The importance of the Certificate of Analysis and updating the Master Formulation Record

By Lori A. DeVito, RPh., HDDP, PCAB Compounding Pharmacy Specialist

When compounding with APIs for non-sterile and sterile preparations in USP <795> and USP <797>, a quality assurance program must be in place per USP <1163> Quality Assurance in Pharmaceutical Compounding. USP <797> contains an entire section titled “Quality Assurance (QA) Program.” Quality Assurance is also mentioned throughout the Appendices. USP<1163> is specifically referenced in USP<795> under “Responsibilities of the Compounder“ and “Compounding Process.”

In this issue, we will continue our journey, maneuvering through USP chapters and delving into the importance of USP <731> Loss of Drying (enforceable) and USP <1160> Pharmaceutical Calculations in Pharmacy Practice, which are referenced within USP <1163> Quality Assurance in Pharmaceutical Compounding.

When an Active Pharmaceutical Ingredient (API) is received, the Certificate of Analysis (CofA) should be reviewed and the Master Formulation Record updated. Since the CofA for each API is specific to each lot number, the same API can yield different results even though it meets the USP requirements. One of the most significant reasons a compounded preparation can be out of specification (OOS) is that the Master Formulation Record (MFR) was not updated to reflect the most recent Certificate of Analysis (CofA) of the API’s specific manufacturer and lot number. Compounding software will make adjustments, but will only be accurate if the correct information is entered from the CofA upon receipt of the inventory!

Certificates of analysis provide an overview of test results obtained from the API. Review the water correction, assay correction and salt-to-base correction to see if any or all need to be adjusted for the final compounded preparation. With regards to Loss of Drying, the Assay section and the Water section of the  CofA are necessary for calculating and are referenced in USP <1160> Pharmaceutical Calculations in Pharmacy Practice, which also touches on how to calculate salt forms, esters and hydrates. Depending on the salt form, you may also need to make salt-to-base corrections.

The term Loss of Drying (LOD) indicates the amount of moisture that the API has absorbed in the manufacturing and storage process. If this is not adjusted, it can greatly change the final product when compounding. The higher the LOD, the more the API can absorb water. This could result in a reduction in potency, especially if the API was stored incorrectly or in an area with high humidity. For example: An LOD of 7% means that 100mg of an API (weighed) will contain 7mg of water. The water correction factor is: 100/(100-7.0) = 1.075. The water correction factor is more accurate than using the Molecular Weight. (USP <1160> shows a good example of the difference in MW versus using LOD.)

The Water section of the CofA represents the water that is a part of the chemical formula versus the water that has been absorbed and/or loss on drying, which indicates the amount of moisture the API has absorbed in the manufacturing and storage process. USP does allow for a percentage of water, but the CofA would be more accurate.

When you receive an API, have clear documentation, including date of receipt, open date, and transfer date. Since some drugs retain full chemical stability, but can gain or lose moisture during storage and use, be sure storage precautions are followed, such as maintaining storage area humidity and “keeping the lid on” when not in use! (Remember, if you receive an API without an expiration date, the maximum expiration date is three years.)

Include Loss of Drying (LOD) as part of staff training and include calculations in didactic testing to be sure your staff fully understands the concept. For potency testing during competencies, have the staff compound using an API with a high LOD, which will reveal any LOD/calculation issues.

Monitoring moisture content per USP <731> Loss on Drying for quality assurance is useful in identifying problematic batches, which can save time/money, but more importantly, ensure the product’s potency is accurate and consistent.

The Bottom Line: Anytime an API is received, look at the CofA and pull your current Master Formulation Record. Be sure the MFR reflects the Manufacturer and Lot numbers of the received API. Double-check the Assay, Water and Salt-to-Base sections. Follow USP <731> Loss of Drying and USP <1160> Pharmaceutical Calculations in Pharmacy Practice to avoid any potency issues.

