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Based on staff interviews and document review, the facility failed to ensure Punjabi-speaking patients were informed of their rights and received admission documents in their native language. This had the potential to deny patients their right to such information which could prevent them from making informed choices and advocating for their care.

Findings:

During an interview and concurrent document review on 6/11/15 at 9:22 a.m., Ancillary Staff AA was asked about the patient admission process. She stated she verified the patient's name, address, insurance carrier, reviewed the Conditions of Admission consent form, and gave them a, "pass code," for receiving their patient information, as well as a copy of their Medicare rights and HIPAA (Health Insurance Portability and Accountability Act) privacy rules. When asked if the information was printed in languages other than English, Ancillary Staff AA stated they are also printed in Spanish. For patients speaking other languages, she stated, if the patient arrived without English-speaking family, she utilized the AT&T interpreter phone line to convey the admission information. Regarding the Conditions of Admission consent form, Ancillary Staff AA stated she did not read the entire consent form, but rather summarized 4 of the 13 items through the interpreter phone line (Legal Relationship Between Hospital and Physicians, Financial Agreement, Advance Directive, and Personal Belongings).

During an interview on 6/11/15 at 9:35 a.m., Ancillary Staff BB was asked about the information given to non-English speaking patients. She stated the Medicare rights were available in English, Spanish, and Hmong. When asked about the Punjabi language, she stated she was able to speak Punjabi, but was only allowed to communicate and obtain basic information to/from these patients, such as name, date of birth, insurance carrier, etc. When asked about the size of the local Punjabi-speaking population, Ancillary Staff BB described it as, "good size."

Review of facility-provided statistics regarding patient languages for the two counties served by the facility indicated in July 2012:
In County A (Sutter)--0% spoke Hmong and 6.4% spoke Punjabi
In County B (Yuba)--2.1 % spoke Hmong and 0.1% spoke Punjabi

Review of the information provided to English-speaking patients upon admission found it to include: Your Right to Make Decisions About Medical Treatment, Patient Rights, Advance Directives, contact information for the Physical Therapy Board of California, and the facility's Financial Assistance Programs. Review of the information provided to Spanish-speaking patients found it to include Patient Rights and Your Right to Make Decisions About Medical Treatment. The facility did not provide to the surveyor any information printed in Hmong or Punjabi.

Based on observation, interview and record review, the hospital failed to assure Pharmaceutical Services included all high risk activities in the department's Quality Assessment and Performance Improvement program when a Food and Drug Administration (FDA-federal institution charged with oversight of the safety of medication production and use in the United States) 2014 Warning Letter was not incorporated into the department's Quality Assurance process and the quality of products obtained from a 503 B outsourcing facility (an entity allowed to compound medications according to section 503 B of the Food, Drug, and Cosmetic Act as amended) was not reviewed. The hospital staff was not aware of the warning letter and had not pursued further investigation with the outsourcing facility and had not requested batch specific data on each of the products purchased from the Outsourcing Facility to assure strength, sterility, and stability of its products. These failures had the potential for patient exposure to contaminated drugs.

Findings:

A 503 B Outsourcing Facility is a facility engaged in the compounding, (mixing of sterile drugs) that has registered with the Federal Drug Administration. A 503 B facility must comply with Current Good Manufacturing Practices (CGMP), CGMP for finished drug products are established in Title 21 of the Code of Federal Regulations (CFR parts 210 and 211). CGMP include requirements that finished drug products be tested to determine if they meet final product specifications before their release for distribution, including identity and strength of active ingredient, sterility and stability. (Batch testing)

During an observation on 6/9/15 at 2:30 p.m., the anesthesia cart in Operating Room 2 at Hospital MM contained eight prefilled syringes labeled Succinylcholine, of varying strengths, and eight prefilled syringes of various strengths of Rocuronium. Both medications are neuromuscular blocking agents given intravenously to paralyze a patient for surgery, (LexicompOnline, a medication resource). Review of labeling indicated the medications were products of Outsourcing Facility QQQ.

During interview and concurrent record review, on 6/11/15 at 9:32 a.m., the Director of Pharmacy stated the hospital used seven additional sterile products from Outsourcing Facility QQQ. Pharmacy Technician D stated she had been the drug buyer for the hospital for four years and provided lists of medications purchased from Outsourcing Facility QQQ in April and May of 2015. Review of the lists indicated a total of nine separate medications had been ordered from Outsourcing Pharmacy QQQ in April and May, which Pharmacy Technician D confirmed.

During an observation, on 6/11/15 at 1:15 p.m. the pharmacy storage area of Hospital OO contained 19 bags 1000 milliliter (ml-a unit of measurement) bags of Lactate Ringers containing Oxytocin, (used to induce, stimulate labor), a bin filled with bags of Oxytocin in 250 ml of normal saline, boxes of a local anesthetic called Ropivacaine, and boxes of Magnesium Sulfate, used as an electrolyte replacement. Boxes of prefilled syringes containing Succinylcholine and Rocuronium were locked in a drawer in the pharmacy. Review of labeling on the medications indicated the medications were products of Outsourcing Facility QQQ.

During an interview, on 6/11/15 at 3:42 p.m., the Director of Pharmacy agreed that sterile compounding was a high-risk activity.

The United States Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the quality, purity, identity, and strength of medicines. USP's drug standards are enforceable in the United States by the Food and Drug Administration and are published in the United States Pharmacopeia/National Formulary (USP/NF). The USP revised general chapter <797> entitled PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS documents in the Introduction that, "The objective of this chapter is to describe conditions and practices to prevent harm, including death to patients that could result from microbial contamination and excessive bacterial toxins [introduced during the compounding process] among other things."

On 7/18/14, the Food and Drug Administration issued a Warning Letter to Outsourcing Facility QQQ which documented, "It appears you [Outsourcing Facility QQQ] are producing drugs that violate the Federal Food, Drug and Cosmetic Act..." The letter presented examples of such violations. On page 3 of 7 it documented that Outsourcing Facility QQQ had registered with the FDA as a 503 B Outsourcing Facility, and that the letter focused on unsanitary conditions and violations of CGMP (current good manufacturing practices, found in Title 21 Code of Federal Regulations, Part 210 and Part 211 and which provide regulations for manufacturing medications) requirements that continued to apply to Outsourcing Facility QQQ even though it had registered with the FDA. On page 4 of 7 it documented that Outsourcing Facility QQQ's, "Attention is directed in particular to the provisions with regard to sterility testing ... and the establishment of beyond use dates." On page 5 of 7 it documented that, "The violations cited in this letter are not intended to be an all-inclusive statement of violations at your facilities..."

During an interview, on 6/11/15 at 9:32 a.m., the Director of Pharmacy stated he had not seen the 7/18/14, Warning Letter from the FDA to Outsourcing Facility QQQ. The Director of Pharmacy stated he had not reviewed the requirements for 503 B Outsourcing Facilities and agreed the hospital was responsible to diligently investigate products used in the hospital(s) to assure their quality.

During an interview, on 6/11/15 at 2:40 p.m., when asked how he could assure the sterility of the products purchased from Outsourcing Facility QQQ, the Director of Pharmacy replied, "Good question." The Director of Pharmacy stated a State Board of Pharmacy inspector said the hospital needed to get a report of end use batch specific testing data from the outsourcing facility, but he had not yet gotten that information.

Review of hospital policy titled OUTSOURCED COMPOUNDED STERILE PRODUCTS-PHARMACY (1), created 3/17/14, and Published 4/1/14, POLICY III E. 5. indicated, "Initial...and quarterly receipt and review of quality reports that are specific to the CSPs (Compounded Sterile Products) obtained to ensure the quality and safety of the product(s)."

