Primary Plus Kid 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 Hematology proficiency testing results from the Wisconsin State Laboratory Hygiene proficiency testing agency on 05/06/2019, the laboratory failed to successfully participate in the Red Blood Cell (RBC) certified analyte in three of five consecutive testing events. This is the second unsuccessful proficiency failure. See the first unsuccessful failure dated 05/07/2018. See D2121 and D2130 D2121 HEMATOLOGY CFR(s): 493.851(a) 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 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 desk review of Hematology proficiency testing results from the Wisconsin State Laboratory Hygiene on 05/06/2019, the laboratory failed to attain a satisfactory score of at least 80 percent on the Red Blood Cell analyte. Findings include: 1. The laboratory failed to achieve a satisfactory score for the Red Blood Cell analyte in the third testing event of 2017 with a score of 0 percent. 2. The laboratory failed to achieve a satisfactory score for the Red Blood Cell analyte in the first testing event of 2018 with a score of 60 percent. 3. The laboratory failed to achieve a satisfactory score for the Red Blood Cell analyte in the first testing event of 2019 with a score of 0 percent. 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 desk review of Hematology proficiency test results from the Wisconsin State Laboratory Hygiene on 05/06/2019, the laboratory failed to successfully achieve satisfactory performance for the Red Blood Cell Count in three of five consecutive testing events. Findings include: 1. The facility failed to achieve a satisfactory score for the Red Blood Cell analyte in the third testing event of 2017 for an unsuccessful performance. 2. The facility failed to achieve a satisfactory score for the Red Blood Cell analyte in the first testing event of 2018 for an unsuccessful performance. 3. The facility failed to achieve a satisfactory score for the Red Blood Cell analyte in the first testing event of 2019 for an unsuccessful performance. 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 Hematology proficiency testing results from the Wisconsin State Laboratory Hygiene proficiency testing agency on 05/06/2019, the laboratory director failed to fulfill the responsibility of evaluating the laboratory's performance of the failed Red Blood Cell certified analyte. Findings include: The

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on staff interview and record review, the laboratory failed to monitor and document the humidity of the laboratory where the ACT-Diff analyzer testing was performed. Humidity of the laboratory was not recorded from November 16, 2016 through November 26, 2018. Findings include: The Manufacturer's Operations Manual for the ACT-Diff analyzer lists an operating range for humidity for the analyzer to be between twenty percent (20%) and eighty-five percent (85 %). Review of the Maintenance Log, on 11/27/18 at 11:50 AM, revealed no documented evidence the humidity of the laboratory where the ACT-Diff analyzer testing was performed had been monitored from November 16, 2016 through November 26, 2018. Testing personnel acknowledged in an interview on 11/27/18 at 11:50 AM, the laboratory failed to have a system in place to ensure the humidity of the laboratory was monitored and documented daily. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from 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 -- the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on staff interview, and record review, the laboratory failed to ensure there was a system in place to ensure data entered manually into the electronic medical record was checked for clerical errors. Findings include: Record review revealed the laboratory did not have a system in place for detecting clerical errors entered manually into the electronic medical record from 11/16/16 through 11/26/18. Staff acknowledged in an interview, on 11/27/18 at 1:00 PM, there was no system in place from 11/16/16 through 11/26/18 to check for clerical errors introduced into the electronic medical record due to manual entry. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

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 desk review from the Wisconsin State Laboratory Hygiene proficiency testing agency on 05/03/2018, the laboratory failed to participate successfully in Red Blood Cell test (RBC) in two (2) consecutive testing events. See D2121 and D2130 D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte 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 -- in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on desk review of Hematology proficiency test results from the Wisconsin State Laboratory Hygiene proficiency testing agency on 05/03/2018, the laboratory failed to attain a satisfactory score of at least eighty percent (80%) on the Red Blood Cell analyte. The findings include: The laboratory scored an unsatisfactory zero percent (0%) in the third testing event of 2017 and scored an unsatisfactory sixty percent (60%) in the first testing event of 2018. 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 desk review of Hematology proficiency test results from the Wisconsin State Laboratory Hygiene proficiency testing agency on 05/03/2018, the laboratory failed to successfully achieve satisfactory performance for Red Blood Cell analyte in two (2) consecutive testing events. The findings include: The facility scored zero percent (0%) in the third testing event of 2017 and scored 60 percent (60%) in the first testing event of 2018 for an unsuccessful performance. -- 2 of 2 --