled surgical instruments in a proper container following accepted protocols to the reprocessing area; ensure staff members are trained in the use of respirators; ensure surgical team members used proper personal protective equipment (ppe) during surgical procedures; verify that staff and physicians comply with required vaccinations or declinations of vaccinations; follow accepted standards of practice when loading surgical instruments for sterilization; ensure staff members follow proper hand washing as required; monitor and document temperature readings in the drug room and medication room. (See A0747)

8. Maintain a sanitary environment for surgical services to avoid sources and transmission of infections and communicable disease in the OR. By failing to monitor and oversee and assure surgical services were performed in a safe and sanitary environment. (See A0951)

9. Assure Outpatient Surgery Services and Outpatient Pain Services were approved services by the Governing Body and licensed under the scope of services provided by the facility. (See A1081)

10. Ensure a safe and effective pharmaceutical service processs, meeting the needs of the facility and patients. (See A0490)

The cumulative effects of these systemic problems resulted in the Facility's inability to ensure the provision of quality health care in a safe and sanitary environment.

Based on observation, interview, and record review, the facility failed to:

A. Ensure the cleanliness of the clean utility room; ensure patient supplies were separated from each other in the clean utility room. (See A0749)

B. Transport soiled surgical instruments in a clean, covered container to the reprocessing area following a surgical procedure. (See A0749)

C. Ensure that staff members are trained in the use of and fitted for respirators. (See A0749)

D. Establish surgical team members were wearing proper personal protective equipment (PPE) and attire during a surgical procedure. (See A0749)

E. Document staff and physicians completed required vaccinations. (See A0749)

F. Follow accepted standards of practice when loading surgical instruments into trays for sterilization. (See A0749)

G. Maintain distance between operating room scrub sink from surgical supplies. (See A0749)

H. Ensure all nursing staff performed hand hygiene and used aseptic technique during preparation and administration of injectable medication at a patient care area. (See A0405)

I. Certify that a working scrub sink was available for use in the preparation area outside the post anesthesia care unit (PACU) or the recovery room, in the surgery department. (See A0726)

J. Maintain a sanitary environment for surgical services, to avoid sources and transmission of infections and communicable disease in the Operating room. (See A0951)

K. Assure Outpatient Surgery Services and Outpatient Pain services were approved Services by the Governing Body and Licensed under the Scope of Services Provided by the Facility. (See A1081)

The cumulative effect of these deficiencies resulted in the facility's inability to avoid sources and transmission of infections and communicable diseases.

0084
Contracted Services: The Standard is not met:
Based on observation, interview and record review the facility Governing body failed to fulfill its responsibilities for monitoring and implementing policy and procedures for Contracted services. The Governing Body failed to ensure all hospital services were licensed and within the scope of service of the facility.


1. Assure Outpatient Surgery Services and Outpatient Pain Services were included in the Hospitals contracted services and was included in the Hospital's Licensed Scope of Services.

2. Maintain an ongoing Transfer agreement with an Accepting hospital if a Patient requires a transfer to higher level of care. The Governing Body failed to provide contracted services for a safe and effective transfer.


Findings:
During an interview with The Facility Administrator (Admin1) on 7/17/18 at 2:20 pm Admin 1 stated that the facility performed inpatient and outpatient surgical procedures. A review of the facility license and scope of practice did not include outpatient surgical and pain procedures. A review of the facilities list of contracted services did not include a transfer agreement with a general acute care hospital. On 7/19/18 at 4:00pm, a copy of the hospital transfer agreement was requested and Admin1 indicated the facility did not have a hospital transfer agreement. During an Interview with Admin 1 On 7/23/18 at 09:10 am, Admin 1 stated the facility did not have any outpatient surgery contracts for review. Admin 1 stated that the Chief Nursing Officer (CNO), oversees outpatient surgeries.
During an Interview with CNO on 7/23/18 at 3:10 pm, the CNO stated that the outpatient procedures included: Epidurals; Arthroscopies (knees and shoulders); carpel tunnel procedures and Canneloplasty. The CNO stated that the patients for outpatient procedure are admitted to the Pre op Room Patient Room 105 and after the procedure in procedure room or OR are then Discharged in the PM from the Post Anesthesia Care Unit (PACU). Orders for PACU completed by the MD. Patients are are observed and discharged from the PACU. A review of the Hospital census for 4/23/18 to 7/23/18 indicated that 29 patients were admitted for Epidural procedures and 25 patients were admitted for out patient surgical procedures. All of the patients were same day outpatients and were discharged home from the PACU following the pain or surgical procedure.

A review of the Hospital policy titled "Contract Services: Dated3/2007 revised 4/2011 indicated all Contracts are reviewed and Approved yearly and Department managers, CEO and Medical Staff included in reviewed contracts. A review of the Governing Body Minutes, QAPI Meeting Minutes and the MEC minutes for 4/26/18;1/28/18;10/27/17;7/26/17 did not include any documentation of Contracted Services or Obtaining an License for Out Patient Surgery and Outpatient Pain Services or an Hospital Transfer agreement.



The cumulative effects of these systemic problems resulted in the Facility's inability to ensure contracted services were provided in a safe manner.

Based on observation and interview the facility failed to display the correct phone number and address of the State agency responsible for receiving reports of complaints as per regulation.

Findings:

Upon entering the facility on 7/18/2018 at 1:30 PM, it was noted that the information located on the wall next to the reception window for addressing complaints was the Department of Public Health's old address and phone number.

At that time, the Chief Nursing Officer (CNO) stated she did not know the correct address; she was given the correct address and phone number to which to report complaints regarding patient care; she stated the appropriate changes would be forthcoming.

Based on record review and interview, the facility failed to properly execute an informed consent. There was an addendum to the procedure and no indication when this was done.

This deficient practice had the potential for the patients not being fully informed of the procedure(s) and being unable to give informed consent.

