Feminist Health Center Of Portsmouth

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 record review, the laboratory (lab) failed to successfully particiapte in proficiency tesing (PT) program for subspecialty ABO/RHO and analyte D (RHO) blood type testing in PT events 1 and 2 of 2025. Findings include: 1. The lab failed to participate in PT events 1 and 2 of 2025 resulting in unsatisfactory performance. Refer to D2155. 2. The lab failed to accheive satisfactory performance in 2 consecutive PT events 1 and 2 of 2025 resulting in unsuccessful PT performance for the analyte D (RHO). Refer to D2162. 3. The lab failed to acheive an overall satifactory peformance score in 2 consecutive PT events 1 and 2 of 2025 resulting in unsuccessful PT performance for subspecialty ABO/RHO blood typing. Refer to D2163. 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 -- D2155 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(c) (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 record review, the laboratory (lab) failed to obtain satisfactory proficiency testing (PT) scores for D (RHO) in PT events 1 and 2 of 2025. Findings include: 1. Review on 8/1/2025 of the lab's AAB/MLE PT results for events 1 and 2 of 2025 revealed the lab failed to submit results in both events for D (RHO) blood type testing to AAB/MLE PT company resulting in a 0% analyte score for each PT event. 2. Review on 8/1/2025 of CASPER report 0155D confirmed the lab obtained unsatisfactory scores of 0% for D (RHO) blood type testing in both AAB/MLE PT events 1 and 2 of 2025. D2162 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(f) (f) Failure to achieve satisfactory performance for the same analyte 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 record review, the laboratory (lab) obtained unsatisfactory analyte scores for D (RHO) blood typing in consecutive proficiency testing (PT) events 1 and 2 of 2025 resulting in unsuccessful PT performance for analyte D (RHO). Findings include: 1. Review on 8/1/2025 of the lab's AAB/MLE PT results for events 1 and 2 of 2025 revealed the lab failed to submit results in both events for D (RHO) blood type testing to AAB/MLE PT company resulting in a 0% analyte score for the two consecutive PT events. 2. Review on 8/1/2025 of CASPER report 0155D confirmed the lab obtained unsatisfactory scores of 0% for D (RHO) blood type testing in both AAB/MLE PT events 1 and 2 of 2025. D2163 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(g) (g) Failure to achieve an overall testing event score of satisfactory 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 record review, the laboratory (lab) obtained overall unsatisfactory -- 2 of 3 -- performance scores for D (RHO) blood typing in consecutive proficiency testing (PT) events 1 and 2 of 2025 resulting in unsuccessful PT performance for the overall subspecialty ABO/RHO. Findings include: 1. Review on 8/1/2025 of the lab's AAB /MLE PT results for events 1 and 2 of 2025 revealed D(RH) (RHO) testing was the only immunohematology test listed for the lab and no results were submitted to AAB /MLE PT company resulting in a 0% analyte score for both events and a 0% overall score for subspecialty ABO/RHO blood typing. 2. Review on 8/1/2025 of CASPER report 0155D confirmed the lab obtained an overall unsatisfactory score for both AAB /MLE PT events 1 and 2 of 2025 for ABO/RHO blood typing. -- 3 of 3 --

Summary Statement of Deficiencies D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to perform a positive and negative Rh antigen control on 8 of 8 days of patient testing between October 1, 2020 to January 26, 2021. Findings include: 1) Review on 1/26/2021 of the laboratory's procedure titled "Lab Quality Control" revealed on page 1, paragraph 1: "Rh Controls will be run each day that Rh testing occurs in the laboratory." The procedure failed to specify a positive and negative control. 2) Review on 1/26/2021 of control records for Rh antigen typing from October 2020 to January 26, 2021 revealed one positive control had been run on 12/30/2020 for test kit lot #20161 (expiration date: 2/28/2022). The laboratory could not provide documentation of control testing for previous test kit lot(s) used between 10/1/2020 through 12/29/2020, and could not provide quality control test results for dates when patient testing had been performed. 3) Interview with the Technical Consultant on 1/26/2021 at approximately 1030 a.m. revealed the laboratory only performed a positive control one time for each new shipment. 4) Review of patient records from 10/1/2020 through 1/26/2021 revealed a combined total of 29 patient Rh tests had been performed on the following dates (# patient tests): 10/3/2020 (7), 10/6/2020 (2), 11/5/2020 (3), 12/4/2020 (2), 12/12/2020 (3), 12/18/2020 (3), 1/8/2021 (4), and 1/23/2021 (5). 5) Interview with the Executive Director on 1/26/20021 at 10:45 a.m. confirmed the above findings. 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 --

