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Based on interview and record review, the GB failed to ensure the contracted services for the C-arm was evaluated for quality of service and patient safety. This failure increased the risk of poor health and safety outcomes to the patients.

Findings:

Review of the hospital's P&P titled Contract Administration dated 8/2/17, showed the purpose of the P&P is to establish and maintain a system of implementation, review, approval and archival review of all contracts/letters of agreement (LOA). The responsibilities, functions, objectives, and terms of agreement, including financial arrangements and charges will be delineated in writing. All LOAs require the original signature of the CEO or a designated administrative officer. The LOAs for patient care requires authorization by the appropriate Medical Staff Committee, MEC, and Board of Directors. All LOAs must be continuously monitored and evaluated. All patient care and LOA contracts will also be formally evaluated by the appropriate MEC and Board of Directors. The quality control or performance improvement measures will be developed, monitored, and evaluated as needed.

During the Sample Validation survey from 7/22 to 7/24/19, the following deficient practices related to radiation safety were identified:

- The caution signage was not posted for OR 2 where the C-arm machine. Cross reference to A536.

- The C-arm machine was not monitored and maintained for quality control and radiation exposure as per the manufacturer's guidelines. Cross reference to A537.

Review of the CHCM Radiation Safety Report dated 3/28/19, showed Physicist 1's evaluations showing the posting requirements and "Fluoroscopic QC Log" were "Satisfactory."

Review of the CHCM Clinical Contract List for the 2nd quarter of 2019 failed to show the contracted service was evaluated for quality of service. There was no documented evidence of the evaluation of performance measures for the contracted service.

On 7/24/19 at 1108 hours, an interview was conducted with the CEO and CNO. The above identified concerns were shared with the CEO and CNO. The CNO stated the radiation safety program was evaluated annually by a physicist endorsed by the hospital's contracted service for the fluoroscopy evaluation including the assessment of the C-arm and fluoroscopy services.

In addition, the CNO stated the radiation safety committee met annually and the radiation audit report was reviewed as one of the components to evaluate the radiation safety. The annual evaluation of the radiation safety program was not due until later in the year. The CNO stated all contract evaluations were to be performed by the service department and reviewed collectively every quarter by the QAPI committee. The CNO verified there was no previous or existing contract for the fluoroscopy testing service, and the GB did not perform the evaluations of the contracted service. The CEO verified the GB was not aware the contract for the fluoroscopy testing service did not exist, and they should have provided an oversight.

Based on interview and record review, the hospital failed to ensure four of 30 sampled patients (Patient 1, 8, 11, and 24) or their representatives were informed of the care as evidenced by:

1. Patient 11's conservator was not provided with the seclusion and restraint advisement upon admission. Additionally, the patient's conservator was not informed of three seclusion and restraint events during Patient 11's hospitalization.

2. Patient 1's 5250 legal hold status was enforced prior to the completion of the 5150 legal status hold.

3. The psychotropic medication consents were not obtained from the patients/conservators for Patients 1, 8, and 24.

These failures created the risk of the patients not being informed, involved or have the ability to make informed decision regarding their treatments.

Findings:

1. On 7/23/19 at 0918 hours, an interview and concurrent review of Patient 11's medical record was initiated with the Clinical Educator. Patient A was admitted to the hospital on 5/22/19, with a history of schizophrenia.

a. Review of the Reappointment of LPS Conservator dated 6/13/19, showed the initial date of conservatorship for Patient 11 was 5/14/13. A petition for reappointment as the conservator for Patient 11 and estate was filed on 5/20/19. Patient 11 was granted a new conservator on 6/13/19. The court found Patient 11 remained mentally incompetent and gravely disabled. Further review of the document showed it was for the purpose of protection that a conservator was reappointed.

However, upon admission, the Philosophy and Practice for Seclusion and Restraint Use dated 5/22/19 (no time), showed Patient 11 signed the advisement related to S&R, not the conservator.

b. Review of the Patient's Rights Denial - Monthly Tally showed Patient 11 was in the S&R on 6/19, 6/22, and 6/27/19.

Review of the S&R Monitoring Form showed Patient 11 was in the S&R as follows:

* On 6/19/19, Patient 11 was placed in the S&R from 1730 to 1915 hours.

* On 6/22/19, Patient 11 was placed in the S&R from 1745 to 2145 hours.

* On 6/27/19, Patient 11 was placed in the S&R from 1855 to 2200 hours.

However, further review of Patient 11's medical record showed no documented evidence the patient's conservator was notified each time the patient was placed in the S&R.

The Clinical Educator verified the above finding and stated he did not know why Patient 11 signed for the S&R advisement. The Clinical Educator stated the patient's conservator should have been notified when Patient 11 was placed in the S&R each time.


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2. According to the California Welfare and Institutions Code (WIC) Division 5 Part 1, under the LPS Act, individuals can be detained in a locked psychiatric facility as follows:

ARTICLE 1. Detention of Mentally Disordered Persons for Evaluation and Treatment [5150 - 5155]

(a) When a person, as a result of a mental health disorder, is a danger to others, or to himself or herself, or gravely disabled, a peace officer, professional person in charge of a facility designated by the county for evaluation and treatment, member of the attending staff, as defined by regulation, of a facility designated by the county for evaluation and treatment, designated members of a mobile crisis team, or professional person designated by the county may, upon probable cause, take, or cause to be taken, the person into custody for a period of up to 72 hours for assessment, evaluation, and crisis intervention, or placement for evaluation and treatment in a facility designated by the county for evaluation and treatment and approved by the State Department of Health Care Services.

ARTICLE 4. Certification for Intensive Treatment [5250 - 5259.3]

If a person is detained for 72 hours under the provisions of Article 1 (commencing with Section 5150), or under court order for evaluation pursuant to Article 2 (commencing with Section 5200) or Article 3 (commencing with Section 5225) and has received an evaluation, he or she may be certified for not more than 14 days of intensive treatment related to the mental health disorder or impairment by chronic alcoholism, under the following conditions:

(a) The professional staff of the agency or facility providing evaluation services has analyzed the person's condition and has found the person is, as a result of a mental health disorder or impairment by chronic alcoholism, a danger to others, or to himself or herself, or gravely disabled.