Findings:

During a review, on July 23, 2018, at 11:30 a.m., of Patient 13's medical record the Consent to Perform Surgery or Special Diagnostic or Therapeutic Procedures dated July 17, 2018, indicated "lumbar four to lumbar five- posterior spinal fusion-decompression lumbar two through lumbar five spinal decompression and stem cell injection" ......had an additional procedure written in, was " ....possible lumbar two to five fusion." There was no date and initials who had added this or when. The consent was signed by Patient 13 and the registered nurse.

During an interview, the administrator reviewed P 13 medical record and stated, "The consent was not properly done. There was an additional add on which should have had some notations of a date and initials."

A review of a facility's policy titled, "Informed Consent," dated April 2011, indicated informed consent is a legal and ethical precondition for medical treatment. Documentation of informed consent was required for all patients under going procedures.The policy indicated that it is the treating physician's responsibility to obtain informed consent.

Based on record review and interviews, the facility failed to implement patient's rights to make decisions concerning medical care, such as the right to formulate advance directives.


Findings:

During a review of the medical records, on July 21, 2018, the followings were observed:

1. Patient 18 was admitted to the facility on July 18, 2018 for lumbar pain. The face sheet indicated, "No, advance directive." A review of the Advance Directive Acknowledgement indicated that Patient 18 did not execute an Advance Directive, was signed and witnessed. However, there was no further action done by the facility's staff.

2. Patient 20 was admitted to the facility on May 29, 2018 for left knee pain. The face sheet indicated, "No, advance directive." A review of the Advance Directive Acknowledgement indicated that Patient 20 did not check any of the advance directive acknowledgement boxes, was signed and witnessed. However, there was no further action done by the facility's staff.

Based on observation, interview and record review the standard is not met. The Governing Body failed to monitor and evaluate the facility QAPI program to assure patients safety including overseeing ongoing studies monitoring and tracking of;

1. SPD, including assuring SPD followed manufacturers weight guidelines when sterilizing wrapped and packaged surgical instruments instruments.
2. ICRA for ongoing Construction from 2015 and 2016.
3. Studies and onsite oversite for Radiological Services studies and procedures.
4. Contracted Services including, Hospital Transfer agreement, Outpatient Surgery and Outpatient Pain services

Findings:

During a review of the facility QAPI program, ongoing studies did not include (1) contracted services for Hospital transfer, (2)Outpatient Surgery and Outpatient Pain services, (3) no studies or monitoring for manufacturer weight guide line for sterilization of instruments and utensils in SPD, (4) no Studies were included for the ongoing Construction an (5) no Studies were documented evaluating the ICRA, completed in 2015 and 2016.

During an Interview with Administrator on 7/23/18 at 9:10 am. The administrator indicated that she oversees the Hospital QAPI Projects. During a Review Of the QAPI meeting minutes for the last year, she stated there were no Radiology or SPD ongoing studies over the last year and there was no reporting for neither SPD or radiology to MEC or Governing Body minutes over the past year. She indicated the ICRA provided was what the assessment available. During an interview with Administrator on 7/23/18 at 9:20 am, the administrator indicated MD#5 (Director of Rediology) does not come in to the hospital. She stated that the Director of Radiology (MD 5) only does Tele-radiology and did not provide onsite Radiologic services or Oversight of the Radiology Department.


A review of a facility document titled, "Performance Improvement Summary 2018" indicated "The purpose of the Performance improvement plan is to ensure that patient care in a safe environment." and to "incorporate quality planning throughout the facility".

The Governing Body failed to implement a QAPI program that monitored services within the facility to assure that Quality patient care was provided in a safe and secure environment.

Based on interview and record review, the facility failed to ensure the staff had competencies and annual evaluations to provide nursing care to all patients as needed.

This deficient practice had the potential for not providing the care and services to the patients.


Findings:


On July 19, 2018, at 2 p.m., during a review the personnel files, the following were noted;
1. RN 4 did not have a hire date.
- no job/position statement.
- the Medical/Surgical Nursing Skills Inventory dated April 1, 2018 was missing reviewer signature, title, and date.
-there was no competency and/or annual for 2017. The was Core Competency RN Med/Surg dated July 30, 2015.


2. RN was hired on January 24, 2018, as a registered nurse. The job description did not have signature of acknowledgement.
- Core Competency/RN-MedSurg was done on January 25, 2018. There was no preceptor's signature, printed name, and date.


3. LVN (licensed vocational nurse) was hired on December 3, 2018.
- Competency Evaluation was dated July 14, 2017.

4. CNO was hired as RN on February 14, 2016 and RN/LVN Core Competency Checklist was dated the same day.
- Nurse Supervisor job description was dated September 1, 2016.
- Chief Nursing Officer (CNO) indicated "Annual" and had CNO signature.
- Job Description & Competency Evaluation for CNO was signed on October 18, 2017. There was no manager's signature or evaluator's signature.
- A Physical/Mental Requirements Job Requirement for Director of Surgical Services.

There were no probationary, annuals performance and competency for RN to Nurse Supervisor to CNO. There was no job description for Director of Surgical Services.


A review of a policy titled, Contract Services, revised April 2011, indicated that the purpose of the policy was to ensure that individuals providing services within the facility are competent.
The document indicated that Personnel files are to included the following documents; current license, required credentials including CPR, resume, application, and background investigations, job descriptions and job task analysis, performance evaluations including probationary and annual skills competency.

Based on record review and interview, the facility failed to ensure the level of pain was initially assessed and re-assessed after pain medication was administered.
This deficient practice had the potential of not to meeting the patient's needs for pain control.

Findings:


During a review of P 13's Medication Record dated;
1. On July 19, 2018, 9:27 a.m., indicated hydrocodone (opioid pain medication) 10/325 mg (1) tablet was administered for mild pain (1-3), by mouth for "pain." There was no indication the fifth vital sign which was pain, was re-assessed for effectiveness.

2. On July 19, 2018, at 12 p.m., the medical record for patient 13 indicated hydromorphone (narcotic used to treat moderate to severe pain) 0.5mg, was administered IVP (Intravenous administration), for severe pain (7-10), as needed, for "pain." There was no indication the fifth vital sign which was pain was re-assessed for effectiveness following administration.

