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Based on observation, interview and record review the Quality Assessment and Performance Improvement Program failed to fulfill its responsibilities for monitoring and implementing policies and programs in the hospital to ensure quality of care, patient safety, and reduction of medical errors.

The Condition for Coverage: Quality Assessment and Performance Improvement Program was not met as evidenced by:

1. The hospital's failure to ensure Nursing Services provided administration of opioid medications in accordance with the physicians' orders, policies and procedures, manufacturers' recommendations, State of CA Laws, and current nursing standards of practice. (Refer to A-405.)

2. The hospital's failure to ensure Nursing Services provided pain assessments for patients prior to and after administration of opioid medications. (Refer to A-395.)

The cumulative effect of these systemic deficits resulted in the hospital's failure to ensure patient safety and quality healthcare when administering opioid medications.

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

1. Ensure that nurses administered Percocet and Norco (opioid medications) in accordance with the practitioner's orders for pain management, policies, manufacturer's recommendations, State law, and current nursing standards of practice. (Refer to: A-405.)

2. Ensure that nurses documented and assessed pain levels prior to and after administration of a narcotic medication for one (Patient 2) of 30 sampled patients. (Refer to: A-395.)

Definitions:

Percocet 5-325: The generic name for the opiate combination of oxycodone 5 milligrams (mg) and 325 mg acetaminophen tablets. Percocet is classified as a Schedule II (A class of drugs having a high potential for abuse which may lead to severe psychological or physical dependence. Schedule II drugs have currently accepted medical uses with severe restrictions.) controlled substance. Oxycodone is a semisynthetic pure opioid agonist whose principal therapeutic action is analgesia. Acetaminophen is a non-opiate, non-salicylate analgesic and antipyretic (fever-reducing agent).

Percocet has a Boxed Warning (It appears on a prescription drug's label and is designed to call attention to serious or life-threatening risks.) Norco 10-325: The generic name for the combination of hydrocodone bitartrate 10 mg and acetaminophen 325 mg tablets. Norco is classified as a Schedule II controlled substance. Norco has a Boxed Warning on the manufacturer's label. (Reference: dailymed.nih.gov)

The cumulative effects of these failures had the potential to negatively affect the health and safety of all patients.

Based on observation, interview and record review, the hospital failed to document pain levels assessed for the administration of a narcotic medication for one (Patient 2) of 30 sampled patients. For Patient 2, the narcotic pain medication Dilaudid was given to alleviate Patient 2's severe pain, however there was no documentation for pain assessment prior to or after the administration of the medication. This failure had the potential to inadequately address Patient 2's health care needs.

Findings:

During an observation and interview on 8/30/17 at 2:30 p.m., both Nurse Manager (NM) 1 and Registered Nurse (RN) 2 stated that Patient 2 was in contact isolation for MRSA (methicillin-resistant Staphylococcus aureus- a staph bacterium that is resistant to antibiotics), and was complaining of abdominal pain upon admission.

During a concurrent interview and record review, on 8/30/17 at 2:40 p.m., with NM 1, the History and Physical showed Patient 2 was admitted for abdominal pain with vomiting, on 8/20/17, and had a mass located on her left pelvis. Further review of the nursing Medication Administration Record (MAR -which included pain assessment documentation) and the physician orders showed that Patient 2 was receiving Dilaudid (a narcotic pain medication used for severe pain levels) 0.6 milligrams (mg) every two hours by injection prn (when necessary) for complaints of severe pain.

Continued review of the MAR showed that Patient 2 received a Dilaudid injection, on 8/21/17 at 8:56 a.m., when according to her documented pain scale at 8:00 a.m., her pain level was "0" for mild pain. Further review showed, on 8/21/17 at 11:03 p.m., Patient 2 was given a Dilaudid injection for severe pain when the last documented pain level was at 8:00 p.m. and was rated at a level "4" for moderate pain.

Continued review of the MAR showed, on 8/22/17 at 9:37 p.m., Patient 2 received a Dilaudid injection for severe pain. The last documented pain level, at 7:10 p.m., rated her at a level "2" for mild pain.