CMS Lifts Home Health Moratoria in FL, TX, MI & IL

According to the Centers for Medicare & Medicaid Services (CMS), “As of January 30, 2019, there are no active Medicare Provider Enrollment Moratoria in any State or U.S. territories.”  CMS announced Wednesday that the provider enrollment moratoria on home health agencies in Illinois, Michigan, Texas, and Florida have expired. The notice from CMS can be read here.

ACHC is able to expeditiously conduct an Initial Medicare Certification Survey for home health agencies (HHAs) in these states. An organization may apply for accreditation if the following eligibility requirements are met.

The organization must:

  1. Be currently operating within the United States and/or its territories.
  2. Be licensed according to applicable state and federal laws and regulations and maintain all current legal authorization to operate.
  3. Have completed the Medicare Enrollment Application Form CMS-855A and had this form verified by the assigned Medicare Administrative Contractor (MAC), if applicable.
  4. Have established policies and procedures.
  5. Have successfully completed a test Outcome and Assessment Information Set (OASIS) transmission to the state repository, if applicable.
  6. Have met capitalization requirements, if applicable.
  7. Occupy a building in which services are provided/coordinated that is identified, constructed, and equipped to support such services.
  8. Clearly define the services it provides directly or under contract.
  9. Submit all required documents and fees to ACHC within specified time frames.
  10. Be providing home health nursing and at least one qualifying therapeutic service.
    1. The qualifying therapeutic services include physical therapy, speech therapy, occupational therapy, medical social services, and home health aide (Reference in Centers for Medicare and Medicaid Services (CMS) 42 CFR 484.105(f).
    2. A Distinction is a non-qualifying therapeutic service.
  11. Have provided care to a minimum of 10 patients requiring skilled care (not required to be Medicare patients). At least seven of the 10 required patients are receiving skilled care from the Home Health Agency (HHA) at the time of the initial Medicare survey. If the HHA is not able to meet the minimum number of patients required, the initial survey will not be conducted. If the HHA is located in a medically underserved area, they can contact the CMS Regional Office (RO). If the CMS RO determines that the HHA is located in a medically underserved area, the CMS RO may reduce the minimum number of patients from 10 to five. At least two of the five required patients should be receiving skilled care from the HHA at the time of the initial Medicare survey. It is the organization’s responsibility to notify ACHC if it is located in an underserved area.


For more information call (855) 937-2242 ext. 457

Welcome to the U!

As of Jan. 14, you’ll see a new, more dynamic branding message from Accreditation Commission for Health Care (ACHC), as Accreditation University is now known as ACHCU.

With exciting growth on the horizon, we saw the need to meet the increasing demand for our services with a refreshed design and enhanced energy. And closely aligning our educational division with ACHC delivers an unmistakable element of brand continuity to ACHCU. We think this new look is a great way to show how we’ve evolved while remaining loyal to our values!

Greg Stowell, ACHCU’s Senior Manager of Education & Consulting, cheered the added cohesion that the rebranding delivers.

“We are excited to align our image and brand essence to the support we provide our customers,” Stowell said. “It was important for ACHCU to continue into the International marketplace aligned in parallel with ACHC as much as possible.”

New year, new us, new U!

Essentially, adding the “U” identifies how unique each piece of our business is, while showcasing how we remain focused on our providers’ success. Our decision was fueled by a desire to build our brand so that it resonates across all of our business avenues with every customer, consultant, provider, and vendor, while highlighting all of the educational tools we offer.

ACHCU will assist providers in elevating healthcare practices around the world. Now more than ever, providing education to empower providers is our ultimate goal.

“We are excited for this new chapter with our brand,” Stowell said, “and look forward to providing our customers the education that will enable them to improve their avenues of healthcare.”

ACHCU will continue to provide its signature educational offerings—workshops, accreditation preparation tools, the ACHC Accreditation Guide to Success workbook for all ACHC programs, webinars, certifications, ACHC Standards Gap Analysis and customized educational preparation. Be on the lookout for new educational resources that we will be adding later this year!

To see what we’ve done, visit To learn more about our educational services, contact or (855) 937-2242.

