Planned Parenthood Ncsnj - Shrewsbury

Summary Statement of Deficiencies D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. 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 review coded results for potassium Hydroxide (KOH) Testing performed with the American Proficiency Institute (API) in the second event of 2024 and third event of 2023. The findings include: 1. The laboratory received a coded result (Code 2 -No Consensus) "See Data Summary" for Vaginal Wet Preparation as follows: a) 2nd event 2024 sample VA-02 b) 3rd event 2023 sample VA-03 2. There was no documented evidence that coded PT result was reviewed. 3. The OM confirmed on 1/3/25 at 11:15 am that the laboratory did not review coded PT results. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) (d)(10) Establish or verify the criteria for acceptability of all control materials. (d)(10) (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (d)(10)(ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (d)(10)(iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. 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 the lack of Quality Control Verification (QCV) records and interview with the Office Manager (OM)), the laboratory failed to verify QC material before patient testing for Rhesus factor performed on Eldoncard test system from May 2024 to the date of survey. The findings include: 1) There was no documented evidence that QCV was performed on the aforementioned test system. 2) The OM confirmed 1/3/25 at 11: 00 am there was no documented evidence that QC material was verified before patient testing. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual and interview with Office Manager (OM), the laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems from 9/20/23 to the date of survey. The finding includes: 1. The laboratory lacked a Quality Control Verification (QCV) procedure for all Rhesus factor (Rh) testing performed by the laboratory. 2. The OM confirmed on 1/3/25 at 11:45 am that the laboratory failed to have a QCV procedure for Rh testing. -- 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 surveyor review of the Competency Assessment (CA) records, Procedure Manual (PM) and interview with the Laboratory Manager (LM) the laboratory failed to establish and follow written policies and procedures for assessing the competency of Testing Personnel (TP) from 3/4/21 to the date of survey. The findings include: 1. The PM states " Document Annual evaluation of staff competency at time of initial orientation and annual evaluation (see appendix for evaluation form)." 2. The laboratory failed to establish a written policy for semiannual competency assessment of TP during the first year of employment after the initial training is completed. 3. 3 out of 6 TP did not have documented evidence semiannual CA were performed. 4. The LM confirmed on 9/20/23 at 11:00 am the laboratory failed to establish and follow CA policies. 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: 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 -- Based on surveyor review of the Procedure Manual (PM) and interview with Laboratory Manager (LM), the laboratory failed to follow the procedure for "Quality Assurance Activities" from 3/4/21 to the date of survey. The findings include: 1. The PM states " On-going monitoring and evaluation of test results and report retrieval system is achieved through periodic in-house audits." 2. There was no documented evidence any in-house audits were performed. 2. The LM confirmed on 9/20/23 at 10: 45 am the laboratory failed to follow the above mentioned procedure. 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; This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual, Competency Assessment (CA) records and interview with the Laboratory Manager (LM), the Laboratory Director (LD) failed to establish a CA policy with all the required elements to ensure TP are competent to perform tests from 3/4/21 to the date of the survey. The findings include: 1. The LD failed to have a written policy stating how Testing Personnel (TP) are assessed for competency. 2. The LD failed to establish a written policy for semiannual competency assessment of TP during the first year of employment after the initial training is completed. Cross refer D5209. 3. The LM confirmed on 9/20/23 at 12:30 pm a CA policy was not adequately established. -- 2 of 2 --