American Women's Services

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 an office review of the CASPER reports 153 and 155 and proficiency testing provider reports, the laboratory failed to achieve 80% or more in two out of three events for ABO and Rh Factor testing with the American Association of Bioanalysts. D2153 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(a) Failure to attain a score of at least 100 percent of acceptable responses for each analyte or test in each testing event is unsatisfactory analyte performance for 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 3 -- testing event. This STANDARD is not met as evidenced by: Based on an office review of the CASPER reports 153 and 155 and Proficiency Testing (PT) provider reports, the laboratory failed to attain an overall testing event score of at least 100 percent for D (Rho) typing with the American Association of Bioanalysts PT in the Sewcond and third event of 2023. The finding includes: 1. The laboratory scored 0 % for ABO Group and D (Rho) Typing in the second and third events of 2023 D2154 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(b) Failure to attain an overall testing event score of at least 100 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on an office review of the CASPER reports 153 and 155 and Proficiency Testing (PT) provider reports, the laboratory failed to attain an overall testing event score of at least 100 percent for D (Rho) typing prformed the findings include. 1. The laboratory scored 0% for D (Rho) Typing and ABO Group event 2, 2023 with American Association of Bioanalysts (AAB). 2. The laboratory scored 0% for D (Rho) Typing and ABO Group event 3, 2023 with AAB. D2155 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(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 surveyor review of the Proficiency Testing (PT) records and review of CASPER reports 153 and 155, the laboratory failed to submit ABO Group and D (Rho) Typing results to the American Association of Bioanalysts in events 2 and 3 in 2023. 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. -- 2 of 3 -- This CONDITION is not met as evidenced by: Based on an office review of the laboratory's performance in Proficiency Testing (PT) surveys, the laboratory director failed to provide appropriate direction to the laboratory personnel to ensure that the PT surveys are performed satisfactorily and compliance with the CLIA regulations are maintained. -- 3 of 3 --

Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: a) Based on an in-office review of the laboratory's requirements for a New Jersey State Clinical Laboratory License (NJCLL) under New Jersey Statutes Annotated: N.J. S.A. 45:9-42.28. License; necessity; categories, the laboratory failed to obtain a NJCLL before the laboratory started patient testing. The Supervisor for the Clinical Laboratory Improvement Services (CLIS) confirmed on 12/20/22 that the laboratory did not obtain its NJCLL license before the laboratory started testing. b) Based on interview with the office manager, and an in-office interview with Supervisor for the CLIS both confirmed on 11/30/22 that Laboratory Director (LD) did not hold a license for bioanalytical laboratory director under New Jersey State Administrative Code: N.J.A.C. 8:44-2.3. The the LD listed on the CMS 209 form is not a qualified LD as stated above. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on the lack of Competency Assessment (CA) records and interview with the Office Manager (OM), the laboratory failed to perform a CA on five out of fivew 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 -- testing personnel for the calendar years 2020 and 2021. The OM confirmed on 12/20 /22 at 10:30 am that the CA was not performed as stated above. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM), the lack of Quality Assurance records and interview with the Office Manager (OM), the laboratory failed to follow their procedure for"Quality Assurance Procedures" in the calendar years 2021 and 2022. The findings include: 1. The procedure "Quality Assurance Procedures" stated "Every three months the following items will be reviewed by the Lab Director": a) "Daily Laboratory Logs" b) "The Quality Control Log" c) "The Refrigerator Temperature log" d) "participation in a proficiency testing program" 2. There was no documented evidence the above mentioned procedure was performed in the calendar years 2021 and 2022 3. The OM confirmed on 12/20/22 at 11:38 am that the laboratory did not follow the PM. 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 surveyor review of the Daily Laboratory Log (DLL) and interview with the Office Manager (OM), the laboratory failed to monitor and document Room temperature, Refrigerator temperature, and View box temperature where immunohematology tests are performed on the date of survey. The finding include: 1. Room temperature, Refrigerator temperature, and View box temperature were not documented on the DLL 7/11/22, 7/18/22, 12/17/22 2. The OM confirmed on 12/20 /22 at 11:35 am that Room temperature, Refrigerator, and View box temperature were not documented . D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. -- 2 of 5 -- This STANDARD is not met as evidenced by: Based on surveyor observation of Capillary tubes and interview with the Office Manager (OM), the laboratory failed to discard expired Capillary tubes from 4/30/21 to the date of survey. The finding include: 1. Capillary Tubes used on the Adams Micro Hematocrit analyzer expired 4/30/2021. 2. Approximately 300 patients were tested with expired Capillary Tubes . 3. The OM confirmed on 12/20/22 at 10:30 am that the laboratory used expired Capillary Tubes. 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 surveyor review of the Quality Control (QC) records and interview with the Office Manager (OM), the laboratory failed to perform and document Immunohematolgy QC on each day of patient testing on the date of survey. The findings include: 1. The QC records reviewed showed that the lab did not perform positive and negative QC on the following dates: 7/9/22, 7/11/22,7/15/22, 7/16/22, 7 /18/22, 12/17/22 2. Approximately 70 patients where run and reported. 3. The OM confirmed on 12/20/22 at 11:30 am that positive and negative QC were not run every day of patient testing. 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: a) Based on surveyor review of the Laboratory records and interview with the Office Mnager (OM)), the Laboratory Director (LD) failed to provide overall management and direction to the laboratory from 10/08/19 to the date of survey. The findings include: 1. The LD failed to ensure that all PT results received were reviewed . Cross refer D6018 2. The LD failed to ensure that the QC program was maintained. Cross refer D6020. 3. The LD failed to maintained a QA plan. Cross refer D6021. 4. The LD failed to maintain all QC records: Cross refer D6072 b) Based interview with the Office Manager (OM) and in-office interview with the Supervisor for the Clinical Laboratory Improvement Services (CLIS) The laboratory failed have a a qualified Laboratory Director (LD) an the date of survey. Cross refer 3009 D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of -- 3 of 5 -- 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 D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Office Manager (OM), the laboratory failed to ensure that Testing Personnel (TP) who performed Rhesus Factor Tests participated in the American Association of Bioanalysts PT events in the calendar years 2018 and 2019. The finding includes: 1. A review of all PT event revealed that one out of five TP performed PT events in 2018 and 2019. 2. The OM confirmed on 10/8/19 at 1:30 pm that PT events were not rotated between TP. 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 --