Based on interview and record review the facility failed to ensure that one (1) certified nursing assistant (CNA) had completed training in cardio-pulmonary resuscitation so as to ensure patients' safety during their stay.

Findings:

During a record review of facility staff members, the file for CNA 1 contained a certificate indicating training for Cardiopulmonary Resuscitation (CPR/BLS) had expired May 2016.

According to the Miracle Mile Medical Center Position Description, beside the responsibilities expected from a CNA education and experience required include the following: Active BLS and fire card; Able to pass the pre-employment physical; Certification as Certification Nursing Assistant; High School graduate or GED

During a brief conversation with the Administrator on 7/23/2018 at 4 PM, she acknowledged that the CPR/BLS certification for CNA 1 had in fact expired.

Based on interviews and medical record reviews, the hospital failed to:

1. Ensure the nursing staff followed the policy and procedure for patients who were on medications for pain management. There were multiple pain orders for pain assessed greater than a score of 4.

2. Follow acceptable standards with regard administration of medication. Completion of physician orders ensure the safety and effectiveness of medications to be given.

3. Ensure nursing staff would perform hand hygiene and use aseptic technique during the preparation and administration of a sterile injectable medication at a patient care area.

These deficient practices had the potential of inadequate patient monitoring that might lead to unnecessary pain suffering, increase risk of adverse/side effects, and/or medication errors and for all patients requiring injectable or intravenous medications to be exposed to avoidable contamination with the potential to affect patient safety and/or health.

Findings:

1. A review of Patient 19's face sheet indicated he was admitted on May 29, 2018, for left shoulder pain. The Post Anesthesia Care Unit Orders dated July 12, 2018, indicated "Physician please circle or check desired orders." Pain orders (Rx) included;
-Fentanyl (is an opioid used as a pain medication) 50 mcg, every (q) (not indicated how often to administer) minutes, IV (intravenous), PRN (as needed), for pain greater than
-Dilaudid (a narcotic, hydromorphone is used to treat moderate to severe pain) 0.5 mg to 1 mg, q 15 minutes, IV, PRN, for pain greater than 4.

A review of PACU Record dated May 29, 2018 indicated medication administered;
- Fentanyl 50 mcg, IVP, at 8:50 a.m.
- Fentanyl 50 mcg, IVP, at 9:05 a.m.,
- Diluadid 0.5 mg, IVP, at 9:15 a.m.,
-Diluadid 1 mg, IVP, at 9:50 a.m., and
-Diluadid 1 mg, IVP, at 10:10 a.m.

A review of the Pain Level from 8:45 a.m. through 10:30 a.m., indicated 10/10.

There was no specific completion of physician orders ensure the safety and effectiveness of medications to be given.


2. A review of Patient 21's face sheet indicated she was admitted on July 12, 2018. The Post Anesthesia Care Unit Orders dated July 12, 2018, indicated "Physician please circle or check desired orders." Pain orders (Rx) included;
-Fentanyl (is an opioid used as a pain medication) 50 mg (milligrams), every (q), 5 minutes IV (intravenous), PRN (as needed), for pain greater than 4.
-Demerol (is an opioid/powerful painkiller and a Schedule II controlled substance) 12.5 mg, q 5 minutes, IV, PRN, for pain greater than 4.
-Dilaudid (a narcotic, hydromorphone is used to treat moderate to severe pain) 0.2 mg, q 5 minutes, IV, PRN, for pain greater than 4.


A review of PACU Record dated July 12, 2018, indicated Dilaudid 0.2 mg was administered at 5:12 p.m. IV. Pain was controlled with Diluadid IVP.

There was no specific completion of physician orders ensure the safety and effectiveness of medications to be given.

During a interview on July 23, 2018, at 11:30 a.m., the DOP review the PACU Record and stated the pain orders should be specific and not leave it to the license staff to decide which PRN to give. There should be guidelines according to standards of practice for medication administration and policy.

Review of the hospital policy and procedure, "After Hours Pharmacist Review of Physician Orders," dated January 2018, indicated "To provide a pharmacist-review of physician orders during after hours to ensure medication safety....Physician orders are reviewed by a pharmacist before administration..."


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3. On 7/19/2018 at 2:07 pm during an observation in the Med-Surg unit, the registered nurse (RN ) was in the "Clean Utility Room", which also served as the medication storage area. RN accessed the automated dispensing cabinet (ADC) and removed one (1) vial of Dilaudid (hydromorphone, an opiate or narcotic pain medication) 2 mg (strength in milligrams) per 1 ml (volume in milliliters) in concentration, total 1 ml volume in vial. RN then went to the Med-Surg (medical-surgical) unit nursing station and retrieved three syringes from a cabinet. At the nursing station counter by the sink, RN did not clean the preparation area before unwrapped the syringes with bare hands, without handwashing nor donning gloves. RN also did not wear face mask, hair cover, and/or gown. RN pulled the needle cap off, inserted the needle, and withdrew the vial contents without sanitizing the vial top with an isopropyl alcohol swab. RN withdrew the entire content of the 1 ml vial into the 1 ml syringe, filling it to its maximum syringe volume, with a small amount of overfill left in the vial. RN accessed the Sharps container and shot 0.25 ml through the air into the opening as wastage. RN took the ten (10) ml syringe filled with normal saline (0.9 % sodium chloride) flush, and shot about three (3) ml into the sink as wastage. RN performed a syringe to syringe transfer of the medication, injecting 0.75 ml (1.5 mg of Dilaudid) from the 1 ml syringe directly into the 10 ml syringe. Then, RN reused the same needle, removing it from the 1 ml syringe and attaching it to the 10 ml syringe. RN proceeded to administer the compounded Dilaudid solution in Patient XX's room without performing hand hygiene.

During an interview, on July 19, 2018, at 3:00 p.m., RN stated that the counter area by the sink was the usual medication preparation area at the nursing unit; RN also indicated there was no procedure for preparing medications and did not receive in-service for medication compounding and drawing up medications, quoted "not since I have been here". Furthermore, RN indicated the unawareness of the current standards in performing hand hygiene and the use of appropriate personnel protective equipment (such as gloves) during the preparation and administration of injectable or intravenous medication.

