Conway Womens Health Center Pa

Summary Statement of Deficiencies 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 review of policy and procedure manuals, temperature logs, and interview with staff, the laboratory failed to follow instructions for operational environment policies for temperature and relative humidity. Findings follow: A) Review of the "The Lab Area: Safety and Environment Monitoring', section "Procedures for Monitoring Temperature; Record the temperature of the room and the laboratory refrigerator, along with the humidity, at the beginning of each day. Use the Temperature/Humidity Chart (behind FORMS Tab) to document these readings. Adjust temperature and humidity readings that are out of range, then recheck to verify that readings have returned to the acceptable range", and section "What to Do if Temperatures Are Out of Range; Document all remedial action taken on the reverse side of the Temperature/Humidity Chart". B) Review of the normal operating condition for Affirm VPIII test system must be operated at 22-28C (71.6-82.4F) and 10-85% humidity. C) Review of the Temperature/Humidity Chart January 2024 revealed 9 days out of 21 days temperature below 71.6F. February 2024, 2 days out of 21 days temperature below 71.6F. December 2023, 5 days out of 19 days temperature below 71.6F. November 2023, 4 days out of 20 days temperature below 71.6F. September 2023, 6 days out of 19 days temperature below 71.6F. June 2023, 2 days out of 22 days temperature below 71.6F. D) During an interview on 5/28/2024 at 12: 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 -- 47 p.m. the Testing Personnel (TP) #1, listed on the CMS-209 form, confirmed the 29 days temperature below 71.6F. No

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: . Through a review of proficiency test documentation for 2021 and 2022 (four testing events), it was determined the laboratory failed to maintain a copy of attestation sheets for three of five testing events reviewed. Survey findings include: A. The surveyor reviewed documentation for the First, Second, and Third Microbiology Proficiency Test Events in 2021 and the First and Second Events in 2022. Attestation statements were not available for the First and Third Testing Events of 2021 and the First Testing Event of 2022. B. In an interview, 10:32 a.m. on 9/6/2022, laboratory employee #2 (as listed on the form CMS-209) confirmed the attestation statements were not available for three Proficiency Test Events in 2021 and 2022. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform 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 -- 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)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: . Through a review of personnel files for the seven testing personnel listed on the form CMS-209, lack of documentation, and interviews with laboratory staff, it was determined the laboratory director failed to authorize two of seven testing personnel to perform testing without direct supervision. Survey findings include: A. During a review of personnel files for seven testing personnel listed on form CMS-209 (Personnel #2 - #8) the surveyor determined employees #4 and #5 (as listed on the form CMS-209) failed to have written authorization, from the laboratory director, to perform testing without direct supervision. B. In an interview, at 10:32 a.m. on 9/6 /2022, laboratory employee #2 (as listed on the form CMS-209) confirmed the lack of written authorizations to test for employees #4 and #5. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: . Through a review of personnel records for seven testing personnel listed on the form CMS-209 it was determined the technical consultant failed to annually document competency on five of seven employees. Survey findings include: A. The surveyor reviewed personnel files for the seven testing personnel listed on the CMS-209 form as #2 through #8. B. Five of Seven testing personnel (#2, #3, #6, #7, and #8 as listed on the form CMS-209) did not have annual competency assessment documented since 1/28/2021 (19 months). C. In an interview, at 10:32 a.m. on 9/6/2022, laboratory employee #2 (as listed on the form CMS-209) confirmed the lack of annual competency assessments for five of seven testing personnel. -- 2 of 2 --

Summary Statement of Deficiencies D0000 This is the CLIA recertification survey of the laboratory conducted on 2/5/2020. At the time of the survey the laboratory was not in compliance with the following Condition of Participation: 493.1421 Laboratory Testing Personnel 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: Through a review of the BD (Becton Dickinson) MAX manufacturer's instructions, TEMPERATURE/HUMIDITY CHARTS for February 2019 through January 2020 (12 months), and interviews with staff, it was determined the laboratory failed to define acceptable humidity requirements which were consistent with the manufacturer's instructions. Survey findings include: A. The manufacturer's instructions for the BD MAX state that the acceptable operating humidity for the instrument is 20% to 80%. B. The humidity range in use on the TEMPERATURE /HUMIDITY CHARTS for February 2019 through January 2020 is 10% to 85%. C. Due to the incorrect humidity range being used the laboratory failed to identify that humidity was unacceptable on 40 of 251 days during the 12 months reviewed. D. During an interview on 2/5/2020 at 11:34, laboratory employee #2 confirmed the incorrect range was in use and that temperatures were outside of the manufacturer's acceptable range. 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 -- 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: Through a review of personnel files for eleven of eleven laboratory testing personnel listed on the form CMS-209, through a lack of documentation, and through interviews with staff, it was determined that two of eleven laboratory testing personnel failed to meet qualification requirements as testing personnel as evidenced by: D6065 - two of eleven laboratory testing personnel lacked documentation of appropriate education to qualify as a testing personnel 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 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: Through a review of personnel files for eleven of eleven laboratory testing personnel listed on the form CMS-209, through a lack of documentation, and through interviews with staff, it was determined that two of eleven laboratory testing personnel lacked documentation of appropriate education to qualify as a testing personnel. Survey findings follow: A. Documentation of appropriate education was not available for laboratory employees #7, and #11 (listed as testing personnel) as listed on the form CMS-209. B. In an interview at 11:37 on 2/5/2020, laboratory employee #2 (as listed on CMS-209) confirmed the lack of documentation of appropriate education for two of eleven testing personnel. -- 2 of 2 --

Summary Statement of Deficiencies D5785