(b) The facility providing intensive treatment is designated by the county to provide intensive treatment, and agrees to admit the person. No facility shall be designated to provide intensive treatment unless it complies with the certification review hearing required by this article. The procedures shall be described in the county Short-Doyle plan as required by Section 5651.3.

On 7/22/19 at 1410 hours, a review of Patient 1's medical record was initiated with Nurse Manager 1.

The medical record showed Patient 1 was admitted on 7/4/19, on a 5150 hold for danger to others and gravely disabled. Patient 1's 5150 hold had expired on 7/7/19 at 1433 hours. However, the patient was placed on a 5250 hold on 7/6/19 at 1600 hours, 24 hours prior to the expiration of the 5150 hold.

On 7/22/19 at 1410 hours, an interview was conducted with the RN Clinical Educator regarding the 5150 and 5250 holds dates and times. When asked why Patient 1 was placed on the 5250 hold before the end of the 5150 hold, the Clinical Educator stated he did not know, other than the doctor wrote the order for the 5250 hold on 7/6/19.

Further review of the medical record showed the patient was advised of the 5250 hold by the LPS RN on 7/6/19 at 1600 hours. However, the physician's order was not written until 1606 hours, after the patient was placed on the 5250 hold. When asked if the psychiatrist had seen and evaluated Patient 1 prior to the 5250 placement, the Clinical Educator stated he did not know.

3. Review of the medical records for Patients 1, 8, and 24 showed the consents for the psychotropic medications were not obtained from the patients/conservators as follows:

a. On 7/22/19 at 1410 hours, a review of Patient 1's medical record was initiated with Nurse Manager 1.

The medical record showed Patient 1 was admitted on 7/4/19, on a 5150 hold for danger to others and gravely disabled. The patient was placed on a 5250 hold on 7/6/19 at 1600 hours.

Review of Patient's 1 MAR dated 7/10/19, showed the Riese (a capacity hearing to determine if a patient can refuse psychotropic medications) was expired on 7/20/19.

Review of the Notice of certification dated 7/20/19, showed Patient 1 was placed on a 30 days hold. There were no documented evidence Patient 1 had a certification review hearing (a hearing to determine if patients have the capacity to understand and knowingly evaluate information that concerns giving consent for treatment). There was no documented evidence to show if Patient 1 gave consent for the psychotropic medications after the Riese expired on 7/20/19, or had another Riese hearing to determination Patient 1's ability to refuse the psychotropic medications.

b. Review of the medical record for Patient 24 showed the patient was admitted to the hospital under a 5150 hold for a danger to self on 5/31/19.

Review of Patient 24's conservatorship document dated 7/11/19, showed, "This authorization does not include the right to administer psychotropic medications, ECT or perform surgery. Consent for these treatments or for any other treatment not related to the mental disorder should be obtained from the conservatee."

Further review of the medical record showed the patient's Riese had expired on 7/20/19.

However, review of Patient 24's MAR showed the patient continued to receive Zyprexa (antipsychotic medication) 10 mg TID on 7/21, 7/22, 7/23, and 7/24/19, after the Riese had expired and no consents had been signed by Patient 24. In addition, Patient 24 received Haldol (antipsychotic medication) 5 mg PO BID.

Patient 24 was placed on a Temporary Conservatorship by the court on 7/11/19, but had not signed consents for psychotropics since the appointed guardian was put in place. There was no documented evidence Patient 24 had given consent for psychotropic medications.


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c. Review of Patient 8's medical record and concurrent interview with Nurse Manager 1 was conducted on 7/22/19 at 1425 hours. The medical record showed Patient 8 was admitted to the hospital on 4/12/19, with diagnoses including depression and bipolar disorder.

Review of the Initial Psychiatric Evaluation and Initial Treatment Plan dated 4/13/19, showed Patient 8 was on a 5150 hold for having suicidal thoughts.

Review of the medical record showed Patient 8 was found to be gravely disabled and was appointed a temporary conservator effective 4/29/19. In addition, on 5/23/19 the Court appointed a conservator for Patient 8.

Further review of the medical record showed the patient received the following medications:

- Paxil (antidepression medication) from 5/5/19 through 7/22/19;

- Effexor (antidepression medication) from 5/5/19 through 7/22/19;

- Neurontin (antianxiety medication) from 5/7/19 through 7/22/19;

- Zyprexa (antipsychotic medication) from 5/9/19 through 7/22/19;

- Ativan (antianxiety medication) from 5/10/19 through 7/22/19; and

- Clozaril (antipsychotic medication) from 5/24/19 through 7/22/19.

However, there was no documented evidence the hospital obtained the consent from the conservator to administer the above psychotropic medications after the conservation was appointed on 4/29/19.

During a concurrent interview with Nurse Manager 1, she acknowledged the finding.

Based on observation, interview, and record review, the hospital failed to ensure the safe environment was maintained as evidenced by:

1. The telephone cords in the phone rooms on multiple units were found to be at a length that could possibly be used as a ligature device.

2. Patient A's room and shower room had the same room number.

3. One patient room's door was propped open with a wash cloth.

These created the risk of substandard healthcare outcomes to the patients in the hospital.

Findings:

1. On 7/22/19 at 0853 hours, the Adolescent Unit and West Unit were toured with Nurse Manager 2. The telephone jack cords, handset, and power cords were observed in each of the telephone rooms where the patients were permitted privacy for phone calls. However, these cords were long and could be used as a ligature device.

On 7/22/19 at 1330 hours, the telephone cords in the phone room for each unit was measured with Maintenance Staff 2 as follows:

- On the Adolescent Unit, the telephone receiver spring cord was 48 inches long and phone line to the jack was 82 inches long.

- On the West Unit, the telephone receiver spring cord was 50 inches long and the phone line to the jack was 80 inches long.

- On the North Unit, the telephone receiver spring cord was 50 inches long and the phone line to the jack was 80 inches long.