In an interview on 8/30/17 at 2:45 p.m., NM 1 stated that pain levels should always be assessed and documented as per the hospital's policy.

Review of the hospital's undated policy and procedure, entitled, "Pain Management Protocol", showed that nursing staff would "assess pain with vital signs upon admission, pre-medication, and post medication, and on discharge. Document pain assessment on admission, at discharge, pre-medication and within one hour post medicated. Document pain assessment including pain scale used before and one hour after pain management interventions".

Based on interview and record reviews the hospital failed to ensure dangerous drugs, Percocet and Norco (opioid medications used to manage post-surgical pain), were administered and authorized as ordered by the prescriber, and in consideration of clinical data (pain score monitoring) to support their safe use. Registered nurses (RN 11 and RN 12) furnished three doses of opioids designated as High Risk High Alert medications by the hospital, labeled with Boxed Warnings, to two of 30 sampled patients (Patient 11, and Patient 13) on the JR (Joint Replacement) Unit, between 8/29/17 and 8/30/17, in a manner not in accordance with:

1. The practitioner's orders for pain management;

2. Medical staff approved policies to ensure patient safety (e.g. High Alert High Risk Medications, Medication Administration Structure Standards, and Pain Management Protocol);

3. The manufacturer's labeled indications and recommendations which included U.S. Boxed Warnings for Percocet and Norco;

4. Current nursing standards of practice related to medication administration adopted by the hospital (e.g. Lippincott's textbook of Basic Nursing, Mosby's textbook of Clinical Nursing Skills and Techniques, the American Pain Society, and the World Health Organization (WHO).

5. State law (e.g. Social Security Act, Title 22, Section 70263(g) (2); California Business and Professions Code Division 2 Chapter 9 Article 3 4059 (a).

The hospital's failure had the potential to place surgical patients at risk for hepatotoxicity (liver toxicity), over-sedation, and subsequent respiratory depression or respiratory arrest which can be fatal.

Definitions:

Percocet 5-325: The generic name for the opiate combination of oxycodone 5 milligrams (mg) / 325 mg acetaminophen tablets. Percocet is classified as a Schedule II controlled substance. Oxycodone is a semisynthetic pure opioid agonist whose principal therapeutic action is analgesia (pain relief). Acetaminophen is a non-opiate, non-salicylate analgesic and antipyretic (fever-reducing agent).

Percocet has a Boxed Warning on the manufacturer's label. Norco 10-325: The generic name for the combination of hydrocodone bitartrate 10 mg / acetaminophen 325 mg) tablets. Norco is classified as a Schedule II controlled substance. Norco has a Boxed Warning on the manufacturer's label. (Reference: dailymed.nih.gov)

Boxed Warning: The strongest warning that the Food and Drug Administration (FDA) requires, and signifies that medical studies indicate that the drug carries a significant risk of serious or even life-threatening adverse effects. [Reference: dailymed.nih.gov]

Dangerous Drug: "Any drug that bears the legend: "Caution: federal law prohibits dispensing without a prescription." (Reference: The Business and Professions Code, California Code of Regulations, Title 16, Section 4022(a))

Furnish: "Furnish means to supply by any means, by sale or otherwise." (Reference: The Business and Professions Code, California Code of Regulations, Title 16, Section 4026)

High Alert Medications: The Institute for Safe Medication Practices (ISMP), a nationally-recognized safety organization: "High Alert Medications are drugs that bear a heightened risk of causing significant patient harm when they are used in error." (Reference: ISMP.org)

High Risk High Alert Medications: " ...medications that have narrow margin of safety and high risk of causing injury if misused." (Reference: Hospital Policy titled, "High Risk High Alert Medications")

Findings:

1. During a random record review on the JR patient care unit, Patient 11's medical records showed the following:

The Registration Facesheet, dated 8/31/17, showed the patient was in her 60's and admitted, on 8/29/17 at 11:18 a.m., for elective surgery.

The History and Physical (H&P), dated 8/31/17, showed a medical doctor and surgeon (MD 11) planned to perform surgery to her left knee to relieve chronic pain from osteoarthritis.

The Physicians' Orders, dated 8/30/17 at 8:27 a.m., showed a linked opiate medication order set, signed by MD 11, with parameters to treat mild, moderate, and severe pain.

