Convenientmd Westbrook

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on record review and staff interview with the practice manager (PM), the laboratory director (LD) failed to sign the attestation sheet for the American Proficiency Institute (API) proficiency testing (PT) samples in the specialty of Hematology. Findings include: 1. Record review on 1/11/2022 of the laboratory's PT attestation sheet for API Hematology/Coagulation 2020 event 3 revealed the LD did not sign the attestation sheet. 2. Staff interview on 1/11/2022 at 11:45 AM with the PM confirmed the above findings. 3. The laboratory performs 5,250 tests annually in the specialty of Hematology. D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of the proficiency testing (PT) data report (CASPER Report 0155D), PT graded results from the American Proficiency Institute (API) and staff interview, the laboratory failed to attain a score of at least 80% for the regulated analyte WBC in the specialty of Hematology. Findings include: 1. Record review on 1/11/2022 of the CASPER Report 0155D, revealed: a. The laboratory received an unsatisfactory PT Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- score of 40% for the regulated analyte 0805 WBC for 2020 Event 3. 2. Record review on 1/11/2022 of the laboratory's 2020 API PT records revealed: a. Unsatisfactory PT score of 40% for the regulated analyte 0805 WBC for 2020 Event 3. b. Investigation or remedial action was not documented for the above unacceptable result. 3. Staff interview on 1/11/2022 at 11:45 AM with the practice manager confirmed the above findings. 4. The laboratory performs 5,250 tests annually in the specialty of Hematology. D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on review of the proficiency testing (PT) data report (CASPER Report 0155D), PT graded results from the American Proficiency Institute (API) and staff interview, the laboratory failed to investigate or take remedial action when unsatisfactory or unacceptable PT scores are received. Findings include: 1. Record review on 1/11/2022 of the CASPER Report 0155D, revealed: a. The laboratory received an unsatisfactory PT score of 40% for the regulated analyte 0805 WBC for 2020 Event 3. 2. Record review on 1/11/2022 of the laboratory's 2020 API PT records revealed: a. Unsatisfactory PT score of 40% for the regulated analyte 0805 WBC for 2020 Event 3. b. Investigation or remedial action was not documented for the above unacceptable result. 3. Staff interview on 1/11/2022 at 11:45 AM with the practice manager confirmed the above findings. 4. The laboratory performs 5,250 tests annually in the specialty of Hematology. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and interview with the practice manager (PM), the laboratory failed to follow the written procedure to assess the competency of all laboratory personnel. Findings include: 1. Review of the laboratory's 2020 and 2021 employee competency records on 1/11/2022 revealed the laboratory did not have competency documentation for the Technical Consultant (TC) for his/her CLIA federal regulatory responsibilities. 2. Review on 1/11/2022 of the laboratory's 'Competency Assessment' Policy revealed: a. "Documented competency assessment shall be required for individuals fulfilling the following responsibilities outlined in Subpart M of the CLIA regulations: Clinical Consultant (CC), Technical Consultant (TC), Technical Supervisor (TS), General Supervisor (GS) and Testing Personnel (TP)." b. "CCs, TCs, -- 2 of 4 -- TSs, and GSs who perform testing are required to have the six (6) required procedures in their competency assessment in addition to a competency assessment based on their federal regulatory responsibilities." 3. Staff interview with the PM on 1/11/2022 at 11: 45 AM confirmed the laboratory did not follow the policy in place to assess the competency of the TC and they were not assessed. 4. The laboratory performs 5,250 tests annually in the specialty of Hematology. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on maintenance record review and interview with the practice manager (PM) the laboratory failed to document routine maintenance and function checks for laboratory equipment in the specialty of Hematology. Findings include: 1. Record review of the Sysmex XP-300, 2020 and 2021 maintenance logs on 1/11/2022 revealed the laboratory failed to document weekly maintenance and function checks for the following: a. 16 of 52 weeks in 2020. b. 8 of 52 weeks in 2021. 2. Record review on 1/11/2022 of the laboratory's 'Laboratory Quality Assurance' policy revealed: a. "The designated team member with assistance of the Practice Manager must review laboratory equipment maintenance on a weekly basis." b. "Documentation of this review must be made on the weekly Practice Manager dashboard and notation must be made noting the last date of maintenance. Laboratory maintenance includes: CBC device weekly maintenance." 3. Record review on 1/11 /2022 of the Sysmex XP-300 Automated Hematology Analyzer Quick Guide, Maintenance Section, Page 9, Weekly maintenance revealed: a. "Clean the SRV tray." 4. Record Review on 1/11/2022 of the 2020 and 2021 plumbed eyewash maintenance records revealed: a. Eyewash maintenance and function checks were not documented for 52 of 52 weeks in 2020. b. Eyewash maintenance and function checks were not documented for 42 of 52 weeks in 2021. 5. Record review on 1/11/2022 of the The American national Standards Institute (ANSI) standards for plumbed eyewashes revealed: a. Plumbed flushing equipment "shall be activated weekly for a period long enough to verify operation and ensure that flushing fluid is available." 6. Staff interview with the practice PM on 1/11/2022 at 11:45 AM confirmed the above findings. 7. The laboratory performs 5,250 tests annually in the specialty of Hematology. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iv) Ensure that an approved

