IDRs and POCs

IDRs and POCs Professional development and writing of your CMS 2567 IDR and POC

07/05/2018

Was hoping to win 3 for a facility but all 3 were a stretch and won 1! That is 4 in the last week!

06/30/2018

Long time for results but 3 more IDRs won! Brings average deficiencies for 7 facilities to 3.85!

08/03/2017

3 more IDRs won today!

07/12/2017

Another successful IDR with the results of a zero deficiency survey!

05/13/2017

Sample IDR Written and Won

Post-Acute Rehabilitation
1115 B Street
###X, CA 94952
(707) 765-###X

To: ###
Licensing and Certification
California Department of Public Health
2170 Northpoint Parkway
Santa Rosa, CA 95407

From: ###, Administrator
Post-Acute Rehab

Date: April 14, 2017

Dear ###;

Thank you for the opportunity to utilize the Informal Dispute Resolution process. ###X Post-Acute Rehabilitation disputes the deficient practices and asserts that the facility does follow and is in compliance with these statutes.

The facility is respectfully disputing the written statement of deficiencies for:

F155
483.10(c)(6)(8)(g)(12) 483.24(a)(3) RIGHT TO REFUSE; FORMULATE ADVANCE DIRECTIVES

The department stated:
This REQUIREMENT is not met as evidenced by: Based on interview and record review, the facility failed to ensure care consistent with the rights of four of 15 sampled residents (Residents 1, 2, 10 and 13), when it did not follow its policy to:

1) Inform Resident’s 1 and 2 about their right to formulate advance directives; and
2) Include a copy of Resident 10’s and 13’s executed advance directive on each resident’s POLST (Physician Orders for Life-Sustaining Treatment, a physician-order form)

Allegation
Social Services Director concurred Resident 2 did not have an Advance Directive.

Facility Response:

The term capacity is frequently mistaken for competency. Capacity is determined by a physician, often (although not exclusively) by a psychiatrist, and not the judiciary. Capacity refers to an assessment of the individual's psychological abilities to form rational decisions, specifically the individual's ability to understand, appreciate, and manipulate information and form rational decisions. The patient evaluated by a physician to lack capacity to make reasoned medical decisions is referred to as de facto incompetent, i.e., incompetent in fact, but not determined to be so by legal procedures. Such individuals require another individual, a de facto surrogate, to make decisions on their behalf.

Per the California Advanced Health Care Directive, Part 1 lets you name another individual as agent to make health care decisions for you if you become incapable of making your own decisions or if you want someone else to make those decisions for you now even though you are still capable. In addition, the document requires a statement of witnesses where the witness acknowledges that the individual executing the directive appears to be of sound mind and under no duress, fraud, or undue influence. As such, in order to execute the California Advanced Health Care Directive, the individual must have capacity to make reasoned medical decisions. A person without capacity can’t contract. See Exhibit “A”

Per the Department of Health and Human Services Centers for Medicare & Medicaid Services Directions to Form CMS-672:
F143: Who have advanced directives: Who have advance directives, such as Physician’s Orders for Life-Sustaining Treatment (POLST), a living will or durable power of attorney for health care, recognized under state law and relating to the provisions of care when the individual is incapacitated. See Exhibit “B”

Resident 2 was admitted to the facility on 12/21/2013 and at that time had capacity. She had her granddaughter sign her admission agreement where she was offered assistance to execute an advance directive should she choose the option to formulate an advanced directive. When an advance directive exists, the facility requests a copy. See Exhibit “C” (page 3 In November of 2014, the resident’s physician determined the resident no longer had capacity. As such the resident would not have been able to execute the California Advance Health Care Directive. There is no requirement that each resident must execute the California Advanced Health Care Directive or that the resident is mandated to provide the facility a copy even upon request. The facility does have a POLST on file in the medical record and per the CMS-form 672, a POLST qualifies as an advance directive and as such, the facility met the requirements of the regulation. See Exhibit “D”

Allegation:

During a review of the Physician’s Orders for Life-Sustaining Treatment (POLST) dated 9/10/16 and signed by family member D (the responsible party), indicated Resident 1 did not have an advanced directive.

