Allentown Women's Center Inc

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 observation in the laboratory, review of laboratory temperature records, and interview with Testing Personnel(TP)#2, the laboratory failed to monitor daily temperatures to ensure reagent stability and proper operating conditions for 358 of 708 days from 4/10/2023 to 4/8/2025. Findings include: 1. On the day of survey, 4/8 /2025, at 11:30 am, during the tour of the laboratory, the surveyor observed the following reagents stored in the laboratory: - 2 boxes Monoclonal QC Albacheck. Storage requirements 2C to 8C. - 2 Anti D Blend Albaclone. Storage requirements 2C to 8C. - 2 Stanbio Hemoglobin Set. Storage requirements 2C to 8C. - 6 Aimstep Pregnancy Test kits. Storage requirements 15C to 30C. - 3 Siemens Uristix. Storage requirements 15C to 30C. - 4 Siemens Multistix. Storage requirements 15C to 30C. - 3 Hemopoint Cuvettes. Storage requirements 15C to 30C. 2. Review of the laboratory's temperature records revealed the laboratory failed to monitor and document refrigerator and room temperatures for 358 of 708 days from 4/10/2023 to 4 /8/2025. 3. The TP #2 confirmed the findings above on 4/8/2025 at 12:45 pm. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 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 -- The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on record review and interview with the laboratory director (LD) and Testing Personnel (TP) #2, the LD failed to provide overall management and direction of the laboratory in accordance with 493.1445 from 4/10/2023 to 4/8/2025. Refer to D6089, D6091, D6101, and D6106, D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under subpart H of this part; This STANDARD is not met as evidenced by: Based on review of the laboratory's procedures, proficiency testing results from the American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE), and interview with testing personnel (TP)#2, the laboratory director failed to ensure proficiency testing samples are tested as required under subpart H of this part from 4 /10/2023 to 4/8/2025. Findings include: 1. On 4/8/2025, at 10:15 am, review of the laboratory's proficiency testing recordsrevealed proficiency testing samples were run by two different testing personnel for 2 of 4 testing events in 2024 and 2025. - AAB- MLE M1 2025 was tested by TP#2 on 2/10/2025, retested by TP#3 on 2/25/2025, and the results were reported to the AAB-MLE proficiency program on 2/21/2025. - AAB- MLE M3 2024 was tested by TP#3 on 9/19/2024, retested by TP#5 on 9/19/2025, and the results were reported to the AAB-MLE proficiency program on 9/22/2024. 2. The laboratory failed to provide documentation that directed patient testing to be performed in duplicate by different testing personnel. 3. TP#2 confirmed the findings on 4/8/2025 at 11:30 am. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) (e)(4)(iii) All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratorys performance and to identify any problems that require

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: Based on review of the American Association of Bioanalysts (AAB) proficiency testing records and interview with testing personnel (TP) #2, the laboratory failed to provide 5 of the 6 attestation statements for chemistry, immunohematology, and microbiology testing in 2021 and 2022. Findings Include: 1. On the day of the survey, 04/10/2023 at 10:15 am, the laboratory could not provide the following 5 of 6 AAB PT attestation statements for chemistry, immunohematology, and microbiology testing in 2021 and 2022: - AAB Chemistry/Nonchemistry: - 2021 : Event #2, Event #3. - 2022: Event #1, Event #2, Event #3. 2. TP #2 confirmed the findings above on 04/10 /2023 around 10:30 am. D5463 CONTROL PROCEDURES CFR(s): 493.1256(d)(7)(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-- 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 -- Over time, rotate control material testing among all operators who perform the test. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of quality control records and interview with testing personnel #2 (TP), the laboratory failed to over time rotate control material testing between 5 of 6 TP who perform Rhesus factor (Rh) Group testing from 02/09/2021 to the date of the survey. Findings include: 1. On the date of the survey, 04/10/2023 at 10:15 am, review of the laboratory's daily Rh Control log revealed that 5 of 6 TP (CMS 209 personnel # 3, 4, 5, 6, and 7) did not perform QC for Rh testing performed from 02/09 /2021 to 04/10/2023. 2. The laboratory performed 2,280 Rh examinations in 2022 (CMS-116 annual volume). 3. TP #2 confirmed the finding above on 04/10/2023 around 10:30 am. -- 2 of 2 --

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 of Laboratory procedure manuals and interview with the Director of Nursing and testing personnel (TP) #1, the laboratory failed to establish a competency assessment policy to assess TP who performed Rhesus (Rh) D testing from 07/09 /2018 to the date of survey. Findings include: 1. On the day of survey, 02/08/2020, the Director of Nursing and TP#1 could not provide a written competency assessment policy that reviews how to assess the competency of TP who performed Rh D testing in 2018, 2019, 2020 and 2021. 2. The Director of Nursing and TP #1 confirmed the finding above on 02/08/2021 around 1:20 pm. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) 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)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; 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 -- This STANDARD is not met as evidenced by: Based on review of laboratory procedure manuals and interview with the Director of Nursing and testing personnel (TP) #1, the laboratory Director failed to establish a proficiency testing (PT) procedure for TP who performed the American Association of Bioanalysts (AAB), Rhesus (Rh) D PT samples from 07/09/2018 to the date of survey. Findings include: 1. On the day of survey, 02/08/2020, the Director of nursing and TP #1 could not provide a written PT procedure that reviews how TP were to perform AAB Rh D PT samples in 2018, 2019, 2020 and 2021. 2. The Director of Nursing and TP #1 confirmed the finding above on 02/08/2021 around 1:30 pm. -- 2 of 2 --