Hollandale Family Care Pc

Summary Statement of Deficiencies 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 a review of documented annual evaluations/competencies for laboratory personnel and interview with the Technical Consultant (TC) at 4:30 pm on 9/4/19, the laboratory failed to follow written policies to assess competency of the TC at least annually since employment began in December 2017. On the day of survey there was no annual competency available for review for the TC for 2018 performed by the laboratory director. Findings include: 1. Based on review of the personnel records on 9 /4/19, there was no annual competency of the TC for the year 2018 performed by the laboratory director. 2. Interview with the TC listed on the Centers for Medical & Medicaid Services (CMS) 209 form indicated that no evaluation/competency had been performed by the laboratory director on the TC since initial employment in December 2017. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other 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 -- materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

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 Surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 5/22/19, the laboratory has not successfully participated in proficiency testing for HEMATOLOGY. Findings include: Our records indicate the following proficiency testing scores for your laboratory for HEMATOLOGY: PROFICIENCY TESTING PROVIDER: American Academy of Family Physicians HEMATOLOGY/WBC, RBC, Hemoglobin, Hematocrit, Platelets, WBC Diff: Year 2018 3rd Event 0% Year 2019 1st Event 0% Scores less than 80% for this analyte or parameter indicate failure for unsatisfactory performance. A failure 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 the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on Surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 5/22/19, the laboratory has not successfully participated in proficiency testing for HEMATOLOGY. Findings include: Our records indicate the following proficiency testing scores for your laboratory for HEMATOLOGY: PROFICIENCY TESTING PROVIDER: American Academy of Family Physicians HEMATOLOGY/WBC, RBC, Hemoglobin, Hematocrit, Platelets, WBC Diff: Year 2018 3rd Event 0% Year 2019 1st Event 0% Scores less than 80% for this analyte or parameter indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. D2131 HEMATOLOGY CFR(s): 493.851(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 Surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 5/22/19, the laboratory has not successfully participated in proficiency testing for HEMATOLOGY. Findings include: Our records indicate the following proficiency testing scores for your laboratory for HEMATOLOGY: PROFICIENCY TESTING PROVIDER: American Academy of Family Physicians HEMATOLOGY/WBC, RBC, Hemoglobin, Hematocrit, Platelets, WBC Diff: Year 2018 3rd Event 0% Year 2019 1st Event 0% Scores less than 80% for this analyte or parameter indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. -- 2 of 2 --

Summary Statement of Deficiencies No Tags No deficiency details available. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --