Prevea Altoona Mob

Summary Statement of Deficiencies D6175 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1495(b)(1) Each individual performing high complexity testing must follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory procedures, laboratory records and patient chart, and interview with the general supervisor, testing personnel did not follow the procedure to document critical value reporting. Findings include: 1. Review of the "Critical Value Reporting" procedure stated "any critical value that is not directed communicated to the ordering provider must also have a "critical value read back" documented into Epic". Further review stated "If the provider is not at the clinic the result must be called to the provider. A "critical value read back" must be documented." 2. Review of the critical value report log showed patient 1 had three critical values called on October 17, 2021 to the cancer center nurse, not the provider, and documentation of the critical value read back was not documented on the log. 3. Review of the patient chart in Epic showed no documentation of critical value reporting and read back value for patient 1 on October 17, 2021. 4. Interview with the general supervisor on March 15, 2022 at 12:50 PM confirmed testing personnel did not follow the procedure to document critical value reporting. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

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 surveyor review of laboratory records and proficiency testing (PT) registration, and interview with the technical consultant, the laboratory had not enrolled in a PT program for serum pregnancy testing. Findings include: 1. Review of laboratory worksheets and test list showed the laboratory performed serum pregnancy testing. 2. Review of PT registration records for the laboratory showed the laboratory did not enroll in a PT program for serum pregnancy testing. 3. Interview with the technical consultant on September 6, 2018 at 11:15 AM confirmed the laboratory had not enrolled in a PT program for serum pregnancy testing as required in subpart I. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. 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 -- This STANDARD is not met as evidenced by: Based on surveyor review of laboratory procedures and worksheets, and interview with the technical consultant, the laboratory has not tested negative and positive control materials each day of patient serum hCG (Human chorionic gonadotropin) testing. Findings include: 1. Review of laboratory procedures showed the laboratory requires testing of two levels of quality control material each day of patient serum hCG testing. 2. Review of the Quidel QuickVue hCG worksheet for June 2018 showed controls were tested on June 1, 2018 and a patient sample was tested on June 6, 2018. The worksheet shows controls were not tested on June 6, 2018. 3. Interview with the technical consultant on September 6, 2018 at 11:15 AM confirmed the patient sample tested on June 6, 2018 was a serum sample and also confirmed controls were not tested that day. Further interview confirmed an Individualized Quality Control Plan had not been developed for serum hCG testing. -- 2 of 2 --