- On the East Unit, the receiver spring cord was 41 inches long and the phone line to the jack was 79 inches long. The computer's laptop cord was 108 inches in length.

- On the South Unit, the telephone receiver spring cord was 34 inches long and the phone line to the jack was 68 inches long.

Nurse Manager 2 and RN 3 acknowledged the findings.


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2. The hospital failed to ensure the safety of the patients was maintained as evidenced by:

On 7/22/19 at 1300 hours, an observation of Patient A's room identifier was displayed with the same number as the Shower Room across the hall.

During a concurrent interview Nurse Manager 1 stated she had not noticed the identical room identifiers until today, but confirmed the numbers should not have the same as it could possibly cause confusion to the patients.

On 7/23/19 at 1340 hours, an interview was conducted with the Engineer Director. The Engineer Director was asked how the staff and patient would be able to identify the rooms in the event of a fire or emergency. The Engineer Director stated the Fire Department would be able to determine the location on the fire annunciator panel. When asked, the Engineer Director stated it was a possible safety risk for the patents.

3. On 7/22/19 at 1000 hours, the North Unit was toured with RN 4. A washcloth was observed being used to prop open Room 1's door.

During a concurrent interview, RN 4 acknowledged the finding and stated all patient rooms needed to remain open at all times. RN 4 further stated the door was propped open with the wash cloths because "it closes, swings," and, "Needs a little adjustment on hinges."

RN 4 did not identify that propping a door open could be a safety issue, specifically during a fire.

Based on interview and record review, the hospital's QAPI program failed to identify the opportunities for improvement related to the medical records for the outpatient services. This resulted in persistent of poor performance and incomplete medical records for the outpatient services.

Findings:

Review of the Performance Improvement and Patient Safety Plan approved 5/2/18, showed the organization-wide patient safety plan is designed to reduce medical errors and hazardous conditions by utilizing a systematic, coordinated and continuous approach to the improvement of patient safety. This approach centers on the establishment of mechanisms that support effective responses to actual occurrences and hazardous conditions; ongoing proactive reductions in the medical/health care errors; establish hand hygiene programs; and integration of patient-safety priorities in the design and redesign of all relevant organizational processes, functions and services. The plan is implemented through the Patient Safety Quality Committee.

The medical records for Patients 28 and 30 did not have the General Health Statement or history and physical examinations completed. Cross references to A449 and A1081.

On 7/22 and 7/23/19, when asked, the Clinical Educator stated the General Health Statement was formerly a part of the Physician order sheet when the hospital had the paper medical records. The Clinical Educator further stated they did not get the transfer to the electronic medical records and were missed.

During a follow-up interview the Director of Health Information Management and Clinical Educator on 7/24/19 at 0800 hours, the Director of Health Information Management was asked if this had been identified as an issue during the medical record audits and discussed as a part of their Patient Safety Quality Committee. The Director of Health Information Management stated, "no, the issue had not been identified." During the interview, the Clinical Educator stated the electronic medical record system was implemented two years ago; therefore, all patients that were admitted to the outpatient services since that time had been affected.

Based on interview and record review, the hospital failed to ensure the MEC performed the complete reappraisals for MD 1 and Anesthesiologist 1 as per the Medical Staff Bylaws, creating the risk of substandard of care provided to the patients.

Findings:

Review of the hospital's Medical Staff Bylaws, Section 6.2, approved 2/18 showed each applicant for appointment and reappointment to the Medical Staff must contain a request for the specific clinical privileges desired by the applicant. The request should be submitted to the Service Chief in writing and supported by documentation of training or experience demonstrating current competence. Each Clinical Service is responsible for developing criteria for granting clinical privileges.

Further review of the hospital's Medical Staff Bylaws, Section 10.5, Functions of Clinical Services approved 2/18 showed the role of the Service Chief is to review, evaluate, and confirm the qualifications of each practitioner applying for initial appointment, reappointment or modification of clinical privileges. The Service Chief will evaluate the Medical Staff Reappointment profile and any supporting documentation. The Chief will submit required reports and information on the clinical qualification

On 7/23/19 at 1305 hours, an interview and concurrent review of the credential files for MD 1 was conducted with the Director of Medical Staff Services.

a. Review of MD 1's privileges in Pathology showed MD 1 did not request any core pathology specific privileges. However, the Service Chief approved MD 1 on 10/17/17, and MD 1 was reappointed on 12/31/17.

b. Review of Anesthesiologist 1's reappointment profile for the reappointment period of 10/1/16-7/31/18, showed the anesthesiologist performed 2,015 cases in the reviewed period. However, further review of the profile failed to show an evaluation and recommendation from the Service Chief regarding Anesthesiologist 1's performance. The Service Chief signed the document on 9/20/18, and Anesthesiologist 1 was reappointed on 9/30/18.

The Director of Medical Staff Services verified and acknowledged the above findings.

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

1. The 12 hour nursing assessment was completed for one of 30 sampled patients (Patient 8).

2. The RN performed the nursing assessments for two of 30 sampled patients (Patients 3 and 13).

3. The hospital's P&P for Patient Reassessment was conformed with the state regulatory requirement.

These failures had the potential for the hospital to fail to identify health and safety concerns and a delay in providing treatment and care.

Findings:

According to the California Code of Regulations, Title 22, Division 5, Chapter 1, Article 3(a)(1), a registered nurse shall directly provide ongoing patient assessment as defined in the Business and Professions Code, Section 2725(d). Such assessments shall be performed and the findings documented in the patient's medical record, for each shift, and upon receipt of the patient when he/she is transferred to another patient care area.

The California Nursing Practice Act, Business and Professions Code Chapter 6, Section 2725(d), defines an assessment as an observation of signs and symptoms of illness, reactions to treatment, general behavior, or general physical condition, and determination of whether the signs, symptoms, reactions, behavior, or general appearance exhibit abnormal characteristics, and implementation, based on observed abnormalities, of appropriate reporting, or referral, or standardized procedures, or changes in treatment regimen in accordance with standardized procedures, or the initiation of emergency procedures.

