Horizon Health Mission

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 proficiency testing (PT) record review and interview with the nurse manager and laboratory director, the laboratory failed to achieve successful performance for the test methods erythrocyte count, hemoglobin, hematocrit, leukocyte count, platelet count, white blood cell differential and the specialty of hematology. Unsatisfactory results had been received in two of three PT events (American Proficiency Institute Hematology/Coagulation 2024 1st and 3rd events) resulting in unsuccessful PT performance. Refer to D2130 and D2131. D2130 HEMATOLOGY 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 -- CFR(s): 493.851(f) (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 review of CASPER Reports and interview with the nurse manager and laboratory director, the laboratory failed to achieve satisfactory proficiency testing (PT) performance for the erythrocyte count, hemoglobin, hematocrit, leukocyte count, platelet count, and white blood cell (WBC) differential test method in two out of three events (American Proficiency Institute [API] Hematology/Coagulation 2024 1st and 3rd testing events) resulting in unsuccessful performance. Findings include: 1. Review of the laboratory's CASPER 153D and 155D reports revealed the API PT scores for the erythrocyte count, hemoglobin, hematocrit, leukocyte count, platelet count, and WBC differential test methods were less than the 80% required to pass per Clinical Laboratory Improvement Amendment requirements found at CFR 493.861(a): a. API Hematology/Coagulation 2024 1st testing event- *Erythrocyte count score = 40% (HSY 2, 3, and 4 were graded as unacceptable). *Hemoglobin score = 40% (HSY 2, 3, and 4 were graded as unacceptable). *Hematocrit score = 40% (HSY 2, 3, and 4 were graded as unacceptable). *Leukocyte count score = 60% (HSY 3 and 4 were graded as unacceptable). *Platelet count score = 40% (HSY 2, 3, and 4 were graded as unacceptable). *WBC differential score = 60% (HSY 2, 3, and 4 were graded as unacceptable). b. API Hematology/Coagulation 2024 3rd testing event- *Erythrocyte count score = 60% (HSY 14 and 15 were graded as unacceptable). *Hemoglobin score = 60% (HSY 14 and 15 were graded as unacceptable). *Hematocrit score = 60% (HSY 14 and 15 were graded as unacceptable). *Leukocyte count score = 60% (HSY 14 and 15 were graded as unacceptable). *Platelet count score = 60% (HSY 14 and 15 were graded as unacceptable). *WBC differential score = 60% (HSY 14 and 15 were graded as unacceptable). 2. Interview via email with the nurse manager and the laboratory director on 12/31/24 confirmed the failure. The nurse manager stated they had been aware of the issue. The investigation revealed the PT samples had been run properly and the results had been within the acceptable ranges. The results had been reported under the incorrect sample ID number when the results were submitted electronically. Staff education had been provided by the laboratory director regarding the processing and submission of PT results. D2131 HEMATOLOGY CFR(s): 493.851(g) (g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of CASPER Reports and interview with the nurse manager and laboratory director, the laboratory failed to achieve satisfactory proficiency testing (PT) performance for the specialty of hematology in two out of three testing events (American Proficiency Institute [API] Hematology/Coagulation 2024 1st and 3rd testing events) resulting in unsuccessful performance. Findings include: 1. Review of the laboratory's CASPER 153D and 155D reports revealed the API PT scores for the specialty of hematology were less than the 80% required to pass per Clinical -- 2 of 3 -- Laboratory Improvement Amendment requirements found at CFR 493.861(a): a. Hematology/Coagulation 2024 1st testing event specialty of hematology score = 47%. *Erythrocyte count score = 40% (HSY 2, 3, and 4 were graded as unacceptable). *Hemoglobin score = 40% (HSY 2, 3, and 4 were graded as unacceptable). *Hematocrit score = 40% (HSY 2, 3, and 4 were graded as unacceptable). *Leukocyte count score = 60% (HSY 3 and 4 were graded as unacceptable). *Platelet count score = 40% (HSY 2, 3, and 4 were graded as unacceptable). *WBC differential score = 60% (HSY 2, 3, and 4 were graded as unacceptable). b. Hematology/Coagulation 2024 3rd testing event specialty of hematology = 60%. *Erythrocyte count score = 60% (HSY 14 and 15 were graded as unacceptable). *Hemoglobin score = 60% (HSY 14 and 15 were graded as unacceptable). *Hematocrit score = 60% (HSY 14 and 15 were graded as unacceptable). *Leukocyte count score = 60% (HSY 14 and 15 were graded as unacceptable). *Platelet count score = 60% (HSY 14 and 15 were graded as unacceptable). *WBC differential score = 60% (HSY 14 and 15 were graded as unacceptable). 