Based on observation, interviews, and record reviews, the hospital failed to ensure a safe and effective pharmaceutical service process that met the needs of their patients, as evidenced by:

1. The hospital failed to ensure nurses who prepared and administered sterile injectable medication at patient care area would perform hand hygiene and use aseptic technique. (Refer to A0405, and Cross reference to A0747)

2. The hospital failed to ensure its policy and procedures for the preparation and administration of all medications delineated the process and provide guidance for its nursing staff (Refer to A0501)

3. The hospital failed to ensure the movement of controlled substances (narcotic drugs) was accounted for. Two tablets dispensed from the ADC (automated drug dispensing cabinet) did not have documented administration, wastage, or return. (Refer to A0494)

4. The hospital failed to ensure its ADC policy and procedure addressed all aspects of its operations including override transactions and reports reviewed at least for accuracy. (Refer to A0500)

5. The hospital failed to ensure after-hours physician orders were reviewed as per policy. (Refer A0501)

6. The hospital failed to ensure there was documented ambient temperature monitoring for two (2) out of three medication storage areas. (Refer to A0726)

7. The hospital failed to ensure discharged patients' personal or home medications were returned or destroyed as per policy. (Refer to A0500)

The cumulative effects of these systemic deficient practices resulted in the hospital's inability to provide pharmaceutical services in a safe and effective manner in accordance with the Condition of Participation for Pharmaceutical Services.

Based on interviews and records reviews, the hospital failed to ensure the movement of controlled substances (narcotic drugs) was accounted and documented. Two tablets dispensed from the ADC did not have documented administration, wastage, or return. This deficient practice had the potential for medication errors and/or drug diversion.

Findings:

Review of a report of the medDispense (an automated drug dispensing cabinet, a medication storage and dispensing device that would allow medications to be stored and dispensed at the nursing station by nurses or authorized personnel) revealed all transactions occurred from 7/12/2018 at 12 midnight to 7/19/2018 at 11:59 p.m. This transaction report indicated there was an overrideen transaction of Norco (brand name for hydrocodone and acetaminophen combination medication, a narcotic and a potent opioid to treat pain) 10/325 milligram (mg) on 7/14/2018 at 3:15 p.m. In this transaction, the medDispense dispensed two tablets of Norco for Patient 22. The reason for override was recorded as "other".

On 7/20/2018 at around 4 p.m., during an interview and a concurrent review of Patient 22's medication administration record (MAR) on 7/14/2018, the director of pharmacy (DOP) confirmed there was no administration record for the above mentioned Norco dose; there was also no wastage or return record for the dispensed dose.

Review of the hospital policy and procedure, Medication Administration, reviewed on 1/2018, indicated " ... Document on the MAR each dose administered or not administered ..."

Based on interviews and record reviews, the hospital failed to:

1. Ensure its automated dispensing cabinet or system policy and procedure addressed all aspects of its operations including override transactions and reports reviewed at least for accuracy.
2. Ensure discharged patients' personal or home medications were returned or destroyed as per policy.

These deficient practices had the potentials for lack of accountability, patient properties misappropriation, and/or drug diversion.

Findings:

1. On 7/18/2018 around 2:10 p.m. during an interview, the director of pharmacy (DOP) stated the hospital utilized two automated drug dispensing cabinets (ADC), "medDispense"; there was one at each of two departments, the surgery department and the medical-surgical department.

On 7/20/2018 around 3:30 p.m. during a review of medDispense transactions reports and a concurrent interview, the DOP confirmed almost all of the override (a function of the ADC to allow nurses to access medications without pharmacist verifications or outside of medication orders parameters) transactions performed by nursing staff did not include a valid reason or comment. The DOP stated he regularly reviewed overrides however there was no documented process to validate. The DOP also stated there was no pharmacy and/or nursing policy and procedure developed for the override process.

(Also see A0494)

Review of a report of medDispense all transactions occurred from 7/12/2018 at 12 midnight to 7/19/2018 at 11:59 p.m. revealed there was an overridden dispensing of Norco (brand name for hydrocodone and acetaminophen combination medication, a narcotic and a potent opioid to treat pain) 10/325 milligram (mg). This transaction indicated two tablets of Norco were dispensed on 7/14/2018 at 3:15 p.m. for Patient 22.

Review of another medDispense transactions report for Patient 22's medication usage during the course of stay from 7/10/2018 to 7/14/2018 did not reveal the dispensing of Norco mentioned above.

On 7/20/2018 at 4:25 p.m. during an interview, the DOP confirmed the discrepancy of transactions reports for Patient 22 and acknowledged there may be a software glitch and such glitch could hinder his ability to accurately reconcile and review for therapeutic appropriateness of the transactions.

2. During an observation, on July 18, 2018, at 3:49 p.m., in the drug room, there were two (2) vials of narcotic pain medications (with unknown quantity remaining) on an open shelf. One of the two vials of medications was Norco (hydrocodone, a Schedule II controlled drug used to treat pain) 10/325 (10 mg of hydrocodone and 325 mg acetaminophen in combination) tablets, dispensed on January 9, 2018, by an outside retail Pharmacy; the other vial of medication contained alprazolam (a Schedule IV controlled drug used for the management of anxiety) 1 mg tablets, dispensed on February 7, 2017, and expired on February 7, 2018.

During an interview, on July 18, 2018, at 4 p.m., the director of pharmacy (DOP) indicated that the aforementioned vials of medications were patients' personal medication. DOP further indicated the medications were documented in the patients' respective medical charts on discharge stating "the patients did not want medications".

Review of the hospital policy and procedure, Patient's Personal Medication, reviewed/revised in 1/2018, indicated " ... Drugs belonging to discharged patients shall be returned to the patient, family, or significant others upon discharge, unless the return is not authorized by the responsible practitioner ... Personal drugs not authorized for return to discharged or expired patients, and personal drugs on hand more than thirty (30) days after discharge shall be destroyed."

Based on interviews and records review, the hospital failed to:

1. Ensure after-hours physician orders review policy reflected the actual process;
2. Ensure the medication administration policies delineate the process required by application regulations and practice standards.