1. On 7/22/19 at 1100 hours, an interview and concurrent medical record review was conducted with RN 4.

The medical record showed Patient 8 was admitted to the hospital on 4/12/19, with a diagnoses including depression and bipolar disorder.

Review of the Initial Psychiatric Evaluation and Initial Treatment Plan dated 4/13/19, showed Patient 8 was on an involuntary 72 hour hold for having suicidal thoughts.

Review of the 12 Hour Re-Assessment dated 7/21/19 at 2239 hours, failed to show Patient 8 had been assessed for anxiety, AWOL, and fall risk.

In a concurrent interview with RN 4, he acknowledged the finding.


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2. On 6/22/19 at 1045 hours, during a tour of the North Unit, RN 4 was interviewed. RN 4 stated the LVNs performed and documented the patient assessments every shift. In addition, RN 4 stated at the end of each shift, the RN reviewed and confirmed the LVNs' documented assessments.

On 7/22/19 at 0940 hours, an interview was conducted with RN 2 during a tour of the West Unit. When asked, RN 2 stated when the LVN was assigned for patient's care, the LVN performed the assessment and RN signed off the LVN's assessment. For example:

* Patient 3's medical record was reviewed on 7/22/19. The medical record showed Patient 3 was admitted to the hospital on 7/18/19.

The 12 Hour Re-Assessment Form dated 7/20/19 at 0327 hours, showed the following:

- Patient 3 was sent to another hospital's ED for elevated liver enzyme and came back to the unit around 0300 hours.

- LVN 1 performed the nursing assessments, including mental status, neurological, cardiovascular, GI, and integumentary systems.

- The RN reviewed and confirmed the LVN's assessments.

* Patient 13's medical record was reviewed on 7/22/19. The medical record showed Patient 13 was admitted to the hospital on 7/6/19.

The 12 Hour Re-Assessment Form dated 7/18/19 at 1342 hours, showed LVN 2 performed the nursing assessments, including mental status, neurological, cardiovascular, GI, and integumentary systems. The RN reviewed and confirmed LVN 2's nursing assessment on 7/18/19.

On 7/23/19 at 1430 hours, an interview with Nurse Manager 2 was conducted. Nurse Manager 2 verified RN did not directly perform and document the nursing assessments for the patients.

3. The hospital's P&P titled Patient Reassessment: Psychiatric Services revised 3/19 showed the following:

- Each patient is to be assessed by an RN according to the P&P upon admission.
- Thereafter, each patient is to be reassessed by a Nurse every 12 hours utilizing the Psychiatric Services 12 Hour Reassessment Form.

However, the P&P did not address that the reassessment should be directly performed and documented by the RN. The LVNs had performed the nursing reassessments. Cross reference to the above example #2.

On 7/23/19 at 1430 hours, Nurse Manager 2 verified the above finding.

Based on interview and record review, the hospital failed to ensure the medical records contained information necessary to support admission to the outpatient program for two of 30 sampled patients (Patients 28 and 30).

Findings:

The medical records for Patients 28 and 30 did not contain the history and physical examinations or General Health Statementa. Cross reference to A1081.

Based on observation, interview, and record review, the hospital failed to ensure the patient's own medication was handled in accordance to the hospital's P&P for one of 30 sampled patients (Patient 23), creating the potential for the patients receiving the wrong medication.

Findings:

Review of the hospital's P&P titled Patient's own medication dated 11/18 showed the nursing staff will collect all medications brought in to the facility at time of admission. Nursing staff will note these on the medication list and catalogue all medications, bag and label them with patient name and room number. Bags will be sent to pharmacy for storage. Upon discharge, the nursing staff will verify the physician's written order to return the medications to the patients. Pharmacy will store the unclaimed medications for a minimum of 30 days.

On 7/22/19 at 1006 hours, during an observation of the medication room on the South Unit with the DOP, a vial of detemir insulin (a long acting insulin used to reduce blood sugar) from a community pharmacy labeled with Patient 23's name was in the medication refrigerator.

Review of Patient 23's record showed the patient was discharged from the hospital on 6/24/19. Review of the MAR showed Patient 23 received glargine insulin (a long acting insulin used to reduce blood sugar) during the hospital stay.

During an interview on 7/22/19 at 1325 hours, the DOP acknowledged Patient 23 received the glargine insulin because the detemir insulin was not on the hospital formulary. She was unable to explain why the detemir insulin was not sent home with the patient or sent back to the pharmacy after the patient had been discharged.

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

1. The vasopressin medication was labeled with the expiration date as per the manufacturer's guidelines.

2. The correct thermometer was used to monitor the temperature for one of two medication refrigerators on the Med/Surg Unit.

3. The correct temperature log was used to monitor the temperature for one of two medication refrigerators on the Med/Surg unit.

These failures had the potential for the patients to receive the medications which may no longer provide the intended benefit.

Findings:

Review of the hospital's P&P titled Medication Storage dated 11/18 showed medications will be stored at appropriate temperatures to assure stability. All medication refrigerator and freezer temperatures will be checked daily and a temperature log maintained. Temperatures are obtained from an alarmed electronic thermometer.

Review of the hospital's P&P titled Medication refrigerator dated 11/18 showed electronic alarmed thermometers are monitoring each refrigerator. Temperatures are recorded daily on temperature log. The department supervisor is to be notified if any reading is outside the appropriate temperature range 36-46 degrees Fahrenheit.

1. Review of vasopressin (antidiuretic hormone used to increase blood pressure in patients when there is a failure of the circulatory system to adequately perfuse vital organs) manufacturer's package insert dated 12/16 provided by the hospital showed to store the vasopressin vials in the refrigerator. Vials may be held up to 12 months upon removal from the refrigerator to the controlled room temperature storage condition, 68-77 degrees Fahrenheit. Once removed from the refrigeration, an unopened vial should be marked to indicate the revised 12- month expiration date.

On 7/22/19 at 0930 hours, during an observation on the Med/Surg unit with the DOP, the crash cart was inspected. A vasopressin vial was stored at room temperature and not labeled with a revised 12-month expiration date as specified by the manufacturer.

