Crown Heights Medical Pc

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 a proficiency testing (PT) desk review of Center for Medicaid and Medicare Service (CMS) PT data reports, the laboratory failed to enroll in an approved PT program for the sub- specialty Bacteriology/Throat Culture for the calendar year 2020. D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) 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)(4) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on PT desk review of the CMS PT data reports, the laboratory director failed to 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 -- enroll the laboratory in an approved HHS PT program for the sub-specialty Bacteriology/throat culture in the calendar year 2020. Refer to D2000. -- 2 of 2 --

Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor's review of American Proficiency Institute (API) Proficiency Testing (PT) records, lack of documentation and confirmed in an interview with the chief operations officer , the laboratory failed to retain API records to include: signed attestation forms, test result forms, and signed PT summary reports for the 2017 3rd event and all three events for 2018. FINDINGS: 1. The chief operations officer confirmed on February 12, 2019 at approximately 12:30 PM, the laboratory failed to retain API records to include: signed attestation forms for 2017 3rd event and all three events in 2018, test result forms for 2017 3rd event and all three events in 2018, and signed PT summary reports for the 2017 3rd event and all three events in 2018. 2. Surveyor was not able to determine if the PT samples were tested by all testing personnel who perform bacteriology/throat culture testing for the 3rd event in 2017 and all three events in 2018. 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. This STANDARD is not met as evidenced by: Based on surveyor's review of the laboratory's Quality Assessment (QA) policies and 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 -- procedures, lack of documentation and confirmed in an interview with the chief operations officer, at the time of this survey, the laboratory failed to follow their established QA policy and perform a QA review for the 2018 calendar year. FINDINGS: The chief operations officer confirmed on February 12, 2019 at approximately 1:00 PM, the laboratory failed to follow their laboratory's QA policy to include an annual review of the following systems: monitoring, assessing, and, when indicated, correct problems identified in the general laboratory system. actions must be taken to correct the situation for specimen identification and integrity; personnel competency; Quality control for bacteriology and proficiency testing performance. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require