Summary Statement of Deficiencies 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 record review and staff interview conducted on 9/19/2018, the laboratory director (LD) failed to meet LD qualification requirements for moderately complex testing in 2017 and 2018. Refer to tag D6003. D6003 LABORATORY DIRECTOR QUALIFICATIONS CFR(s): 493.1405 AND 493.1406 The laboratory director must be qualified to manage and direct the laboratory personnel and the performance of moderate complexity tests and must be eligible to be an operator of a laboratory within the requirements of subpart R of this part. (a) The laboratory director must possess a current license as a laboratory director issued by the State in which the laboratory is located, if such licensing is required; and (b) The laboratory director must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the Laboratory is located; and (b)(2)(ii) Have had laboratory training or experience consisting of: (b)(2)(ii)(A) At least one year directing or supervising non- waived laboratory testing; or (b)(2)(ii)(B) Beginning September 1, 1993, have at least 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 -- 20 continuing medical education credit hours in laboratory practice commensurate with the director responsibilities defined in 493.1407; or (b)(2)(ii)(C) Laboratory training equivalent to paragraph (b)(2)(ii)(B) of this section obtained during medical residency. (For example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine); or (b)(3) Hold an earned doctoral degree in a chemical, physical, biological, or clinical laboratory science from an accredited institution; and (b)(3)(i) Be certified by the American Board of Medical Microbiology, the American Board of Clinical Chemistry, the American Board of Bioanalysis, or the American Board of Medical Laboratory Immunology; or (b)(3)(ii) Have had at least one year experience directing or supervising non-waived laboratory testing; (b)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; (b)(4)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing; and (b)(4)(iii) In addition, have at least one year of supervisory laboratory experience in non-waived testing; or (b)(5)(i) Have earned a bachelor's degree in a chemical, physical, or biological science or medical technology from an accredited institution; (b)(5)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing; and (b)(5)(iii) In addition, have at least 2 years of supervisory laboratory experience in non-waived testing; (b)(6) Be serving as a laboratory director and must have previously qualified or could have qualified as a laboratory director under 493.1406; or (b)(7) On or before February 28, 1992, qualified under State law to direct a laboratory in the State in which the laboratory is located. Laboratory director qualifications on or before February 28, 1992 The laboratory director must be qualified to manage and direct the laboratory personnel and test performance. (a) The laboratory director must possess a current license as a laboratory director issued by the State, if such licensing exists; and (b) The laboratory director must: (b)(1) Be a physician certified in anatomical or clinical pathology (or both) by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; (b)(2) Be a physician who: (b)(2)(i) Is certified by the American Board of Pathology or the American Osteopathic Board of Pathology in at least one of the laboratory specialties; or (b)(2)(ii) Is certified by the American Board of Medical Microbiology, the American Board of Clinical Chemistry, the American Board of Bioanalysis, or other national accrediting board in one of the laboratory specialties; or (b)(2)(iii) Is certified by the American Society of Cytology to practice cytopathology or possesses qualifications that are equivalent to those required for such certification; or (b)(2)(iv) Subsequent to graduation, has had 4 or more years of full-time general laboratory training and experience of which at least 2 years were spent acquiring proficiency in one of the laboratory specialties; (b)(3) For the subspecialty