Based on interview and record review, the hospital failed to ensure that all information related to the patient assessment by licensed staff was recorded in the medical record for two of two patients (Patient 51 and Patient 52) requiring telemetry monitoring. Failure to effectively evaluate telemetry monitoring strips may result in delayed intervention, further compromising clinical status.

Findings:

1. Patient 51's face sheet, dated 6/8/15, and timed 3:08 a.m., indicated he was an 73-year-old patient receiving nursing care on 4 Main medical/telemetry nursing unit for symptomatic neutropenic fever (abnormally low count of neutrophils, a type of white blood cell that helps fight off infections) requiring telemetry monitoring. (Telemetry is a method of remotely monitoring cardiac rhythm via a portable unit to a central display terminal).
Patient 51's telemetry strip posted on the Telemetry Log dated, 6/9/15 at 7:41 a.m., indicated incomplete documentation. The telemetry strip lacked a date, time and staff signature, per the policy.

Patient 51's telemetry strip posted on 6/10/15 at 6:55 a.m., indicated incomplete documentation. The telemetry strip lacked a date, time and staff signature, per the policy.

Patient 51's telemetry strip posted on 6/10/15 at 7:41 p.m., indicated incomplete documentation. The telemetry strip lacked a date, time and staff signature, per the policy.

During an interview on 6/11/15 at 3 p.m., Administrative Staff S confirmed Patient 51's telemetry strips posted did not include a review and documentation by the registered nurse.

2. Patient 52's face sheet, dated 6/9/15, and timed 2:07 p.m., indicated he was an 60-year-old patient receiving nursing care on 2 West medical/telemetry nursing unit for ascites (the accumulation of fluid in the abdominal cavity, causing abdominal swelling) requiring telemetry monitoring. (Telemetry is a method of remotely monitoring cardiac rhythm via a portable unit to a central display terminal).

Patient 52's telemetry strip posted on the Telemetry Log, dated 6/11/15 at 4:22 a.m., indicated incomplete documentation. The telemetry strip lacked a date, time and staff signature, per the policy.

During an interview on 6/11/15 at 2:30 p.m., Administrative Staff S confirmed Patient 52's telemetry strips posted did not include a review and documentation by the registered nurse.

The facility policy and procedure titled, "Telemetry Monitoring - Nursing (v4)," dated 10/29/14, last review, indicated, "Purpose: To provide safe consistent care and early recognition of cardiac dysrhythmias to the patient requiring continuous telemetry monitoring....F. Primary care nurse is to assess the daily rhythm strip. Nurse is to date, time, and sign this strip and document in the medical record as stated above..."

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Based on nursing staff interview and medical record review, the hospital failed to ensure development of a care plan that was individualized for 1 patient (Patient 126) with poor dietary intake as evidenced by lack of implementation of documented care plan elements. Failure to comprehensively develop nutrition care plans for patients at nutritional risk may result in further weight loss, compromising medical status.

Findings:

Patient 126 was admitted on 6/4/15, with diagnoses including osteoporosis (a bone thinning disorder), iron deficiency anemia and chronic kidney disease. Admission diet order was a Regular Diet. Medical record review was conducted on 6/10/15, beginning at 2:30 p.m.

A history and physical, dated 6/4/15, completed by the physician, noted that Patient 126 presented to the emergency room with dementia, increased falls and decreased appetite. The physician also noted a 9-pound weight loss over the previous two weeks. Patient 126 presented with family members as the party providing information. Admission height was 5 feet 2 inches and weight was 105 pounds. Review of nutrition screening assessment, dated 6/4/15, failed to document Patients 126's weight loss. Review of dietary intake during admission revealed that on 6/5/15, Patient 126 consumed 75% of her meals. Beginning on 6/7/15, Patient 126's meal intake decreased. Nursing staff documented an average meal intake for nine meals, beginning on 6/7/15 as 40%. Review of her care plan, developed on 6/4/15, failed to note the decreased dietary intake; however there was the development of a care plan related to hyperglycemia that included providing nutrition dense foods, between meal snacks and small frequent meals, all of which may benefit a patient with demonstrated poor intake and a history of weight loss. It did not appear that the interventions on the care plan were considered or implemented.

In an interview on 6/10/15 beginning at 3:45 p.m., with Registered Nurse TT, she stated that care plans were developed based on diagnosis. She also stated that during the development of care plans if a specific diagnosis, such as hyperglycemia, was identified and selected as an issue, the computer automatically prepopulated multiple interventions that could be implemented. She further stated nursing had the ability to modify the electronic medical record to determine which of the interventions to implement. She was unable to explain why none of the interventions were implemented.

Hospital document titled, "Care Planning, Interdisciplinary-Hospitalwide," dated 2/13/14, noted that the procedure for developing care plans was to, "...1. Select appropriate Standard Care Plan ...2. On chosen care plan: ...select and circle or mark the checkbox for appropriate nursing diagnosis/problems ..." While the facility had a procedure for developing comprehensive care plans, there was no development of a nutrition care plan in relationship to decreased dietary intake.




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Based on observation, interview, and review of clinical records and hospital policy, the hospital failed to assure medications were administered as ordered by the physician, when licensed staff did not give Patient 104 a medication from home for six days. This potentially interrupted the therapeutic levels of the medication for Patient 104.

Findings:

Medication pass observations included four licensed staff passing medications to seven patients on several nursing units of Hospital MM. One medication error occurred out of 15 opportunities for error.

During observation of med pass, on 6/9/15 at 8:58 a.m., Licensed Staff E gave Patient 104 five oral medications.

Review of physician medication orders for Patient 104, on 6/9/15 at 10:03 a.m., indicated Licensed Staff E had not given Flaxseed 1000 milligrams (mg) as ordered by the physician on 6/3/15. The prescribing order read, "Flaxseed 1000 mg po (by mouth) Note to pharmacist Patient's own medication, last dose taken unknown." Review of the e-MAR (Electronic Medication Administration Record) indicated Patient 104 had not received Flaxseed since it had been ordered on 6/3/15, six days.

Administrative Staff F identified the order as an active order, at 10:07 a.m. on 6/9/15.

Flaxseed, a nutritional supplement, is a plant based source of dietary fiber and Omega-3 fatty acids, and is used for conditions related to the gastrointestinal tract and disorders related to the heart and blood vessels. (WebMD.com)

Review, on 6/9/15 at 1:07 p.m., of the hospital policy and procedure titled MEDICATIONS FROM HOME-PHARMACY (6), 2895, publication date 6/4/14, indicated medication definitions included 3. Herbal remedies and 5. Nutritional Supplements. Review indicated there was not a procedure of how to obtain medications from home or what to do if the medication was not available.

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Based on observation, interview, review of clinical records and hospital policy, the hospital failed to assure that: 1. Medication dose adjustments for renal dosing were complete, when hospital policy and procedure for renal dose adjustments contained gaps in the dosing guidelines for 10 of 16 reviewed medications, with potential for drug toxicity if patients received too large a dose of drugs cleared through the renal system; and 2. A system for obtaining medications from home was not incorporated into the hospital policy and procedure, for medications from home, which resulted in one patient (Patient 104) not receiving a prescribed medication for six days.

Findings:

1. Renal (kidney) disease alters the effects of many medications. Doses of medications excreted through the kidneys usually should be reduced in proportion to the reduction in drug clearance. Decreased kidney function causes decreased clearance (excretion), which results in increased drug concentrations and the potential for increased effects from the drug, with associated adverse effects.

During observation of med pass, on 6/9/15 at 8:58 a.m., Licensed Staff E gave Patient 104 five oral medications, including Famotidine 20 milligrams (mg- a measure of amount). Subsequent review, at 10:03 a.m., of the physician orders, indicated a physician order for, "Famotidine 20 mg oral every twelve hours." Famotidine is a medication that reduces the amount of acid in the stomach and is used to treat ulcers and gastric reflux.

During review, of the Pharmacy Patient Profile, a list of current medication orders for Patient 104, a message box popped up that read, "Disp Msg dose of Famotidine 20 mg BID (twice a day) for Cr Cl > 50, Famotidine 20 mg HS (bedtime) for Cr Cl 10-49."

During interview, on 6/9/15 at 10:11 a.m., Administrative Staff F stated when a Registered Pharmacist verified an order, the Dispensing Message would pop up.

Cr Cl stands for Creatinine Clearance, a blood test that provides information about how well the kidneys (renal system) are working. Creatinine is removed, or cleared, from the body entirely by the kidneys. If kidney function is abnormal, the creatinine level in the blood increases, and the creatinine clearance is lower. Creatinine is measured in milliliters/ minute (ml/min), normal values for a woman are 88-128 ml/min. Abnormal results, lower than normal, may indicate kidney problems.

The Pharmacy Patient Profile (PPP), on 6/9/15, for Patient 104, included a notation in the upper right corner (in the banner) that read, "Cr Cl 24.58."
Administrative Staff F stated the profile was updated with the last creatinine clearance done for Patient 104 entered into the system automatically.

During an interview, on 6/9/15 at 10:24 p.m., Registered Pharmacist G stated the physician order for Patient 104, for Famotidine 20 mg. po twice a day, was written on 6/3/15.

Review, on 6/9/15 at 3:22 p.m., of Patient 104's creatinine clearance levels, as per the hospital Vigilance system (a clinical documentation tool that picks up data every minute from the hospital Electronic Medical Record system [EMR]), indicated on 6/3/15 at 11:17 a.m., Patient 104's creatinine clearance was 49.89.

According to the Dispensing Message seen with the physician order for Famotidine; for a creatinine clearance greater than 50, the dose of Famotidine should be 20 mg twice a day. If the creatinine clearance is 10-49, the Famotidine dose should be 20 mg once a day at bedtime. The message did not give directions for creatinine clearance more than 49 and less than 50, as was Patient 104's on the day the Famotidine 20 mg twice a day was ordered, 6/3/15, leaving a gap in the renal dosing guidelines.

A further review of Patient 104's creatinine clearance (Cr/Cl) indicated on 6/4/15, Patient 104's Cr/Cl had dropped to 33.74 and continued to drop until on 6/9/15, Patient 104's Cr/Cl was 24.58, however the dose of Famotidine was not adjusted per the Dispensing Message guidelines.

Review, on 6/10/15 at 8:30 a.m. of the hospital policy titled DRUG DOSING ADJUSTMENTS BASED ON RENAL FUNCTION-PHARMACY (4), 2901, published 11/25/14, indicated that pharmacists were authorized to automatically adjust doses of selected medications to reflect the patient's estimated renal function. Section IV Procedure B.5. stated the pharmacist would use the approved list of medications to find the usual dose of the selected medication based on the patient's estimated creatinine clearance. If the dose was not correct as originally ordered, the pharmacist would write a new order for the adjusted dose, along with the phrase, "per renal dosing protocol." The DRUG DOSING ADJUSTMENTS BASED ON RENAL FUNCTION (4) policy included an appendix, RENAL DOSING LIST, APPENDIX A.

The RENAL DOSING LIST, APPENDIX A was reviewed and indicated that dosing for Famotidine was as follows: Estimated Cr/Cl (Creatinine Clearance) >50 Famotidine 20 mg BID (twice a day). Cr/Cl 10-49 Famotidine 20 mg HS (bedtime, and Cr/Cl <10 Famotidine 20 mg every 48 hours. APPENDIX A did not specify what dose of Famotidine a patient should receive when Cr/CL was between 49 and 50.

During an interview, on 6/10/15 at 10:38 a.m., the Director of Pharmacy verified that DRUG DOSING ADJUSTMENTS BASED ON RENAL FUNCTION (4) was the current policy. The Director of Pharmacy agreed that Patient 104's Cr/Cl of 49.89 on 6/3/15, was what the pharmacist saw on the Pharmacy Patient Profile when the Famotidine was ordered. The Director of Pharmacy agreed that there was a gap between 49 and 50 in the Famotidine dosing guidelines, and technically the pharmacist should have called the physician on the first day that Patient 104's Cr/Cl dropped, to adjust the dose of Famotidine. The Director of Pharmacy stated he would have waited another day to see if the drop in Cr/Cl was a trend, however the dose should have been decreased and was not.

A total of 16 medications on the Renal Dosing List were reviewed, the dosing guidelines for ten of the 16 medications reviewed had gaps in the dosing guidelines; antibiotics- Unasyn, Aztreonam, Cefazolin, Cefepime, Ciprofloxin oral and IV, Primaxin, Levofloxacin, and an anti-Parkinson's agent, Amantadine, and Famotidine. Several medications had overlaps in the dosing guidelines. The gaps in the dosing guidelines were verified by the Director of Pharmacy.

2. During observation of med pass, on 6/9/15 at 8:58 a.m., Licensed Staff E gave Patient 104 five oral medications.

Review of physician medication orders, on 6/9/15 at 10:03 a.m., indicated Licensed Staff E had not given Flaxseed 1000 milligrams (mg), as ordered by the physician on 6/3/15. The prescribing order read, "Flaxseed 1000 mg po (by mouth) Note to pharmacist Patient's own medication, last dose taken unknown." Review of the e-MAR (Electronic Medication Administration Record) indicated Patient 104 had not received Flaxseed since it had been ordered on 6/3/15.

Administrative Staff F identified the order as an active order, at 10:07 a.m. on 6/9/15.

Flaxseed, a nutritional supplement, is a plant based source of dietary fiber and Omega-3 fatty acids, and is used for conditions related to the gastrointestinal tract and disorders related to the heart and blood vessels. (WebMD.com)

Review, on 6/9/15 at 1:07 p.m., of the hospital policy and procedure titled MEDICATIONS FROM HOME-PHARMACY (6), 2895, publication date 6/4/14, indicated medication definitions included 3. Herbal remedies and 5. Nutritional Supplements. Review indicated there was not a procedure of how to obtain medications from home or what to do if the medication was not available.

Based on observation, interview, and review of records, the hospital failed to ensure Pharmaceutical Services staff followed hospital policy and procedure for Sterile Compounding and adhered to the United States Pharacopeial Standards Chapter 797 (USP<797>), which establishes standards for making Compounded Sterile Products (CSPs) such as intravenous (IV) solutions when:

1. Posted directions for garbing were not in correct order, as specified in the hospital policy for garbing or with USP<797> at Hospital MM.

2. No instrument was available for cleaning under the fingernails, as per the posted directions for garbing at Hospital MM.

3. Direct air flow was blocked to the injection port during the compounding of a sterile intravenous solution at Hospital MM.

4. The hospital compounded medium risk intravenous solutions in a Sterile Compounding Area specified as a low risk compounding area at Hospital MM.

5. Air displacement was not measured across the line of demarcation between the ante-area and the buffer area at Outpatient Services PP.

6. A wheeled cart straddled the demarcation line between the ante-area and the buffer area at Outpatient Services PP.

7. No evidence was provided that the Compounding Aseptic Isolator (CAI), in use in the pharmacy, could be placed in a worse than ISO 8 environment at Hospital OO.

These deficient practices had the potential to result in microbial contamination of Compounded Sterile Products (CSPs).