The first linked order for Norco 5-325 (generic name hydrocodone 5 mg /acetaminophen 325 mg) one tablet every three hours as needed for mild pain with instructions to repeat within two hours for pain unrelieved by the first dose. Administration Instructions showed "Mild (1-3)."

The second linked order was for "Norco 10-325 (generic name hydrocodone 10 milligrams (mg) /acetaminophen 325 mg) one tablet every three hours as needed for moderate pain. May repeat within two hours for pain unrelieved by the first dose. Administration Instructions showed "Moderate (4-6)."

The third linked order was for Percocet 5-325 (generic name oxycodone 5 mg /acetaminophen 325 mg) one tablet every three hours as needed for severe pain. May repeat within two hours for pain unrelieved by the first dose. Administration Instructions showed "Severe (7-10)."

The Medication Administration Record (MAR), dated 8/29/17, showed Registered Nurse (RN) 12 administered a dose of Norco 10-325 (ordered for moderate pain), on 8/29/17 at 8:54 p.m.

The Analog Pain Score Flowsheet, dated 8/29/17, showed RN 12, prior to administering the dose of Norco 10-325, documented a pain score of "1", on 8/29/17 at 7:40 p.m., which, according to the MAR, corresponded to mild pain. A pain score documented at the reassessment at 9:00 p.m., showed, "denies pain/discomfort." There were no other pain scores documented, between 7:40 p.m., and 9:00 p.m., in the record or in the nurses' notes and no pain scores or notes which indicated the patient was experiencing moderate pain.

The MAR, dated 8/30/17, showed a second registered nurse, RN 11, administered a dose of Norco 10-325 to Patient 11 on 8/30/17 at 6:24 a.m.

A review of the Care Plan for Acute Pain, dated 8/30/17, included a goal to maintain an acceptable level of pain control and comfort. The plan showed, "Pt's [Patient's] goal of <3/10 prior to discharge."

The Analog Pain Score Flowsheet, dated 8/30/17, showed that RN 11, prior to administering the dose of Norco for moderate pain, documented a pain score of "3" on 8/30/17 at 4:00 a.m., which corresponded to mild pain on the Physician's Order. A pain score documented for the pain intervention reassessment at 7:24 a.m., was "0" which corresponded to no pain. On 8/30/17 there were no other pain scores documented between 4:00 a.m. and 7:24 a.m.

The Nurses Notes, dated 8/29/17 through 8/30/17, showed no indication Patient 11 experienced moderate pain at the time of Norco 10-325 administrations by RN 12 on 8/29/17 at 8:54 p.m. or by RN 11 on 8/30/17 at 6:24 a.m.

On 8/30/17 at 10:54 a.m., during an interview, a JR charge nurse (RN SUPV 13) was asked by the surveyor who decided what pain medications patients received. She said, "We stick with what was working for them and we follow the order. We do both." She indicated if there was a conflict between what the patient requested and what the doctor ordered, the nurse was supposed to call the doctor.

On 8/30/17 at 11:42 a.m., during an interview, RN 14 indicated each patient had a goal pain score determined during admission. She referred to Patient 11's record and said, "While she's here she wants her pain to be less than three. We try to maintain her pain less than three. If it goes above three we medicate her." She indicated non-pharmacological interventions included ice, elevation, and repositioning.

On 8/30/17 at 3:33 p.m., during an interview, MD 11 indicated nurses were authorized to administer pain medications to his patients in consideration of monitoring parameters specified in his orders. He said, "I expect orders to be followed." He indicated he found pain scores a useful tool to assess the effectiveness of the post-surgical treatment plan. He indicated that most of his patients were assessed using the analog score. He indicated nurses called him if there is a concern with an order. He indicated he did not recall whether or not a nurse called him about Patient 11.