Partial Shutdown Not Expected to Hamper Providers, ACHC

As the new year begins with the continuation of a partial federal government shutdown, we are keeping our attention focused on what this may mean for our providers and their patients. Essentially, we are able to deliver good news, with little to no impacts foreseen.

We have been in contact with CMS and they have assured us that there will be no impact to their operations as they are funded through the end of their fiscal year, September 30, 2019. This means there will be no effect on payments to healthcare providers through the federal government payment system, and no changes with state-level survey and certification operations.

As for accreditation, ACHC is not a federal agency and our operations will not be affected by the shutdown. All surveys, reviews, and support services performed by ACHC and its affiliates will be provided according to normal schedules.

We will continue to stay abreast of any impact the shutdown may have at both federal and state levels and make you aware of any noteworthy developments as soon as we become aware of them. In the meantime, if you have any questions about your accreditation or would like to bring our attention to any issues, please do not hesitate to contact your Account Advisor or call ACHC at (855) 937-2242.

Thank you for your continued dedication to serving your patients with excellence and distinction and may 2019 bring you and your loved ones good health, happiness and success.


Barbara Sylvester, RN, BBA, MSOLQ
Director, Regulatory Affairs and Quality

Mapping Community Palliative Care

Palliative care is well established in U.S hospitals, with seventy-five percent of those with fifty beds or more reporting a palliative care program. Recognizing the needs of seriously ill patients and their families in all care settings, many palliative care programs are working to extend services in their communities – either by expanding existing hospital programs to other settings, or building new programs in non-hospital settings.  These programs provide palliative care in patient’s homes, nursing homes, doctor’s offices, and outpatient clinics, and are vital in reaching a patient population that would otherwise not be served through traditional hospital palliative care. However, little is known about the locations or extent of this community reach, or how these community palliative care services are staffed and structured to meet patient and family need.

To fill this gap, the Center to Advance Palliative Care (CAPC), in collaboration with the National Coalition for Hospice and Palliative Care (NCHPC), launched Mapping Community Palliative Care.  The goal of this initiative is to develop a comprehensive inventory of community palliative care programs and estimate their prevalence nationwide.

The three-year project, funded by the Gordon and Betty Moore Foundation, will catalog palliative care programs in the community and analyze palliative care access across settings. By completing a short eight-question survey, community palliative care programs nationwide can put their program “on the map,” identifying themselves, where their services are provided, and what services they offer. Mapping Community Palliative Care is committed to increasing access to palliative care services for patients, families, caregivers, and providers. Programs participating in Mapping Community Palliative Care will have the option to be listed in the Provider Directory on, the leading online resource for palliative care information for people with serious illness and their families. Anyone looking for palliative care resources will be able to search the directory by location and service type (hospital, home, nursing home, and office/clinic). As more and more programs add their profiles to the directory, patients and families will be able to find local resources and programs to meet their specific needs.

Mapping participants are also invited to participate in the National Palliative Care Registry™ – by providing annual aggregate data on program structure and operations, participants receive reports comparing their palliative care programs to their peers. Mapping Community Palliative Care and the National Palliative Care Registry™ are both free and open to programs across all care settings.

Mapping Community Palliative Care is working to bring the field of palliative care one step closer to a comprehensive national profile of palliative care services across care settings.

To participate, please visit and “make your mark” today!

If you are interested in learning more about Mapping Community Palliative Care, please contact Rachael Heitner, MA, CHPCA, Research Associate at CAPC, at

Don’t let a natural disaster interrupt your patients’ oxygen supply

How prepared are you and your staff for an emergency? Do you have a solid plan for your patients?

Anything that impacts service for your patients should be addressed in your plan

ACHC corporate surveyor Cynthia Gray breaks it down: What to do when nature wreaks havoc on the supply line for oxygen-dependent patients (as recently published in the August edition of AARC Times)

By Cynthia Gray, BS, RRT-RPFT

Cindy Gray

“Providing oxygen tanks for a short amount of time is reasonable. Most home medical equipment companies provide the patient with three times the maximum response time. When a power outage is extended to days, weeks, or even months, alternative plans must be initiated. RTs can be a key resource for patients if that should occur. Patients and their caregivers can plan ahead and be prepared for alternative living arrangements if an extended outage is a possibility.