Findings:

1 and 2. During an observation, on 6/8/15 at 3:08 p.m., in the ante-room of the sterile compounding room at Hospital MM, a sign hung on the wall above the sink. The sign was titled, CORRECT ORDER FOR GOWNING AND GARBING IN THE IV ROOM, and listed the steps for garbing. Garbing is the donning of personal protective equipment (PPE) to prevent microbial contamination of Compounded Sterile Products (CSP) by particles of skin shed by the compounding staff.

The CORRECT ORDER OF GOWNING AND GARBING...read as follows: 1. Put on shoe covers. 2. Put on hair cover. 3. Put on beard cover (if necessary) followed by mask. 4. Clean under fingernails.
5. Wash hands and arms to elbows. 6. Dry hands with low shedding wipes. 7. Apply alcohol based hand sanitizer and allow to dry. 8. Put on clean gown. 9. Put on sterile powder free gloves."

An implement for cleaning nails was not at the sink or available in the ante- room.

During an interview, on 6/10/15 at 11:05 a.m., the Director of Pharmacy stated there was usually a fingernail scrubber at the sink (in the ante-room).

USP <797> specifies the order of compounding garb and washing as: Shoe covers, head and facial hair covers, face mask, fingernail cleaning, hand and forearm washing and drying, non-shedding gown, hand cleansing with alcohol based product, let dry, sterile gloves.

USP<797> was reviewed with the Director of Pharmacy during an interview, on 6/10/15 at 11:08 a.m. The Director of Pharmacy agreed that #7 and #8 on the posted list in the ante room should be reversed to put on gown first and then the use of alcohol based hand scrub just prior to putting on sterile gloves.

Review, on 6/11/15 at 8:16 a.m., of the hospital policy and procedure titled, STANDARD OPERATING PROCEDURES FOR STERILE COMPOUNDING-PHARMACY (4), 2893, published 5/8/15, and received at 7:45 a.m. on 6/11/15, indicated the purpose of the policy was, "...ensure all compounded sterile preparations (CSPs) are prepared in a safe and accurate manner." Section IV PROCEDURE: C. "Personnel Cleansing and Gowning," documented the proper garbing procedure, "...don... uniform components in the following order: Shoe covers, hair covers and face mask. Hands and and arms up to elbows...washed with soap for at least 30 seconds. Next, knee-length coats...will be put on. 3. An alcohol based surgical hand scrub...will be applied to hands and allowed to dry prior to donning powder free sterile gloves," as opposed to the sign observed in the ante room on 6/8/15. The policy however, did not include the necessary direction to clean under the fingernails.

3. During an observation on 6/8/15 at 3:15 p.m., Pharmacy Technician H prepared two normal saline 100 milliliter (ml), bags for intravenous (IV), administration by adding 10 milliequivalents (meq) of Potassium Chloride (KCl) to each IV bag, under the laminar air flow hood.

A laminar air flow hood is a workbench that is enclosed on all sides except the front. Air is drawn in the top of the workbench through a HEPA air filter (High Efficiency Particulate Assistance-the HEPA filter removes at least 99.7% of particles that have the size of 0.3 microns from the air). The air is then directed down the back and across the surface of the workbench toward the technician, pushing any remaining particulate matter out of the Direct Compounding Area (DCA). The laminar air flow hood provided an ISO Class 5 DCA within the hood.

International Organization for Standardization (ISO) classified air environments (specified by the numbers of particles in the air per cubic meter at a specified particle size), used for sterile compounding, decrease the risk of microbial contamination. An ISO Class 5 air environment has 3,520 particles, sized 0.3 microns or less per cubic meter of air. Outside, on the street, is an ISO Class 9 environment with 35 million particles sized 3 microns, in a cubic meter of air.

Pharmacy Technician H laid two bags of normal saline on the work surface, then opened the multidose vial of KCl. After drawing the first 10 meq of KCl up into a syringe, Pharmacy Technician H placed the bottle of KCl directly between first air (the air directly from the HEPA filter) and the injection port of one IV bag, which blocked the flow of clean air to the injection port, a critical site (A critical site is defined in USP<797> as a location that includes any components or fluid pathway surfaces exposed and at risk for direct contact with air).

Pharmacy Technician H acknowledged the obstruction of air flow, as the issue was discussed on 6/8/15, and discarded the prepared IV solutions.

Review, on 6/11/15 at 8:16 a.m., of the hospital policy and procedure titled, STANDARD OPERATING PROCEDURES FOR STERILE COMPOUNDING-PHARMACY (4), 2893, published 5/8/15, Section IV PROCEDURE D 15. indicated, "...supply items...are so arranged that a clear uninterrupted path of HEPA-filtered air will bathe the critical sites at all times during the planned procedures. That is, no objects may be placed behind an exposed critical site in a horizontal position or above in the vertical laminar flow workbench."

4. During an interview, on 6/8/15 at 3:15 p.m., Pharmacy Operations Manager JJ stated pharmacy services treated the compounding area in the pharmacy as a, "segregated compounding area" (SCA), as medications compounded there were considered, "low risk," and had Beyond Use Dates of 12 hours only. Pharmacy Manager JJ stated the SCA was also, "used occasionally," to compound TPN, a medium risk compound (TPN-Total Parenteral Nutrition, supplies amino acids, dextrose, essential fatty acids, electrolytes, vitamins in an IV form for those patients that cannot eat).

USP<797> defines compounding risk levels according to the potential for the introduction of contamination during the compounding process. Low Risk compounds are compounded in an ISO Class 5 air quality device, using sterile products, components and devices. Compounded products do not involve more than three commercially manufactured packages of sterile products and not more than two entries into any one sterile container.

Medium Risk Compounds are compounded in the same environment as low risk product and of sterile components, however Medium Risk products are compounded for multiple individual doses or multiple small doses that are pooled together to prepare one sterile compounded product and involve four or more sterile ingredients.

During an interview, on 6/8/15 at 4:16 p.m., the Director of Pharmacy described the use of a 10 gram vial of an antibiotic to make four separate doses for IV use and confirmed that the SCA was used for medium risk compounding.

5. and 6. During an observation on 6/10/15 at 3:30 p.m., at Outpatient Services PP Pharmacy, the medication sterile compounding area consisted of three attached rooms, closed off from the main pharmacy area. The compounding area was entered into an ante-room. To the right was a wide open doorway that led into a buffer area for a horizontal laminar air flow hood, used to make non-hazardous sterile compounded products. A stainless steel cart on wheels sat in the doorway, across the line of demarcation between the buffer area and ante-room, about six inches in the buffer area.

During an interview, on 6/10/15 at 1:32 p.m., Registered Pharmacist KK stated that the air displacement from the buffer area to the ante-room was measured every six months by a contracted certification service.

USP<797> states,"For buffer areas not physically separated from the ante-areas the principle of displacement airflow shall be be employed...Using displacement air flow typically requires an air velocity of 40 feet per minute or more from the buffer area across the line of demarcation into the ante-area...A velocity meter shall be installed to measure the...air flow between the buffer area and ante-area...the results shall be reviewed and documented at least every work shift (minimum frequency shall be at least daily)...differential airflow shall maintain a minimum velocity of ...40 feet per minute between the buffer area and the ante-area."

During an interview, at 2:01 p.m., the Director of Pharmacy stated the cart should be on one side or the other of the demarcation line. Registered Pharmacist KK stated she would move the cart to the left, into the anteroom.

Review of the hospital policy and procedure titled, STANDARD OPERATING PROCEDURES FOR STERILE COMPOUNDING-PHARMACY (4), 2893, published 5/8/15, indicated under IV D5: "Carts used to convey supplies in the clean area cannot be rolled beyond the demarcation line. If these carts are removed from the buffer area they cannot be re-entered unless cleaned and sanitized before returning."