On 8/31/17 at 11:02 a.m., during an interview, the pharmacist and Medication Safety Officer (MSO) said, "Our policy is to ensure controlled substances - all medications - are administered as ordered." He indicated opiates were identified by the hospital as High Alert High Risk medications and that a Pain Management Protocol and a new Pain Management Service had been developed to ensure safe administration practices. MSO indicated the hospital was aware of "use errors with opiates", and he was working on an action plan which included plans to review all order sets, related to pain management. MSO said, "We became aware of this problem, 8/24/17, when general pain orders were identified on the licensing survey." He indicated that the opiate orders, for Patient 11 and 12, included monitoring parameters on each order which were duplicated on the MAR. "The patients had opiate orders with parameters for mild pain, moderate pain, and severe pain." He indicated that the parameters were expressed as a range of pain scores.

On 8/31/17 at 1:20 p.m., during an interview, RN SUPV 13 indicated RN 11 was unavailable for interview throughout the survey. RN SUPV 13 said, "Based on the order, the nurse [Nurse 11] should not have given Norco 10 because there was no pain score to justify administration." RN SUPV 13 said, "I spoke to [RN 11] today, at 8:10 a.m., and she told me the patient's pain score was a 4 or 5 and she forgot to document."

On 8/31/17 at 1:20 p.m., during the same interview, RN SUPV 13 indicated RN 12 was not available for interview during the survey. RN SUPV 13 indicated she researched the Norco 10-325 dose administration by RN 12, on 8/29/17 at 8:54 p.m. She said, "I spoke to [RN 12] and she told me the patient felt like she needed a little stronger pain medication. She did not call the doctor she just gave it."

On 8/31/17 at 2:30 p.m., during an interview, the Chief Nursing Officer (CNO) said, "The expectation is that you follow the physician's orders. When you don't you're out of scope. They need to pick up the phone and call the physician. This has been an issue and it tends to happen with the surgical patients." She indicated the hospital first became aware of nurses not following the physicians' orders in July during a survey by a deeming organization. She said, "[MSO] is working on an action plan...staff education...order sets." She said, [RN 11] forgot to document it [pain score]. It was a four or five. [RN 12]...the patient felt like Percocet." CNO said, "I see these as med errors. It's failure to follow policies." CNO indicated the hospital used Lippincott's nursing procedures as practice standards as well as state and federal requirements.

A review of Patient 13's medical records showed the following:

The Registration Facesheet, dated 8/29/17, showed the patient was in her 70's and was admitted, on 8/29/17 at 8:50 a.m., for elective surgery.

The H&P, dated 8/28/17, showed MD 11 planned to perform surgery to her right knee to relieve chronic pain.

The Physicians' Orders, dated 8/29/17 at 2:31 p.m., showed a linked opiate medication order set, signed by MD 11, with parameters to treat mild, moderate, and severe pain.

The first linked order was for "Norco 10-325 /acetaminophen 325 mg) one tablet every three hours as needed for mild pain. May repeat within two hours for pain unrelieved by the first dose. Administration Instructions showed "Mild (1-3)."

The second linked order was for Percocet 5-325 (generic name oxycodone 5 mg /acetaminophen 325 mg) one tablet every three hours as needed for moderate pain. May repeat within two hours for pain unrelieved by the first dose. Administration Instructions showed "Moderate (4-6)."

The third linked order was for Percocet 10-325 (generic name oxycodone 10 mg /acetaminophen 325 mg) one tablet every three hours as needed for severe pain. May repeat within two hours for pain unrelieved by the first dose. Administration Instructions showed "Severe (7-10)."

The MAR, dated 8/30/17, showed RN 11 administered a dose of Percocet 5-325 to Patient 13, on 8/30/17 at 4:46 a.m., and RN 13 administered a dose of Percocet 5-325 to Patient 13, on 8/30/17 at 8:47 a.m.

A review of the Care Plan for Acute Pain, dated 8/30/17, included a goal to maintain an acceptable level of pain control and comfort. The plan showed, "Pt's [Patient's] goal of <5/10 prior to discharge."

The Analogue Pain Score Flowsheet showed RN 11, prior to administering the 4:46 a.m. dose, showed no pain assessment documentation. A pain score documented at the reassessment, at 5:45 a.m., showed, "denies pain/discomfort." There were no pain scores documented, between 8/29/17 at 9:56 p.m., and 8/30/17 at 8:00 a.m. On 8/29/17 at 9:56 p.m., the pain score was 2 which corresponded to mild pain. At 8/30/17 at 8:00 a.m., the pain score was 0 which corresponded to no pain. There was no documentation to indicate the patient had experienced moderate pain or severe pain which justified administration of the dose of Percocet at the time it was administered.

