Westside Surgical Hospital, Llc

Summary Statement of Deficiencies D0000 The laboratory was found out of compliance with the CLIA regulations. The conditions not met were: D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director; D6033 - 42 C.F.R. 493.1409 Condition: Laboratories performing moderate complexity testing; technical consultant; D6056 - 42 C.F.R. 493.1415 Condition: Laboratories performing moderate complexity testing; clinical consultant; Noted deficiencies and plans of correction were discussed with the laboratory representative at the exit conference. The facility representatives were given an opportunity to provide evidence of compliance with noted deficiencies and no such evidence was provided prior to survey exit. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: A. Based on review of manufacturer's instructions for the Eurotrol Glucotrol-AQ quality control material, surveyor observation of control material currently in use, review of the laboratory's quality control records, and staff interview, it was revealed the laboratory performed quality control testing utilizing expired quality control material. The findings were: 1. A review of the manufacturer's instructions for the Eurotrol Glucotrol-AQ quality control material (AN01326) under the section titled "Storage and stability" revealed: "After opening the vial, Glucotrol-AQ is stable for 1 month when properly closed and stored at 2 - 30C." 2. Surveyor observation of control material currently in use in the laboratory on 11/27/2018 at 1130 hours revealed the following: a) Glucotrol-AQ Low control lot: 74737 opened: 09/12/18 b) Glucotrol-AQ High control lot: 74739 opened: 09/12/18 Thus the control material had Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- been expired since 10/12/2018 3. A review of the laboratory quality control records from November 2018 revealed the expired control material was used on the following 21 days: 11/1 11/2 11/5 11/8 11/9 11/10 11/11 11/12 11/13 11/14 11/15 11/16 11/17 11/18 11/19 11/20 11/21 11/22 11/23 11/24 11/25 11/26 11/27 - 1st run 11/27 - 2nd run 4. An interview with testing personnel number 1 (as listed on Form CMS 209) on 11/27/2018 at 1130 hours in the laboratory - after her review of the records - confirmed the findings. 25846 B. Based on review of the manufacturer's instructions for the Consult hCG Combo Cassette Test; BD Vacutainer tubes, surveyor observation of stored test kits and supplies, and staff interview, it was revealed the hospital failed to follow the manufacturer's instructions for ensuring the proper storage temperature of test kits and supplies tn the emergency room area. The findings were: 1. A review of the manufacturer's instructions for the Consult hCG Combo Cassette Test revealed the manufacturer required the test kits to be stored in an environment where the temperature was 2 - 30C. 2. A review of the manufacturer's instructions for the BD Vacutainer tubes revealed the manufacturer required the test kits to be stored in an environment where the temperature was 4 - 25C. 2. Surveyor observation of test kits and supplies stored in the Emergency Room area on 11/27 /2018 at 0935 hours revealed the following kits and supplies were stored: 1 box Consult hCG Combo Cassette Test BD Vacutainer SST (ref 367988) BD Vacutainer K2EDTA Tubes (ref 367856) There was not documentation of the temperature of the room being monitored to ensure the temperature stayed within the manufacturer's requirements. 3. In an interview of the Administrator/CNO on 11/27/2018 at 0937 hours, she stated that the room was electronically monitored. The Administrator/CNO was asked to provide documentation of monitoring the temperature where the products were stored. 4. An interview with the Administrator/CNO on 11/27/2018 at 1009 hours revealed the hospital did not electronically monitor the temperature of the emergency room. This confirmed the findings. C. Based on observation of laboratory supplies available for use at the facility at the time of the survey and interview of facility personnel it was revealed that the hospital failed to ensure that expired supplies were not available for use in the emergency room area. Findings were: 1. Observation of the laboratory supplies available for use at the time of the survey on 09 /06/2013 revealed the following supplies were expired: 20 tubes BD Vacutainer K2EDTA Tubes (ref 367856) expired 2018-10-31 3 swabs Coplan Transystem (lot 1080c) expired 2018/10 2. An interview of the Administrator/CNO on 11/27/2018 at 0935 hours in the emergency room and after the facility representative's own observation of the supplies the above findings were confirmed. Key hCG - human chorionic gonadotropin BD- Becton, Dickinson and Company D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the laboratory's American Proficiency Institute's proficiency testing records from 2017 and 2018, and staff interview, it was revealed the laboratory failed to have documentation of the laboratory director signing 3 of 11 attestation statements and testing personnel signing 3 of 10 attestation statements. The findings were: 1. A review of the laboratory's American Proficiency Institute's proficiency testing records from 2017 (hematology events 1, 2, and 3, and chemistry events 1, 2, -- 2 of 11 -- and 3) and 2018 (hematology events 1 and 2, and chemistry events 1, 2 and 3) revealed the following missing signatures: a) Laboratory director 2018 Chemistry event 2 2018 Chemistry event 3 2018 Hematology event 2 b) Testing personnel 2018 Chemistry event 3 2018 Hematology event 1 2018 Hematology event 2 2. The laboratory was asked to provide documentation of the missing signatures on attestation statements. No documentation was provided. 