Isbell Medical Group Pc

Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of the quality control (QC) records for the BD Affirm VPIII, and interviews with Testing Personnel #1, the laboratory failed to ensure kit lot numbers were documented with the QC results, since before the previous survey on 11/17 /2021. The findings include: 1. During the entrance tour on 5/11/2023 at approximately 9:15 AM, Testing Personnel #1 stated the only non-waived instrument was the BD Affirm VPIII, which tests for the presence of Trichomonas vaginalis, Candida species, and Gardnerella vaginalis. 2. A review of the BD Affirm VPIII QC records revealed the laboratory had implemented an IQCP (Individual Quality Control Plan) which specified external positive and negative quality controls should be performed for each new lot number of kits; Testing Personnel #1 stated she performed QC each time she opened a new box of kits. 3. A review of a BD Affirm VPIII form (not in use by the laboratory) revealed the following instructions, "Record the reactions of the BD Affirm VPIII external controls for each reagent lot # [number] tested". 4. A review of the BD Affirm VPIII QC records revealed the laboratory recorded the "DATE, LOT #, EXP [Expiration] DATE" of the external QC swabs, along with the QC reactions (Positive or Negative) each day of QC performance. However, there was no record of the BD Affirm VPIII kit lot # on which the QC was 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 -- run since before the previous survey on 11/17/2021. 5. During an interview with Testing Personnel #1 on 5/11/2023 at 11:15 AM, the surveyor reviewed the kit lot numbers currently in use including Lot # 2327952 which had been used for patient testing since April 2023. The surveyor reviewed the QC records, and asked Testing Personnel #1 when she had performed QC on BD Affirm VPIII kit Lot # 2327952; Testing Personnel #1 stated she did not know. Testing Personnel #1 stated she only recorded the lot # and expiration date from the package of the Tri-valent Positive and Negative QC swabs. No one had instructed her in the requirement of recording the kit lot # when she performed the QC. . D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on a review of the quality control (QC) records for the BD Affirm VPIII, and interviews with Testing Personnel #1, the previous and current Laboratory Directors failed to ensure the laboratory documented the kit lot numbers with the QC results, since before the previous survey on 11/17/2021. The findings include: 1. Refer to D5445. SURVEYOR ID# 32558 Licensure and Certification Surveyor -- 2 of 2 --

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 a review of the API (American Proficiency Institute) Proficiency Testing records and an interview with Testing Personnel (TP) #1, the surveyor determined the laboratory failed to retain program report forms and signed attestation statements for six of seven surveys reviewed. The findings include: 1. A review of the poorly organized 2017-2019 API Microbiology Proficiency Testing records revealed the following missing documentation or signatures for the surveys: A) 2017-Event #2: no signatures of the Laboratory Director or the testing personnel on the attestation statements (the names were written in by TP #1) B) 2017-Event #3, 2018-Event #1 and 2019-Event #1: no signatures of the Laboratory Director or the testing personnel on the attestation statements (forms were blank) C) 2018-Events #2 and #3: Missing program forms and attestation statements 2. In an interview on 6/25/2019 at 1:10 PM, the above noted findings were reviewed and confirmed with TP #1. SURVEYOR ID#32558 Licensure and Certification Surveyor 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 --