During a concurrent interview, the DOP acknowledged the vasopressin vials in all the crash carts stored at the room temperature were good for 12 months. However; the vials were not labeled with revised expiration dates.

2. On 7/22/19 at 0910 hours, an observation and inspection of the medication storage areas in the Med/Surg unit was conducted with the DOP. Observation of the medication room revealed two medication refrigerators. Inspection of the black refrigerator showed a circular kitchen thermometer inside the refrigerator. The refrigerator did not contain an alarmed electronic thermometer as specified in hospital's P&P. One insulin vial (medication used to reduce the blood sugar) labeled with beyond use date of 28 days was stored in the refrigerator.

During a concurrent interview, the DOP acknowledged the kitchen thermometer in the refrigerator. The DOP was unable to provide information on how the hospital monitored the minimum and maximum temperatures in that refrigerator to ensure the medications stored at the appropriate range in that refrigerator.

3. On 7/22/19 at 0910 hours, an observation and inspection of the medication storage areas in the Med/Surg Unit was conducted with the DOP.

Observation in the medication room showed two medication refrigerators. Review of the medication refrigerator temperature logs revealed a food temperature log was being used to monitor the temperature of the black refrigerator instead of the medication temperature log. One insulin vial was stored in the refrigerator. The food temperature log showed the appropriate temperature range as 32-40 degrees Fahrenheit which is different from appropriate temperature range of 36-46 degrees Fahrenheit for the refrigerated medication.

During a concurrent interview, the DOP acknowledged the use of incorrect temperature log.

Based on interview and record review, the hospital failed to ensure the missing controlled medications were reported as required by the state law, creating the potential for controlled medication diversion.

Findings:

The state law states "Reporting drug loss: The owner (in this case the hospital) shall report to the Board within thirty (30) days of discovery of any loss of the controlled substances, including their amounts and strengths."

On 7/23/19 at 1300 hours, the Unresolved Controlled Medication Discrepancies report was reviewed with the DOP.

The report showed the hospital was unable to account for one tablet of phenobarbital (barbiturate/hypnotic/antiseizure medication) 30 mg on 3/27/19 and two tablets of hydrocodone/acetaminophen (opioid analgesic medication) 5/325 on 5/8/19.

During a concurrent interview, the DOP verified she reported the unaccounted controlled medications to the hospital's CEO but did not report to the state Board of Pharmacy. She was not aware of the requirement to report to the Board of Pharmacy.

Based on observation and interview, the hospital failed to ensure the radiation signage was posted for OR 2 in which the C-arm machine was used, creating the risk of the patients and personnel not being aware of potential radiation exposure.

Findings:

On 7/24/19 at 0915 hours, a tour of OR 2 was conducted with the Radiology Manager and Director of Case Management.

A tour of OR 2 showed a C-Arm was parked along the long wall facing the entry door. The Radiology Manager stated OR 2 was the only room that the C-arm was used in. However, further inspection of the room failed to show appropriate radiation signage to alert the patients and staff of radiation usage in OR 2.

The Radiology Manager stated the signage should be clearly posted at the entry door for OR 2.

Based on interview and record review, the hospital failed to ensure the C-arm was monitored and maintained for quality control and radiation exposure as per the manufacturer's guidelines, creating the risk of unsafe radiation practices in the hospital.

Findings:

The Siemens Siremobil Compact L C-arm manufacturer's manual showed in the interest of safety, it is recommended that the operating safety and function of the equipment be maintained by inspections every 12 months. However, the monthly inspections include the following:

* Run and check the automatic dose rate control.

* Open the iris and slit diaphragms to maximum aperture.

* Press the dose rate control "Stop" function.

* Select 110 kV with the +/- keys.

* Release the dose rate control "Stop" function.

* Release radiation and ensure the monitor image is not overexposed. A kV value of greater than or equal to 45 kV must be displayed.

On 7/24/19 at 0915 hours, an interview and concurrent review of the facility documents was conducted with the Radiology Manager.

Review of the C-arm Fluoroscopy log showed the last phantom test was performed was on 9/4/18.

During the concurrent interview, the Radiology Manager verified the above finding and stated the weekly testing was no longer performed as the C-arm was not recently used.

Based on observation, interview, and record review, the hospital failed to ensure the comprehensive management of the dietary department as evidenced by:

1. Failure to label the food items and discard the expired food items.

2. Failure to ensure hand hygiene was performed by the dietary staff.

3. Failure to date the food items in the patient nourishment refrigerators on the West Nursing Unit.

Findings:

1a. During a tour of the kitchen accompanied by the Dietary Supervisor and Infection Control Assistant on 7/22/19 at 0930 hours, the following observations were made:

* In the walk-in refrigerator, five containers of blueberries had expired, 1 head of lettuce was unwrapped and undated, and four packs of muffins were undated.

* In the walk-in freezer, two packages of frozen salmon, four packages of muffins, and three packages of hamburgers were undated.

b. During the food trayline observation in the kitchen on 7/23/19 at 1130 hours, the reach-in refrigerator contained five undated packages of vegetables.

During a concurrent interview with the Dietary Manager, she stated the frozen foods were taken out of the boxes in the walk-in freezer and stickers are placed on the packages, but they fall off.

2. Review of the hospital's P&P titled Employee Hygiene last reviewed 10/18, showed separate hand washing sinks shall be used for the purpose of washing hands. Hands are to be washed prior to any food handling.

During the food trayline observation in the kitchen on 7/23/19 at 1135 hours, Kitchen Staff 1 was observed returning to the kitchen from the patient unit pushing the cart used to transport the patient meal trays. Kitchen Staff 1 was observed wearing the gloves upon entering the kitchen, removing the gloves, and putting on new gloves without performing handwashing. The Infection Control Assistant was present and verified this was not the correct practice and the employee should have washed hands between glove changes.

During a subsequent observation in the kitchen on 7/23/19 at 1145 hours, Kitchen Staff 2 was observed entering the kitchen without the gloves. Kitchen Staff 2 did not wash hands and began touching lid covers for the plates and placing them on the patient food trays. The Infection Control Assistant was present and verified the observation.