2. Interview via email with the nurse manager and the laboratory director on 12/31/24 confirmed the failure. The nurse manager stated they had been aware of the issue. The investigation revealed the PT samples had been run properly and the results had been within the acceptable ranges. The results had been reported under the incorrect sample ID number when the results were submitted electronically. Staff education had been provided by the laboratory director regarding the processing and submission of PT results. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A recertification survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 8/29/19. The Mission Community Health Center laboratory was found not in compliance with the following requirements: D6028 and D6053. D6028 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(10) 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)(10) Employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities described in this subpart; This STANDARD is not met as evidenced by: Based on review of employee files, the CMS 209 Laboratory Personnel Report Form, and interview with laboratory staff A, the laboratory director failed to ensure competency evaluations for two of nine laboratory staff (B and C) were completed by authorized personnel (their credentials had not been reviewed to determine if they were qualified to serve as technical consultants) for the nonwaived test methods they had been performing under the laboratory's certificate. Findings include: 1. Review of employees' files for laboratory staff B and C revealed laboratory staff B and C had competency evaluations performed on 10/2/18 by laboratory staff A and D. The laboratory director had signed the competency evaluation. There was no indication the laboratory director was involved in the competency assessment process nor had he dated the evaluations. Review of the the CMS 209 Laboratory Personnel Report Form signed by the laboratory director on 7/16/19 revealed the laboratory director was also 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 -- serving as the technical consultant. Laboratory staff A and D were listed only as testing personnel and not listed as technical consultants. Interview on 8/29/19 at 10:40 a.m. with laboratory staff A revealed neither she nor laboratory staff D had received written authorization from the laboratory director to perform employee competencies. The laboratory director was at the facility approximately every two weeks. 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 employee files, the Laboratory Testing Personnel Performance Review Policy, the December 2018 quarterly Quality Assurance (QA) form, and interview with the laboratory staff A, the laboratory director, also serving as the the technical consultant, failed to ensure: *One of one newly hired staff (B) had received two competency evaluations during her first year of patient testing for the test methods she had been performing under the laboratory's certificate. *One of nine staff (E) had received competency evaluations on an annual basis for the test methods she had been performing under the laboratory's certificate. Findings include: 1. Review of the employee files for laboratory staff B revealed: *She had a completed and signed orientation/training checklist dated 12/4/17. *A competency assessment had been completed on 10/2/18. *No records of additional competency evaluations were available. 2. Review of the employee files for laboratory staff E revealed no record of competency evaluation in 2018 or to date in 2019. Laboratory staff E's last competency evaluation had been dated 9/21/17. Review of the facility's Laboratory Testing Personnel Performance Review Policy last revised on 1/3/08, revealed: "In the first year laboratory testing personnel performance review will be done twice for a new employee. From there, this review will be done for each employee once a year." Review of the December 2018 quarterly QA form completed by laboratory personnel A on 12/10/18 and signed by the laboratory director 1/15/19 revealed laboratory personnel competency evaluations to be acceptable. Interview on 8/29/19 at 10:40 a. m. with laboratory staff A revealed no competency evaluations had been performed for laboratory staff E in 2018 or to date in 2019. She stated laboratory staff E rarely did laboratory work. -- 2 of 2 --