Summary Statement of Deficiencies D0000 The ConvenientMD - Westbrook laboratory is not in compliance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The following requirements have not been met. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on proficiency testing record review, the laboratory failed to successfully participate in 2 of 3 Proficiency Testing (PT) events for the regulated analyte of Lymphocyte % Cell differential. Findings include: 1. A desk review of American Proficiency Institute (API) PT results on January 23, 2020 revealed that the laboratory failed to obtain a satisfactory score of 80% leading to unsuccessful participation in 2 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- of 3 events for the regulated analyte of Lymphocytes % Cell differential. 2. The laboratory received the following proficiency testing scores: Event # Score 2019 Event - 2 0% 2019 Event - 3 60% This is the first unsuccessful PT performance for the regulated analyte of Lymphocyte % Cell differential. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on record review and communication with staff, the laboratory failed to successfully achieve satisfactory performance in 2 of 3 testing events in the specialty of hematology for the regulated analyte of Lymphocyte % Cell differential. Findings include: 1. A record review of American Proficiency Institute Proficiency Testing (PT) records on January 23, 2020 revealed that the laboratory failed to obtain an acceptable score of 80% leading to unsuccessful PT participation in 2 of 3 testing events for the regulated analyte of Lymphocyte % Cell differential. Event #: Score 2019 Event - 2 0% 2019 Event - 3 60% 3. The laboratory performs approximately 250 Complete Blood Counts annually. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The laboratory at ConvenientMD Urgent Care - Westbrook is not in compliance with the requirements of 42 CFR Part 493, Clinical Laboratory Improvement Amendments (CLIA). The following requirements have not been met: D2005 ENROLLMENT CFR(s): 493.801(a)(4) Authorize the proficiency testing program to release to HHS all data required to-- (i) Determine the laboratory's compliance with this subpart; and (ii) Make PT results available to the public as required in section 353(f)(3)(F) of the Public Health Service Act. This STANDARD is not met as evidenced by: Based on interview with the Regional Manager (RM) and review of 2018 and 2019 proficiency testing (PT) records, the laboratory failed to authorize the PT program to release PT results to Health and Human Services (HHS), Centers for Medicare and Medicaid Services (CMS). Findings include: 1. Record review conducted on 07/31/19 of the Proficiency Testing (PT) data report (CASPER 0096) revealed no PT results were reported to CMS in 2018 and 2019 in Specialty of Hematology. 2. Record review conducted on 07/31/19 of 2018 and 2019 graded results from the PT organization American Proficiency Institute (API) revealed that the laboratory's CLIA identification number 20D2137805 was missing on all 2018 and 2019 performance evaluation reports. 3. The RM stated in an interview on 07/31/19 at 11:28 AM that the laboratory submitted the API PT enrollment form in 2018 without the laboratory's CLIA ID because the laboratory was awaiting their CLIA ID following their CLIA registration. The RM also stated that a second API PT enrollment form was submitted with the laboratory's CLIA ID after receiving it, but the enrollment form was submitted to API without the Laboratory Director's (LD) signature which caused the laboratory's CLIA number 20D2137805 to be missing from all 2018 PT result records. The RM further stated that the 2019 API PT enrollment form was submitted to API Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- without the laboratory's CLIA ID 20D2137805 which resulted in laboratory's CLIA number to be missing from all 2019 PT result records. 4. The laboratory performed approximately 2000 Complete Blood Counts (CBCs) annually on the Sysmex XP-300 in 2018 and 2019. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to maintain copies of American Proficiency Institute (API) Proficiency Testing (PT) records for the 1st Event of 2019 for two years from the date of the PT testing event. Missing records included raw data from the Sysmex XP-300 Hematology analyzer documenting that PT samples were tested in the same manner as patient specimens. Findings include: 1. Record review of 2018 and 2019 PT records conducted on 07/31/2019, revealed that the raw data from Sysmex XP-300 Hematology analyzer for the PT 2019 Event 1 results reported to American Proficiency Institute (API) was not maintained by the laboratory. 2. Interview with the Regional Manager (RM) at approximately 1:45 PM confirmed the finding above. -- 2 of 2 --