Facility Response:

Resident 1 was deemed to not have the capacity to understand and make medical decisions on 9/7/2016. She was admitted on 9/5/2016. Her responsible party signed the admission agreement where she was given the information regarding refusing treatment and advance directives (page 3). When an advance directive exists, the facility requests a copy. See Exhibit “E” (page 3) As this resident does not have capacity this resident would not have been able to execute the California Advance Health Care Directive. There is no requirement that each resident must execute the California Advanced Health Care Directive or that the resident is mandated to provide the facility a copy even upon request. The facility does have a POLST on file in the medical record and per the CMS-form 672, a POLST qualifies as an advance directive and as such, the facility met the requirements of the regulation. See Exhibit “F”

Allegation:

During a review of the Physician’s Orders for Life-Sustaining Treatment dated 9/24/2014 and signed by Family Member D (the responsible party), indicated Resident 13’s advance directive was not available.

Facility Response:

Resident 13 was deemed to not have the capacity to understand and make medical decisions on 11/7/2015 and 12/3/2016. She was admitted on 9/24/2014. Her responsible party signed the admission agreement where he was given the information regarding refusing treatment and advance directives. When an advance directive exists, the facility requests a copy. See Exhibit “G” (page 3) There is no requirement that each resident must execute the California Advanced Health Care Directive or that the resident is mandated to provide the facility a copy even upon request. The facility does have a POLST on file in the medical record and per the CMS-form 672, a POLST qualifies as an advance directive and as such, the facility met the requirements of the regulation. See Exhibit “H”

Allegation:

During review of Resident’ 10’s medical record on 3/9/17 and 3/10/17, the medical record did not indicate how Resident 10 had assigned the resident’s decision making authority. A copy of Resident 10’s DPOA agreement was not in the resident’s paper or electronic medical record.

Facility Response:

Resident 10 who has capacity stated that his daughter served as the resident’s DPOA. He was not admitted in the Spring of 2016 but on 12/26/2016. His daughter signed the admission agreement. When each resident is admitted they or their responsible party sign the admission agreement. In the admission agreement advance directives are discussed. When an advance directive exists, the facility requests a copy. See Exhibit “I” (page 3) There is no requirement that the resident must provide a copy of the advance directive and this resident’s daughter could not remember providing the facility a copy. The facility does have a POLST on file in the medical record and per the CMS-form 672, a POLST qualifies as an advance directive and as such, the facility met the requirements of the regulation. See Exhibit “J”

Conclusion:

The facility has clearly demonstrated that each resident and/or responsible party who is admitted to the facility is informed about their right to formulate advance directives through the admission agreement signing process. In addition, the facility maintains that through the same admission agreement signing process, that the facility encourages the resident and/or responsible party to provide the facility with a copy of an Advance Directive if one exists, however they are not required to prepare one, or to provide one as a condition to be admitted to the facility. The facility has also demonstrated that each resident has a POLST, which per CMS 672 directions qualifies as an advance directive. As such, the facility respectfully requests that F155 be removed from the 2567.

05/13/2017

Sample IDR Won and Reduced Facility Tags to 4

Post-Acute Rehab

To: Insert name, District Manager
From: ###, Administrator
Date: March 19, 2017
RE: Informal Dispute Resolution

Thank you for the opportunity to utilize the Informal Dispute Resolution process. Danville Post-Acute Rehab disputes the deficient practices and asserts that the facility does follow and is in compliance with these statutes.

F431
483.45(b)(2)(3)(g)(h) DRUG RECORDS, LABEL/STORE DRUGS & BIOLOGICALS

The department stated:
“This REQUIREMENT is not met as evidenced by: Based on observation, interview, and record review, the facility failed to ensure the temperature of a storage room used to store biologicals (a therapeutic substance made for living organisms) was below 77 degrees Fahrenheit. This failure had the potential to result in loss of stability for the stored biologicals.

Allegation 1:

During an observation and concurrent interview on 3/2/2017 at 10:20 a.m. with the Director of Nursing and the Maintenance Manager, the Maintenance Manager checked the temperature of the utility room and the temperature of the room was 78.5 degrees.

###X believes that the facility does follow and is in compliance with this regulation as evidenced by:

Facility Response
The facility has submitted the U.S. Pharmacopeia 10.30.60. Controlled Room Temperature. “Controlled room temperature” indicates a temperature maintained thermostatically that encompasses the usual working environment of 20 degrees to 25 degrees (68 degrees to 77 degrees F); that results in a mean kinetic temperature calculated to be not more than 25 degrees; and that allows for excursions between 15 degrees and 30 degrees (59 degrees and 86 degrees F) that are experienced in pharmacies, hospitals and warehouses. Provided the mean kinetic temperature remains in the allowed range, transient spikes up to 40 degrees are permitted as long as they do not exceed 24 hours. Spikes above 40 degrees may be permitted if the manufacturer so instructs. Articles may be labeled for storage at “controlled temperature” or at “up to 25 degrees) or other wording based on the same mean kinetic temperature. The mean kinetic temperature is a calculated value that may be used as an isothermal storage temperature that simulated the nonisothermal effects of storage variations.

