Synergy Women's Health Care

Summary Statement of Deficiencies D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of

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 review of Proficiency Testing (PT) records for 2020 and 2021 and interview with the Office Manager, the laboratory failed to ensure the testing personnel (TP) and the Laboratory Director (LD) both signed the Attestation form. Findings include: 1. For event #2 Hematology, 2020, the attestation form was not signed by the TP or the LD. 2. For event #3 Hematology, 2020, the attestation form was not signed by the TP or the LD. 3. For event #1 Microbiology, Hematology and Chemistry 2021, the attestation form was not signed by the TP or the LD. 4. For event #2 Microbiology and Chemistry, 2021, the attestation form was not signed by the TP or the LD. D2026 BACTERIOLOGY CFR(s): 493.823(d) (1) For any unsatisfactory 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) 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 Proficiency Testing (TP) results for 2020 and 2021 and discussion 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 -- with the Office Manager, the laboratory failed to ensure that

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: Record review of the American Proficiency Institute (API) proficiency testing reveals that your laboratory has unsuccessful proficiency testing in Endocrinology for Human chronic gonadotropin (HCG). Refer to D2107. D2107 ENDOCRINOLOGY CFR(s): 493.843(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is 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 -- unsuccessful performance. This STANDARD is not met as evidenced by: Record review of proficiency testing from American Proficiency Institute (API) revealed that your laboratory has had unsuccessful performance for two out of three consecutive testing events for the analyte Human chronic gonadotropin (HCG) . Findings include: 1. 2nd Event 2020 HCG - 40% 2. 3rd Event 2020 HCG - 0% -- 2 of 2 --

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of Proficiency Testing records and discussion with the staff the laboratory failed to verify the accuracy of the test or procedure twice annually for the Potassium Hydroxide (KOH) test system. Findings include: 1. The surveyor requested and the laboratory failed to provide biannual verification for the KOH test system for 2018 and 2019. 2. The last biannual verification documentation was done 07/13/2017. 3. The Lead testing personnel and the Nurse Practitioner confirmed these findings on 08/21/2019 at 05:00PM. 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 review of personnel, training and competency records the laboratory director failed to provide overall management and direction of the laboratory. Refer to D6029 and D6030. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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 -- 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review of Personnel and training records and discussion with the staff the Laboratory Director failed to ensure that prior to patient testing the laboratory testing personnels have the proper education and training documentation. Findings include. 1. The surveyor requested and the laboratory failed to provide copies of diplomas or transcript of records of 5 out of 6 testing personnel (TP) performing moderately complexity testing at the time of survey. 2. The lead and the assistant lead testing personnel confirmed these findings on 08/21/2019 at 05:00 PM. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) 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)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on review of Personnel competency records and discussion with the staff the Laboratory Director who also served as the Technical Consultant failed to document competency assessment of the testing personnels performing moderate complex testing. Findings include: 1. The surveyor requested and the laboratory failed to provide documentations of competency assessment for the testing personnels performing moderate complexity testing at the time of survey. 2. 3 testing personnels that started working in the laboratory on 06/2018 have their initial training documentations but do not have their 6 months and annual comptency assessments. 2. 2 testing personnel that were hired 03/2019 and 04/2019 have their intial training documentations but do not have their 6 months competency assessments. 3. The lead testing personnel have annual competency documentation for 2017 and 2019 but no documentation for 2018. 4. The lead and the assistant lead testing personnel confirmed these findings on 08/21/2019 at 05:00PM. -- 2 of 2 --