… In an emergency, a documented plan is easier to follow than trying to remember what was discussed.

… RTs have a great opportunity to help patients understand that early action is imperative. If your institution is alerted about an impending disaster, act early.”


Key Steps to Opening a Medicare-Certified Home Health Agency

While starting a new skilled home health agency (HHA) can be exciting and rewarding, it can also be a long and time-intensive process. Although there is a growing need for HHAs with the population of people age 65 and older expected to reach 19.6 percent by 2030, CMS in recent years has imposed significant financial and operational barriers that HHAs must navigate.

Because ACHC was created by home care providers, we understand these unique challenges that you face. Our goal as your partner in accreditation is to offer resources and education to help you through this process and fully prepare you for accreditation. One of these resources that ACHC has recently developed is a free On-Demand Home Health Start-Up Webinar that walks you through the process of starting an HHA in more detail. This webinar can be found on

Below we have outlined some of the key steps to opening a Medicare-Certified HHA.

  1. Determine your states requirements concerning a Certificate of Need (CON)
  2. Determine if state licensure is required in the state where you want to operate
  3. Must meet requirements of CMS State Operations Manual, Chapter 2, Section 2180C
    • Provide Skilled Nursing services and other therapeutic services
    • These services are supervised by a physician or RN
    • Have established policies & procedures
    • Maintain clinical records on all patients
    • Have an overall plan and budget
    • Meet the Medicare Conditions of Participation (CoPs)
    • Meet capitalization requirements
  4. Complete and submit an 855A application to CMS
    • Once approved, submit approval letter to ACHC
  5. Complete a successful test OASIS transmission
  6. Develop patient caseload
    • Must have 10 patients served with 7 active at the time of survey
    • Must meet the definition of CMS skilled care per the Medicare Benefits Policy Manual Chapter 7
  7. Download and review ACHC Accreditation Standards
  8. Submit your ACHC Accreditation application and Preliminary Evidence Report (PER) Checklist
  9. ACHC will complete an on-site survey within 60 days of HHA’s stated readiness


IACHC_Certified-Consultant_Sealf you would like more help with getting your agency off the ground, or preparing for accreditation, you may be interested in reaching out to an ACHC Certified Consultant. Our Certified Consultants have been trained in ACHC Accreditation Standards, survey approach, and processes to better prepare healthcare clients for the accreditation survey. Find a Certified Consultant on

ACHC Approved for Ongoing Home Health and Hospice Licensure Surveys by State of Maryland

In a recent press release, Accreditation Commission for Health Care (ACHC) announced its approval by the Maryland Department of Health, to perform accreditation surveys in lieu of ongoing state licensure surveys for Home Health agencies and Hospices, in accordance with state law.

“This approval from the Maryland Department of Health means that home health agencies and hospices who are accredited by ACHC will no longer receive ongoing state licensure surveys,” said Teresa Harbour, ACHC’s Program Director for Home Health, Hospice, and Private Duty programs. “We appreciate the value Maryland
Department of Health sees in accreditation and we applaud their willingness to work with us to offer ACHC accredited agencies an alternative to ongoing licensure surveys.”

The Maryland Department of Health has reviewed ACHC’s Accreditation Standards and survey process and confirmed that they meet the state’s licensure requirements. On December 12, 2017, Dr. Patricia Tomsko Nay announced that home health agencies and hospices accredited by ACHC are deemed to comply with Maryland State licensure requirements and are exempt from routine licensure surveys conducted by the Department.

To remain licensed, deemed Home Health agencies and Hospices must continue to submit a renewal application and comply with applicable Maryland Health Care Commission requirements. With the application, the licensee seeking deemed status for state licensure proposes, must submit its currently applicable ACHC inspection results and all supporting documentation.

For more information on ACHC accreditation in-lieu of ongoing licensure surveys in Maryland, contact us at

The Medicare Home Health CoP Implementation Day is Here!