7. During an observation on 6/11/15 at 12:15 p.m., in the pharmacy at Hospital OO, a Compounding Aseptic Isolator (CAI), sat against the far wall of the main pharmacy area. A red line of tape on the floor at the front and sides of the CAI designated an approximately three foot by six foot area as the buffer area.

Registered Pharmacist LL stated traffic was restricted in the area of the CAI when it was in use.

The CAI was a positive pressure glove box, divided into sections; an antechamber with a pass through to the main work chamber. Supplies were placed in the antechamber and the exterior door closed. With hands placed in, "robot gloves," the technician could then retrieve the supplies from the antechamber, bring them into the main work chamber via the pass through between the sections. A HEPA filter provided vertical laminar airflow.

Review, of the manufacturer's manual for the specific brand of CAI, indicated it was preferable that the CAI be located in an ISO Class 7 buffer air quality area. The manual did not document that the CAI could be placed in an ISO Class 8 or worse environment.

USP<797> directs that CAIs shall be located within a restricted access ISO Class 7 buffer area unless specific standards are met. USP<797> specifies that the compounding personnel should obtain documentation from the manufacturer that the CAI will meet these specific standards when placed in environments where the background particle counts exceed ISO Class 8 for 0.5 micron and larger particles.

Based on dietetic services observations, dietary staff interview, and dietary departmental document review, the hospital failed to ensure the supervisor, in charge of the day-to-day operations of the department met education, experience, and/or specialized training requirements.

Findings:

During initial tour of dietetic services on 6/8/15 beginning at 2:50 p.m., it was noted that the provision of dietary management staff was a contracted service. Dietary Management Staff QQ identified himself as the dietary departments' operations manager, with overall responsibility of day-to-day operations which included supervision of dietary staff. During initial tour, the surveyor had multiple questions in relationship to food storage practices. Dietary Management Staff QQ was unable to demonstrate a working knowledge of operational procedures. In an interview on 6/10/15 at 9 a.m., with Dietary Management Staff RR he stated that he was designated as the Executive Chef for both the Hospital MM and Hospital OO campuses. He also stated that he had supervisory oversight of food production staff. In an interview on 6/10/15 at 10:50 a.m., with Dietary Staff SS, a food production employee, she was asked whom she viewed as the supervisor for the day-to- day operations. She stated, "I don't know. It's confusing," she stated there were multiple supervisors in the kitchen and went on to describe that the Executive Chef (Dietary Management Staff RR) was the person who was most readily accessible, as he spent the majority of his shift working alongside staff, and he was the person to whom she went to for guidance.

In an interview on 6/10/15 at 9 a.m., with the Director of Food Services, she stated that the departments' operations manager office was not located within the department, rather was located at the Hospital OO campus, two miles from the facility. Similarly the Director of Food Services' office, a Registered Dietitian, was located in another building on the campus of the hospital.

Review of the hospitals' position descriptions for the Director of Food Services, titled "GM 4 [General Manager], Food," dated 8/2003, noted that this position, "Provides local leadership and strategic direction to build client relationships and new business opportunities to enhance profitability for the Company." While the position noted there was supervision of day-to-day work activities, it was accomplished through delegation rather that direct supervision. Review of the hospitals' position description titled, "Ops Mgr 3, Food [Operations Manager]," dated 9/2005, also designated this position as being responsible for, "Supervision of food services at an account/unit," with duties including supervision of day-to-day work activities. This position also described the supervision of day-to-day work activities by delegating authority. Similarly the position titled, "Executive Chef 2," dated 9/2005, documented the position summary as the person who, "Supervises all aspects of food production including menu planning and food preparation at an account to ensure client satisfaction ... " The duties also included, "directing daily operations of food production including menu planning ...food preparation ..."

Review of the employee files for Dietary Management Staff QQ and RR respectively, revealed that neither of these employees fully met the educational qualifications to manage the day-to-day operations of dietetic services. While the facility had a Registered Dietitian designated as the Director of Food Services, the position functions were split between managing the Clinical Nutrition Care as well as the operations of food services.

Based on food distribution observations, dietary staff interview, and dietary document review, the hospital failed to ensure: 1) the development of a vegetarian menu to be utilized at the Hospital OO campus for pre/postnatal women; 2) ensure comprehensive nutrition assessment of one patient (Patient 126) in a sample of 5 reviewed for nutrition care, who failed to trigger for nutritional risk despite poor dietary intake throughout the course of hospitalization; and 3) timely follow up for implementation of vitamin/mineral supplementation for one patient (Patient 127), with Registered Dietitian recommendations.

Findings:

Hospital OO
1. During tray line observation on 6/9/15, beginning at 12 p.m., it was noted there were two random patients with physician-ordered vegetarian diets. Both of the patients were post-partum (following childbirth) women. Post-partum women have increased nutritional needs, in particular increased calorie requirements for breastfeeding, as well as replenishment of vitamins and minerals depleted during pregnancy (Association of Reproductive Health Professionals, 2013). The trays of each of the patients consisted of pasta with tomato sauce, broccoli, bread, two crackers and a green salad. There were no protein based products. In a concurrent interview with Dietary Staff UU, the surveyor asked her to describe the menu for vegetarian diets. She stated that she would modify the main entrée to include a non-meat product, in this case the tomato sauce. In a follow up interview on 6/9/15 at 3:30 p.m., the Director of Food Services (DFS) stated that the Hospital MM campus had a vegetarian menu; however the Hospital OO campus did not. The DFS also acknowledged that, without a menu, the hospital would not be ensured that the specialized nutritional needs of post-partum women would be met.

Hospital MM
2. Patient 126 was admitted on 6/4/15, with diagnoses including osteoporosis (a bone thinning disorder), iron deficiency anemia and chronic kidney disease. Admission diet order, dated 6/4/15 ,was a Regular diet. Medical record review was conducted on 6/10/15, beginning at 2:30 p.m.

A history and physical, dated 6/4/15, completed by the physician, noted that Patient 126 presented to the emergency room with dementia, increased falls and decreased appetite. The physician also noted a 9-pound weight loss over the previous two weeks. Patient 126 presented with family members as the responsible party. Admission height was 5 feet 2 inches and weight was 105 pounds. Review of nutrition screening assessment, dated 6/4/15, failed to document the Patient 126's weight loss. Review of dietary intake during admission revealed that on 6/5/15, Patient 126 consumed 75% of her meals; however beginning on 6/7/15, nursing staff failed to record two meal intakes. The remaining average meal intake for nine meals, beginning on 6/7/15, was noted to be 40%.

In an interview on 6/10/15 beginning at 3:30 p.m., with Registered Nurse TT, she was asked to describe the nursing practice for referring patients to the Registered Dietitian if their nutritional intake changed during the course of hospitalization. She stated she was unsure if there were any guidelines to address change in nutritional status.

Review of hospital documents titled, "Standards of Practice-Med Surg [Medical Surgical] - Nursing," dated 6/1997, and "Practice Standards-Critical Care RN [Registered Nurse] Nursing," dated 9/1/99, revealed that while both of these documents described an assessment of nutritional status at the time of admission to the units (within eight hours and two hours respectively), there were no guidelines for referral to the Registered Dietitian during the course of hospitalization, in particular if there was a change in dietary intake.