of oral pathology only, be certified by the American Board of Oral Pathology, American Board of Pathology or the American Osteopathic Board of Pathology or possesses qualifications that are equivalent to those required for certification; (b)(4) Hold an earned doctoral degree from an accredited institution with a chemical, physical, or biological science as a major subject and (b)(4)(i) Is certified by the American Board of Medical Microbiology, the American Board of Clinical Chemistry, the American Board of Bioanalysis, or other national accrediting board acceptable to HHS in one of the laboratory specialties; or (b)(4)(ii) Subsequent to graduation, has had 4 or more years of full-time general laboratory training and experience of which at least 2 years were spent acquiring proficiency in one of the laboratory specialties; (b)(5) With respect to individuals first qualifying before July 1, 1971, have been responsible for the direction of a laboratory for 12 months between July 1, 1961, and January 1, 1968, and, in addition, either: (b)(5)(i) Was a physician and subsequent to graduation had at least 4 years of pertinent full-time laboratory experience; (b)(5)(ii) Held a master's -- 2 of 3 -- degree from an accredited institution with a chemical, physical, or biological science as a major subject and subsequent to graduation had at least 4 years of pertinent full- time laboratory experience; (b)(5)(iii) Held a bachelor's degree from an accredited institution with a chemical, physical, or biological science as a major subject and subsequent to graduation had at least 6 years of pertinent full-time laboratory experience; or (b)(5)(iv) Achieved a satisfactory grade through an examination conducted by or under the sponsorship of the U.S. Public Health Service on or before July 1, 1970; or (b)(6) Qualify under State law to direct the laboratory in the State in which the laboratory is located. Note: The January 1, 1968 date for meeting the 12 months' laboratory direction requirement in paragraph (b)(5) of this section may be extended 1 year for each year of full-time laboratory experience obtained before January 1, 1958 required by State law for a laboratory director license. An exception to the July 1, 1971 qualifying date in paragraph (b)(5) of this section was made provided that the individual requested qualification approval by October 21, 1975 and had been employed in a laboratory for at least 3 years of the 5 years preceding the date of submission of his qualifications. This STANDARD is not met as evidenced by: Based on record review and staff interview conducted on 9/19/2018, the laboratory director (LD) failed to meet training or experience qualification requirements for directing a laboratory performing moderately complex testing in 2017 and 2018. Findings include: 1) Review on 9/19/2018 of the memorandum of understandings between the laboratory and medical director revealed effective February 1, 2017, the medical director accepted responsibilities as the LD. 2) Review on 9/19/2018 of the LD's qualifications revealed the LD failed to meet qualification requirements for training or experience found at 493.1403(b)(2)(ii). 3) The laboratory was unable to provide any other documentation that the laboratory director met qualification requirements during the time of the survey. 4) Interview on 9/19/2018 at 11:30 a.m. with the executive director confirmed the above findings. D9999 493.51 Notification requirements for laboratories issued a certificate of compliance Laboratories issued a certificate of compliance must meet the following conditions: (a) Notify HHS or its designee within 30 days of any change in-- (1) Ownership; (2) Name; (3) Location; (4) Director; or (5) Technical supervisor (laboratories performing high complexity only). This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to notify the HHS designee at the State Agency (SA) of a change in laboratory director within 30 days. Findings include: 1) Review on 9/19/2018 of the memorandum of understandings between the laboratory and the laboratory director revealed the a change in laboratory director effective February 1, 2017. 2) Review on 09/18/2018 of licensing unit in New Hampshire (NH) records received on 6/25/2018 revealed a change in laboratory director. The laboratory failed to notify the CLIA program in NH's certification unit (the HHS designated SA) of the laboratory director change. 3) Interview on 9/19/2018 at 11:30 a.m. with the executive director confirmed the above findings. -- 3 of 3 --