During an interview with the Dietary Manager on 7/23/19 at 1200 hours, she stated she was not aware the staff had to wash hands between the glove changes. The Manager also stated there was only one handwashing sink and it was difficult to access during trayline. When asked if this had been discussed with Infection Control or hospital administration, the Dietary Manager stated she was not aware that it had been discussed.


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3. Review of the hospital's P&P titled Refrigerators reviewed 8/18 showed all open containers without dates in the patient's food refrigerator will be discarded.

On 7/22/19 at 0940 hours, a tour of the West Unit was conducted with Nurse Manager 2. The patient's refrigerator was inspected. One large carton of juice was observed to be half full with no open date. Nurse Manager 2 stated it should have been discarded.

Based on interview and record review, the hospital failed to provide adequate nutritional screening and assessment for one of 30 sampled patients (Patient 18). This failure created the risk of not providing necessary care and services to meet the patient's nutritional needs.

Findings:

Review of the hospital's P&P titled Dietary Screening and Consultation last reviewed 2/19 showed upon admission, all patients will be screened by the dietary department within 24 hours. After the initial screening if the Nutritional Risk identifies the patient at risk, the patient will be seen by the RD within 48 hours of admission.

The following indicators are used during the screening process to identify the patients at nutritional risk. A partial listing of this criteria showed greater than 200% of ideal body weight upon admission.

Patient 18's medical record was reviewed with the Clinical Educator on 7/22/19 at 1300 hours. The history and physical examination dated 5/29/19, showed the patient's present illness included obesity. The nursing vital signs flowsheet showed Patient 18's weights as follows:

- 5/29/19, 265 lbs, BMI 40.
- 6/13/19, 252 lbs
- 6/17/19, 251 lbs
- 6/24/19, 257 lbs
- 7/1/19, 257 lbs
- 7/8/19, 257 lbs
- 7/15/19, 261 lbs
- 7/17/19, 157 lbs - a weight loss of 104 lbs

Review of Patient 18's diet preferences and special instructions for 7/22/19, showed a regular diet with a turkey sandwich for snack daily.

However, there was no documented evidence the patient's weight was rechecked. There was no documented evidence the patient's weight loss of 104 lbs triggered the nutrition consultation.

During the concurrent interview, the Clinical Educator stated the nutritional screening was completed by the nursing staff and did not trigger the nutritional consult by the RD. The Clinical Educator also stated the documented weight loss of 104 lbs was probably a documentation error, but the patient should have been reweigh on the next shift.

On 7/23/19 at 1030 hours, an interview with the Dietary Manager who was also the RD was conducted. The Dietary Manager stated the patient who considered as obese should have triggered a consultation by the RD. The Dietary Manager also stated the patient with a significant weight loss should have triggered a nutritional consultation within 48 hours.

Based on observation, interview, and record review, the hospital failed to ensure the IC officers developed an effective system to implement the P&Ps and professional standards for identification, investigation, reporting, and preventing infections within the hospital as evidenced by:

1. Failure to ensure the food items in the refrigerators were labeled and the expired food items were discarded.

2. Failure to ensure the dietary staff performed hand hygiene.

3. Failure to ensure the clinical laboratory and patient care units were maintained in a clean and sanitary manner.

4. Failure to ensure the temperature and humidity level were monitored in the sterile processing clean room.

5. Failure to maintain the sterilized instrument processing logs for the instruments processed outside of the hospital.

6. Failure to ensure the surgical attire was worn in the OR as per the hospital's P&P.

7. Failure to ensure aseptic technique was followed during IV medication administration for one of 30 sampled patients (Patient 2).

8. Failure to ensure two members of the medical staff (Chief of Medical Staff and Anesthesiologist 1) were screened for TB annually.

9. Failure to ensure the medication storage night locker was maintained in a clean and sanitary manner.

These failures created the risk of spread of infections.

Findings:

1. The hospital failed to ensure the food items in the refrigerators were labeled and failed to discard the expired food items. Cross reference to A620, example #1.



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3a. On 7/23/19 at 1011 hours, a tour of the Clinical Laboratory was initiated with the Assistant Director of Laboratory, Clinical Laboratory Scientist 1, Laboratory Assistants 1, and 2. The following was observed:

* Multiple counters had peeling and broken edges of laminate.

* Multiple counters had stains.

* Multiple laminate counters had large holes (approximately 1-2 inches in diameter)

* Multiple surfaces and counters made from porous material (e.g., wood, plywood) had faded and chipped paint.

* Two specimen refrigerators and one specimen freezer had a dry white substance, sticky residue and multiple pieces of paper taped on the exterior.

* Walls throughout the laboratory had worn, faded, and chipped paint exposing the material underneath.

* Debris, dust, and paint chips were on the floor throughout the laboratory.

* Flooring had rust colored stains.

* Multiple areas of flooring showing signs of wear and seams were lifting and separating.

* Multiple sinks had rust colored stains.

* One metal cabinet had rust colored stains,on the interior and the exterior.

* One soiled linen hamper was stored in the clean supply room.

* A drain pipe leak under the double sink. In addition, the wood surface underneath the double sink had a large green colored stain (approximately 2 feet in length x 2 feet in width).

* Walls with drywall were damage below the counters

* Clinical Laboratory Scientist 2's working area had multiple drawers that were lined with paper, had multiple brown stains and dust, and cluttered with multiple laboratory supplies.

* One sink had a missing faucet, with two plastic tubes draining deionized water into the sink.

b. Review of the Clorox Healthcare Bleach Germicidal Wipes manufacturer's instructions showed in part, to clean and disinfect nonporous surfaces with a necessary contact time of three minutes to kill TB, parvoviruses and fungi.

* At 1016 hours, Clinical Laboratory Scientists 1 and 2 were interviewed about the type of disinfectant used to clean the counter tops (including porous surfaces). Both of them stated Clorox wipes (disinfectant) were used to disinfect all surfaces.

