Women's Health Associates Llp

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing company, American Proficiency Testing (API). The facility was found to be out of compliance with the conditions of the CLIA program. The conditions not met were: D2016 - 42 C.F.R. 493.803 Condition: Successful participation in a proficiency testing program D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director 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 review of the CMS Casper 153 & 155 proficiency testing reports and the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- American Proficiency Institute proficiency testing records for the 1st and 2nd testing events in 2020, the laboratory failed to successfully participate in proficiency testing for Bacteriology, Mycology, and Parasitology (See D2028, D2046, and D2055). D2021 BACTERIOLOGY CFR(s): 493.823(b) 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 desk review of proficiency testing records, the laboratory failed to participate in two consecutive testing events resulting in a test score of 0% in Bacteriology for the 1st and 2nd Events, respectively in 2020. Findings follow. Review of the CMS Casper Report 153 showed the facility received 2 out of 3 consecutive failures with scores of 0 in the report. Review of the CMS Casper Report 155 showed scores of 0 in Bacteriology for the 1st and 2nd events of 2020. Review of the American Proficiency Institute Performance Summary for the 2020 Microbiology 1st and 2nd Events, respectively, show scores of 0% for Gardnerella vaginalis under the subspecialty of Bacteriology in the specialty of Microbiology and a Failure to Participate under the notes. D2028 BACTERIOLOGY CFR(s): 493.823(e) 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 desk review of proficiency testing records, the laboratory failed two consecutive testing events resulting in unsuccessful performance with a test score of 0% in Bacteriology for the 1st and 2nd Events, respectively in 2020. Findings follow. Review of the CMS Casper Report 153 showed the facility received 2 out of 3 consecutive failures with scores of 0 in the report. Review of the CMS Casper Report 155 showed scores of 0 in Bacteriology for the 1st and 2nd events of 2020. Review of the American Proficiency Institute Performance Summary for the 2020 Microbiology 1st and 2nd Events, respectively, show scores of 0% for Gardnerella vaginalis under the subspecialty of Bacteriology in the specialty of Microbiology. D2039 MYCOLOGY CFR(s): 493.827(b) Failure to participate in a testing event is unsatisfactory performance and results in a -- 2 of 5 -- 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 desk review of proficiency testing records, the laboratory failed to participate in two consecutive testing events resulting in a test score of 0% in Mycology for the 1st and 2nd Events, respectively in 2020. Findings follow. Review of the CMS Casper Report 153 showed the facility received 2 out of 3 consecutive failures with scores of 0 in the report. Review of the CMS Casper Report 155 showed scores of 0 in Bacteriology for the 1st and 2nd events of 2020. Review of the American Proficiency Institute Performance Summary for the 2020 Microbiology 1st and 2nd Events, respectively, show scores of 0% for Candida sp. under the subspecialty of Mycology in the specialty of Microbiology and a Failure to Participate under the notes. D2046 MYCOLOGY CFR(s): 493.827(e) 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 desk review of proficiency testing records, the laboratory failed two consecutive testing events resulting in unsuccessful performance with a test score of 0% in Mycology for the 1st and 2nd Events, respectively in 2020. Findings follow. Review of the CMS Casper Report 153 showed the facility received 2 out of 3 consecutive failures with scores of 0 in the report. Review of the CMS Casper Report 155 showed scores of 0 in Bacteriology for the 1st and 2nd events of 2020. Review of the American Proficiency Institute Performance Summary for the 2020 Microbiology 1st and 2nd Events, respectively, show scores of 0% for Candida sp. under the subspecialty of Mycology in the specialty of Microbiology. D2048 PARASITOLOGY CFR(s): 493.829(b) 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. -- 3 of 5 -- This STANDARD is not met as evidenced by: Based on desk review of proficiency testing records, the laboratory failed to participate in two consecutive testing events resulting in a test score of 0% in Parasitology for the 1st and 2nd Events, respectively in 2020. Findings follow. Review of the CMS Casper Report 153 showed the facility received 2 out of 3 consecutive failures with scores of 0 in the report. Review of the CMS Casper Report 155 showed scores of 0 in Bacteriology for the 1st and 2nd events of 2020. Review of the American Proficiency Institute Performance Summary for the 2020 Microbiology 1st and 2nd Events, respectively, show scores of 0% for Trichomonas vaginalis under the subspecialty of Parasitology in the specialty of Microbiology and a Failure to Participate under the notes. D2055 PARASITOLOGY CFR(s): 493.829(e) 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 desk review of proficiency testing records, the laboratory failed two consecutive testing events resulting in unsuccessful performance with a test score of 0% in Parasitology for the 1st and 2nd Events, respectively in 2020. Findings follow. Review of the CMS Casper Report 153 showed the facility received 2 out of 3 consecutive failures with scores of 0 in the report. Review of the CMS Casper Report 155 showed scores of 0 in Bacteriology for the 1st and 2nd events of 2020. Review of the American Proficiency Institute Performance Summary for the 2020 Microbiology 1st and 2nd Events, respectively, show scores of 0% for Trichomonas vaginalis under the subspecialty of Parasitology in the specialty of Microbiology. 