3. Patient 127 was admitted on 6/4/15, with diagnoses including a severe hiatal hernia (a protrusion of the stomach to the esophageal opening-preventing food/fluids from entering the stomach readily), high blood pressure, thyroid disorder, malnutrition and dehydration. Medical record review was conducted on 6/10/15 beginning at 3 p.m. Admission diet order, dated 6/4/15, was for a full liquid diet. A comprehensive nursing admission assessment, dated 6/4/15, noted that Patient 127 had difficulty chewing and swallowing. A comprehensive nutrition assessment, completed by the Registered Dietitian (RD), dated 6/5/15, noted that Patient 127 was having difficulty swallowing and could only consume approximately 50% of one beverage. There was also a recommendation for a vitamin/mineral supplement. In a concurrent interview with Registered Dietitian (RD) VV, he was asked to describe the process for nutrition recommendations. He stated that the individual RD would contact the physician and request a telephone order for any recommendations. Review of physicians' orders, beginning 6/5/15, failed to note the implementation of the vitamin/mineral supplement. In an interview on 6/10/15, beginning at 3:45 p.m., with the Clinical Nutrition Manager (CNM), she stated that in addition to contacting the physician, the RD's documented the recommendations on an interdepartmental tracking sheet (recommendation log). In a follow up interview on 6/11/15 at 9:30 a.m., with the CNM, she stated she checked the recommendation log, and the vitamin/mineral supplement was not documented on the sheet, resulting in lack of follow up with the physician.

Hospital policy title, "Clinical SVS-RD Nutrition Care Recommendations to Physicians-FNS (4,)" noted it was the responsibility of the dietitian to log recommendations to physicians on a daily basis if unable to reach the physician. It was also the responsibility to check the RD recommendation log and follow up with physicians, as appropriate.

Based on food storage observations, dietary staff interview, and dietary document review, the hospital failed to ensure the development and training of a comprehensive plan, as evidenced by the inability of eight hospital staff members to locate and access emergency food supplies at the Hospital OO campus. Failure to ensure a compressive, well developed plan may affect the implementation of the feeding plan during a widespread disaster.

Findings:

On 6/9/15, beginning at 9:30 a.m., the feeding plan for disaster preparedness was reviewed with the Director of Food Services (DFS) and Dietary Management Staff (DMS) RR, both positions with supervisory responsibility for dietetic services. The surveyor asked DMS RR to briefly describe the feeding plan components. He stated he was aware of the location of the patient food supply; however was not familiar with the menu or the details of the plan, such as the number of patients and/or employees that the plan was projected for. In a concurrent interview with the DFS, she acknowledged that DMS RR was not trained/oriented to the disaster feeding plan. She also stated that the food supply adjacent to the kitchen was for staff, and that employees would be fed, "ready to eat meals," which were in another location. It was noted that none of the dietary staff present had access to the supply area where the meals were stored. It was also noted that the hospitals' security guard did not have access to the supply area either. In a concurrent interview with Security Guard WW, he stated that there were two guards on duty at all times. One of the guards manned the visitor checkpoint in the lobby of the hospital, and it was the second guards' responsibility to patrol throughout the hospital. The second guard was also the person that had the master set of keys. He was unaware he did not have access to all areas of the hospital. Entry to the supply area occurred at 10:10 a.m. It was noted that neither the DFS, DMS, RR, nor the Clinical Nutrition Manager (CNM) were able to locate the food supply. In an interview on 6/10/15 at 10:15 a.m., the DFS stated that the meals must be stored in a central supply area. Upon entry to the area none of the staff were able to locate the items. It was noted that it required multiple phone calls, and greater than 45 minutes for numerous staff member, to locate the employee disaster meals.

Hospital policy titled, "Disaster Plan-FNS [Food and Nutrition Services] Overview," dated 12/14, noted that while the policy described the location of the Fremont campus food supplies, the document was not consistent with the location of the observed food supplies, nor did it address the location of employee provisions.



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Based on observation, interview, and record review, the facility failed to maintain the pediatric emergency crash cart in the mobile computerized tomography department (CT) (computer-processed combinations of many X-ray images) to ensure pediatric emergent equipment was accessible in the event of a pediatric emergency situation. This failure had the potential to prohibit staff from providing essential patient care.

Findings:

During an observation and concurrent interview during a tour of the mobile CT on 6/8/15 at 4 p.m., Licensed Staff Q was asked where the Broselow Tape (the Broselow Tape is a color-coded tape measure that is used for pediatric emergencies. The Broselow Tape relates a child's weight class and height as measured by the tape to provide medical instructions including medication dosages, the size of the medical equipment that should be used, and the level
of shock voltage when using a defibrillator) was located within the Pediatric Crash Cart in the event of a pediatric emergency. Licensed Staff Q and Administrative Staff R searched for the Broselow Tape, on the adult and pediatric emergency carts, then stated they could not locate the Broselow Tape.

During a review of the Crash Cart Check Record for the CT Trailer, dated June 2015, indicated the Crash Cart Check Record was initialed as checked by Licensed Staff Q as completed on 6/1, 6/2, 6/3, 6/4, 6/5 and 6/8/15. The Crash Cart Check Record's instructions to the staff indicated, "Crash Carts are to be checked DAILY. If the cart is not checked because unit is closed, write, 'closed' next to date. Each signature indicates that the following items have been checked...PEDIATRIC CRASH CART CHECKED (LOCKED) (if applicable) Broselow tape is on top of Cart."

The facility policy and procedure titled, "Crash Cart Care, Locking, Emergency Medication, Supplies and Exchange - Hospitalwide (5)," dated 5/11/15, indicated "...V. 1. Crash Cart Record...to be completed...each time the cart is checked."

Based on observation, interview and document review, the facility failed to develop a system for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel when:

1. Secondary containers of disinfectant were not labeled in accordance with EPA (Environmental Protection Agency) recommendations nor nationally recognized guidelines.
2. A physician administered a Parenteral medication, after contaminating hands, without performing proper hand hygiene.
3. Contract employees did not have evidence of immunizations or immunity in their health files.
4. Licensed Staff (Licensed Staff I) did not use aseptic technique when performing a wound dressing change.
5. Licensed Contracted Staff (Licensed Contracted Staff K) did not use aseptic technique while accessing a patient's (Patient 26) hemodialysis fistula site.
6. Lack of comprehensive cleaning/sanitation of the automatic beverage dispensing system.
7. Hospital MM lack of an effective air gap in the food production sink and steamer, as well as the ice machine in the café at Hospital OO.
8. During food production observations, dietary staff touched multiple unclean surfaces with gloved hands and handled ready-to-eat food without changing gloves.
9. Nursing staff did not have an effective procedure in the neonatal intensive care unit (NICU) that mitigated the potential for cross-contamination of infant breast milk/formula. In addition staff was utilizing a chemical sanitizer that was not intended for food contact surfaces.
Failure to ensure effective infection control practices may put patients at risk of acquiring an illness, resulting in compromised medical status and, in severe instances, may result in death.

Findings:

1. On 6/8/15 at 1:45 p.m., during an interview with Administrative Staff CC, she stated that the facility followed CDC (Centers for Disease Prevention and Control), WHO (World Health Organization), AORN (Association of periOperative Nurses) and AAMI (Association for the Advancement of Medical Instrumentation) as their nationally recognized guidelines.

On 6/8/15 at 2 p.m., during a tour of the facility, an environmental services cleaning cart was observed to have a container that Ancillary Staff EE identified as containing Ecolab® QC (Trademark) A456 (Trademark) II Disinfectant and microfiber mops. There was no label visible on the container. This observation was verified by Management Staff FF, Ancillary Staff EE and Administrative Staff CC.

The CDC states that chemical germicides formulated as sanitizers, disinfectants, or sterilants are regulated ...by the Antimicrobials Division, Office of Pesticides Program, EPA under the authority of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) of 1947, as amended. FIFRA also requires users of products to follow explicitly the labeling directions on each product. The following standard statement appears on all labels under the, "Directions for Use," heading: "It is a violation of federal law to use this product in a manner inconsistent with its labeling." This statement means a health-care worker must follow the safety precautions and use directions on the labeling of each registered product. Failure to follow the specified use-dilution, contact time, method of application, or any other condition of use is considered a misuse of the product and potentially subject to enforcement action under FIFRA.