3. An interview with testing personnel number 1 (as listed on Form CMS 209) on 11/27/2018 at 1135 hours in the laboratory - after her review of the records - confirmed the findings. NOTE: THIS IS A REPEAT DEFICIENCY FROM THE SURVEY CONDUCTED 04/12/2017 D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's American Proficiency Institute's proficiency testing results from 2017 and 2018, and staff interview, it was revealed the laboratory failed to have documentation of the review of results for 3 of 11 events. The findings were: 1. A review of the laboratory's American Proficiency Institute's proficiency testing results from 2017 (hematology events 1, 2, and 3, and chemistry events 1, 2, and 3) and 2018 (hematology events 1 and 2, and chemistry events 1, 2 and 3) revealed the following were missing documentation of review: 2018 Chemistry Event 2 2018 Chemistry Event 3 2018 Hematology Event 2 2. The laboratory was asked to provide documentation of the review of the identified results. No documentation was provided. 3. An interview with testing personnel number 4 (as listed on Form CMS 209) on 11/27/2018 at 1135 hours - after her review of the records- confirmed the findings. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on a review of the laboratory's procedure manuals and staff interview, it was revealed that the Quality Monitoring Plan (PI. 005) and Quality Assurance Indicators (PI.006) procedures were not approved, signed and dated by the new laboratory director. The findings were: 1 A review of the laboratory procedure manuals revealed they were not approved, signed and dated by the current laboratory director. The procedures without documentation of laboratory director review and approval were: a) Quality Monitoring Plan (PI. 005) (signed by previous laboratory director on 1-04-17) b) Quality Assurance Indicators (PI.006) (signed by previous laboratory director on 1- 04-17) 2. An interview with the primary testing person on 11/27/218 at 1335 hours in the laboratory she revealed the new laboratory director started on 10/05/218 but did not sign the quality assurance procedures. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 -- 3 of 11 -- The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a review of the CMS-209 Laboratory Personnel Report, CMS-116, laboratory records and confirmed in interview the laboratory failed to employ personnel to provide overall management and direction of the laboratory that met the qualifications of laboratory director for the moderate complexity tests performed from 09/05/2018 to the date of the survey 11/27/2018. (refer to D6003) This is a repeat deficiency from the survey conducted on 04/12/2017. Key: CMS- Centers for Medicare & Medicaid Services D6003 LABORATORY DIRECTOR QUALIFICATIONS CFR(s): 493.1405 AND 493.1406 The laboratory director must be qualified to manage and direct the laboratory personnel and the performance of moderate complexity tests and must be eligible to be an operator of a laboratory within the requirements of subpart R of this part. (a) The laboratory director must possess a current license as a laboratory director issued by the State in which the laboratory is located, if such licensing is required; and (b) The laboratory director must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the Laboratory is located; and (b)(2)(ii) Have had laboratory training or experience consisting of: (b)(2)(ii)(A) At least one year directing or supervising non- waived laboratory testing; or (b)(2)(ii)(B) Beginning September 1, 1993, have at least 20 continuing medical education credit hours in laboratory practice commensurate with the director responsibilities defined in 493.1407; or (b)(2)(ii)(C) Laboratory training equivalent to paragraph (b)(2)(ii)(B) of this section obtained during medical residency. (For example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine); or (b)(3) Hold an earned doctoral degree in a chemical, physical, biological, or clinical laboratory science from an accredited institution; and (b)(3)(i) Be certified by the American Board of Medical Microbiology, the American Board of Clinical Chemistry, the American Board of Bioanalysis, or the American Board of Medical Laboratory Immunology; or (b)(3)(ii) Have had at least one year experience directing or supervising non-waived laboratory testing; (b)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; (b)(4)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing; and (b)(4)(iii) In addition, have at least one year of supervisory laboratory experience in non-waived testing; or (b)(5)(i) Have earned a bachelor's degree in a chemical, physical, or biological science or medical technology from an accredited institution; (b)(5)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing; and (b)(5)(iii) In addition, have at least 2 years of supervisory laboratory experience in non-waived testing; (b)(6) Be serving as a laboratory director and must have previously qualified or could have -- 4 of 11 -- qualified as a laboratory director under 493.1406; or (b)(7) On or before February 28, 1992, qualified under State law to direct a laboratory in the State in which the laboratory is located. Laboratory director qualifications on or before February 28, 1992 The laboratory director must be qualified to manage and direct the laboratory personnel and test performance. (a) The laboratory director must possess a current license as a laboratory director issued by the State, if such licensing exists; and (b) The laboratory director must: (b)(1) Be a physician certified in anatomical or clinical pathology (or both) by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; (b)(2) Be