Summary:
Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on lack of proficiency testing (PT) records and interview with the laboratory director (LD), the laboratory failed to enroll in an approved PT program for the bacteriology, mycology, and parasitology sub-specialties. FINDINGS: 1.The laboratory failed to implement bacteriology, mycology, and parasitology PT after initiating patient testing on January 1, 2021. It was noted that the laboratory performed Chlamydia Trichromatic (CT), Neisseria Gonorrhea (GC), and Trichomoniasis Vaginalis (TV) on the Beckman Dickinson (BD) Max analyzer. 2. The LD confirmed the findings on February 28, 2024, at approximately 10:00 A.M. Refer to D6015. D2003 ENROLLMENT CFR(s): 493.801(a)(2)(ii) For those tests performed by the laboratory that are not included in subpart I of this part, a laboratory must establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1) 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 -- This STANDARD is not met as evidenced by: Based on review of potassium hydroxide (KOH) and wet mount test records as well as interview with the LD, the laboratory failed to perform twice-year verification for KOH and wet mount slides. FINDINGS: 1. There was no documentation verifying KOH and wet mount slide interpretation accuracy for the three Provider Performed Microscopy (PPMP) providers during calendar years 2021, 2022, and 2023. 2. Approximately 1800 patients were tested by KOH, wet mount slides and results reported for calendar years 2021, 2022, and 2023. 3. The LD confirmed the findings on February 28, 2024, at approximately 10:30 A.M. Refer to D5217. 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 testing person (TP) six-month and annual competency evaluation records, lack of training documentation, lack of competency evaluation policy, as well as interview with LD, the LD failed to draft, approve a competency evaluation policy as well as perform, document TP training, six-month, and annual competency evaluations. FINDINGS: 1.The LD failed to draft, approve a competency evaluation policy including the following guidelines: a. Direct observations of routine patient test performance, specimen preparation, processing and testing; b. Monitoring the recording and reporting of test results; c. Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records; d. Direct observations of instrument maintenance performance and function checks; e. Assessment of patient test performance through testing previously analyzed specimens, internal blind testing samples, or external proficiency testing samples; f. Assessment of problem solving skills. 2. There was no documentation of TP training, six-month, and annual competency evaluation from January 2021 hire through date of survey. 3. The LD confirmed the findings on February 28, 2024, at 11:30 A.M. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on lack of 2021, 2022, and 2023 calendar year records as well as interview with the LD, the laboratory failed to perform twice-year verification for KOH and wet mount slides for the three providers who performed PPMP testing. Refer to D2003. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an -- 2 of 5 -- ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on lack of Quality Assessment (QA) policy and interview with the LD, the laboratory failed to draft, approve a QA policy. FINDINGS: 1. The current, approved Gramercy Gynecology, PC standard operating procedures (SOPs) did not include a QA policy. 2. The LD confirmed the findings on February 28, 2024, at approximately 11:30 A.M. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)