These deficient practices had the potential for medication errors and/or affecting medication safety.

Findings:

1. On 7/18/2018 at 2:10 p.m. during an interview, the director of pharmacy (DOP) indicated he was the only pharmacist on staff and there was no other pharmacy personnel. The DOP stated the pharmacy department operated a "drug room" on Mondays through Fridays and the DOP would be on call 24/7 for after-hours duties. The DOP also indicated the hospital utilized two automated drug dispensing cabinets (ADC) that nurses could access after-hours; there was one at each of two departments, the surgery department and the medical-surgical (med-surg) department.

On 7/20/2018 at around 3:30 p.m. during another interview, the DOP indicated he would verify the after-hours physician orders retrospectively in the regular hours.

Review of the hospital policy and procedure, After-hours Pharmacist Review of Physician Orders, reviewed/revised on 1/2018, indicated "To provide a pharmacist-review of physician orders during after-hours to ensure medication safety ... Physician orders are reviewed by a pharmacist before administration. For review of these orders during after-hours when the pharmacy is closed, the nursing staff shall fax all orders to be administered to an afterhour's night pharmacy company ..."

Review of the hospital contracted services did not reveal a contract with a night pharmacy company.

2. On 7/19/2018 at around 2:07 pm during an observation in the Med-Surg unit, a registered nurse prepared and administered an intravenously (into the vein) injected medication without performing hand hygiene and aseptic technique. (Refer to A0405)

Review of the hospital policies on aseptic technique, medication administration and preparation, did not delineate the proper procedures and process for nursing staff to prepare sterile injectable medication at patient care area and patient bedside. The policies also did not identify the reference sources that indicate the use of most current practice standards.

Based on Interview and Record review The Governing Body failed to assure appointment of a Director of Radiology who provided Oversite of Radiologic Services .

During an interview with Admin 1 indicated on 7/23/18 at 9:20 am she indicated that MD#5 was the Director of Radiology. Admin1 indicated he does not come to the hospital. Director of Radiology only does Tele-radiology and did not provide onsite radiologic services or oversight of the Radiology Department. When asked for radiation department meeting minutes for the last year Admin1 indicated there were none. When asked for any MEC or Governing Body Meeting minutes reviewing radiologic Services she indicated there were none.

A review of MD #5 appointment and review of his Credential file did not include documentation of appointment or responsibilities of Director of Radiology.

The Governing Body failed to appoint a Director of Radiology and failed to provide radiologic services in a Safe manner .

Based on observation, interview, and record review the facility failed to present a therapeutic diet manual that was approved by medical staff and the contracted dietician. This deficient practice may lead to inappropriate diets being prescribed by attending physicians and delay of healthy patient outcomes.

Findings:

During a tour of the facility's kitchen on 7/23/2018 at 10:30 AM, accompanied by the Chef, the therapeutic diet manual was not identified.

Later in the day, a review of the Dietary Consultant's employee file indicated that she had been employed with the facility since 6/1/2015 (per contract entered into on that date). Part of the Dietary Consultant's duties included:

1. Maintaining patient menu cycles
2. Conducting nutritional assessments and consultations
3. Coordinating with physicians regarding menu cycles
4. Following rules and regulations for nutritional and dietary services

Later that day on 7/23/2018, the facility's staff presented the current Clinical Diet Manual. A review of the documents in the manual showed that the facility follows dietary guidelines with regard to Recommended Dietary Allowances (RDA, quantities of nutrients required to maintain good health that are established by the Food and Nutrition Board of the National Academy of Sciences) as directed by the United Stated Department of Agriculture (USDA). The first page of the manual showed the Dietary Consultant had approved the contents of the therapeutic dietary manual on 1/2/2016. However there was documented signature of approval by a medical staff member.

During a conversation with the Administrator on 7/23/2018 at 3:15 PM, she acknowledged the Therapeutic Dietary Manual lacked the signature of approval by a current medical staff member.

Based on observations and interviews, the hospital failed to ensure the water faucet in the handwashing sink located in the preparation area just outside of the post-anesthesia care unit (PACU), or the recovery room, in the surgery department was working. (Refer to A0724, cross reference to A0747)

Findings:

During an observation, on July 18, 2018, at 3:10 p.m., in the preparation area of the post anesthesia care unit (PACU), the surveyor attempted to activate two (2) electronic sensors, one of each side of the faucet of the trough sink, neither was functional and did not turn on the water. The soap refill container was missing on the soap dispenser mounted to the right side of the faucet. The director of pharmacy, DOP, also attempted to activate the two sensors, and the water did not turn on.

During an interview, on July 18, 2018, at 3:10 p.m., the DOP stated that he did not know how long the water faucets were not working.

Based on observation and interview, the hospital failed to ensure there was documented room temperature monitoring of the medication storage areas, to assure temperature range for safe medication storage, in accordance with manufacturers' specifications, in two (2) out of three medication storage areas. This deficient practice had the potential of affecting the integrity and/or potency of the drug products stored in the areas.

Findings:

During an observation, on July 18, 2018, at 3:49 p.m., in the drug room adjacent to the operation room, the room thermometer was functional, but there was no room temperature log.

During an interview, on July 18, 2018, at 4:00 p.m., the director of the pharmacy (DOP) acknowledged that there was no room temperature log.

During an observation, on July 19, 2018, at 12:08 p.m., the medication storage area in the Med-Surge unit, with a sign labeled as "Clean Utility Room"; the room had no room thermometer and no room temperature log. The DOP propped the door open stating the room was warm. An automated dispensing cabinet (ADC), and its attached refrigerator, both generating heat, were present in the room.

Based on observation, interview, and record review the hospital failed to:

A. Ensure the cleanliness of the clean utility room; ensure patient supplies were separated from each other in the clean utility room. Ensure the Clean Room/Supplies/ Medication Room did not have clutter

B. Transport soiled surgical instruments in a clean, covered container to the reprocessing area following a surgical procedure.

C. Ensure that staff members are trained in the use of and fitted for respirators.

D. Establish surgical team members were wearing proper personal protective equipment (PPE) and attire during a surgical procedure.