The Nurses Notes, dated 8/30/17, showed no indication Patient 13 experienced moderate pain at the time of Percocet 5-325 administration by RN 11 on 8/30/17 at 8:47 a.m..

On 8/31/17 at 11:00 a.m., during an interview, RN SUPV 13 indicated she spoke with RN 11 about the Percocet dose, administered on 8/30/17 at 8:47 a.m., to Patient 13. RN SUPV 13 indicated RN 11 told her the patient said she was allergic to Norco so she gave Percocet instead. RN SUPV 13 said, "She [RN 11] did not call the doctor."

On 8/31/17 at 11:02 a.m., during a concurrent interview and record review, the MSO said, "The patient did not have a true allergy to Norco. Nausea, vomiting is listed as an allergy but it is not a true allergy. It's an intolerance." The MSO said, "She should not have given the Percocet...she should have called the doctor...if the patient refused she should have documented. This is a medication administration error." MSO indicated the hospital incorporated guidelines and definitions from the National Coordinating Council for Medication Reporting and Prevention, (NCCMERP) when policies for prevention and reporting medication errors was developed. He indicated the hospital also incorporated standards from a professional society, the American Society of Health-System Pharmacists.

On 8/31/17 at 11:44 a.m., during an interview with a registered Nurse Practitioner for the hospital's Pain Management Service NP 1), she said, "I depend on numeric pain scores to help assess the patient's pain. NP 1 indicated the hospital's analog scale was a valid clinical tool. She said, "The pain score consistently describes intensity...the score is internally consistent with the perceptions of the patient. We use it for trending and [for] potential changes in the plan and dosing with opiates." NP 1 said, "I think using the pain scale makes patients safer. It makes it easier for me to do my job."

2. A review of the hospital's policy, titled, "Pain Management Protocol", revised 3/17, showed, "Assess patient's pain with proper pain intensity scales: Analog, Verbal, Wong-Baker Faces..." The policy showed, "After all interventions, pain must be re-assessed and documented in the patient's chart. Assess pain score within one hour post medication." Addendum A of the protocol showed under the subheading "Pain Intensity Scale" a definition for the analog pain scale, "Analog: Rating scale from 0 to 10, with 0-3 mild pain, 4-6 moderate pain, 7-10 severe pain." The policy was developed using practice standards and recommendations from the following organizations and publications: the American Pain Society, Pain Clinical Manual Mosby, Clinical Nursing Skills and Techniques Mosby, The National Guideline Post-operative Pain Management, and the World Health Organization.

A review of the hospital's policy, titled, "High Risk High Alert Medications", revised 7/17, showed, "Opiates and other medications that alter consciousness" were identified by the hospital as High Risk High Alert medications. The policy showed, in the section, "Action in Preventing Medication Error": "...Pain Scale, sedation scale, and vital signs are monitored per nursing policy." The policy was developed using practice standards and recommendations from the Institute for Safe Medication Practices and the United States Pharmacopeia.

A review of the hospital's policy, titled, "Medication Administration Structure Standards", Addendum O-3, revised 3/17, showed, "Controlled drugs shall be administered as ordered and in compliance with established procedures for medication administration." The same policy showed, "An actual medication error is any preventable event that causes or leads to inappropriate medication use or patient harm while the medication is under the control of the health care professional...Actual medication errors include but are not limited to the following: Wrong dose: the medication dose administered to the patient is different from the dose prescribed by the physician." The policy was developed using practice standards and recommendations from the National Coordinating Council for Medication Reporting and Prevention, the Institute for Safe Medication Practices.