a physician who: (b)(2)(i) Is certified by the American Board of Pathology or the American Osteopathic Board of Pathology in at least one of the laboratory specialties; or (b)(2)(ii) Is certified by the American Board of Medical Microbiology, the American Board of Clinical Chemistry, the American Board of Bioanalysis, or other national accrediting board in one of the laboratory specialties; or (b)(2)(iii) Is certified by the American Society of Cytology to practice cytopathology or possesses qualifications that are equivalent to those required for such certification; or (b)(2)(iv) Subsequent to graduation, has had 4 or more years of full-time general laboratory training and experience of which at least 2 years were spent acquiring proficiency in one of the laboratory specialties; (b)(3) For the subspecialty of oral pathology only, be certified by the American Board of Oral Pathology, American Board of Pathology or the American Osteopathic Board of Pathology or possesses qualifications that are equivalent to those required for certification; (b)(4) Hold an earned doctoral degree from an accredited institution with a chemical, physical, or biological science as a major subject and (b)(4)(i) Is certified by the American Board of Medical Microbiology, the American Board of Clinical Chemistry, the American Board of Bioanalysis, or other national accrediting board acceptable to HHS in one of the laboratory specialties; or (b)(4)(ii) Subsequent to graduation, has had 4 or more years of full-time general laboratory training and experience of which at least 2 years were spent acquiring proficiency in one of the laboratory specialties; (b)(5) With respect to individuals first qualifying before July 1, 1971, have been responsible for the direction of a laboratory for 12 months between July 1, 1961, and January 1, 1968, and, in addition, either: (b)(5)(i) Was a physician and subsequent to graduation had at least 4 years of pertinent full-time laboratory experience; (b)(5)(ii) Held a master's degree from an accredited institution with a chemical, physical, or biological science as a major subject and subsequent to graduation had at least 4 years of pertinent full- time laboratory experience; (b)(5)(iii) Held a bachelor's degree from an accredited institution with a chemical, physical, or biological science as a major subject and subsequent to graduation had at least 6 years of pertinent full-time laboratory experience; or (b)(5)(iv) Achieved a satisfactory grade through an examination conducted by or under the sponsorship of the U.S. Public Health Service on or before July 1, 1970; or (b)(6) Qualify under State law to direct the laboratory in the State in which the laboratory is located. Note: The January 1, 1968 date for meeting the 12 months' laboratory direction requirement in paragraph (b)(5) of this section may be extended 1 year for each year of full-time laboratory experience obtained before January 1, 1958 required by State law for a laboratory director license. An exception to the July 1, 1971 qualifying date in paragraph (b)(5) of this section was made provided that the individual requested qualification approval by October 21, 1975 and had been employed in a laboratory for at least 3 years of the 5 years preceding the date of submission of his qualifications. This STANDARD is not met as evidenced by: Based on a review of the CMS-209 Laboratory Personnel Report, laboratory records -- 5 of 11 -- and confirmed in interview the laboratory failed to employ personnel to provide overall management and direction of the laboratory that met the qualifications of laboratory director for the moderate complexity tests performed from 09/05/2018 to the date of the survey 11/27/2018. Findings were: 1. A review of the CMS-209 Laboratory Personnel Report dated 11/27/2018 and signed by the current laboratory director on 11/28/2018 revealed the laboratory director held the position effective 10 /05/2018. The former laboratory director end date was 9/04/2018. There was no documentation of a laboratory director for the time period of 9/05/2018 to 10/04/2018. 2. In an interview of the Administrator/CNO on 11/27/2018 at 1300 hours in the laboratory she confirmed the above findings. She stated there were financial issues. 3. A review of the records submitted for laboratory director (effective 10/05/2018) revealed no documentation he met the education requirements for moderate complexity testing. The only documentation submitted was a contract and Curriculum Vitae. No supporting documentation was available for review. 4. In an email sent by the state agency on 10/24/2018 at 1529 hours to the Administrator/CNO "Please send your LD board certification documents and fill out the attached form [Qualification Appraisal form] (include credentials) for your histology technical supervisor." 5. In an email sent by the Administrator/CNO on 11/20/2018 at 0936 am she stated that he was a "certified CAP lab director. I am awaiting his a copy of his certificate, then will forward to you." 6. In an interview of the Administrator/CNO on 11/27/2018 at 1300 hours in the laboratory she confirmed that the only credentials submitted were a Curriculum Vitae. She stated she had asked for documentation of education, but had not received anything. 7. A review of patient logs from 09/05/2018 to 11/27/2018 revealed the facility had performed 112 moderate complexity chemistry and hematology tests during the time period they had no technical consultant. Please refer to patient alias list. This is a repeat deficiency from the survey conducted on 04/12 /2017. Key: CMS- Centers for Medicare & Medicaid Services 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