U.S. Pharmacopeia in section 10.30.70 Warm
Any temperature between 30 degrees and 40 degrees (86 degrees and 104 degrees F)
See Exhibit “A”

The facility has submitted Title 22 72357 Pharmaceutical Service – Labeling and Storage of Drugs
(f) Drugs shall be stored in appropriate temperature. Drugs required to be stored at room temperature shall be stored at a temperature between 15 degrees C (59 degrees F) and 30 degrees C (86 degrees F). See Exhibit “B”
The facility is also submitting documentation from Medline Industries. The documentation from Medline states that per USP/NF storage condition allows for an excursion up to 30 degrees C/86 degrees F. Therefore, Puracol, Puracol Plus and Puracol AG products stored within the defined limits per USP/NF do not affect the quality, safe and efficacy of the product as long as packaging is not damaged and all other labeling and instructions for use are followed. See Exhibit “C”
The facility has also contacted Medline and received the following email regarding storage of Puracol Collagen Dressing. See Exhibit “D”

The facility would also like to address the fact that the utility room had a fan to assist in maintaining the room temperature. The fan had been temporarily removed for cleaning and the Maintenance Supervisor was returning the clean fan to the room when the HFEN requested to take the temperature of the room. The HFEN would not allow the Maintenance Director to turn on the fan before taking the temperature of the room. See Exhibit “E”

Conclusion:
The facility maintains that the utility room was being maintained at temperatures at or below 77 degrees F and that the spike in temperature was due to the fan being temporarily removed for cleaning. Per the U.S. Pharmacopeia, the spike in temperature of 1.5 degrees F would be allowed as it was a temporary spike and was not greater than 24 hours. Also the facility has presented Title 22 for drug storage to be maintained between 59 degrees F and 86 degrees F, which is congruent with the U.S. Pharmacopeia.

In addition, ###X communicated to the facility that per USP/NF storage condition allows for an excursion up to 30 degrees C/86 degrees F. Therefore, Puracol, Puracol Plus and Puracol AG products stored within the defined limits per USP/NF do not affect the quality, safe and efficacy of the product as long as packaging is not damaged and all other labeling and instructions for use are followed.

As the temperature of the room was only 1.5 degrees above 77 degrees and this was attributable to the fan being cleaned and the facility has provided documentation from the manufacturer that there was no potential for the loss of the stability of the product, the facility respectfully requests that F431 be removed from the 2567.

F456
483.90(c)(2)(d) ESSENTIAL EQUIPMENT, SAFE OPERATING CONDITION

The department stated:
“This REQUIREMENT is not met as evidenced by: Based on observation, interview, and facility document review, the facility failed to ensure that all essential equipment was properly maintained when two drain pipes for a food preparation sink were missing air gaps. This failure had the potential to put residents at risk for food borne illness.

Allegation 1:

An observation and consecutive interview with the Maintenance Manager on 3/1/2017 at 9:40 a.m. showed a food preparation skink had two drain pipes and each drain pipe led directly into a plastic bell which eliminated the presence of air gaps. MM confirmed there was not an air gap for both drain pipes.

Facility Response
The facility is unclear as to why the air gap finding was written under F456 versus F371. F456 is maintaining all mechanical, electrical, and patient care equipment in safe operating condition. The air gaps are not mechanical, electrical or patient care equipment. The facility has presented F371 below where the facility would request this finding to be written.

F371
(Rev. 127, Issued: 11-26-14, Effective: 11-26-14, Implementation: 11-26-14)
§483.35(i) - Sanitary Conditions
The facility must –
§483.35(i)(1) - Procure food from sources approved or considered satisfactory by Federal, State or local authorities; and
§483.35(i)(2) - Store, prepare, distribute and serve food under sanitary conditions

INTENT: (Tag F371) 42 CFR 483.35(i) Sanitary Conditions
The intent of this requirement is to ensure that the facility:
• Obtains food for resident consumption from sources approved or considered satisfactory by Federal, State or local authorities; and
• Follows proper sanitation and food handling practices to prevent the outbreak of foodborne illness. Safe food handling for the prevention of foodborne illnesses begins when food is received from the vendor and continues throughout the facility’s food handling processes.