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 the CMS Casper 153 & 155 proficiency testing reports and the American Proficiency Institute proficiency testing records for the 1st and 2nd testing events in 2020, the Laboratory Director failed to provide direction and management for the laboratory testing performed (see D6017). D6017 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(ii) 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 -- 4 of 5 -- and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(ii) Ensure that results are returned within the timeframes established by the proficiency testing program. This STANDARD is not met as evidenced by: Based on review of the CMS Casper 153 & 155 proficiency testing reports and the American Proficiency Institute proficiency testing records for the 1st and 2nd testing events in 2020, the Laboratory Director failed to ensure the laboratory participated in proficiency testing for Bacteriology, Mycology, and Parasitology (See D2028, D2046, and D2055). -- 5 of 5 --

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 upon a review of proficiency testing records for program years 2018 and 2019 and staff interview, the laboratory failed to ensure that the attestation statements for Microbiology were signed by testing personnel and the laboratory director or designee in two of five events reviewed. Findings included: 1. Review of proficiency test records from the American Proficiency Institute (API) proficiency testing program revealed that Testing personnel and the Laboratory director or designee failed to physically sign attestation statements in two of five testing events between the first testing event of 2018 and the second testing event of 2019 (3 testing events per year). a. 2018 Microbiology 2nd Testing Event failed to have a physical signature of the testing personnel, only the Laboratory Director's signature. b. 2019 Microbiology 1st Testing event failed to have a physical signature of the testing personnel or the Laboratory Director. 2. Interview of the office manager conducted on October 3, 2019 at 9:42 AM confirmed the above findings. D2021 BACTERIOLOGY CFR(s): 493.823(b) 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 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 -- 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: Review of the laboratory's CMS 155 report, proficiency testing records from 2018 and 2019 and staff interview found the laboratory failed to participate in one of five Microbiology testing events reviewed. The findings included: 1. Review of the CMS report 155 ( printed August 8, 2019) found that the proficiency testing agency reported a score of 0% for Bacteriology in the 2018 1st testing event. 2. A review of the laboratory's American Proficiency Institute's (API) bacteriology proficiency testing records from 2018 and 2019 found documentation on the 2018 Microbiology 1st event performance evaluation: "Samples were misplaced and run after the submission deadline. Positive (trivalent) and negative controls were run without interruption. After testing results were received, our results were compared to the correct results and were fond to be 100% correct." 3. Interview of the Office Manager conducted on Thursday, October 3, 2019 at 9:46 AM confirmed the laboratory failed to test and submit the results of the 2018 Microbiology 1st testing event prior to the submission date resulting in an overall score of 0% for the event. 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: Review of proficiency testing results and interview of facility personnel found that the laboratory director failed to ensure that attestation statements were signed by testing personnel and the laboratory director in two of five Microbiology testing events between the 1st testing event of 2018 and the 2nd testing event of 2019. (See D 2009) D6017 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(ii) 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)(ii) Ensure that results are returned within the timeframes established by the proficiency testing program. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing records from 2018 and 2019 and staff interview the laboratory director failed to ensure proficiency test results were -- 2 of 3 -- returned prior to the submission deadline in one of five Microbiology testing events. (refer to D2121). -- 3 of 3 --