* In a subsequent interview with Clinical Laboratory Scientists 1 and 2, both of them were asked how long the surface needed to remain wet. The Clinical Laboratory Scientists were not able to provide an answer. In addition, the Clinical Laboratory Scientists did not know to check the instructions on the Clorox wipe container for the wet time.

During a concurrent interview with the Assistant Director of Laboratory, the Assistant Director of Laboratory acknowledged the above findings.

c. At 1032 hours, MD 1 accompanied the tour of the Laboratory. During an inspection of the phlebotomy cart and caddy, the following was observed:

* Multiple pieces of tape and sticky residue.

* One phlebotomy cart had multiple towels and plastic liner used to prevent the sharp supplies from falling out. The plastic liner was observed with multiple holes and tears.

During a concurrent interview Laboratory Assistant 2 stated he disinfected the cart and caddy and changed the towels and plastic line every three months.

d. On 7/24/19 at 0859 hours, the double sink in the laboratory was observed with the following:

* A gray wash basin was filled with a blue liquid.

* Two plastic tubes were draining into the sink.

* Yellow stains, rust colored residue, and a dry white substance were observed around the sink

*An eyewash station

In a concurrent interview, Clinical Laboratory Scientist 1 stated the double sink in the laboratory had multiple uses, including:

* For eyewash if a splash with a hazardous substance occurred;

* For hand hygiene;

* For cleaning hematology glassware; and

* For draining excess waste, from the immunoassay analyzer, into the sink via two plastic tubes.

In a concurrent interview with the Assistant Director of Laboratory, the Assistant Director of Laboratory acknowledged the finding.

In a subsequent interview with MD 1 and the Assistant Director of Laboratory, they were asked about the frequency of Environment of Care rounds and/or rounds conducted by the Infection Preventionist or the Laboratory department. MD 1 and the Assistant Director of Laboratory stated at least every month.

e. On 7/24/19 at 1016 hours, during the IC committee meeting, the IC Assistant stated the EOC, IC, and Department rounds were conducted twice a year for the Laboratory Department.

The IC Assistant stated there were no "outstanding issues found," for the Laboratory Department.

f. On 7/22/19 at 0844 hours, a tour of the North Unit was initiated with RN 3. The following was observed:

* In the Phone Room, a wall had peeling paint and rust colored residue.

* In Room 1,

- A base board was peeling.

- Drywall debris were on the floor.

- Multiple brown stains were on the ceiling

- One hole was on the ceiling (approximately 1/2 inch in diameter)

- The room door had laminate that was peeling and had broken edges

In a concurrent interview, RN 3 acknowledged the findings.

g. On 7/22/19 at 1000 hours, a tour of the North Unit hallway was initiated with RN 4. Walls were observed with drywall damage and peeling paint.

h. On 7/22/19 at 1350 hours, a tour of the Nurse Station on the North Unit was initiated with RN 3. The following was observed:

* Multiple drawers and cabinets that stored the patient snack and drinks had sticky residue and chipped laminate.

* Utensils were stored in a wash basin and open to air.

* A medication cart had dust and multiple piece of tape and sticky residue.

* Flooring, walls, and furniture made of porous material had brown stains.

In a concurrent interview, RN 3 acknowledged the findings.


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i. On 7/22/19 at 0853 hours, the Adolescent Unit was toured with Nurse Manager 2. The following was identified:

* The patient shower room had a brownish discoloration of the white caulking between the tiles.
* The bottom of the cabinet in the nursing station was chipped.
* The counter top laminate at the nursing station was chipped.

j. On 7/22/19 at 0940 hours, the West Unit was toured with Nurse Manager 2. The following was identified:

* Three shower rooms were observed with the posted "Clean." However, hairs were observed in the showers.

* The laminate of the table in Day Room 2 was chipped exposing the material underneath the surface.

* The observation room had chipped wall paint and a hole in the wall.

Nurse Manager 2 verified the above findings.


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k. On 7/22/19 at 0930 hours, a tour was conducted with Nurse Manager 1. On the South Unit, the patient refrigerator was placed in the room identified as clean/dirty utility room.

During a concurrent interview with Nurse Manager 1, she confirmed the potential risk of cross contamination as the room was being used to stored the patient's dirty clothes hamper, other patient equipment, and the patients' refrigerator which was sitting on the counter on the dirty utility side of the room.

l. On 7/22/19 at 1320 hours, a tour was conducted with Nurse Manager 1. On the South Unit, an observation of two pink patient basins and a pink pitcher dated 7/21/19, were sitting inside the freezer. One of the pink basins was filled with solid ice and another basin was filled with loose ice cubes. The basins had no date labeled. When asked, when the basin were placed in the freezer, Nurse Manager 1 stated she did not know. When asked if the dated pitcher was placed in the freezer on 7/21/19, or the date was an expiration date, Nurse Manager 1 stated she did not know.


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4. The AORN's Guidelines for Perioperative Practice, 2019 edition, Guideline for Design and Maintenance of the Surgical Suite, Recommendation II.e.1. Table 3 showed the design parameters for the interdisciplinary team to use when selecting the HVAC system equipment. The recommendation showed the following:

- The sterile processing clean room temperature must be between 68 to 73 degrees Fahrenheit, with the humidity level not higher than 60%. There must be a positive pressure relationship to the adjacent areas.

On 7/22/19 at 0938 hours, a tour of the OR corridor was conducted with the Manager of OR and Med/Surg and the Director of Case Management. A sterilizer was observed along the wall where all the ORs were located. The Manager of OR and Med/Surg stated the sterilizer was not used regularly, however, it was maintained weekly and the preventative maintenance was performed yearly. When asked if the temperature and humidity level was checked in the OR corridor where the sterilizer located, the Manager of OR and Med/Surg stated it was not part of the temperature and humidity level checks in the OR.

5. The AORN's Guidelines for Perioperative Practice, 2019 edition, Guidelines for Sterilization, Recommendation XIV.a. showed records provide data for the identification of quality improvement opportunities and demonstrate compliance with regulatory requirements and accreditation agency standards. Sterilization records should be maintained for a time period specified by the health care organization and in compliance with regulatory and accreditation requirements.

