Oregon Medical Group Center For Women

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on September 17, 2024. At the time of review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following condition deficiencies cited: D2016 - 42 CFR 493.803 Condition: Successful Participation D6000 - 42 CFR 493.1403 Condition: Moderate Complexity 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 proficiency testing (PT) desk review of the Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing failure summary results, review of the CASPER Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- Report 0155D, and phone conversation with the technical consultant (TC), revealed the laboratory had unsuccessful participation for three (3) consecutive testing events for the subspecialty of Endocrinology. Refer to D2100 & D2107. D2100 ENDOCRINOLOGY CFR(s): 493.843(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 proficiency testing (PT) desk review of the Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing results, review of the Casper Report 0155D , and phone conversation with the technical consultant (TC), revealed the laboratory failed to participate in two (2) consecutive events resulting in zero score for the 1st and 2nd event of 2024 in subspecialty of Endocrinology. Findings includes: 1. Review of WSLH PT revealed 1st and 2nd events 2024. a. Endocrinology = 0% b. Human Chorionic gonadotropin (HCG) = 0% 2.. Review of Casper Report 0155D 1st and 2nd events 2024 a. Endocrinology = 0% b. HCG = 0% 3. Phone conversation with the TC on 09/17/2024 at 11:06 AM confirmed these findings. 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 unsuccessful performance. This STANDARD is not met as evidenced by: Based on proficiency testing(PT) desk review of the Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing results, review of the Casper Report 0155D, and phone conversation with the technical consultant (TC), revealed the laboratory had unsuccessful participation for three (3) consecutive events for the analyte human chorionic gonadotropin (HCG) in subspecialty of Endocrinology. Findings include. 1. Review of the WSLH PT revealed. a. 3rd Event 2023 HCG = 20% b. 1st Event 2024 HCG = 0% c. 2nd event 2024 HCG = 0% 2. Review of the Casper report 0155D revealed. a. 3rd event 2023 HCG = 20% b. 1st event 2024 HCG = 0% c. 2nd event 2024 HCG = 0% 3. Phone conversation with the TC on 09/17/2024 at 11:06 AM confirmed these findings D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. -- 2 of 4 -- 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 proficiency testing(PT) desk review of the Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing results, review of the Casper Report 0155D, and phone conversation with the technical consultant (TC), revealed the laboratory director failed to provide overall management and direction to the laboratory. Refer to D6016 & D6017. 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: Based on proficiency testing (PT) desk review of the Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing results, review of the Casper Report 0155D, and phone conversation with the technical consultant (TC) revealed, the laboratory director (LD) failed to ensure the laboratory had successful participation in an HHS approved proficiency testing program on three (3) consecutive events for the analyte human chorionic gonadotropin (HCG) in subspecialty of Endocrinology. Findings include. 1. Review of the WSLH PT revealed. a. 3rd Event 2023 HCG = 20% b. 1st Event 2024 HCG = 0% c. 2nd event 2024 HCG = 0% 2. Review of the Casper report 0155D revealed. a. 3rd event 2023 HCG = 20% b. 1st event 2024 HCG = 0% c. 2nd event 2024 HCG = 0% 3. Phone conversation with the TC on 09/17/2024 at 11:06 AM confirmed the LD failed to ensure the laboratory had successful proficiency testing participation. 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 Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing performance summary reports, and Casper Report 0155D, and phone interview with the technical consultant (TC), the laboratory director (LD) failed to ensure the laboratory participated and submitted the proficiency testing (PT) results on time to the their proficiency testing provider which resulted in zero scores for the 1st and 2nd -- 3 of 4 -- event of 2024 in Endocrinology.. Findings include: 1. Review of WSLH PT revealed 1st and 2nd event 2024. a. Endocrinology = 0% b. Human Chorionic Gonadotropin( HCG) = 0% 2. Review of Casper Report 0155 D 1st and 2nd events 2024 a. Endocrinology = 0% b. HCG = 0% 3. Phone conversation with the TC on 09/17/2024 @ 11:06 AM confirmed that the laboratory director failed to ensure the laboratory participated and submitted the PT results on time to the PT provider. -- 4 of 4 --

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) desk review of the Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing results, review of the Casper Report 0155D , and phone conversation with the technical supervisor (TS) revealed the laboratory had unsuccessful participation for two consecutive testing event for the specialty endocrinology. Refer to D2107. D2107 ENDOCRINOLOGY CFR(s): 493.843(f) 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 achieve satisfactory performance for the same analyte or test in 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 proficiency testing(PT) desk review of the Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing results, review of the Casper Report 0155D, and phone conversation with the technical supervisor(TS) revealed the laboratory had unsuccessful participation for two(2) consecutive events for the analyte human chorionic gonadotropin (HCG). Findings include. 1. Review of the WSLH PT revealed. a. 3rd Event 2023 HCG = 20% b. 1st Event 2024 HCG = 0% 2. Review of the Casper report 0155D revealed. a. 3rd event 2023 HCG = 20% b. 1st event 2024 HCG = 0% 3. Phone conversation with the TS on 07/16/2024 at 15:20 PM confirmed these findings 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 proficiency testing(PT) desk review of the Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing results, review of the Casper Report 0155D, and phone conversation with the technical supervisor(TS) revealed the laboratory director failed to provide overall management and direction to the laboratory. Refer to D6018. 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 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 upon review of competency records for providers and discussion with the Lab Manager, the laboratory failed to ensure all providers performing microscopy participated in biannual verification. Findings include: 1. One (1) out of five (5) providers at the clinic failed to complete the biannual verification for providers performing microscopy for 2019. 2. The Lab Manager confirmed during interview on 8/12/2019 at approximately 1245 that this provider had not participated in the biannual verification 2019 she oversees. 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 --