A review of the hospital's policy, titled, "Total Knee Replacement Management Protocol", revised 7/17, showed, under the section "Reportable Conditions...Increase in pain or inadequate relief from pain medication." The policy instructed nurses to, "Document all assessments, interventions and outcomes and patient/family education." The policy was developed using practice standards and recommendations from: "The use of "as Needed" range orders for Opioid Analgesics in the Management of Acute Pain" published in A Consensus Statement of the American Society for Pain Management Nursing, the American Pain Society, the American Society for Pain Management Nursing, and Pain Assessment and Pharmacologic Management published by Mosby.

3. According to the manufacturer, Norco is not indicated for mild pain. The label states, "Norco is indicated for the relief of moderate to moderately severe pain." Norco 10-325 has a Boxed Warning for hepatotoxicity (liver toxicity). The warning states, "Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product." (Reference: dailymed.nih.gov)

According to the manufacturer, "Percocet is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate." Percocet was not indicated for mild pain for Patient 13 because alternatives treatments were ordered and available but not tried. Percocet 5-325 has a Boxed Warning for Life-Threatening Respiratory Depression. The warning states, "Serious, life-threatening, or fatal respiratory depression may occur with use of Percocet. Monitor for respiratory depression, especially during initiation of Percocet or following a dose increase." (Reference: dailymed.nih.gov)

4. A review of RN 11's Orientation Summary Record, dated 7/16/17, showed she received passed written tests for "Basic Medication" and "Basic Critical Thinking", on 7/15/13. The record showed she reviewed "Policies, Procedures, and Standards" for medication administration and Pain Management. Her signature was under the statement, "I acknowledge the receipt of the above information and training." The record was also signed by a registered nurse instructor and trainer, RN 15. The record did not specify any practice standards; however, the hospital's policies (e.g. the "Medication Administration Policy", "Pain Management Protocol" and "Pain Scale Documentation") and staff referenced a number of authoritative textbooks, professional associations and safety organizations.

According to Lippincott's, a nationally recognized nursing practice authority, who publishes safe medication procedures for nurses included: "Monitor medication dosing carefully, especially if dosing adjustments are necessary because of narrow therapeutic windows. Monitor and document the effectiveness of all medications administered." (Reference: Lippincott Procedures, Safe Medication Administration Practices, General, revised: October 02, 2015)

According to the American Society of Health-System Pharmacists (ASHP) publication, "ASHP Guidelines on Preventing Medication Errors in Hospitals", under the section, "Recommendations for Nurses" includes the recommendation, "Nurses should review patients' medication with respect to desired outcomes, therapeutic duplications, and possible drug interactions. Nurses should talk with patients or caregivers to ascertain that they understand the use of their medications and any special precautions or observations that might be indicated." The ASHP publication defines "Unauthorized drug error" as "Administration to the patient of a medication not authorized by a legitimate prescriber for the patient." (Reference: Am J Hosp Pharm. 1993; 50:305-14)

According to the National Coordinating Council on Medication Error Reporting and Prevention (NCCMERP), makes the following recommendations to reduce medication errors associated with at-risk behaviors:

* Eliminate organizational tolerance of risk.
* Increase awareness of at-risk behaviors.
* Determine system-based reasons for risk taking behavior.
* Eliminate system-wide incentives for at-risk behaviors.
* Motivate through feedback and rewards.
* Involve patients and families in the processes of safe medication administration and monitoring.

5. State requirements are standards of practice with regard to medication administration as follows:

Title 22 of the California Code of Regulations, Division 5, Chapter 1, Article 3, Pharmaceutical Service General Requirements 70263(g)(2) stipulates requirements for administration of drugs in hospitals: "(g) No drugs shall be administered except by licensed personnel authorized to administer drugs and upon the order of a person lawfully authorized to prescribe or furnish ... (2) Medications and treatments shall be administered as ordered.

The California Business and Professions Code, Division 2, Chapter 9, Definitions Section 4019, specifies circumstances which authorize nurses to administer drugs to patients in hospitals pursuant to a practitioner's orders. "An "order," entered on the chart or medical record of a patient registered in a hospital or a patient under emergency treatment in the hospital, by or on the order of a practitioner authorized by law to prescribe drugs, shall be authorization for the administration of the drug from hospital floor or ward stocks furnished by the hospital pharmacy or under licensure granted under Section 4056, and shall be considered to be a prescription if the medication is to be furnished directly to the patient by the hospital pharmacy or another pharmacy furnishing prescribed drugs for hospital patients; provided that the chart or medical record of the patient contains all of the information required by Sections 4040 and 4070 and the order is signed by the practitioner authorized by law to prescribe drugs, if he or she is present when the drugs are given."