DEFINITIONS
Definitions are provided to clarify terms related to sanitary conditions and the prevention of foodborne illness.
• “Cross-contamination” refers to the transfer of harmful substances or disease-causing microorganisms to food by hands, food contact surfaces, sponges, cloth towels, or utensils which are not cleaned after touching raw food, and then touch ready-to-eat foods. Cross-contamination can also occur when raw food touches or drips onto cooked or ready-to-eat foods. 1
• “Danger Zone” refers to temperatures above 41 degrees Fahrenheit (F) and below 135 degrees F that allow the rapid growth of pathogenic microorganisms that can cause foodborne illness. Potentially Hazardous Foods (PHF) or Time/Temperature Control for Safety (TCS) Foods held in the danger zone for more than 4 hours (if being prepared from ingredients at ambient temperature) or 6 hours (if cooked and cooled) may cause a foodborne illness outbreak if consumed.
• “Dry Storage” refers to storing/maintaining dry foods (canned goods, flour, sugar, etc.) and supplies (disposable dishware, napkins, and kitchen cleaning supplies).
• “Food Contamination” refers to the unintended presence of potentially harmful substances, including, but not limited to microorganisms, chemicals or physical objects in food. 2
• “Food Preparation” refers to the series of operational processes involved in getting foods ready for serving, such as: washing, thawing, mixing ingredients, cutting, slicing, diluting concentrates, cooking, pureeing, blending, cooling, and reheating.
• “Food Service/Distribution” refers to the processes involved in getting food to the resident. This may include holding foods hot on the steam table or under refrigeration for
cold temperature control, dispensing food portions for individual residents, family style and dining room service, or delivering trays to residents’ rooms or units, etc.
• “Foodborne Illness” refers to illness caused by the ingestion of contaminated food or beverages.
• “Highly Susceptible Population” refers to persons who are more likely than the general population to experience foodborne illness because of their susceptibility to becoming ill if they ingest microorganisms or toxins. Increased susceptibility may be associated with immuno-compromised health status, chronic disease and advanced age. The Food and Drug Administration’s Food Code (Section 3-801.11) includes nursing facilities in its definition of a “highly susceptible population.”
• “Pathogen” refers to an organism capable of causing a disease (e.g., pathogenic bacteria or viruses).
• “Potentially Hazardous Food (PHF)” or “Time/Temperature Control for Safety (TCS) Food” refers to food that requires time/temperature control for safety to limit the growth of pathogens or toxin formation.
• “Ready-to-Eat Food” refers to food that is edible with little or no preparation to achieve food safety. It includes foods requiring minimal preparation for palatability or culinary purposes, such as mixing with other ingredients (e.g., meat type salads such as tuna, chicken, or egg salad).
• “Storage” refers to the retention of food (before and after preparation) and associated dry goods.
• “Toxins” refer to poisonous substances that are produced by living cells or organisms (e.g., pathogenic bacteria) that cause foodborne illness when ingested.

OVERVIEW
Nursing home residents risk serious complications from foodborne illness as a result of their compromised health status. Unsafe food handling practices represent a potential source of pathogen exposure for residents. Sanitary conditions must be present in health care food service settings to promote safe food handling. CMS recognizes the U.S. Food and Drug Administration’s (FDA) Food Code and the Centers for Disease Control and Prevention’s (CDC) food safety guidance as national standards to procure, store, prepare, distribute and serve food in long term care facilities in a safe and sanitary manner.
Effective food safety systems involve identifying hazards at specific points during food handling and preparation, and identifying how the hazards can be prevented, reduced or eliminated. It is important to focus attention on the risks that are associated with foodborne illness by identifying critical control points (CCPs) in the food preparation processes that, if not controlled, might result in food safety hazards. Some operational steps that are critical to control in facilities to prevent or eliminate food safety hazards are thawing, cooking, cooling, holding, reheating of foods, and employee hygienic practices.

Conclusion:
The facility is not disputing the lack of air gaps and the Maintenance Manager corrected the air gaps immediately. The facility respectfully requests the department to move the deficiency to F371.

05/13/2017

Going through the federal survey process is stressful enough, why write your own plan of correction or IDR when you can get professionals to do it for you? IDRsandPOCs.com is the solution to maintaining your 5 star status!

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