E. Document staff and physicians completed required vaccinations.

F. Follow accepted standards of practice when loading surgical instruments into trays for sterilization.

G. Maintain distance between operating room scrub sink from surgical supplies.
This deficient practice had the potential for cross contamination.

Findings:

During a tour, on July 18, 2018, at 3:35 p.m., with the administrator, the following were observed:
1. In the Utility Room/Supplies/Medication Room ( next to nurses station);
-The medication refrigerator was dusty, dirty including the refrigerator gasket.
- (1) one corrugated cardboard box on the floor with IV fluids bags.
- a small safe, on a stool, opened.

The administrator stated, "I keep telling the staff no boxes on the floor. The small safe does not belong here and should be placed in admitting department."

2. During an observation, on July 19, 2018, at 12:45 p.m., the operating doors to the scrub room, the left lower had paint peeling markings.
3. In the Laboratory Room there was a chair for blood draws. The left arm rest was padded with a white towel of some sort and held by clear tape. There was an opened used dirty alcohol wipe at the arm rest area.

The administrator stated, "She was unaware who had padded the arm rest and placed tape to secure the towel. She further stated the alcohol wipe should have been through out."



36329


Findings:

A. During an inspection of the 'Clean Utility Room' on 7/18/18 at 3:30 PM, there were clean patient care supplies mixed with care plan forms, urinalysis forms, and other forms on a rack; the air conditioning duct over the supply rack was covered with dust.

The CNO acknowledged the condition of the room and stated that these products should not be mixed together and that staff members are responsible for cleanliness of the room.

The Centers for Disease Control and Prevention (CDC) recommends the following Keep housekeeping surfaces such as floors, walls, and tabletops clean on a regular basis. Use an EPA registered hospital detergent/disinfectant for general housekeeping in patient care areas where the nature of the soiling of the surface is uncertain. Detergent and water is sufficient for cleaning surfaces in nonpatient-care areas e.g. physician offices. Clean walls, blinds, window curtains and other areas that appear dusty or soiled. (https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5210a1.htm)

B. After an observed operation was performed in the operating room of the facility on 7/19/18 at approximately 11:30 AM, Surgical Tech 1 was observed to have gathered the surgical instruments used during the previous procedure. The instruments were placed in their respective type of instrument trays and the trays were then set inside a large, red, plastic bag designated as a bag intended for hazardous material. There were other instruments randomly scattered on the bottom of the bag.

During an interview with Surgical Tech 1 at that time, she stated that she had sprayed the instruments with Empower (enzymatic cleaner for surgical instruments) before being placed in the bag; the bag was then to be taken to the reprocessing room through a door inside the operating room. When asked why the instruments were taken in this manner to be cleaned, Surgical Tech 1 asserted that was the advice given to her by the facility's accrediting agency.

According to "Guideline for Cleaning and Care of Surgical Instruments - Recommendation IV", contaminated instruments must be contained during transport to a decontamination area as soon possible after completion of the procedure to ease cleaning; instruments must be transported in a closed container or enclosed transport cart that is leak proof, puncture resistant, large enough to contain all contents, and labeled with an orange label containing a biohazard symbol. (http://www.aornstandards.org/content/1/SEC36.body)

C. During a tour of the facility's medical/surgical unit on 7/20/18 at 8:45 AM, room number 103 was noted to have only bed inside. There were gloves, masks, and gowns in a cart in a nearby room; there were no respirators apparent. The room had its own bathroom with hand sanitizer near the sink.

During a discussion with RN 1 at that time, she stated room 103 is dedicated to patients that need isolation; the facility occasionally receives patients with wounds that require isolation techniques. She verified that this room always only has one bed inside and that the supply cart is kept in another room until it is needed.

During a brief discussion with the CNO on 7/23/18 at 10:30 AM, she stated that staff members are not fitted with N95 respirators because patients are screened before they enter the facility.

D. During an observation of a surgery in the operating room involving Patient 1 on 7/19/18 at 9:02 AM, the Neurologic Tech appeared to be wearing nursing scrubs, shoe coverings, a cap covering his hair, and a mask covering his nose and mouth. The mask, however, did not cover the hair of his sideburns. Under his scrub top was a long sleeve, gray, cotton shirt that covered his arms down to the wrists.

When questioned about the attire he was wearing at that time, the Neurologic Tech stated that he did not need to dress like the rest of the surgical team because he was not directly involved in the procedure.

During a subsequent conversation with the Infection Preventionist on 7/20/18 at 10:25, she stated that the facility follows Association of periOperative Registered Nurses (AORN) and Centers for Disease Control and Prevention (CDC) standards with regard to infection control standards.

According to AORN, in order to preserve the sterile integrity of the sterile field within the perioperative environment should be mindful of the following. "Perioperative personnel entering the OR or invasive procedure room for any reason (eg, stocking supplies, bringing procedural supplies and equipment into clean rooms) should wear clean scrub attire, including a freshly laundered or single use, long sleeved jacket snapped closed with the cuffs down to the wrists, and surgical head covers or hoods that cover all hair and scalp skin, including facial, sideburns, and the hair at the nape of the neck." (Guideline for Sterile Technique - Guidelines for Perioperative Practice.)

E. During a review of employee personnel records, 3 of 5 sampled records were missing influenza and/or hepatitis B immunization documentation or waivers of said immunizations:

· The record of CNA 1 showed TB screening last performed 7/11/17; there was no documentation for influenza immunization or waiver of immunization; there was no documentation for hepatitis B immunization or waiver of immunization
· The record of RN 3 showed TB screening last performed 5/24/17; there was documentation RN 3 waived influenza immunization 6/26/17; there was no documentation for hepatitis B immunization or waiver of immunization
· The record of Surgical Tech 1 showed TB screening last performed 7/20/16, there was no documentation Surgical Tech 1 received or waived influenza immunization; there was no documentation Surgical Tech 1 received or waived hepatitis B immunization.

During a conversation with the Administrator on 7/23/18 at 5:00 PM, the Administrator acknowledged the facility's deficiency in administering and documenting vaccinations for some staff members.

