Center For Women's Health

Summary Statement of Deficiencies D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on documentation of testing personnel (TP) competencies, and personnel qualifications, the laboratory failed to have a qualified person performing duties as a technical consultant. See D6035. D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant 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 at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i) Hold an earned doctoral or master's 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 -- degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (b)(3)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. Note: The technical consultant requirements for "laboratory training or experience, or both" in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service, excluding waived tests. For example, an individual who has a bachelor's degree in biology and additionally has documentation of 2 years of work experience performing tests of moderate complexity in all specialties and subspecialties of service, would be qualified as a technical consultant in a laboratory performing moderate complexity testing in all specialties and subspecialties of service. This STANDARD is not met as evidenced by: Based on the review of the CMS 209 personnel report, documentation of testing personnel (TP) competencies, personnel qualifications, and interview, the laboratory failed to have a qualified person(s) performing duties as a technical consultant (TC). Findings: 1. Review of the CMS209 revealed one technical consultant and six TP for moderate complexity testing. Four of six TP had been employed for longer than six months. 2. Review of "Center for Women's Health Individual competency" forms revealed: a. Competencies in 2023 and 2024 for TP #2, #3, and #4 included direct observations that were performed by TP #1 who did not qualify as a TC. b. Competency in 2023 and 2024 for TP #1 included direct observations that were performed by a nurse practitioner who did not qualify as a TC. 3.Interview with the TP #1 on 7/30/24 at 9:30 a.m. confirmed, the laboratory failed to have a qualified person(s) performing duties as a technical consultant. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on review of the CMS 209 form, personnel records, and interview with the practice consultant, the laboratory failed to have educational credentials required to qualify one of six testing personnel (TP) to perform moderate complexity testing prior to reporting patient results (refer to D6065). D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology -- 2 of 3 -- from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on review of the CMS 209 form, personnel records, and interview with the practice consultant, the laboratory failed to have educational credentials required to qualify one of six TP to perform moderate complexity testing prior to reporting patient results. Findings: 1. Review of the CMS209 revealed six moderate complexity TP. 2. The surveyor requested credentials to qualify the TP. No educational credentials were made available to qualify TP #5 at the time of survey. TP #5 performed and reported 112 patient results from 12/5/22 to 4/20/23. 3. Interview with the practice consultant on 7/30/24 at 11:45 a.m. confirmed, the laboratory failed to have educational credentials required to qualify one of six TP to perform moderate complexity testing prior to reporting patient results. -- 3 of 3 --

Summary Statement of Deficiencies 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 review procedures and interview with the laboratory supervisor on January 18, 2019 at 10:30 AM confirmed the laboratory failed to establish a written procedure to assess employee competency. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of manufacturer's insert, observation of Eldoncard RhD, quality control and interview the laboratory failed to meet condition: Analytic systems. The laboratory failed to follow manufacturer's insert (refer to D5411); failed to label Eldoncard RhD with open date or expiration date (refer to D5415) and failed to perform quality control each day of patient testing (refer to D5449). 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 -- D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of Eldoncard RhD manufacturer's insert and interview with the laboratory supervisor the laboratory failed to follow the manufacturer's requirements for storage and stability. Findings: 1. Review of the Eldoncard manufacturer's insert revealed "An EldonBag can be opened for removal of cards at least 50 times during the six months period." No documentation for amount of times EldonBag has been opened could be provided. 2. Interview with the laboratory supervisor on January 18, 2019 at 10:30 AM confirmed the laboratory failed to follow the manufacturer's guidelines for storage and stability of Eldoncards for Rh testing. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation of Eldoncard RhD cards lot # 18411 in use and interview with the laboratory supervisor the laboratory failed to label Eldoncard RhD cards in use with an expiration date. Findings: 1. Observation of Eldoncard RhD card package states "expires 6 months after first opening". 2. Observation of Eldoncard RhD card package showed no open date or expiration date on package. 3. Interview with the laboratory supervisor on January 18, 2019 at 10:30 AM confirmed the laboratory failed to label Eldoncard RhD cards in use with open date or expiration date. 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 review of Eldoncard RhD quality control (QC) and interview with the laboratory supervisor on January 18, 2019 at 10:30 AM the laboratory failed to perform a positive and negative control for Eldoncard RhD each day of patient testing. -- 2 of 4 -- 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