2. On 6/8/15 at 1:45 p.m., during an interview with Administrative Staff CC, she stated that the facility followed CDC (Centers for Disease Prevention and Control), WHO (World Health Organization), AORN (Association of periOperative Nurses) and AAMI (Association for the Advancement of Medical Instrumentation) as their nationally recognized guidelines.

On 6/9/15 at 10:25 a.m., in Operating Room 3, Physician DD, reached under the head of the operating room table and moved some electrodes on the floor with his bare hands having contact with the floor. He then reached for a syringe of medication, without performing hand hygiene, and administered the medication into the patient's intravenous line.

The hospital policy entitled, "Hand Hygiene and Surgical Hand Antisepsis-Infection Control (3)," dated 5/8/15, section IV, 3, b. noted the indications for hand hygiene included to decontaminate hands before and after having direct contact with patients.

The CDC states that indications for hand washing and hand antisepsis included when hands were visibly dirty or contaminated with proteinaceous (containing protein) material or were visibly soiled with blood or other body fluids, wash hands with either a non-Antimicrobials soap and water or an Antimicrobials soap and water, and if hands were not visibly soiled, use an alcohol-based hand rub for routinely decontaminating hands ... decontaminate hands before having direct contact with patients.

3. On 6/8/15 at 1:45 p.m., during an interview with Administrative Staff CC, she stated that the facility followed CDC (Centers for Disease Prevention and Control), WHO (World Health Organization), AORN (Association of periOperative Nurses) and AAMI (Association for the Advancement of Medical Instrumentation) as their nationally recognized guidelines.

On 6/11/15 at 1:30 p.m., during interview and record review of employee health files, two out of 22, Administrative Staff GG and Ancillary Staff HH, did not have evidence of immunity or immunization for measles, mumps and rubella in their employee health file. These employees were contract employees. These findings were verified by Management Staff II.

According to the hospital policy, "Immunization Program: Measles (Rubeola)-Mumps-Rubella-Employee Health," dated 9/30/14, employment is contingent upon proof of immunity and/or consent to vaccination, unless contraindicated.

Employee health policies and procedures did not follow the facility-adopted, nationally recognized CDC guidelines for immunizations of health care workers that state:
· "Healthcare workers include physicians, nurses, emergency medical personnel, dental professionals and students, medical and nursing students, laboratory technicians, pharmacists, hospital volunteers, and administrative staff ."
· "( ...recommends that health care providers receive vaccinations for diseases for which routine vaccination or documentation of immunity is recommended because of risks in the workplace (i.e. hepatitis B, seasonal influenza, measles, mumps, rubella, pertussis, and varicella)."



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4. During an observation and concurrent interview on 6/9/15 at 9 a.m., Licensed Staff I changed the dressings of Patient 27's bilateral leg wounds. Licensed Staff I removed the old dressings, cleansed the sites, then without changing her gloves or performing hand hygiene, she proceeded to apply the new, clean dressings. When asked about her failure to change gloves or perform hand hygiene between removing the old dressings and applying the clean ones, Licensed Staff I acknowledged this failure and stated she should have done so.

During an interview on 6/11/15 at 8:40 a.m., Infection Control Nurse J stated it was her expectation that staff would change gloves, and perform hand hygiene, after removing an old dressing and before application of a new, clean dressing.

Review of the policy titled, "Dressing Change: Clean Technique and Sterile Technique--Nursing," reviewed 4/25/12, did not indicate under, "Clean Technique," to change gloves and perform hand hygiene following removal of the soiled dressing and prior to the placement of a new, clean dressing.

5. During an observation and concurrent interview on 6/9/15 at 11:09 a.m., Licensed Contracted Staff K prepared Patient 26's upper right arm fistula (vascular access) sites for access prior to the start of her hemodialysis treatment [Patient 26 was in isolation on contact precautions for a urinary infection]. For each of the two sites, she gently used a Chlora-Prep (disinfectant) swabstick in a circular motion for approximately 10 seconds. She then immediately wiped off the cleansed sites with gauze. Licensed Contracted Staff K then proceeded to touch the cleansed sites with the index finger of her right, gloved hand. She then administered lidocaine (a numbing medication) to the sites, wiped the sites with the same gauze used to dry the ChloraPrep, and changed her gloves. Without performing hand hygiene or re-disinfecting the sites, she donned new gloves and inserted the needles into Patient 26's arm. When asked about her preparation technique, Licensed Contracted Staff K stated she let the access sites dry for three minutes prior to cannulation (insertion of the needles), "scrubbed," the access sites in a circular motion, and denied wiping the actual insertion sites with gauze. Licensed Contracted Staff K offered no comment when asked about not re-disinfecting the sites after palpation (feeling via touch) and the administration of lidocaine prior to cannulation.

During the same observation and concurrent interview on 6/9/15 at 11:09 a.m., Licensed Contracted Staff K was asked about how she cleaned the outside of the dialysis machine following treatment. She stated she cleaned all the exterior surfaces of the machine with, "purple-top," Super Sani-cloth Wipes (non-bleach disinfectant wipes containing quaternary ammonia and isopropyl alcohol). The metal support rails of the cart were observed to be rusted (making disinfection questionable) and the cart wheels and brake foot levers were dirty. Licensed Contracted Staff K acknowledged the rusty areas and stated, even after cleaning, the wheels and brake levers looked dirty. When asked who was responsible for the maintenance of the dialysis machines, Licensed Contracted Staff K stated it was the responsibility of the contracted dialysis facility.

During an interview on 6/9/15 at 12 p.m., Licensed Contracted Staff K was asked if her supervisors at the contracted dialysis facility observed her for competency. She stated the Clinical Manager observed her care "a couple of times a quarter."

During an interview on 6/9/15 at 2:05 p.m., Licensed Contracted Staff L was asked about the use of ChloraPrep when disinfecting accessing sites. He stated the disinfectant required, "no certain motion," and needed to dry for three minutes. When asked about scrubbing or, "contact," time, Licensed Contracted Staff L provided no answer. When asked if hospital or contracted management staff had observed him during dialysis treatments, he stated no one from the hospital had observed his care, but contracted staff observed him quarterly.

During an interview and concurrent document review on 6/11/15 at 8:40 a.m., Infection Control Nurse J stated she observed 4-5 contracted dialysis nurses per month and corroborated the lack of specific staff names on the completed surveillance audit tools. She acknowledged this was important for tracking the infection control practices of specific staff. She also acknowledged the audit tool did not include infection control observations of staff performing access site preparation and cannulation, nor Central Venous Catheter (CVC) dressing changes.

The contracted facility's policy titled, "Infection Control in the Hospital Dialysis Setting," revised 9/2014, indicated: "...teammates will follow hospital policies for infection control, as mandated by the hospital/facility...Hand hygiene is to be performed per Hand Hygiene policy...The outside of all equipment will be wiped with a bleach solution prior to removal from treatment area."

The contracted facility's policy titled, "Hand Hygiene," revised 4/2013, indicated alcohol-based hand rubs, "may," be used before gloving and after glove removal.

The contracted facility's policy titled, "AV (arterio-venous) Fistula or Graft Cannulation With Safety Fistula Needles (SFN) and Administration of Heparin," revised 3/2014, indicated for the use of ChloraPrep swabsticks: "Completely wet skin site for 30 seconds to 'dry skin sites' such as arm. Allow to dry for 30 seconds for 'dry skin sites' such as arm. Do not re-palpate site once it has been prepared. Clean sites with ChloraPrep swabstick in a back and forth/up and down friction motion."

The hospital's policy titled, "Hand Hygiene and Surgical Hand Antisepsis--Infection Control," reviewed 5/8/15, indicated: "Decontaminate hands after removing gloves."

