Valley Hospital Fertility Center, The

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 review of PT records and interview with the Laboratory Director, General Supervisor, and phone-in interview with the General Supervisor during the time of alleged interlaboratory communication in April 2017, the laboratory failed to prevent in engaging in an inter-laboratory communication with GYN-Endocrinology laboratory (CLIA# 07D1043038) for the CAP K-A 2017 Ligand Assay General Survey module. Refer to D2011. D2011 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(3) Laboratories that perform tests on proficiency testing samples must not engage in any inter-laboratory communications pertaining to the results of proficiency testing sample (s) until after the date by which the laboratory must report proficiency testing results to the program for the testing event in which the samples were sent. Laboratories with multiple testing sites or separate locations must not participate in any communications or discussions across sites/locations concerning proficiency testing sample results Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- until after the date by which the laboratory must report proficiency testing results to the program. This STANDARD is not met as evidenced by: Based on review of Proficiency Testing records of CAP K-A 2017 Ligand Assay, General Survey Module, email communications, Immulite instrument printouts, and interview with the Laboratory Director, General Supervisor, and phone conversation with a laboratory personnel who was the General supervisor at the time of the alleged inter-laboratory communication, the laboratory failed to prevent in engaging in inter- laboratory communication with GYN Endocrinology laboratory (CLIA # 07D1043038) prior to the official Proficiency testing results submission on May 2, 2017. The findings included: 1. On June 6, 2019, NYRO ( New York Regional Office) Laboratory Consultants received survey records of CT (Connecticut) surveyors that conducted a complaint survey at GYN Endocrinology (GYN Endo-CT) lab, based on a anonymous complaint that an alleged inter-laboratory communication occurred between GYN Endo-CT lab and Valley Hospital Fertility Clinic (VHFC-NJ) laboratory in New Jersey for the testing of CAP ( College of American Pathologists) K-A 2017 Ligand Assay- General Survey module. The CT survey records indicated both laboratories were enrolled in the same PT program and module for serum HCG (Human Chorionic Gonadotropin) and TSH (thyroid stimulating hormone) analytes. PT sample numbers were K-1 through K-5. 2. The CT survey records indicated GYN Endo lab received its own PT samples on 4/11/2017 and tested the samples and reported the results on 4/15/2017 to CAP. 3. On July 2, 2019 NYRO Laboratory Consultant interviewed the Laboratory Director of VHFC-NJ laboratory starting at around 10:30 AM until 12:00 pm, at which time she admitted transporting the five (5) PT samples of GYN Endo-CT lab to VHFC-NJ lab in her attempt to assist GYN Endo- CT laboratory in resolving an alleged tampering of the PT samples and or possibly the Roche Cobas instrument, thus submitting possible erroneous PT results to CAP by GYN-Endo--CT. She stated she transported the CT PT samples on 4/26/2017 and handed them to a testing personnel for testing in the Immulite instrument. 4. On July 1 and 2, 2019, the General Supervisor provided documentation pertaining to K-A 2017 Ligand Assay for General Survey module. Documents showed the laboratory received its own PT samples on 4/11/2017. Immulite instrument printout showed testing of PT samples on 4/19/2017, and CAP record showed electronic submission on May 2, 2017, the same day of official deadline for PT results submission. 5. On July 2, 2019, the General Supervisor provided Immulite instrument printouts for testing dates from 4 /10/2017 through 5/3/2017. The printout showed GYN Endo-CT PT samples testing on 4/26/2017 at approximately 12:17 through 12:19 pm. The HCG test results were: K-1= 4.95; K-2= 27.2; K-3= 2232; K-4= 675; K-5: 1456. The NYRO laboratory consultants did not find test results of TSH in the Immulite instrument printout. These HCG values did not appear in the tabulated columns that was included in the email communication mentioned at an email dated 4/25/2017. 6. The Laboratory Director stated during the interview that she acted as the "unofficial" interim laboratory director of GYN Endo-CT lab in the absence of its own laboratory director, who was on medical leave. She presented documentation of email communication between her and the laboratory director of GYN Endo-CT lab discussing and comparing PT results of both laboratories. The email communications showed tabulated PT results of various testing/submission dates and laboratory location. Specifically, an email communication dated 4/25/2017 at 1:47 pm from LD of VHFC-NJ to the LD of GYN Endo-CT indicated the former LD created a tabulated test results for the following PT sample # K-1 through K-5 HCG, K-1 through K-5 TSH. Column for 4/15/2017. Hand written note: Yale Column for 4/18/17. Handwritten note: Yale Column for 4/25/17 -- 2 of 3 -- indicated. Handwritten note: Yale Column for 4/20/ 2017 indicated "Immulite offsite." Handwritten note: Valley samples run at Valley. 6. During the interview, both LD and General Supervisor corrected the actual date of testing of PT samples on 4/19/2017, as shown in the Immulite printout, rather than the 4/20/2017 date in the column mentioned in the 4/25/2017 email communication. 6. On July 2, 2019, at around 11 am, a NYRO Laboratory Consultant interviewed, via phone, the laboratory personnel who was the General Supervisor at the time of alleged PT interlaboratory communication. The General Supervisor stated she was on leave when the testing of CT PT samples was done, but she was the one that electronically submitted the VHFC- NJ PT results to CAP on May 2, 2017. 7. The NYRO Laboratory Consultants reviewed the Proficiency Testing Protocol and Procedure of Valley Health Care System to which the Valley Health Fertility Clinic laboratory belongs to. The Procedure Guidelines specifically stated, "Inter laboratory communication is prohibited." D6076 LABORATORY DIRECTOR CFR(s): 493.1441 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 interview with the laboratory director, general supervisor, and phone-in interview with a laboratory personnel at the time of alleged PT inter-laboratory communication, review of proficiency testing records and instrument printouts, the laboratory director failed to provide direction in preventing inter-laboratory communication with GYN Endocrinology laboratory (CLIA # 07D1043038) of Proficiency testing results of K-A 2017 Ligand Assay, General Survey module. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on interview with the laboratory director, general supervisor, and phone-in conversation with a laboratory personnel who was the General Supervisor at the time of alleged interlaboratory PT communication, review of Proficiency testing records, Immulite instrument printouts and email communications, the laboratory director failed to prevent in engaging inter-laboratory communication with GYN- Endocrinology Laboratory (07D1043038) about proficiency testing results of CAP K- A 2017 Ligand Assay, General Survey module. Refer to D2011. -- 3 of 3 --