Pathology Consultants, Pc Physician Office Lab

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 laboratory records and interviews it was determined that Facility B (CLIA 35D2002387) failed to enroll in an approved cytology proficiency testing (PT) program for gynecologic examination (refer to D2001); failed to meet the specified requirements for testing of samples for the gynecologic cytology PT program by engaging in inter-laboratory communications with Facility A (CLIA 35D0408903) prior to the date the proficiency testing results were reported to the program (refer to D2011); failed to examine cytology PT samples (slides) received from the PT program as required by the PT provider; and failed to meet the specified requirements in accordance with 493.801(b)(4) including the failure to notify CMS of the receipt of PT samples (slides) from another laboratory (refer to D2013). The cumulative effect of this systemic problem resulted in the laboratory's failure to meet certification requirements to accurately and reliably evaluate patients' gynecologic cytology specimen slides for 2017 and 2018. D2001 ENROLLMENT CFR(s): 493.801(a)(1)(2)(i) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 16 -- The laboratory must-- (1) Notify HHS of the approved program or programs in which it chooses to participate to meet proficiency testing requirements of this subpart. (2)(i) Designate the program(s) to be used for each specialty, subspecialty, and analyte or test to determine compliance with this subpart if the laboratory participates in more than one proficiency testing program approved by CMS; This STANDARD is not met as evidenced by: Based on the lack of cytology PT enrollment records and interview it was determined that Facility B failed to enroll in an approved cytology PT program for 2017 and 2018. Findings include: 1. The Survey Team requested and Facility B failed to provide records of enrollment in an approved cytology PT program for 2017 and 2018. 2. During an interview on October 21, 2019 at 10:00 AM, the Laboratory Director/Technical Supervisor A stated that Facility B was not enrolled in an approved cytology PT program for 2017 and 2018. 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 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 interviews and review of PT records it was determined that Facility B failed to meet the specified requirements for testing of samples for the gynecologic cytology PT program by engaging in inter-laboratory communications with Facility A prior to the date the proficiency testing results were reported to the program in 2017 and 2018. Findings include: 1. During an interview on October 21, 2019 at 10:00 AM, the Laboratory Director/Technical Supervisor A stated that there were two laboratories under the pathology group that performed gynecologic cytology testing and that each facility had a separate cytology CLIA certificate. The Laboratory Director/Technical Supervisor A further stated: a. Facility A was the main laboratory where cytology specimens were accessioned, processed and screened by Cytotechnologists. Cases requiring technical supervisory review were sent to Facility B. b. The PT samples (slides) were received at Facility A. c. Staff B (located at Facility A) was the proctor and administered the PT test to the Cytotechnologists at Facility A, submitted the test result forms and cleaned the slides. d. The PT samples (slides) were referred from Facility A to Facility B for testing. e. A Cytotechnologist from Facility A went to Facility B to screen and dot the slides for the Technical Supervisors at Facility B. f. Staff B administered the PT test to the Technical Supervisors and submitted the test results. 2. During an interview on October 22, 2019 at 3:00 PM, Technical Supervisor D stated that Facility A and Facility B had "always done it (PT testing) that way." 3. During an interview on October 22, 2019 at 3:15 PM, Technical Supervisor E stated "thought we could take the PT like we do the rest of gyn testing." 4. During an interview on October 23, 2019 at 8:45 AM, Staff B stated that Staff B administered the PT test to the Cytotechnologists at Facility A and submitted the test results. Staff -- 2 of 16 -- B then transported the PT samples (slides) to Facility B and administered the test to the Technical Supervisors. 5. The Survey Team reviewed PT testing records from 2017 for six Technical Supervisors that took the PT test event at Facility B. The PT testing records stated the CLIA number was for Facility A. a. Three of six Technical Supervisors tested on slideset #34426. Technical Supervisors include: - Technical Supervisor A - Technical Supervisor C - Technical Supervisor E b. Three of six Technical Supervisors tested on slideset #34423. Technical Supervisors include: - Technical Supervisor B - Technical Supervisor D - Technical Supervisor F 6. The Survey Team reviewed PT testing records from 2018 for five Technical Supervisors that took the PT test event at Facility B. The PT testing records stated the CLIA number was for Facility A. a. Three of five Technical Supervisors tested on slideset #33989. Technical Supervisors include: - Technical Supervisor A - Technical Supervisor C - Technical Supervisor D b. Two of five Technical Supervisors tested on slideset #34006. Technical Supervisors include: - Technical Supervisor B - Technical