The hospital's audit tool titled, "Surveillance for Dialysis Staff and Equipment," indicated contracted staff were observed for hand hygiene and use of Personal Protective Equipment (PPE). It did not include items related to preparation/disinfection of the access sites, nor assessment of the dialysis machines and carts for the presence of visible dirt and rust. The completed audits performed by hospital staff did not include the names of observed staff.





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6. During general dietetic services observations on 6/8/15, beginning at 3:30 p.m., it was noted that the hospital had a beverage dispensing system that was designated by Dietary Management Staff QQ as a, "bag in a box," system. It was noted this system dispensed a variety of juice beverages. It was also noted that the syrup connectors were covered with a clear sticky substance, as well as unidentified particles, resembling dust. In a concurrent interview with Dietary Management Staff QQ, he was asked to describe the process for changing the connector hoses when the bag was empty. He stated that the old bag was removed and replaced with a new bag. The surveyor asked if there were any additional steps, he replied there were not. He also stated that he was unaware of any manufacturers' recommendations for cleaning and sanitizing the hoses and/or connectors.

The standard of practice for the cleaning of beverage dispensing systems, including dispensing lines or tubes, be maintained in accordance with manufacturers' guidance or absent manufacturers' guidance at a frequency to preclude the accumulation of soil or mold (Food Code, 2013). A document from the beverage dispenser, dated 6/10/15, timed at 11:42 a.m., noted that the vendor, "does not have a sanitation procedure for changing out the BIBS [connecting devices]. We only have a troubleshooting guide ...if the flow ...is constricted ..."

7. During general kitchen observations at the Hospital OO campus on 6/9/15, beginning at 4:35 p.m., it was noted that a dietary staff member was cleaning cauliflower in a food production sink adjacent to the walk-in refrigerator. It was noted that there was no air gap, rather the sink was plumbed directly into the wastewater system. Similarly it was also noted that there were ineffective air gaps in the steamer at the Hospital OO campus. Additionally, it was also noted there were ineffective air gaps in the ice machine at the Hospital MM campus, as well as the café ice machine at the Hospital OO campus. The purpose of an air gap is to prevent cross-contamination from potential backflow associated with the waste water system. The standard of practice would be to ensure the installation of an effective air gap in all food and non-food equipment in dietetic services (Food Code 2013).

8. During general food production observations on 6/10/15, beginning at 11:30 a.m., Dietary Staff XX was utilizing poor infection control techniques during food production activities. She was observed opening a refrigerator door with gloved hands and unwrapping and touching individual slices of cheese with the same gloves that were used to open the refrigerator door. There was no observed hand hygiene or change of gloves. Dietary Staff XX was also observed opening the walk-in refrigerator with the same pair of contaminated gloves, removing several hard boiled eggs from a bag, touching them with the same gloves. A follow-up observation on 6/10/15 at 12:05 p.m., noted there was a similar lack of hand hygiene when she opened the refrigerator again with gloved hands and removed additional cheese slices with the same gloves.

Hospital policy titled, "Hand Hygiene and Surgical Hand Antisepsis-Infection Control," revised 5/18/15, guided staff to clean hands before, "...and after any hand-contaminating activities."

In an interview on 6/11/15, beginning at 11 a.m., with the Administrative Staff CC, she described that she conducted regular environment of care rounds in dietetic services. She also stated that she had provided hand hygiene training to all dietary staff.

9. On 6/9/15, beginning at 1:30 p.m., at the Hospital OO campus, the hospital's handling of breast milk and infant formula were reviewed in the neonatal intensive care unit (NICU). In a concurrent interview with Registered Nurse (RN) QQQ, she was asked to describe the process of adding nutritional fortifiers to infant formula and/or breast milk. RN QQQ described the process as follows: The process would take place in the area surrounding the hand washing sink within the NICU; 1) The surface would be cleaned using a germicidal disposable wipe; 2. The RN would wash his/her hands; and 3) remove the breast milk and/or formula from storage, add the fortifier packet and would then warm the feeding using water. Concurrent review of the germicidal wipe noted that the product was not intended for food contact surfaces. In a concurrent interview with the Clinical Nutrition Manager, the surveyor asked if she had reviewed the process for safe food handling practices or had compared the process to any standards of practice. She replied that she had not.

Hospital policy titled, "Perinatal-Recommendations for Collection, Storage and Handling of Mothers Own Expressed Milk," dated 2/11/14, noted that the policy included nationally recognized standards for handling breast milk; however it did not address the addition of fortifiers to infant feedings.




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Based on staff interviews and document review, the facility failed to ensure the Medical Director of Anesthesia Services and the Nursing Clinical Coordinator for Outpatient Surgical Services, provided oversight of Registered Nurses administering conscious sedation to patients. This had the potential that nurses were not competently trained in the administration of conscious sedation, which could result in patients having an adverse reaction thereby jeopardizing their health and safety.

Findings:

During an interview on 6/10/15 at 9:25 a.m., Management Staff M stated she was responsible for conducting annual evaluations and competencies for nursing staff. When asked if she observed nursing staff performing conscious sedation, she stated, "No." When asked if there was physician oversight of the conscious sedation program, Management Staff M stated, "I'm not sure."

During an interview on 6/10/15 at 9:35 a.m., Licensed Staff N was asked to describe the annual process for determining competency in the administration of conscious sedation. She stated it involved completing a computer module and test. When asked if Management Staff M observed her performing conscious sedation on an annual basis, she stated, "No." When asked if the Director of Anesthesia Services or another delegated anesthesiologist observed her performing conscious sedation on an annual basis, Licensed Staff N stated the only physician who observed her performing conscious sedation, was the physician performing the patient procedure, who gave the orders for the type of medications to be administered.

During an interview on 6/10/15 at 9:40 a.m., Licensed Staff O was asked to describe the annual process for determining competency in the administration of conscious sedation. She stated it involved completing a computer module and test. When asked if Management Staff M observed her performing conscious sedation on an annual basis, she stated, "No." When asked if the Director of Anesthesia Services or another delegated anesthesiologist observed her performing conscious sedation on an annual basis, Licensed Staff O stated the only physician who observed her performing conscious sedation, was the physician performing the patient procedure.

During an interview on 6/11/15 at 2:10 p.m., Physician P was asked to describe the degree of his involvement in the oversight of nurses performing conscious sedation. He stated, "Not much," adding his oversight was of the medical staff and, "nursing," oversaw the nurses. Physician P also stated he reviewed and approved the conscious sedation module used by nursing staff and approved the anesthesia/sedation policies and procedures. When asked if he conducted an audit of staff performing conscious sedation, he stated he developed an audit tool, "for sedation quality in general," which he used when observing medical staff. Physician P stated he used another audit tool, which included nursing staff; however, this tool was not submitted to the surveyor prior to the end of the survey. Physician P was asked if he conducted any conscious sedation in-services to nursing staff, he stated, "No."

Review of several facility-submitted, "Competency Statements," for nursing staff, found no competency criteria for the administration of conscious sedation.

Review of the policy and procedure titled, "Procedural Anesthesia / Analgesia--Adult Hospitalwide," created 1/2012, found no indication that nursing staff performing conscious sedation would be observed for competencies by nursing management staff or the Director of Anesthesia Services or his/her designee on an annual basis. Section IV, titled, "Procedure--Requirements for Adult Moderate Sedation," sub-section "A" indicated while performing sedation, nurses would be "under the supervision of a physician...physically present during sedation." Sub-section "C" indicated the physician performing the patient procedure would be the person, "supervising the sedation." The two items listed under, "Annual Competency," indicated nursing staff would complete the Moderate Sedation learning module and pass the post-test.