The California Business and Professions Code, Division 2, Chapter 9, Article 3, Section 4059 (a) limits furnishing dangerous drugs except on the prescription of an authorized prescriber. "A person may not furnish any dangerous drug, except upon the prescription of a physician, dentist, podiatrist, optometrist, veterinarian, or naturopathic doctor pursuant to Section 3640.7. A person may not furnish any dangerous device, except upon the prescription of a physician, dentist, podiatrist, optometrist, veterinarian, or naturopathic doctor pursuant to Section 3640.7."

Based on observation, interview, and record review, the facility failed to: 1. ensure Environmental Services Staff performed hand hygiene, donned appropriate PPE, and terminally cleaned an isolation room and operating room in accordance with hospital policy and procedures and 2. provide evidence of EVS (environmental services) staff training, and being monitored and evaluated, for compliance with the infection control program. These failures had the potential for the spread of infections and communicable diseases.

Findings:

1. During an observation, interview, and record review, on 9/1/17 at 4:30 p.m., the EVS (Environmental Services) Supervisor participated in an observation of EVS (EVS staff) 1 as she cleaned the empty room of a former respiratory isolation patient. EVS 1 removed one pair of gloves during the room cleaning and then placed a clean pair of gloves over the remaining pair of gloves. EVS 1 did not remove both pair of gloves, nor did she perform hand hygiene after removal of one pair of gloves. EVS Supervisor said that all gloves should be removed and hand hygiene should be performed before gloves were re-applied. The facility policy and procedure titled, "Hand Hygiene," dated March 16, 2017, indicated that "D. All personnel and physicians must wash their hands:..5. After removing gloves."

During an observation and interview with EVS Supervisor, on 9/1/17 at 4:30 p.m., EVS 3 was cleaning a discharged patient's room who had a respiratory isolation. EVS 3 took contaminated patient paperwork from inside the isolation room and reached into the hallway and placed it on top of a pile of cleaning cloths on an EVS cart. The EVS Supervisor said this should not have been done. EVS 3 said that she did it because it was health records belonging to the patient that needed to be protected. The paperwork was copies of the patient's admission documents that were left in the room.

During an observation, interview, and record review on 9/1/17 at 5:30 p.m., EVS 2 and EVS 3 did not wear shoe covers or masks or face shields when performing a terminal cleaning (Cleaning performed at the end of the day after the room was used and and involves cleaning and disinfection of all exposed surfaces.) on an operating room. The facility policy and procedure titled, "Procedure for terminal cleaning of operating room- Surgical Suites," dated March, 2017 indicated in Procedure #338-A, 2, "Wear scrubs or scrub suit and proper PPE (Personal Protective Equipment: shoe covers, surgical cap, disposable gloves, mask or face shields) as needed. The EVS Sup said that personnel should follow hospital procedure.

During an observation, interview, and record review, on 9/1/17 at 5:30 p.m., the EVS Supervisor said terminal cleaning of the Operating Room should begin from top to bottom. As EVS 1 and EVS 2 cleaned the operating room, they cleaned the lights suspended down over the operating table and then to the table, and lastly cleaned the ceiling and ceiling air vents. The facility policy and procedure titled "Procedure for terminal cleaning of operating room- Surgical Suites" dated March, 2017 indicated in Procedure #338-A, 4. indicated, "As with other cleaning procedures, work methodically in an organized pattern through the room, starting from the ceiling down, dirty to clean." The EVS Supervisor said cleaning should be from top to bottom and said the way it was done at the time was improper.

2.In an observation, interview, and record review, on 9/1/2017 at 3:30 p.m., the EVS Director said that while he did training with the employees, he was "lax in documentation." EVS Director was unable to present documentation of EVS employee training and regular assessment. EVS Director had no evidence that he monitored compliance of EVS staff cleaning protocols, procedures, or policies as part of an ongoing infection control program.