North Whiteville Urgent Care

Summary Statement of Deficiencies 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 desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D 9/23/24 and desk review of 2024 WSLH (Wisconsin State Laboratory of Hygiene) proficiency testing results 9/30/24, the laboratory failed to successfully participate in proficiency testing for WBC (white blood cell) Differential on two consecutive test events. Findings: See the deficiency cited at D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- 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 desk review of CMS Casper reports 153D and 155D 9/23/24 and desk review of 2024 WSLH proficiency testing results 9/30/24, the laboratory failed to achieve satisfactory performance for WBC Differential on two consecutive test events, resulting in unsuccessful performance. Findings: 1. Desk review of CMS Casper reports 153D and 155D and 2024 WSLH proficiency testing results revealed the laboratory received a score of 0% for WBC Differential on the 2024 HemeReg1 test event. 2. Desk review of CMS Casper reports 153D and 155D and 2024 WSLH proficiency testing results revealed the laboratory received a score of 0% for WBC Differential on the 2024 HemeReg2 test event. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on desk review of CMS Casper reports 153D and 155D 9/23/24 and desk review of 2024 WSLH proficiency testing results 9/30/24, the laboratory director failed to provide overall management and direction to ensure successful proficiency testing participation. Findings: See the deficiency cited at D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on desk review of CMS Casper reports 153D and 155D 9/23/24 and desk review of 2024 WSLH proficiency testing results 9/30/24, the laboratory director failed to ensure successful participation in proficiency testing as required in Subpart H. Findings: See the deficiency cited at D2130. -- 2 of 2 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of 2020 Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing (PT) records, the absence of PT records, interview with Admin /Lab Manager 12/5/2023, and phone interview with PT provider representative 12/11 /2023, the laboratory failed to enroll in PT for 2021, 2022, and 2023. Findings: Review of PT records revealed the laboratory's last PT enrollment was for 2020. No records available to show PT enrollment for the speciality (Hematology) that the regulations require for enrollment for 2021, 2022, and 2023. During an interview at approximately 2:56 PM on 12/5/2023, the Admin/Lab Manager confirmed the last time the laboratory enrolled in PT was 2020. She confirmed there was no PT enrollment for 2021, 2022, and 2023. She stated the laboratory participated in an off- schedule event in 2021 and requested off schedule samples from American Association of Bioanalysts-Medical Laboratory Evaluation (AAB-MLE) and College of American Pathologists (CAP) prior to the survey 12/5/2023. She stated the laboratory was not enrolled in PT with WSLH PT for 2024. During a phone interview at approximately 10:39 AM on 12/11/2023, WSLH PT representative confirmed the laboratory's last PT enrollment was in 2020. The representative verified the laboratory was not enrolled for 2021, 2022, 2023, and 2024. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, review of personnel records, and interview with the Admin/Lab Manager 12/5/2023, the laboratory director (LD) failed to ensure technical consultant (TC) duties were delegated to personnel meeting the qualification requirements for a TC. Findings: Review of the laboratory policies and procedures revealed a document titled "Laboratory Director/Delegation of Duties" that stated, "The laboratory director is responsible for the overall operation of the laboratory ... To assist in his duties, several of the responsibilities of the laboratory director may be delegated to the laboratory manager... The lab manager will review all proficiency testing results and summaries. All results will be signed and dated by the lab manager ... PT failures or problems will be investigated by the lab manager and a final resolution will be reported to the laboratory director." LD listed the Admin/Lab Managers name as designee of delegated duties. Review of personnel records revealed no documentation available to ensure Admin/Lab Manager met the qualifications to serve as TC. During interview at approximately 9:38 AM, 12/5/2023, Admin/Lab Manger stated she did not know if she is the TC or meets TC qualifications. This is a repeat deficiency previously cited at survey on 1/21/2020. D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) 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) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, and interview with the Admin /Lab Manager 12/5/2023, the laboratory director (LD) failed to ensure the laboratory was enrolled in proficiency testing (PT) for 2021, 2022, and 2023. Findings: Review of the laboratory policies and procedures revealed no PT enrollment for 2021, 2022, and 2023. See D2000. The laboratory did not follow policy for the document entitled "Proficiency Testing Program." This document states, "This office laboratory shall be enrolled in a COLA and HCFA approved proficiency testing program. Proficiency testing will be performed on each regulated analyte tested in the laboratory. The laboratory director or designee will evaluate the complexity of all new tests and will -- 2 of 3 -- enroll them in proficiency testing if they are non-waived tests. Proficiency testing specimens should be treated according to the criteria set forth by the proficiency testing company and by HCFA..." During interview at approximately 2:56 PM, 12/5 /2023, Admin/Lab Manager stated she failed to ensure PT enrollment. She stated she forgot. -- 3 of 3 --

Summary Statement of Deficiencies D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, review of personnel records, and interview with the laboratory manager 1/21/2020, the laboratory director failed to ensure technical consultant (TC) duties were performed by personnel meeting the qualification requirements for a TC and failed to ensure that all duties were properly performed. Findings: The laboratory's "LABORATORY DIRECTOR /DELEGATION OF DUTIES" states "The laboratory director is responsible for the overall operation of the laboratory and the competency of all laboratory personnel. To assist in his duties, several of the responsibilities of the laboratory director may be delegated to the laboratory manager... The lab manager will assist in the training and assessments of laboratory personnel. The lab manager will do periodic quality assurance reviews of personnel records to ensure that all training and assessments of personnel and documentation is current." Review of personnel records revealed: 1. The laboratory manager did not have documentation available that she meets the requirements to serve as TC. 2. Competency evaluations for Testing personnel (TP) were performed by the Office manager and TP #1. The Office manager performed the competency evaluation for TP#1 in April 2019, and the 6-month competency 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 -- evaluation for TP# 4 in December 2018. TP#1 performed the competency evaluations for TP#2, TP#3, and TP#4 in April 2019. 3. TP#1 has a high school diploma and does not meet the requirements to serve as a TC. The office manager did not have documentation available that she meets the requirements to serve as a TC. 4. 6-month competency evaluation was not performed or documented for TP#3. See D6053. 5. Annual competency evaluations in 2018 were not performed or documented for TP#1, TP#2, and TP#3. See D6054 At approximately 11:25am, the laboratory manager confirmed the office manager and TP#1 performed competency evaluations for the TP. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of personnel records and interview with the Laboratory manager 1/21 /2020, the TC failed to perform and document competency evaluation for 1 of 4 TP (TP#3) at least semiannully during the first year. Findings: Review of personnel records revealed TP#3 was trained on the Cell Dyn 1700 hematology analyzer in April 2017. There was no semiannual( six month) competency completed for TP#3 during her first year of testing patient specimens. During interview at approximately 11:25am, the Laboratory manager stated the laboratory was not performing testing between July 2017 and February 2018. She confirmed a semiannual competency evaluation was not performed for TP#3 when testing resumed. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on review of the personnel records and interview with the Laboratory manager 1 /21/2020, the TC failed to perform and document annual competency evaluations for 3 of 4 TP. Findings: Review of personnel records revealed there was no annual competency evaluations completed for TP#1, TP#2, and TP#3 in 2018. During interview at approximately 1 pm, the Laboratory manager confirmed the 2018 competency evaluations were not performed if not on file in the personnel records. -- 2 of 2 --