Summary:
Summary Statement of Deficiencies D0000 Based on an on-site initial survey conducted on 10/4/18, deficiencies were cited for St Peters Health in Helena, MT. 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 record review and interview, the laboratory failed to enroll in proficiency testing for serum human chorionic gonadotropin (shCG) from 5/23/18 to 10/4/18. The findings include: 1. A review on 10/4/18 at 10:00 a.m. of the College of American Pathologists (CAP) proficiency testing binders lacked proficiency testing documentation for shCG. 2. On 10/4/18 at 10:45 a.m., staff member A stated shCG did not have proficiency testing. 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 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 -- 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 observation, record review, and interview, the laboratory failed to include site specific risks for one of two locations in one of one Individual Quality Control Plan (IQCP) reviewed for the BD Affirm analyzer. The findings include: 1. On 10/4 /18 at 8:30 a.m., a BD Affirm analyzer was observed in the laboratory. 2. A review on 10/4/18 at 11:20 a.m. of the paper BD Affirm log documented controls performed per lot number. 3. On 10/4/18 at 11:20 a.m., staff member B stated the personnel at an affiliated facility wrote the IQCP for both locations. 4. A review on 10/4/18 at 1:30 p. m. of the IQCP-BD Affirm VPIII Microbial Identification Test for St. Peters Health Microbiology Department and St. Peter's North Medical Laboratory lacked information for individual risks at the North Medical Laboratory. -- 2 of 2 --