On 7/22/19 at 1024 hours, an inspection of the central supply sterile storage room was conducted with the Manager of OR and Med/Surg and the Director of Case Management. The Manager of OR and Med/Surg stated all the reprocessing for the instrument trays was performed at the offisite location. The Manager of OR and Med/Surg stated when the sterilized instruments were received from the offsite hospital, the log was maintained with the records of validation testing to ensure the instruments were processed correctly.

Review of the Instrument Sterilization Logs showed a "Minor Basic Tray" was sent on 6/4/19, to be reprocessed offiste. The document showed the instrument was sterilized on 6/18/19, and returned to the hospital on 6/19/19. However, further review of the log failed to show documented evidence the processing data to validate the instruments were properly sterilized. The Manager of OR and Med/Surg stated she would have to locate the original tests as they were not kept in the binder but should have been.

6. Review of the hospital's P&P titled Attire-Surgical dated 11/7/18, showed all personnel entering the semi-restricted and restricted areas of the surgical suite will be in operating room attire. Operating room attire consists of standard multi-use fabric or a limited-use non-woven scrub and a low lint hat or hood. All head and facial hair is to be covered. Arms will also be covered using a "warm-up" jacket provided by the facility.

On 7/22/19 at 0926 hours, an observation of Patient 2's procedure in OR 3 was conducted with the Manager of OR and Med/Surg, and the Director of Case Management. MD 2 was observed with the lower arms exposed during the procedure.

The Manager of OR and Med/Surg and Director of Case Management verified the above finding.

7. Review of the hospital's P&P titled Intravenous Therapy: Heparin Lock and Peripheral Lines dated 11/7/18, showed intermittent intravenous administration of medication will be given in a consistent and aseptic manner. When administering medication through the IV, the junction of the IV tubing will be cleansed with alcohol.

On 7/22/19 at 0922 hours, an observation of Patient 2's procedure in OR 3 was conducted with Anesthesiologist 1. At 0923 hours, Anesthesiologist 1 was observed injecting the medication into Patient 2's IV. However, the anesthesiologist did not wipe the IV junction with alcohol prior to the medication administration.

The above finding was shared with the Manager of OR and Med/Surg and Director of Case Management.

8. Review of the hospital's P&P titled Communicable Disease Screening for Medical Staff dated 5/2/18, showed an annual TB screening is required for all Medical Staff. Providers are responsible for providing medical staff service office with evidence of current and annual tuberculosis screening or are subject to suspension.

On 7/23/19 at 1305 hours, a review of the physician credentialing files was conducted with the Director of Medical Staff Services. The following was identified:

* The Chief of Medical Staff's health file showed the Tuberculosis Screening dated 8/21/17.

* Anesthesiologist 1's health file showed the last TB skin test was performed on 6/18/18.

The Director of Medical Staff Services stated the Chief of Medical Staff and Anesthesiologist 1 were required to have the updated annual TB screening and testing.


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9. On 7/22/19 at 1245 hours, during an observation of the night locker (area where medications are stored and available for use when the pharmacy is closed), a black box with medical supplies was identified. Inspection of the supplies inside the black box revealed three green top lab tubes with the expiration dates of 3/19, three brown/green top lab tubes with the expiration dates of 1/19, and four blue top lab tubes with the expiration dates of 4/19.

The Director of Pharmacy verified the outdated lab tubes.

During an interview on 7/24/19 at 1125 hours, the CNO stated she did not know the lab tubes were stored in the night locker.

Based on observation, interview, and record review, the hospital failed to ensure the outpatient services met the patients' needs for two of five sampled patients (Patients 28 and 30) as the history and physical examinations were not completed upon admission to the outpatient program as per the hospital's Medical Staff Rules and Regulations. This failure created a risk for not providing necessary care and services to these patients.

Findings:

Review of the Medical Staff Rules and Regulations approved 2/18 showed the following:

1. Psychiatric Outpatient Program (OPTS):

Within seven (7) days after admission to the program the patient's health status will be documented by:

a. A General Health statement indicating the patient has no medical problems that would interfere with treatment in the program; or

b. If a complete history and physical has been performed within thirty (30) days prior to the patient's admission to the OPTS, a reasonable durable, legible copy of such examination may be used in the patient's medical record in lieu of the admission history and physical examination, provided the reports were recorded by a licensed Physician and authenticated and validated by the attending CHCM Physician and an updated note is recorded by a practitioner within 7 days of admission; or

c. A complete history and physical will be completed within seven (7) days after admission to the OPTS.

2. Partial Hospitalization Program (PHP):

Within forty eight (48) hours of admission to the Partial Hospitalization Program the patient's health status will be documented by:

a. If a complete history and physical has been performed within thirty (30) days prior to the patient's admission to the PHP, a reasonably durable, legible copy of such examination may be used in the patient's medical record in lieu of the admission history and physical examination, provided the reports were recorded by a licensed Physician and authenticated and validated by the attending CHCM Physician and an updated note is recorded by a practitioner within 48 hours of admission delineating any changes in the patient's condition; or

b. A complete medical history and physical examination will be performed. If needed, the admitting physical examination shall be comprehensive and include all necessary laboratory and ancillary tests deemed necessary by the attending physician.

On 7/22 and 7/23/19, five outpatient and PHP medical records were reviewed with the Clinical Educator and VP of Outpatient Services and Outpatient Program Director and showed the following:

- Patient 28 was admitted to the outpatient program on 6/12/19.
- Patient 30 was admitted to the outpatient program on 7/10/19.

However, the medical records showed no documented evidence of the history and physical examination or General Health Statements for these patients. When asked, the Clinical Educator showed the General Health Statement was formerly a part of the Physician order sheet when the hospital had paper charting. The Clinical Educator further stated they did not get transfer to the electronic medical records and were missed.

During a follow-up interview on 7/24/19 at 0800 hours, the VP of Outpatient Services stated if the General Health Statement was missing, then the history and physical examination should have been ordered and completed. The VP of Outpatient Services and Clinical Educator verified this was not done for Patients 28 and 30.