A review of the facility's "Infection Control Policies and Procedures - Immunizations for Health-Care Workers" indicated that physicians, nurses, and other personnel in the hospital settings who have contact with patients who might be infected with influenza are candidates for influenza vaccination; Those who refuse this vaccination will be asked to sign a declination form and will be identified as at risk individuals. The "Immunization Schedule for Health-Care" stated Hepatitis B vaccination should be administered '3 does of 1 milliliter (ml) directly into the muscle (IM) at 0, 1, and 6-12 months'; the schedule for influenza vaccination is '1 dose of 0 .5 ml IM annually'.

According to the Centers for Disease Control and Prevention, Occupational Health programs and other responsible for infection control programs should identify all staff who are at risk of exposure to blood or other potentially infectious body fluids, including attending clinicians, and encourage vaccination. A Federal standard was issued in December of 1991 under the Occupational Safety and Health Act requires that Hepatitis B vaccination be made available to all health care personnel who are at risk of exposure to blood/blood products, body fluids, or other infectious materials. (CDC Immunization of Health-Care Personnel: Recommendations of the Advisory Committee on Immunization Practices-ACIP from https://www.cdc.gov/mmwr/preview/mmwrhtml/rr6007a1.htm)

F. Accompanied by Surgical Tech on 7/19/18 at 1:12 PM, surveyors inspected a laminectomy tray (instrument set typically use to remove a portion of the spine called the lamina). The instruments inside the tray were underlain by a green towel. On the bottom of the tray was a chemical indicator (usually a chemical tape placed inside the tray during sterilization to ensure the correct temperature has been reached). On top of the instruments (and under the tray lid) was another chemical indicator. Inside the tray were approximately 20 clamps on a stringer (device to keep the finger rings of the instrument separated); the jaws of each individual instrument were in the closed position. On the floor of the tray were various retractors, forceps, a hammer, and a cup, as well as various other instruments. In a bag were several knife handles and other instruments. [See pictures]

During an interview with the Instrument Tech on 7/19/18 at 1:45 PM, he stated that he received his training to sterilize surgical instruments under guidance from the infection control officer at a facility for which he previously worked. He stated they did not have a scale to weigh instrument trays that are ready to be sterilized and there is no weight limit for loading instruments to be autoclaved. He concluded that the Administrator knew where the loading manual for sterilizing instruments was. The survey team requested the manual but it was not located by the end of the survey.

A review of an online Association of periOperative Registered Nurses (AORN) Journal article, titled, "Recommended Practices for Sterilization in the Perioperative Practice Setting", March 2006, Vol 83, No 3, included the following: "Instruments should be held in an open and unlocked position. Preparation and assembly procedures should consider the type of surgical instruments in the set and total set weight, configuration, and density. Paper/peel pouches should not be placed in a container or wrapped set... Additional packaging materials inside a set can interfere with sterilization efficacy and drying..."

Furthermore, AORN recommends that instrument sets and container systems should be of a weight specified by the instrument manufacturers, sterilizers, and container systems. If container systems are used, the manufacturer's written instructions regarding maximum weight, set preparation, loading procedures, steam exposure times and drying times should be followed. According to AORN, sets weighing more than 20 pounds are known to be difficult to dry without lengthy drying times.

G. During an observation on 7/19/18 at 1:40 with ST1 demonstration of how sterile supplies are transported to the OR#1, from SPD; The Sterile instruments are brought in to the OR through an entrance from a hospital hallway next to SPD and the Kitchen. The OR entrance door from the Hospital hallway was unlocked and marked for Authorized employees only. There was no redline behind the Hallway door leading to OR#1. Three trash bags were observed and a scrub sink was observed by the entrance to OR#1. Three trash bags were observed in front of the redline in front of another door leading to OR#1; a shelf with 3 liters saline IV fluid; sterile surgical gloves used for surgery; adhesive tape in an open box. Surgical Tech 1 indicated the OR entrance into the OR behind the Red line (demarcation to signify need for increased infection control precautions) from the Hospital Hallway is used to bring sterile processed surgical equipment into the OR.

Surgical Tech 1 at that time indicated the trash bags should not be near the scrub sink and the supplies should not be near the Red line.

Based on Observation; Interview and Record Review: The Facility failed to: maintain a sanitary environment for surgical services, to avoid sources and transmission of infections and communicable disease in the Operating room by failing to monitor and oversee and assure surgical services were performed in a safe and sanitary environment, including :

1. Implement an infection control program that followed acceptable standards of practice: in handling and storage of sterile medical supplies in OR Supply storage; Sterile Processing of Surgical instruments followed manufacturers guidelines; assure running water was available in the central OR scrub sink, and restrict traffic behind the red line in the OR.

2. Assure ICRA for ongoing construction from 2015 and 2016 was reevaluated and updated.

3. Assure Medical Staff had documented Hep B vaccination or waiver on file.

Findings:

1. During a tour of OR on 7/19/18 at 9:30am with the CNO, the central OR(OR#1) Scrub sink located behind the red line next to the OR#1, PACU and Procedure room was documented to not work. When asked where the OR staff and Surgeons washed their hands CNO explained the Staff go through OR#1 and a second scrub sink is at the other side of the OR#1 through a second set of doors. CNO did not know how long the scrub sink faucet had not been working. A third set of doors from OR#1 leads directly from OR#1 to the Decontamination room. CNO indicated the Facility followed AORN guidelines. During a Tour of the SPD on 7/19/18 at 1:20pm with ST1. When asked if the surgical instruments were weighed prior to sterilization in the AMSCO steam sterilizer (AS#1) she indicated none of the instruments were weighed. When asked for a list of the instruments in each load ST1 indicated there were no lists. In services for SPD and Manufacturers Guideline for sterile processing and weight requirements and SPD in services were requested on 7/19/18 at 1:20 and again at 2pm. To Admin1, ST 1 and CNO and were not provided.