Today, January 13, 2018, is the day for which all home health agencies have been preparing since CMS finalized the first major revision to the Medicare Home Health Conditions of Participation (CoPs) in more than 20 years. Today, these new CoPs officially go into effect and all home health agencies that bill Medicare must be in full compliance.

ACHC released the revised Home Health Accreditation Standards, which incorporate the new CoPs, on November 15, 2017, and these standards are available to download on Customer Central. As of today, all ACHC customers will be surveyed to these new standards.

As always, agencies must adhere to the most stringent regulations. Requirements deleted from the CoPs may still be valid in your state, so check state licensure requirements, as applicable, prior to revising any current practice.

Make sure to take advantage of the tools and resources ACHC has developed to help educate providers on the expectations for compliance with the new CoPs and ACHC Accreditation Standards:

Accreditation University

Customer Central

We will continue to work diligently to revise all educational materials as we receive more information from CMS, including the Interpretive Guidelines and survey protocols. Watch your email and Customer Central account for these updates.

If you have any questions about the new ACHC Home Health Accreditation Standards or the Medicare CoPs, please contact your personal Account Advisor.

ACHC Accreditation – A New Option for California Home Health Licensure

With more than 500 initial licensure applications pending approval in California, home health agencies are being forced to wait up to two years before receiving their license. To help combat this delay, the California Department of Public Health (CDPH) has given home health agencies the option of working with a CMS-deemed accreditation organization to obtain an initial licensure survey. CDPH is encouraging home health agencies to take advantage of this new option in order to expedite their licensure approval process.

The Accreditation Commission for Health Care (ACHC), a nationally recognized accreditation organization known for providing value, integrity, and the industry’s best customer service, is one of the approved accreditors.

“ACHC is ready to immediately accept applications and assist start-up agencies seamlessly through the licensure process,” said Teresa Harbour, ACHC’s Program Director for Home Health, Hospice, and Private Duty.  “Meeting the needs of California providers is essential to ACHC, so we have created accreditation prep tools and resources specific for these providers.”

Faina Neveleva, Administrator of Signature Home Health Care, was grateful for the training and support her agency received from ACHC. She attended the ACHC Home Health workshop in preparation for her agency’s recent accreditation survey.

“The workshops were so educational. Lisa [ACHC Clinical Compliance Educator] was very patient and answered all of our questions,” added Neveleva. “The free ACHC Accreditation Guide to Success workbook tells you exactly what the Surveyors are looking for. We rely on this so much.”

ACHC is accepting applications for home health licensure and accreditation in California and has already started surveying agencies. Once the application is completed, ACHC guarantees agencies will be surveyed within 25 days.

“We were impressed with how simple and straightforward the ACHC application process was and how quickly we were surveyed,” said Neveleva. “Throughout the whole process, our Account Advisor was very knowledgeable and helpful, returning calls usually within an hour and making sure all our questions were answered.”

Partnering with ACHC not only provides a faster route to licensure, it also allows agencies to reap the benefits of accreditation – ensuring compliance with the Medicare Conditions of Participation (CoPs) and the highest quality standards.

VNA Hospice & Palliative Care of Southern California has been accredited for over 20 years and recently switched to ACHC. Paula Natale, Director of Regulatory Affairs, said the organization switched because the ACHC Accreditation Standards are easy to understand and are more applicable to the home health and hospice services provided by the agency.

“It is a way for us to show our patients, payors, and referral sources that we have achieved a higher standard above and beyond the Medicare CoPs and that we are committed to continuously improving the care we provide,” Natalesaid, reflecting on the value of accreditation.

With more than 1,200 accredited home health agencies across the country, ACHC prides itself on the fact that 98 percent of customers say they would recommend ACHC – and Natale agrees.

“I have recommended ACHC to several colleagues,” she said. “Having experience with other accrediting organizations, I can say that the knowledge, professionalism, and customer service from ACHC Account Advisors, Surveyors, and Clinical team is unmatched in the industry.”

This article was published on Home Health Care News on December 20, 2017.