Supervisor E 7. During an interview on October 23, 2019 at 9:50 AM, the Laboratory Director/Technical Supervisor A confirmed Facility B received PT samples (slides) improperly referred from Facility A for testing and Facility B failed to notify CMS that gynecologic cytology samples (slides) were received from another laboratory for testing. a. There was inter-laboratory communication between Facility B and Facility A during participation in gynecologic cytology PT testing. D2013 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(4) The laboratory must not send proficiency testing samples or portions of proficiency testing samples to another laboratory for any analysis for which it is certified to perform in its own laboratory. Any laboratory that CMS determines intentionally referred a proficiency testing sample to another laboratory for analysis may have its certification revoked for at least one year. If CMS determines that a proficiency testing sample was referred to another laboratory for analysis, but the requested testing was limited to reflex, distributive, or confirmatory testing that, if the sample were a patient specimen, would have been in full conformance with written, legally accurate and adequate standard operating procedures for the laboratory's testing of patient specimens, and if the proficiency testing referral is not a repeat proficiency testing referral, CMS will consider the referral to be improper and subject to alternative sanctions in accordance with 493.1804(c), but not intentional. Any laboratory that receives a proficiency testing sample from another laboratory for testing must notify CMS of the receipt of that sample regardless of whether the referral was made for reflex or confirmatory testing, or any other reason. This STANDARD is not met as evidenced by: Based on interviews and review of PT records it was determined that Facility B failed to meet the specified requirements for testing of samples for the gynecologic cytology PT program in 2017 and 2018, including the receipt of PT samples (slides) from another laboratory for testing. Cross refer to D2011 D5032 CYTOLOGY CFR(s): 493.1221 If the laboratory provides services in the subspecialty of Cytology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1274, and 493.1281 through 493.1299. -- 3 of 16 -- This CONDITION is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records and interviews it was determined that Facility B failed to establish written procedures for three laboratory processes (refer to D5403); failed to ensure that one of five Technical Supervisors had received the appropriate training to evaluate Hologic ThinPrep gynecologic specimens (refer to D5411); failed to establish written policies and procedures for the review of all negative gynecologic specimens received within the previous five years for each patient with a current high-grade squamous intraepithelial lesion (HSIL) or malignancy (refer to D5625); failed to establish policies and procedures for the annual evaluation and comparison of six of six laboratory statistics, and failed to document six of six required annual gynecologic statistics and two of three required annual nongynecologic statistics (refer to D5629); failed to follow written policies and procedures to ensure that Facility B would maintain records of the total number of hours spent examining slides (refer to D5645); failed to establish written policies and procedures to ensure that final gynecologic reports signed by Technical Supervisors reflected an electronic signature authorized by the Technical Supervisor (refer to D5651); failed to establish written policies and procedures to ensure that unsatisfactory gynecologic cytology slide preparations were identified and reported as unsatisfactory, and failed to identify and report one gynecologic cytology case as being "Unsatisfactory for Evaluation" (refer to D5655); and failed to maintain the dates of all testing (refer to D5787). The cumulative effect of these systemic problems resulted in the laboratory's inability to ensure the accuracy and reliability of patient test results in the subspecialty of Cytology. 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 policies and procedures and interview it was determined that Facility B failed to establish written policies and procedures to assess the competency of five of five Technical Supervisors in 2017, 2018 and to the date of the survey in 2019. Findings include: 1. The Survey Team requested and Facility B failed to provide written policies and procedures to describe the laboratory's process for assessing the diagnostic competency of five of five Technical Supervisors. Technical Supervisors include: - Technical Supervisor A - Technical Supervisor B - Technical Supervisor C - Technical Supervisor D - Technical Supervisor E 2. During an interview on October 23, 2019 at 9:50 AM, the Laboratory Director/Technical Supervisor A confirmed these findings. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. -- 4 of 16 -- This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records and interview it was determined that Facility B failed to establish written policies and procedures for an ongoing mechanism to monitor, assess and correct problems identified in the general laboratory systems. Cross refer to D5209 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)