The facility failed to provide surgical services in a safe and sanitary manner. The facility failed to follow manufacturer's guideline when using AS#1. The facility failed to follow acceptable standards of infection control and to assure that Surgical Procedures were provided in a safe and sanitary manner to avoid sources and transmission of infections and communicable disease.

During an Interview with the CNO and the Admin1 on 7/23/18 at 10:20am. When asked who is in charge of SPD, Admin1 stated the CNO was in charge of SPD. When asked for any in- services given to SPD about manufactures guidelines for Sterile processing of surgical instruments none were provided. Manufacturers guideline for SPD use of the AS#1 steam sterilizer, were requested but were not provided. The CNO indicated SPD followed AORN and CDC guidelines.

When asked for any MEC or Governing body or QAPI meeting minutes discussing SPD in the last year. Admin1 indicated there were none. A review of the Governing Body minutes from 7/2017 to 4/2018 did not have any SPD reports.

During an observation on 7/19/18 at 1:40 p.m., with ST1 demonstrating how sterile supplies are transported to the OR#1, from SPD, the sterile instruments are brought in to the OR through an entrance from a hospital hallway next to SPD and the kitchen. The OR entrance door from the Hospital hallway was unlocked and marked for Authorized employees only. There was no redline behind the Hallway door door leading to OR#1. Three trash bags were observed and a scrub sink were observed by the entrance to OR#1. Three trash bags were observed in front of the redline in front of another door leading to OR#1. A shelf with 3 liter saline IV fluid, Sterile surgical gloves, used for surgery, Adhesive tape in an open box. ST1 indicated the OR entrance into the OR behind the Red line from the Hospital Hallway is used to bring sterile processed surgical equipment into the OR.

ST1 indicated the trash bags should not be near the sterile and patient use supplies cart.

2. Finding:

During a Tour of the Hospital on 7/18/18 at 3:10 pm when asked about construction signs posted in a Hospital Hallway. A review of the Governing Body Minutes dated 4/26/18 indicated two construction projects were a seismic retrofitting a review of a Hospital Document titled "Infection Control Construction/Renovation Permit", dated 8/2/2015, a documented titled "A review of the Infection Control Risk Assessment( ICRA), dated 9/1/2015, estimated duration of construction 1 (one) year. A review of a hospital document titled, "Infection Control Construction/Renovation, for a second construction site at the hospital for water damage in the hospital Permit", undated, a documented review of the Infection Control Risk Assessment( ICRA) dated 11/21/16, estimated duration of construction to be 3 to 4 weeks for the water damage project. The ICRA documented was documented to include, "SPD; Radiology and dining room etc". The construction from water damage was documented to, "generate moderate to high levels of dust" and the infection control risk was Medium/High Risk. During an interview with Admin1 on 7/23/18 at 4:20pm she indicated the construction was on going she did not have any updated ICRA for ongoing Seismic Construction or Water Damage construction. There was no Policy and procedure for review of the on going construction ICRA or updates of the ICRA.

Finding:

3. During a review of 10 out of 10 Medical staff credentialing files, none of the 10 Medical Staff had Hepatitis B status or waiver on file. On 7/20/18 at 1040:am during an interview with the Medical Staff Credential Supervisor, The supervisor was asked if medical staff were evaluated for Hepatitis B status. The Medical Staff Credentialling Supervisor indicated the facility currently did not have a policy for Hepatitis B status screening and evaluation for the medical staff. During an Interview with the CNO on 7/23/18 at 4 :10 pm, the CNO indicated the Facility followed CDC guidelines for Hep B screening recommendations.

The Governing Body failed to provide a sanitary environment to avoid sources and transmission of infections and communicable disease.

Based on Observation; Interview and Record Review: The Governing Body failed to assure Outpatient Surgery Services and Outpatient Pain Services were services approved by the Governing Body and Licensed under the Scope of Services Provided by the facility.

Finding:

During an interview with The Facility Administrator on 7/17/18 at 2:20 p.m., the Facility Administrator indicated the facility performed inpatient and outpatient surgeries. A review of the Facility License and Scope of Services did not include outpatient surgery and there were no outpatient pain services documented on the license. On 7/23/18 at 3:15.p.m. the CNO indicated the Facility did not have any outpatient surgery contracts for review of the outpatient surgery services. When asked how long out patient surgical services had been provided, Admin1 did not have any documentation delineating when the Governing Body approved outpatient surgeries and outpatient pain services. Admin 1 indicated the CNO oversees outpatient surgeries and that the facility was in the process of hiring an RN Director of OR. During an Interview with CNO on 7/23/18 at 3:10 p.m., the CNO indicated the outpatient pain procedures included: EpiduralInjections and outpatient surgery procedures included; knee and shoulder arthroscopies, carpel tunnel procedures and canneloplasty. The CNO indicated the patients for outpatient procedure are admitted to the Preop Room Patient Room 104 and 105 and after the procedure in the procedure room or OR, discharged in the PM from PACU . Discharge and PACU orders are completed by MD.

A review of the hospital census for outpatient surgery and outpatient pain procedures from 4/23/18 to 7/23/18 indicated 29 patients were admitted for Epidural procedure and 25 patients were admitted for out patient surgery. All Patients were same day outpatients and discharged home after the Epidural Pain Procedure or outpatient surgery. A review of the QAPI meeting minutes dated 1/24/18, documented for the year 2017 the facility had 118 outpatient surgeries and 145 outpatient pain procedures. A review of the Governing Body Minutes, QAPI Meeting Minutes and the MEC minutes for 4/26/18, 1/28/18, 10/27/17, 7/26/17, did not include any documentation of contracted services or obtaining a license for out patient surgery and outpatient pain services.

A review of the Facility Policy and Procedure titled "Scope of Service Governance Plan" dated 3/2007 and revised 4/2011 documented under Surgical Services, "Procedures /Services included "Outpatient Surgeries/Procedures" and under staffing planning "Director of Surgical Services has a 24 hour accountability for Surgical Services".

The Governing Body failed to assure outpatient surgery services and outpatient pain services were licensed and provided under the scope of the hospital services. The Governing Body failed to provide outpatient surgical service and outpatient pain services and to provide outpatient services in a safe manner.